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CONSUMER PRODUCT SAFETY reduce the risk of injury associated with infant or toddler products to meet COMMISSION such products. 15 U.S.C. 2056a(b)(1)(B). consumer registration rule Additionally, section 104(b)(2) of the requirements. All durable infant or 16 CFR Parts 1112, 1130, and 1236 CPSIA directs the Commission to toddler products identified in § 1130.2 [CPSC Docket No. 2017–0020] periodically review and revise the must meet the product registration card standards set forth under this requirement; and because rules issued Safety Standard for Infant subsection, to ensure that such under section 104 of the CPSIA are Products standards provide the highest level of children’s product safety rules, these safety for such products that is feasible. products must also meet the third-party AGENCY: Consumer Product Safety Section 104(d) of the CPSIA requires testing and certification requirements in Commission. manufacturers of durable infant or section 14 of the CPSA, and ACTION: Final rule. toddler products to establish consumer implemented by the Commission in 16 registration card programs that comply SUMMARY: Pursuant to the Consumer CFR parts 1107, 1109, and 1110. with CPSC’s implementing rule, 16 CFR Product Safety Improvement Act of CPSC issued a notice of proposed part 1130. Additionally, under section 2008 (CPSIA), the U.S. Consumer rulemaking in 2017 (the 2017 NPR), 14 of the CPSA, children’s products Product Safety Commission (CPSC) is proposing to categorize infant inclined (such as durable infant or toddler issuing this final rule establishing a sleep products as a ‘‘durable infant or products) must comply with testing and safety standard for infant sleep toddler product’’ under section 104 of certification requirements that CPSC products, which are products marketed the CPSIA, as a subset of the implemented through 16 CFR parts or intended to provide a sleeping and category. 82 FR 16963, 1107, 1109, and 1110. Section 104(f)(1) accommodation for an infant up to 5 16969–70 (Apr. 7, 2017). In 2019, CPSC of the CPSIA states that a ‘‘durable months of age, and that are not subject issued a supplemental notice of infant or toddler product’’ is a ‘‘durable to any of CPSC’s mandatory standards proposed rulemaking (the 2019 SNPR), product intended for use, or that may be for infant sleep. CPSC is also finalizing proposing to identify an ‘‘infant sleep reasonably expected to be used, by an amendment to its regulations product,’’ a broader category of infant children under the age of 5 years.’’ Id. regarding third party conformity 2056a(f)(1). Section 104(f)(2) of the sleep, as a durable infant or toddler assessment bodies, to include the safety CPSIA provides a non-exhaustive list of product under section 104(f) of the standard for infant sleep products in the categories of products that are durable CPSIA, also as a subcategory of list of notices of requirements (NORs) infant or toddler products, such as cribs, and cradles. 84 FR 60949, and an amendment to the consumer toddler beds, and bassinets and cradles. 60957 (Nov. 12, 2019). The 2019 SNPR registration rule, to identify infant sleep Id. 2056a(f)(2). The Commission’s proposed to remove the term ‘‘inclined’’ products as a durable infant or toddler consumer registration rule at 16 CFR from the proposed mandatory standard, product subject to consumer registration 1130.2(a) defines a ‘‘durable infant or which included removing the term requirements, as a subcategory of toddler product’’ as: ‘‘inclined’’ from the title, scope, bassinets and cradles. introduction, and definitions of ASTM DATES: This rule is effective June 23, DEFINITION OF DURABLE INFANT OR F3118–17a, and to include within the 2022. The incorporation by reference of TODDLER PRODUCT means the following rule, instead: ‘‘any infant sleep product products intended for use, or that may be the publication listed in this rule is reasonably expected to be used, by children not currently covered by another approved by the Director of the Federal under the age of 5 years. The listed product mandatory rule for infant sleep Register as of June 23, 2022. categories are further defined in the products: Bassinets/cradles, cribs (full- FOR FURTHER INFORMATION CONTACT: applicable standards that the Commission size and non-full-size), play yards, and Keysha Walker, Compliance Officer, issues under section 104(b) of the Consumer bedside sleepers.’’ 84 FR at 60951. U.S. Consumer Product Safety Product Safety Improvement Act of 2008, and Accordingly, the 2019 SNPR proposed Commission, 4330 East-West Highway, include products that are combinations of [17 that the scope of the rule include two Bethesda, MD 20814; telephone: 301– listed] product categories.... types of sleep products that are 504–6820; email: [email protected]. B. Infant Sleep Products Are Durable currently unregulated by CPSC under SUPPLEMENTARY INFORMATION: Infant or Toddler Products any mandatory standard, including inclined sleep products, meaning infant I. Statutory Authority and Background This rule establishes a category of products called ‘‘infant sleep products,’’ sleep products with a sleep surface A. Statutory Authority which are all products marketed or angle greater than 10 degrees from Section 104(b) of the CPSIA, 15 U.S.C. intended to provide a sleeping horizontal, and flat (non-inclined) sleep 2056a(b), requires the Commission to: accommodation for an infant up to 5 products, meaning infant sleep products (1) Consult with representatives of months of age, and that are not already with a sleep surface angle equal to or consumer groups, juvenile product subject to a mandatory CPSC sleep less than 10 degrees. manufacturers, and independent child standard. The product category ‘‘infant For this final rule, CPSC will finalize product engineers and experts, to sleep products’’ is not included in the the definition of an ‘‘infant sleep examine and assess the effectiveness of statutory list of products in section product’’ as a durable infant or toddler any voluntary consumer product safety 104(f)(2) of the CPSIA. However, similar product, a category of products that is standards for durable infant or toddler sleep products, such as bassinets and a subset of the bassinet and cradle products (15 U.S.C. 2056a(b)(1)(A)); and cradles, and cribs, are listed in the standard, consistent with the 2019 (2) promulgate, in accordance with 5 statute; and the Commission has the SNPR. The final rule defines an ‘‘infant U.S.C. 553, consumer product safety authority to add product categories to sleep product’’ as ‘‘a product marketed standards that are substantially the same the statutory list. The Commission adds or intended to provide a sleeping as such voluntary standards, or are more product categories to the list of ‘‘durable accommodation for an infant up to 5 stringent than such voluntary standards infant or toddler products’’ through a months of age,’’ and that is not already if the Commission determines that more rulemaking to amend 16 CFR 1130.2, subject to one of CPSC’s mandatory stringent standards would further the Commission’s rule requiring durable standards for infant sleep:

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• 16 CFR part 1218—Safety Standard represent producers, users, consumers, and other inclined sleep for Bassinets and Cradles government, and academia.1 products, to address the characteristics • 16 CFR part 1219—Safety Standard In 2011, ASTM began work on a new of inclined products. Accordingly, the for Full-Size Baby Cribs standard for infant inclined sleep infant inclined sleep products safety products. Development of this new standard was an outgrowth of the • 16 CFR part 1220—Safety Standard ASTM standard for infant inclined sleep bassinet and cradle standard, intended for Non-Full-Size Baby Cribs products, F3118, arose from efforts to to address products with an incline • 16 CFR part 1221—Safety Standard update the voluntary standard for greater than 10 degrees from horizontal. for Play Yards, or bassinets and cradles. Accordingly, In approximately 2011, at the time • 16 CFR part 1222—Safety Standard staff’s consultation process for the CPSC separated infant inclined sleep inclined sleep product rulemaking products from the bassinets and cradles for Bedside Sleepers. commenced in approximately 2011, standard, ASTM simultaneously began As defined in the final rule, an ‘‘infant when ASTM, with CPSC’s concurrence, work on developing a voluntary sleep product’’ meets the definition of a decided to separate hammocks and standard for infant inclined sleep ‘‘durable infant or toddler product’’ other inclined sleep products from the products. ASTM published the resulting because the products are intended for development of the bassinet standard, infant inclined sleep products standard infants up to 5 months old, and the ASTM F2194, to develop a new in May 2015, and updated the standard products are ‘‘intended for use,’’ and voluntary standard that would twice in 2016, and twice in 2017. ‘‘reasonably expected to be used,’’ by specifically address the characteristics ASTM’s latest standard for this product children under 5 years old. Moreover, of inclined sleep products. For example, category is designated, ASTM F3118– products marketed or intended as a the bassinet standard requires a sleep 17a, Standard Consumer Safety sleeping accommodation for an infant surface angle of 10 degrees or less, and Specification for Infant Inclined Sleep are similar to the products for infant inclined products have a sleep angle Products (ASTM F3118–17a). sleep that are already included in the greater than 10 degrees. Since then, staff CPSC’s 2017 NPR proposed a statutory list of durable infant or toddler has been actively participating in mandatory standard for infant inclined products, such as cribs and bassinets developing the voluntary standard for sleep products, incorporating by and cradles. We also note that ‘‘infant infant inclined sleep products. reference the then-current voluntary sleep products’’ are further defined in In addition to working on ASTM’s standard, ASTM F3118–17, with a the final rule, as provided in part 1130. inclined sleep standard, staff also has modification to the standard’s definition Accordingly, adding ‘‘infant sleep been working with the ASTM of ‘‘accessory.’’ 82 FR 16964 (April 7, products’’ as a durable infant or toddler subcommittee developing the bassinet 2017). The 2017 NPR for infant inclined product is consistent with the standard since before 2011, and to this sleep products, which included Commission’s approach of adding a day, continues to provide incident data hammocks, discussed 14 fatal incidents durable infant or toddler product and participate in task group and related to infant inclined sleep category that has a mandatory standard subcommittee meetings, including products, which were reported to have to the list of products in part 1130, to meetings and ASTM ballots involving occurred between January 1, 2005 and clarify that these products must meet the currently unregulated flat sleep September 30, 2016. The 2017 NPR the consumer registration rule, and the products within the scope of this final indicated that ASTM F3118–17 third-party testing and certification rule. addressed the primary hazard patterns requirements for children’s product Sections V.A.3 and V.B.2 of this CPSC identified in the 657 incidents safety rules. preamble contain additional (including 14 deaths), except for the information about CPSC staff’s work on definition of ‘‘accessory,’’ which was C. Consultation Regarding the the products within the scope of the defined too narrowly to address Effectiveness of the Voluntary Standard final rule, both inclined and flat sleep potential hazards. Specifically, the 2017 products, through the ASTM standards NPR proposed that CPSC’s standard To meet the first requirement in would not include the term ‘‘rigid section 104(b) of the CPSIA that the development process for the bassinet and cradle standard, the infant inclined frame’’ in the definition of ‘‘accessory Commission consult with inclined sleep product’’ in section 3.1.1 representatives of consumer groups, sleep standard, and a new, unpublished standard for in- sleepers. of ASTM F3118–17, broadening the juvenile product manufacturers, and definition to encompass a new product independent child product engineers D. 2017 NPR and 2019 Termination that did not have a rigid frame. Id. at and experts to examine and assess the Notice 16968–69, and 16975. The Commission effectiveness of the relevant voluntary When staff began working on the concluded that for the mandatory standards, CPSC staff regularly mandatory standard for bassinets and standard, more stringent requirements participates in the juvenile products cradles, and participating with the were necessary to further reduce the risk subcommittee meetings of ASTM ASTM standards development of injury associated with infant inclined International (ASTM). Staff’s subcommittee, staff considered whether sleep products relating to the use of an participation in ASTM’s voluntary infant hammocks and other inclined inclined sleep product accessory. Id. at standards process includes providing sleep products should fall within the 16967. anonymized incident data, participating scope of the bassinet and cradle As the 2017 NPR explained, durable in meetings to assess the ability of a standard. Because the bassinets and infant or toddler products are children’s voluntary standard to address the cradles voluntary standard did not products that must be certified as incident data, and working through the address products on the market that had complying with all applicable CPSC- ASTM process to develop performance a sleep incline greater than 10 degrees, enforced requirements. 15 U.S.C. and labeling requirements to address the Commission directed staff to initiate 2063(a); 82 FR at 16969. Certification identified hazards. Staff also comments a separate rulemaking effort for infant must be based on testing conducted by or votes on certain ASTM ballots to a CPSC-accepted third party conformity revise voluntary standards. ASTM 1 ASTM International website: www.astm.org, assessment body (test laboratory). 15 subcommittees consist of members who ‘‘About ASTM International.’’ U.S.C. 2063(a)(2). CPSC must publish an

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NOR for the accreditation of test The Commission published an SNPR • 16 CFR part 1222—Safety Standard laboratories to assess a product’s on November 12, 2019. 84 FR 60949. for Bedside Sleepers. conformity with a children’s product The 2019 SNPR proposed to issue a Products intended for sleep that already safety rule. The 2017 NPR proposed that standard for ‘‘infant sleep products,’’ conform to a CPSC sleep standard in if issued as a final rule, the new Safety meaning products that (1) provide this list are not within the scope of the Standard for Infant Inclined Sleep sleeping accommodations for infants final rule. Products, to be codified at 16 CFR part and (2) are not currently subject to a The scope of the final rule, and the 1236, would be added to the list of CPSC mandatory standard for infant definition of ‘‘infant sleep product,’’ are NORs for children’s product safety rules sleep: Bassinets/cradles, cribs (full-size purposely broader than the scope of the in 16 CFR part 1112, so that test and non-full size), play yards, and bassinet and cradle standard, and the laboratories applying for CPSC bedside sleepers (collectively, CPSC definition of a ‘‘bassinet/cradle,’’ to acceptance could seek accreditation to sleep standards). The 2019 SNPR capture within the scope of the final test inclined sleep products. 82 FR at proposed to incorporate by reference rule all products marketed for infant 16969. The 2017 NPR also proposed to ASTM F 3118–17a, with modifications sleep for infants up to 5 months old that amend 16 CFR part 1130, the to require that for each infant sleep are not covered by a CPSC sleep Commission’s requirements for product: (1) The seat back angle standard; those that are currently on the consumer registration for durable infant intended for sleep must be equal to or market, and any future products or toddler products, to amend the less than 10 degrees from horizontal, developed for this age group. CPSC’s definition of ‘‘durable infant or toddler and (2) must meet the requirements for intent is to set a baseline of safety for product’’ to clarify that infant inclined a bassinet and cradle in the standard at infant sleep products so that all of these sleep products fall within the term, and 16 CFR part 1218. 84 FR at 60956. The products must, at a minimum, meet the are subject to the consumer registration Commission also proposed to amend the performance and labeling requirements card requirements. Id. at 16969–70. consumer registration rule to identify in 16 CFR part 1218, including On June 12, 2019, CPSC staff ‘‘infant sleep products’’ as a category of conforming to the definition of a submitted a briefing package and a draft durable infant or toddler products under ‘‘bassinet/cradle,’’ and being tested and Federal Register notice to the section 104(f) of the CPSIA, and certified as meeting these requirements. proposed to amend the regulation at 16 Commission, recommending that the Based on the Commission’s review of CFR part 1112, to add infant sleep Commission terminate the 2017 NPR. inclined and flat sleep product incident products to the list of products that Staff recommended terminating the data, and consideration of the comments require third-party testing. Id. at 60957. 2017 NPR because, since issuing the on the 2017 NPR and the 2019 SNPR, 2017 NPR, CPSC had received reports of F. Overview of the Final Rule the Commission is finalizing the 42 additional fatalities associated with For the final rule, the Commission is requirements as proposed in the 2019 rocker-like inclined sleep products, and finalizing the requirements largely as SNPR, with the following clarifications because the Commission had issued proposed in the 2019 SNPR. The final in the: additional safety alerts and recalls rule incorporates by reference the 1. Scope of the final rule, 16 CFR involving infant inclined sleep voluntary standard, ASTM F3118–17a, 1236.1, by removing the examples of products. To date, the Commission has Standard Consumer Safety infant inclined sleep products, and not voted on the notice to terminate the Specification for Infant Inclined Sleep aligning the scope of the rule to be 2017 NPR. Products, with modifications to the consistent with the definition of ‘‘infant E. 2019 SNPR introduction, scope, performance, and sleep product,’’ to avoid confusion testing requirements, to further reduce about the scope of the rule, which On October 16, 2019, staff provided the risk of injury associated with infant includes inclined and flat products; the Commission with a briefing package sleep products, both flat and inclined. 2. Introduction of ASTM F3118–17a, recommending that instead of The final rule requires that ‘‘infant sleep by explaining more clearly that both terminating the 2017 NPR, the products,’’ defined as products inclined and flat sleep products fall Commission issue an SNPR. During the marketed or intended to provide a within the definition of an ‘‘infant sleep development of Staff’s 2019 SNPR sleeping accommodation for an infant product,’’ and that the purpose of the Briefing Package, staff received reports up to 5 months of age, and that are not rule is to reduce deaths associated with of 451 new incidents; 59 were deaths covered by a CPSC sleep standard, be known infant sleep hazards, including, that occurred in infant inclined sleep tested to confirm the seat back/sleep but not limited to, seat back or sleep products. Commission staff contracted surface angle is 10 degrees or less from surface angles that are greater than 10 with Dr. Erin Mannen, Ph.D., a horizontal, and meet the requirements degrees from horizontal; mechanical engineer with a of 16 CFR part 1218, Safety Standard for 3. Scope of ASTM F3118–17a, by biomechanics specialization, to conduct Bassinets and Cradles, including revising section 1.3 to explain more infant testing to evaluate the design of conforming to the definition of a clearly that inclined and flat products inclined sleep products. Tab B of the ‘‘bassinet/cradle.’’ The scope of the final fall within the scope of the rule, and Staff’s 2019 SNPR Briefing Package rule is also consistent with this that products subject to the rule are contains Dr. Mannen’s study, definition of an ‘‘infant sleep product.’’ infant sleep products that do not already Biomechanical Analysis of Inclined meet a mandatory standard for a 2 The final rule specifies CPSC’s sleep Sleep (Mannen Study). standards as: product intended for infant sleep. • Consistent with the 2019 SNPR, revised 2 The October 16, 2019, Staff Briefing Package: 16 CFR part 1218—Safety Standard Draft Supplemental Notice of Proposed Rulemaking for Bassinets and Cradles section 1.3 lists existing infant sleep for Infant Sleep Products under the Danny Keysar • 16 CFR part 1219—Safety Standard standards, but the final rule lists the five Child Product Safety Notification Act (Staff’s SNPR for Full-Size Baby Cribs CPSC sleep standards with a reference Briefing Package) is available at: https:// • 16 CFR part 1220—Safety Standard to the ASTM standard incorporated by www.cpsc.gov/s3fs-public/SupplementalNoticeof _ _ for Non-Full-Size Baby Cribs reference in each mandatory standard; ProposedRulemakingforInfantSleepProducts 10 • 16_2019.pdf?TPVAJZEQcz9x9sKeEGlt 16 CFR part 1221—Safety Standard 4. Scope of ASTM F3118–17a, by m4LskkonxUWv. for Play Yards, or adding a new section 1.3.2 stating that

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crib that meet the voluntary also refers to a ‘‘sleep surface angle.’’ products in the 2017 NPR, plus standard for crib mattresses, ASTM This revision is intended to reduce additional products marketed or F2933, are not included within the confusion, because flat sleep surfaces do intended to provide a sleeping scope of the rule. The final rule does not not have a seat back; and accommodation for an infant up to 5 cover a crib because a crib 10. Requirements in ASTM F3118– months of age, and that are not currently mattress is not used by itself, and 17a, by revising section 6.9.3 to remove covered by any of the five CPSC sleep instead, is used as the sleep surface in the references to accessory, compact, standards. Accordingly, as proposed in a crib, a product that already must and newborn sleep products, and to the 2019 SNPR, the final rule includes conform to a CPSC sleep standard; state that infant sleep products must the currently unregulated inclined sleep 5. Referenced documents in ASTM meet the requirements of 16 CFR part products, such as frame-type inclined F3118–17a, by revising section 2.1 to 1218, Safety Standard for Bassinets and sleep products, hammocks, compact add the voluntary standard for crib Cradles, including conforming to the inclined sleep products, and accessory mattresses, ASTM F2933; definition of a bassinet/cradle. This inclined sleep products (collectively, 6. Definition of ‘‘infant sleep product’’ revision is intended to streamline the inclined sleep products). The final rule in ASTM F3118–17a, by revising section regulation text to reduce confusion, and also includes the currently unregulated 3.1.7 to remove the phrases to add a specific requirement to meet non-inclined, flat, infant sleep products, ‘‘freestanding’’ and ‘‘generally the definition of a bassinet, which which means products with a seat back supported by a stationary or rocker clarifies that infant sleep products must or sleep surface angle that is already 10 base’’ from the definition, to not have a stand to meet the performance degrees or less from horizontal (i.e., inadvertently exclude certain infant and labeling requirements in part 1218. baby boxes, in-bed sleepers, baby nests sleep products from the scope of the The Commission is also finalizing the and pods, rigid-sided and rigid-framed rule, such as those that may not initially amendment to part 1112, to include compact bassinets without a stand or have a base, or may be sold as an ‘‘infant sleep products’’ in the list of legs, various designs of ‘‘travel attachment to another product. children’s product safety rules for bassinets’’ with soft padded or mesh Additionally, we revised the age limit in which CPSC has issued NORs, as well sides, and baby tents (collectively, flat this definition from ‘‘approximately 5 as the amendment to part 1130, to sleep products)). 84 FR at 60951. Tabs months of age’’ by removing the term identify ‘‘infant sleep products’’ C and E of Staff’s Final Rule Briefing ‘‘approximately.’’ This revision is specifically as a subcategory of bassinets Package contain additional information intended to reduce confusion about and cradles. and characteristics, as well as pictures which products fall within the scope of This final rule is based on information of the infant sleep products subject to the rule, and to clarify that any infant and analysis provided in Staff’s Final the final rule. sleep product marketed or intended for Rule Briefing Package, submitted to the B. Products Excluded From the Scope of an infant up to 5 months of age, and that Commission on May 12, 2021, which the Final Rule is not already covered by a CPSC sleep can be found on the Commission’s standard, falls within the scope of the website at: https://www.cpsc.gov/s3fs- Consistent with the 2019 SNPR, for final rule; public/FinalRuleSafetyStandardfor the final rule, products with inclined or 7. Definitions in ASTM F3118–17a, by InfantSleepProducts.pdf adjustable seat back positions that are revising section 3.1 to remove the ?7s3LjLlkZ4Vm_0GWP2.vstoEzBylG8xg. covered by other CPSC standards, such definitions for ‘‘accessory inclined sleep as infant bouncer seats, strollers, hand- product,’’ ‘‘compact inclined sleep II. Product Description held carriers, frame carriers, and infant swings, are excluded from the scope of product,’’ and ‘‘newborn inclined sleep A. Scope of Products Within the Final the ASTM infant inclined sleeper product,’’ to simplify the regulation text, Rule because these definitions are standard, and they are also excluded The scope of products covered by the unnecessary based on the other from the scope of the final rule, unless 2017 NPR tracked the scope of ASTM modifications made to ASTM F3118– the product is specifically marketed for F3118–17, covering ‘‘a free standing 17a in the final rule, and because these infant sleep for an infant up to 5 months product with an inclined sleep surface products are subsumed within the of age. Id. at 60951–52. If a product’s primarily intended and marketed to definition of an ‘‘infant sleep product,’’ packaging, marketing materials, inserts, provide sleeping accommodations for an and the final rule does not contain any or instructions indicate that the product infant up to 5 months old or when the is for sleep, or includes pictures of unique requirements for these infant begins to roll over or pull up on sleeping infants, then CPSC will products; 3 sides, whichever comes first.’’ The 8. Requirements in ASTM F3118–17a, consider the product to be marketed for scope of products covered by the 2019 by revising section 6.9 to remove sleep. SNPR broadened from the 2017 NPR, Products that are already compliant separate ‘‘Maximum Seat Back Angle’’ proposing to incorporate by reference with another CPSC sleep standard, such tests for three product types (accessory, ASTM F3118–17a with substantial as the bassinet standard (16 CFR part compact, and newborn), and leaving modifications, including revisions in 1218), or the crib standard (16 CFR part only the test for ‘‘infant sleep products,’’ the scope of the standard, section 1.3, to 1219), are excluded from the scope of because all products fall within the remove the term ‘‘inclined,’’ and to the final rule. Sleep wedge and definition of an ‘‘infant sleep product’’ include any infant sleep product not sleep positioners are out of scope for the in the final rule, and because this test currently covered by another CPSC final rule, and may be covered by Food is the same for all products; and Drug Administration (FDA) 9. Requirements in ASTM F3118–17a, mandatory rule for a product intended regulations as medical devices, if they by revising section 6.9 and 6.9.1 to more for infant sleep: Bassinets/cradles, cribs are marketed to treat a medical accurately describe the name of the test (full-size and non-full-size), play yards, condition, such as acid reflux. Infant by clarifying that the seat back angle and bedside sleepers. 84 FR at 60951. For the final rule, the scope of pillows are also out of scope for the 3 Note that in the 2019 SNPR the Commission products that fall within the rule is final rule, and these products are subject proposed to revise these terms by removing the consistent with the 2019 SNPR, and to 16 CFR § 1500.18, ‘‘Banned toys and word ‘‘inclined.’’ includes all of the inclined sleep other banned articles intended for use

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by children.’’ Hammocks intended as CPSC’s sleep standards and with other (a) Hard-Frame Inclined Sleepers, photo props are out of scope for the small, portable products that are not Compact Foam Inclined Sleepers, and final rule. accessories marketed for sleep. One goal of the final Play Yard Accessories intended for shopping carts are also not rule is to make it clearer to consumers Freestanding, inclined hard-frame in scope, as those products are not which products are certified as sleepers retail for $40 to $120, intended for infant sleep. Bath chairs compliant with a CPSC sleep standard, depending on brand and features, such with inclined backs are out of scope, as regardless of the product name or as attached toys, fabric coverings, they are covered by another standard advertising. battery-operated sounds, and adjustable and are not intended for infant sleep. The proliferation of physically positions. Compact foam inclined Pet beds, toy hammocks, and play tents different products with similar names sleepers retail for about $100. Hard- labeled for children over 5 months are (particularly ‘‘bassinets’’), the many frame inclined play yard accessories are out of scope of the final rule. Loungers, suppliers in the market, and new not sold separately; they are included in floor chairs, and rockers are out of scope product types each season, reflect a the price of the play yard. of the final rule, unless they are competitive market for innovative sleep In recent years, sales of inclined marketed for infant sleep on the product products. New sleep products are sleepers have totaled at least 722,000 itself or its packaging, marketing marketed as filling a need for a small, units per year.6 The sales of these materials, inserts, or instructions, or the portable sleeping or napping space. products alone total nearly a quarter of product is advertised with pictures of Many items are also marketed all households with newborn infants, sleeping infants. specifically to facilitate bed-sharing.5 In given that just under 3.8 million live Finally, in response to a comment on addition to the marketing as secondary births occurred in the United States in the 2019 SNPR, the Commission sleeping options, some of these compact 2018.7 Additionally, more than 4,000 specifically is excluding from the scope and relatively inexpensive sleep adoptions from foreign countries of the final rule crib mattresses that fall products are also marketed as primary occurred, but most of those infants were within the scope of the voluntary sleep spaces for families with limited at least 1-year-olds by the time the standard for crib mattresses, ASTM living space and budget. Baby boxes, in- adoption was finalized.8 We assume F2933. A crib mattress, alone, does not bed sleepers, and hammocks, in that some of the market for inclined meet the definition of an ‘‘infant sleep particular, are marketed as primary sleepers has shifted to other flat sleep product,’’ and is always used in sleep spaces for babies. product categories covered by this rule, conjunction with a sleep product, such CPSC did not find any evidence that or shifted to small portable sleep as a crib or play yard, that falls within consumer demand for compact, products compliant with existing CPSC one of CPSC’s sleep standards. The inexpensive, and portable sleep spaces sleep standards. Since the CPSC Commission issued a notice of proposed cannot be met by products compliant published the NPR in 2017, some rulemaking for crib mattresses in 2020, inclined sleep products have been with an existing CPSC sleep standard. and intends to finalize a separate rule recalled or otherwise removed from the Many small bassinets that are compliant later this fiscal year, providing market. However, although reselling with CPSC’s bassinet standard sell for performance and labeling requirements recalled products is prohibited, $50 to $75 and have a footprint similar for crib mattresses, based on ASTM discontinued items sold on the to the flat sleep products covered by this F2933. secondary market that have not been rule. As for bed-sharing, bedside recalled, as well as non-recalled C. Market Description 4 sleepers retail for as little as $100. physically similar products sold by Cradles compliant with the bassinet and Infant sleep products covered by this small companies, are still available. rule may be purchased at general cradle standard have a swinging retailers, online retailers, mattress and function similar to a hammock with a (b) Baby Hammocks stores, and baby specialty frame, often at a lower retail price. Hammocks range in price from about stores. At least 60 small U.S.-based Innovative products compliant with the $50 for a simple fabric hammock manufacturers and importers are in this existing CPSC sleep standards have without a frame, to more than $300 for market, as well as five large domestic been introduced in recent years, a hammock with a wooden or metal companies, and dozens of foreign including small, foldable play yards, stand. Crib hammocks, which are companies, some that ship these items oval cribs and bassinets, bassinets that intended to attach to cribs or play yards directly to customers in the United are attached to an adult chair, bassinets of any brand, retail for about $50 to States via online marketplaces. More with rocking functions, and bedside $100. than a thousand home-based sleepers with a rocking base. Baby hammocks are widely available manufacturers, hundreds based in the 1. Inclined Sleep Products from small domestic companies, United States, sell soft-sided baby nests importers, and home-based sellers. The and pods, in-bed sleepers, and infant The 2019 SNPR described four types websites of several major general hammocks directly to consumers via of inclined sleep products within the retailers sell these items from third- online marketplaces and as third-party scope of the rule: Frame-type inclined party sellers. Hammocks are made of a sellers via major retailers’ websites. We sleep products, hammocks, compact variety of fabrics and may include estimate total sales in this market at inclined sleep products, and accessory padded sides or bottoms. They may more than $125 million per year, to at inclined sleep products. 84 FR at 60951. come without a frame, or with a wooden least a third of U.S. households with We update the market for these products newborns. below, grouping frame-type, compact, 6 The recalled inclined products alone had sales Products within the scope of the final and accessory inclined products into of nearly 6.5 million from May 2010 to August one category, and hammocks into 2019. Assuming that the recalled products rule compete with products for infant represented most of the market, 6.5 million divided sleep that are compliant with one of another category. by 9 years is 722,000. 7 https://www.cdc.gov/nchs/nvss/births.htm. 4 Tab E of Staff’s Final Rule Briefing Package 5 Tab D of Staff’s Final Rule Briefing Package 8 https://travel.state.gov/content/travel/en/ contains CPSC staff’s analysis of the market for contains CPSC staff’s analysis of the hazards Intercountry-Adoption/adopt_ref/adoption- infant sleep products. associated with bed-sharing. statistics-esri.html.

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or metal stand. Some items are solid the bassinet standard. Items marketed as other rigid-sided products without a fabric, while others are mesh or crochet. changing pads are not considered to be stand are marketed for infant sleep, The market is fragmented, and all of the infant sleep products. sometimes as ‘‘compact’’ or ‘‘travel’’ sellers in the United States are small The prices for baby nests, baby pods, bassinets. Some compact bassinets have companies, although some sellers are and in-bed sleepers range from about mesh sides with a rigid metal or plastic importers of items made by large foreign $40 to $200, with the lower-priced items frame. Larger rigid-sided items that companies. The large number of sellers, tending to come from home-based comply with the play yard standard, including at least one company that manufacturers and foreign direct and play yard accessories that are sells only baby hammocks, and dozens shippers, and the more expensive items compliant with the bassinet standard, of home-based sellers, suggests that coming from larger U.S. companies. are out of scope for the final rule. Most thousands of baby hammocks are sold Smaller products intended only for flat sleep surface, rigid-sided products each year. infants up to 5 months of age also tend are rectangular, but oval and round ones to be cheaper than larger products are also available. As noted, some flat, 2. Flat Sleep Products intended for children up to 2 years old. soft-sided items are also marketed as (a) Flat Sleep Surface, Soft-Sided The various soft-sided travel bassinets ‘‘travel’’ bassinets. The term ‘‘bassinet’’ Products and ‘‘travel beds,’’ some that fold up is used in product names for rigid-sided The flat sleep surface, soft-sided into a backpack, have a similar price items with a stand that meet CPSC’s products that are not covered by a CPSC range. At least 30 small businesses, bassinet standard, but the term is also sleep standard include baby pods or mostly importers, sell the soft-sided flat used in product names of flat and baby nests, which are marketed for use sleep surface products.9 Dozens of inclined items without a stand, some on a hard surface or as in-bed sleepers, foreign companies ship these sleep with low and soft padded sides, which and soft-sided ‘‘bassinets.’’ Some soft- products directly to U.S. customers via do not meet the bassinet standard. The sided products are marketed for use U.S. Internet retailers, and there are final rule addresses this issue, and, in inside a crib or bassinet. Some sleep more than 1,000 home-based sellers of part, is intended to make it clearer to products are marketed as portable or baby pods and baby nests. consumers which products are safe for travel infant beds. The flat infant sleep The estimated annual sales of in-bed infant sleep, regardless of the product 10 name. products currently not covered by any sleepers alone are 1 million units, Rigid-sided and rigid-framed compact voluntary or mandatory sleep standard, based on public comment and staff analysis. The Durable Nursery Products bassinets and travel bassinets typically but would be regulated under the final sell for about $50 to $150, which is rule, include: Exposure survey (DNPES) indicated that 38 percent of parents slept with their comparable to the lower end of the price • Baby pods and baby nests—These child under 1 year of age at least once range of bassinets that comply with the products have a soft floor, usually a week, with 18 percent indicating they bassinet standard. Retail prices for baby padded in some way, with low soft sleep with their child under 1 year of boxes start at about $50 to $75, fabric or mesh sides, resembling a age every night. The CDC similarly depending on the brand and decorative small pet bed. They can be found 11 that 24.4 percent of parents design, although some are sold only as rectangular, oval, or figure 8-shaped. bed-shared with their infant ‘‘often or part of a $300, or more, bundle with Some come with a wedge . always’’ and 37 percent indicated they clothes, diapers, and other baby items. They are sometimes marketed as bed-shared ‘‘rarely or sometimes.’’ If Baby boxes were given away for free by suitable for use inside a crib or play parents who regularly sleep with their some state governments and hospitals, yard. so the cost to the consumer was $0, • Soft-sided ‘‘travel bassinets’’ or infants commonly purchase or make a soft-sided baby nest or other type of in- although those organizations purchased ‘‘travel beds’’—These products can them from a small domestic company have either a soft or semi-rigid floor. bed sleeper, then these products could be owned by 25 percent of households that is no longer offering them. Play Some products come with straps and yard accessories are not priced or sold zippers so that they can be rolled up with newborns, representing about 1 million units sold per year, which is separately; rather, they are included in and carried like a backpack when not the price of the play yard. in use. Some are marketed as ‘‘3-in-1’’ consistent with the estimate from a public comment on the 2019 SNPR. Products in this category have a products that can also be used as a variety of names. Several small changing mat and include pockets for (b) Flat Sleep Surface, Rigid-Sided and domestic manufacturers and small diapers. Some products have a Rigid-Framed Compact Bassinets, Travel importers, as well as large domestic and ‘‘cocoon’’ design, with a soft padded Bassinets, and Similar Products foreign companies, sell small, rigid- top, intended to cover the body of the This infant sleep product category sided or rigid-framed products that occupant. includes flat sleep surface, free-standing resemble a bassinet without a stand as • Hand-held carriers marketed for products that resemble a bassinet ‘‘compact,’’ ‘‘portable,’’ or ‘‘travel’’ sleep—These products are marketed without a stand or legs. Baby boxes and bassinets, or as infant ‘‘travel beds.’’ as both a hand-held carrier and a About a dozen sellers ship these (soft) bassinet, suitable for napping or 9 This number is approximate, as the proliferation products from the United States, and a sleeping. few foreign companies sell through • of internet retailing allows importers to enter and In-bed sleepers—These products have exit the market quickly, and to switch their product internet marketplaces. The presence of low, soft sides and a soft floor, line based on demand. several large domestic and foreign specifically intended and marketed 10 A public comment on the SNPR estimated the companies in this market, as well as for bed-sharing. annual sales of ‘‘in-bed sleep products’’ at 500,000 to 1.5 million units, which is consistent with the introductions of innovative products Play yard accessories have mesh or estimates in the DNPES and from CDC on each year, indicate that a strong fabric sides that attach to the rails of the prevalence of bed-sharing. consumer demand for these products. play yard and are marketed for infant 11 Bombard JM, Kortsmit K, Warner L, et al., Vital CPSC believes it likely that some of the Signs: Trends and Disparities in Infant Safe Sleep sleep, including ‘‘napping’’; and they Practices—United States, 2009–2015. MMWR Morb demand for inclined rigid-sided would not fall within the scope of the Mortal Wkly Rep 2018;67:39–46. DOI: http:// products has shifted to this market rule if they are already compliant with dx.doi.org/10.15585/mmwr.mm6701e1. sector. Unlike the soft-sided products,

