# Safety Standard for Bassinets and Cradles > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-07706 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** April 16, 2024 - **Citation:** 89 FR 27246 ## Text CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1218 [CPSC Docket No. CPSC-2010-0028] Safety Standard for Bassinets and Cradles AGENCY: Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. SUMMARY: In 2013, the United States Consumer Product Safety Commission (Commission or CPSC) published a safety standard for bassinets and cradles (bassinets/cradles). By statute, after promulgating a mandatory rule, the Commission must periodically review and revise rules for durable infant or toddler products to ensure that they provide the highest level of safety for such products that is feasible. Accordingly, this proposed rule (NPR) would revise the existing rule for bassinets/cradles to ensure that it addresses identified hazards and that these sleep products for young infants provide the highest level of safety feasible. DATES: Submit comments by June 17, 2024. ADDRESSES: Comments related to the Paperwork Reduction Act aspects of the marking, labeling, and instructional literature requirements of the NPR should be directed to the Office of Information and Regulatory Affairs, the Office of Management and Budget, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to: oira_submission@omb.eop.gov. Submit all other comments, identified by Docket No. CPSC-2010-0028, by any of the following methods: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https://www.regulations.gov. Follow the instructions for submitting comments. CPSC typically does not accept comments submitted by email, except through www.regulations.gov. CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Mail/Hand Delivery/Courier/Confidential Written Submissions: Submit comments by mail, hand delivery, or courier to: Office of the Secretary, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301) 504-7479. If you wish to submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public, you may submit such comments by mail, hand delivery, or courier, or you may email them to: cpsc-os@cpsc.gov. Instructions: All submissions must include the agency name and docket number. CPSC may post all comments without change, including any personal identifiers, contact information, or other personal information provided, to https://www.regulations.gov. Do not submit through this website: Confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for mail/hand delivery/courier/confidential written submissions. Docket: For access to the docket to read background documents or comments received, go to: https://www.regulations.gov, and insert the docket number, CPSC-2010-0028, into the “Search” box, and follow the prompts. FOR FURTHER INFORMATION CONTACT: Celestine T. Kish, Project Manager, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; 301-987-2547; ckish@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Background and Statutory Authority Section 104(b) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), 15 U.S.C. 2056a(b), requires the Commission to promulgate standards for durable infant or toddler products that are “substantially the same as” any applicable voluntary standards, or more stringent than the voluntary standards, if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product. 15 U.S.C. 2056a(b)(1)(B). Pursuant to section 104(b)(1) of the CPSIA, the Commission promulgated the current mandatory standard for bassinets and cradles (bassinets/cradles) in October 2013, Safety Standard for Bassinets and Cradles, codified at 16 CFR part 1218 (part 1218). 78 FR 63019 (Oct. 23, 2013). The current bassinet/cradle rule found in part 1218 incorporates by reference the 2013 version of the bassinets/cradles voluntary standard, ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and Cradles (ASTM F2194-13), with modifications to make the standard more stringent, to further reduce the risk of injury associated with bassinets/cradles. 1 Part 1218 modifies ASTM F2194-13 by: clarifying the scope of rule, exempting from the flatness requirement bassinets with seams less than 15 inches long, requiring a more stringent stability test, and requiring a smaller CAMI dummy 2 for testing. After issuing the mandatory standard in 2013, ASTM International (ASTM) published several revisions to ASTM F2194, including ASTM F2194-2013a, -2016, and -2016 ε 1 . ASTM did not notify CPSC of these revisions, so the mandatory rule has not been updated since 2013. However, ASTM F2194-2016 ε 1 is substantially the same as the existing mandatory rule for bassinets/cradles codified in part 1218. 86 FR 33022, 33034-35 (June 3, 2021). 1 Bassinets/cradles are durable infant or toddler products that, since 2013, require product registration cards and certificates based on testing by a CPSC-accepted third party laboratory. Section 104(f)(2)(L) of the CPSIA specifically identifies bassinets/cradles as durable infant or toddler products. The NPR proposes to add testing and labeling requirements that will not change the existing requirements for product registration cards and third party testing and certification. Additionally, although ASTM F2194-22 ε 1 is copyrighted, by permission of ASTM the voluntary standard can be viewed as a read-only document during the comment period at: http://www.astm.org/cpsc.htm. 2 Designated ASTM testing device. CAMI (Civil Aeromedical Institute) dummies are based on child anthropometric data and come in multiple sizes. The CPSC mandatory safety standard for bassinets and cradles specifies the newborn size CAMI. 3 After challenge, the United States Court of Appeals for the District of Columbia Circuit held that CPSC did not exceed its authority in promulgating the ISP Rule. Finnbin, LLC v. CPSC, 45 F.4th 127 (D.C. Cir. Aug. 2, 2022). In June 2021, also pursuant to section 104 of the CPSIA, the Commission promulgated a Safety Standard for Infant Sleep Products (ISP Rule), codified at 16 CFR part 1236. 86 FR 33022 (June 23, 2021). The ISP Rule applies to products that are marketed or intended to provide a sleeping accommodation for infants up to five months of age that do not already meet the requirements of one of the following CPSC sleep standards: full-size cribs, non-full-size cribs, play yards, bedside sleepers, or bassinets/cradles. The ISP Rule requires that such infant sleep products, at a minimum, have a head-to-toe sleep surface angle of 10 degrees or less from horizontal, and meet the mandatory rule for bassinets/cradles, including the definition of a bassinet/cradle, which means that products must have a stand. Because of the ISP Rule, the bassinets/cradles rule provides a safe sleep baseline for infant sleep products. 3 The intent of the ISP Rule was to ensure that infants are placed to sleep on a firm, flat sleep surface and that caregivers are discouraged from placing infant sleep products, including those bassinets that were lightweight and low to the ground, on unsafe surfaces, such as beds, couches, tables, and countertops. In 2022, ASTM approved and published another revised voluntary standard for bassinets/cradles—ASTM F2194-22 ε 1 —and notified CPSC of the revision on July 18, 2022. Revised ASTM F2194-22 ε 1 added a new product category—compact bassinets/cradles—and new requirements for these products, including stability requirements and marking and labeling requirements. Among its other provisions, ASTM F2194-22 ε 1 eliminated stands for compact bassinets/cradles, but also included new requirements for battery compartments, warnings, and instructional literature. CPSC issued a notice of availability (NOA) requesting comment on the revised ASTM standard. 87 FR 45303 (July 28, 2022). Pursuant to the procedure outlined for revised voluntary standards in section 104(b)(4) of the CPSIA, 15 U.S.C. 2056a(b)(4), CPSC had 90 days from receiving notice of ASTM's 2022 revision to either allow the revised ASTM F2194 to become the new mandatory standard for bassinets/cradles, or to notify ASTM that the Commission determined that the revised ASTM standard did not improve the safety of bassinets/cradles and that CPSC was retaining the existing mandatory standard. On September 14, 2022, CPSC staff provided to the Commission a Staff Briefing Package: ASTM's Notice of a Revised Voluntary Standard for Bassinets and Cradles (2022 Bassinet Rejection Staff Briefing Package) which reviewed the comments from the NOA and assessed ASTM F2194-2 ε 1 . Staff recommended that the Commission reject ASTM F2194-22 ε 1 . 4 4 Available at: https://www.cpsc.gov/s3fs-public/ASTMs-Notice-of-a-Revised-Voluntary-Standard-for-Bassinets-and-Cradles.pdf?VersionId=x73F5OmeW4AJujWJEq8.kBZ28aTFLb2x. In the 2022 Bassinet Rejection Staff Briefing Package, staff advised that the requirements for compact bassinets/cradles in ASTM F2194-22 ε 1 were less stringent than the requirements for traditional bassinets/cradles in the existing bassinets/cradles rule (part 1218), in part because ASTM F2194-22 ε 1 did not require that compact bassinets/cradles have a stand. Moreover, because the ISP Rule, part 1236, makes the bassinet rule, part 1218, the baseline for safe sleep requirements, amending part 1218 to allow compact bassinets that are low to the ground, as specified in ASTM F2194-22 ε 1 , would also allow infant sleep products that were less stable and could be placed on unsafe surfaces, such as elevated and soft surfaces. Staff explained in the 2022 Bassinet Rejection Staff Briefing Package that consumers are likely to place smaller, lighter, and more portable compact bassinets in unsafe locations, such as elevated and soft surfaces (tables, counters, couches, and beds), and that CPSC's data demonstrate that infants have suffered serious head injuries and death when using these products in unsafe locations. 5 Additionally, staff advised that ASTM F2194-22 ε 1 added a new stability test that applies only to compact bassinets/cradles, and that this new stability test is less stringent than the stability test for regular-sized bassinets/cradles. Staff advised that infant sleep products without a stand present a risk of injury from falls that may lead to suffocation, head injuries, and/or death. 5 Tab A of the 2022 Bassinet Rejection Staff Briefing Package discusses consumer behavior with portable, compact products. On September 23, 2022, the Commission voted 5-0 to determine that ASTM F2194-22 ε 1 did not improve the safety of bassinets and cradles or infant sleep products. 6 Staff notified ASTM of the Commission's rejection of ASTM F2194-22 ε 1 by letter on October 6, 2022. 7 Subsequent to the Commission's rejection of ASTM F2194-22 ε 1 , staff continued to work with the ASTM F15.18 Bassinets and Cradles Subcommittee and the ASTM F15.18 Bassinet Elevated Surface and Data Task Group to revise the performance requirements for bassinets/cradles to set acceptable baseline safe sleep requirements for bassinets/cradles and for infant sleep products. 6 See Record of Commission Action at: https://www.cpsc.gov/s3fs-public/RCA-ASTMs-Notice-of-a-Revised-Voluntary-Standards-for-Bassinets-and-Cradles.pdf?VersionId=cfj.qZe5KlTS2AY3G69UwltalltP4LRk. 7 October 6, 2022 letter to K. Morgan, available at: https://www.cpsc.gov/s3fs-public/Bassinet_Rule_Update_letter_to_ASTM_2022-10-06%2010-7-2022.pdf?VersionId=PpvmrIEhQT.z3P57h8lhtc1UTvQITpSR . The Commission is now proposing to revise the existing rule for bassinets/cradles to address the hazards identified in this NPR and ensure that the mandatory bassinet/cradle regulation in part 1218 provides the highest level of safety feasible. 