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this sector does not have many home- are a relatively niche product, compared injury incidents may change in the based businesses or foreign direct to some of the other types of sleepers, future. shippers. there appears to be sufficient demand (a) Fatalities Baby boxes are a sub-type of compact for baby tents to support the market bassinet that are made of cardboard. presence of dozens of companies, Since the 2019 SNPR, the They are sold in the United States by including a few large companies selling Commission is aware of 10 fatalities two small domestic companies and one a variety of other baby products. associated with the use of an inclined foreign company and can also be sleep product that reportedly occurred III. Incident Data and Hazard Patterns purchased directly from several foreign during the period from January 1, 2019 companies. The sales are relatively A. Inclined Sleep Products through December 31, 2020. small; estimated at under 20,000 per • 1. Incident Data Three of the 10 fatal reports year.12 This means that less than 1 describe infants placed supine (on their percent of households with newborns The 2017 NPR discussed 14 fatal back) in a rocker-like sleeper product, purchase these items. Baby boxes are incidents related to inclined sleep but who ended up rolling over, fully or sometimes marketed as ‘‘Finnish’’ baby products, which were reported to have partially, resulting in suffocations or boxes, because the government of occurred between January 1, 2005 and positional asphyxiations. Staff does not Finland provides new parents with a September 30, 2016. Eight of the 14 know whether a restraint was used in baby box or cash equivalent. As noted, deaths involved rocker-like inclined any of these cases. All three decedents in the past, some state and local sleep products; in three cases, the were 3- or 4-month-old infants. hospitals gave away baby boxes to new unstrapped decedent was found to have • One report describes a fatality parents or made them widely available rolled over into a facedown position. involving a foam-type reclined infant 13 through social service agencies. Like Two additional cases also reported a seat. The seat was placed on an adult other compact bassinets, baby boxes are rollover into a facedown position, but bed, where the parents were also asleep. the reports did not include any marketed as a primary sleep The seat was found tipped over on the information about the use of a restraint. environment for newborns. floor, with the 4-month-old decedent CPSC had little information about the found underneath the seat. (c) Baby Tents cause or manner of the three remaining • One incident reports a fatality of a Baby tents, which are a small mesh or deaths. The 2017 NPR recognized that solid fabric products with a fabric floor reporting was ongoing and that the 3-month-old infant, found supine in an are marketed for sun protection, play, number of reported fatalities could infant rocker-like product (in the same and baby sleep. They are sometimes change. 82 FR at 16965–66. position as originally placed) with a marketed as a combination of tent and The 2019 SNPR updated fatal and covering the infant’s face. • ‘‘travel bed’’ or ‘‘travel bassinet.’’ Some nonfatal incident reports associated Five remaining fatality reports baby tents come with flaps, covers, or with the use of an inclined sleep provide very little information on the shades so that the baby can sleep in product. At the time of the 2019 SNPR, incidents. Lack of any information on darkness. Some products come with CPSC was aware of 451 incidents (59 the circumstances leading up to the poles or stakes to fasten the tent to the fatal and 392 nonfatal) related to death does not allow CPSC staff to ground or in the sand at the beach. inclined sleep products that occurred classify these deaths. Of the known Some tents have a shallow fillable pool/ from January 1, 2005 through June 30, ages, the decedents ranged in age from sandbox in the bottom, which indicates 2019, and reported between October 1, 1 to 6 months old. they are not intended primarily for 2016 and June 30, 2019. This count (b) Nonfatal Incidents sleep, but rather, for play. included incidents reported after the Baby tents retail for about $20 to $75; reporting end date stated in the 2017 Since the 2019 SNPR, the larger and more expensive tents are NPR. Forty-three percent of the incident Commission has received reports of 61 available, but they are marketed for reports (196 out of 451) were based nonfatal incidents associated with the older children. Baby tents are offered for solely on information from use of an inclined sleep product that sale on major internet general retailer manufacturers/retailers. Various occurred between January 1, 2019 and websites and in general retail stores by sources, such as hotlines, internet December 31, 2020. Among these 61 about a dozen small importers and a few reports, newspaper clippings, medical reports, 17 reports involved an injury. large companies. Dozens of foreign examiners, and other state/local We describe the severity of the 17 companies ship these baby tents directly authorities provided the remaining injuries below: to U.S. customers via U.S. Internet incident reports to CPSC. 84 FR at • Four infants required hospital retailers; the majority of suppliers in 60952–53. Tab A of the October 16, admission. Three of the hospitalizations this category are foreign direct shippers. 2019 Staff SNPR Briefing Package were for respiratory problems due to Baby tents are marketed as a specialty describes the incident data and the mold on the sleep product, and one was item for outdoor use, particularly beach hazard patterns associated with infant for treatment of injuries from a fall trips or camping, to shade the baby from inclined sleep products at the time of when an accessory-type product sun and provide a place for playing and the SNPR. collapsed. sleeping. Indoor ‘‘play’’ tents are also For the final rule, the Directorate for • Three infants were treated and marketed for sleep, but those products Epidemiology staff, Tab B of Staff’s released from emergency departments. are mostly marketed for children over 3 Final Rule Briefing Package, describes Those infants were treated for years of age. Indoor play yards with 71 new incident reports associated with respiratory problems from exposure to tent-like covers are in the scope of the inclined sleep products since the 2019 mold or for fall injuries. play yard standard. Although baby tents SNPR. Of the 71 new reported incidents, • Ten infants required other medical 10 are fatalities; among the remaining 61 care, mostly for plagiocephaly (flat head 12 A public comment estimated 2018 sales from nonfatal incidents, 17 reported an syndrome), torticollis (twisted neck two of the three U.S. baby box companies at more than 10,000. injury. Reporting is ongoing, and syndrome), or both conditions, which 13 Similar programs now offer free cribs or play therefore, the number of reported were associated with prolonged use of yards. fatalities, nonfatal injuries, and non- inclined sleep products; two of the 10

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infants suffered minor bumps/bruises categories for inclined sleep products ailments due to the growth of mold on due to falls or near falls. are very similar to those identified in the product. The remaining 44 incidents reported the 2019 SNPR. Following a CPSC- The design category includes three no injuries, or provided no information issued safety recall on inclined sleep deaths, three hospitalizations, one ED about any injury. However, many of the products in April 2019, staff observed a visit, and eight non-hospitalized, non- descriptions indicated the potential for surge of reports related to the recall; ED injuries. a serious injury, or even death. Thirty- these reports are combined with other four percent of the incidents involved consumer comments in the hazard (c) Other product-related issues: Four infants 0 to 5 months of age, and 9 categories. Staff identified the following of the 71 incidents (6 percent) report percent involved infants 6 months to 12 hazard patterns among the 71 reported other product-related issues, such as months of age. CPSC does not know the incidents (10 fatal and 61 nonfatal) instability (posed by products that have infant’s age in 58 percent of the associated with the use of infant completely or nearly flipped over) or incidents. inclined sleep products. The categories lock/latch problem (i.e., the sleep surface failed to remain in position 2. Hazard Patterns are presented in descending order of frequency: during use). One of the three instability The 2017 NPR identified nine hazard (a) Consumer comments: Thirty-one incidents was a fatality that occurred patterns among the 657 reported of the 71 reported incidents (44 percent) when a foam-type reclined seat tipped incidents associated with inclined sleep fall into this category. The reports over and fell from the adult bed to the products. These hazard patterns consist of consumer comments/ floor, trapping the decedent underneath. included: Design issues, lack of observations of perceived safety No injury is reported in this category. structural integrity, inadequate hazards, complaints about unauthorized (d) Lack of structural integrity: Three restraints, electrical issues, non- sale of infant inclined sleep products, or of the 71 incidents (4 percent) report product-related or unknown issues, inquiries regarding the April 2019 safety components breaking, such as the rail, difficulty with correct positioning, recall on inclined sleep products. hardware, or other unspecified part. miscellaneous product-related issues, Although one complaint describes a This category includes one unspecified falls, and consumer minor injury incident, none of the hospitalization and one non-ED-treated comments. 82 FR at 16965–66. remaining reports indicate that an injury due to a fall. For the 2019 SNPR, CPSC staff incident actually occurred. considered all 451 reported incidents (b) Design of the inclined sleep (e) Electrical issue: One of the 71 (59 fatal and 392 nonfatal) to identify product: Twenty-four of the 71 reported incidents (1 percent) describes an odor hazard patterns associated with inclined incidents (34 percent) fall into this emanating from the product after a short sleep products; and staff described the category. period of use indicative of overheating; variety of sleep products considered, (i) Ten incidents report that infants further investigation revealed molten such as: Hammocks, which are rolled over—fully or partially—from plastic inside. No injury is reported. suspended in air, seat-like products their original supine (on their back) (f) Non-product-related issues: One of meant to be placed on a floor level (yet position. Although a few of the infants the 71 incidents (1 percent) reports a incident reports indicate these products were strapped into the product, for fatality in an unsafe sleep environment. often were not placed on floor level), others, whether a restraint was used is A 3-month-old was placed supine (on and products that sit on top of larger unreported. Reports describe infants as their back) in an infant rocker-like nursery products as attachments. CPSC young as 1 month of age rolling over. product with a blanket covering the staff identified eight hazard patterns Some parents/caregivers, who witnessed face; the decedent was found in the among 451 reported incidents in the and reported some of the nonfatal same position, with the blanket still 2019 SNPR, which differed, depending incidents, were able to rescue distressed covering the face. on which product was involved, and infants quickly; some of the other (g) Insufficient information: Seven of how the product was being used: Design infants died due to suffocation or the 71 incident reports (10 percent) issues, electrical issues, consumer asphyxiation. contain insufficient information for staff comments, undetermined issues (due to (ii) One infant stopped breathing to categorize them accurately. For five confounding information), structural temporarily, due to difficulty deaths, staff has no information on the integrity issues, other product-related positioning his head correctly. issues, infant placement issues, and (iii) Eight incidents report that infants circumstances of the deaths. Reports for insufficient information. Staff’s developed physical deformations, such two injuries in this category describe identified hazard pattern categories as plagiocephaly (flat head syndrome) unspecified falls treated in hospital EDs, were very similar between the 2017 NPR and/or torticollis (twisted neck with no information on restraint usage. and the 2019 SNPR. 84 FR at 60952–53. syndrome), from extended product use. Table 1 presents the distribution of For the final rule, staff again reports (iv) According to five reported the 71 reported incidents by hazard that the staff-identified hazard incidents, infants developed respiratory patterns and severity of incidents.

TABLE 1—HAZARD PATTERNS AND INCIDENT SEVERITY ASSOCIATED WITH INFANT INCLINED PRODUCTS 2019–2020 INCIDENTS [Reported since 2019 SNPR]

Total incidents Deaths Injuries Issues Count Percentage Count Percentage 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

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TABLE 1—HAZARD PATTERNS AND INCIDENT SEVERITY ASSOCIATED WITH INFANT INCLINED PRODUCTS 2019–2020 INCIDENTS—Continued [Reported since 2019 SNPR]

Total incidents Deaths Injuries Issues Count Percentage Count Percentage Count Percentage

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 of these non-inclined sleep products are 1. Incident Data In response to the 2019 SNPR, the flat and come with mattress pads. Some products have short legs; many can sit CPSC staff received a total of 183 Commission received public comments incident reports related to flat sleep regarding the safety of non-inclined on the floor or can be used on a bed or products available in the marketplace. sleep products, or flat sleep products, a . The data show that some that do not fall within an existing CPSC products were placed inside a standard- These incidents reported a date of sleep standard or a voluntary standard sized crib, play yard, or bassinet. occurrence between January 1, 2019 and that are available in the marketplace. For the final rule, we characterize the December 31, 2020. Manufacturer and Staff completed a review of CPSC’s number of deaths and injuries and the retailer reports submitted through epidemiological databases, CPSRMS types of hazards related to flat sleep CPSC’s ‘‘Retailer Reporting Program’’ and NEISS, to respond to these products. CPSC’s characterizations are serve as the only source of information comments and concerns. based on anecdotal incident reports for 73 percent (133 out of 183) of the Flat sleep products include: In-bed received by the Commission. The incidents. Of the 183 reported incidents, sleepers, baskets (that can function as number of emergency department (ED)- 11 are fatalities. Among the remaining hand-held carriers as well), baby boxes, treated injuries associated with flat 172 nonfatal incidents, 16 reported an compact bassinets (most of which are sleep products, for the covered time injury. Additionally, staff’s flat sleep portable for travel), and baby tents. frame, is insufficient to derive any product data search was limited to 14 Based on the descriptions in the reportable national estimates. children age 12 months or under, incident reports received, some have Accordingly, we do not present injury because that is typically the soft, puffy sides along the sleep area estimates here, but include ED-treated manufacturer-recommended use age for perimeter; others have semi-rigid sides, injuries in the total count of reported these products. One hundred and fifteen incidents. Moreover, reporting is with mesh or soft-padded sidewalls incident reports provided the victim’s held in place by tubular structures along ongoing and staff considers 2019–2020 age; among them, 24 involved a fatality the perimeter. Baby boxes have data incomplete, so the number of or injury. Table 2 provides the age cardboard walls, while baby tents have reported fatalities, nonfatal injuries, and flexible wires which provide structural non-injury incidents reported here may breakdown among the 183 incident support for fabric/mesh tent walls. All change in the future.15 reports.

TABLE 2—AGE DISTRIBUTION IN FLAT SLEEP PRODUCTS-RELATED INCIDENTS IN 2019–2020

All incidents Injuries and fatalities Age of child Frequency Percentage 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 surface products marketed for infant reported to have occurred during the The Commission is aware of 11 sleep that are not currently within the period of January 1, 2019 through fatalities associated with the use of a flat scope of an existing CPSC sleep December 31, 2020. Seven of the 11 sleep product, meaning flat sleep standard or a voluntary standard,

14 According to the NEISS publication criteria, an 15 In the reports received by CPSC, consumers products—often unfamiliar to CPSC staff—staff’s estimate must be 1,200 or greater, the sample size referred to flat sleep products as ‘‘cribs,’’ data search for this analysis was challenging, and must be 20 or greater, and the coefficient of ‘‘bassinets,’’ ‘‘cosleepers,’’ ‘‘cribettes,’’ ‘‘nests,’’ staff believes it is possible that some relevant variation must be 33 percent or smaller. ‘‘pads,’’ or ‘‘positioners.’’ Because of the variety of reports may have been missed. terms used by consumers to describe these

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fatality reports describe a suffocation • Two infants required hospital closing of the cover on the product death, as follows: admission. An 8-day-old infant suffered failed. Some reports describe that the • A 1-month-old was found partially unspecified breathing difficulties; inability of the cover to open completely rolled over onto their side in a soft- another 2-month-old infant fell out of an results in the product not lying flat. The sided compact bassinet/travel bed. in-bed sleeper and suffered head single report about a different product • A 2-month-old infant was found injuries when a sibling jumped onto the describes a foldable sleeper not completely rolled over the edge of an in- couch where the in-bed sleeper was remaining flat; the unit reportedly folds bed sleeper. situated. up while the baby is in the product. • A 2-month-old was placed in an in- • Ten infants, ranging in age from 1 None of the reports mention any bed sleeper, in a prone position, month to 9 months, required emergency injuries. stomach down, with his face turned to department (ED) visits after falling out (b) Comments/Concerns: Twenty-nine one side; he was discovered with part of of the sleeper product. For most cases, of the 183 reports (16 percent) expressed his body outside the sleeper, face down the sequence of events leading to each consumers’ or safety advocates’ into a blanket. fall was unreported. In two cases, the concerns about the perceived safety • A 2-month-old infant was put into infant fell while being transported in the hazard of a product, non-compliance a compact bassinet/travel bed placed on sleeper; and in another case, the sleeper with the relevant standard(s) for which top of an adult bed, with one side of the slipped off of the adult bed on which it a product is being labeled, and/or compact bassinet/travel bed leaning was placed. The injuries included head misleading marketing statements about against the wall. According to the injuries, such as a skull fracture, closed- a product. None of the reports indicate official report, the combination of the head injury, and head contusion, or that an incident actually occurred. travel bed’s non-reinforced flexible other injuries, such as face abrasion and (c) Falls/Containment issues: Twelve knee contusion. bottom, along with the soft surface of • of the 183 incidents (7 percent) report the adult bed, allowed the infant to sink; Four other injury incidents reported an infant falling out of the product or an he was found trapped between the bed an allergic reaction; a mold-related infant not being kept contained within breathing difficulty episode; laceration and the wall. the product. Examples include infants of the nose on the rough mesh wall • A 3-month-old, in a handheld rolling out of a sleeper onto an adult bed surface on the sleeper; and a fall when basket that was placed on an adult bed, and then onto floor; an infant falling out a sibling pulled on the sleeper, causing was found completely rolled over from of a sleeper when a sibling jumped onto it to flip over. One of these infants her original supine position. the couch containing the sleeper; an required repeated visits to a medical • A 4-month-old was placed on his infant crawling/rolling (unwitnessed) professional, but the level of care the back in an in-bed sleeper that was out of a sleeper and getting entrapped other infants received was unspecified. placed inside a standard bassinet; the between an adult and infant was discovered in a prone The remaining 156 incidents reported mattress. This category includes one position deceased. no injuries, or provided no information death, one hospital admission, and nine • A 7-month-old was wrapped in a about any injury. However, many of the ED visits. descriptions were similar to incidents in blanket and placed supine in an in-bed (d) Instability issues: Twelve of the which a serious injury or death sleeper. The infant was found deceased, 183 reported incidents (7 percent) occurred. Therefore, CPSC staff having rolled over into a prone position. describe problems with the product not indicated the potential for a serious remaining stable. The incident reports The remaining four fatalities are as injury or even death. Forty-nine percent describe some products with legs lifting follows: of the incidents involved infants 0 to 5 • up higher or leaning on one side; other A 1-month-old was placed in an in- months of age, and 4 percent involved products have slipped off or flipped bed sleeper inside a play yard. The infants 6 to 12 months of age. The age official reports describe the decedent as was unknown in 37 percent of the over from the adult beds/ on having suffocated on the puffy sides of incidents. which they were resting. This category the sleeper or becoming entrapped includes two reported injuries, one somehow, suffering positional asphyxia. 2. Hazard Patterns involving an ED visit. • A 7-month-old was placed in an in- Similar to the inclined sleep products, (e) Asphyxiation/Suffocation hazard: bed sleeper for a nap. According to the hazard patterns reported for the flat Nine of the 183 indents (5 percent) fall official reports, at some point, the infant sleep products varied according to the into this category. The products were got to the edge of the adult bed and type and usage pattern of the product. compact bassinets/travel beds, baskets, became entrapped between the Many of the products are new in the as well as in-bed sleepers, one being footboard and the mattress of the adult marketplace, and consumers and safety used inside a standard bassinet and bed and died of positional asphyxia. advocates expressed concern about their another, inside a play yard. All but one • Official reports deemed the cause safety. Staff identified the hazard of the infants had rolled over from their and manner of death for two additional patterns among the 183 reported initial position—either fully or partially; fatalities as undetermined. Both incidents (11 fatal and 172 nonfatal) positional information is not available decedents were 1-month-olds, one associated with the use of these flat for one infant. Eight of the incidents placed in a basket, while the other was sleep products. We present the staff- were fatalities due to suffocation or in an in-bed sleeper. identified hazard patterns below in positional asphyxia; one was a near- descending order of frequency among suffocation episode, with a parent (b) Nonfatalities the reports. nearby to rescue the infant. From among the 172 nonfatal reports, (a) Lock/Latch problems: One (f) Miscellaneous product-related CPSC identified 16 injury reports hundred and fifteen of the 183 reports issues: Three of the 183 incident reports associated with the use of flat sleep (63 percent) fall in this category. All but (2 percent) are about mold or quality of products that occurred between January one of these reports pertain to different the product material. Two of the three 1, 2019 and December 31, 2020. We models of a particular stand-alone products were in-bed sleepers, and the describe the severity of the injury type compact bassinet. The locking/latching third was a compact bassinet/travel bed. among the 16 injuries below: mechanism that controls the opening/ All three report an injury.

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(g) Undetermined issues: In three of inclined sleep products. The 2019 SNPR • 16 CFR part 1222—Safety Standard the 183 incident reports (2 percent), stated that from May 10, 2000 to August for Bedside Sleepers. staff could not definitively identify the 20, 2019, CPSC conducted 13 consumer- issue involved. Two of the incidents level recalls involving infant inclined The Commission considers products were fatalities; in both cases, CPSC sleep products. 84 FR at 60953–54. that fall within the scope of a CPSC Field investigation reports indicate that CPSC conducted recalls in response to sleep standard to generally follow safe the cause of death is undetermined. The hazards involving strangulation, sleep principles. Additionally, third incident resulted in a suffocation, falls, structural stability, caregivers can expect that regulated hospitalization due to unspecified entrapment, exposure to mold, and products intended for infant sleep are breathing difficulties suffered by the death. Six recalls involved infant tested for compliance to the applicable infant. hammocks, six recalls involved infant standard, as well as to any other inclined sleep products, and one recall applicable CPSC rule, such as lead in C. Safety Alerts, Press Releases, and involved an infant inclined sleep Product Recalls paint and lead content. Pursuant to accessory included with a play yard. Id. section 14 of the CPSA, products within The Commission issued two safety Tab G in the October 2019 Staff SNPR the scope of a children’s product safety alerts involving infant inclined sleep Briefing Package contains a detailed rule, which includes all of CPSC’s sleep 16 products. A May 31, 2018 safety alert chart outlining recalls involving infant standards, must be tested for advised of infant rollover deaths in inclined sleep products up through compliance to the standard by a CPSC- inclined sleep products, and reminded August 20, 2019. accepted third party laboratory, and caregivers to always use restraints and Since the issuance of the 2019 SNPR, such compliance must be certified by to stop using the product as soon as an CPSC conducted six additional recalls the manufacturer or importer of the infant can roll over. An April 5, 2019 for a suffocation hazard involving infant safety alert 17 advised consumers to stop inclined sleep products. These six product. Staff regularly participates in using the inclined sleep product when recalls affected approximately 268,300 ASTM subcommittees for these an infant reaches 3 months of age, or as units. Tab F of Staff’s Final Rule products, and routinely updates soon as an infant exhibits rollover Briefing Package contains a chart incident data associated with regulated capabilities. Since issuing the 2019 outlining these recalls. CPSC did not products, to address identified hazards SNPR, the Commission issued two press conduct any recalls for flat sleep through the ASTM process. If a releases regarding infant inclined sleep products from August 2019 through voluntary standard that has been products. A January 16, 2020 press January 2021. adopted by the Commission is revised to release warned the public about the risk address identified hazards, section IV. Overview of CPSC Sleep Standards of suffocation associated with the 104(b)(4)(B) of the CPSIA provides an Summer Infant SwaddleMe By Your The final rule would require that any update process, whereby the revised Bed Sleeper, an infant inclined sleeper. ‘‘infant sleep product,’’ defined as a voluntary standard becomes the new The release advised consumers to stop product marketed or intended to mandatory standard.21 Additionally, 18 using the product immediately. An provide a sleeping accommodation for section 104(b)(2) of the CPSIA requires October 31, 2020 press release warned an infant up to 5 months old, and that the Commission to periodically review is not already subject to one of CPSC’s consumers that infant inclined sleep and revise rules issued under section products were not safe for infant sleep mandatory standards for infant sleep, 104, to ensure that such rules provide based on the results of the Mannen must meet the requirements of the the highest level of safety for such Study, and advised caregivers to stop mandatory standard for bassinets and using infant sleep products with an cradles, 16 CFR part 1218, Safety products that is feasible. Table 3 inclined seat back of more than 10 Standard for Bassinets and Cradles, summarizes CPSC sleep standards degrees.19 including conforming to the definition applicable to regulated infant sleep The Commission also conducted of a ‘‘bassinet/cradle.’’ Currently, the products. numerous recalls involving infant five mandatory CPSC sleep standards are: 20 16 https://www.cpsc.gov/content/cpsc-consumer- • 16 CFR part 1218—Safety Standard 21 Under section 104(b)(4)(B) of the CPSIA, the alert-caregivers-urged-to-use-restraints-with- for Bassinets and Cradles organization must notify the Commission of a inclined-sleep-products. revised voluntary standard, and the revised 17 • 16 CFR part 1219—Safety Standard https://www.cpsc.gov/Newsroom/News- standard becomes a consumer product safety Releases/2019/CPSC-ALERT-CPSC-and-Fisher- for Full-Size Baby Cribs standard issued by the Commission unless within Price-Warn-Consumers-About-Fisher-Price-Rock-N- • 16 CFR part 1220—Safety Standards 90 days after notification, the Commission Play-Due-to-Reports-of-Death-When-Infants-Roll- for Non-Full-Size Baby Cribs determines that the revised standard does not Over-in-the-Product. • 16 CFR part 1221—Safety Standards 18 https://www.cpsc.gov/Newsroom/News- improve the safety of the consumer product covered Releases/2020/CPSC-Warns-Consumers-to-Stop- for Play Yards, and by the standard, and the Commission is retaining Using-Summer-Infant-USA-Inc-s-SwaddleMe-By- the existing consumer product safety standard. The Your-Bed-Sleeper. 20 Tab E of Staff’s Final Rule Briefing Package revised voluntary standard will become the 19 https://www.cpsc.gov/Newsroom/News- contains a description of each CPSC sleep standard mandatory standard, effective 180 days after the Releases/2020/CPSC-Cautions-Consumers-Not-to- and the associated voluntary standard the rule is Commission received notification of the revision (or Use-Inclined-Infant-Sleep-Products. based upon. a later date specified by the Commission in the Federal Register). 15 U.S.C. 2056a(b)(4)(B).

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TABLE 3—REGULATED INFANT SLEEP PRODUCTS AND APPLICABLE STANDARDS

Product Voluntary standard Mandatory standard

Bassinet/Cradle ...... ASTM F2194–16e1 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 requirements to address the hazard standard to address hammocks and intended for infant sleep are not patterns related to the use of inclined inclined sleep products, whose product regulated by one of the five existing sleep products. ASTM first approved characteristics at that time did not CPSC sleep standards. Additionally, ASTM F3118 on April 1, 2015, and appear to align with bassinets, because new products continue to enter the published it in May 2015. Through the the bassinets standard requires a sleep market for infant sleep, but some are ASTM process, CPSC staff consulted surface of 10 degrees or less, while the also not within the scope of an existing with manufacturers, retailers, trade inclined product category at that time CPSC sleep standard. Such products organizations, laboratories, consumer included products with an incline of 10 may not follow safe sleep principles, advocacy groups, consultants, and to 30 degrees. Staff has been actively and are not tested for compliance to a members of the public. The current participating in the development of the CPSC sleep standard. These unregulated standard, ASTM F3118–17a, was voluntary standard for inclined sleep sleep products collectively include approved on September 1, 2017, and products since then. products such as: Infant inclined sleep published in October 2017. This is the CPSC staff participated in the ASTM products, in-bed sleepers, baby boxes, fourth revision of the standard since it process by attending meetings,23 compact/travel bassinets without was first published in May 2015. ASTM working on task groups, commenting on handles or handholds, and infant travel F3118–17a states that it is intended to ballots,24 and providing incident data. tents. Hand-held bassinet/cradles are address hazards from falls, positional CPSC staff provided incident data and regulated as part of 16 CFR part 1225, asphyxiation, and obstruction of nose hazard pattern analysis associated with Safety Standard for Hand-Held Infant and mouth by bedding. inclined sleep products for the 2017 Carriers, but part 1225 does not address NPR and the 2019 SNPR, and updated 2. Description hazards associated with infant sleep. this information in this final rule Accordingly, hand-held carriers are The 2017 NPR described the key preamble. Additionally, staff last unregulated if marketed or intended for provisions of ASTM F3118–17, provided ASTM with incident data infant sleep. including: Scope, terminology, general associated with inclined sleep products The final rule seeks to address requirements, performance in May 2018. hazards associated with infant sleep requirements, test methods, marking Since the SNPR published on products, both inclined and flat. and labeling, and instructional November 12, 2019, ASTM has not Products that already meet a CPSC sleep literature. 82 FR at 16967. The 2019 updated ASTM F3118–17a to address standard are, by definition, outside the SNPR proposed to incorporate by hazards associated with inclined scope of the rule. The final rule reference the most recent version of the products. Staff’s SNPR Briefing Package addresses hazards associated with infant voluntary standard, ASTM F3118–17a, was posted on the Commission’s sleep products by requiring them to which is substantially the same as website on October 16, 2019, before meet the requirements of the bassinet ASTM F3118–17, except that the ASTM held fall meetings on voluntary and cradle standard, 16 CFR part 1218, ‘‘accessory’’ definition was updated to standards for juvenile products, and including conforming to the definition match the modification recommended before the Commission voted on the of a ‘‘bassinet/cradle.’’ in the 2017 NPR. Like the previous SNPR, so that ASTM members and other version, ASTM F3118–17a describes the stakeholders could review the package, V. Voluntary Standards Overview— scope of the voluntary standard, defines including the Mannen Study, before the ASTM F3118 and ASTM F2194 terms for various types of infant ASTM meetings, and so that staff could A. Infant Inclined Sleep Products— inclined sleep products, and sets out discuss the package and the Mannen ASTM F3118 requirements for performance (such as Study with ASTM members. The ASTM for structural integrity and stability) and Agenda for Infant Inclined Sleep 1. History for warnings and instructions. As Products meeting that occurred on As a result of incidents associated discussed elsewhere in this preamble, October 21, 2019, included a link to with the use of inclined sleep products, CPSC’s final rule makes substantial Staff’s SNPR Briefing Package. CPSC the Commission directed CPSC staff to modifications to ASTM F3118–17a. staff discussed the 2019 SNPR Briefing work with ASTM to develop voluntary 3. CPSC Staff’s Work Within the ASTM 23 Process Meeting logs detailing CPSC’s work with ASTM 22 CPSC’s mandatory standard, 16 CFR part 1218, on the infant inclined sleep product voluntary Safety Standard for Bassinets and Cradles, CPSC staff’s work on the infant standard can be found here: https://www.cpsc.gov/ incorporates by reference ASTM F2194–13, inclined sleep product voluntary Newsroom/FOIA/ReportList?field_nfr_date_value Standard Consumer Safety Specification for %5Bvalue%5D%5Bmonth%5D=&field_nfr_date_ Bassinets and Cradles, with modifications to make standard arose from staff’s work through value_1%5Bvalue%5D%5Byear%5D=&field_nfr_ the standard more stringent. In 2016, ASTM revised the ASTM process on the voluntary type_value=meeting&title=incline&=Apply. the voluntary standard to include the modifications standard for bassinets and cradles in 24 CPSC staff’s correspondence with ASTM since set forth in the mandatory standard. Accordingly, approximately 2011, in preparation for issuing the 2017 NPR regarding these products can ASTM F2194–16e1 is substantially similar to the be found on www.regulations.gov under supporting mandatory standard, and we assess this version of a proposed rule on bassinets and materials: https://www.regulations.gov/docket/ the voluntary standard in this preamble, to simplify cradles. ASTM began developing the CPSC-2017-0020/document?documentTypes= our analysis. infant inclined sleep products voluntary Supporting%20%26%20Related%20Material.

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Package at the ASTM meetings in 3. That the voter could not support minimum safe sleep requirements for October 2019, including the ASTM changing the title, introduction, and these products is supported by the subcommittees for infant inclined sleep scope without seeing the underlying assessment presented in Staff’s Final products, in-bed sleepers, and bassinets, requirements; and Rule Briefing Package and in this final discussing the Mannen Study findings, 4. Editorial comments. rule. as well as addressing the fact that flat The ASTM F3118 subcommittee B. Bassinets and Cradles—ASTM F3194 sleep products were covered by the discussed the ballot results at a meeting SNPR. Dr. Mannen attended the on January 27, 2021. During this 1. History and Description meeting, ASTM members disagreed on subcommittee meeting for infant The voluntary standard for bassinets the intent and consequences of changes inclined sleep products via telephone, and cradles, ASTM F2194, was first to the voluntary standard, and the to discuss the Mannen Study and to approved and published by ASTM in meeting ended without a consensus on answer questions. 2002, as ASTM 2194, Standard a path forward. However, CPSC staff After the SNPR published in the Consumer Safety Specification for participates on an ASTM task group to Federal Register on November 12, 2019, Bassinets and Cradles. The voluntary review safe sleep requirements across CPSC staff urged the ASTM standard was revised several times infant sleep product standards (the subcommittee for ASTM F3118 to meet between 2002 and CPSC’s promulgation comparison task group), and reports that and discuss how to address issues of a mandatory standard for bassinets in this task group has met at least four presented in the 2019 SNPR. However, 2013. CPSC’s mandatory standard for times since the January 27, 2021 the F3118 subcommittee did not meet bassinets and cradles, codified at 16 meeting. Based on the ballot results and again until August 26, 2020, following CFR part 1218, incorporates by 25 the discussions in these ASTM a July 16, 2020 letter from CPSC staff. reference ASTM F2194–13, with the meetings, staff advises that it is unlikely After staff’s letter, the ASTM F3118 following modifications to the voluntary that ASTM will be able to move forward subcommittee established a task group standard: to revise the infant inclined sleep with changes to ASTM F3118 that 1. Clarify the scope of the standard to standard’s title, introduction, and scope, address safe sleep requirements in the 26 include multi-mode products in which to be more in line with the proposal in near term. a mode meets the definition of a Recently, on April 22, 2021, at an the 2019 SNPR. In December 2020, the ‘‘bassinet/cradle’’ (seat incline is 10 ASTM task group meeting on the title, ASTM subcommittee introduced ballot degrees or less from horizontal) F15–18 (20–1) to change the standard’s introduction, and scope of the voluntary 2. Modify the stability test procedure title, introduction, and scope to include standard, task group members discussed to require the use of a newborn CAMI all infant sleep products (and not just balloting the proposed regulatory text in dummy, rather than an infant CAMI inclined sleep products). The ballot the 2019 SNPR for the voluntary dummy. sought to: standard, to prevent the sale of infant 3. Add stability requirements for • Remove the word ‘‘inclined’’ inclined sleep products that purport to removable bassinet beds. throughout the standard. certify to ASTM F3118–17a, meaning 4. Add more stringent mattress • Include in the scope, products products with an incline above 10 flatness performance requirements to intended for infants up to 12 months degrees, while ASTM works to revise limit measured angle to 10 degrees old. the voluntary standard to be more in (versus 14 degrees allowed in ASTM • Include in the scope, products line with the 2019 SNPR. However, the F2194–13). marketed or intended to provide task group does not plan to ballot the 5. Exempt bassinets that are less than sleeping accommodations. 2019 SNPR requirement that infant 15 inches across from the mattress • Change the scope to include all infant sleep products meet the requirements of flatness requirement. sleep products that do not fall within the bassinet standard, because ASTM is In 2016, ASTM approved and the scope of an existing infant sleep working to create minimum safe sleep published the most recent version of the product standard: requirements in a revised ASTM F3118 standard, ASTM F2194–16e1, with new D Full-Sized Cribs (F1169) standard. Staff is participating in this requirements to bring the voluntary D Bassinets (F2194) effort as well, but staff has advised the ASTM standard in line with the D Bedside Sleepers (F2906) task group that staff’s expertise does not mandatory standard for bassinets in 16 D Non-Full-Size Cribs/Play Yards suggest that requirements that are CFR part 1218. In developing ASTM (F406) different and less stringent than the F2194–16e1, ASTM harmonized the • Exempt crib mattresses from the scope requirements in the bassinet standard voluntary standard with all of the standard. will adequately address the risk of modifications specified in part 1218. In • Limit the sleep surface in all positions injury associated with infant sleep addition to including all modifications to be 10 degrees or less. products. Additionally, staff’s contained in part 1218, ASTM added: However, in January 2021, the ballot did conclusion that the Safety Standard for 1. Additional clarification that not pass due to six negative votes. The Bassinets and Cradles contains the strollers with a removable bassinet must negative votes objected to a variety of be tested to the bassinet standard, different aspects of the ballot, including 26 The ASTM task group approach is different 2. Minor formatting and editorial four broad categories: than CPSC’s approach in this final rule, because changes, and 1. That the proposal would discourage ASTM is attempting to put safe sleep requirements in ASTM F3118, rather than rely on the 3. An additional warning statement to innovation and be too broad; performance and labeling requirements in the be applied to bassinet bed products that 2. That the ballot appeared to allow bassinets and cradles standard. The Commission are removable from the base/stand products that fall under other sleep determines in this final rule that the performance without the use of tools and that contain standards to opt to meet ASTM F3118 and labeling requirements in the bassinet standard are the minimum safe sleep requirements for infant a lock/latch mechanism that secures the instead; sleep products. Thus, it remains unclear whether bassinet bed to the base/stand. ASTM’s approach can be successful. However, if 25 Available at: https://www.cpsc.gov/s3fs-public/ the ASTM committee revises ASTM F3118–17a and Staff assessed the additional changes to IISPLettertoASTM-07162020.pdf?6ntZUkyau.r2mlr notifies the Commission, the staff will evaluate the the voluntary standard, beyond QnM31s0B3g1EkUg.9. revised voluntary standard at that time. harmonization with 16 CFR part 1218,

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and advises that the changes are either and (5) corner post extension subcommittees, CPSC staff reiterated non-substantive, or an improvement in requirements intended to prevent concerns with weakening the safe sleep safety. We evaluate and discuss ASTM pacifier cords, ribbons, necklaces, or requirements in the voluntary standard F2194–16e1 in this preamble to the final clothing that a child may be wearing for bassinets and cradles in order to rule, and CPSC will update the from catching on a projection. 78 FR accommodate unregulated products, reference in part 1218 to ASTM F2194– 63019, 63020–21 (Oct. 23, 2013). such as in-bed sleepers, compact 16e1 as soon as feasible. 2. CPSC Staff’s Work Within the ASTM bassinets, and baby boxes.29 The more significant requirements of Process Additionally, on October 16, 2020, staff ASTM F2194 include: voted negatively on an ASTM ballot to • Scope—describes the types of CPSC has been working with ASTM modify the bassinet standard to include products intended to be covered under on the voluntary standard for bassinets less stringent stability and side height the standard. and cradles since before publication of • Spacing of rigid-side components— the original voluntary standard in 2002. requirements for compact bassinets, 30 is intended to prevent child entrapment CPSC began rulemaking under section versus traditional bassinets. To ensure between both uniformly and non- 104 of the CPSIA, to create a mandatory safe sleep, staff’s negative ballot vote uniformly spaced components, such as standard for bassinet and cradles based urged ASTM to maintain the same side slats. on the voluntary standard, in height and stability requirements for • Openings for mesh/fabric—is approximately 2009, following passage compact bassinets that are required of intended to prevent the entrapment of of the CPSIA. CPSC issued a notice of bassinets. children’s fingers and toes, as well as proposed rulemaking in 2010 (75 FR In June 2019, ASTM began to develop button ensnarement. 22303 (Apr. 28, 2010)), a supplemental a separate in-bed sleeper voluntary • notice of proposed rulemaking in 2012 Static load test—is intended to standard. Staff provided data to ASTM (77 FR 64055 (Oct. 18, 2012)), and a ensure structural integrity even when a regarding in-bed sleepers in 2017, and child three times the recommended (or final rule in 2013 (78 FR 63019 (Oct. 28, has participated in ASTM meetings for 95th percentile) weight uses the 2013)). The final rule is codified at 16 in-bed sleepers since June 2019, as well product. CFR part 1218, Safety Standard for • Stability requirements—is intended Bassinets and Cradles. The final rule as working with performance and 31 to ensure that the product does not tip incorporated by reference the then- labeling task groups. Task groups over when pulled on by a 2-year-old current voluntary standard, ASTM working on the in-bed sleeper standard male. F2194–13, with modifications to make have been unable to reach consensus on • Sleeping pad thickness and the standard more stringent. performance requirements for in-bed dimensions—is intended to minimize CPSC staff has continually sleepers, and have been focusing on gaps and the possibility of suffocation participated in the ASTM process, developing warning labels for these due to excessive padding. including attending subcommittee products. CPSC staff continues to • Tests of locking and latching meetings,27 participating in task participate in all of these ASTM efforts, mechanisms—is intended to prevent groups,27 commenting and voting on and to urge ASTM members to retain unintentional folding while in use. ballots to revise the voluntary safe sleep principles in standards • Suffocation warning label—is standard,28 and providing incident data, development. For example, in a July 8, intended to help prevent soft bedding when requested. This has included 2020 letter to the Subcommittee incidents. ASTM’s recent efforts to address Chairman for ASTM’s in-bed sleeper • Fabric-sided openings test—is hazards associated with currently committee, CPSC staff stated: intended to prevent entrapments. unregulated flat sleep products, such as • Rock/swing angle requirement—is compact bassinets, baby boxes, and in- We would like to be clear that based on our intended to address suffocation hazards bed sleepers, since approximately 2015. evaluation of incident data related to in-bed that can occur when latch/lock ASTM has not yet been successful in sleepers, we have great concerns regarding problems and excessive rocking or adding any of these flat sleep products the safety of in-bed sleepers and the swinging angles press children into the to the bassinet standard. feasibility of developing any safety standard side of the bassinet/cradle. CPSC staff’s correspondence with that fully addresses potential hazards. Based • Occupant restraints—is intended to ASTM states that staff is opposed to on the 12 deaths discussed with the In-bed prevent incidents where unused removing or reducing the requirements Sleeper Data Task Group members, CPSC restraints have entrapped and strangled of the bassinet and cradle voluntary staff cannot foresee how these products can children. standard to create new requirements be designed and regulated to ensure safe use • Side height requirement—is specifically for these products, when for infants. Staff is not confident that an in- intended to prevent falls. such requirements are inconsistent with bed sleeper voluntary standard that differs • Segmented mattress flatness—is safe sleep principles already required in intended to address suffocation hazards 29 Available at: https://www.cpsc.gov/s3fs-public/ the bassinet standard. Accordingly, for _ _ _ associated with ‘‘V’’ shapes that can be LetterToASTMBassinet IISP 121219.pdf?uMq example, in a December 12, 2019 letter ImMYhtrDmFkoDH9I6vdwNI0hsm00. created by the segmented mattress folds. to both the inclined sleep and bassinet 30 Available at: https://www.cpsc.gov/s3fs-public/ The voluntary standard also includes: VoteCommentToASTMBassinet_10162020.pdf (1) Torque and tension tests to prevent 27 CPSC meeting logs associated with staff’s work ?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI. CPSC’s components from being removed; (2) with ASTM can be found here: https:// website, at https://www.cpsc.gov/Regulations-Laws- requirements for several bassinet/cradle www.cpsc.gov/Newsroom/FOIA/ReportList?field_ -Standards/Voluntary-Standards, contains nfr_date_value%5Bvalue%5D%5Bmonth%5D=& information on staff activities as well as features to prevent entrapment and cuts field_nfr_date_value_1%5Bvalue%5D%5Byear correspondence with voluntary standards (minimum and maximum opening size, %5D=&field_nfr_type_value=meeting&title= organizations. small parts, hazardous sharp edges or bassinet&=Apply. 31 Meeting logs describing ASTM meetings are points, and edges that can scissor, shear, 28 CPSC correspondence with the ASTM available on CPSC’ website: https://www.cpsc.gov/ Subcommittee for Bassinets and Cradles can be Newsroom/FOIA/ReportList?field_nfr_date_value or pinch); (3) requirements for the found here: https://cpsc.gov/s3fs-public/Vote %5Bvalue%5D%5Bmonth%5D=&field_nfr_date_ permanency and adhesion of labels; (4) CommentToASTMBassinet_10162020.pdf value_1%5Bvalue%5D%5Byear%5D=&field_nfr_ requirements for instructional literature; ?NbTgq8p5FBJ12mr1IAQeG0weJUDh_6ZI. type_value=meeting&title=in-bed&=Apply.

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from the current bassinet standard will result 1. Mannen Study Summary three percent of the reported incidents in a safe sleep product.32 During the development of the 2019 involved infants rolling from their original supine (on their back) position. VI. Assessment of the Voluntary SNPR, staff reviewed 450 incidents, 59 • Standards To Address Identified were deaths that occurred while in Electrical issues (28 percent). This Hazard Patterns Associated With Infant infant inclined sleep products. hazard involved no deaths and two Sleep Products Commission staff contracted with Dr. reports of injuries. • Undetermined (8 percent). This A. Inclined Sleep Products Erin Mannen, Ph.D., a mechanical engineer with a biomechanics hazard involved 28 deaths and six injuries. Among the 28 deaths, staff was The 2019 SNPR assessed the specialization, to conduct infant testing unable to determine the product’s role, adequacy of ASTM F3118–17a to to evaluate the design of inclined sleep but often unsafe sleep environment was address the risk of injury associated products. The Mannen Study examined cited as a co-contributing condition to with inclined sleep products. 84 FR how the degree of a seatback angle sudden infant death syndrome (SIDS). 60955–56. The assessment relied, in affects an infant’s ability to move within • Structural Integrity (6 percent). This part, on the Mannen Study regarding the the products and whether those designs hazard involved no deaths and two safety of inclined sleep surfaces for directly impact safety or present a risk injuries. infant sleep, attached as Tab B to Staff’s factor that could contribute to the • Insufficient information (4 percent). SNPR Briefing Package, and also suffocation of an infant. The testing This hazard involved eight deaths and summarized in the 2019 SNPR. Id. at compared infants’ muscle movement six injuries. The reports did not provide 60954. Based on the Mannen Study, and oxygen saturation on a flat crib information on the circumstances of CPSC staff advised that a flat sleep mattress at 0 degrees, 10 degrees, and 20 deaths and injuries involved surface, meaning one that does not degrees, versus seven different inclined unspecified falls. exceed 10 degrees from the horizontal, sleep products. The Mannen Study • Other Product-Related Issues (3 is the safest sleep surface for infants. Id. concluded that none of the inclined percent). This hazard involved no Accordingly, the Commission proposed sleep products tested were safe for deaths and nine injuries. The category in the 2019 SNPR to remove the term infant sleep. Id. includes reports of instability (product ‘‘inclined’’ in CPSC’s mandatory The Mannen Study concluded that tipping over) and inadequacy of standard, and to require that all sleep muscle activity for infants who rolled restraints, and most of the injuries products not otherwise subject to a over in inclined sleep products with a involved falls. CPSC sleep standard (full-size cribs, 20-degree incline sleep surface was • Infant placement issues (1 percent). non-full-size cribs, play yards, bedside significantly different than in products This hazard involved four deaths and no sleepers, and bassinets and cradles), with a zero-degree incline surface. The injuries. Three of the four deaths meet the requirements of 16 CFR part increased demand on the abdominal involved infants placed in a prone 1218, Safety Standard for Bassinets and muscles could lead to increased fatigue position. Cradles, which, among other and suffocation if an infant is unable to requirements, mandates a seat back/ reposition themselves after rolling from Id. at 60952–53. sleep surface angle intended for sleep to a supine to prone position. The Mannen Since the 2019 SNPR, CPSC received be 10 degrees or less from horizontal. Id. Study also concluded that inclined a total of 71 new incident reports related Here, we summarize the results of the sleep products with a 10-degree or less to inclined sleep products. While the Mannen Study again, summarize the sleep surface incline do not significantly distribution of the data in this update assessment of ASTM F3118–17a in the impact infant motion or muscle activity. varies somewhat, staff advises that the 2019 SNPR, and update our assessment Based on the Mannen Study, staff broader hazard categories are very to determine whether the voluntary recommended that 10 degrees is the similar. The 71 new reports included 10 standards, ASTM F3118–17a, or ASTM maximum sleep surface angle that fatalities and 17 injuries. Of the 10 F2194–16e1, are adequate to address the should be allowed for any product fatalities, three deaths involved an incidents associated with inclined sleep intended for infant sleep, similar to the infant who rolled from a supine products, including the 71 new requirements found in the EN 1130:2019 position, one death involved an incidents reported since the 2019 SNPR. children’s cribs, EN 1466:2014 carry overturned sleeper, one death involved cots, and the AS/NZS 4385:96 infant an infant placed with a blanket, and five Based on the following analysis, the rocking cradles international standards. deaths without reports containing Commission determines that ASTM Id. information on the circumstances of the F3118–17a is inadequate to address the death. Of the 17 injuries 12 involved 2. Hazard Pattern Categories risk of injury associated with inclined design issues, two involved structural sleep products, and that more stringent In the 2019 SNPR, CPSC reviewed 451 integrity, and two involved unspecified requirements are necessary in the final reported incidents involving inclined falls. rule to further reduce the risk of injury sleep products, which included 59 associated with infant inclined sleep fatalities and 96 injuries. CPSC 3. Assessment of ASTM Standards in products. Specifically, the Commission identified seven hazards that involved Addressing Hazards determines that the performance deaths and injuries (for this analysis, we Below we summarize the hazard requirements in the mandatory did not consider patterns, such as patterns associated with deaths and standard, 16 CFR part 1218, Safety consumer comments, that did not injuries from all 522 incident reports Standard for Bassinets and Cradles, involve injuries or deaths): related to inclined sleep products CPSC would adequately address the risk of • Design issues (31 percent). This received and reviewed since the 2017 injury associated with these products. hazard involved 19 deaths, 17 resulting NPR. CPSC did not consider patterns, from infants rolling over into a prone such as consumer comments, that did 32 See July 8, 2020 Letter from C. Kish to ASTM (face down) position. An additional 71 not involve injuries or deaths. The 522 Subcommittee for In-bed Sleepers, available at: injuries were reported in this category, incidents involved 69 deaths and 113 https://www.cpsc.gov/s3fs-public/InbedSleepers_ 07082020ASTM%20Letter.pdf?3SpzS3cG3zv including five hospitalizations and four injuries. We assesses the adequacy of PjCLFamcCz.9FxNjpUu2s. emergency department visits. Thirty- the voluntary standard for infant

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inclined sleep products (ASTM F3118) for infant sleep, merely that if higher angles to 10 degrees or less.34 Therefore, and the adequacy of the voluntary angles are considered, additional for the mandatory standard specified in standard for bassinets (ASTM F2194) in biomechanical testing is required. The this final rule, with respect to sleep addressing hazards associated with Mannen Study also stated that its testing surfaces, all infant sleep products, injuries and deaths. of awake infants was a limitation including inclined sleep products, must In the 2019 SNPR, CPSC determined because ‘‘while the muscle use and meet the more stringent sleep surface that the voluntary standard for infant motion may be similar, it is likely that angle requirement of the voluntary inclined sleep products, ASTM F3118– infants who find themselves in a standard for bassinets, ASTM F2194– 17a, is inadequate to address the risk of compromised position in an inclined 16e1, as codified in 16 CFR part 1218, injury associated with the incline of sleep product during a nap or overnight to further reduce the risk of death from sleep products, because the standard sleep may not have enough energy or suffocation. allows for products with a seatback alertness to achieve self-correction and (b) Hazard: Undetermined Product Issue angle greater than 10 degrees. Id. at may succumb to suffocation earlier or 60955–56. The majority of deaths (in more easily than infants who are fully This hazard category is associated which the circumstances were known) awake.’’ with 28 deaths and six injuries. Among were due to suffocation after the infant the 28 deaths and six injuries, staff was rolled over in the product, and the same Given the vulnerability of newborn unable to determine the product’s role. hazard pattern was reported in nonfatal infants and infant fatalities who were Without information on the product’s incidents. For the mandatory standard, most likely asleep at the time of role in deaths or injuries, we are unable CPSC proposed to modify ASTM incidents in inclined products, we to assess whether the voluntary F3118–17a to limit the seatback angle conclude that additional research of standard for infant inclined sleep, for all infant sleep products to 10 inclines above 10 degrees is ASTM F3118–17a, or the voluntary degrees or less, and to replace the unnecessary for the final rule. Based on standard for bassinets, ASTM F2194– performance requirements with the the biomechanical results of the 16e1, would adequately address the performance requirements in 16 CFR Mannen Study, and its conclusion that hazards in this category. 10 degrees is likely a safe incline for part 1218, Safety Standard for Bassinets (c) Hazard: Insufficient Information and Cradles, which incorporates by infant sleep, which supports the 10 reference ASTM F2194–13 Standard degrees stated in the scope of ASTM This hazard category is associated Consumer Safety Specification for F2194–16e1, the Commission concludes with 13 deaths and eight injuries. The Bassinets and Cradles, with that 10 degrees is the maximum sleep reports did not provide information on modifications. With the modifications surface angle that should be allowed for the circumstances of deaths and injury in the mandatory standard, the standard any product intended for infant sleep reports involving unspecified falls. is substantially similar to ASTM F2194– for young infants up to 5 months old. Without information on the 16e1, which we use for the assessment Additionally, other research 33 has circumstances of deaths or injuries, staff here. demonstrated a discernable difference is unable to assess if the voluntary in infant ability between 5, 7, and 10 standard for infant inclined sleep, (a) Hazard: Design Issues degrees in a side-to-side tilt, which ASTM F3118–17a, or the voluntary When combining the data from the formed the basis of the 7-degree standard for bassinets, ASTM F2194– 2019 SNPR with new incident data maximum sleep surface angle in Health 16e1, would adequately address the received since the SNPR, the ‘‘design Canada’s regulations. Staff advises that hazards in this category. Falls are issues’’ hazard is associated with 22 additional research at angles higher than discussed in more detail in ‘‘Other deaths and 83 injuries. At least 20 10 degrees is unlikely to alter their Product-Related Issues,’’ below. deaths involved infants rolling into a assessment that 10 degrees is the (d) Hazard: Infant Placement prone position (face down) and maximum safe incline for infant sleep. suffocating. More than one-third of the This hazard category is associated The current voluntary standard for incidents also reported that infants with five deaths and no injuries. Three infant inclined sleep products, ASTM rolled over—fully or partially—from of the deaths involved infants placed in F3118–17a, defines an ‘‘inclined sleep their original supine (on their back) a prone position, and one death product,’’ in part, as having a seatback position. involved an infant placed in a supine In the 2019 SNPR, we concluded that angle greater than 10 degrees and not position with a blanket covering the a flat sleeping surface that does not exceeding 30 degrees. Based on the face. Based on the Mannen study, sleep exceed 10 degrees from horizontal offers Mannen Study and the other factors surfaces with a 20-degree incline infants the safest sleep environment. discussed above, we conclude that significantly increased the demand on This conclusion was based on findings ASTM F3118–17a does not adequately abdominal muscles and could lead to from the Mannen Study. 84 FR at address the risk of injury related to a increased fatigue and suffocation if an 60955–56. Although some comments to sleep surface incline greater than 10 infant is unable to reposition themselves the 2019 SNPR stated that more testing degrees, because the voluntary standard after rolling from a supine to prone should be done to determine if the does not limit the sleep surface to a safe position. In three of the deaths in this maximum angle for safe sleep may be incline angle. In comparison, the hazard category, the infant was placed between 10 degrees to 20 degrees, the voluntary standard for bassinets, ASTM in the prone position and the inclined Mannen Study suggested if future work F2194–16e1, defines a sleep surface as sleep surface may have contributed to were done on safe sleep angles, one area being less than or equal to 10 degrees, suffocation if the angle of the sleep of study would be additional and includes performance requirements surface led to fatigue that prevented the biomechanical testing to determine for mattress flatness that limit measured infant from rolling to a supine position. ‘‘which, if any, angles between 10- and 20-degrees may be safe for infant sleep.’’ 33 Beal SM, Moore L, Collett M, Montgomery B, 34 In the final rule for bassinets, the Commission Sprod C, Beal A. The danger of freely rocking stated they intended to limit the scope of the The Mannen Study recommendations cradles. J Paediatr Child Health. 1995 Feb;31(1):38– bassinet standard to exclude all inclined products do not imply that an incline angle 40. doi: 10.1111/j.1440–1754.1995.tb02910.x. PMID: ‘‘when the incline is more than 10 degrees from between 10 and 20 degrees may be safe 7748688. horizontal.’’ 78 FR 63,021.

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While infants can die in flat products lb. horizontal force to the product with structural integrity, its effectiveness in when placed to sleep in the prone a newborn CAMI dummy occupant, and evaluating the product’s strength is position, based on the Mannen Study, this requirement applies to all products; minimal, compared to the static test. an inclined surface could further it does not provide exemptions for The load in the dynamic test being one- contribute to deaths in the prone ‘‘Compact Inclined Sleep Products’’ to third of the static load, the low drop position. A sleep surface limited to a 10- meet only the less stringent 20-degree height, short test timeframe, and degree or less incline, as required in the inclined test platform test. The rationale presence of energy-absorbing material bassinet standard (ASTM F2194–16e1), in ASTM F2194 states the dual (shot bag and flexible product material), could reduce the risk of injury application of forces simulates a 2-year- combine to minimize the effect of this old male pulling on the side of the associated with the prone position, test on the product’s structural integrity. when compared to an inclined sleep product; staff advises that sibling In contrast, the static test applies a product. Therefore, with respect to sleep interaction is a reasonable scenario surfaces, for the mandatory rule, all which may cause the product to tip much larger load, three times the infant sleep products, including over. Due to the portability of some of heaviest infant in the product, with a inclined sleep products, must meet the the unregulated compact sleep products, rigid applicator applied continuously more stringent sleep surface angle incident data confirm that the products for 60 seconds. Therefore, staff advises requirement of the voluntary standard are used on raised surfaces from which that the static test is the more stringent for bassinets, ASTM F2194–16e1, as set infants and product may fall. Therefore, evaluator of product integrity than the forth in 16 CFR part 1218, to further regarding the product’s stability, in the dynamic test. reduce the risk of death from final rule, all infant sleep products, The static load in ASTM F2194–16e1 suffocation. including inclined products, must meet is 54 lbs., which is a more stringent load the more stringent stability requirement (e) Hazard: Other Product-Related Issues compared to the static load of 50 lbs. in of the voluntary standard for bassinets, (Instability, Restraints, etc.) ASTM F3118–17a. Therefore, to further ASTM F2194–16e1, as codified in 16 This hazard category includes reports reduce the risk of injury associated with CFR part 1218, to further reduce the risk structural defects, for the final rule, the of instability (product tipping over) and of injury from tip over of the product. containment; the category is associated Commission concludes that the static with one death and nine injuries. One (f) Hazard: Structural Integrity load test in ASTM F2194 is adequate to death occurred when a foam-type This hazard category includes reports assess structural integrity of infant sleep reclined product tipped over and fell of some component failures on the products, and is more stringent than the from the adult bed to the floor, trapping product such as buckles/straps, static load test in ASTM F3118–17a. the infant underneath. Most of the hardware coming loose, hub/rail/leg The final rule requires that all infant injuries involved falls and at least 10 coming loose, or other unspecified sleep products, including inclined sleep reports (with no injury reported) related components breaking. This hazard products, meet the more stringent to nearly or completely flipped over category involved no deaths and four structural integrity requirement of the products. injuries. All injuries were related to voluntary standard for bassinets, ASTM The death, and most likely the falls, and include one hospitalization F2194–16e1, as codified in 16 CFR part injuries, relate to the stability of the and three emergency department visits. 1218. product and how easy it is to tip the The voluntary standard for infant product over into a hazardous situation. inclined sleep products, ASTM F3118– (g) Hazard: Electrical Issues The voluntary standard for infant 17a, includes performance requirements inclined sleep products, ASTM F3118– to assess the integrity of inclined sleep This hazard category involved no 17a, includes two stability performance products. The requirements specify a deaths and two reports of injuries requirements that apply to ‘‘Compact dynamic test in which an 18-lb. load, related to electric shock. Non-injury Inclined Sleep Products’’ and ‘‘Infant or consisting of a 6- to 8-inch steel shot incidents reported overheating/melting Newborn Inclined Sleep Products.’’ For bag, is dropped 50 times from a height of components and issues with batteries. the ‘‘Compact Inclined Sleep Products,’’ of 1.0 inch onto the seat surface. The As noted in the 2019 SNPR, the infant the product must remain upright when requirements also specify a static test in inclined sleep products standard, ASTM placed on a 20-degree inclined test which a 50-lb. load or three times the F3118–17a, does not include any platform. For the ‘‘Infant or Newborn product’s maximum recommended performance requirements for electrical Inclined Sleep Products,’’ a 23-lb. weight, whichever is greater, is components. 84 FR at 60956. The vertical force and 5-lb. horizontal force gradually applied through a 6-inch voluntary standard for bassinets, ASTM are applied to the product’s side with a square wooden block to the seat surface F2194–16e1, also does not address newborn CAMI dummy occupant to for 60 seconds. The current voluntary electrical hazards. However, CPSC staff simulate an older sibling pulling up on standard for bassinets, ASTM F2194– advises that they raised this issue with the side to view the infant in the 16e1, has a performance requirement to ASTM, and that the ASTM Ad Hoc task bassinet, and the product must remain address structural integrity that group is developing performance upright containing the CAMI dummy. specifies a static load test that applies a requirements to address electrical The ‘‘Compact Inclined Sleep Products’’ 54-lb. load or three times the hazards across juvenile products. As are exempt from the 23- and 5-pound manufacturer’s recommended weight, these electrical requirements are added force requirements, with the rationale whichever is greater, through a 6-inch during the ASTM voluntary standard that the compact products are intended aluminum block to the sleep surface for updates, CPSC can review the updated to sit on a floor and are unlikely to have 60 seconds. The rationale in ASTM an older sibling attempt to pull up to see F2194 states 54 lbs. is three times the voluntary standard pursuant to the the infant inside. weight of the 95th percentile of a 3- to update provision in Public Law 112–28, The current voluntary standard for 5-month-old infant. and determine whether to revise the bassinets, ASTM F2194–16e1, includes Although the voluntary standard for mandatory standard based on a revised an identical stability requirement that infant inclined sleep products, ASTM voluntary standard. applies a 23-lb. vertical force and a 5- F3118–17a, requires a dynamic test for

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4. Assessment of International ASTM F2194–16e1 bassinet standard arms depend upon the product’s Standards tests both the stand and the bassinet as geometry. Using a 10-inch wide by 10- (a) EN1466:2014 Carry Cots a fully assembled product. inch tall sidewall box on a 10-inch The ASTM F2194–16e1 bassinet stand as a reference product for The BS EN 1466:2014 Child use and standard requires products without a comparison, staff determined the care articles—Carry cots and stands— latching or locking device not to fold reference product would fail the ASTM Safety requirements and test methods when a 20 pound-force is applied to the F2194 bassinet standard’s test and pass European standard applies to products top edge of the bassinet in the direction the EN 1466 standard’s test. Therefore, intended for carrying a child in a lying most likely to cause it to fold. The staff assesses that the ASTM 2194–16e1 position using a handle or stand. This ASTM F2194–16e1 bassinet standard bassinet standard’s stability requirement standard applies to children who cannot requires a lower force than the EN is more stringent for this reference sit unaided or roll over or push up on standard, but the force is applied at a product. their hands and knees and is a higher location (top side of the bassinet) maximum weight of 19.84 pounds. than the EN standard (force applied to v. EN1466:2014 Summary i. Side Height the stand). The higher location of the The EN 1466:2014 carry cots standard force can create a higher torque at the has a side height and sleep surface angle For cots on a stand, EN 1466:2014 latch due to the longer lever arm. For requirement similar to ASTM F2194– standard requires an internal height of bassinets with a locking hinge or latch, 16e1’s bassinet standard. However, the at least 7.87 inches (200 mm) from the the locking mechanism must withstand ASTM F2194–16e1 standard has a top of a mattress, compressed by a a 10-pound force in the direction most potentially more stringent stability 19.84-pound (9kg) steel plate, to the likely to release it. Determining which requirement. lowest point of the upper edge of the latching requirement is more stringent is sides. For carry cots not on a stand, the difficult because the test parameters are (b) EN 1130:2019 Children’s Cribs and standard requires an internal height 5.9 not directly comparable. Staff assesses Cradles inches (150mm) to 7.09 inches that testing the product fully assembled, The European Standard, EN 1130–1: (180mm), depending on the length of as required by ASTM, is a better test 2019 ‘‘Furniture—Cribs and Cradles for the cot, using the same test method. because it simulates realistic use of the Domestic Use’’ has several requirements This requirement measures the internal product. not found in ASTM F2194–16e1. Most side height when an occupant of the The ASTM standard also includes a of these additional requirements address maximum weight compresses the Removable Bassinet Bed Attachment to hazards associated with cribs intended mattress. This standard has a side height Base/Stand requirement and testing to for use with older children (in excess of requirement similar to the ASTM address latching and locking devices the 5-month recommended maximum F2194–16e1 bassinet standard, which intended to secure removable bassinet age for bassinets); and thus, these requires a minimum side height of 7.5 beds to the base/stand. These requirements are not applicable to inches from an uncompressed mattress. requirements and test are unique bassinets. For bassinets on a stand, if the mattress because they address known incidents i. Side Height compresses more than 3⁄8 of an inch, of false latching of a removable bassinet ASTM F2194–16e1 requires a higher bed. By considering the latching, The EN 1130:2019 standard requires a side. For bassinets not on a stand, unintentional folding, and bassinet bed side height of at least 7.87 inches (200 ASTM F2194–16e1 has a higher side attachments to the stand requirements mm) when a 19.84-pound (9kg) steel height of 7.5 inches from an in total, staff assesses that the ASTM plate is placed on the compressed uncompressed mattress, compared to F2194–16e1 bassinet standard’s latching mattress. This measures the crib’s the EN 1466:2014 requirement, which is requirements are adequate. internal side height with a 19.84-pound 7.09 inches from a compressed mattress. iv. Stability Requirements occupant is compressing the mattress. Additionally, ASTM F2194–16e1 This standard has a side height requires a consistent side height no The EN1466:2014 standard requires requirement similar to the ASTM matter the configuration. products with an occupant test mass of F2194–16e1 bassinet standard, which 15.43 pounds not to tip over when requires a minimum side height of 7.5 ii. Sleep Surface Angle placed on a 20-degree surface. inches from an uncompressed mattress. EN1466:2014 rationalizes this test by 3 The EN 1466:2014 standard requires a If the mattress compresses more than ⁄8 maximum sleep surface angle of 10 stating: ‘‘Carry cots shall be designed so of an inch, ASTM F2194–16e1 requires degrees. This requirement is similar to that they do not tip over when they are a higher side. the ASTM F2194–16e1 bassinet placed on slightly sloping ground or standard, which requires a maximum when the child leans against one side of ii. Sleep Surface Angle sleep surface angle of 10 degrees. the carry cot.’’ This is different The EN 1130:2019 standard requires a compared to the ASTM F2194–16e1 maximum sleep surface angle of 10 iii. Latching Requirements bassinet standard that requires the degrees. This standard has a sleep The EN 1466:2014 standard requires product (with simulated newborn surface angle requirement similar to the products with a folding stand occupant) to withstand a 23-lb. vertical ASTM F2194–16e1 bassinet standard, mechanism not to collapse after the force and 5-lb. horizontal force along its which requires a maximum sleep latch is operated (closed and opened) side, without tipping. The rationale in surface angle of 10 degrees. 300 times, and after a 44.96 pound-force ASTM F2194 states the dual application (200N) is applied in the area of the of forces simulates a 2-year-old male iii. Latching Requirements stand most likely to cause the product pulling on the side of the product; staff The EN 1130:2019 standard requires to fold. The EN 1466:2014 standard’s advises that this is a reasonable scenario folding products to contain a dual- latching requirement only simulates the in which the product may tip over. action locking mechanism, and to action of unintentionally folding the Determining which stability unlock with a tool, and to fold only stand without the carry cot or box requirement is more stringent is when the crib is lifted, or not collapse assembled on the stand. In contrast, the difficult, because both standards’ torque after the latch is operated (closed and

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opened) 300 times, and at least an the ASTM F2194–16e1 standard has a F2194–16e1 bassinet standard, which 11.24-pound force (50N) is required to more extensive and stringent latching requires the product (with simulated unlock it. The EN 1130:2019 standard’s requirement. newborn occupant) to withstand a 23- latching requirement only simulates the pound vertical force and 5-lb. horizontal (c) AS/NZS 4385:1996 Infant’s Rocking action of unintentionally folding the force along its side, without tipping. Cradles product’s folding or adjustable legs, The rationale in ASTM F2194 states the while the ASTM F2194–16e1 bassinet The Australian/New Zealand standard dual application of forces simulates a 2- standard tests both the standard and the (AS/NZS 4385:1996) contains year-old male pulling on the side of the bassinet as a fully assembled product. requirements for rocking and swinging product; staff concludes that this is a The ASTM F2194–16e1 bassinet angles used to develop some of the reasonable scenario in which the standard requires products without a ASTM F2194–12 requirements. The product may tip over. locking mechanism to withstand a 20- ASTM rock/swing rest angle pound force applied to the top edge of performance requirement is more v. AS/NZS 4385:1996 Summary the bassinet in the direction most likely stringent because the occupant The AS/NZS 4385:1996 infant’s to cause it to fold. For products with a surrogate, a CAMI dummy, is placed rocking cradle standard has a side locking hinge or latch, the locking against the sidewall, resulting in higher height, sleep surface angle, and stability mechanism must withstand a 10-pound rest angles. requirement similar to the ASTM force in the direction most likely to F2194–16e1 bassinet standard. i. Side Height release it. Staff’s assessment is that However, the ASTM F2194–16e1 testing the product fully assembled, as The AS/NZS 4385:1996 standard bassinet standard has a more stringent required by ASTM, is a better test requires a minimum side height of 11.81 latching requirement. because it simulates realistic use of the inches (300 mm) between the top of the product. mattress support to the top edge of the (d) Canadian Standard (SOR/2016–152) The ASTM standard also includes a lowest rocking cradle’s side. The Cribs, Cradles, and Bassinets Removable Bassinet Bed Attachment to maximum mattress thickness the AS/ The Canadian standard (SOR/2016– Base/Stand requirement and testing to NZS standard permits is 2.95 inches 152) includes requirements for cribs, address latching and locking devices (75mm). Therefore, the minimum side cradles, and bassinets. Staff focused intended to secure removable bassinet height between the top of the mattress their analysis on the requirements for beds to the base/stand. These and the top edge of the lowest side is ‘‘bassinets,’’ which are defined as requirements and the test are unique 8.85 inches. This is similar to the ASTM providing sleeping accommodations for because they address known incidents F2194–16e1 bassinet standard, which a child with sides to confine the child, of false latching of a removable bassinet requires a minimum side height of 7.5 and a sleep surface area less than or bed. By considering the latching, inches between the top of the mattress equal to 4000 cm2 (620 in2). unintentional folding, and bassinet bed and the top of the lowest sidewall. i. Side Height attachments to the stand requirements in total, staff assesses that the ASTM ii. Sleep Surface Angle The Canadian standard requires a F2194–16e1 bassinet standard’s latching The AS/NZS 4385:1996 standard minimum side height of 230 mm (9.05 requirements are adequate. requires the mattress angle on rocking inches), measured from the mattress cradles without a self-leveling device support. Because ASTM F2194–16e1 iv. Stability Requirements not to exceed 5 degrees and 10 degrees allows a bassinet mattress of 1.5 inches, The EN1330:2019 standard requires on rocking cradles with a self-leveling measuring from the upper surface of the products not to tip over when a 19.87- device. This is similar to the ASTM mattress support to the upper surface of pound weight is placed on one side of F2194–16e1 bassinet standard, which the side would be 1.5 inches greater the crib, while on the opposite side’s requires a maximum sleep surface angle than measuring from the upper surface top rail, a 6.74 pound-force is of 10 degrees. of an uncompressed mattress. Therefore, horizontally applied towards the staff advises that the 7.5-inch side weight. This test is similar to the ASTM iii. Latching Requirements height, from the upper surface of an F2194–16e1 bassinet standard with The AS/NZS 4385:1996 standard does uncompressed mattress, is functionally reasonably similar forces. EN1330:2019 not contain any latching requirements to equivalent to the 9-inch side height, rationalizes the test, stating the product address the unintentional folding measured from the upper surface of the ‘‘should remain stable when the child hazard. The ASTM F2194–16e1 bassinet mattress support in the Canadian moves in the crib or when the crib standard is more stringent because it standard. swings along the amplitude permitted requires products without a locking ii. Sleep Surface Angle by the suspension device.’’ ASTM mechanism to withstand a 20-pound F2194–16e1 is based on U.S. incident force without folding, or a 10-pound The Canadian standard requires the data of a 2-year-old sibling pulling over force for hinges with locking sleep surface angle not to exceed 7 a bassinet, which is a more severe mechanisms. The ASTM F2194–16e1 degrees, which is based on a 1995 study condition than an infant moving within also addresses the false latching of a that demonstrated a discernable the product. Therefore, staff concludes removable bassinet bed with difference in infant ability between 5, 7, the ASTM F2194–16e1 bassinet requirements including an automatic and 10 degrees in a side-to-side tilt. standard’s stability requirements are locking latch or a false latch indicator. Staff advises they understand that adequate. Health Canada selected 7 degrees and iv. Stability Requirements applied it to all sides of the product, v. EN 1130:2019 Summary The AS/NZS 4385:1996 standard regardless of head-to-toe or side-to-side The EN 1130:2019 children’s cribs requires a product not to tip over when tilt. The ASTM F2194–16e1 bassinets and cradle standard has side height, a 19.84-pound (9 kg) weight is on the standard allows for a side-to-side resting sleep surface angle, and stability mattress and a 4.49-pound force (20N) is angle of 7 degrees for rocking cradles, requirements similar to the ASTM applied horizontally to the uppermost and limits head-to-toe angle to 10 F2194–16e1 bassinet standard; however, rail. This test is similar to the ASTM degrees. As discussed in section