8 The Commission is authorized to issue this NPR pursuant section 104(b)(2) of the CPSIA, 15 U.S.C. 2056a(b)(2), which requires that after the Commission issues mandatory safety standards for durable infant or toddler products, the Commission shall periodically review and revise the standards to ensure that such standards provide the highest level of safety for such products that is feasible. Building on staff's continued work with ASTM on safe sleep requirements, the Commission is issuing this NPR to adopt ASTM F2194-22 ε 1 with modifications. The proposed modifications remove the compact bassinet category and address five hazard patterns associated with young infants placed in or on: 8 On March 20, 2024, the Commission voted (4-0) to publish this NPR, available at: https://www.cpsc.gov/s3fs-public/Commission-Meeting-Minutes-NPR-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=GwpmKZ4S9sRrEiBmDFaEWn1fBre6eZ2r. • Non-level bassinets/cradles (suffocation hazard); • Bassinets/cradles on elevated and soft surfaces such as beds, couches, tables, and countertops (falls, suffocation, skull fractures, and asphyxia hazards); • Mattresses that are non-flat, too thick, too soft, ill-fitting, or unattached to the bassinet/cradle (suffocation hazard); • Bassinets/cradles with design issues, such as low to the ground or unstable, or with loose sidewalls and/or non-mesh sidewalls (containment, tipping, gap entrapment, and suffocation hazards); and • Products with electrical problems such as smoke, shock, and battery leakage (shock and burn). The Commission is also proposing to align the rule's warnings with ASTM F2194-22 ε 1 but not to include warnings related solely to compact bassinets. The NPR proposes to require warnings on all bassinets within the scope of the rule. Staff provided a February 28, 2024, Memorandum, Staff's Draft Proposed Rule to Revise the Safety Standard for Bassinets and Cradles in support of the NPR, which is available at: https://www.cpsc.gov/s3fs-public/Briefing-Package-Draft-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=l37iJVSjn32WnUTBDV27L6c37uJC4Iis. This NPR contains an overview of staff's assessment and analysis, and the Commission's basis for issuing this NPR, which is also based on the 2022 Bassinet Rejection Staff Briefing Package. Based on the information and analysis in this NPR and the above staff packages, the Commission preliminarily determines that the proposed requirements are more stringent than the requirements in ASTM F2194-22 ε 1 , would further reduce the risk of injury associated with products within the scope of the NPR, and would provide the highest level of safety that is feasible for such products. The Commission specifically seeks comment on the feasibility of each proposed requirement, including technical feasibility. II. The Product A. Definition of Bassinet/Cradle The existing mandatory standard defines a “bassinet/cradle” based on the incorporated section 3.1.1 of ASTM F2194-13, as a “small bed designed primarily to provide sleeping accommodations for infants, supported by free standing legs, a stationary frame/stand, a wheeled base, a rocking base, or which can swing relative to a stationary base.” The definition also requires that while a bassinet/cradle is in a resting, non-rocking, or swinging position, “a bassinet/cradle is intended to have a sleep surface less than or equal to 10° from horizontal.” ASTM F2194-22 ε 1 introduced a new “compact bassinet” product category, defined as “a bassinet/cradle having a distance of less than 6.0 inches (152.4 mm) between the lowest point of the underside of the sleep surface support and the product support surface (floor).” In the 2022 Bassinet Rejection Staff Briefing Package, staff assessed the compact bassinet category and advised the Commission that including compact bassinets/cradles within the scope of the voluntary standard, which contain product characteristics that the Commission specifically stated in the ISP Rule were not safe for infant sleep, and allowing a less-stringent stability test for these products, contradicts the Commission's safe sleep goals in part 1218 and in the ISP Rule. The Commission now proposes to amend part 1218 to incorporate ASTM F2194-22 ε 1 by reference, but with modifications that exclude from the mandatory rule “compact bassinets” and associated requirements. As described in section V of this preamble, the modifications in the NPR further clarify the products within the scope of the rule and seek to enhance the safety requirements in part 1218, and thus also the minimum safe sleep requirements in the ISP Rule. B. Scope of Products Within the NPR The NPR would apply to: (1) bassinets and cradles; (2) combination products in bassinet or cradle mode, including play yards, bedside sleepers, strollers, and cradle swings that have a bassinet or cradle mode; (3) play yard and stroller bassinet accessories, when used separately from the play yard or stroller; (4) small bassinets, sometimes marketed as “travel bassinets” or “floor bassinets,” including both items with rigid frames and with soft sides; (5) Moses baskets, sold with or without a stand; (6) travel bassinets, outdoor bassinets, and “play pens” that do not meet the side height requirements of the mandatory play yard standard and are marketed for sleep; and (7) after-market bassinet mattresses. 9 9 Several related products are out of scope of this NPR. A few products marketed as “bassinets” have relatively high side rails, rigid sides, and a distance between the top rail and the sleep surface of at least 22 inches. Some of these products are marketed as compliant with the mandatory safety standard for non-full-size cribs and play yards. These products may be within the scope of the mandatory standard for non-full-size cribs and play yards specified in 16 CFR part 1220, rather than this rule, but the performance requirements of the two standards are very similar. Moreover, hospital bassinets are medical devices regulated by the Food and Drug Administration (FDA) and are not within the scope of this rule. See 21 CFR 880.5145 “Medical bassinet.” Finally, thin mattress protectors and covers, such as waterproof mattress covers, that cannot be used as a standalone mattress, are not within the scope of this proposed rule. Commonly, bassinets have multiple-use modes and therefore fall within the scope of multiple CPSC regulations, particularly the standard for hand-held infant carriers in 16 CFR part 1225, and/or the standard for infant sleep products in 16 CFR part 1236. Combination products must meet the bassinet standard when in the bassinet mode. All multi-mode products, as sold, including stroller bassinets, play yard bassinets, and Moses baskets, would need to meet the requirements of a revised rule, regardless of whether the product is sold with or without a stand. This means that stroller and play yard bassinets marketed for use without the stand, or that can be foreseeably used without the stand, would need to meet the requirements of a final rule. Part 1218 requires bassinets to be sold with a mattress and includes requirements for these mattresses and original equipment manufacturer (OEM) replacements that are equivalent in dimensions and specifications to the mattress provided with the original product. This NPR proposes also to include after-market bassinet mattresses within the scope of the rule. After-market bassinet mattresses are sold separately from the bassinet and are typically small oval or rectangular mattresses marketed to fit a bassinet, including products marketed to fit a bassinet accessory product to a play yard or stroller. OEM replacement mattresses are, and have always been, included in part 1218 and are not considered after-market mattresses. The NPR also includes products marketed as “mattress toppers” as a type of after-market bassinet mattress. C. Market Description As discussed in section VIII of this preamble, staff estimates the annual sales of new bassinets/cradles, including items with a bassinet mode or attachment, to be approximately 3.1 million units per year in the United States. Staff estimates the annual U.S. sales of used bassinets/cradles to be 500,000 units per year, and the annual sales of new after-market bassinet mattresses to be 680,000 units per year. Prices for traditional bassinets range from under $50 to more than $1,500, with most products in the $50 to $125 range. Prices for cradles range from $100 to more than $1,000, with most products in the $100 to $200 range. Solid hardwood cradles are available for more than $1,000. Combination bedside sleeper/bassinets typically sell for $75 to more than $600, with most products in the $125 to $200 range. Bassinet attachments to play yards are usually not priced or sold separately. Some stroller bassinet attachments are sold separately, with most such products in the $100 to $200 range. Play yard and stroller bassinet attachments are designed to attach to a specific model or set of models from one manufacturer, and/or to a stand sold separately by that manufacturer. The stands typically sell for $125 to $175. Prices for after-market bassinet mattresses range from $20 to $180, with most products in the $30 to $40 range. Bassinets do not have a single, best-selling size, price range, or set of features. The wide range of prices and features reflect that parents and other caregivers buy bassinets for different purposes, including but not limited to as primary sleep space or for occasional use, and as a permanent piece of nursery furniture or an easily portable sleep space. With approximately 3.1 million new bassinets sold per year, including items such as bedside sleepers, play yards, and strollers with a bassinet mode, at an average price of approximately $100 per unit, the total U.S. bassinet market is approximately $310 million dollars in sales per year. This total does not include the market for used items. At an estimated used price of $40, based on observed prices of used bassinets on Ebay and Mercari as a percentage of original retail prices, the used market represents approximately $20 million dollars in sales per year. Staff estimates annual unit sales of new after-market bassinet mattresses to be 680,000 units, with a market of $23.8 million per year. Many manufacturers and importers, as well as foreign direct shippers, supply bassinets and cradles to the U.S. market. In March 2023, CPSC staff identified more than 120 suppliers, including suppliers that sell play yards or strollers with bassinet attachments. The Juvenile Product Manufacturers Association (JPMA) currently has 22 member companies that are certified for bassinets/cradles. Bassinets and cradles are available from online general retail sites, online baby product sites, and brick and mortar general retail stores, including “big box” stores. Additionally, hundreds of suppliers, including importers and U.S. based hand crafters, supply after-market bassinet mattresses, which are sold almost exclusively online. III. Incident Data and Hazard Patterns Staff searched two CPSC-maintained databases to identify incidents and hazard patterns addressed in this NPR that are associated with bassinets and cradles: the Consumer Product Safety Risk Management System (CPSRMS) 10 11 and the National Electronic Injury Surveillance System (NEISS). 12 From these sources, for this NPR staff identified seven fatalities and 13 injuries related to bassinets/cradles from January 1, 2017, through December 31, 2022. CPSC staff is also aware of 182 non-injury incidents from January 1, 2021, through December 31, 2022. Staff identified the following hazard patterns from this data. 10 CPSRMS includes data primarily from three groups of sources: incident reports, death certificates, and in-depth follow-up investigation reports. A large portion of CPSRMS consists of incident reports from consumer complaints, media reports, medical examiner or coroner reports, retailer or manufacturer reports (incident reports received from a retailer or manufacturer involving a product they sell or make), safety advocacy groups, law firms, and Federal, State, or local authorities, among others. It also contains death certificates that CPSC purchases from all 50 states, based on selected external cause of death codes (ICD-10). The third major component of CPSRMS is the collection of in-depth follow-up investigation reports. Based on the incident reports, death certificates, or National Electronic Injury Surveillance System (NEISS) injury reports, CPSC Field staff conduct in-depth investigations (on-site, telephone, or online) of incidents, deaths, and injuries, which are then stored in CPSRMS. 