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VI.A.3(a) of this preamble, based on the and a 22 N (approximately 4.9 pounds) nonfatal incidents, 16 reported an Mannen Study and other factors, the horizontal force, without tipping. Staff injury. Seven of the 11 fatalities Commission concludes that a flat advises that this test evaluates the same involved suffocation. We identified six sleeping surface that does not exceed 10 stability hazard and is substantially hazards related to the risk of injury or degrees from horizontal offers infants equivalent to the ASTM F2194–16e1 death (we did not consider patterns that the safest sleep environment. bassinets standard, differing slightly did not relate to injuries or deaths, such due to conversions to metric. as consumer comments). The hazard iii. Latching Requirements patterns identified among the 183 v. SOR/2016–152 Summary The Canadian standard requires incidents are: Lock/latch problems, folding products to contain an auto- The Canadian standard has a side falls/containment issues, instability, locking mechanism that requires a dual- height and stability requirement similar asphyxiation/suffocation, product- simultaneous action to disengage and to the ASTM F2194–16e1 bassinet related issues, and undetermined that does not fold when a 52.91-pound standard. While the Canadian standard causes. (24kg) load is applied on any area most has a more stringent sleep surface angle Engineering staff analyzed whether likely to damage the mattress support. requirement, the ASTM F2194–16e1 the voluntary standard for bassinets, While the Canadian standard requires bassinet standard has a more extensive ASTM F2194–16e1, would address the an auto-locking mechanism that latching requirement. Staff concludes identified hazards for flat sleep requires a dual-simultaneous action to that the requirements in the ASTM products. The voluntary standard for disengage, it also tests the latching standard are adequate to address the bassinets, ASTM F2194–16e1, is more strength by loading the mattress risk of injury demonstrated in the applicable to these flat products than support. The ASTM F2194–16e1 incident data. ASTM F3118–17a, because these bassinet standard requires that products B. Flat Sleep Products 35 products have a sleep surface less than without a latching or locking device not 10 degrees, and because, as set forth fold when a 20-pound force is applied CPSC received public comments on below, the standard addresses the to the top edge of the bassinet in the the 2019 SNPR regarding the safety of identified hazards associated with these direction most likely to cause it to fold. currently unregulated flat infant sleep products. The current voluntary The ASTM F2194–16e1 bassinet products available in the marketplace. standard for infant inclined sleep standard requires a lower force than the In response, for the final rule CPSC staff products, ASTM F3118–17a, is not Canadian standard, but the force is completed a review of CPSC’s applicable to these flat sleep surface applied at a higher location (top side of epidemiological databases, CPSRMS products, and it does not address the bassinet) than the Canadian and NEISS. CPSC received a total of 183 hazards associated with flat sleep standard (force applied to the mattress incident reports from January 1, 2019 surfaces. support). The higher location of the through December 30, 2020, related to In the 2019 SNPR, the Commission force could create a greater torque at the flat sleep products available in the proposed expanding the scope of ASTM latch, due to the longer lever arm. For marketplace that are currently not under F3118–17a for the mandatory rule, to bassinets with a locking hinge or latch, the purview of any mandatory or include all infant sleep products the locking mechanism must withstand voluntary standard that addresses sleep (inclined and flat) that are not covered a 10-pound force in the direction most hazards. These flat sleep products by another CPSC sleep standard, likely to release it. Determining which include: In-bed sleepers, baskets (that including the bassinets, cribs (full-size latching requirement is more stringent is can function as hand-held carriers as and non-full size), play yards, or difficult because the test parameters are well), baby boxes, compact bassinets, bedside sleepers standards. The 2019 not directly comparable. most of which are portable for travel, SNPR proposed to require that all The ASTM standard also includes a and travel tents. All of these products marketed or intended for Removable Bassinet Bed Attachment to unregulated sleep products are flat infant sleep have a seatback angle of 10 Base/Stand requirement and testing to (sleep surface has no incline) and most degrees or less, and meet 16 CFR part address latching and locking devices come with mattress pads (with the 1218, Safety Standard for Bassinets and intended to secure removable bassinet exception of some baby travel tents). Cradles, which includes the beds to the base/stand. These Based on the following analysis, the performance requirements of ASTM requirements and test are unique Commission determines that the F2194–16e1 bassinets. The following are because they address known incidents performance and labeling requirements the identified hazards for flat sleep of false latching of a removable bassinet of the voluntary standard for bassinets products are discussed below. bed. By considering the latching, and cradles, ASTM F2194–16e1, as (a) Hazard: Lock/Latch Issue unintentional folding, and bassinet bed codified in 16 CFR part 1218, Safety attachments to the stand requirements Standard for Bassinets and Cradles, are One hundred fifteen of the 183 in total, staff assesses that the ASTM adequate to address the risk of injury incidents, and no deaths, were related to F2194–16e1 bassinet standard’s latching associated with flat infant sleep latches that control the opening/closing requirements are adequate. products, and furthermore, finds that of the cover on the product failed. requiring flat products to conform to Although these latch incidents did not iv. Stability Requirements these requirements would also further relate to a product folding or collapsing, The Canadian requirement in reduce the risk of injury associated with they illustrate, nevertheless, that these Schedule 11, Test for Stability of flat sleep products. products have latch failures. From Cradles, Bassinets, and Stands, of their 1. Hazard Pattern Categories analyses on other products, staff is regulation is substantially equivalent to aware that failure of a product’s latch the requirement in ASTM F2194–16e1. Of the 183 reported incidents, 11 are can cause the product to fold or collapse The requirement specifies that the fatalities; among the remaining 172 unintentionally and pose a suffocation product (with a simulated newborn hazard to the infant. The ASTM F2194– 35 Tab C of Staff’s Final Rule Briefing Package e occupant) must withstand a 10-kg contains CPSC staff’s assessment of the adequacy of 16 1 bassinets standard addresses (approximately 22 pounds) static ASTM F2194–16e1 to address incidents associated hazards posed by a lock/latch failure vertical load over a period of 5 seconds with flat sleep products. with an unintentional folding

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requirement. The requirement specifies bassinet unintentionally unlatching the upper surface of the lowest side. that if a folding product does not have from its stand. Staff also assesses that This requirement remains in effect in a latching or locking device, then it the ASTM F2194–16e1 bassinets the most recent version of the bassinets shall not fold when a 20-lb. force is standard’s requirement is more stringent standard, ASTM F2194–16e1. Canada applied in the direction most likely to compared to the ASTM F3118–17a requires a side height of 230 mm (9 fold the product (with simulated infant infant inclined sleep products standard, inches), measured from the mattress occupant). The requirement also which lacks a requirement for products support. Because ASTM F2194–16e1 specifies if a folding product does have that can be removed from a stand. allows a bassinet mattress of 1.5 inches, a single-action latch, then it shall not Therefore, the final rule requires that measuring from the upper surface of the fold when a 10-lb. force is applied in the flat sleep products meet the ASTM mattress support, which is underneath direction most likely to fold the F2194–16e1 bassinets standard’s the mattress, to the upper surface of the product. Staff assesses that this ‘‘unintentional folding requirement’’ side would be 1.5 inches greater than requirement adequately simulates the and the ‘‘Removable Bassinet Bed measuring from the upper surface of an action of unintentionally folding the Attachment to Base/Stand uncompressed mattress. Therefore, staff product, and therefore, to address this requirement,’’ if applicable, to address assesses that the 7.5-inch side height, risk of injury, we conclude that all flat the risk of injury associated with locks from the upper surface of an sleep products with a lock or latch and latching features on these products. uncompressed mattress is functionally should at least meet the ASTM F2194– (b) Hazard: Falls/Containment Issue equivalent to the 9-inch side height, 16e1 bassinets standard’s unintentional measured from the upper surface of the folding requirement. Twelve of the 183 incidents were mattress support in Canada. related to falls or an infant otherwise The ASTM F2194–16e1 bassinets Products that CPSC staff identified as not being kept contained within the standard also includes a ‘‘Removable flat sleep products are not currently product. Of the 12 incidents, one Bassinet Bed Attachment to Base/ subject to a voluntary or mandatory resulted in a death, one required Stand’’ performance requirement. A standard that specifies a minimum side hospital admission, and nine required removable bassinet bed attaches to the height. Flat sleep products that are ED visits. Failure to contain occupants bassinet stand and is secured with a considered hand-held carriers under 16 in an infant sleep product can lead to latch/lock. This requirement states a CFR part 1225, Safety Standard for infants falling or climbing out of the removable bassinet bed shall: Hand-Held Infant Carriers, and ASTM infant sleep product into a hazardous • Not be supported by the bassinet F2050–19, Standard Consumer Safety stand in an unlocked/latched area. Typically, regulated sleep products do SpeciÉcation for Hand-Held Infant configuration; not allow an active occupant restraint Carriers, can be defined as a ‘‘hand-held • automatically lock to the bassinet system for occupant containment. bassinet/cradle’’ product intended for stand and can’t be placed in an Active restraint systems are only sleep, but ‘‘hand-held bassinet/cradles’’ unlocked position on the bassinet effective when the caregiver actively are not subject to a side height stand; uses them and adjusts them correctly; requirement in the mandatory or • clearly and obviously be unstable however, in a sleep environment, active voluntary standard. Products without a when the product is unlocked/latched restraints can create an entanglement minimum side height could fail to by placing the sleeping surface at a and asphyxiation hazard. contain occupants, which can lead to 20-degree incline; The ASTM F2194–16e1 bassinets infants falling or climbing out of the • have a false latch/lock visual standard does not allow the use of product into a hazardous area. indicator designed to visually alert restraints, and instead addresses Table 4 shows the side height caregivers when the bed is not containment-related hazards posed with requirements for each sleep product properly locked to the stand; or a side height requirement, a passive standard. Sleep products that have a • have a lock/latch mechanism that is safety feature. The requirement specifies minimum side height requirement range not needed to pass the stability that the product’s interior side height from 2-inches for the voluntary standard requirement. with an uncompressed mattress shall be for infant inclined sleep products, to 9- The purpose of this requirement is to at least 7.5 inches. inches for cribs. Bassinets, bedside ensure that bassinets that can be In 2012, the ASTM F2194–12 sleepers, and infant inclined sleep removed from their stand are securely bassinets standard first required a products are intended for infants from latched to the stand when in use. Staff minimum 7.5-inch side height based on birth to 5-months old. Cribs are assesses that the ASTM F2194–16e1 the Canadian standard.36 The side intended for newborns up to children bassinets standard’s requirement height is measured from the upper 35-inches tall, which is equivalent to a adequately simulates the action of a surface of the uncompressed mattress to 95th percentile in stature 21-month-old.

TABLE 4—SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTS

Standard Side height requirement Age range

16 CFR 1218—Safety Standard for Bassinets and Cradles ...... 7.5 inches ...... 0–5 months, or sit up. ASTM F2194–16e1, Standard Consumer Safety Specification for Bas- sinets and Cradles. 16 CFR 1219—Safety Standard for Full-Size Baby Cribs ...... 9 inches ...... 0–35 inches tall (95th percentile ASTM F1169–19, Standard Consumer Safety Specification for Full- 21-month old). Size Baby Cribs.

36 78 FR 63,109 (Oct. 23, 2013).

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TABLE 4—SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTS—Continued

Standard Side height requirement Age range

16 CFR 1220—Safety Standards for Non-Full-Size Baby Cribs ...... 9 inches ...... 0–35 inches tall (95th percentile 16 CFR 1221—Safety Standards for Play Yards. 21-month old). ASTM F 406–19, Standard Consumer Safety Specification for Non- Full-Size Baby Cribs/Play Yards. 16 CFR 1222—Safety Standard for Bedside Sleepers ...... 4 inches on side next to adult bed. 0–5 months, or sit up. ASTM F2906–13, Standard Consumer Safety Specification for Bed- 7.5 inches for other 3 sides. side Sleepers. ASTM F3118–17a, Standard Consumer Safety Specification for Infant 3 inches ...... 0–5 months, or sit up. Inclined Sleep Products. 2 inches ...... 0–3 months. 16 CFR part 1225 Safety Standard for Hand-Held Infant Carrier ...... No requirements. ASTM F2050–19 Standard Consumer Safety Specification for Hand- Held Infant Carrier.

Inclined sleep products covered in incidents. Of the 12 incidents, two final rule is codified by requiring ASTM F3118–17a can meet the standard resulted in injuries, one involved an ED products to meet the definitional with a minimum side height of 3-inches, visit. The data summarized in Tab B of requirement of a ‘‘bassinet/cradle.’’ for products intended for newborns, to the Staff’s Final Rule Briefing Package Additionally, the ASTM F2194–16e1 5-month of age and a minimum side includes at least one incident in a small, bassinets standard addresses hazards height of 2-inches, for products portable infant sleep product involving posed by the product’s instability with intended for newborns up to 3-months a sibling interaction resulting in a fall. a stability requirement. The requirement old. Specifically, the NEISS report states: specifies that the product (with Upon review of applicable standards, ‘‘7WKOF WITH HEAD INJURY, FELL simulated newborn occupant) withstand CPSC staff determined that the ASTM FROM PORTABLE BASSINET THAT a 23-lb. vertical force and 5-lb. F2194–16e1 bassinets standard’s 7.5- WAS ON COUCH, APPROX 1.5FT, horizontal force along its side, without inch side height requirement provided YOUNGER BROTHER PULLED THE tipping. The rationale in ASTM F2194 the greatest safety for the intended use BASSINET AND IT FLIPPED ONTO states the dual application of forces for newborns to 5-months of age. Staff THE PLAYMAT, PT LANDED ON RT simulates a 2-year-old male pulling on assesses that the minimum side height SIDE OF HEAD.’’ This sibling the side of the product; staff assesses requirement of 2-inches and 3-inches in interaction-type incident is addressed that this is a reasonable scenario in ASTM F3118–17a is inadequate to by the bassinet standard, as discussed which the product may tip over. address the incidents of infants failing below. Incident data also demonstrate that to be contained in low-sided products, these compact products are used on Unregulated flat sleep products are and the 3-inch side height is lower than elevated surfaces, such as beds and not required to have a stand. Therefore, the center of gravity of a 5-month-old couches, from which the infant and infant on its side. Staff determined that these products can be placed directly on product fell. Therefore, with respect to because most flat sleep products are the floor or on potentially hazardous or the product’s stability, the final rule intended for infants under 5 months, unstable elevated surfaces, such as requires that all infant sleep products who cannot sit upright unassisted, the tables, countertops, soft mattresses, or meet the stability requirement of the side height requirement in ASTM couches. The ASTM F2194–16e1 voluntary standard for bassinets, ASTM F2194–16e1 is adequate to address bassinets standard addresses this hazard F2194–16e1, as provided in 16 CFR part containment incidents. Based on staff’s scenario by requiring bassinets to have 1218, to further reduce the risk of injury analysis, the Commission determines a stand/base/frame. ASTM F2194–16e1 associated with product tip-over. that flat sleep products with no side defines a ‘‘bassinet’’ as a small bed The Canadian requirement in height requirements pose a potential fall ‘‘supported by free standing legs, a Schedule 11, Test for Stability of hazard, as reflected in the incident data. stationary frame/stand, a wheeled base, Cradles, Bassinets and Stands, of their Staff’s analysis demonstrates that the a rocking base, or which can swing regulation is substantially equivalent to ASTM F2194–16e1 bassinets standard’s relative to a stationary base.’’ This the requirement in ASTM F2194–16e1. 7.5-inch side height requirement is requirement to have a stand, and be The requirement specifies that the appropriate and would adequately raised off the floor, increases the product (with a simulated newborn address the falls/containment hazard in stability of a portable product by occupant) withstand a 10-kg flat sleep products for infants up to 5 discouraging or preventing use of the (approximately 22 pounds) static months old or who cannot sit up product on other, less stable, surfaces, vertical load over a period of 5 seconds unassisted. Therefore, consistent with such as elevated surfaces or soft surfaces and a 22 newton (approximately 4.9 the 2019 SNPR, the final rule requires (couches and adult beds). Therefore, pounds) horizontal force without that all infant sleep products, inclined with respect to this hazard scenario, and tipping. Staff advises that this test is and flat, meet the side height as proposed in the 2019 SNPR, the final substantially equivalent to the ASTM requirement of the ASTM F2194–16e1 rule requires that all infant sleep test, differing slightly due to bassinets standard, as provided in 16 products, flat and inclined, meet the conversions to metric. CFR part 1218, to address fall/ ASTM F2194–16e1 bassinets standard’s (d) Hazard: Asphyxiation/Suffocation containment hazards. requirements, including requiring products to have a stand, to further Nine of the 183 incidents were related (c) Hazard: Instability reduce the risk of injury from a product to infants that partially or fully rolled Twelve of the 183 incidents were placed on a hazardous elevated surface over from their initial position in infant related to the instability of the product. or an unstable surface, such as a couch sleep products. Of the nine incidents, An unstable product can lead to tip-over or adult bed. This requirement in the eight resulted in a death, and one

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resulted in a near-suffocation prevented bassinet to prevent the 5th percentile 0 are unable to assess whether the by a nearby parent. to 2-year-old torso probe from passing voluntary standard for bassinets, ASTM The voluntary standard for bassinets, through. This requirement prevents a F2194–16e1, would adequately address ASTM F2194–16e1, addresses the child’s torso from fitting through any the hazards in this category. asphyxiation/suffocation hazard with openings in the fabric sidewalls; 2. Assessment of International the following general/performance therefore, staff concludes this Standards requirements: requirement would prevent a feet-first • 5.10 Corner Posts: This head entrapment. (a) EN12790:2009 Reclined Cradles • requirement addresses corner post 6.9 Rock/Swing Angle. This The scope of the European Standard, extensions that can entangle ribbons, requirement limits the bassinet’s EN 12790–2009 ‘‘Child use and care pacifier cords, necklaces, or occupant sleeping surface angle to less than 20 articles—Reclined cradles’’ includes clothing. Entanglement of any of these degrees when rocked, and seven degrees inclined bassinets/cradles, car seat items could lead to the asphyxiation of when the bassinet is at rest. In the 2019 carriers, hammocks, and bouncers. the occupant. This requirement limits SNPR, and in this final rule, the Some of the general requirements could the extension of a bassinet’s corner post Commission determined that a flat sleep apply, but because the scope of the from extending more than .06 inches surface that does not exceed 10 degrees products that fall within this standard is above the upper edge of an end or side offers infants the safest sleep not the same as the final rule, most of panel. Corner posts that extend at least environment. This conclusion is based the requirements are not applicable to 16 inches above the top of a side rail are on the Mannen Study. infant sleep products. exempt because they are deemed In total, these requirements address inaccessible to the occupant. These are known suffocation hazards with infant i. Side Height the same requirements found in the sleep and create a minimally safe sleep The EN 12790:2009 standard does not regulated ASTM F406–19 (non-full- environment. Therefore, for the final have a side height requirement, but it sized cribs) and ASTM F1169–19 (full- rule, with respect to the asphyxiation/ includes a three-point restraint to sized cribs) standards that CPSC staff suffocation hazard, we finalize the 2019 address the containment hazard. The previously concluded adequately SNPR proposal, by requiring that all ASTM F2194–16e1 bassinet standard is address the corner post entanglement infant sleep products meet general and more stringent by requiring a minimum hazard. performance requirements of the side height of 7.5 inches. Restraints are • 6.1 Spacing of Rigid-Sided voluntary standard for bassinets, ASTM an active safety feature that might not Bassinet/Cradle Components. This F2194–16e1, as provided in 16 CFR part always be used, while the side height requirement limits the distance between 1218, to further reduce the risk of death requirement is a passive safety feature. slats to less than 23⁄8 inches to mitigate from suffocation. the suffocation hazard from feet-first ii. Sleep Surface Angle head entrapment. (e) Hazard: Product-Related Issues • The EN 12790:2009 standard requires 6.2 Openings for Mesh/Fabric- Three of the 183 incidents were a seatback angle between 10 degrees and Sided Bassinets/Cradle. This related to mold or quality of the product 80 degrees, while the ASTM F2194– requirement tests openings in the material. Two of the three products 16e1 bassinet standard is more stringent bassinet’s mesh for entrapment of were in-bed sleepers, while the third by requiring a maximum sleep surface fingers, toes, and snaring buttons, often was a compact bassinet/travel bed. All angle of 10 degrees. The EN 12790:2009 used on infant clothing. The snaring of three reported an injury. None of the standard was written for products that a button entraps the button and could voluntary standards currently address may or may not be intended for sleep, lead to asphyxiation as the infant conditions such as mold that manifest such as car seats, a scope that is broader becomes entangled and entrapped. In due to the conditions under which a than the scope of the ASTM bassinet this performance requirement, the product is used. A moisture-resistant standard. The Mannen Study concluded mesh-sided bassinet’s openings cannot requirement has been discussed in the that a seatback angle of 10 degrees or allow a 1⁄4-inch rod to fit through. ASTM task group for baby boxes (which • less is safe. Accordingly, the sleep 6.5.3 Pad Dimensions. This is under the bassinet subcommittee), but surface requirement in the final rule requirement mitigates the hazard of the task group has not reached a remains consistent with the Mannen suffocating when entrapped in the space consensus on appropriate performance Study findings, and as already codified between the edge of the mattress and the requirements to address mold and in 16 CFR part 1218. bassinet’s sidewall, by limiting the moisture resistance. CPSC staff will available space to less than 1 inch. continue to work with this task group. iii. Latching Requirements • 6.7 Bassinets with Segmented (f) Hazard: Undetermined Issues The EN 12790:2009 standard specifies Mattress: Flatness Test. This that infant rocking cradles must have at requirement limits sleep surface Three of the 183 incidents did not least one automatic locking latch variability of a segmented or folding have enough reported information for us mechanism, and that the locking mattress to 10 degrees or less. This angle to determine the issue involved. Two of mechanisms: was determined to reduce the likelihood the incidents were fatalities; in both • Require 50N (11.24 pounds-force) to of an infant’s face becoming engulfed by cases, CPSC Field investigation reports unlatch after operating the latch 300 a small ‘‘V’’ shape formed by the creases indicate that the cause of death is times; in a folded mattress, potentially present undetermined. The third incident • Require a tool to unlatch; in a bassinet that uses a folding play resulted in a hospitalization due to • Require two consecutive actions to yard mattress as the bassinet mattress. unspecified breathing difficulties unlatch; or • 6.8 Fabric-Sided Enclosed suffered by the infant. The reports did • Require two independent and Openings. This requirement addresses not provide sufficient information on simultaneous actions to unlatch. the hazard of a feet-first head the circumstances of deaths, and injury The EN 12790:2009 standard’s entrapment through the openings of reports involved unspecified falls. latching requirement simulates the fabric-sided bassinets. This requirement Without information on the action of unintentionally folding the limits the openings in a fabric-sided circumstances of deaths or injuries, we product. The ASTM F2194–16e1

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bassinets standard similarly includes reclined cradle on an uneven surface. height for containment and permits a requirements that address the This is different compared to the ASTM more inclined sleep surface angle for unintentional folding hazard and F2194–16e1 bassinets standard, which products that include reclined cradles requirements that address the false requires the product (with simulated and car seats for children up to 19.84 latching of a removable bassinet bed. newborn occupant) to withstand a 23-lb. pounds. Therefore, staff assesses that the ASTM vertical force and 5-lb. horizontal force F2194–16e1 bassinets standard’s along its side, without tipping. The C. Applicability of ASTM F2194–16e1 to latching requirements are adequate. rationale in ASTM F2194 states the dual Flat Sleep Product Hazards application of forces simulates a 2-year- iv. Stability Requirements Table 5 summarizes the hazards old male pulling on the side of the The EN 12790:2009 standard requires product; staff concludes that this is a associated with flat sleep products and products with a test mass not to tip over reasonable scenario in which the how each hazard category is addressed when placed on a 15-degree surface. product may tip over. by the voluntary standard for bassinets, The test mass for cradles designed for ASTM F2194–16e1. Table 5 occupants up to 13.22 pounds is 19.84 v. EN 12790:2009 Summary demonstrates that four hazard categories pounds. The test mass for cradles The EN 12790:2009 reclined cradle (shaded) are addressed by ASTM designed for occupants up to 19.87 standard is less stringent than the F2194–16e1: Latching, Falls/ pounds is 33.06 pounds. This standard ASTM F2194–16e1 bassinets standard Containment, Instability, and simulates the stability of an occupied by not requiring any minimum side Asphyxiation/Suffocation. TABLE 5—FLAT SLEEP PRODUCT HAZARDS ADDRESSED BY BASSINETS VOLUNTARY STANDARD

Infant sleep hazards Applicable Product voluntary Falls/ Asphyxiation/ Miscellaneous standard Latching containment Instability suffocation product-related Undetermined

Flat Sleep Products ...... 115 incidents: 12 incidents: 1 12 incidents: 2 9 incidents: 8 deaths; not 3 mold-related 3 incidents: Two (flat and inclined). Not currently death. Not cur- injuries. Not currently addressed. incidents; not deaths. Too lit- addressed. rently ad- currently ad- currently ad- tle information dressed. dressed. dressed. to determine addressability. Bassinet/Cradle ..... ASTM F2194– Unintentional Side height re- Stability require- Max sleep surface angle Not currently ad- Too little infor- 16e1. folding require- quirement. ment. defined in definition; dressed; task mation to de- ment. Restraints not allowed; group work. termine Flatness/hazardous Vs addressability. identified; Pad dimen- sions; Corner posts; fabric sided enclosed openings; Spacing; Mesh openings.

Based on this assessment of the definition of ‘‘accessory.’’ 82 FR 16964 Commission received 56 comments hazards associated with flat sleep (April 7, 2017). The Commission also within the comment period. We also products, and consistent with the 2019 collected comments on the 2019 SNPR, considered two late-filed documents, SNPR, the final rule requires that all which proposed to incorporate by one received on February 2, 2021, and infant sleep products not already reference the current voluntary standard one received on April 30, 2021. We regulated by a CPSC sleep standard for infant inclined sleep products organized the comments by rulemaking meet the requirements in the ASTM (ASTM F3118–17a), with modifications notice (2017 NPR or 2019 SNPR), and F2194–16e1 bassinets standard, as to make the standard more stringent, to then by topic. provided in 16 CFR part 1218, to further reduce the risk of injury. 84 FR Numerous commenters on the 2019 address the risk of injury associated 60949 (Nov. 12, 2019). The 2019 SNPR SNPR, such as the American Academy with these sleep products. Specifically, proposed to expand the scope of the of Pediatrics (AAP), consumer groups, the final rule requires that infant sleep rule to include all unregulated infant and individual parents, supported the products, meaning products that are sleep products, including inclined SNPR, because the products covered in marketed or intended as a sleeping products and non-inclined, flat the final rule will be required to follow accommodation for an infant up to 5 products. The 2019 SNPR invited the the AAP safe sleep guidelines. Based on months of age, and that are not subject public to submit written comments consideration of the comments received, to a CPSC sleep standard (bassinets and during a 75-day comment period, for the final rule, the Commission will cradles, cribs (full-size and non-full- beginning on the SNPR publication maintain the proposed 12-month size), play yards, or bedside sleepers), date, and ending on January 27, 2020. In effective date, and make several meet the requirements of 16 CFR part response to a request for an extension of clarifications, as listed in section I.F of 1218, including conforming to the the comment period, the Commission this preamble. definition of a ‘‘bassinet/cradle.’’ extended the comment period by 30 days, closing on February 26, 2020. 85 A. Comments on the 2017 NPR VII. Response to Comments FR 4918 (Jan. 28, 2020). 1. Safety of Inclined Products The Commission collected comments Below we consolidate the on the 2017 NPR, which proposed to Commission’s responses to comments Comment 1: Three commenters incorporate by reference the then- on the 2017 NPR and the 2019 SNPR. disagreed with the 2017 NPR, stating current voluntary standard for infant In response to the 2017 NPR, the that infant sleep products with a 30- inclined sleep products, ASTM F3118– Commission received seven comments. degree seat back angle are not safe and 17, with a modification to the standard’s In response to the 2019 SNPR, the contradict the AAP’s safe sleep

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recommendations. One commenter also manufacturers to market the product in products to contain the infant in the indicated that the Commission should: a way to avoid meeting the requirements product. Consistent with the 2019 • Conduct more research on the 30- of the rule. SNPR, the Commission removed the degree seat back angle; Response 2: Although the definition restraint requirement in the final rule, • Conduct more research on the commenter refers to in the standard because restraints can create a developmental implications when an no longer includes the term ‘‘inclined,’’ strangulation hazard. The passive infant is restrained while sleeping; we respond here to the concept of containment provision in the bassinet • Provide performance requirements including the phrase ‘‘marketed or and cradle standard, which requires a to address product misassembly; intended’’ in the definition of ‘‘infant product side height of 7.5 inches and a • Make the side height requirement sleep product’’ in the final rule. A flat (below 10 degree) sleep surface, match the 7.5 side height requirement in manufacturer’s intended use of the follows safe sleep practices for the bassinets and cradles standard; product and marketing guide informs containment: A bare, flat, infant sleep • Develop performance or design caregivers about the product’s safe use. surface. changes for compact units so they Manufacturers of products that are not cannot be placed on a raised surface, in designed or marketed for use as an B. Comments on the 2019 SNPR crib, or on soft surface; infant sleep product should provide 1. Scope of the Final Rule • Add seat back height requirement caregivers with instructions and (a) All Products Marketed, Promoted, or for infant products like newborn warnings regarding safe use of the Otherwise Indicated for Sleep products; product. Including a manufacturer’s • Add requirements for hammocks to marketing and intent in the definition Comment 4: A commenter suggested: increase stability; also assists the Commission to enforce ‘‘[t]he new standard should apply not • Add requirements for flat sleep the regulation, because it provides just to those infant products intended by products, so an infant cannot move into objective criteria for CPSC staff to apply the manufacturer for sleep or certified as an unsafe chin to chest position; to a product’s name, packaging, being for sleep, but also any product • Add pictograms to warnings like warnings, labeling, and marketing that is marketed, promoted, or otherwise slings and hand-held carriers; materials about whether the product indicated—or may be reasonably • Include ‘‘marking’’ on products to falls within the scope of the rule. CPSC interpreted as indicating—as being for show compliance with new regulations; staff has experience using marketing any kind of sleep, including products • Conduct market surveillance after a materials to enforce CPSC’s regulations, described using substitute language for regulation becomes effective; and and CPSC is required to use such sleep, such as ‘nap’ or ‘snooze.’ ’’ • Have a 6-month effective date for materials in some cases. For example, Several other commenters expressed the final rule. section 3 of the CPSA provides factors concern that various terms used in the Response 1: We agree, based on the for determining whether a product is a 2019 SNPR were vague, and Mannen Study, that infant sleep ‘‘children’s product,’’ and includes recommended that more precise products, as defined in the final rule, several factors that require reviewing definitions be provided for ‘‘sleep’’ and should not have a seat back/sleep labeling, promotion, and advertising, to ‘‘sleeping accommodations.’’ In surface angle greater than 10 degrees. determine whether a product is addition, commenters requested The Commission proposed to address ‘‘designed or intended primarily for clarification regarding which products many of the commenter’s in-scope children 12 years of age or younger.’’ 15 are included in the definitions. recommendations noted above in the U.S.C. 2052(a)(2). Products that have no Response 4: In response to this 2019 SNPR, and is now finalizing the use other than infant sleep, based on the comment, the preamble and regulation requirements, by requiring inclined and product’s design, cannot be labelled as text for the final rule: (1) Clarify that the flat sleep products that are marketed or not intended for infant sleep to avoid scope of the rule includes products with intended to provide a sleeping meeting the requirements of the final inclined and flat sleep surfaces, and (2) accommodation for an infant up to 5 rule. more precisely explain the definition of months old, to meet the bassinet an ‘‘infant sleep product.’’ For example, standard. Due to the expected 3. Comments Superseded by the 2019 to clarify that the scope of the rule significant economic impact on some SNPR includes inclined and flat sleep manufacturers, the Commission will Comment 3: Two commenters agreed products, the scope of CPSC’s regulation maintain the proposed 12-month with the modification of the ‘‘accessory’’ text in § 1236.2, and the scope of the effective date for the final rule. definition in the 2017 NPR, and with revised voluntary standard in section the 12-month effective date. One 1.3, explain that the scope of the infant 2. Definition of ‘‘Infant Inclined Sleep commenter had a specific comment sleep products rule includes products Product’’ related to restraint requirements in the with inclined and flat sleep surfaces. Comment 2: A commenter stated that NPR. The final rule also broadens the the phrase, ‘‘primarily intended and Response 3: The 2019 SNPR definition of an ‘‘infant sleep product’’ marketed to provide sleeping supersedes the 2017 NPR. The proposed to include the term ‘‘marketed’’: Which accommodations,’’ in the proposed modification to the definition of is ‘‘a product marketed or intended to definition of an ‘‘infant inclined sleep ‘‘accessory’’ is no longer at issue in the provide sleeping accommodations for an product,’’ is not needed, because final rule, because this definition has infant up to 5 months old that is not ‘‘incorporating a manufacturer’s been removed, along with other subject to any of the following . . . .’’ marketing intentions into a definition of requirements related to inclined sleep The definition then lists CPSC’s five a product which impacts the safety products. The Commission will infant sleep standards, to ensure that all standard of that product opens the door maintain the 12-month effective date for infant products marketed or intended to potential conflicts of interests.’’ The the final rule, to provide manufacturers for infant sleep meet the requirements of commenter reasoned that a child’s age and importers sufficient time to come a CPSC sleep standard, so that all and the product incline are objective into compliance. Allowance of a products meet minimum safe sleep factors, while a manufacturer’s intent is restraint requirement in an infant sleep requirements. Staff modified the more subjective, and could allow product was unique to inclined sleep introduction, scope, and definitions in