11 Staff searched all data coded under product code 1537 (Bassinets or Cradles). In addition, staff extracted data coded under 1513 (Playpens and Play Yards), 1529 (Portable Cribs), 1542 (Baby Mattresses or Pads), 1505/1522 (Baby Carriages/Strollers), 1519/1548 (Car Seats/Baby Carriers), 1502 (Baby Changing Tables), 1558 (Baby Bouncer Seats), and 1553 (Portable Baby Swings). Staff further screened data searched from this wide range of products using keywords to identify the potentially in-scope bassinet accessories or multi-mode products that may have been used as a bassinet at the time of the incident. Staff extracted data on January 13, 2023, and restricted age to 12 months and younger. Upon careful joint review with CPSC's Directorates for Engineering Sciences, Health Sciences, and Economics, staff considered many cases out-of-scope for the purposes of this NPR. For example, staff excluded from this analysis cases with Sudden Unexpected Infant Death (SUID) or other pre-existing medical conditions as official cause of death and no additional circumstantial information available. 12 NEISS is the source of the injury estimates; it is a statistically valid injury surveillance system. NEISS injury data are gathered from EDs of about 100 hospitals, with 24-hour EDs and at least six beds, selected as a probability sample of all U.S. hospitals. The surveillance data gathered from the sample hospitals enable staff to make timely national estimates of the number of injuries associated with specific consumer products. A. Products Not Sitting Level Two deaths, three non-emergency department (ED)-treated injury, and 95 of the 182 non-injury product-related incident reports describe a bassinet or cradle not sitting level. The narratives describe the products as non-level, leaning forward or to one side, and having legs or sides with uneven heights. A bassinet not sitting level creates a hazardous situation where an infant is more likely to roll into a compromising position as described below, whether the infant is developmentally capable of rolling or not, thereby posing a risk of asphyxia/suffocation. The fatal incidents involve infants rolling to the side, often into the mesh/siding of the bassinet: • In CPSC In-Depth Investigation (IDI) 13 200211HCC3248, a 2-month-old male was found unresponsive in his bassinet after moving into a compromising position where his nose was positioned adjacent to a crease on the right side of the bassinet. The bassinet was not level, and the edge of an adult bed was protruding into the mesh right sidewall of the bassinet. 13 IDIs are CPSC-generated investigation summaries of events surrounding product-related injuries or incidents. Based on victim/witness interviews, the reports provide details about incident sequence, human behavior, and product involvement. • In IDI 190610CCC3431, a 1-month-old male was found unresponsive in his bassinet after a non-level sleep surface allowed the victim to roll into a compromising position in the presence of excess bedding. According to the American Academy of Pediatrics (AAP), infants should be placed to sleep in a supine position (on their back) on a firm, flat, level surface without soft bedding in the sleep setting. 14 15 Positional asphyxia is a type of asphyxia associated with abnormal body position, where the position of the subject compromises adequate breathing. 16 17 18 Infants under 12 months of age are considered at risk of positional asphyxia, but infants 2 to 6 months of age, premature infants, and infants who are born as a set of multiples are particularly vulnerable and at highest risk because they may be developmentally capable of moving around in the sleep environment and moving into a vulnerable situation but do not yet have the physical capability to extricate themselves from a hazardous situation. 19 20 21 22 23 24 14 Moon RY, Carlin RF, Hand I. The Task Force on Sudden Infant Death Syndrome and the Committee on Fetus and Newborn; Evidence Base for 2022 Updated Recommendations for a Safe Infant Sleeping Environment to Reduce the Risk of Sleep-Related Infant Deaths. Pediatrics July 2022; 150 (1): e2022057991. 10.1542/peds.2022-057991. 15 Task Force on Infant Positioning and SIDS. Positioning and infant death syndrome (SIDS): update Arch Pediatr Adolesc Med. 1996;150:834-837. 16 Chmieliauskas S, Mundinas E, Fomin D, Andriuskeviciute G, Laima S, Jurolaic E, Stasiuniene J, Jasulaitis A. Sudden deaths from positional asphyxia: A case report. Medicine (Baltimore). 2018 Jun;97(24):e11041. doi: 10.1097/MD.0000000000011041. PMID: 29901602; PMCID: PMC6023692. 17 Gordon I, Shapiro HA. Deaths usually initiated by hypoxia or anoxic anoxia. In: Gordon I, Shapiro HA, editors. Forensic medicine: 2nd ed. Edinburgh, UK: Churchill Livingstone, 1982; 95-129. 18 Gordon I. The medicolegal aspects of rapid deaths initiated by hypoxia and anoxia. Leg Med Annu. 1975:29-47. PMID: 768671. 19 Dwyer T, Ponsonby A-L, Blizzard L, Newman NM, Cochane JA. The contribution of changes in prevalence of prone sleeping position to the decline in sudden infant death syndrome in Tasmania. JAMA. 1995;273:783-789. 20 Byard RW, Beal S and Bourne AJ. Potentially dangerous sleeping environment and accidental asphyxia in infancy and early childhood. Arch Dis Child 1994; 71: 497-500. 21 Fleming PJ, Blair PS, Bacon C, et al. Environment of infants during sleep and risk of the sudden infant death syndrome: results of 1993-5 case-control study for confidential inquiry into stillbirths and deaths in infancy. BMJ. 1996;313:191-195. 22 Hauck FR, Herman SM, Donovan M, et al. “Sleep Environment and the Risk of Sudden Infant Death Syndrome in an Urban Population: The Chicago Infant Mortality Study.” Pediatrics 2003; (111): 1207-1214. 23 Ponsonby AL, Dwyer T, Gibbons LE, Cochrane JA, Wang Y-G. Factors potentiating the risk of sudden infant death syndrome associated with prone position. N Engl J Med. 1993;329:377-382. 24 Smialek, JE, Smialek, PZ and Spitz, WU. Accidental bed deaths in infants due to unsafe sleeping situations. Clinical Pediatrics 1977; 15 (11):1031-1035. An infant can suffocate/asphyxiate against anything that partially or fully obstructs the nose and mouth and prevents breathing. 25 Once an infant's airflow is compromised, decreased levels of oxygen in the blood can further impair the infant's ability to respond to the situation. If an infant cannot respond, a feedback loop of decreased heart and respiration rate develops that can eventually lead to cessation of breathing and may become fatal if uninterrupted. 26 27 28 29 30 The prognosis for hypoxic (experiencing a state of low levels of oxygen in body tissues) victims due to smothering depends primarily on the extent of oxygen deprivation, the duration of unconsciousness, and the speed at which cardiopulmonary resuscitation (CPR) is attempted relative to the timing of cardiac arrest. Rapid reversal of the hypoxic state is essential to prevent or limit the development of pulmonary and cerebral edema that can lead to serious injury or death. Thus, victims who are oxygen deprived for short durations or quickly receive cardiopulmonary resuscitation to reestablish air flow have the most favorable clinical outcomes. 25 Wanna-Nakamura S. White Paper—Unsafe Sleep Settings: Hazards associated with the infant sleep environment and unsafe practices used by caregivers: a CPSC staff perspective. Bethesda, MD: Office of Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 2010. 26 Rosen CL et al., Two siblings and recurrent cardiorespiratory arrest; Munchausen syndrome by proxy or child abuse Paediatrics 1983; 71:715-720. 27 Medalia AA, Merriam AE, Ehrenreich JH. The neuropsychological sequelae of attempted hanging. J Neurol Neurosurg Psychiatry. 1991; 54:546-8. 28 Jongewaard WR, Cogbill TH, Landercasper J. Neurologic consequences of traumatic asphyxia. J Trauma. 1992 Jan;32(1):28-31. doi: 10.1097/00005373-199201000-00006. PMID: 1732570. 29 Polson CJ. Hanging In: Polson CJ and Gee DJ (eds.) Essentials of forensic medicine Oxford England, 1973 371-404. 30 Spitz WU. Asphyxia. In: Spitz WU, Spitz DJ, editors. Spitz and Fisher's medico-legal investigation of death: guidelines for the application of pathology to crime investigation, 4th edn. Because the brain is the organ in the body most sensitive to oxygen deprivation, a period of oxygen deprivation of as short as three minutes can lead to a wide range of serious injuries. The severity of oxygen deprivation ultimately governs the infant's chance for survival and the degree of neurological damage. The extent of injury is directly related to the duration and magnitude of hypoxia. Inadequate supply of oxygen to the brain can lead to loss of consciousness, cardiac arrest, and death. Victims who are rescued from oxygen deprivation of less than four minutes can still suffer a wide range of serious injuries and lasting neurological issues, including delays to reach milestones, paralysis, sensory disturbances, seizures, cognitive and memory deficits, and neuropsychological problems. 31 32 33 Patients who survive cardiac arrest can remain in a coma for various periods and some may remain in a persistent vegetative state. Patients who survive prolonged anoxic episodes require a multidisciplinary rehabilitation that may include speech therapy, physical therapy, and/or prolonged specialized care inside or outside of the home, with the level of care dependent on the severity of the injury. 31 Dzikienė R, Lukoševičius S, Laurynaitienė J, Marmienė V, Nedzelskienė I, Tamelienė R, Rimdeikienė I, Kudrevičienė A. Long-Term Outcomes of Perinatal Hypoxia and Asphyxia at an Early School Age. Medicina (Kaunas). 2021 Sep 18;57(9):988. doi: 10.3390/medicina57090988. PMID: 34577911; PMCID: PMC8466311. 32 Jongewaard WR, Cogbill TH, Landercasper J. Neurologic consequences of traumatic asphyxia. J Trauma. 1992 Jan;32(1):28-31. doi: 10.1097/00005373-199201000-00006. PMID: 1732570. 33 van Handel, M., Swaab, H., de Vries, L.S. et al. Long-term cognitive and behavioral consequences of neonatal encephalopathy following perinatal asphyxia: a review. Eur J Pediatr 166, 645-654 (2007). https://doi.org/10.1007/s00431-007-0437-8. B. Bassinet Mattresses and Mattress Supports Mattresses that are not flat ( e.g., bent, warped, sagging, with bumps, bulges, or dips) or not well-fitting, or mattress boards that are bent, warped, pop out of place, or provide little or no support, or that have bars (that support the mattress boards) that are broken or not staying in place, can lead to an uneven sleep surface, putting the infant at risk of asphyxia/suffocation. Staff illustratively identified two deaths, one ED visit, one non-ED injury, and 75 of the 182 non-injury product-related incidents that demonstrate this hazard. These non-injury incidents could have resulted in asphyxiation/suffocation if someone had not intervened to rescue the occupant. One death associated with a bassinet mattress involved a depression in the middle of the mattress, while the other death involved poor fit of the mattress, which allowed enough space for the infant to get wedged between the mattress and the sidewall of the bassinet. • In IDI 220804HCC1109, a 3-month-old male was found unresponsive in a concave depression in the center of a bassinet. • In IDI 210824HCC1792, a 3-month-old female was found prone wedged in a gap between the bassinet mattress and bassinet frame under a pillow. Any object that obstructs an infant's airway, including an overly soft mattress, can lead to serious injury or death. This category includes a bassinet that was subject to a CPSC safety recall because the mattress support was disengaging, posing fall and entrapment hazards. 