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the final rule to clarify the applicability products have use patterns very similar The purpose of the rule is to set of the rule to any infant sleep product to products that fall within the scope of minimum safe sleep requirements for not covered by another CPSC sleep ASTM F3118. The commenter requested products that are marketed or intended standard. clarification of the distinguishing for infant sleep up to 5 months old. The While newborns can and do fall features or characteristics that Commission is aware that infant sleep asleep in many products, because young differentiate these two types of products products share hazard patterns that can infants sleep for extended hours with very similar usage patterns. be addressed by performance and throughout the day, certain products are Response 5: The purpose of the final labeling requirements; but currently, a designed, marketed, and intended for rule is to regulate all products marketed gap exists between regulated and infant sleep. Therefore, ‘‘sleep’’ and or intended for infant sleep for infants unregulated products. Therefore, the ‘‘sleeping accommodations’’ refer to up to 5 months old. Accordingly, the scope of the final rule includes all infant products that are marketed or intended products within the scope of the final sleep products not already covered by a for both extended, unattended sleep, rule are all marketed and intended for mandatory CPSC sleep standard and also napping, snoozing, and other sleep, and do not include car seats, (bassinets, full-sized cribs, non-full- types of sleep in which a parent may or swings, or rockers, unless a product is sized cribs, play yards, or bedside may not be present, awake, and marketed or intended for sleep. sleepers), and requires the product to be attentive. Additionally, if a product Newborns can and do fall asleep in tested to the bassinet standard as a name implies the product is for use as many products, because young infants default, so that all infant sleep products an infant sleep product, such as use of typically sleep 16 to 17 hours a day, 1 follow a mandatory safety standard for the terms ‘‘bed,’’ ‘‘bassinet,’’ or ‘‘crib,’’ to 2 hours at a time. By 3 months, infant sleep, specifically (and but does not already comply with the infants can sleep 4 to 5 hours during the minimally) the standard for bassinets bassinet or crib regulation, the product day and 9 to 10 hours during the and cradles. Based on staff’s evaluation, falls within the scope of the final rule. night.37 However, products such as car following the requirements of the If a product, through marketing, seats, swings, and rockers typically are bassinet and cradle standard would pictures, and written description, not marketed for use as an infant sleep address the hazard patterns found in the indicates that the product is being sold product; these products are intended for incident data for unregulated inclined as an infant sleep product for infants up use while the child is awake. Moreover, and flat sleep products (see section VI to 5 months old, that product will be regarding car seats, CPSC has of this preamble and Tab B and C of covered by this regulation if it is not jurisdiction only for use outside of an Staff’s Final Rule Briefing Package). already subject to a CPSC sleep automobile, when the product is being The Commission is also concerned standard. used as an infant carrier; while the about new infant sleep products that The 2019 SNPR included four National Highway Traffic Safety come on the market and that do not definitions, ‘‘infant sleep products,’’ Administration (NHTSA) has follow any CPSC sleep standard. The ‘‘newborn sleep products,’’ ‘‘compact jurisdiction over car seats being used in concern is that caregivers may view sleep products,’’ and ‘‘accessory sleep an automobile, including the car seats’ these products as safe because they are products.’’ However, this distinction is angle and design for safe use in an on the market, even though these not necessary and creates confusion automobile. products may not address known infant Comment 6: Several commenters when identifying infant sleep products, sleep hazards or may not be tested to an stated that the scope of the 2019 SNPR because there are no unique appropriate standard. Accordingly, the was too broad, and expressed concerns requirements in this rule based on these final rule requires all products marketed that non-sleep products would be definitions. Accordingly, for the final or intended for sleep for infants up to included. Some of the comments rule, to clarify which infant sleep 5 months old to follow core safe sleep requested specific exclusions or products are subject to the rule, the principles, which the Commission, in inclusions to the scope of the final rule. Commission removed the separate agreement with AAP, states are: Place Response 6: The final rule does not definitions of ‘‘newborn,’’ ‘‘compact,’’ infants alone, on their back, and on a apply to products that are not marketed and ‘‘accessory’’ sleep products, and flat, firm surface with no restraints or or intended for infant sleep, such as will rely solely on the definition of an loose fabric nearby. bouncer seats, swings, infant chairs, or ‘‘infant sleep product’’: Rather than list specific inclusions other similar durable infant or toddler 3.1.7 infant sleep product, n—a and exclusions, other than excluding products that are marketed for use while product marketed or intended to crib mattresses, the scope and a child is awake. In addition, the provide a sleeping accommodation for definitions in the final rule address Commission is specifically excluding an infant up to 5 months of age, and that potential confusion about which infant crib mattresses that fall within the scope is not subject to any of the following: sleep products are covered. For • of the voluntary standard for crib 16 CFR part 1218—Safety Standard example, the definition of an ‘‘infant mattresses, ASTM F2933, from the for Bassinets and Cradles sleep product’’ states: • scope of the final rule. A crib mattress, 16 CFR part 1219—Safety Standard 3.1.7 infant sleep product, n—a alone, does not meet the definition of an for Full-Size Baby Cribs product marketed or intended to • ‘‘infant sleep product,’’ and is always 16 CFR part 1220—Safety Standard provide a sleeping accommodation for used in conjunction with a sleep for Non-Full-Size Baby Cribs an infant up to 5 months of age, and that • 16 CFR part 1221—Safety Standard product, such as a crib or play yard, is not subject to any of the following: for Play Yards which are within one of the five existing • • 16 CFR part 1222—Safety Standard CPSC sleep standards. The Commission 16 CFR part 1218—Safety Standard for Bedside Sleepers issued a notice of proposed rulemaking for Bassinets and Cradles • 16 CFR part 1219—Safety Standard (b) Distinguishing Non-Sleep Products for crib mattresses in 2020, and we intend to finalize a separate rule on crib for Full-Size Baby Cribs • Comment 5: A commenter stated that mattresses this fiscal year. 16 CFR part 1220—Safety Standard infant car seats, swings, and rockers for Non-Full-Size Baby Cribs • typically have seatback angles greater 37 https://www.stanfordchildrens.org/en/topic/ 16 CFR part 1221—Safety Standard than 30 degrees, adding that these default?id=infant-sleep-90-P02237. for Play Yards

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• 16 CFR part 1222—Safety Standard Commission declines to explicitly as they may roll out of the product, or for Bedside Sleepers exclude sleep positioners from the final pull themselves out of the product. Comment 7: Several commenters rule at this time. The unregulated products on the asked for clarification regarding whether market with which CPSC has concerns, (c) Upper Age Limit for Infants Up to 5 e.g., in-bed sleepers, baby boxes, and products, similar in design to inclined Months Old sleepers but marketed as a ‘‘soother,’’ compact bassinets, are intended for this ‘‘rocker,’’ or ‘‘lounger,’’ are in-scope for Comment 9: The 2019 SNPR posed a younger, more vulnerable population. In the rule, and suggested that such question regarding whether the addition, CPSC data indicate that 34 products should be in-scope due to the Commission should remove the upper percent of the incidents involving potential for consumer confusion as to age limit from the scope of the inclined sleep products and 49 percent intended uses. We also received a mandatory standard, to accommodate a of the incidents involving unregulated, comment asking that inclined products broad scope of infant sleep products. flat, sleep products happened to infants for activity and transport, such as a Several commenters stated that the final 0 to 5 months of age. Infants 6 to 12 bouncers, strollers, and swings, be rule should remain applicable to months old were involved in 9 percent excluded from the scope of the rule. products intended for infants up to 5 of inclined sleep products and 4 percent Response 7: Infant products, inclined months old. Otherwise, the commenters of unregulated, flat sleep product or flat, do not fall within the scope of said new requirements addressing incidents, respectively. Therefore, consistent with the 2019 SNPR, the final the final rule as long as they are not containment, stability, and side height rule limits the scope of the standard to intended for sleep, and they are would need to be added to the bassinet infants up to 5 months of age. Due to the marketed conspicuously as not for sleep standard for products intended for ages size and design of these unregulated by infants up to 5 months old. This 6 to 12 months, noting that the existing compact/travel products, older infants means that the product packaging, bassinet requirements are designed only should not be placed to sleep in these marketing materials, inserts, and for infants up to 5 months old. products, and older infants are not instructions cannot indicate that the Response 9: After further included within the scope of the final product is for sleep, or imply through consideration, the Commission agrees rule. pictures of sleeping infants that sleeping that changing the scope of the final rule in the product is acceptable. In addition, to remove the upper age limit, or to (d) Consumer Registration Rule if ‘‘attended’’ or ‘‘supervised’’ sleep is include products intended for infants Comment 10: A commenter expressed indicated, then the product would be up to 12 months old (as suggested at an no objection to requiring product considered within the scope of the final ASTM task group meeting), would registration cards for products within rule. The product name, description, require new performance, labeling, and the scope of the rule, but suggested that and instructions also cannot include testing requirements in the bassinet the Commission ‘‘remain open to references to sleep, snooze, dream, or standard. As the commenters noted, the innovation as to the specific methods of nap. CPSC staff would consider bassinet standard only applies to infants achieving optimum product traceability, decorations on the product that include up to 5 months of age. Therefore, a particularly now that so many products pictures of sleeping animals or sleeping number of requirements in the ASTM are linked to internet devices.’’ cartoon figures to imply the product is F2194–16e1 bassinet standard, would Response 10: In the 2009 NPR for the intended for sleep. Additionally, the need to be changed to address older, consumer registration rule (74 FR 30986 product must not be described as a bed. larger, and more mobile and active (June 29, 2009)), the Commission said it: Some of these products, such as stroller infants, including changes to the scope ‘‘intends to encourage innovation in the accessories, are already required by the in section 1.3, the stability requirement use of the internet for product mandatory standard for that product in section 6.4, and the side height registration,’’ and the methods of type to meet the bassinet standard when requirement in section 6.5.4. registration online are encouraged, the product is in bassinet mode. Additionally, the final rule focuses on whether through a website or email. The Comment 8: One commenter hazards to young infants associated with Commission is open to innovation in acknowledged that the scope of the rule infant sleep products because infants this area, but we note that section 104(e) does not include sleep positioners and under 5 months old are the most of the CPSIA sets forth a process the requested ‘‘the CPSC to better enforce vulnerable, due to their limited mobility Commission must follow to allow new the ban on sleep positioners.’’ and young, developing respiratory technology for product registration, in Response 8: Neither CPSC, nor FDA, system. Requiring currently unregulated lieu of the product registration card has a ‘‘ban on sleep positioners’’; inclined and flat sleep products to meet requirements in part 1130. however, both agencies advise the bassinet standard sets minimum Comment 11: A commenter supported consumers not to use them with infants requirements for safe sleep. Bassinets the Commission’s amendment of the due to the risk of suffocation. Sleep are designed for children who are not consumer registration rule, 16 CFR part positioners are considered accessories, yet mobile, and the final rule addresses 1130, to identify infant sleep products and not an ‘‘infant sleep product’’ under the hazards seen in this population. as durable infant or toddler products the definition proposed in the 2019 Older infants, i.e., 6 to 12 months old, subject to the product registration SNPR or as clarified in the final rule. have different needs for sleep, and the requirements, so that freestanding sleep Similar to crib mattresses, sleep existing standards for this older age products without a frame, are included positioners are not intended to be used group are designed to address those within the scope of part 1130. as the sole product for sleep; instead, needs. By 6 months of age, infants have Staff Response 11: To avoid they are used in conjunction with a developed enough mobility that they confusion, and to ensure that all infant sleep product, for example, to hold an can perform such actions as rolling back sleep products fall within the infant in a position while inside a crib. and forth and pulling themselves up. requirements of part 1130, the final rule Therefore, sleep positioners do not fall The Commission agrees with CPSC updates the list of durable infant or within the final rule because they are staff’s assessment that it is unsafe for 6 toddler products in part 1130 to not intended to provide a sleeping to 12 month olds to be in a confined explicitly identify ‘‘infant sleep accommodation for an infant. The space, such as a bassinet, for sleeping, products’’ as durable infant or toddler

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products, as a subcategory of bassinets prone position, or rolling out of the hazard patterns, consistent with the and cradles. product and becoming entrapped. The incident data discussed in this final final rule identifies the flat sleep rule, involved infants falling out of in- 2. Incident Data products that fall within the scope of bed sleepers, rolling into the side, (a) Inclusion of Flat Sleep Products the rule, provides incident data, bedsharing, and consumer complaints. Comment 12: Multiple commenters describes hazard patterns, analyzes the An overlay hazard typically occurs expressed concern about in-bed effectiveness of the bassinet standard to during bed-sharing, when a parent lays sleepers, baby boxes, and compact address the hazards, and compares the over their infant, and typically does not bassinets being subject to the standard. performance requirements in realize they have done so because they Concerns included: international standards to demonstrate are asleep. Accordingly, during task that these products have similar hazard group and subcommittee meetings, staff • In-bed sleepers, baby boxes, and patterns that can be addressed by the expressed additional concerns with low compact bassinets are not identified requirements in the bassinet standard. side height, soft-sided, in-bed sleepers, in CPSC data; Comment 13: Several commenters because use of such products may • Bed-sharing is a common practice in urged the Commission to work with provide parents with a potentially false the United States and abroad; ASTM to develop product-specific sense of security when bed-sharing. • Potential disparity in safety among in- safety standards for each of the Based on this information, and bed- bed sleepers versus a potential ban of identified flat products, such as in-bed sharing concerns generally, CPSC has in-bed sleepers; sleepers, baby boxes, and compact • Interest in increased advocacy substantial concerns that a low, soft- bassinets, and to do so in a separate sided, in-bed sleeper may not prevent a regarding bed-sharing; and • Differences among products effort. parent from inadvertently laying over an Response 13: The ASTM process for necessitates different requirements infant and suffocating the baby. CPSC developing the voluntary standard for based on demonstrable hazard data. data for in-bed sleepers is anecdotal in infant inclined sleep products took nature, and therefore, we may not have Commenters objected to including non- close to 5 years before the standard was received overlay incidents that involve inclined sleep products in this published. The bassinet subcommittee an in-bed sleeper, but the large number rulemaking, including objecting to also has been working about 5 years to of overlay incidents reported to the replacing the term ‘‘infant inclined add ‘‘compact bassinets’’ to the CPSC generally indicate that bed- sleep products,’’ with the more general standard, which has not been sharing can be hazardous. ‘‘infant sleep products.’’ Instead, these completed. CPSC staff has participated Comment 15: A commenter stated that commenters urged the Commission to in these efforts and provided incident the 2019 SNPR is well-intentioned, but focus on inclined products for this data to the ASTM committees and task that it is premature, and that the scope rulemaking and to review requirements groups. Throughout all this time, of the rule ultimately may harm for non-inclined products in separate inclined and compact infant sleep consumer safety, because consumers rulemaking efforts. A commenter stated products have entered the retail market will use soft bedding and other tools to that it is inappropriate to require all without meeting any safe sleep testing, replace an entire category of products products not subject to an existing voluntary or mandatory. The incident that effectively are banned under the standard to comply with the bassinet data discussed in section III of this SNPR. The commenter stated that the standard. preamble (Tab B of Staff’s Final Rule data necessary to support the rule is Response 12: The Commission Briefing Package), and the engineering either missing or incorrect. Another recognizes that bed-sharing is a common and human factors analysis in section VI commenter stated that the data on in- practice of parents, both in the United of this preamble (Tabs C and D of Staff’s bed sleepers, and the existing CPSC States and abroad. However, we cannot Final Rule Briefing Package), sleep standards, do not support CPSC’s recommend bed-sharing as a safe sleep demonstrate that inclined, compact, and approach in the 2019 SNPR, noting that practice, due to the increased risk of in-bed sleep products pose risks to babies die in all types of infant sleep SIDS, overlay, and other hazards. AAP infants and therefore, should not be products despite having an existing safe sleep recommendations encourage allowed to be sold as infant sleep standard, citing bassinets, cribs, and infants to room-share with parents, but products without meeting one of CPSC’s play yards. Infants die for reasons not to provide infants with their own firm, mandatory sleep standards. associated with the product, the flat space, near the parents, but not in Comment 14: A commenter stated that commenter asserted, adding that CPSC the same bed. For a more detailed no data indicate that overlay injuries or has not presented data to warrant all discussion on bed-sharing, please see fatalities exist while using an infant in- infant sleep products without a standard CPSC human factor’s staff memorandum bed sleeper. to comply with the bassinet standard. at Tab D of Staff’s Final Rule Briefing Response 14: As part of CPSC staff’s This commenter maintained that CPSC Package. participation with ASTM voluntary is using a ‘‘back-door method’’ to As discussed in section III of this standards groups, in fall 2017 38 and remove infant products from the market preamble, in response to the comments, summer 2019,39 CPSC staff provided the without the data to support or justify the Directorate for Epidemiology staff ASTM in-bed sleeper working group this action. The commenter opined that identified 183 incident reports related to with incident data that identified fatal CPSC should write safety standards that non-inclined, flat products marketed as and nonfatal incidents involving in-bed will ensure safe sleep for each product infant sleep products, such as in-bed sleepers. This data demonstrated 11 type, and not funnel various products sleepers, and compact bassinets. The fatalities and 22 nonfatalities associated into one standard, bassinets and cradles, incident data, reported to have occurred with in-bed sleepers. The primary which was not intended for these during the period from January 1, 2019 products. through December 31, 2020, identified 38 October 2, 2017 email from Hope Nesteruk to Response 15: In coordination with a 11 fatalities and 16 injury reports. Seven Lisa Trofe and Meredith Thomas, JPMA contacts for range of stakeholders, CPSC has ASTM meetings. of the 11 fatalities described a 39 Email dated June 4, 2019, from Hope Nesteruk carefully developed safety regulations suffocation death. The other deaths to Meredith Thomas, JPMA contact for ASTM for five infant sleep products (cribs: full- involved the infant rolling over to a meetings. size and non-full-size, bassinets, play

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yards, and bedside sleepers), and we the number of incidents related to each increased fatigue and suffocation, if an encourage consumers to use these type of product reviewed. infant is unable to reposition themselves products for infant sleep. The Many of the fatality reports contain after an accidental roll from supine to Commission is aware that deaths occur unclear, conflicting, and/or inconsistent prone. The Mannen Study concluded in these products, but as noted, infant information. For example, for some that a sleep surface that is 10 degrees or deaths are not always associated with deaths, medical examiners may have less, is comparable to a crib mattress the product. We particularly urge concluded the cause of death to be SIDS surface and can be considered a safe consumers to follow the AAP safe sleep or Sudden Unexpected Infant Death sleep surface. The Mannen Study recommendations when using any (SUID), but they also may mention co- suggested if future work were done on product intended for infant sleep. CPSC contributing conditions, such as an safe sleep angles, one area of study data, in section III of this preamble (Tab unsafe sleep environment (e.g., soft would be additional biomechanical B of Staff’s Final Rule Briefing Package), bedding, inclined sleep surface) or other testing to determine ‘‘which, if any, and evaluated in section VI of this pre-existing medical condition(s). This angles between 10- and 20-degrees may preamble (Tabs C and D of Staff’s Final can confound CPSC’s ability to be safe for infant sleep.’’ Rule Briefing Package), show that deaths determine a predominant factor in the The Mannen Study recommendations and injuries occur in untested and fatality. Staff used a consensus-based do not imply that an incline angle above unregulated infant sleep products, decision-making process to review 10 degrees may be safe; rather, the including inclined and flat sleep incident data. If an unsafe sleep Mannen Study merely suggests that if products, and sometimes these environment or a product design was higher angles are considered, additional incidents involve a use contrary to AAP one of the factors, staff classified the biomechanical testing is required. We recommendations. However, CPSC’s death under that category. Otherwise, are not aware of existing research that evaluation of the incidents in section VI staff classified the reported incident suggests that an inclined sleep surface of this preamble demonstrates that under the ‘‘undetermined’’ category, between 10 and 20 degrees is safe, nor requiring currently unregulated infant when no one factor stood out, or staff is CPSC currently conducting similar sleep products to meet the requirements classified the incident under the research. The Mannen Study also stated of the bassinet standard will further ‘‘insufficient information’’ category, that its testing of awake infants was a reduce the risk of death and injury when staff did not have enough limitation because ‘‘while the muscle associated with these products (Tab C of information to classify the incident in use and motion may be similar, it is Staff’s Final Rule Briefing Package). another category to avoid overestimating likely that infants who find themselves in a compromised position in an The argument that parents will use the risk. inclined sleep product during a nap or soft bedding and other tools to replace 3. Degree of Incline overnight sleep may not have enough products taken off the market is the energy or alertness to achieve self- same argument used in support of (a) Additional Testing for Inclines correction and may succumb to creating a separate voluntary and Between 10 and 20 Degrees suffocation earlier or more easily than mandatory standard for infant inclined Comment 17: Several commenters infants who are fully awake.’’ Given the sleep products, and infants died in these stated that the Commission should vulnerability of newborn infants and the products that did not meet AAP safe conduct additional research on the precedence of fatalities of infants who sleep guidelines. Accordingly, to further safety of inclines between 10 and 20 were most likely asleep in inclined reduce the risk of death and injury, the degrees for infant sleep products. A products at the time of incidents, final rule requires that all products commenter stated that CPSC has failed additional research of inclines above 10 marketed or intended as a sleeping to provide relevant data to support the degrees is unnecessary for the final rule. accommodation for infants up to 5 2019 SNPR’s approach regarding Additionally, other research 41 has months old be tested and certified to an inclined sleep products, to limit the seat demonstrated a discernable difference existing CPSC sleep standard, and that back angle to 10 degrees or less, and not in infant ability between 5, 7, and 10 CPSC, the AAP, and the industry, to conduct additional study on the 10 to degrees in a side-to-side tilt, which continue to promote and educate 20 degree angle, or to provide formed the basis of the 7-degree caregivers about safe sleep practices for information or incidents to support this maximum sleep surface angle in Health infants. decision. Canada’s regulations and the 5-degree Response 17: During the development (b) Statistically Significant Data limit in the Australian requirement. The of the 2019 SNPR, Commission staff 10-degree sleep surface limit in the final Comment 16: One commenter contracted with Dr. Erin Mannen to rule is a slightly higher allowed sleep questioned whether the data presented examine how the degree of a seat back surface angle than other countries. in the 2019 SNPR are statistically angle affects an infant’s ability to move Based on the Mannen Study and the significant for inclined sleep products, within inclined sleep products, and if research that supports sleep surface or are the deaths due to SIDS? the incline angle directly impacts safety angles in international standards Response 16: The analysis presented or presents a risk factor that could reviewed by CPSC staff, staff believes in the 2019 SNPR and in this final rule contribute to the suffocation of an that it is unlikely that additional is based on reported incidents, and infant.40 The Mannen Study findings research at angles higher than 10 therefore, anecdotal in nature. This showed that infants in products with a degrees will demonstrate that an angle means that the data do not constitute a seat back angle greater than 20 degrees greater than 10 degrees is safe for infant statistical sample representing all exhibit increased demand on their sleep. Accordingly, for the final rule, incidents related to inclined and flat abdominal muscles. The Mannen Study infant sleep products must be tested for sleep products; nor do the data concluded that this could lead to a seat back or sleep surface angle of 10 represent a complete set of incidents that may have occurred involving the 40 Read the full report from Dr. Mannen beginning 41 Beal SM, Moore L, Collett M, Montgomery B, products. As such, no statistical on page 91, Tab B, of CPSC Staff’s SNPR Briefing Sprod C, Beal A. The danger of freely rocking Package: https://cpsc.gov/s3fs-public/ cradles. J Paediatr Child Health. 1995 Feb;31(1):38– inference is possible. However, the data SupplementalNoticeofProposedRulemaking 40. doi: 10.1111/j.1440–1754.1995.tb02910.x. PMID: do provide at least a minimum count for forInfantSleepProducts_10_16_2019.pdf. 7748688.

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degrees or less from horizontal, and they Thus, to reduce this confusion in the (c) Use of Unsafe Products by Sleep must meet the requirements of the final rule, we replace the term ‘‘seat Deprived Parents bassinet and cradle standard. back’’ with the term ‘‘Seat Back/Sleep Comment 22: One commenter (b) Adopt Canadian Standard of 7 Surface.’’ expressed concern that parents, Degrees 4. Safe Sleep Principles particularly those who are sleep Comment 18: One commenter stated deprived, cannot reasonably be (a) Request to Ban Infant Inclined Sleep expected to use a product that is unsafe that Canada only allows up to 7-degree Products seat back angle in sleep products, and by design in a safe manner. suggested CPSC should consider Response 22: Lack of sleep may have Comment 20: Approximately 25 a detrimental effect on a parent’s adopting the Canadian standard. commenters requested that CPSC ‘‘ban’’ Another commenter supported the judgment when using an infant sleep or ‘‘remove’’ infant inclined sleep product. Research demonstrates that SNPR proposal that infant sleep surfaces products from store shelves. Of those be no more than 10 degrees from fatigue can negatively affect memory, commenters, three indicated that their concentration, and decision making.42 horizontal. child died while sleeping in an inclined Response 18: The Mannen Study The final rule is the most effective sleep product. concluded that a seatback angle of 10 method of ensuring that infant sleep degrees or less is safe. This seatback Response 20: Many products with an products for infants up to 5 months of angle is consistent with CPSC’s Safety incline greater than 10 degrees from age are safe for use. Standard for Bassinets and Cradles, horizontal have been removed from the 5. Definitions which also requires a 10 degree or less market through CPSC recalls. To incline. We recognize that Health address newly manufactured products, (a) Remove ‘‘Intended’’ From Canada is using a 7-degree maximum the final rule does not ‘‘ban’’ all infant Definitions incline; however, that requirement is sleep products with an angle, but Comment 23: A commenter requested based on a side-to-side tilt study of addresses the hazards associated with that the word ‘‘intended’’ be struck from infants in rocking cradles published in inclined sleep products by requiring the definitions of infant and newborn 1995. The 2019 Mannen Study that any product marketed or intended sleep products. compared infant muscle and breathing for sleep for infants up to 5 months old Response 23: We disagree with the behavior on a flat crib mattress and on must not have a sleep surface angle request to remove ‘‘intended’’ from the a crib mattress, head-to-toe 10 degrees greater than 10 degrees, and that any definitions. Manufacturer’s intent, from horizontal, and determined that currently unregulated infant sleep which can be evaluated through stated infant responses were essentially the product meet the bassinet standard. The warning messages, marketing photos, same on both sleep surfaces. purpose of these requirements is to product instructions and other factors, Accordingly, based on the Mannen ensure that all infant sleep products must remain a factor for staff’s Study findings, to provide a safe sleep meet minimum safe-sleep principles, consideration. As the commenter noted, surface, the final rule is consistent with including the sleep surface angle, as some products are marketed for the current requirement in the bassinet addressed through an existing CPSC swinging or bouncing. If infant products and cradle standard, requiring that sleep standard. are not intended for sleep and are not infant sleep products must have a head- marketed in ways that imply they are for to-toe incline angle of 10 degrees or less. (b) Aligning with AAP Safe Sleep sleeping or napping, they are not subject (c) Highest Seat Back Angle Clarification Practices to the infant sleep product standard. CPSC will evaluate a manufacturer’s Comment 19: A commenter requested Comment 21: One commenter intent using all available materials, that CPSC replace the phrase: ‘‘the acknowledged that the 2019 SNPR including marketing. Accordingly, the manufacturer’s recommended highest aligns with the AAP’s safe sleep final rule maintains the word seat back angle position intended for recommendations, and encourages ‘‘intended’’ and also broadens the sleep,’’ with ‘‘the seat back angle CPSC to ensure that the proposed rule definition of an ‘‘infant sleep product’’ position that is the highest position sends a clear message addressing safe to include the word ‘‘marketed.’’ intended for sleep or that is the highest sleep practices. position that a reasonable consumer (b) Define or Clarify ‘‘Free Standing’’ Response 21: The Commission is would consider as being for infant sleep, Infant Sleep Products whichever is higher.’’ committed to addressing safe sleep practices in this rulemaking and Comment 24: One commenter Response 19: The commenter’s contended that ‘‘free standing’’ is an suggestion, by focusing on the ‘‘seat ensuring that all products marketed, intended, promoted, or otherwise ambiguous term. back’’ of an infant sleep product, Response 24: A ‘‘free-standing’’ infant indicated as being for any kind of infant illustrates some confusion with sleep product is a sleep product that can sleep for infants up to 5 months old are terminology. The 2019 SNPR applied to be used by itself, without the need of addressed. Therefore, the final rule infant sleep products, and required all another product, such as a portable play requires that all infant sleep products, infant sleep products to be 10 degrees or yard. ASTM F3118—17a contains a less from horizontal–the same as the including inclined and flat products, be separate definition for ‘‘accessory sleep surface in bassinets. However, the subject to 16 CFR part 1218, Safety inclined sleep product,’’ which applies safe sleep principle requirement from Standard for Bassinets and Cradles, to products that are supported by the Mannen Study, and already because part 1218 includes safe sleep another product, such as a play yard. reflected in the bassinet standard, is that requirements. Additionally, CPSC’s The term ‘‘free-standing’’ is used infants should sleep flat on their backs. website provides extensive information without issue in other ASTM and CPSC Accordingly, the SNPR term ‘‘seat back’’ regarding best practices for safe sleep standards. For the final rule, the created confusion, because the term through its CPSC’s Safe Sleep Campaign implies that infant sleep products are and Baby Safety information at: https:// 42 https://www.sleepfoundation.org/sleep- for ‘‘sitting’’ in a device with a ‘‘seat.’’ www.cpsc.gov/SafeSleep. deprivation.

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definition of ‘‘infant sleep product’’ is infant sleep products. Although an The final rule is considered a broadened to cover all inclined and flat exposure study is an effective means to consumer product safety standard products marketed or intended as a estimate exposure, we can estimate issued under the Commission’s sleeping accommodation, regardless of exposure by comparing annual sales of authority in section 104 of the CPSIA. whether the product is free-standing or products to the number of live births, Section 104(b)(1)(B). We are unclear attached to another product. and staff identifies the hazard patterns regarding what the commenters’ ‘‘sold Accordingly, we removed the term from the incident data. The Commission by’’ date references. The Consumer ‘‘free-standing’’ from the definition of is not required to conduct cost-benefit Product Safety Act (CPSA) sets forth ‘‘infant sleep product’’ in the final rule, analyses under section 104 of the requirements for manufacturers and to reduce confusion about which infant CPSIA, and has not done so for any importers once a rule becomes effective. sleep products are subject to the rule. durable infant or toddler rulemaking. Section 19(a)(1) of the CPSA states: (a) It shall be unlawful for any person 6. Warnings and Instructions We are uncertain what the purpose of such an analysis would accomplish for to— (a) Provide Information About Scoliosis a rule promulgated under section 104 of (1) sell, offer for sale, manufacture for and Torticollis the CPSIA, where cost/benefit sale, distribute in commerce, or import Comment 25: One commenter considerations are not germane to the into the United States any consumer recommended that information about Commission’s rulemaking authority. product, or other product or substance that is regulated under this Act or any deformities, such as scoliosis and 8. Effective Date torticollis, be included on an insert with other Act enforced by the Commission, all infant sleep products. Comment 28: Commenters both that is not in conformity with an Response 25: Providing parents with supported and opposed the 12-month applicable consumer product safety rule information and resources regarding effective date. Some opposing under this Act, or any similar rule, various infant deformities is beneficial, commenters supported a 6-month regulation, standard, or ban under any and manufacturers are not prevented effective date instead, because other Act enforced by the Commission; 15 U.S.C. 2068(a)(1). Accordingly, the from including this information if they additional time for the rule to become CPSA provides that, as of the effective desire. However, as indicated in the effective puts infants at risk, while other date of the final rule, it is unlawful to 2019 SNPR, increases in the number of opposing commenters wanted a longer ‘‘sell, offer for sale, manufacture for sale, children with plagiocephaly may effective date, or an indefinite delay actually be attributed to the AAP’s distribute in commerce, or import into until ASTM completes additional the United States,’’ any infant sleep recommendation to place infants to standards for specific products. The sleep on their backs to decrease the risk product, as defined in the rule, that is 2019 SNPR proposed that the effective not in conformity with the final rule. of SIDS. The final rule does not contain date would apply to products any modifications to the voluntary manufactured or imported after the final 9. Procedural Comments standard to address this issue. rule effective date. We received multiple (a) Products Subject to the Final Rule (b) Placement of Warnings comments that the effective date should apply to products sold after the final Comment 29: A commenter stated that Comment 26: One commenter rule effective date instead of the ‘‘sold the proposed rule would apply to recommended that warnings should be by date,’’ to prevent stockpiling and domestic products, and not to products placed on the outside and inside of the remove the hazards as soon as possible. made overseas. The commenter stated packaging, as well as on the product. that the rule should apply to products The commenter also recommended that Response 28: For the final rule, the made overseas and sold in the United packaging should be labeled, easily Commission will maintain the 2019 States, for ‘‘optimal consumer safety.’’ visible, and easy to read/understand. SNPR proposed effective date of 12 Response 29: The commenter appears Response 26: Consistent with the months after the date of publication in to misunderstand the scope of products 2019 SNPR, the final rule requires that the Federal Register. A 6-month subject to the final rule. If finalized, the infant sleep products not already subject effective date may seem reasonable rule would make it unlawful to sell, to a CPSC sleep standard, be subject to because suppliers have had ample lead offer for sale, manufacture for sale, the warning requirements set forth in time to prepare for this rule since the distribute in commerce, or import into the bassinet standard, ASTM F2194– SNPR was published in 2019, and many the United States, an infant sleep 16e1, which requires that warning labels of the products within the scope of the product that is not in conformity with be present on the product and its final rule have been withdrawn from the this rule, regardless of whether the packaging, and that warning market or redesigned, particularly for product was manufactured in the information be present in the inclined sleep products. However, for United States or overseas. manufacturers of other unregulated flat instructional literature. ASTM F2194– (b) Incorporation by Reference 16e1 also requires that the warnings be sleep products that remain in the conspicuous, permanent, and easy to market, there will likely be a significant Comment 30: A commenter states that read/understand. economic impact as a result of this final the Commission should publish the rule. While some suppliers can reduce legal standard for infant sleep products, 7. Economic Analysis the impact of this rule by relabeling rather than incorporate the standard by Comment 27: A commenter suggested their products as not for infant sleep, reference. The commenter stated: that CPSC conduct an exposure study to not all manufacturers can simply • Publishing the legal standard ‘‘will research the relative risks of these remarket the product if the physical advance fundamental principles of different sleep products. This form of the product demonstrates that it fair notice and due process by commenter also suggested that CPSC is intended for sleep. For some of these ensuring that the public has open and perform a full cost-benefit analysis of products, manufacturers could relabel unimpeded access to the law.’’ the final rule. them as intended for infants older than • The law belongs to the people, Response 27: CPSC is continuing five months, or, in some cases, for pets. regardless of who drafts the law, and research topics related to safe sleep, However, the demand for infant sleep thus citizens have a fundamental right which may potentially involve types of products for pet use is probably limited. to know what the law contains.

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• When the public is not informed 1 CFR 51.7. To ensure the material is view the proposed law. The commenter about relevant legal standards, this ‘‘reasonably available,’’ an agency must contends that CPSC’s actions to allow has the potential for arbitrary or summarize the material it will public access to the proposal, including discriminatory enforcement. incorporate by reference and discuss summarizing the proposed requirements • People cannot comply with a law if how that material is available to in the preamble to the proposed rule, they do not know the substance of the interested parties in the Federal making the voluntary standard available law. Register notice. Id. §§ 51.3(a), 51.5(a). for review at CPSC’s offices, or reading Response 30: Section 104 of the Manufacturers and importers of infant the standard on ASTM’s website free of CPSIA directs the Commission to issue sleep products represent the class of charge, are all problematic, as the standards for durable infant or toddler persons affected by the final rule. regulations are not ‘‘reasonably products that are ‘‘substantially the Although any interested person has available’’ to the class or persons same as,’’ or more stringent than, access to the content of CPSC’s affected. The commenter states that applicable voluntary standards. Thus, regulations through Federal Register ASTM’s restrictions on downloading or unless the Commission determines that notices of proposed and final rules, the printing the standard (unless the more stringent requirements are CFR, and the content of voluntary standard is purchased) are an necessary to further reduce the risk of standards on ASTM’s website, under the impediment to accessing the law, and injury, the Commission’s rules must be, statutory scheme set forth in the CPSIA, describes the Commission’s access to for the most part, the same as the it is those manufacturers and importers the proposed law as ‘‘limited’’ and who want to ‘‘sell, offer for sale, applicable voluntary standard. In this insufficient to ‘‘ensure robust public manufacture for sale, distribute in case, the final rule would incorporate by access to the law.’’ Specifically, the commerce, or import into the United reference ASTM F3118–17a, with commenter notes that without the States,’’ any durable infant or toddler substantial modifications to make the ability to download graphs and charts in product, that must conduct testing using standard more stringent, to further the ASTM standard, the graphs are a third party conformity assessment reduce the risk of injury associated with unreadable in portrait view. The body (lab) and certify their product as infant sleep products. This final rule commenter states that ‘‘reasonably compliant with the applicable consumer available’’ is not defined in the APA, would set forth in the Code of Federal product safety rule. 15 U.S.C. but should be interpreted broadly ‘‘to Regulations (CFR): Definitions, one test § 2063(a)(2). promote fundamental constitutional for the seatback/sleep surface angle of The Commission complies with the values. . . .’’ an infant sleep product, and otherwise requirement that publications, including Response 31: We disagree with the require infant sleep products that do not standards, are ‘‘reasonably available to commenter that CPSC’s efforts to make already meet a CPSC sleep standard to and usable by the class of persons voluntary standards ‘‘reasonably meet the requirements of the bassinet affected,’’ whenever incorporating available’’ are ‘‘limited.’’ For rules standard, to further reduce the risk of material by reference. For example, issued under section 104 of the CPSIA, injury associated with inclined and flat when the Commission proposes a rule stakeholders have several ways to access infant sleep products. CPSC’s bassinet under section 104 of the CPSIA, the the content of the voluntary standard standard, 16 CFR part 1218, currently Commission describes and summarizes proposed to be incorporated by incorporates by reference performance the requirements of the rule, including reference, and after the standard is and labeling requirements in ASTM the voluntary standard, in the preamble incorporated by reference into a F2194–13, with modifications set forth of the rule printed in the Federal regulation, including reading a in the CFR. CPSC’s mandatory standard Register, and explains that ASTM’s summary of the requirements of a is substantially similar to ASTM F2194– copyrighted voluntary standards are voluntary standard in a proposed or 16e1. available to review online for free final rule (free), reviewing voluntary ASTM’s voluntary standards are during the comment period at https:// standards in person at CPSC’s offices protected by copyright, which the www.astm.org/CPSC.htm. Once a rule (free), reviewing read-only copies of the Commission (and the federal becomes effective, ASTM provides a voluntary standard on ASTM’s website government generally) must observe. read-only copy of the standard for (free), and by purchasing a copy of the The United States may be held liable for review on the ASTM website at: https:// standard. The OFR’s regulations do not copyright infringement. 28 U.S.C. 1498. www.astm.org/READINGLIBRARY/. As require free access to the contents of Accordingly, the Commission cannot always, any person can purchase a copyrighted materials. In developing a violate copyright law by publishing voluntary standard from ASTM, or may regulation, the OFR considered whether ASTM’s voluntary standards in the CFR. schedule a time to review a voluntary to require free access to materials that The Office of the Federal Register (OFR) standard (for free) at the Commission’s are incorporated by reference into has established procedures for headquarters in Bethesda, MD, or at the regulations, and specifically declined to incorporation by reference that seek to National Archives and Records do so. 79 FR 66267 (Nov. 7, 2014). The balance the interests of copyright Administration (NARA). Accordingly, OFR found that adopting requirements protection and public accessibility of citizens who are interested in the to summarize the content of the material material. 1 CFR part 51. OFR’s content of the law have unimpeded incorporated, and explaining to regulations are based on Freedom of access to the regulation, and have stakeholders how to obtain the material, Information Act provisions that require several avenues for free access to the was adequate to make the material materials to be ‘‘reasonably available’’ text of voluntary standards incorporated ‘‘reasonably available.’’ Id. at 66,270. when incorporated by reference with by reference into a mandatory CPSC Accordingly, CPSC’s efforts to make approval of the Director of the Federal standard for a durable infant or toddler copyrighted materials reasonably Register. 5 U.S.C. 552(a)(1). Under the product. available exceed the OFR’s OFR’s requirements, an agency may Comment 31: A commenter states that requirements. incorporate by reference specific CPSC’s practice of incorporating Comment 32: A commenter states that publications, including standards, if voluntary standards by reference into incorporation by reference, without they are ‘‘reasonably available to and law forces citizens to either visit the providing free access to the law, usable by the class of persons affected.’’ agency in person, or pay for access, to undermines due process because it may

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limit public input and exclude law and legal proceedings are directly that are not already addressed by meaningful participation by some relevant here.’’ another standard.’’ 84 FR at 60949. stakeholders. The commenter explains, Response 33: As described in • ‘‘CPSC proposes to define ‘infant for example, that to participate in ASTM response to comments 30 and 31, CPSC sleep products’ as products that provide standards development, one must be an exceeds the OFR’s regulation requiring sleeping accommodations for infants ASTM member, which costs $75 per that voluntary standards that are that are not currently covered by year. The commenter notes that the incorporated by reference be made bassinets/cradles, cribs (full-size and regulated community can afford this reasonably available to the class of non-full size), play yards, and bedside and participate, while members of the persons affected, because the voluntary sleepers . . .’’ Id. at 60950. Similar public cannot meaningfully participate. standards incorporated by reference by statements are also made on pages Response 32: Stakeholders have CPSC in rules under section 104 of the 60951 (three times), 60956, and in the several options to review the content of CPSIA are available for review by all draft regulatory text (proposed § 1236.1, a voluntary standard for free, as interested parties. ASTM provides § 1236.2(b)(4)(D) and § 1236.2(b)(11)(i)) described in response to comments 30 access to review voluntary standards at 60962–63). and 31. ASTM typically seeks a cross incorporated by reference before and • ‘‘The Supplemental NPR proposes section of stakeholders to participate in after a rulemaking, free of charge, on to incorporate ASTM F3118–17a with standards development. While ASTM ASTM’s website. Additionally, any substantial modifications, including requires membership to vote on balloted person can schedule a time to review a revisions in the scope of the standard, items to create or revise a voluntary voluntary standard (for free) at the section 1.3, to remove the term standard, ASTM does not require Commission’s headquarters in Bethesda, ‘‘inclined,’’ and to include any infant membership to participate in ASTM MD, or at the National Archives and sleep product not currently covered by meetings where stakeholders discuss Records Administration (NARA). another mandatory rule for infant sleep standards development for durable (c) Alleged Notice and Comment and products. . . .’’ infant or toddler products. Thus, if a Section 104 Procedural Defects • The request for comments on page consumer wanted to participate in an Comment 34: A commenter states that 60961 asks for comments on non- ASTM meeting, they could do so the rulemaking process for including inclined products likely to be impacted without membership. Additionally, if a flat products within the scope of the by the SNPR, including, for example, a consumer wanted to become an ASTM request for comment on: 2019 SNPR, such as in-bed sleepers, is Æ voting member and cannot afford the procedurally deficient and does not ‘‘. . . any additional types of membership fee, that person can contact follow the procedure for rules issued products that commenters believe may ASTM to learn about additional options be impacted by the Supplemental NPR.’’ under section 104 of the CPSIA, because Æ for membership. For example, students the Commission’s 2019 SNPR did not ‘‘. . . products with inclines less can be ASTM members free of charge. include sufficient data demonstrating than or equal to 10 degrees that do not We further note that CPSC’s the need for a rule to cover non-inclined already comply with the bassinet regulation at 16 CFR part 1031 does not sleep products. The commenter states standard.’’ Æ allow staff to participate in voluntary that the data set for non-inclined removing the upper age limit of 5 standards meetings that are not open to products is incomplete and months because the SNPR ‘‘proposes to the public. CPSC staff’s participation in insufficiently reviewed, suggesting that address ‘infant sleep products’ not ASTM meetings discussing durable the Commission did not review incident already covered by traditional sleep infant or toddler products are posted on data for non-inclined products with the product [standards].’’ CPSC’s calendar (on CPSC’s website) at ASTM committee. The commenter • The Staff’s October 16, 2019 SNPR least a week in advance. The meeting states that the Commission’s failure to Briefing Package, referenced in the notice provides the date, time, purpose publish a revised SNPR to include CPSC Federal Register notice, contains similar of the meeting, the staff attending, and staff’s concerns with compact bassinets, statements about the scope of the rule contact information for staff (to obtain baby boxes, and in-bed sleepers, as (pages 15, 16, 21, 117, 136), and on page ASTM login information) so that any described in a December 12, 2019 letter 133 also specifically states (and on page person who wants to participate in the from staff to several ASTM 134, Figure 1 provides a picture of an ASTM meeting may do so. Moreover, subcommittees, which the commenter unregulated flat sleep product): CPSC staff creates a written meeting log states did not appear in the 2019 SNPR, The draft supplemental proposed rule for each ASTM meeting where staff and to instead provide a 30 day would also cover products with inclined participates, which summarizes the extension of the comment period, was sleep surfaces greater than 30 degrees meeting content. insufficient notice to all interested and less than 10 degrees, if they are We encourage members of the public parties, and may result in a flawed intended or marketed for children under to meaningfully participate in standards standard that is unable to withstand 5 months of age for sleep purposes, and development efforts for durable infant judicial scrutiny. they are not subject to another sleep or toddler products through the ASTM Response 34: The 2019 SNPR product standard. For example, the draft process and by commenting on CPSC’s provided notice to stakeholders that supplemental proposed rule would proposed rules. unregulated, non-inclined, flat infant include the hammock-style crib Comment 33: A commenter describes sleep products were included in the accessory shown in Figure 1. It appears a recent holding by the Eleventh Circuit proposal, by proposing to remove the to have an incline of 10 degrees or less, finding that annotations to a Georgia term ‘‘inclined’’ from the standard, and but does not fall under another sleep statute were ‘‘sufficiently law-like’’ to to include within the scope of the rule category. require free public access. The currently unregulated infant sleep CPSC’s description of the scope of the commenter also describes two district products, including inclined and non- rule throughout the 2019 SNPR and the court cases challenging PACER system inclined products. For example, the Staff’s SNPR Briefing Package, and the fees, but notes the cases are in the early SNPR states: request for comment on these products, stages of litigation, but ‘‘the underlying • ‘‘CPSC’s proposed standard would were sufficient to inform stakeholders principles of free public access to the cover products intended for infant sleep that these unregulated flat sleep

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products were included within the specifically, ASTM members, which the same as the voluntary standards, or scope of the rule. include manufacturers of these more stringent than the voluntary In addition, ASTM members had products, have been well aware of CPSC standards, if the Commission finds that actual notice of the contents of the 2019 staff’s concerns with these products for more stringent standards would further SNPR before and after publication. years, based on activity on the bassinet reduce the risk of injury. Sections V.A.3 and V.B.2 of this subcommittee which has been Although CPSC staff’s standards preamble discuss staff’s work with the developing requirements for these development work through the ASTM ASTM subcommittees and task groups. products to include in the bassinet process can colloquially be termed Staff’s SNPR Briefing Package was standard, but has thus far been ‘‘collaborative,’’ nothing in section 104 posted on the Commission’s website on unsuccessful. With regard to in-bed of the CPSIA requires ‘‘collaboration’’ October 16, 2019, before ASTM held fall sleepers, ASTM created a separate on a rule outside of the rulemaking meetings on voluntary standards for standards development effort for this process. Under section 104, the juvenile products, and before the product, which CPSC staff has Commission is not required to ‘‘defer’’ Commission voted on the SNPR, so that participated in, and provided incident to the voluntary standard, rather, the ASTM members and other stakeholders data on the products, including notice Commission must promulgate rules, and could review the package, including the of the injuries and fatalities associated those rules must be substantially the Mannen Study, before the ASTM with these products. Indeed, through same as the voluntary standard, or more meetings, and so that staff could discuss staff’s participation in the ASTM stringent than the voluntary standard, if the package and the Mannen Study with process, including attending meetings, more stringent requirements would ASTM members. The ASTM Agenda for providing incident data, and providing further reduce the risk of injury. Section the Infant Inclined Sleep Products comments and votes on ballot efforts, 104 requires the Commission to consult meeting that occurred on October 21, staff’s concerns with unregulated flat regarding the effectiveness of a 2019 included a link to Staff’s SNPR sleep products, and the incident data voluntary standard; the Commission is Briefing Package. CPSC staff discussed associated with these products, is not not required to consult on the timing of the 2019 SNPR Briefing Package at the unknown to stakeholders and these a proposed rule, the Commission’s ASTM meetings in October 2019, commenters. enforcement work, or on the content of including with the ASTM Comment 35: A commenter states that a proposed rule outside of the subcommittees for infant inclined sleep CPSC statutes require the Commission rulemaking process. In the case of products, in-bed sleepers, and bassinets, to defer to voluntary standards under bassinets, unregulated flat sleep discussing the Mannen Study findings, certain conditions, and that CPSC’s products, and inclined sleep products, as well as addressing the fact that flat website states that CPSC follows OMB staff has been consulting on the sleep products were covered by the Circular A–119, but the Commission has effectiveness of the voluntary standards, SNPR. Dr. Mannen attended the done neither in this case. Another or lack thereof, for these products for subcommittee meeting for infant commenter states that the 2019 SNPR many years. inclined sleep products via telephone, did not rely on the ASTM consensus- Generally, CPSC staff’s work through to discuss the Mannen Study and to driven process to develop a standard, the ASTM process has improved the answer questions. and that CPSC’s data cannot be safety of durable infant or toddler The SNPR published in the Federal presented belatedly to ASTM products. However, nothing in section Register on November 12, 2019. In a participants, after or at the same time as 104 of the CPSIA requires the December 12, 2019 letter to both the the SNPR was provided to the Commission to delay addressing risks of ASTM inclined sleep and bassinet Commission. This commenter states that harm to the most vulnerable infants in subcommittees, CPSC staff again while CPSC claims the process was a sleep products that parents rely upon as reiterated its concerns with weakening collaborative one, for the 2019 SNPR, a safe place for an infant, until all the safe sleep requirements in the the process was not. ASTM members have reached a voluntary standard for bassinets and Response 35: Rulemaking pursuant to consensus on whether and how to create cradles to accommodate unregulated sections 7 and 9 of the CPSA requires or revise a voluntary standard to address products, such as in-bed sleepers, the Commission to rely on a voluntary the risk. The Commission would be compact bassinets, and baby boxes. standard, rather than promulgate a rule, relinquishing the statutory mandate to Thus, the letter represents an additional if: (1) The voluntary standard protect consumers by ceding product effort to ensure that the relevant ASTM adequately addresses the risk of injury safety to the very industry Congress subcommittees (and thus subcommittee associated with a product, and (2) there required the agency to regulate. CPSC members) were aware of CPSC staff’s is likely to be substantial compliance met the requirement to consult on the concerns with these products, as well as with the voluntary standard. If either of effectiveness of the voluntary standards. the content of the 2019 SNPR, which these criteria are not met, the The lengthy record of staff’s proposed that flat sleep products would Commission may proceed with participation with the infant inclined need to meet the requirements of the rulemaking under sections 7 and 9 of sleep committee since the 2017 NPR is bassinet standard. Even though this the CPSA, if the Commission can make available on regulations.gov, as well as letter was in addition to, and not instead the other required findings. Those through ASTM records. A similarly of, the notice provided in the 2019 criteria are not relevant under section robust record of staff’s participation on SNPR, the Commission extended the 104 of the CPSIA, which requires the the bassinet and cradle committee, comment period for an additional 30 Commission to consult ‘‘with outside of the rulemaking process, is days, to accommodate any confusion representatives of consumer groups, available through ASTM, on CPSC’s among stakeholders. The final rule juvenile product manufacturers, and website, and through CPSC’s Office of addresses scope and data concerns independent child product engineers the Secretariat.43 submitted by commenters on the and experts, examine and assess the Finally, as reviewed in response to inclusion of unregulated flat sleep effectiveness of any voluntary consumer comment 12, the final rule addresses products. product safety standards for durable With regard to in-bed sleepers, baby infant or toddler products,’’ and to 43 https://cpsc.gov/Regulations-Laws--Standards/ boxes, and compact bassinets promulgate rules that are substantially Voluntary-Standards.

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scope and data concerns submitted by Generally, CPSC staff’s work through do not have a consensus on moving commenters on the inclusion of the ASTM process to improve the forward to address the hazards unregulated flat sleep products, by requirements of voluntary standards to associated with infant sleep products, specifically listing the products address hazards associated with durable despite CPSC’s 2019 SNPR and staff’s included within the scope of the final infant or toddler products has improved continued participation in the process. rule in this preamble, reviewing the safety of these products, and CPSC Although ASTM task groups continue to incident data and hazard patterns will continue its work through the work on revisions to the voluntary associated with flat products, and by ASTM process. Accordingly, CPSC did standard, staff reports that the ASTM demonstrating that the requirements in not, and is not, subverting the ASTM process is not close to completing their the bassinet standard are adequate to process to address the hazards work, and staff was not confident that address the risk of injury associated associated with inclined and flat sleep ASTM would achieve consensus on with flat infant sleep products. CPSC’s products. CPSC staff has been revisions to the standard in the near description of the scope of the rule participating in the infant inclined sleep term. throughout the 2019 SNPR and Staff’s product standards development process, In a recent ASTM task group meeting SNPR Briefing Package, and the request as well as the bassinet and cradle on revisions to the title, introduction, for comment on these products standards development committee, for and scope of the standard (April 22, (including a 30 day comment many years, both before and after the 2021), task group members discussed extension), were sufficient to inform Commission issued the 2019 SNPR. balloting the proposed regulatory text in stakeholders that these unregulated flat ASTM did not hold subcommittee the 2019 SNPR to replace ASTM F3118– sleep products were included within the meetings or task group meetings on 17a, to prevent the sale of infant scope of the rule. Moreover, the inclined sleep products or the SNPR for inclined sleep products that purport to Commission received comments on the almost one full year after the October certify to ASTM F3118–17a, meaning inclusion of flat sleep products within 2019 ASTM meetings, and did not products with an incline above 10 the scope of the rule, demonstrating schedule any meetings until after CPSC degrees, while ASTM works to revise knowledge of their inclusion. staff sent a letter to the ASTM the voluntary standard. However, the Comment 36: A commenter states that subcommittee for infant inclined sleep task group did not plan to ballot the CPSC had been participating products on July 16, 2020. After staff’s requirement that all infant sleep collaboratively with the ASTM letter, the ASTM F3118 subcommittee products meet the bassinet standard, established a task group to revise the because an ASTM task group is committee for ASTM F3118 before the infant inclined sleep standard’s title, attempting to identify minimum safe summer of 2019, when the commenter introduction, and scope, to be more in sleep requirements that could apply to states the Commission rescinded its line with the proposal in the 2019 infant sleep products to include in rulemaking to adopt ASTM F3118 as a SNPR. In December 2020, the ASTM F3118. Staff is participating in this effort mandatory standard, and to modify the subcommittee introduced ballot F15–18 as well, but, based on the assessment in standard through the SNPR. The (20–1) to change the standard’s title, this final rule, does not believe that commenter states that the better practice introduction, and scope to include all requirements that are different and less would be to issue an advanced notice of infant sleep products (and not just stringent than the requirements in the proposed rulemaking (ANPR) while also inclined sleep products). A more bassinet standard will adequately seeking modifications to ASTM F3118 detailed description of this ballot is in address the risk of injury associated through the ASTM process, so that section V.A.3 of this preamble. with infant sleep products. stakeholders can ‘‘work with urgency’’ However, in January 2021, the ballot did Section 104 of the CPSIA requires toward addressing CPSC incident data not pass due to six negative votes. The CPSC to consult regarding the to develop a performance-based ASTM F3118 subcommittee discussed effectiveness of the voluntary standard; standard, versus a design restrictive the ballot results at a meeting on it does not require CPSC to consult on standard. The commenter also January 27, 2021. During this meeting, the timing of rulemaking, the content of expressed disappointment that CPSC is ASTM members disagreed on the intent a rule outside the rulemaking process, ‘‘subverting’’ the ASTM process, which and consequences of changes to the or to delay rulemaking until ASTM has a proven track record for resolving voluntary standard, and the meeting members achieve consensus. Moreover, product problems. The commenter ended without a consensus on a path stakeholders have now had sufficient requests that CPSC ‘‘correct its course’’ forward. time to consider and comment on the and provide the relevant data to the Based on the ballot results and the Mannen Study, which has been ASTM committee, so that the committee discussions in these ASTM meetings, available on CPSC’s website as an can address the problems associated staff advises that it is unlikely that attachment to Staff’s SNPR Briefing with inclined sleep products through ASTM will be able to move forward Package since October 2019, and how to the ASTM process. The commenter with changes to ASTM F3118 that address hazards associated with requests that CPSC hold the SNPR in address safe sleep requirements in the products within the scope of the SNPR, abeyance while proceeding as the near term. However, we note that a task through the rulemaking and the ASTM commenter has suggested, with an group to review safe sleep requirements processes. Despite having a year and a ANPR and working through the ASTM across infant sleep product standards half to make progress through the ASTM process. (the comparison task group) has met process, stakeholders have not achieved Response 36: Although staff four times since the January 27, 2021 consensus on how to move forward. submitted an NPR termination package meeting. CPSC staff has participated in When ASTM members do not have, or for infant inclined sleep products to the all of these ASTM efforts, including cannot achieve, consensus on whether Commission on June 12, 2019, the commenting on ASTM’s ballot. or how a voluntary standard can address Commission never voted on the The December 2020 ASTM ballot to associated hazards, product safety is not termination package. Instead, the revise the title, introduction, and scope improved. Commission voted (5–0) on October 25, of ASTM F3118, and the January 2021 The Commission’s statutory mandate 2019 to issue the SNPR for infant sleep meeting to discuss the negatives on the under section 104 of the CPSIA is to products. ballot, demonstrate that ASTM members ensure that durable infant or toddler

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product standards provide the highest however, that the 2019 SNPR for infant Commission determines that more level of safety for such products that is sleep products did not meet these two stringent standards would further feasible. Accordingly, CPSC will not requirements in the CPSIA. Instead of reduce the risk of injury associated with delay the final rule, and section 104 of consulting with consumer groups, such products.’’ the CPSIA does not require CPSC to manufacturers, and product safety The regulated community participates delay under the circumstances. experts through the section 104 process, in the rulemaking process by Comment 37: A commenter states that CPSC staff ‘‘informed’’ stakeholders commenting on a proposed rule. Neither the scope of the 2019 SNPR includes about the Commission’s change in section 104 of the CPSIA nor the APA many different types of products, with direction at the October 2019 ASTM requires that stakeholders craft a CPSC different sizes, age capacities, committee meetings, after the SNPR was mandatory rule. CPSC is required to breathability, firmness, geometry, already issued. Moreover, although consult regarding the effectiveness of perceived usage, and different warnings. CPSC staff remains engaged in the the voluntary standard and to The SNPR did not explain CPSC’s ASTM F3118 subcommittee, their promulgate rules. As set forth in section rationale to include all of these products engagement is in support of the SNPR. V.A.3 and V.B.2 of this preamble, CPSC under ASTM F3118 and to conclude The commenter maintains that the 2019 staff has been consulting about the that all of these products are unsafe. SNPR was not a collaborative effort, and effectiveness of the voluntary standards Response 37: The 2019 SNPR stated that CPSC did not consult with at issue, infant inclined sleep products that the rule applied to all infant sleep stakeholders before issuing the SNPR. and bassinets and cradles, for many products not subject to a CPSC sleep The commenter states: ‘‘The stakeholder years, through participation with the standard, including products with an community, impacted and potentially relevant ASTM subcommittees and task incline less than 10 degrees, as outlined impacted manufacturers, are in the very groups. For example, since ASTM began in response to comment 34. CPSC staff unfortunate position of being subject to development of an infant inclined sleep has been participating on the ASTM a mandatory rule that they had no part product standard in or around 2011, committees for bassinets and infant in helping to craft, by way of the ASTM CPSC has participated in the inclined sleep for many years about the development process.’’ The commenter development of the standard. Similarly, hazards associated with products that also suggests that CPSC staff has acted CPSC staff has participated in the would fall within the scope of the final in an ‘‘ultra vires manner to sanitize development and revisions to the rule. The infant inclined sleep product from incline sleep products’’ that are bassinet and cradle standard since at standard and the developing in-bed otherwise subject to an existing least 2002. For both standards, CPSC sleeper standard both evolved from the standard and to the rulemaking. The staff has provided incident data, bassinet standard, and ASTM is commenter recommends that the participated in subcommittee and task currently trying to create new Commission issue another SNPR to group meetings, and submitted requirements in the bassinet standard to clarify the scope of the rulemaking and comments and/or votes on ASTM accommodate designs of certain flat evaluate and mitigate any unintended ballots. For this final rule, CPSC has sleep products. Accordingly, as consequences, and to allow time for reviewed the incident data, hazard provided in response to comment 36 stakeholders and CPSC staff to work patterns, and the adequacy of the regarding staff’s efforts through the through the ASTM process to examine voluntary standards to address the risk ASTM process, stakeholders understand the impact of the proposed rule. of injury associated with products the scope of products addressed in the within the scope of the final rule, Another commenter similarly urges the 2019 SNPR and the final rule, ASTM’s unregulated inclined and flat sleep Commission to proceed in accordance efforts to modify the bassinet products, and is promulgating a rule with section 104 of the CPSIA by requirements to accommodate these that is more stringent than the voluntary working with ASTM to develop a products, and CPSC staff’s objection to standard, as proposed in the 2019 standard with a clearly defined scope, modification of the safe sleep SNPR, to further reduce the risk of clear definitions, and creation of requirements in the bassinet standard. injury associated with infant sleep performance requirements based on To address comments on the 2019 products. SNPR, the final rule includes additional specific product types within the infant ASTM members have now had ample incident data and analysis to sleep product category. This approach time to consider the hazards associated demonstrate that the performance and would require working with ASTM, and with infant sleep products, to comment labeling requirements of the bassinet then reissuing an SNPR, before on the SNPR, and to address associated standard would address the risk of proceeding with a final rule. hazards through revised voluntary injury associated with currently Response 38: Section 104(b)(1) of the standards. ASTM is still working on unregulated flat and inclined sleep CPSIA requires the Commission to: ‘‘(A) these issues and staff will continue products. in consultation with representatives of working with ASTM to develop a Comment 38: A commenter states that consumer groups, juvenile product voluntary standard that addresses the CPSC followed the process set forth in manufacturers, and independent child risk of injury associated with infant section 104 of the CPSIA when it issued product engineers and experts, examine sleep products. If and when ASTM has the 2017 NPR to incorporate by and assess the effectiveness of any revised ASTM F3118–17a, it may send reference into a mandatory rule, ASTM voluntary consumer product safety the revised standard to CPSC to F3118. The commenter notes that the standards for durable infant or toddler evaluate, through the update process set NPR was substantially the same as the products;’’ and (B) in accordance with forth in section 104 of the CPSIA. voluntary standard, and that CPSC staff the informal notice and comment Comment 39: Commenters allege that consulted with representatives from rulemaking requirements under section the 2019 SNPR represents an consumer groups, juvenile product 553 of the Administrative Procedures unprecedented effort by CPSC to issue manufacturers, and independent child Act (APA), ‘‘promulgate consumer a mandatory rule that would create a product engineers and experts, to product safety standards that—(i) are pre-market testing and approval process examine and assess the effectiveness of substantially the same as such voluntary for an entire product category. ASTM F3118, as required by section 104 standards; or (ii) are more stringent than Commenters state that creating an of the CPSIA. The commenter states, such voluntary standards, if the omnibus rule that requires infant sleep

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products to meet the bassinet standard, consumers, and specifically, under permit the application of the bassinet instead of creating product specific section 104, to promulgate standards for standard to an open-ended and standards, would have the unintended product categories that the Commission undefined scope of products. The consequence of stifling innovation. determines to be of the highest priority, commenter contends that section 104 Response 39: As with all of CPSC’s and to ensure that such standards requires the Commission to consider regulations to set performance and provide the highest level of safety for specific product types, characteristics, labeling requirements, CPSC’s such products that is feasible. and hazards. The commenter states that mandatory rules for durable infant or Because CPSC staff has been working the 2019 SNPR approach is ‘‘arbitrary’’ toddler products set a floor for safe with ASTM members on the bassinet and ‘‘is a reversal of the Section 104 consumer products. CPSC does not and cradle subcommittee for years, on process’’ for existing and new products require pre-market approval of both inclined sleep products, as well as that are sleep products, but not consumer products, nor does the agency unregulated flat infant sleep products, bassinets or cradles. The commenter have the authority to do so. However, ASTM members should be well aware of states that CPSC must clearly define the CPSC does have the authority to create staff’s efforts and concerns with both scope of the rule and the products that mandatory performance requirements product types. Once CPSC issues an fall within the scope of the rule. through rulemaking, and to require that NPR, CPSC’s docket on Regulations.gov Response 40: As set forth in response all products offered for sale in the includes a record of staff’s participation to comment 34, the 2019 SNPR United States meet these requirements through the ASTM process, and ASTM provided notice that the rulemaking to protect consumers from injuries or records should reflect this participation included flat infant sleep products. death. When the Commission is aware as well. CPSC’s Office of the Secretariat Moreover, the preamble to this final rule of a gap in the regulatory framework for maintains meeting logs summarizing identifies product types that fall within infant sleep products, the Commission staff’s participation with external the scope of the rule, as well incident can use its authority to address the parties, such as ASTM, outside of the data, hazard patterns, and an analysis of associated hazards. rulemaking process, and these meeting how the requirements in the bassinet Mandating a safety standard for infant logs are searchable on CPSC’s website. and cradle standard address the risk of sleep products offered for sale in the Finally, performance and labeling injury associated with flat infant sleep United States that are not already within requirements for consumer products products. The purpose of the rule is to the scope of another CPSC sleep allow for innovation with certain regulate any product marketed or standard is not ‘‘unprecedented’’ and is baseline safety requirements. While we intended as a sleeping accommodation no different than standards for other understand the concerns that innovation for an infant up to five months old that durable infant or toddler products that beyond the baseline safety requirements is not already regulated by another contain different product types within may be discouraged, we note the CPSC sleep standard. Accordingly, the the same standard, such as strollers and development of infant inclined sleep scope of the rule is not ‘‘open-ended,’’ high chairs, each of which include a products as a prime example of and the final rule demonstrates that the variety of product types. No company innovation preceding safety. Infant bassinet standard provides minimum can sell a stroller in the United States inclined sleep products were first safe sleep characteristics for these infant that does not comply with the stroller marketed as an innovative sleep sleep products. standard, simply based on the type of solution for parents; however, no safety Comment 41: A commenter states that stroller. Similarly, no company can sell standard existed for these products to implement a rule that requires a high chair in the United States unless when they were introduced to the specific products to meet the it complies with the high chair market. Commenters to the 2010 NPR requirements of the bassinet standard, standard. This is not a novel idea. The and 2012 SNPR for bassinets indicated CPSC must provide a rationale that is only difference in these product that hammocks and inclined sleep supported by ‘‘substantial evidence.’’ categories is how the voluntary products should have their own The commenter states that the 2019 standards evolved. The scope of the standard because they could not meet SNPR did not provide a rationale for the stroller and high chair standards are the requirements for bassinets, and application of the bassinet standard to broad for the purpose of encapsulating parents were likely to create their own specific products within the infant sleep all products. Standards for sleep ‘‘unsafe’’ alternative if a regulated product category. products evolved on a different track. product was not available. The ASTM Response 41: As stated in response to But the Commission is not required to standards development process for comment 37, CPSC and stakeholders continue a patchwork regulatory scheme inclined sleep products took many years have been working through the ASTM that does not serve the interests of before the standard was published in process regarding requirements for consumer safety. In this case, the 2015, and during that time, unregulated flat and inclined sleep Commission seeks to ensure that all manufacturers were designing and products for many years, as part of products marketed or intended for selling innovative inclined products. As development of the bassinet standard. infant sleep, for infants up to 5 months time went on, the hazards posed by Accordingly, based on the 2019 SNPR of age, meet the infant sleep product inclined products became apparent in and this ongoing work with ASTM, standard to set a floor for safe infant the accumulation of infant deaths and staff’s efforts have been to maintain the sleep. CPSC’s mission is to protect incidents associated with this product safe sleep requirements in the bassinet consumers, and the agency will use its category. To avoid a repeat of this standard and apply them to all sleep authority to protect the most vulnerable process, involving the most vulnerable products marketed and intended for infants, up to 5 months old, and their infants up to 5 months old, the infants up to 5 months old. In response unsuspecting parents, from sleep Commission is issuing this infant sleep to comments, the final rule makes surfaces that do not follow known safe product standard that contains key clearer the unregulated flat sleep sleep principles, as set forth in the elements of safe sleep, so that product products that fall within the scope of existing CPSC sleep standards. innovation does not compromise safe the rule, provides incident data, Accordingly, the Commission’s effort in sleep for infants up to 5 months old. identifies hazard patterns, analyzes the the 2019 SNPR is consistent with Comment 40: A commenter states that effectiveness of the bassinet standard to CPSC’s statutory mandate to protect section 104 of the CPSIA does not address the hazards, and compares the

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performance requirements in products are intended for infants up to durable infant or toddler products are international standards to demonstrate 5 months old, the products are regulated by CPSC. Similarly, when that products within the scope of the ‘‘intended for use,’’ and ‘‘reasonably products fall within an ASTM standard, final rule have similar hazard patterns expected to be used,’’ by children under CPSC should not be bound by ASTM’s that can be addressed by the 5 years old. Products intended for infant categorization of such products if CSPC requirements in the bassinet standard. sleep are similar to products on the can demonstrate that the voluntary Comment 42: A commenter states that statutory list intended for infant sleep, standard is inadequate to address the the Commission previously recognized such as cribs, and bassinets and cradles. risk of injury associated with the the importance of product specificity in Additionally, ‘‘infant sleep products’’ products, but another voluntary promulgating the consumer registration are further defined in the final rule. standard would be adequate. rule, 16 CFR part 1130. Despite this, the Accordingly, adding ‘‘infant sleep Comment 44: A commenter states that commenter states that the 2019 SNPR products’’ as a durable infant or toddler CPSC must not only specifically identify failed to discuss which product types product is consistent with the product types that fall within the infant would be considered ‘‘durable infant or Commission’s approach of adding a sleep product category, but must also toddler products’’ for product durable infant or toddler product provide the rationale for applying the registration card purposes, and ‘‘simply category with a mandatory standard to bassinet and cradle standard concludes in a circular fashion that the list of products in part 1130, to requirements to each product type infant sleep products are durable infant clarify that these products must meet within the category, as well as or toddler products.’’ The commenter the consumer registration rule, and the establishing the product type is a believes that a specific rationale is testing and certification requirements durable infant or toddler product. The required for each product to for durable infant or toddler products. commenter contends that this analysis ‘‘independently qualify’’ as a durable Comment 43: A commenter contends must identify the specific characteristics infant or toddler product. The that the creation of specific types of for each product type and the related commenter concludes that under the infant sleep products is not by the hazards, to describe how the bassinet APA, CPSC must specifically define Commission’s choice, but required by standard would address each hazard products that fall within an ‘‘infant section 104 of the CPSIA. The pattern. The commenter contends that a sleep product’’ in another SNPR before commenter states that Congress requirement that may be applicable to it can issue a final rule. purposely listed different types of infant one product type may not be applicable Response 42: The preamble for the sleep products separately in section 104, to another product type. The commenter final rule identifies product types that because ‘‘differences between these contends that ‘‘[n]o broad product fall within the scope of the rule. products warrant individual category to date has ever been subject to However, the 2019 SNPR and the final consideration in any rulemaking a rule without such specificity.’’ The rule purposely do not define product proceeding,’’ and that this principle is commenter states this level of types by name in the regulation text, true with the remaining infant sleep specificity is required to avoid banning and instead identify product types by product types. existing safe products or chilling future purpose and age limit, to ensure that all Response 43: The commenter offers innovation. infant sleep products meet minimum no legislative history to support the idea Response 44: As set forth in response safe sleep requirements in the bassinet that Congress listed sleep products to comment 34, the 2019 SNPR standard, including existing products separately because product differences provided notice that the rulemaking and future products. warranted individual rulemaking included flat infant sleep products, and Section 104(f)(1) of the CPSIA does proceedings. The products listed as multiple other efforts, including those at not require any further product type durable infant or toddler products are ASTM, reinforced this. In response to specificity to identify these products as examples of durable infant or toddler comments, the preamble to this final durable infant or toddler products. The products that Congress expected the rule provides further clarity, identifying statute defines a durable infant or Commission to regulate by issuing a product types that fall within the scope toddler product as ‘‘a durable product mandatory standard. Most of these of the rule, including inclined and flat intended for use, or that may be products had existing voluntary sleep products, as well associated reasonably expected to be used, by standards in 2008 when Congress incident data and hazard patterns. This children under the age of 5 years’’ and passed the CPSIA. Congress gave CPSC final rule also provides an analysis then provides a list of products that are the authority to add products to the list demonstrating that the requirements of durable infant or toddler products. The of durable infant or toddler products, the bassinet standard are adequate to Commission’s implementing rule at 16 gave CPSC the mission to protect address each risk of injury associated CFR 1130.2(a) states: consumers, and instructed CPSC to with infant sleep products, both flat and ‘‘periodically review and revise the inclined product types. As set forth in DEFINITION OF DURABLE INFANT OR standards set forth under this subsection response to comment 39, we disagree TODDLER PRODUCT means the following to ensure that such standards provide that a rule under section 104 of the products intended for use, or that may be reasonably expected to be used, by children the highest level of safety for such CPSIA cannot have a scope that is under the age of 5 years. The listed product products that is feasible.’’ broader than one product type. For categories are further defined in the Flat sleep products that are subject to example, many types of carriages and applicable standards that the Commission the final rule are not currently defined strollers fall within the Safety Standard issues under section 104(b) of the Consumer or covered by any existing ASTM for Carriage and Strollers. Strollers Product Safety Improvement Act of 2008, and standard. If CPSC could not use its offered for sale in the United States include products that are combinations of the authority to expand the scope of a rule must meet the requirements in this following product categories . . . to include such products, especially regulation, regardless of product type. Based on this definition in part 1130, when staff’s analysis demonstrates that The Commission’s statutory mandate a product marketed or intended as a the existing bassinets and cradles under section 104 of the CPSIA is to sleeping accommodation for an infant standard would address the risk of ensure that durable infant or toddler up to 5 months old is a durable infant injury associated with such products, product standards provide the highest or toddler product. Because the ASTM could dictate when and if level of safety for such products that is