34 34 DaVinci Recalls Bassinets Due to Fall and Entrapment Hazards (Recall Alert) | CPSC.gov . C. Structural Integrity/Quality Products with insufficient structural robustness (including components of the bassinet/cradle that reportedly break or crack; hardware coming loose; and stitching coming undone) can also increase the potential for infants to get into a compromising position, increasing the risk of asphyxiation/suffocation. Staff identified one reported hospitalization (laceration injury), one reported ED visit (broken metal piece injured infant), and seven of the 182 non-injury product-related incidents that demonstrate this hazard pattern. D. Product Design Product design can lead to safety concerns, including products being unstable (increasing risk of rolling into a compromising position and suffocating), products sitting too low to the ground (allowing easier access by older siblings and creating suffocation hazards), and products having non-mesh sidewalls that create a suffocation hazard. Staff identified two deaths, one non-ED injury, and three of the 182 non-injury product-related incident reports that demonstrate this hazard. One product reportedly was unstable, while another reported that the non-mesh sidewall was a suffocation hazard. The two deaths involved play yard accessories that were reportedly very low to the ground, allowing access by older siblings. • In IDI 210929HCC1229, a 1-month-old female was found unresponsive in a bassinet placed on the floor with her 2-year-old sibling partially resting on top of her. • In IDI 200713HCC2638, a 5-month-old female was found unresponsive in a bassinet placed on the floor with her 15-month-old sibling asleep on top of the victim. E. Electrical Problems Some bassinets contain battery-operated or plug-in powered features including sounds, lights, vibrations, and motorized rocking movements. Electrical problems with bassinets can result in smoke, shock, or battery leakage. Staff identified one hospitalization, one non-ED-treated injury, and two of the 182 non-injury product-related incident reports demonstrating this hazard pattern. F. Falls From Elevated Heights In the 2022 Bassinet Rejection Staff Briefing Package, staff of CPSC's Division of Human Factors, Directorate for Engineering Sciences (HF staff), examined the revisions made to ASTM F2194—22 ε 1 and expressed concern regarding the inclusion of “compact bassinets/cradles” and products with a “compact bassinet/cradle mode” within the scope of the voluntary standard. Specifically, HF staff concluded that products covered by the definition of a “compact bassinets/cradle” are significantly more likely to be placed onto a soft and/or elevated surface, such as a table, sofa, countertop, or bed, and that the less stringent stability requirements for compact products make them more prone to tipping over. In the same briefing package, staff identified one fatality and three injuries related to infants falling out of compact bassinets, where the product was placed on an elevated or soft surface, such as an adult bed, countertop, and couch. Of these three incidents, one incident (IDI 200940506) involved placement on a countertop, one (IDI 201234191) involved placement on a couch, and one (IDI 210246657) involved placement on a chair. The incidents involving placement on a countertop and couch resulted in head injuries. Staff is also aware of several additional incidents in which bassinets were placed on soft/elevated surfaces resulting in one fatal incident (IDI 2101050001), when a bassinet was placed on top of an adult bed, leaning against a nearby wall. Staff is also aware of an incident (IDI 211207687) in which an infant climbed out of a bassinet placed on an adult bed and fell off the bed. Further, customer reviews of various compact bassinets indicate use in/on mattresses, sofas, tables, and countertops. G. National Estimates From NEISS Based on NEISS data, staff estimates 3,500 injuries (sample size=160, coefficient of variation=0.23) related to bassinets and cradles were treated in U.S. hospital emergency departments over a five-year period from 2017 through 2021. Of the 160 sample cases, four incidents were fatal. About 59 percent of the injuries involved infants 5 months of age or younger and about 89 percent involved infants 8 months or younger. Forty-one percent of the injured infants were male, while 59 percent were female. The most commonly occurring ED-treated injuries related to bassinets and cradles were falls and interaction with other children. • Falls (52 percent): the majority of reports did not specify the manner or cause of the fall. An additional 5 percent indicated that the infant had been dropped, and another 2 percent indicated that the infant had climbed out of the bassinet/cradle and fallen. • Interaction with other children (24 percent): many of the reports involved siblings or other young children pulling/tipping the bassinet over, tripping on the bassinet and tipping it over, attempting to pull/lift an infant out of the bassinet, or climbing into the bassinet to be with the infant. These incidents are usually associated with infants falling out of the product. A few scenarios described infants sustaining contusions/lacerations from older children striking/biting them. Sixty-nine percent of reported injuries were to the infant's head, while 9 percent were to the infant's face. Seven percent of reported injuries did not state the injury location. Injury types include internal organs (58 percent) and fractures (10 percent), among others. Regarding patient disposition, 82 percent were treated and released, 14 percent were admitted to the hospital or transferred to another hospital, and 2 percent died from their injuries. H. Availability of Incident Data Upon publication of this NPR in the Federal Register, CPSC will make available for review and comment the CPSRMS and NEISS incident reports relied upon and discussed in this NPR, to the extent allowed by applicable law, along with the associated IDIs. The data will be made available by submitting a request at: https://forms.office.com/g/Pvn3yPePPf. You will then receive a website link to access the data at the email address you provided. I. Bassinet/Cradle Recalls From June 2012 through March 2023, the Office of Compliance and Field Operations conducted 10 recalls of bassinets, cradles, and related products as described in Table 1, including recalls of bassinets, cradles, and multi-modal products where the recall involved the bassinet mode. This summary includes recalls of Infant Sleep Products with flat sleep surfaces that must, pursuant to the ISP Rule, comply with 16 CFR part 1218, Safety Standard for Bassinets and Cradles, because such products are not subject to another mandatory safety standard for a sleep product. Not included in this recall summary are recalls of inclined infant sleep products and multi-modal products where the recall did not involve the bassinet mode, or after-market bassinet mattresses. The recalls involved products with risks of suffocation, entrapment, fall, and choking hazards and involved one reported death, two reported injuries, and 132 reported other incidents. Recalls affected approximately 396,500 units. Table 1—Summary of Bassinet and Cradle Recalls Press release date Firm Hazard Approximate number of recalled units/ product type 35 Number of incidents (injuries & deaths) reported 35 Press release No. October 23, 2012 Dorel Juvenile Group Suffocation 97,000 Bassinet 17 incidents (2 injuries, 0 deaths) 36 13-017 November 16, 2012 KidCo, Inc Suffocation and Entrapment 220,000 Baby tent 6 incidents (0 injuries, 1 death) 37 13-043 January 15, 2013 Bugaboo Americas Fall and choking 46,300 Carriage/stroller with removable carrycot bassinet 58 incidents (0 injuries, 0 deaths) 38 13-092 March 27, 2013 Bugaboo Americas Fall 9,200 Carriage/stroller with removable carrycot bassinet 16 incidents (0 injuries, 0 deaths) 39 13-153 November 13, 2013 Dream on Me Inc Fall 700 Cradle 2 incidents (0 injuries, 0 deaths) 40 14-019 March 3, 2015 Dream on Me Inc Fall 13,000 Bassinet 1 incident (0 injuries, 0 deaths) 41 15-088 September 2, 2015 Sleeping Partners International Inc Fall 5,500 baskets and 800 stands Hand-held infant carrier and Bassinet 0 incidents (0 injuries, 0 deaths) 42 15-230 January 18, 2018 Multipro Limited Fall and Entrapment 1,000 Cradle 0 incidents (0 injuries, 0 deaths) 43 18-716 December 5, 2019 Bexco Enterprises, D/B/A DaVinci Fall 3,000 Bassinet 19 incidents (0 injuries, 0 deaths) 44 20-711 July 9, 2020 Bexco Enterprises, D/B/A DaVinci Fall and Entrapment 3,000 Bassinet 13 incidents (0 injuries, 0 deaths) 45 20-762 Total 46 396,500 132 incidents (2 injuries, 1 death) 10 35 When the recall press release delineates the approximate number of recalled units, number of incidents, or number of injuries by country, this summary only includes the reported United States values. 36 https://www.cpsc.gov/Recalls/2013/Dorel-Juvenile-Group-Recalls-Eddie-Bauer-Rocking-Wood-Bassinets-Due-to-Infant-Suffocation-Hazard. 37 https://www.cpsc.gov/Recalls/2013/Suffocation-Entrapment-Risks-Prompt-Recall-of-PeaPod-Travel-Tents-by-KidCo. 38 https://www.cpsc.gov/Recalls/2013/bugaboo-recalls-strollers-due-to-fall-and-choking-hazards. 39 https://www.cpsc.gov/Recalls/2013/Bugaboo-Recalls-Cameleon3-Strollers. 40 https://www.cpsc.gov/Recalls/2014/Dream-On-Me-Recalls-Cradle-Gliders. 41 https://www.cpsc.gov/Recalls/2015/Dream-on-Me-Recalls-2-in-1-Bassinet-to-Cradle. 42 https://www.cpsc.gov/Recalls/2015/Tadpoles-Baby-and-Kids-Recalls-Moses-Basket-and-Stand. 43 https://www.cpsc.gov/Recalls/2018/Bassinets-Recalled-Due-to-Violation-of-Bassinet-Cradle-Standard-Made-By-Multipro-Recall-Alert. 44 https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-Hazard-Recall-Alert. 45 https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-and-Entrapment-Hazards-Recall-Alert. 46 The Bexco Enterprises D/B/A DaVinci December 5, 2019 and July 9, 2020 recalls involve different hazards with the same products, and so the approximate number of recalled units are not counted twice in the total. IV. Voluntary Standard Development A. Description and Assessment of ASTM F2194-22 ε 1 ASTM F2194-22 ε 1 is the voluntary standard for bassinets/cradles, which includes the general requirements present in most durable infant or toddler product standards, such as restrictions related to lead in paint, small parts, hazardous sharp edges and points, wood parts, scissoring, shearing, or pinching, as well as performance and labeling requirements specific to bassinets/cradles, such as performance tests for static load and segmented mattresses. Compared to previous versions of the F2194 standard, ASTM F2194-22 ε 1 contains revisions to the scope, terminology, performance requirements, test methods, marking and labeling requirements, and instructional literature requirements for bassinets/cradles. Many of these changes relate to the introduction of compact bassinets/cradles. Tabs A and C of the 2022 Bassinet Rejection Staff Briefing Package provide staff's full description of ASTM F2194-22 ε 1 and detailed human factors and engineering assessments of the revised voluntary standard. Based on staff's recommendation in the 2022 Bassinet Rejection Staff Briefing Package that elements of the revised standard decreased safety, the Commission voted to reject ASTM F2194-22 ε 1 and retain the existing mandatory standard in part 1218. The primary reason the Commission stated for rejecting ASTM F2194-22 ε 1 involved the addition of compact bassinets/cradles with legs shorter than six inches, 47 because caregivers are likely to place smaller and more portable compact bassinets in unsafe locations, such as elevated and soft surfaces (tables, counters, couches, and beds). CPSC's data demonstrate that infants have suffered serious head injuries and death when using small, portable products in unsafe locations. Moreover, ASTM F2194-22 ε 1 added a new stability test that applied only to compact bassinets/cradles that is less stringent than the stability test for regular bassinets/cradles. The Commission determined that, taken together, these additions decrease the safety of bassinets/cradles, as well as other infant sleep products subject to the bassinet standard. 47 RCA-ASTMs-Notice-of-a-Revised-Voluntary-Standards-for-Bassinets-and-Cradles.pdf ( cpsc.gov ). B. Voluntary Standards Development Since September 2022 The ASTM subcommittee formed the F15.18 Bassinets Elevated Surface and Data Task Group (Task Group) to work with CPSC staff to develop performance requirements to address the hazards of consumers placing bassinets/cradles on elevated and/or soft surfaces. The Task Group met three times between November 2022 and February 2023 48 49 50 to develop a proposal that all bassinets/cradles must meet either one of the following requirements: 48 Meeting Log for November 16, 2022 task group: https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Data-and-Compact-Bassinet-TG.pdf?VersionId=iMqK1Fy3s2xLSxuhFAbBVY5FJxIQNAgo. 49 Meeting Log for December 14, 2022 task group: https://www.cpsc.gov/s3fs-public/F15-18-Bassinets-Elevated-Surface-and-Data-Task-Group-Meeting.pdf?VersionId=4sDOc.36I7O1.pSw8OLJM7bYmGzTOoTZ. 50 Meeting Log for February 28, 2023 task group: https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Bassinet-Elevated-Hazard-Task-Group-Meeting-Log.pdf?VersionId=xi2Cs5BZSnJWSbBEnBr7jF2gaqoflYbT. 1. The bassinet/cradle only fully supports infants and functions when the top rail is 16 inches or greater above the external floor with a minimum internal side height of 7.5 inches. Examples of ways to meet this requirement include: (a) Bassinet collapses/fails when removed from the stand, so that it cannot be used when removed from the stand. (b) Bassinet does not have a removable stand. 2. The smallest lateral dimension shall be equal to or greater than 24 inches, with a minimum internal side height of 7.5 inches. CPSC staff assessed these proposed requirements developed by the ASTM task group, as follows: Minimum 16-inch external side height requirement: CPSC staff assesses that a 16-inch external product side height is likely to be too low to the ground and to require the caregiver to squat or bend significantly to attend to the infant (Figure 1, first two images on the top left). For a variety of reasons, including to improve their posture while interacting with the baby, caregivers may choose to move the bassinet onto an elevated surface as shown in Figure 1, such as a countertop, dining table, coffee table, sofa, chair, or adult bed, despite this putting the infant at risk. Figure 1 demonstrates a 16-inch-tall bassinet positioned on elevated surfaces. Even a 50th percentile female (height 64 inches 51 ) would have to bend over considerably to access the child on the ground and thus staff assesses that caregivers are likely to use the bassinet in combination with a raised surface. Because of this likelihood, staff assesses that the minimum height of 16 inches may not be sufficient to discourage caregivers from using the bassinet on elevated surfaces. 51 PeopleSize Pro v 2.02, US Female 18-64. EP16AP24.026 Minimum 24-inch lateral dimension requirement: CPSC staff and the ASTM Bassinets Subcommittee also discussed a 24-inch lateral dimension as a means of deterring use of bassinets on soft and/or elevated surfaces. This dimension represents the upper end of typical sofa seat depth range ( i.e., distance from a typical couch seat bight to edge). 52 Based on discussions with the ASTM Bassinets Subcommittee, CPSC staff assesses that “wide footprint” bassinets/cradles are likely to somewhat visually discourage caregivers from placing bassinets/cradles on soft/elevated surfaces. Specifically, the “wide footprint” requirement ( i.e., all lateral dimensions greater than 24 inches) could reduce consumers' ability and likelihood to place products onto soft and/or elevated surfaces to a limited degree, as those products will be less portable and will either no longer fit onto soft/elevated surfaces or will take up enough space that caregivers may not wish to place the product onto said surfaces. 52 The typical sofa seat depth is 21 inches to 24 inches. https://blog.roomstogo.com/what-do-i-need-to-know-about-couch-depth/#:~:text=Outside%20depth%20ranges%20from%2031,sit%20with%20an%20upright%20posture. Figure 2 shows three bassinets of varying lateral dimensions on a sofa with a seat depth of approximately 20.25 inches. Staff assesses that the two bassinets with a lateral dimension greater than or equal to 24 inches (bottom two photos) are less likely to be placed on a narrow sofa because they hang partially off of the edge of the sofa, whereas the bassinet with a smaller lateral dimension (top photo) is more likely to be placed on a sofa, as it fits entirely on the sofa. However, sofas with a larger seat depth, such as “deep-seated” sofa depths which can extend to 36 inches, can accommodate placement of a wide bassinet. 53 53 https://www.thesofareview.com/guides/the-best-deep-seated-sofas and https://blog.roomstogo.com/what-do-i-need-to-know-about-couch-depth/#:~:text=Outside%20depth%20ranges%20from%2031,sit%20with%20an%20upright%20posture. EP16AP24.027 Staff also analyzed the ability to place a wide footprint bassinet on traditional mattress sizes. Staff assesses that a full size mattress, a queen size mattress, and a king size mattress can accommodate a single adult caregiver and a 24-inch-wide bassinet. For two-caregiver households, a 24-inch footprint would take up too much space to allow for two adult occupants in a full size bed. For queen size beds, the bassinet would take up a significant amount of space but would still allow for two adult occupants. For king size beds, two parents can comfortably fit a 24-inch bassinet on the bed. Overall, staff assesses that a bassinet with a 24-inch-wide footprint is still likely to be used on full, queen, and king size adult beds with one or two caregivers (Figure 3). For this reason, staff assesses that the 24-inch footprint does not adequately address the hazard of bassinets being used on adult beds. Additionally, based on typical countertop, dining table, and coffee table dimensions, staff assesses that the 24-inch footprint alone does not deter consumers from placing bassinets on these elevated surfaces, because a bassinet with a 24-inch-wide footprint will likely fit onto many of these surfaces, and consumers would easily be able to reach into the product to place/retrieve the infant. 54 54 Standard countertop depth is 25.5 inches. Dining tables are generally 36″ wide at minimum. Coffee tables often exceed 24″ in length and width. EP16AP24.028 V. NPR Description and Explanation 55 The 50th percentile adult male (18-64) height is 69.64 inches and shoulder breadth is 19 inches (PeopleSize, Pro v 2.02) A. ASTM Approaches Not Requiring Modification The Commission preliminarily determines that three particular aspects of the current part 1218 rule, which are not proposed for revision in ASTM F2194-22 ε 1 , remain adequate to address associated hazards and do not require modification: locking/latching mechanism (section 5.6 of ASTM F2194-22 ε 1 , product finish-related requirements (sections 5.2 and 5.4 of ASTM F2194-22 ε 1 ), and the static load requirement to address mattress support issues (section 7.3 of ASTM F2194-22 ε 1 ). ASTM developed locking/latching requirements for bassinets/cradles to address incidents associated with collapse of the product. After reviewing the reported incidents potentially implicating these requirements, none of which included evidence of injury, staff advises that the existing requirements address the hazard of the product collapsing or folding. Therefore, the Commission preliminarily concludes that the existing performance requirements address the hazard and do not require modification. Currently, no provisions in part 1218 address rough product surfaces. Incidents regarding product finish, such as rough mesh surfaces and labels with sharp edges (addressed in Sections 5.2 and 5.4 of ASTM F2194—22 ε 1 ) were not widespread in the incident data; all but one infant in this type of reported incident received only non-medical treatment. The Commission will continue to monitor these incidents and, in particular, invites comment on how to address the rough mesh surface hazard. Finally, the static load requirement in the existing part 1218, requiring the product to support up to three times the heaviest intended infant, adequately verifies that the bassinet/cradle sleep area is designed to hold and not break or create a hazardous condition when subject to the weight of a child. The NPR does not modify this test and proposes to apply it to all bassinets within the scope of the standard. B. Mechanical and Electrical Hazards Addressed in the NPR Based on incident data (described in section III of this preamble) and staff's engineering and human factors assessments, the NPR proposes revisions and additions to some of the performance and labeling requirements in ASTM F2194-22 ε 1 that would better address known hazards and provide the highest level of safety feasible for bassinets/cradles. 1. Requirements To Discourage Product Use on Unsafe Surfaces To reduce the likelihood of consumers placing bassinets/cradles onto elevated and/or soft surfaces, the NPR proposes both of the following performance requirements and test methods. a. The bassinet/cradle only fully supports infants and functions when the lowest portion of the top side/rail is 27 inches or greater above the product support surface ( i.e., floor) with a minimum internal side height of 7.5 inches. Examples that would meet this requirement include: (1) Products with a removeable stand that collapses or fails when removed. (2) Products that do not have a removeable stand. b. The occupant support surface ( i.e., mattress) shall be at least 15 inches from the product support surface ( i.e., floor). As shown in Figure 4, with these modifications caregivers can comfortably reach and attend to the infant in a 27-inch-tall bassinet located on the floor and will not need to elevate the bassinet. In fact, elevating a 27-inch-tall bassinet into a hazardous position makes it more difficult and inconvenient to reach the baby. Figure 4 demonstrates a 50th percentile female in relation to a bassinet with the proposed requirements on various elevated surfaces. These elevated surfaces are unlikely to be utilized due to caregivers' difficulty to reach the baby compared to their reach when the bassinet is located on the floor (Figure 4, first two images on the top left). EP16AP24.029 While caregivers can easily reach into a 27-inch-tall bassinet when it is on the floor, they may have difficulty reaching their infant if the mattress is positioned too low to the ground (Figure 5); therefore, the combination of the two proposed dimensions would improve the safety of the bassinet by discouraging its use on elevated surfaces while making it more comfortable and convenient to use on the floor. EP16AP24.030 In the 2022 Bassinet Rejection Staff Briefing Package, staff expressed concern about ASTM's removal from the voluntary standard of the requirement for a bassinet to have a stand or base and the Commission rejected the revised standard that included “compact bassinets.” The requirements proposed in this NPR address CPSC's concerns regarding bedsharing and unsafe placement by requiring specific occupant sleep surface and side rail height requirements, while still subjecting products to the same stability requirements as bassinets with a traditional stand. CPSC staff reviewed a variety of products (see Figure 6 for two examples) and determined that some products available to consumers already meet the 27-inch top rail height and 15-inch mattress height requirement. Therefore, implementation of this NPR requirement is feasible. EP16AP24.031 Regarding hazards associated with other children attempting to climb into the bassinet, staff advises that given children's propensity for climbing ( see Staff Briefing Package for Clothing Storage Units 56 ), a 27-inch side height is unlikely to dissuade children from attempting to climb into the product. However, setting a minimum side height taller than 27 inches would likely result in products being significantly less stable in the event of a child climbing them, and would not prevent children from climbing. 