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feasible. Congress specifically included As proposed in the 2019 SNPR, the Specification for Non-Full-Size Baby five products intended for infant sleep definition of an ‘‘infant sleep product’’ Cribs/Play Yards; in the statutory list of durable infant or in the final rule also includes flat sleep Æ 16 CFR part 1222—Safety Standard toddler products (full-size cribs, non- products, such as in-bed sleepers, baby for Bedside Sleepers, incorporating by full-size cribs, play yards, and bassinets boxes, compact bassinets, and baby reference ASTM F2906, Standard and cradles), demonstrating intent for tents, which currently do not fall within Consumer Safety Specification for CPSC to regulate such products. the scope of any voluntary or mandatory Bedside Sleepers. Currently, multiple flat and inclined standard. Staff’s assessment of the The purpose of this revision is to sleep products are not subject to a CPSC incident reports and hazard patterns more clearly establish the scope of the regulation, but CPSC has the authority associated with flat sleep products in final rule, which includes all products to add ‘‘infant sleep products’’ as a this final rule demonstrates that the risk marketed or intended for infant sleep for durable infant or toddler product, and to of injury and death associated with flat children up to 5 months of age, so that regulate this product category. sleep products are similar, and can be these products that are currently Accordingly, the final rule regulates any addressed by meeting the requirements unregulated must now meet one of the product marketed or intended as a in the current voluntary standard for mandatory standards for infant sleep. sleeping accommodation for an infant bassinets and cradles, ASTM F2194, • Revise the scope of the standard to up to 5 months old, that is not already which is incorporated into the explicitly state that crib mattresses that regulated by another CPSC sleep Commission’s mandatory standard, 16 meet the requirements of ASTM F2933 standard. In response to comments, the CFR part 1218. do not fall within the scope of the final rule expands the justification from Accordingly, the final rule standard. This exclusion clarifies that the 2019 SNPR to demonstrate that the incorporates by reference ASTM F3118– crib mattresses that meet the voluntary bassinet standard provides the 17a as the mandatory standard for infant standard do not meet the definition of minimum safe sleep characteristics for sleep products, both inclined and flat, an infant sleep product, and are always these infant sleep products. Finally, the with the following modifications to the used in conjunction with a sleep scope of the final rule is well-defined, voluntary standard: product, such as a crib or play yard, that and allows a manufacturer to • Revise the introduction of the falls within one of CPSC’s sleep intentionally design and market a standard, to state the purpose of the standards. The final rule also modifies product as an infant sleep product, or to standard is to address infant sleep referenced documents in the standard, choose not to design and market a products not already covered by to add the voluntary standard for crib product as an infant sleep product. traditional sleep product standards, to mattresses, ASTM F2933; • VIII. Final Rule Establishing a Safety reduce deaths associated with known Modify the definition of ‘‘infant Standard for Infant Sleep Products sleep hazards, including but not limited inclined sleep product’’ to remove the to, a seat back or sleep surface angle that term ‘‘inclined’’ and revise the This final rule establishes a children’s definition to state that an ‘‘infant sleep product safety standard for infant sleep is greater than 10 degrees from the horizontal. This requirement is intended product’’ is ‘‘a product marketed or products as a type of durable infant or intended to provide a sleeping toddler product under section 104 of the to broaden the purpose of the standard to more clearly address inclined and flat accommodation for an infant up to 5 CPSIA. The Mannen Study and CPSC months of age, and that is not subject to staff’s analysis of the incident reports, sleep products, including known hazards associated with infant sleep. any of the following: hazard patterns, and adequacy of the • Æ voluntary standard, demonstrate that Revise the scope of the standard, to 16 CFR part 1218—Safety Standard remove the term ‘‘inclined’’ and for Bassinets and Cradles ASTM F3118–17a is inadequate to Æ address the risk of injury associated broaden the scope to include infant 16 CFR part 1219—Safety Standard sleep products, including inclined and for Full-Size Baby Cribs with inclined sleep products. ASTM Æ F3118–17a is inadequate to address the flat sleep surfaces, marketed or intended 16 CFR part 1220—Safety Standard to provide a sleeping accommodation for Non-Full-Size Baby Cribs risk of injury associated with inclined Æ sleep products, because it allows for an infant up to 5 months old, and 16 CFR part 1221—Safety Standard that are not already subject to a for Play Yards products with a seat back angle greater Æ than 10 degrees, and does not address mandatory CPSC sleep standard: 16 CFR part 1222—Safety Standard Æ additional hazard patterns associated 16 CFR part 1218—Safety Standard for Bedside Sleepers with inclined sleep products, such as for Bassinets and Cradles, incorporating This requirement aligns the definition of containing the infant. The Commission by reference ASTM F2194, Standard ‘‘infant sleep product’’ with the scope of determines that more stringent Consumer Safety Specification for the rule, including the intent of the rule requirements are necessary in the Bassinets and Cradles; to ensure that all infant sleep products, mandatory standard to further reduce Æ 16 CFR part 1219—Safety Standard inclined and flat, are subject to a the risk of injury associated with for Full-Size Baby Cribs, incorporating mandatory CPSC sleep standard, to inclined sleep products. Staff’s by reference ASTM F1169, Standard address the risk of injury associated assessment in the 2019 SNPR, and Consumer Safety Specification for Full- with infant sleep products. section VI of this preamble, demonstrate Size Baby Cribs; • Remove the definitions of that the performance requirements in Æ 16 CFR part 1220—Safety Standard accessory, compact, and newborn the current voluntary standard for for Non-Full-Size Baby Cribs, inclined sleep products because they are bassinets and cradles, ASTM F2194, incorporating by reference applicable no longer necessary and have no unique which is incorporated into the requirements in ASTM F406, Standard requirements in the standard, because Commission’s mandatory standard, 16 Consumer Safety Specification for Non- all infant sleep products are subsumed CFR part 1218, is adequate to address Full-Size Baby Cribs/Play Yards; under the definition of ‘‘infant sleep the risk of injury associated with infant Æ 16 CFR part 1221—Safety Standard product.’’ inclined sleep products, and will further for Play Yards, incorporating by • Modify seat back/sleep surface reduce the risk of injury associated with reference applicable requirements in angle so the maximum allowable angle, inclined sleep products. ASTM F406, Standard Consumer Safety as tested per the rule, must be equal to

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or less than 10 degrees from horizontal The Commission published a final conducting infant swing testing will in all positions recommended for sleep. rule, Requirements Pertaining to Third already have the gage. Staff advises that Although the bassinet standard also Party Conformity Assessment Bodies, 78 33 labs are currently CPSC-accepted to requires a sleep surface equal to or less FR 15836 (March 12, 2013), codified at test to the bassinet and cradle standard. than 10 degrees, the bassinet standard 16 CFR part 1112 (‘‘part 1112’’) and Of these 33, 19 of the labs are also does not have a test for the sleep surface effective on June 10, 2013, which accredited to test to the infant swings angle. Accordingly, infant sleep establishes requirements for standard, meaning these labs have all of products are required to test for the accreditation of third party conformity the test equipment required to test to the sleep surface angle, in addition to assessment bodies to test for conformity new part 1236. These labs should be meeting the bassinet standard. with a children’s product safety rule in able to more easily become accredited to • Add a new requirement that infant accordance with section 14(a)(2) of the test to part 1236. Also, labs that already sleep products must meet 16 CFR part CPSA. Part 1112 also codifies all of the test to part 1218 bassinets, must only 1218, Safety Standard for Bassinets and NORs issued previously by the acquire the test gage, which staff advises Cradles, including conforming to the Commission. is manufactured with readily available definition of bassinet/cradle. As the All new NORs for new children’s metal and is estimated to cost $800. final rule analysis demonstrates, product safety rules, such as the infant Moreover, labs that previously tested to conforming to the requirements in the sleep products standard, require an the current ASTM F3118–17a for the bassinet standard addresses the risk of amendment to part 1112. Accordingly, JPMA certification program have the injury associated with infant sleep the 2019 SNPR proposed to amend the gage, because F3118 contains a test to products. Requiring products to meet existing rule that codifies the list of all measure the seat back angle using the the definition of a bassinet/cradle also NORs issued by the Commission, 16 gage. Finally, the effective date of this ensures that the products meet the CFR part 1112, to add 16 CFR part 1236, final rule is 12 months from publication requirement to have a stand. Standard Consumer Safety in the Federal Register. Accordingly, • Remove all the performance Specification for Infant Sleep Products, labs seeking to become accredited to requirements except for the above new to the list of children’s product safety part 1236 have a full year to obtain the or modified requirements. rules for which CPSC has issued an necessary test equipment, become ISO NOR, because a final rule would be a • Remove all test methods except for accredited, and have CPSC-accept their children’s product safety rule that accreditation to test to part 1236. maximum seat back/sleep surface angle. requires third party testing by a CPSC- The Commission certified in the 2019 The name of CPSC’s final rule does accepted third party conformity SNPR that the proposed NOR for infant not include the term ‘‘inclined,’’ and assessment body. 84 FR at 60957. The sleep products would not have a will be codified as 16 CFR part 1236, Commission received no comment on significant impact on a substantial Safety Standard for Infant Sleep the proposed amendment, and is number of small laboratories. 84 FR Products. Finally, as proposed in the finalizing the amendment as proposed 60959. CPSC expects that laboratories 2019 SNPR, because infant sleep in the SNPR. that are already accredited to test to the products must meet the bassinet Test laboratories applying for bassinet and cradle standard will find it standard, infant sleep products must acceptance as a CPSC-accepted third relatively easy to become accredited to also meet the warning requirements in party conformity assessment body to test to this standard, because the the bassinet and cradle standard, test to the new standard for infant sleep primary substantive requirement added instead of those stated in ASTM F3118– products are required to meet the third by this standard is the sleep surface 17a. 84 FR at 60956–57. An Appendix party conformity assessment body angle. Moreover, CPSC did not receive to Tab C of Staff’s Final Rule Briefing accreditation requirements in part 1112. any comments regarding the NOR. Package contains a redline of the final When a laboratory meets the Therefore, for the final rule, the rule changes, compared to the requirements as a CPSC-accepted third Commission continues to certify that requirements in ASTM F3118–17a. party conformity assessment body, the amending part 1112 to include the NOR IX. Amendment to 16 CFR Part 1112 To laboratory can apply to CPSC to have 16 for the infant sleep products final rule Include NOR for Infant Sleep Products CFR part 1236, Standard Consumer will not have a significant impact on a Safety Specification for Infant Sleep substantial number of small The CPSA establishes certain Products, included in the laboratory’s laboratories. requirements for product certification scope of accreditation of CPSC safety and testing. Products subject to a rules listed for the laboratory on CPSC’s X. Amendment to Definitions in consumer product safety rule under the website at: www.cpsc.gov/labsearch. Consumer Registration Rule CPSA, or to a similar rule, ban, standard Part 1236 includes one performance test The statutory definition of ‘‘durable or regulation under any other act to check for a seat back/sleep surface infant or toddler product’’ in section enforced by the Commission, must be angle that is 10 degrees or less, and then 104(f) applies to all of section 104 of the certified as complying with all requires infant sleep products to meet CPSIA. In addition to requiring the applicable CPSC-enforced requirements. 16 CFR part 1218, Safety Standard for Commission to issue safety standards 15 U.S.C. 2063(a). Certification of Bassinets and Cradles. for durable infant or toddler products, children’s products subject to a The new 16 CFR part 1236 for infant section 104 of the CPSIA also directed children’s product safety rule must be sleep products should have sufficient the Commission to issue a rule requiring based on testing conducted by a CPSC- testing capacity by the effective date of that manufacturers of durable infant or accepted third party conformity the final rule. The test to check the sleep toddler products establish a program for assessment body. Id. 2063(a)(2). The surface angle required in part 1236 consumer registration of those products. Commission must publish an NOR for involves use of the ‘‘Hinged Weight Section 104(d) of the CPSIA. the accreditation of third party Gage—Infant’’ identified in F3118–17a. In 2009, the Commission issued a rule conformity assessment bodies to assess Because the gage is also used for testing implementing the consumer registration conformity with a children’s product to the 16 CFR part 1223, Safety Standard requirement. 16 CFR part 1130. As the safety rule to which a children’s product for Infant Swings (incorporating by CPSIA directs, the consumer registration is subject. Id. 2063(a)(3). reference ASTM F2088), labs rule requires each manufacturer of a

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durable infant or toddler product to: infant or toddler product’’ in section READINGLIBRARY/. To download or Provide a postage-paid consumer 104(f) of the CPSIA, and in § 1130.2, print the standard, interested persons registration form with each product; which define the term as products may purchase a copy of ASTM F3118– keep records of consumers who register ‘‘intended for use, or that may be 17a from ASTM, through its website their products with the manufacturer; reasonably expected to be used, by (http://www.astm.org), or by mail from and permanently place the children under the age of 5 years,’’ ASTM International, 100 Bar Harbor manufacturer’s name and certain other ‘‘infant sleep products’’ are a durable Drive, P.O. Box 0700, West identifying information on the product. infant or toddler product. ‘‘Infant sleep Conshohocken, PA 19428; http:// When the Commission issued the products’’ are defined in the final rule www.astm.org. Alternatively, interested consumer registration rule, the as a product marketed or intended as a parties may inspect a copy of the Commission identified six additional sleeping accommodation for an infant standard free of charge by contacting products as ‘‘durable infant or toddler up to 5 months old. Accordingly, the Alberta E. Mills, Division of the products’’ to add to the statutory list in products are ‘‘intended for use,’’ and Secretariat, U.S. Consumer Product section 104(f)(2) of the CPSIA: ‘‘reasonably expected to be used,’’ by Safety Commission, 4330 East-West D children’s folding chairs children under 5 years old. Moreover, Highway, Bethesda, MD 20814; D changing tables; products intended for infant sleep are telephone: 301–504–7479; email: cpsc- D infant bouncers; similar to products on the statutory list [email protected]. intended for infant sleep, such as cribs, D infant bathtubs; XII. Effective Date D bed rails; and bassinets and cradles. Moreover, ‘‘infant D infant slings. sleep products’’ are further defined in The Administrative Procedure Act (APA) generally requires that the 16 CFR 1130.2. The Commission stated the final rule. Finally, as discussed in section V of this preamble, the Safety effective date of a rule be at least 30 that the specified statutory categories Standard for Infant Sleep Products, for days after publication of the final rule. were not exclusive, but that the both inclined and flat sleep products, is 5 U.S.C. 553(d). CPSC generally Commission should explicitly identify an outgrowth of efforts to develop a considers 6 months to be sufficient time the product categories that are covered. safety standard for bassinets and for suppliers of durable infant and The preamble to the 2009 final cradles, and may be considered a toddler products to come into consumer registration rule states: subcategory of bassinets. To provide compliance with a new standard under ‘‘Because the statute has a broad greater clarity that inclined sleep section 104 of the CPSIA. Six months is definition of a durable infant or toddler products are durable infant or toddler also the period that the Juvenile product but also includes 12 specific products subject to the consumer Products Manufacturers Association product categories, additional items can registration rule, as well as third party (JPMA) typically allows for products in and should be included in the testing and certification requirements the JPMA certification program to definition, but should also be for durable infant or toddler products, transition to a new standard once that specifically listed in the rule.’’ 74 FR the Commission finalizes the standard is published. 68668, 68669 (Dec. 29, 2009). amendment to 16 CFR 1130.2(a)(12), as The 2019 SNPR proposed 12-month In the SNPR, the Commission proposed, to explicitly include ‘‘infant effective date after publication of the proposed to amend the definition of sleep products’’ as a subcategory of final rule, for products manufactured or ‘‘durable infant or toddler product’’ in bassinets and cradles. imported on or after that date, because: the consumer registration rule to clarify (1) the Commission was proposing to that ‘‘infant sleep products’’ fall within XI. Incorporation by Reference incorporate by reference, ASTM F3118– the term ‘‘durable infant or toddler Section 1236.2(a) of the final rule 17a, a relatively new voluntary standard product’’ as a subset of bassinets and provides that each infant sleep product that covers a variety of products whose cradles, and must comply with the must comply with applicable provisions manufacturers may not be aware that consumer registration rule and section of ASTM F3118–17a. The Office of the their product must comply; and (2) the 104 of the CPSIA. CPSC received a Federal Register (OFR) has regulations Commission proposed to make comment stating that the SNPR failed to concerning incorporation by reference. 1 substantial modifications to ASTM discuss which product types would be CFR part 51. For a final rule, agencies F3118–17a, and a 12-month effective considered ‘‘durable infant or toddler must discuss in the preamble to the rule date would allow time for infant sleep products’’ for product registration card the way in which materials that the product manufacturers to bring their purposes, and ‘‘simply concludes in a agency incorporates by reference are products into compliance after a final circular fashion that infant sleep reasonably available to interested rule is issued. 84 FR 60958. The 2019 products are durable infant or toddler persons, and how interested parties can SNPR stated that the Commission products.’’ The commenter believes that obtain the materials. Additionally, the expects that most firms should be able a specific rationale is required for each preamble to the rule must summarize to comply within the 12-month product to ‘‘independently qualify’’ as a the material. 1 CFR 51.5(b). timeframe. The 2019 SNPR also durable infant or toddler product. The In accordance with the OFR’s requested comment on the proposed 12- commenter concludes that under the requirements, sections VI.A and VIII of month effective date, because of the APA, the Commission must specifically this preamble summarize the provisions hazards involved with infant inclined define products that fall within an of ASTM F3118–17a that the sleep products, and stated that the final ‘‘infant sleep product’’ in another SNPR Commission is incorporating by rule could issue with a shorter effective before it can issue a final rule. reference. ASTM F3118–17a is date, so that safer products would be We disagree with the commenter and copyrighted. Before the effective date of available sooner. Id. finalize the amendment to part 1130, as this rule, you may view a copy of ASTM The 2019 SNPR commenters both proposed in the 2019 SNPR, to include F3118–17a at: https://www.astm.org/ supported and opposed the 12-month ‘‘infant sleep products’’ as a durable cpsc.htm. Once the rule becomes effective date. Some commenters infant or toddler product, as a effective, ASTM F3118–17a can be supported a 6-month effective date, subcategory of bassinets and cradles. viewed free of charge as a read-only urging that additional time for the rule Based on the definition of a ‘‘durable document at: https://www.astm.org/ to become effective puts infants at risk.

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Other commenters requested a longer from the Initial Regulatory Flexibility small importers and nine small effective date, or an indefinite delay of Analysis (IRFA) that accompanied the domestic manufacturers that supply the rulemaking, until ASTM completes 2017 NPR, because the scope of the NPR infant sleep products to the U.S. market, additional standards for specific was inclined sleep products, while the as well as for hundreds of home-based products covered by the final rule. scope of the final rule is infant sleep small businesses that ship from the U.S. For the final rule, the Commission products, defined in the final rule as We provide a summary of the FRFA will maintain the 2019 SNPR proposed products that are marketed or intended below. effective date of 12 months after the date to provide sleeping accommodations for B. The Market for Infant Sleep Products of publication in the Federal Register. an infant up to 5 months of age, and that Accordingly, as of the effective date of are not already covered by a mandatory Section II of this preamble describes the final rule, it is unlawful to ‘‘sell, CPSC sleep standard: Full-size cribs, the infant sleep products within the offer for sale, manufacture for sale, non-full-size cribs, play yards, bassinets scope of the final rule, the products distribute in commerce, or import into and cradles, or bedside sleepers. This excluded from the final rule, and a the United States,’’ any infant sleep change in scope from the proposed rule description of the market for infant product, as defined in the rule, that is was specified in the 2019 SNPR, and sleep products, including a summary of not in conformity with the final rule. 15 includes inclined and non-inclined retail prices for various types of infant U.S.C. 2068(a)(1). (flat) infant sleep products. Some sleep products. inclined sleep products have been A 6-month effective date may seem C. Products and Small Entities to Which recalled or otherwise voluntarily reasonable because suppliers have had the Final Rule Would Apply ample lead time to prepare for this rule removed from the market since 2019, so since the SNPR was published in 2019, some firms that were forecast to be 1. Overview of Products Covered by, and many of the products within the impacted in the IRFA are not likely to and Excluded From, the Final Rule scope of the final rule have been be impacted by this final rule, because Section II.A and B of this preamble withdrawn from the market or the firms have already stopped selling describe the products subject to, and redesigned, particularly for inclined those products. However, a significant excluded from, the final rule. This rule sleep products. However, some economic impact is possible for is intended to cover ‘‘infant sleep manufacturers of flat sleep products that suppliers of flat sleep products that products,’’ defined in the final rule as remain in the market will likely were not analyzed in the IRFA, as well products that are marketed or intended experience a significant economic as remaining suppliers of inclined to provide a sleeping accommodation impact as a result of this final rule. products. Flat sleep products without for an infant up to 5 months of age, and While some suppliers can reduce the inclined sleep surfaces include: Baby that are not already covered by a impact of this rule by relabeling their boxes, compact and travel bassinets that mandatory CPSC sleep standard: Full- products as not for infant sleep, not all do not meet the bassinet standard, in- size cribs, non-full-size cribs, play manufacturers can simply remarket the bed sleepers, baby tents marketed for yards, bassinets and cradles, or bedside infant sleep, baby pods, and baby nests. product if the physical form of the sleepers. A detailed description of the Pursuant to the final rule, firms whose product demonstrates that it is intended products covered by the final rule is set infant sleep products do not comply for sleep. For some of these products, forth in section II.C of this preamble, manufacturers could relabel them as with any CPSC sleep standard will need to evaluate their products, determine and includes: intended for infants older than five • Inclined products, such as: Hard months, or, in some cases, for pets. what changes would be required to meet an existing CPSC standard, or 16 CFR frame inclined sleepers, compact However, the demand for infant sleep foam inclined sleepers, inclined play products for pet use is probably limited. part 1218, the Safety Standard for Bassinets and Cradles, and decide how yard accessories, and baby hammocks; Accordingly, maintaining the proposed and 12-month effective date will provide to proceed. Noncompliant products • would need to be removed from the U.S. Flat products, such as: Soft-sided manufacturers and importers time to products (baby pods and baby nests, spread the impact of the rule over a 12 market, modified to meet the mandatory standard as specified in this final rule, soft-sided travel bassinets or travel month time period, to reduce the beds, hand-held carriers marketed for economic impact of the final rule. remarketed for children older than 5 months, or remarketed as not intended sleep, and in-bed sleepers), rigid- XIII. Regulatory Flexibility Act for infant sleep. New infant sleep sided and rigid-framed compact products introduced to the market bassinets, travel bassinets, and similar A. Introduction would also need to comply with the products (baby boxes, compact, The Regulatory Flexibility Act (RFA), standard, or one of the other CPSC sleep portable, or travel bassinets, or infant 5 U.S.C. 601–612, requires that agencies standards. The final rule defines an travel beds), and baby tents. review a proposed rule and a final rule ‘‘infant sleep product’’ as a product None of these products is covered by an for the rule’s potential economic impact marketed or intended to provide a existing CPSC sleep standard. CPSC on small entities, including small sleeping accommodation for an infant considers that any items marketed for businesses. Section 604 of the RFA up to 5 months of age, and that does not ‘‘napping,’’ ‘‘snoozing,’’ or ‘‘dreaming,’’ generally requires that agencies prepare already meet a mandatory CPSC sleep or any other word that implies sleeping, a final regulatory flexibility analysis standard. CPSC interprets this definition or that are called a ‘‘bed,’’ as well as (FRFA) when promulgating final rules, to include products that are marketed items marketed with a picture of a unless the head of the agency certifies for ‘‘napping,’’ ‘‘snoozing,’’ ‘‘dreaming,’’ sleeping infant, to be an infant sleep that the rule will not have a significant or any other word that implies sleeping, product. economic impact on a substantial or that are called a ‘‘bed,’’ and items Products that are subject to another number of small entities. Staff prepared marketed with a picture of a sleeping CPSC sleep standard, or to another a FRFA that is available at Tab E of infant, to be an infant sleep product. durable infant or toddler product rule Staff’s Final Rule Briefing Package. Based on the staff’s analysis, the that is not marketed for sleep, such as The scope of this FRFA and the Commission anticipates a possible infant bouncers or swings, are not number of firms impacted is different significant economic impact for twelve subject to the final rule. Moreover, a crib

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mattress, as defined in ASTM F2933–19, the suppliers of the unregulated flat- modifying the infant sleeper products to is not an infant sleep product covered bottomed sleep products and infant meet the standard. by the final rule. hammock categories. A large number of For infant sleep products, the third- suppliers exist for these products; the party testing costs are expected to be 2. Suppliers to This Market market is fragmented with many sellers. about $1,500 per testing cycle per Manufacturers of infant sleep Many of the products covered by the model, including both the costs of the products are categorized under many final rule, particularly the soft-sided testing and the costs of the samples to different North American Classification products and the products sold by small be tested. This is consistent with the System (NAICS) categories, because businesses, are only available online. IRFA in the SNPR, which estimated a there is not a NAICS code specifically The majority of the suppliers to which cost of $1,100 for testing alone, not for infant sleep products. These items this final rule would apply are small by including the cost of the samples to be are made by companies that have baby SBA standards. At least 60 small U.S.- tested; we did not receive any furniture, baby bedding items, based manufacturers and importers are comments on the SNPR providing a mattresses, other durable baby items in this market, as well as 5 large different estimate. Based on comments including strollers or car seats, toys, or domestic companies, and dozens of received on the bassinet and cradle final general merchandise as their primary foreign companies, some of which ship rule published in 2013, one-time costs business. Businesses are generally these items directly to customers in the of redesigning a product to meet the considered small per the Small Business U.S. via online marketplaces. In standard could be as high as $500,000 Administration (SBA) size standards if addition, more than a thousand home- for products requiring major redesign. they have fewer than 100 employees for based businesses supply flat sleep As allowed by the component part importers or wholesalers, or fewer than products that would be subject to the testing rule (16 CFR 1109), importers 500 employees for most of the relevant final rule, of which hundreds ship from may rely upon third party tests obtained types of manufacturers for this rule. The the U.S. Some firms sell these items by their suppliers, which could reduce SBA size standard for mattress under multiple brand names and the impact on importers. In addition, all manufacturing is 1,000 employees. The models, including small manufacturers businesses selling products covered by relevant NAICS codes include: that make ‘‘store brands’’ for larger this rule were already required to certify 314999 (All Other Miscellaneous Textile companies. The number of importers compliance to general children’s Product Mills) selling flat sleep products is product rules for lead, phthalates, and 337910 (Mattress Manufacturing) approximate because the proliferation of small parts with third party testing, so 339930 (Doll, Toy, and Game Manufacturing) online retail makes it possible for those third-party testing costs would not 339999 (All Other Miscellaneous importers to quickly change their be considered new costs of compliance Manufacturing) product offerings based on demand for for this rule. 423220 (Home Furnishing Merchant particular products. The number of Wholesalers) foreign companies is approximate for E. Impact of Final Rule by Product 424330 (Women’s, Children’s, and Infants’ the same reason. In addition to the Category Clothing and Accessories Merchant Wholesalers) foreign companies that ship from U.S. The impact on small businesses distribution sites, dozens of third-party would vary by product category. We The SBA size standards for ‘‘small’’ sellers are on major internet retail sites for the relevant NAICS codes mean that describe each product, provide that ship products to U.S. consumers information on the types of firms that most suppliers in this product category directly from a foreign country. The are considered ‘‘small.’’ A U.S. company supply the product, and describe the analysis in this FRFA focuses on the impacts for each product type for that has a factory employing 100 people impact on small U.S. manufacturers and might be a top 10 supplier in a complying with this rule or taking importers that ship from the U.S., as action to exit the market sector. particular infant sleep product category, well as U.S.-based home businesses, but but would be considered ‘‘small’’ by the large and foreign companies will 1. Inclined Sleep Products SBA standards. Similarly, an importer also be impacted by the cost of (a) Hard Frame Inclined Sleepers, with a U.S. warehouse staff of 50 people complying with this rule. The large Compact Foam Inclined Sleepers, and would also be considered ‘‘small.’’ number of companies in the flat sleep Play Yard Accessories Prior to the recalls of some infant products market covered by this rule inclined sleep products, large domestic reflects both a strong market demand for Since the NPR was published in 2017, and foreign companies and the larger these products and a competitive market some inclined sleep products have been ‘‘small’’ companies by SBA size with relatively low margins. recalled or otherwise removed from the standards were responsible for most of market. However, while resale of the sales volume for the hard frame D. Testing and Certification recalled products is prohibited, inclined sleep products and inclined Under section 14 of the CPSA, once discontinued items that were not play yard sleeper accessories. Many of the new infant sleep product mandatory recalled are still available on the the inclined sleep products were standard become effective, all suppliers secondary market, as well as additional available at big box chain retailers, and will be subject to the third party testing physically similar products sold by a few were available at mattress and certification requirements under the small companies that were not recalled. retailers. The larger companies have CPSA and the Testing and Labeling JPMA has two manufacturers that are recalled or discontinued these products, Pertaining to Product Certification rule certified as compliant to the current and most big box stores have stopped (16 CFR 1107), which requires that ASTM F3118 standard for inclined stocking them. However, inclined sleep manufacturers and importers certify that sleepers. While larger companies have products are still available from small their products comply with the removed most of their inclined products manufacturers and importers, and applicable children’s product safety from the market or remarketed them as discontinued items made by large standards, based on third party testing, chairs or loungers, some smaller companies are still available from and subject their products to third party importers and foreign direct shippers online merchants. Small companies testing periodically. Third party testing still offer them as sleep products. Some have always accounted for a majority of costs are in addition to the costs of play yards with inclined sleep

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accessories are still available. To date, volume has shifted to smaller bassinet, changing table, or similar the lack of a CPSC mandatory standard companies as the larger companies have accessories must comply with the means that new entrants are free to enter already removed these items from the applicable requirements of ASTM this market sector with new inclined market or remarketed them as chairs, standards addressing those product sleep products that do not comply with rockers, or chair/swing combos. Two types. Play yard suppliers were already the existing ASTM standard, ASTM small domestic companies that make required to comply with the F3118–17a, or any other ASTM or CPSC inclined sleep products may experience requirement that bassinet accessories sleep standard. Many of the recalled a significant economic impact 45 as these meet the bassinet standard. Because the items were still available from smaller were some of their best-selling products, main product is the play yard, not the internet merchants in the spring and and one of them also supplied the particular accessories, and suppliers summer of 2020. Some items that were product as a ‘‘store brand’’ to another were already required to comply with not recalled, but merely discontinued by company. The other sells multiple types the bassinet standard for bassinet-type the manufacturer, are still available for of sleepers within the scope of the final accessories, this rule should not have a sale from retailers, at least until the rule. Redesigning, relabeling, or significant impact on any of the remaining stock is sold. discontinuing the products could be a suppliers of play yards, unless they had Once the final rule is published and significant impact on these firms. The ‘‘napper’’ or ‘‘inclined sleeper’’ becomes effective, suppliers of inclined rest of the small domestic companies accessories that did not meet the sleep products must either redesign that sold this product and small bassinet standard. The impact could be existing products to comply with the importers will likely not be significantly significant for one small domestic standard and conduct third-party testing impacted because they sell many other company that still sells inclined play to demonstrate compliance, stop selling products that would not be subject to yard accessories, and has other products the products, or remarket the products the final rule. in the scope of this rule. Suppliers of inclined compact foam as not intended for infant sleep. The (b) Baby Hammocks impact of those options will depend products will need to redesign their upon how much redesign the product products with an incline of 10 degrees Suppliers of baby hammocks are requires, and what portion of the or less and meet other requirements of unlikely to be able to redesign their company’s sales are inclined sleep this standard, remove these products product to meet any of the existing products. The impact on small from the market, or relabel them as not CPSC infant sleep standards. An companies that sell many different being intended for sleep by children inclined sleep angle is inherent in the products in different categories, which under 5 months of age. Some of these design of hammocks, which shift shape is relatively common, especially for products have restraining harnesses to as the infant moves. Sleeping pads in importers, will likely not be as keep the infant from sliding down on the bottom of a hammock would still significant as the impact on small the slanted product, which is not leave the product with sides that shift companies that sell only a few types of compliant with any of the existing CPSC shape in use. For hammock accessory products sold separately that attach to products or that concentrate on sleep sleep standards. Some suppliers have the corners of a crib or play yard, there products covered by this rule. already remarketed the products as The impact of remarketing products loungers or floor chairs without is no standard installation that could be for a different use, such as for an older changing the design. Several of the tested to meet incline, gap, side heights, child, a pet, or not for sleep, will companies that sell these products sell or stability requirements: The incline would depend on the size of the crib or depend on the extent to which larger wedge pillow products for adults play yard and the weight of the infant, consumers demand the product for the and older children as ‘‘body pillows’’ or and the gaps between the hammock side different use. Given the proliferation of sleeping positioners, so the infant sleep and the side of the crib or play yard floor chairs, lounger chairs, rockers, and products are not their only product line. would depend on the size of the crib or bouncer seats on the market, it seems Redesign or remarketing could have a play yard. Therefore, relabeling and likely that consumers find value in significant impact for the three small remarketing baby hammocks as being physically similar products that are domestic companies and one importer not for sleep or as being intended only marketed for a different use, and that that have such products, as well as other for children at over 5 months of age may remarketing will not reduce demand. products in the scope of this rule, as a be the only compliance option, other U.S. sales of the combined category of large portion of their product line. Suppliers of inclined play yard than removing the products from the bouncer seats, rockers, and sleepers accessories will need to redesign their market altogether. totaled more than 2 million units and Since the NPR was published, some 44 products with an incline of 10 degrees $126 million dollars in 2018. or less and meet other requirements of baby hammocks have been withdrawn Suppliers of the hard-plastic framed this standard, remove these products from the market by small companies rocker-type items may choose to from the market, or relabel them as not that make and import other types of redesign their items to meet the being intended for sleep by children baby products or adult hammocks. requirements of a different mandatory under 5 months of age, if appropriate. However, many home-based suppliers safety standard, particularly the one for Most play yard suppliers have already remain in the market, as well as several infant bouncer seats. Most of the hard- discontinued or recalled the inclined small domestic businesses, one of which framed products were made by large or accessory products and replaced them appears to have infant crib hammocks as foreign companies, although the market with flat products instead. The ASTM its only product. Multiple importers standard for non-full-size-cribs and play based in the U.S. also sell hammocks 44 Baby feeding, care, and travel accessory unit sales in the United States in 2018, by product yards, F406–19, already specifies that with frames made by foreign companies, type—https://www.statista.com/statistics/891908/ but those companies will not be baby-feeding-care-and-travel-accessory-unit-sales- 45 Please note that the number of companies significantly impacted because they sell by-product-type-us/ And Baby feeding, care, and impacted for each product type sums to more than many other products that would not be travel accessory sales in the United States in 2018, the total number of impacted companies for the rule by product type https://www.statista.com/statistics/ as a whole, because several small companies sell impacted by the final rule. Several 891889/baby-feeding-care-and-travel-accessory- products in multiple product categories impacted foreign companies that make baby sales-by-product-type-us/. by this rule. hammocks will have to stop distributing

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them in the U.S., or conspicuously label Flat play yard accessories are already or for pets, depending on whether the them as being for use only by children required to meet the bassinet or other size is appropriate for those uses. For over 5 months of age. applicable standard. The ASTM the importers, the impact is likely not If baby hammocks are removed from standard for non-full-size-cribs and play significant, as they do not have these the market, the impact will likely be yards, F406–19, already specifies that products as most of their product line significant for one small domestic bassinet, changing table, or similar and can therefore either stop selling the company for which baby hammocks accessories must comply with the product or obtain a compliant product constitute most, if not all, of their applicable requirements of ASTM from a different supplier at minimal cost product line, as well as possibly standards addressing those accessories. to them. For the two domestic significant for several small importers Most flat play yard accessories are hard- manufacturers of these products that that do not appear to have many other framed, not soft-sided, and are have these products as most of their products. The impact will likely be discussed in the next section. Because product line, or sell multiple products significant for dozens of home-based the main product is the play yard, not covered by this rule, the cost of manufacturers that have crib hammocks the particular accessories, and suppliers compliance could be significant. or other fabric hammocks without a were already required to comply with Baby boxes have similar compliance frame as their main or only product, if the bassinet standard for bassinet-type impacts to the larger category of they choose to exit the market. accessories, this rule should not have a compact bassinets. Some compact However, it is possible that some sellers significant impact on any of the bassinets are marketed as suitable for of hammocks will simply relabel and suppliers of flat play yard accessories, bed-sharing, so may be considered as remarket them for older children or as unless they have ‘‘napper’’ accessories rigid in-bed sleepers. Suppliers of baby toy storage hammocks. The demand for that are not compliant with the bassinet these products for older children or toy standard. One importer has only one boxes and in-bed sleepers with rigid or storage uses is unknown. model of play yard with a flat mesh rigid-framed sides may also choose to accessory as their main product; that offer their products with a stand to meet 2. Flat Sleep Products importer could be significantly the bassinet standard. Given that these (a) Flat, Soft-Sided Products impacted if their product is not products already have rigid sides and compliant and they cannot find another flat sleeping surfaces, the redesign may Many of the suppliers of flat, soft- supplier with a compliant product. be relatively minor, but could still cost sided products would likely be hundreds of thousands of dollars to significantly impacted by the final rule. (b) Flat, Rigid-Sided and Rigid-Framed implement and test, especially given the This is because compliance with any of Compact Bassinets, Travel Bassinets, need to adapt them to meet stability the sleep product standards, particularly and Similar Products requirements. These suppliers could the stability, side height, and occupant Compact bassinets with rigid sides or also choose to add a handle to these containment requirements, would be rigid-framed sides but without a stand products and make other design, difficult for a product with low, soft or legs cannot meet the stability or instructions and labeling changes in sides. A product with low, soft sides physical requirements of CPSC’s order to comply with the hand-held cannot meet the bassinet standard by bassinet and cradle standard or this carrier standard. Labeling these simply adding a stand, nor can it meet standard, independent of whether the products as not for infant sleep is likely the hand-held carrier standard by product has an incline. Suppliers may not an option, as these items are simply adding handles. Also, adding choose to offer their products with a intended for sleep, and are too small to rigid higher sides may be contrary to the stand to meet this standard, or add a be used by older children. Remarketing intended product use as in-bed sleepers. handle and redesign the product to meet as storage boxes is possible, but likely Relabeling the products as being not the hand-held carrier standard. In either a much lower price point. The impact intended for infant sleep might not be case, the cost of redesigning the product could be significant for two suppliers of an option if the product is clearly could be significant. These products baby boxes. intended for infant sleep, and is not usually already have flat sleep surface large enough for an older child, and rigid sides, as required by the Flat sleep surface play yard although these items could be bassinet/cradle standard, but may not accessories are already required to meet remarketed as pet beds. At least nine meet the side-height requirement of the the bassinet or other applicable small importers and four domestic bassinet/cradle standard. However, the standard. The ASTM standard for non- manufacturers that supply these cost to redesign could still be full-size-cribs and play yards, F406–19, products have these products as most or significant, as even a simple re-design already specifies that bassinet, changing all of their product line. There are also could cost hundreds of thousands of table, or similar accessories must potentially hundreds of small, home- dollars per model and require new comply with the applicable based businesses for which such low, third-party testing, and all of the requirements of ASTM standards soft-sided products appear to be their product marketing, instructions, and addressing those accessories. Because major product line. The impact for packaging would have to be revised. the main product is the play yard, not suppliers that have these products as Adding a stand would also increase the the particular accessories, and suppliers most of their product line would likely retail price of the product, which would were already required to comply with be significant. In addition, the many likely reduce sales, assuming that the bassinet standard for bassinet-type home-based businesses do not currently demand is responsive to price and that accessories, this rule should not have a have warning labels, instruction other products like hand-held carriers significant impact on any of the manuals, or certification to other CPSC are considered by consumers to be suppliers of flat rigid-sided play yard or ASTM standards. Some products are reasonable substitutes. Moreover, these accessories, with the possible exception already being remarketed as loungers, products likely cannot be remarketed for of a few ‘‘napper’’ products from small nappers, or ‘‘for tummy time’’, but will another use by infants 5 months and importers. Those importers should be be required to comply with the final younger, as the physical design suggests able to find a new compliant supplier rule if they are marketed for sleep, the product is for sleep, although they relatively easily, or relabel the items as including napping. could be remarketed for older children not for sleep.

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(c) Baby Tents be able to redesign their products to market for these products. The Baby tents cannot meet any of CPSC’s meet any of the sleep standards, so they economic impact of the rule on these sleep standards, due to the physical will need to decide whether to exit the home-based manufacturers is likely to form of these products, which includes market or relabel their products for use be significant. In some cases, these slanted flexible sides connected to the by older children. The impact is likely manufacturers might be able to relabel floor, sometimes with hanging cords to be significant for suppliers of these their products for older children, or for and anchoring spikes. Therefore, products if these products constitute a pet use. In the case of hammocks, the relabeling these products as not for substantial portion of their product line, items could also be marketed for toy and they choose to exit the market storage. However, the demand for infant infant sleep or removing the products rather than remarketing the items for sleep products for these types of from the market are the only compliance older children or pets. alternative uses is likely to be limited. options. We assume that most suppliers Some manufacturers and importers, We discussed earlier the impacts for will choose to remarket their items as both large and small, may be able to specific types of sleeper markets. In not for sleep or for older children, and minimize the impact of this rule by summary, the suppliers of inclined that this will not reduce sales, because marketing their products as not for sleepers can redesign their items to meet the advertised primary purpose of the infant sleep, thus effectively putting this standard, remove them from the product is shade and insect screen. their products out of scope of this rule. market, relabel them for use by older Also, most suppliers in this product This may involve conspicuously children, or remarket them as some type sector are importers with many other labeling and marketing their items as of chair. Some inclined items have unrelated products or foreign direct not for sleep by children under 5 already been remarketed as types of shippers. CPSC believes it unlikely most months. Some flat sleep surface rigid- chairs or chair/swing combination of the suppliers in this category will sided products could demonstrate products. The impact would depend on experience a significant economic compliance with this standard and the the demand for these products as chairs; impact as a result of this rule. One small bassinet standard with the addition of a the current remarketing suggests that importer does not appear to have any stand or other rigid support. Some non- companies have found there is indeed other products that might be compliant items might be remarketed demand for these products as chairs. significantly impacted if they cannot for pet use, which has apparently Suppliers of inclined play yard find a compliant supplier. happened with some former children’s accessories have similar options; it F. Summary of Costs and the Economic products, but the market for such appears that most play yard suppliers Impact of the Final Rule products is probably limited. have chosen to remove these items from Remarketing these products could still the market and replace them with flat Suppliers that choose to stay in the result in significant impact of suppliers sleep surface accessories instead. market for infant sleep products will if such relabeling results in a substantial Because play yards were already need to comply with the final rule, or reduction in product demand. required to comply with the bassinet another CPSC sleep standard, and While some items can be credibly standard if in bassinet mode, this may certify compliance through third party remarketed as not for infant sleep, such not be a significant impact. Suppliers of testing. Suppliers that choose to relabel as items that resemble chairs or swings, compact rigid-sided and rigid-framed their products as bouncer seats or the design of other items suggest they products without a stand may be able to swings will need to meet the standards are intended for infant sleep, including redesign their products to meet this for those products. Suppliers that hammock crib accessories, baby boxes, standard, or remarket them for use by relabel their products for use by and in-bed sleepers, as are most older children. The size of some of these children over 5 months will still need compact bassinets and anything products would be appropriate for use to meet general testing and certification marketed as a ‘‘bed’’. Some of these by older children. Some suppliers of requirements required for all children’s products could be marketed for children soft-sided ‘‘travel’’ and ‘‘compact’’ products, such as testing for lead over 5 months, depending on the size of bassinets are unlikely to be able to content and phthalates, as well as small the product, but many are too small for redesign their products to comply with parts, but they were already required to a larger child. Suppliers of products this standard, but may be able to meet those requirements. where the design and function of the remarket them for use by older children. Based on costs for compliance with product communicates to the consumer Similarly, suppliers of in-bed sleepers other ASTM and CPSC standards for that the product is intended for infant and baby hammocks are unlikely to be durable nursery products, the expected sleep may experience a significant able to redesign their products to cost to comply with third party testing economic impact if those products are a comply with this rule, but some may be will be about $1,500 per model tested, substantial portion of their product line. able to remarket them for use by older including the costs of the samples to be Most home-based manufacturers will children or pets, depending on the size tested. This is for compliance with the have the choice of either remarketing of the products, although demand for specific standard for infant sleep their products as not for infant sleep or those uses may be limited. products only; the costs for complying stopping the sale of the products. The In general, suppliers of products with with general requirements for children’s cost of redesigning the product to limited remarketing options, where the products should not be new costs for comply with the standard could be a size of the product is not conducive to any suppliers. Some of the companies significant portion of revenue for home- use by older children, the low, soft sides that are small by SBA standards have up based manufacturers, and redesign cannot easily be redesigned to meet this to a dozen models of different products might not even be possible for some standard, and the physical configuration impacted by this rule, each of which products commonly sold by home-based of the product limits uses other than will have to be tested for compliance manufacturers, such as baby hammocks sleep, are likely to be significantly with this standard. This would suggest and low, soft-sided flat products. impacted. Some suppliers may be able testing costs of about $18,000 per testing Additionally, even if redesign were to remarket their infant sleep products cycle. possible, the testing costs alone could be for alternative uses. However, this The suppliers of low, soft-sided sufficient to induce these home-based market is probably limited; otherwise, products and hammocks are unlikely to manufacturers to withdraw from the some of these suppliers would already

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have been producing products for these week.46 In addition, many inclined standard by marketing them as not alternative uses. At least nine small products have already been removed intended for sleep, or only intended for domestic companies and twelve small from the market or relabeled as not for use by older children, or for pets. importers are likely to be significantly sleep since publication of the 2017 NPR. Companies can also redesign their impacted because products in scope of While some of the inclined products products to meet the requirements of this rule represent most or a substantial may be remarketed as not for infant another standard, such as infant portion of their product line. Hundreds sleep, the final rule will provide parents bouncer seats or hand-held carriers. In of home-based manufacturers based in and other caregivers clearer information some cases where there is another use the U.S. supply baby nests, baby pods, as to the manufacturer’s intended safe for the product, the only change in-bed sleepers, hammocks, and crib use. required to make a product subject to hammocks are likely to be significantly The effective date is a ‘‘sold by’’ date. one of these other standards is to relabel impacted, although some may be able to This means that retailers will need to or remarket the product, removing any relabel their items as not for sleep or for sell or otherwise dispose of their stock references to its use for sleeping. older children. If the products cannot be by that date. Given that this rule has CPSC also published an SNPR in remarketed, many of these home-based been in progress for several years 2019, which means firms have been manufacturers may eliminate infant through a notice and comment aware of this rulemaking effort and have sleep products from their product lines; rulemaking, and that many of the had several years to prepare for it also possible that a significant inclined products have already been implementation of the final rule. Many proportion may go out of business. withdrawn from the market, this should companies that had inclined products not have a significant impact on small that were in the scope of the 2017 NPR In summary, taking all of these factors retailers. have removed those products from the into account, the final rule is likely to This rule would require all infant market since 2019, or remarketed them have a significant economic impact on sleep products not in the scope of other as loungers, bouncer seats, or other a substantial number of small entities. CPSC sleep standards to comply with products not for sleep. G. Other Potential Impacts of the Final this rule. This means that new products While the Commission has exempted Rule would have to comply with this rule, or small batch manufacturers from the one of the other sleep standards. testing requirements proposed under The final rule would make it illegal to Suppliers may introduce new products other rules, under Section 14(d)(4)(C)(ii) sell, offer for sale, manufacture for sale, that comply with any of those of the CPSA, the Commission cannot distribute in commerce, or import into standards, such as an innovative ‘‘provide any alternative requirements the United States products not bassinet design that meets all the or exemption’’ from third party testing compliant with the rule 12 months after requirements of the bassinet standard. for ‘‘durable infant or toddler products,’’ the publication of the rule in the They may also work with ASTM to as defined in section 104(f) of the Federal Register. This means that revise one of the ASTM sleep standards CPSIA. Consequently, staff cannot parents and other caregivers would not to cover their new product, and then recommend a small batch exemption for be able to purchase these items. The CPSC could consider such revision as small baby nest and hammock home- large volume of these products sold or part of CPSC’s procedures for accepting based manufacturers absent a statutory home-made reflect that these products revisions to voluntary standards that are change. The ASTM F3118 committee all address a demand for a compact the basis for CPSC mandatory standards. considered wording that would allow sleep space for babies, so it is reasonable Suppliers of innovative products may manufacturers to choose whether to to assume that demand will continue for also work with ASTM to develop a comply with F3118 or another ASTM new or redesigned products that meet separate, new sleep standard, then seek sleep standard, to allow innovative one of CPSC’s sleep standards. As to have CPSC codify the new ASTM products to enter the market more discussed earlier, products that are standard as a mandatory infant sleep easily. This final rule requires suppliers compliant with the current CPSC sleep standard under section 104 of the to comply with this rule or one of CPSC standards are already widely available, CPSIA. provide compact sleep spaces, and are mandatory standards for full-size cribs, in the same general price range as the H. Efforts to Minimize the Impact on non-full-size cribs, bassinets and items covered by this rule. Small Entities (Alternatives) cradles, play yards, or bedside sleepers. CPSC has attempted to minimize the The approach considered by ASTM to Several public commenters suggested allow suppliers to choose other ASTM that this rule would cause caregivers to impact of the final rule on small entities by defining the scope of this rule to only sleep product standards would allow resort to less safe sleep solutions, such suppliers to sell products that did not as putting infants to sleep in car seats, include infant sleep products that are: • Not within the scope of another meet an existing CPSC sleep standard, or using pillows to position infants on such as a drop side crib, so long as that adult beds. Caregivers may already standard; • marketed or intended for infant product had a sleep surface incline of make home-made sleep places or mis- less than 10 degrees and otherwise use other types of products, and CPSC sleep, including napping; and • marketed or intended for use by complied with ASTM F3118. Staff did is unaware of data to support the children up to 5 months old. not recommend this approach, which assertion that this rule would further These requirements provide small would effectively allow potentially encourage such practices. Directions for businesses the opportunity to remove unsafe, non-compliant sleep products to making home-made baby nests were their products from the scope of this re-enter the market. widely available on the internet before Finally, the IRFA discussed allowing CPSC published the 2017 NPR. The 46 The DNPES reported that in households with a later effective date. A later effective DNPES, which was done in 2014, found children under 6, children slept in bouncer seats at date would reduce the economic impact that a majority of parents were using least once a week in 70% of households that owned on firms in two ways. Firms would be products for sleep that are not marketed a bouncer seat, slept in swings at least once a week in 91% of households with a swing, and slept in less likely to experience a lapse in for sleep, such as swings, bouncer seats, hand-held carriers at least once a week in 87% of production/importation, which could and hand-held carriers at least once a households with hand-held carriers. result if they are unable to comply and

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third-party test within the required Under 44 U.S.C. 3507(a)(1)(D), an non-full-size cribs, play yards, bassinets, timeframe. Also, firms could spread agency must publish the following cradles, or bed-side sleepers. The infant costs over a longer time period, thereby information: sleep products covered by this rule reducing their annual costs, as well as • A title for the collection of include inclined and flat sleep products, the present value of their total costs. information; such as inclined sleepers, play yard • CPSC received comments both a summary of the collection of infant sleep accessories, baby nests and supporting and opposing a later information; • pods, in-bed sleepers, baby hammocks, effective date. Given that many of the a brief description of the need for compact or travel bassinets without a products have already been removed the information and the proposed use of stand or legs, and baby tents. This final from the market or otherwise the information; rule for infant sleep products • a description of the likely remarketed to be out of scope of this incorporates by reference the voluntary respondents and proposed frequency of rule, reducing the impact on domestic standard for infant inclined sleep response to the collection of small businesses, and that companies products issued by ASTM International, already had notice that this final rule information; • an estimate of the burden that shall ASTM F3118–17a, Standard Consumer was in progress since November 2019, result from the collection of Safety Specification for Infant Inclined the Commission will maintain a 12- information; and Sleep Products, with modifications to month effective date, as proposed in the • notice that comments may be further reduce the risk of injury 2019 SNPR. submitted to the OMB. associated with infant sleep products. XIV. Environmental Considerations The preamble to the 2019 SNPR (84 The final rule sets a safety floor for all FR 60959–61) discussed the information infant sleep products sold in the United The Commission’s regulations address collection burden of the supplemental States, by requiring infant sleep whether the agency is required to proposed rule and specifically requested products to have a seat back/sleep prepare an environmental assessment or comments on the accuracy of our surface angle of 10 degrees or less from an environmental impact statement. estimates. The OMB assigned control horizontal, and to meet the Under these regulations, certain number 3041–0177 for this information requirements of 16 CFR part 1218, categories of CPSC actions normally collection. We did not receive any Safety Standard for Bassinets and have ‘‘little or no potential for affecting comment regarding the information Cradles, including conforming to the the human environment,’’ and therefore, collection burden of the proposal in the definition of a bassinet/cradle. Part 1218 they do not require an environmental 2019 SNPR. For the final rule, CPSC incorporates by reference the assessment or an environmental impact adjusts the number of small home-based performance and labeling requirements statement. Safety standards providing manufacturers from 6 to 1,200, and the of ASTM F2194–16e1. Sections 8 and 9 requirements for products come under number of other suppliers from 13 to of ASTM F2194–16e1 contain this categorical exclusion. 16 CFR 125. In accordance with PRA requirements for marking, labeling, and 1021.5(c)(1). The final rule for infant requirements, the Commission provides instructional literature. These sleep products falls within the the following information: requirements fall within the definition categorical exemption. Title: Safety Standard for Infant Sleep of ‘‘collection of information,’’ as XV. Paperwork Reduction Act Products. defined in 44 U.S.C. 3502(3). Description: The final rule defines an The final rule contains information ‘‘infant sleep product’’ as a product Description of Respondents: Persons collection requirements that are subject marketed or intended to provide a who manufacture or import infant sleep to public comment and review by the sleeping accommodation for an infant products. Office of Management and Budget up to 5 months of age, and that is not Estimated Burden: We estimate the (OMB) under the Paperwork Reduction already subject to one of the mandatory burden of this collection of information Act of 1995 (PRA; 44 U.S.C. 3501–3521). CPSC sleep standards: Full-size cribs, as follows:

TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN

Number of Frequency of Total annual Hours per Total burden Burden type Type of supplier respondents responses responses response hours

Labeling ...... Home-based manufacturers 1,200 1 1,200 7 8,400 Other Suppliers ...... 125 2 250 1 250

Labeling Total ...... 8,650 Instructional literature ...... Home-based manufacturers 1,200 1 1,200 50 60,000

Total burden ...... 68,650

Two groups of quantifiable entities sling carriers) assumed that it would manufacturers is 7 hours per model × supply infant sleep products to the U.S. take home-based manufacturers 1,200 entities × 1 models per entity = market that will likely need to make approximately 15 hours to develop a 8,400 hours. some modifications to their existing new label. Given that some home-based The second group of quantifiable warning labels to meet the requirements manufacturers supply infant sleep entities supplying infant sleep products for warnings. The first group consists of products with warning labels already, to the U.S. market that will need to very small home-based manufacturers, we have estimated approximately 7 make some modifications to their which may not currently have warning hours per response for this group of existing warning labels are non-home- labels on their infant sleep products. suppliers. Therefore, the total burden based manufacturers and importers. Similar rulemakings (such as that for hours for very small home-based These firms do not operate at the low

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production volume of the home-based rulemaking, staff tentatively estimates XVII. Congressional Review Act firms. All of the firms in this second that each small entity supplying The Congressional Review Act (CRA; group have existing warning labels on homemade infant hammocks, baby 5 U.S.C. 801–808) states that, before a their products, but not necessarily labels nests, or in-bed sleepers might require rule may take effect, the agency issuing that are compliant with the 50 hours to develop an instruction the rule must submit the rule, and requirements of ASTM F2194, as manual to accompany their products. certain related information, to each specified in 16 CFR part 1218, and These firms typically supply only one House of Congress and the Comptroller would therefore, have to make label infant sleep product model. Therefore, General. 5 U.S.C. 801(a)(1). The modifications. Given that these firms are the costs of designing an instruction used to working with warning labels, we submission must indicate whether the manual for these firms could be as high rule is a ‘‘major rule.’’ The CRA states estimate that the time required to make as $2,022,600 (50 hours per model × 1 any modifications now or in the future × that the Office of Information and model per entity 1,200 entities = Regulatory Affairs (‘‘OIRA’’) determines would be about 1 hour per model. Based $2,022,600). However, this cost estimate on an evaluation of supplier product whether a rule qualifies as a ‘‘major may overestimate the annual cost to rule.’’ Pursuant to the CRA, OIRA lines, each entity supplies an average of industry because many home-based 2 models of infant sleep products; designated this rule as not a ‘‘major firms might not pay average U.S. rule,’’ as defined in 5 U.S.C. § 804(2). A therefore, the estimated burden domestic wage rates. Not all firms associated with labels for this second ‘‘major rule’’ is one that the × would incur these costs every year, but Administrator of OIRA finds has group is 1 hours per model 125 new firms that enter the market would entities × 2 models per entity = 250 resulted in, or is likely to result in: (A) incur these costs, and this is a highly An annual effect on the economy of hours. fluctuating market. Other firms are The total burden hours attributable to $100,000,000 or more; (B) a major estimated to have no burden hours warning labels is the sum of the burden increase in costs or prices for associated with instruction manuals hours for both entity groups: Very small consumers, individual industries, because any burden associated with home-based manufacturers (8,400 Federal, State, or local government burden hours) + non-home-based supplying instructions with infant sleep agencies, or geographic regions; or (C) a manufacturers and importers (250 products would be ‘‘usual and significant adverse effects on burden hours) = 8,650 burden hours. We customary’’ and not within the competition, employment, investment, estimate the hourly compensation for definition of ‘‘burden’’ under the OMB’s productivity, innovation, or on the the time required to create and update regulations. ability of United States-based labels is $33.71 (U.S. Bureau of Labor Based on this analysis, CPSC staff enterprises to compete with foreign- Statistics, ‘‘Employer Costs for estimates that the final rule for infant based enterprises in domestic and Employee Compensation,’’ December sleep products would impose a burden export markets. 5 U.S.C. 804(2). To 2020, Supplementary table 1, total to industry of 68,650 hours at a cost of comply with the CRA, CPSC will submit compensation for all sales and office $2,314,191.50 annually. In compliance the required information to each House workers in goods-producing private with the Paperwork Reduction Act of of Congress and the Comptroller industries: https://www.bls.gov/web/ 1995 (44 U.S.C. 3507(d)), we have General. ecec/ecsuptc.pdf. Therefore, the submitted the information collection List of Subjects estimated annual cost to industry requirements of this final rule to the associated with the labeling OMB. 16 CFR Part 1112 requirements is $291,591.50 ($33.71 per Administrative practice and hour × 8,650 hours = $291,591.50). No XVI. Preemption operating, maintenance, or capital costs procedure, Audit, Consumer protection, Section 26(a) of the CPSA, 15 U.S.C. are associated with the collection. Reporting and recordkeeping ASTM F2194 (section 9) requires 2075(a), provides that when a consumer requirements, Third party conformity instructions to be supplied with the product safety standard is in effect and assessment body. applies to a product, no state or political product. As already noted, the proposed 16 CFR Part 1130 Safety Standard for Infant Sleep subdivision of a state may either Products requires infant sleep products establish or continue in effect a standard Administrative practice and to meet these requirements. Under the or regulation that prescribes procedure, Business and industry, OMB’s regulations (5 CFR 1320.3(b)(2)), requirements for the performance, Consumer protection, Reporting and the time, effort, and financial resources composition, contents, design, finish, recordkeeping requirements. construction, packaging, or labeling of necessary to comply with a collection of 16 CFR Part 1236 information that would be incurred by such product dealing with the same risk persons in the ‘‘normal course of their of injury unless the state requirement is Consumer protection, Imports, activities’’ are excluded from a burden identical to the federal standard. Section Incorporation by reference, Infants and estimate, where an agency demonstrates 26(c) of the CPSA also provides that children, Labeling, Law enforcement, that the disclosure activities required to states or political subdivisions of states and Toys. comply are ‘‘usual and customary.’’ may apply to the Commission for an For the reasons discussed in the We are unaware of infant sleep exemption from this preemption under preamble, the Commission amends Title products that generally require use certain circumstances. Section 104(b) of 16 of the Code of Federal Regulations as instructions but lack such instructions. the CPSIA deems rules issued under follows: However, it is possible that the 1,200 that provision ‘‘consumer product safety home-based manufacturers of infant standards.’’ Therefore, once this final PART 1112—REQUIREMENTS hammocks, baby nests, and in-bed rule for infant sleep products issued PERTAINING TO THIRD PARTY sleepers may not supply instruction under section 104 of the CPSIA takes CONFORMITY ASSESSMENT BODIES manuals as part of their ‘‘normal course effect, the rule will preempt in of activities.’’ Based on information accordance with section 26(a) of the ■ 1. The authority citation for part 1112 collected for the infant slings CPSA. continues to read as follows:

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Authority: 15 U.S.C. 2063; Pub. L. 110– product must comply with ASTM (3) In section 1.2 of ASTM F3118–17a, 314, section 3, 122 Stat. 3016, 3017 (2008). F3118–17a, Standard Consumer Safety replace the term ‘‘infant inclined sleep ■ 2. Amend § 1112.15 by adding Specification for Infant Inclined Sleep products’’ with ‘‘infant sleep products.’’ paragraph (b)(46) to read as follows: Products (approved on September 1, (4) Instead of complying with section 2017). The Director of the Federal 1.3 of ASTM F3118–17a, comply with § 1112.15 When can a third party Register approves this incorporation by the following: conformity assessment body apply for reference in accordance with 5 U.S.C. (i) 1.3 This consumer safety CPSC acceptance for a particular CPSC rule performance specification covers infant and/or test method? 552(a) and 1 CFR part 51. You may obtain a copy from ASTM International, sleep products, including inclined and * * * * * 100 Barr Harbor Drive, P.O. Box C700, flat sleep surfaces, marketed or intended (b) * * * West Conshohocken, PA 19428–2959; to provide a sleeping accommodation (46) 16 CFR part 1236, Safety for an infant up to 5 months old, and Standard for Infant Sleep Products. phone: (610) 832–9585; www.astm.org. A read-only copy of the standard is that are not already subject to any of the * * * * * available for viewing on the ASTM following standards: ■ 3. The authority citation for part 1130 website at https://www.astm.org/ (A) 16 CFR part 1218—Safety continues to read as follows: READINGLIBRARY/. You may inspect a Standard for Bassinets and Cradles, Authority: 15 U.S.C. 2056a, 2056(b). copy at the Division of the Secretariat, incorporating by reference ASTM ■ U.S. Consumer Product Safety F2194, Standard Consumer Safety 4. Amend § 1130.2 by revising Specification for Bassinets and Cradles; paragraph (a)(12) to read as follows: Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814, (B) 16 CFR part 1219—Safety PART 1130—REQUIREMENTS FOR telephone (301) 504–7479, email: cpsc- Standard for Full-Size Baby Cribs, CONSUMER REGISTRATION OF [email protected], or at the National Archives incorporating by reference ASTM DURABLE INFANT OR TODDLER and Records Administration (NARA). F1169, Standard Consumer Safety PRODUCTS For information on the availability of Specification for Full-Size Baby Cribs; this material at NARA, email (C) 16 CFR part 1220—Safety § 1130.2 Definitions. [email protected], or go to: Standard for Non-Full-Size Baby Cribs, * * * * * www.archives.gov/federal-register/cfr/ incorporating by reference applicable (a) * * * ibr-locations.html. requirements in ASTM F406, Standard (12) Bassinets and cradles, including (b) Comply with ASTM F3118–17a Consumer Safety Specification for Non- bedside sleepers and infant sleep with the following additions or Full-Size Baby Cribs/Play Yards; products; exclusions: (D) 16 CFR part 1221—Safety * * * * * (1) Instead of complying with Standard for Play Yards, incorporating by reference applicable requirements in ■ 5. Add part 1236 to read as follows: Introduction of ASTM F3118–17a, comply with the following: ASTM F406, Standard Consumer Safety Specification for Non-Full-Size Baby PART 1236—SAFETY STANDARD FOR (i) Introduction. This consumer safety Cribs/Play Yards; INFANT SLEEP PRODUCTS specification addresses incidents (E) 16 CFR part 1222—Safety associated with infant sleep products Sec. Standard for Bedside Sleepers, identified by the U.S. Consumer Product 1236.1 Scope. incorporating by reference ASTM Safety Commission (CPSC). 1236.2 Requirements for infant sleep F2906, Standard Consumer Safety (A) In response to incident data products. Specification for Bedside Sleepers. Authority: Sec. 104, Pub. L. 110–314, 122 compiled by CPSC, this consumer safety (ii) 1.3.1 If the infant sleep product Stat. 3016 (15 U.S.C. 2056a); Sec. 3, Pub. L. specification attempts to minimize the can be converted into a product for 112–28, 125 Stat. 273. following: which a CPSC regulation exists, the (1) Fall hazards, § 1236.1 Scope. product shall meet the applicable (2) Asphyxiation and suffocation, and requirements of the CPSC regulation, This part establishes a consumer (3) Obstruction of nose and mouth by when in that use mode. If the infant product safety standard for infant sleep bedding. sleep product can be converted into a products, including inclined and flat (B) The purpose of the standard is to product for which no CPSC regulation sleep surfaces, that applies to all address infant sleep products not exists, but another ASTM consumer products marketed or intended to already covered by traditional sleep safety specification exists, the product provide a sleeping accommodation for product standards and to reduce deaths shall meet the applicable requirements an infant up to 5 months of age, and that associated with known infant sleep of the ASTM consumer safety are not already subject to any of the hazards, including, but not limited to, a specification, when in that use mode. following standards: seat back or sleep surface angle that is (iii) 1.3.2 Crib mattresses that meet (a) 16 CFR part 1218 Safety Standard greater than 10 degrees from the the requirements of ASTM F2933 are for Bassinets and Cradles; horizontal. (b) 16 CFR part 1219 Safety Standard not covered by the specifications of this (C) This consumer safety specification standard. for Full-Size Baby Cribs; is written within the current state-of- (c) 16 CFR part 1220 Safety Standard (5) In section 1.4 of ASTM F3118–17a, the-art of infant sleep product replace the term ‘‘infant inclined sleep for Non-Full-Size Baby Cribs; technology and will be updated (d) 16 CFR part 1221 Safety Standard product’’ with ‘‘infant sleep product.’’ whenever substantive information for Play Yards; (6) Instead of complying with section (e) 16 CFR part 1222 Safety Standard becomes available that necessitates 2.1 of ASTM F3118–17a, comply with for Bedside Sleepers. additional requirements or justifies the the following: revision of existing requirements. (i) F406 Standard Consumer Safety § 1236.2 Requirements for infant sleep (ii) [Reserved] Specification for Non-Full-Size Baby products. (2) In section 1.1 of ASTM F3118–17a, Cribs/Play Yards; (a) Except as provided in paragraph replace the term ‘‘infant inclined sleep (ii) F1169 Standard Consumer Safety (b) of this section, each infant sleep products’’ with ‘‘infant sleep products.’’ Specification for Full-Size Baby Cribs;

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(iii) F2194 Standard Consumer Safety (C) 16 CFR part 1220—Safety (17) Do not comply with section Specification for Bassinets and Cradles; Standard for Non-Full-Size Baby Cribs; 7.11.1.3 of ASTM F3118–17a. (iv) F2906 Standard Consumer Safety (D) 16 CFR part 1221– Safety (18) In section 7.11.2 of ASTM Specification for Bedside Sleepers; Standard for Play Yards; F3118–17a, replace ‘‘Infant Inclined (v) F2933 Standard Consumer Safety (E) 16 CFR part 1222—Safety Sleep Product and Infant Inclined Sleep Specification for Crib Mattresses. Standard for Bedside Sleepers. Product Accessory’’ with ‘‘Infant Sleep (7) Instead of complying with section (ii) [Reserved] Products.’’ 2.2 of ASTM F3118–17a, comply with (11) Do not comply with sections (19) Instead of complying with section the following: 3.1.7.1 through 3.1.13 of ASTM F3118– 7.11.2.1 and 7.11.2.2 of ASTM F3118– (i) 16 CFR 1218—Safety Standard for 17a. 17a, comply with the following: Bassinets and Cradles; (12) Do not comply with section (i) 7.11.2.1 If applicable, place the (ii) 16 CFR 1219—Safety Standard for 3.1.15 through 3.1.16 of ASTM F3118– product in the manufacturer’s Full-Size Baby Cribs; 17a. recommended highest seat back/sleep (iii) 16 CFR 1220—Safety Standard for (13) Do not comply with section 5 of surface angle position intended for Non-Full-Size Baby Cribs; ASTM F3118–17a. (iv) 16 CFR 1221—Safety Standard for (14) Do not comply with sections 6.1 sleep. Play Yards; through 6.8 of ASTM F3118–17a. (ii) 7.11.2.2 Place the hinged weight (v) 16 CFR 1222—Safety Standard for (15) Instead of complying with section gage–infant in the product and position Bedside Sleepers. 6.9 of ASTM F3118–17a, comply with the gage with the hinge centered over (8) Do not comply with sections 2.3 the following: the seat bight line and the upper plate and 2.4 of ASTM F3118–17a, including (i) 6.9 Maximum Seat Back/Sleep of the gage on the seat back/sleep Figures 1 and 2. Surface Angle: surface. Place a digital protractor on the (9) Do not comply with sections 3.1.1 (ii) 6.9.1 Infant Sleep Product—The upper torso/head area lengthwise. through 3.1.6 of ASTM F3118–17a. angle of the seat back/sleep surface (20) Do not comply with sections (10) Instead of complying with section intended for sleep along the occupant’s 7.11.3 through 9, or the Appendix, of 3.1.7 of ASTM F3118–17a, comply with head to toe axis relative to the ASTM F3118–17a. the following: horizontal shall not exceed 10 degrees (21) Add section 10.2 to ASTM (i) 3.1.7 infant sleep product, n—a when tested in accordance with 7.11.2. F3118–17a: product marketed or intended to (iii) Do not comply with 6.9.2. (i) 10.2 infant sleep product provide a sleeping accommodation for (iv) 6.9.3 Infant Sleep Products—shall (ii) [Reserved] an infant up to 5 months of age, and that meet, 16 CFR part 1218, Safety Standard is not subject to any of the following: for Bassinets and Cradles, including Alberta E. Mills, (A) 16 CFR part 1218—Safety conforming to the definition of a Secretary, Consumer Product Safety Standard for Bassinets and Cradles; ‘‘bassinet/cradle.’’ Commission. (B) 16 CFR part 1219—Safety (16) Do not comply with sections 6.10 [FR Doc. 2021–12723 Filed 6–22–21; 8:45 am] Standard for Full-Size Baby Cribs; through 7.10 of ASTM F3118–17a. BILLING CODE 6355–01–P

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