57 58 59 60 61 Incidents demonstrate toddlers' ability to climb on raised surfaces including cribs, showing that increasing the bassinet exterior side height to more than 27 inches would not effectively address sibling's access to the product. 56 https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standrd-for-Clothing-Storage-Units.pdf?VersionId=X2prG3G0cqqngUwZh3rk01mkmFB40Gjf . 57 The incident data reported in section III of this preamble contains two climbing-associated deaths: an older sibling (15 months and two years old) climbed into the bassinet and laid on top of the infant inside, suffocating them. Older 1-year-olds are known to be capable of climbing on and off furniture without assistance. 57 Gross motor play and the use of climbers are dominant, starting at about 1 1/2 years of age. 58 Two-year-old children especially enjoy climbing, and can climb steps, short ladders, and jungle gyms. 59 60 Moreover, incident data reported to CPSC include numerous cases involving children climbing on furniture as well as cribs. For example, in an incident reported through NEISS (IDI 210108288), a two-year-old male climbed up on a nightstand and was climbing into baby crib. In another NEISS incident (IDI 200740286), a 22-month-old female climbed into her brother's crib. In another NEISS incident (IDI 200130999), the two-year-old girl climbed into a portable play yard or crib and bit her 15-month-old sister. In a fatal incident (IDI X19C0292A), a one-year-old male was put down for a nap in a room with his toddler brother. The toddler climbed into the crib with him with a pillow and a blanket. 58 Therrell, J.A., Brown, P., Sutterby, J.A., Thornton, C.D., (2002). Age Determination Guidelines: Relating Children's Ages to Toy Characteristics and Play Behavior. T. P. Smith (Ed.), Bethesda, MD: U.S. Consumer Product Safety Commission. 59 Frost, J.L., Wortham, S., & Reifel, S. (2001). Play and Child Development. Upper Saddle River, NJ: Prentice-Hall. 60 Therrell, Brown, Sutterby, & Thornton, 2002. 61 Hughes, F.P. (1991). Children, Play, and Development. Boston: Allyn & Bacon. Caregivers depend on infant sleep products to be safe places in which to leave an infant for sleep; accordingly, these products must be safe for infant sleep as sold. While these modifications, as written, would not necessarily require bassinets/cradles to have a stand, they would ensure that bassinets and cradles, including small portable products, are raised off the ground to discourage caregivers from placing them on elevated and soft surfaces such as beds and couches. The proposed requirements would thus work toward achieving the highest level of safety feasible for sleeping infants left to sleep unattended while in the product. 2. Requirements for Sidewall Rigidity The current mandatory rule in part 1218 does not have a sidewall rigidity requirement. Many bassinets/cradles on the market have sidewalls constructed of fabric, foam, fiberfill, mesh, or cardboard, which can deflect downward, inward, and/or outward when subjected to a load. CPSC is concerned that bassinets with non-rigid sidewalls may permanently deform or collapse and not contain the infant if an external force is applied to the sidewall, such as when a sibling pulls on the sidewall of an occupied bassinet. CPSC engineering staff considered whether the existing bassinet stability test, which simulates a 2-year-old pulling on the bassinet sidewall, could also be used to test adequate sidewall rigidity to contain an infant. To test this concept, staff conducted the stability test in ASTM F2194-13 on three non-rigid sided bassinets as shown in Figures 7-9. 62 Staff applied a 23-pound downward force and a five-pound outward force on the bassinets as specified in the stability test. The cardboard box bassinets bowed outward 3-5 inches (Figure 7b, 8b) during stability testing. The soft sided compact bassinet was not able to support the 23-pound load and collapsed more than 8 inches outward (Figure 9b). These tests demonstrate that bassinets with non-rigid sidewalls may permanently deform or collapse and not contain the infant if an external force is applied to the sidewall of an occupied bassinet, for instance by a sibling pulling on it. 62 The laser line used to determine deflection is enhanced for visibility. EP16AP24.032 Staff next conducted this same stability test on rigid-sided bassinets, which did not deflect or deform during testing. Staff advises that 0.5 inch of deflection in any direction during the stability test allows for reasonable movement of rigid sidewalls to account for minor movements in fasteners in the construction of the product. Based on this testing, the NPR proposes two requirements. First, unlike ASTM F2194-22 ε 1 , the NPR proposes to subject all bassinets/cradles to the stability requirement. 63 Second, the NPR proposes that during this stability test, sidewall deflection can also be measured, requiring that the sidewall shall not deflect in any direction more than 0.5 inches. These proposed modifications ensure bassinet/cradle stability and containment of the infant. 63 As explained in section I of this preamble, the ASTM F2194-22 ε 1 that the Commission has rejected created a new category of “compact bassinets” and subjected this category to a new, less stringent, stability test. 3. Requirements for Mattresses and Mattress Supports a. Requirements for Sleep Surface Deflection/Firmness The NPR proposes mattress firmness requirements consistent with the mandatory crib mattress requirements in 16 CFR part 1241 to address incidents of infant's face/head conforming to the sleep surface. The mandatory crib mattress rule requires a firmness test intended to prevent the hazard of positional asphyxia involving infants suffocating when face down in a soft mattress that can conform to an infant's face. The firmness test involves placing a test fixture, as shown below in Figure 10, level on the sleep surface of the mattress. The mattress must be sufficiently firm and flat to support the weight of the test fixture (approximately 11.5 lb.) so that the feeler arm does not make any contact with the surface of the mattress. EP16AP24.033 Staff tested two samples using the mattress firmness test fixture. Figure 11 shows the mattress firmness test fixture feeler arm touching the surface of the mattress, indicating that the mattress is too soft and fails the draft firmness requirement. Test results showed that some products failed the firmness test (feeler arm contacting the surface of the mattress) because the mattress was too soft (Figure 11). EP16AP24.034 Accordingly, to verify that the bassinet sleep surface (mattress and/or support) is not too soft and does not form a concavity that can pose a positional asphyxia hazard to infants, the NPR proposes to include in part 1218 the same mattress firmness test as is found in the crib mattress rule. b. Requirements for Structural Integrity of Bassinet Mattresses and Mattress Supports Part 1218 currently specifies a static load requirement for the sleep enclosure of the product. Section 6.3 of ASTM F2194-13, Static Load, specifies that the product shall support the static load without causing any hazardous conditions as identified within Section 5 (General Requirements). The static load test (Section 7.3) consists of placing a 54-pound load or three times the manufacturer's recommended weight (whichever is greater) within 5 seconds on an aluminum block and maintain for 60 seconds. For play yard bassinets, the test is conducted in all four corners of the product. The static load test verifies that the bassinet/cradle sleep area is designed to hold and not break or create a hazardous condition upon the weight of a child by requiring the product to support up to three times the heaviest intended occupant (95th percentile 5-month-old male (19.8 lb.)). Although staff advises that the static load requirement is adequate to address some of the mattress and/or support issues, the mattress firmness test (discussed in section V.B of this preamble) is an added verification of the flatness of the sleep surface (mattress and/or support), to further address these mattress/supports issues. c. Requirements for After-Market Mattresses for Bassinets/Cradles The crib mattress rule (part 1241) includes performance requirements for after-market mattresses but does not specifically identify bassinet/cradle mattresses as being included in the regulation. Instead, part 1218 establishes requirements for mattresses sold with bassinets/cradles (generally known as OEM mattresses.) CPSC is aware, however, of incidents that have arisen from consumer use of ill-fitting after-market mattresses. Based on the prominent availability and use of after-market bassinet/cradle mattresses, and the use of bassinets/cradles for infant sleep, the NPR proposes performance requirements for after-market bassinet mattresses to ensure the same level of safety as OEM bassinet/cradles mattresses and after-market mattresses for other infant sleep products. Crib mattresses and bassinet/cradle mattresses, including after-market bassinet/cradle mattresses, share common hazard patterns associated with poorly fitting and overly soft mattresses. The mandatory crib mattress rule in part 1241 addresses similar hazards found in after-market play yard mattresses and non-full-size crib mattresses. Part 1241 requires such mattresses to meet the same performance requirements as the OEM mattress sold with the product, when tested with the product for which the after-market mattress is intended. In particular, these mattresses must have a minimum level of firmness (section V.B.3 of this preamble). Part 1241 already requires after-market mattresses intended for use in the bassinet attachment of a play yard to meet the provisions in the existing bassinet rule, part 1218, when tested with each bassinet/cradle brand and model in which the mattress is intended to be used. 16 CFR 1241.2(b)(5)(iv). Additionally, the crib mattress rule requires that after-market mattresses must be at least the same size as the OEM mattress or larger and must lay flat, must include a floor support structure that is at least as thick as the OEM mattress, and must include equivalent storage accommodations (such as a pouch for the product instruction manual). 16 CFR 1241.2(b)(4). To reduce the risk of injury caused by poorly fitting and overly soft mattresses associated with after-market mattresses for bassinets/cradles, the NPR proposes to adopt the after-market requirements from the crib mattress rule into the bassinet/cradle mandatory standard. 4. Requirements for Bassinet Sleep Surface Angles Minimum safe sleep requirements for young infants, particularly those 5 months old and younger, require that infants be placed to sleep on their backs on a firm, flat, sleep surface. As described in section III of the preamble, this avoids the hazard created by bassinets that are non-level—for example leaning forward or to one side, or with legs or sides with uneven heights—which could cause the infants to roll to the side, often into the mesh/siding of the bassinet/cradle before the infant is developmentally capable of rolling. a. Requirement for Head-To-Toe Incline Angle The definition of bassinet in part 1218 (based on ASTM F2194-13) states that “[w]hile in a rest (non-rocking or swinging) position, a bassinet/cradle is intended to have a sleep surface less than or equal to 10° from horizontal.” 16 CFR 1218.2(b)(1)(i) citing section 1.3 of ASTM F2194-13. The angle limitation in the definition is intended to ensure that the bassinet provides a safe, flat sleep surface. However, neither ASTM F2194—13 nor the revised ASTM F2194-22 ε 1 contain a test to measure the sleep surface incline to ensure that the sleep surface does not exceed 10 degrees from horizontal. The Commission's ISP Rule in part 1236 contains a test to measure the head-to-toe sleep surface angle. This test consists of placing a Hinged Weight Gauge-Infant (17.5 lb.) on the product and measuring the lengthwise incline angle along the upper torso/head area. This 10-degree head-to-toe safe sleep angle is supported in a report by Erin M. Mannen, Ph.D., the Biomechanical Analysis of Inclined Sleep Products—Final Report September 18, 2019. 64 Dr. Mannen's testing showed that angles greater than 20 degrees present a hazard that infants may move into a compromising position in the product from which they cannot self-rescue. Based on the results of Dr. Mannen's biomechanical study, “fewer differences in muscle activity or lying posture were revealed at a 10-degree mattress incline compared to the zero-incline surface. Ten degrees is likely a safe incline for sleep on a crib mattress type of surface.” The NPR proposes to remove the head-to-toe sleep surface angle statement from the definition of a bassinet, and instead to add a performance and test requirement for the 10-degree head-to-toe sleep surface angle limit, using the same incline test from the ISP Rule. This is an improvement to safety because it will ensure consistent and repeatable testing across test labs for all bassinets/cradles. 64 The 10 degree incline angle requirement in the Infant Sleep Product Final Rule, available at: https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Infant-Sleep-Products.pdf, is based on findings in the 2019, Biomechanical Analysis of Inclined Sleep Products—Final Report 09.18.2019 by Erin M Mannen Ph.D., available at: https://www.cpsc.gov/s3fs-public/Dr-Mannen-Study-FINAL-Report-09-18-2019_Redacted.corrected_0.pdf?g.Jao0IN_zU.TjiX4FeSUM3SPc3Zt_25. b. Side-to-Side Tilt Angle Part 1218 specifies a side-to-side tilt angle of no more than 7 degrees for rocking bassinets/cradles when they are at rest (section 6.9.2 of ASTM F2194-13), but does not specify side-to-side tilt requirements for bassinets/cradles without a rocking function. On December 7, 2021, CPSC staff sent a letter 65 to the ASTM subcommittee chair for bassinets/cradles regarding four fatal incidents (occurring from 2019 through 2021) involving bassinets with a cantilever design in which infants reportedly rolled into the side of the bassinet, or into a prone position. The cantilever design supports the bassinet by a leg/frame on one side of the product so that the suspended side without a support can be positioned over an adult bed. In the December 7, 2021 letter, CPSC staff stated concern with the then-current ASTM F2194-16 ε 1 allowance of a side-to-side 7-degree maximum tilt angle, because minimum safe sleep guidance requires infants be placed to sleep on a firm, flat surface. 66 65 Staff letter to Mr. Lewis, chair of ASTM F15.18 on Bassinets and Cradles, dated December 7, 2021. https://www.cpsc.gov/s3fs-public/ BassinetwcantileverltrAttachedSpreadsheet-120821.pdf?VersionId=fyFz2 Ac9HFDyp0yWa83WphujK.KJHEVS. 66 After staff's further review of bassinet-related data, the tilt hazard pattern is evidenced in the 2 deaths, 3 injuries, and 95 non-injury incidents summarized in section III of this preamble. However, on February 14, 2023, ASTM proposed side-to-side tilt requirements in the voluntary standard for non-rocking bassinets/cradles stating that the bassinet sleep surface shall not exceed a side-to-side tilt angle of 7 degrees. This angle limit is based on the existing rocking bassinet/cradle rest angle requirement in section 6.9.2 of ASTM F2194-13. The test consists of two parts: simulating a five-month-old infant located against each side of the sleep surface, and then simulating a low weight newborn infant located against each side and the center of the sleep surface. The current side-to-side tilt angle for at rest rocking bassinets/cradles cannot exceed 7 degrees in either test. Based on this, ASTM's proposed modified test requirements for non-rocking bassinets/cradles provides the following: (i) Five-month-old infant. —The Hinged Weight Gauge-Infant (17.4 lb.) is placed parallel to and contacting one of the lateral sidewalls of the bassinet/cradle, equidistant between both head and toe ends of the sleep surface. The side-to-side angle is measured on top of the Hinged Weight Gauge-Infant. The angle measurement is taken three times and then averaged. The test then is repeated on the other side of the sleep surface. (ii) Newborn infant. —A 6 by 4 by 0.5-inch nominal thickness steel block weighing 3.3 lb. is placed parallel to and contacting one of the lateral sidewalls of the bassinet/cradle, equidistant between both head and toe ends of the sleep surface. The side-to-side angle is measured on top of the steel block. The angle measurement is taken three times and then averaged. The test then is repeated on the other side and in the geometrical center of the sleep surface. CPSC staff has assessed ASTM's proposal. Based on incident data, cantilevered designed bassinets that have 7 degree or less side-to-side tilt angle 67 can still facilitate infants rolling before they are developmentally capable of rolling and present the potential for a suffocation hazard. CPSC staff conducted testing on 10 products with cantilevered designs (see Table 2 below), using the NPR proposed test. Four products, A, B, D, H, were associated with incidents that involved the infant rolling over into a compromising position. Fortunately, the caregiver was able to intervene in these cases before suffocation ensued. However, in one case, Product B, involved a fatality incident (IDI 200211HCC3248). Product H had the largest tilt angle (7.1 degrees) and product D had the smallest tilt angle (1.2 degrees) of models associated with incidents. 67 CPSC proposes that bassinets/cradles have two different tilt angle requirements for head-to-toe and side-to-side, based on how the suffocation hazard manifests. The hazard associated with a head-to-toe tilt greater than 10 degrees occurs when an infant unexpectedly rolls (either side-to-side or into a chin-to-chest position) and the infant cannot self-rescue when on an incline and can suffocate. However, when a bassinet/cradle has a side-to-side tilt, even if the tilt is less than 7 degrees, incident data and sample analysis suggest that this tilt can facilitate rolling before an infant is developmentally capable of rolling and cannot self-rescue. A suffocation hazard presents when the infant's nose and mouth become occluded in the side or mattress. Table 2—Bassinet Tilt Testing Results Product ID Height setting (note 1) Max side-to-side tilt angle [degrees] A (Note 2) Lowest (mattress upper position) 5.6 Highest (mattress upper position) 6.3 Lowest (mattress lower position) 6.1 Highest (mattress lower position) 5.7 B Lowest 3.3 Highest 1.8 C Lowest 3.9 Highest 4.4 D Lowest 1.8 Highest 1.2 E Lowest 2.2 Highest 2.5 F Lowest 3.9 Highest 3.5 G Lowest 2.7 Highest 2.7 H Lowest 6.0 Highest 7.1 I Lowest 1.4 Highest 1.0 J Lowest 2.5 Highest 3.0 Notes: (1) All products had several height settings. Staff tested each sample on the highest and lowest height setting. (2) Product A has several height settings as well as two mattress positioning settings. Staff tested on the highest and lowest height setting for each of the two mattress positioning settings. Based on review of incidents and testing, staff determined that the current ASTM side-to-side tilt restriction of 7 degrees does not adequately address the rolling and suffocation hazard. Staff testing showed that cantilevered bassinets with tilt angles of 1.2-7.1 degrees were associated with rollover incidents. Accordingly, to address the potential for infants to roll into unsafe sleep positions and to provide the highest level of safety that is feasible, the NPR proposes to add the side-to-side tilt angle test requirements from ASTM's February 14, 2023, proposal, with two modifications: (1) decrease the allowed tilt angle to 0 ±1 degree, which means a maximum angle not to exceed one degree from horizontal, and (2) apply this requirement to both rocking bassinets at rest and non-rocking bassinets. The NPR also proposes that for bassinets with adjustable heights, the side-to-side tilt test be performed on both the highest and lowest height settings. The Commission requests comment on a side-to-side tilt angle limit (including the proposed 0-degree angle) and an appropriate manufacturing tolerance (including the proposed 1-degree maximum variation) that is as consistently close to flat as is feasible. 5. Requirements for Electrical Systems Section III of the preamble describes hazards associated with electrical systems, including smoke, shock, and battery leakage. While part 1218 does not address electrical hazards, other Commission rules for durable infant or toddler products, such as the infant swings rule, 16 CFR part 1223, incorporating ASTM F2088-22, Standard Consumer Safety Specification for Infant and Cradle Swings, include adequate requirements to address electrical hazards, such as the conditions that can lead to battery leakage. To address bassinet/cradle incidents associated with defective electrical systems, the NPR proposes to include the battery compartment requirements from part 1223 in part 1218. 6. Requirements for Multi-Use Products Regarding multi-use products, section 5.14 of ASTM F2194-22 ε 1 states that if “converted into another product for which a consumer safety specification exits, the product shall comply with the applicable requirements of that standard when in that use mode.” Because the Commission's mandatory standard and ASTM's “consumer safety specifications” can diverge and are not always the same, the NPR proposes that multi-use products comply with the applicable mandatory CPSC consumer product safety standard when in each use mode, rather than the applicable voluntary standard. This modification clarifies CPSC's expectation and creates certainty for test labs. C. Revised Requirements for Marking, Warning, Labeling, and Instructional Literature Tab A of Staff's 2022 Bassinet Rejection Staff Briefing Package provides a detailed description of the marking and warning requirements in ASTM F2194-22 ε 1 and an analysis of whether the revised labeling requirements improve the safety of bassinets and cradles. Modifications in ASTM F2194-22 ε 1 include additional language or changes addressing battery-related hazards, product warnings, compact bassinets and compact bassinets made of cardboard, and the warning language currently incorporated by reference in part 1218. After considering literature, incident data, and consumer feedback, the Commission preliminarily finds that the marking, warning, labeling, and instructional literature requirements specified in ASTM F2194-22 ε 1 are largely adequate but require several modifications to provide the highest level of safety feasible. Battery Compartment Warnings —ASTM revised section 8 of ASTM F2194-22 ε 1 to include specific marking requirements for battery-operated products (Section 8.4-Battery-Operated Product Marking). The ASTM standard now requires that, for battery-operated products, the product's battery compartment, battery compartment door/cover, or area immediately adjacent to the battery compartment must be marked or labeled permanently and legibly to show the correct battery polarity, size, and voltage. ASTM F2194-22 ε 1 exempts products using one or more non-replaceable batteries, except when they are accessible with the use of a coin, screwdriver, or other common household tool, in which case they must be marked or labeled permanently and legibly with a statement that the batteries are not replaceable. If marking or labeling the product is not practicable, then this statement shall be included in the instructions. The bassinet subcommittee adopted these marking/labeling requirements from ASTM's Ad Hoc Language Task Group 68 and the requirements are consistent with other juvenile product standards. 68 ASTM Ad Hoc Language Task Group (Ad Hoc TG) consists of members of various durable nursery product voluntary standards committees, including CPSC staff. The Ad Hoc TG's purpose is to harmonize the wording of common sections ( e.g., introduction, scope, protective components) and warning label requirements across durable infant and toddler product voluntary standards. Staff advises that these requirements are adequate and necessary to address hazards associated with battery-operated products that are not currently addressed in part 1218. Accordingly, the NPR proposes to incorporate Section 8.4 of ASTM F2194—22 ε 1 without modification. Alignment with Ad Hoc Warnings —Section 8 of ASTM F2194- ε 22 1 also contains multiple revisions intended to align with current recommendations from ASTM's Ad Hoc Language Task Group. ASTM F2194-22 ε 1 now specifies that warnings shall be in English at minimum, states that any additional markings or labels shall not contradict or confuse the required information or mislead the consumer, and sets formatting requirements for warnings ( e.g., font size, text alignment, safety alert symbol, bullet points for cautionary statements). Per Ad Hoc Recommendations, the standard uses ANSI Z535.4-2011, Product Safety Signs and Labels, as a reference for its warning formatting requirements. ANSI Z535.4 is the primary United States voluntary consensus standard for product safety signs and labels. For example, CPSC staff consistently uses this standard when developing or assessing the adequacy of warning labels. Literature on the design and evaluation of on-product warnings frequently cites ANSI Z535.4 as the minimum set of requirements governing products sold in the United States containing such labels, and human factors experts generally consider the ANSI Z535 series of requirements the benchmark and state of the art standards against which warning labels should be evaluated for adequacy. The NPR proposes to adopt all warnings that align with ANSI Z535.4 formatting requirements. Suffocation Hazard Warnings —Section 8 of ASTM F2194-22 ε 1 also contains multiple revisions to the warning statements incorporated in part 1218, specifically to the language for suffocation hazards. ASTM F2194-22 ε 1 specifies that the statement “Failure to follow these warnings and the instructions could result in death or serious injury” shall be the first warning to appear in a message panel, followed immediately by a suffocation hazard warning addressing the following: EP16AP24.035 ASTM F2194-22 ε 1 also requires that warnings address the following statement: Always place baby on back to sleep to reduce the risk of SIDS and suffocation. ASTM F2194-22 ε 1 requires compact bassinets to address the following: Product can roll over on soft surfaces and suffocate child. NEVER place product on beds, sofas or other soft surfaces. The Commission rejected the inclusion of compact bassinets into the mandatory standard for bassinets and cradles in 2022. However, staff advises that this warning language addresses hazards associated with all bassinets/cradles and recommends that this language be required for all products within the scope of the standard. Accordingly, the NPR proposes to require this warning for all bassinets/cradles within the scope of the rule. Fall Hazard Warnings —ASTM F2194-22 ε 1 does not change the existing warning language related to fall hazards. However, in the voluntary standard, fall hazard statements are now required to appear after the suffocation hazard warning statements. Additionally, the warning language, “FALL HAZARD,” required for products where the bassinet bed is removeable from the base/stand without the use of tools and contains a lock/latch mechanism that secures the bassinet bed to the base/stand, is no longer required, as the message is instead required to be located in the fall hazard section of the warning, making the inclusion of a second “FALL HAZARD” statement redundant. However, ASTM F2194-22 ε 1 requires that compact products address the following statements in the “FALL HAZARD” section: (1) Always use product on the floor. Never use on an unintended elevated surface. (2) Do not carry baby in the [ manufacturer to insert type of product ]. [Exception: A product that is intended to carry a baby is exempt from this requirement]. (3) Compact bassinet/cradles constructed of cardboard shall also address: Do not reuse [ manufacturer to insert type of product ] for second child. Like the suffocation warnings for compact bassinets, staff advises that these fall hazard warnings will address fall hazards that are associated with all bassinets/cradles, not just compact bassinets. Accordingly, the NPR proposes that these fall hazard warnings be required for all products within the scope of the standard with two modifications. Specifically, the NPR proposes that the phrase “an unintended elevated surface” in warnings statement (1) be changed to “any elevated surface,” as any elevated surface presents a potential fall hazard. Additionally, for warning statement (3), the NPR proposes that the reference to “compact” bassinets be removed consistent with the Commission's rejection of this product category. The fall hazard warning language in ASTM F2194-22 ε 1 ; also contains requirements for products where the bassinet bed uses a lock/latch mechanism to secure the bassinet bed to the base/stand, so that the bassinet bed is removable without the use of tools. ASTM F2194-22 ε 1 ; requires the following warning language for these products: Always check that the bassinet is securely locked on the base/stand by pulling upwards on the bassinet bed. Lastly, ASTM added three example warnings to the standard: one for bassinet/cradle products, one for compact bassinet/cradles, and one for compact bassinet/cradles made of cardboard. Shown below is an example warning that complies with part 1218 (Figure 12), as well as the example warnings shown in ASTM F2194-22 ε 1 (Figures 13-14). While the warnings shown in Figure 14 are intended for compact products, and the NPR proposes to remove references to “compact” bassinets from the mandatory standard, the text included in the warnings meets proposed NPR requirements and does not make a specific reference to “compact” bassinets, other than the title of the figures. The warnings in Figure 14 contain a statement warning against use on “unintended” elevated surfaces. Fall hazards, however, can occur with non-compact products and on any elevated surface. Additionally, the warning in Figure 13, which is intended for “standard' bassinets/cradles, does not contain language warning consumers against using the product on soft or hard elevated surfaces or carrying infants in the product. Therefore, this NPR proposes that the warning shown in Figure 13 (Fig. 29 in ASTM F2194-22 ε 1 ) be removed, and that the warnings shown in Figure 14 (Fig. 30-31 in ASTM F2194-22 ε 1 ;) be renumbered and renamed to remove the reference to “compact” products and revised so that the statement warning against use on “an unintended elevated surface” instead warns against use on “any elevated surface.” EP16AP24.036 EP16AP24.037 After-Market Bassinet/Cradle Mattresses Warnings —Included in this final rule are warning requirements for after-market mattresses. As discussed above in section V.B.3.c of this preamble, the safety standard for crib mattresses (part 1241) includes performance requirements for after-market mattresses but does not specifically identify bassinet/cradle mattresses as being included in the regulation. However, given the existence of after-market bassinet/cradle mattresses, as well as the similar manners of sleep use between bassinets/cradles, cribs, and play yards, staff advises that similar warning requirements for after-market bassinet/cradle mattresses are appropriate and necessary. Accordingly, the NPR proposes that the warning shown in Figure 15, which is identical to the warning used in part 1241 for after-market mattresses, be required for after-market bassinet/cradle mattresses. 69 All figures with “*” denotation are reprinted, with permission, from ASTM F2194-22 ε 1 Standard Consumer Safety Specification for Bassinets and Cradles, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. A copy of the complete standard may be obtained from ASTM International, www.astm.org. Additionally, the NPR proposes that the statement “Use ONLY mattress provided by manufacturer,” appearing in the warnings for bassinets/cradles in part 1218 and in ASTM F2194-22 ε 1 , be replaced with the statement “USE ONLY one mattress at a time.” This revision communicates to consumers to only use a single mattress in the bassinet/cradle; when combined with other warning statements, the revision signals that the use of after-market bassinet/cradle mattresses is acceptable when the mattress has the appropriate fit for the bassinet/cradle; and will ensure that the warnings on bassinets/cradles are consistent with the warnings on after-market mattresses. This also addresses the potential hazard presented by after-market mattresses marketed as “mattress toppers.” EP16AP24.038 Instructional Literature Warnings —The instructional literature requirements in ASTM F2194-22 ε 1 contain multiple revisions. Many revisions are intended to ensure consistency with on-product markings and warnings and current recommendations from ASTM's Ad Hoc Language Task Group. ASTM F2194-22 ε 1 now specifies that instructions shall be in English at minimum, state that any additional instructions shall not contradict or confuse the required information or mislead the consumer, and sets formatting requirements for warnings ( e.g., font size, text alignment, safety alert symbol, bullet points for cautionary statements). Per the Ad Hoc Language Task Group's recommendations, the ASTM F2194-22 ε 1 standard uses ANSI Z535.4-2011 as reference for its warning formatting requirements. Additionally, ASTM F2194-22 ε 1 requires that instructions for battery-operated products address the following: EP16AP24.039 ASTM F2194-22 ε 1 provides that instructions for products that use more than one battery in any one circuit shall also address the following under the same CAUTION header: • Always replace the entire set of batteries at one time. • Never mix old and new batteries, or batteries of different brands or types. Additionally, ASTM F2194-22 ε 1 states that instructions are now required to address the following statements: Do not use if any part of the (manufacturer to insert type of product) is broken, torn, or missing. Additionally, ASTM F2194-22 ε 1 requires that the instructions for products constructed of cardboard must now address the following statements: Use only on a flat, dry floor. Do not place the (manufacturer to insert type of product) near a space heater, open fire or other source of strong heat. Lastly, ASTM F2194-22 ε 1 contains two example instructional literature warnings, one for bassinet/cradle products, and one for battery-powered bassinets. Figure 16 provides these two example warnings: EP16AP24.040 The Commission preliminarily determines that the instructional literature requirements in ASTM F2194-22 ε 1 are adequate and proposes to adopt these warnings provisions into the mandatory standard. VI. Incorporation by Reference The Commission proposes incorporating ASTM F2194-22 ε 1 by reference into the mandatory standard for bassinets/cradles codified in part 1218, with modifications to reduce the risk of injury associated with these products and to ensure the standard provides the highest level of safety that is feasible. The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. 1 CFR part 51. For a proposed rule, agencies must discuss in the preamble of the NPR ways that the materials that the agency proposes to incorporate by reference are reasonably available to interested persons, and how interested parties can obtain the materials. Additionally, the preamble to the rule must summarize the material. 1 CFR 51.5(b). In accordance with the OFR's requirements, section IV.A of this preamble summarizes the provisions of ASTM F2194-22 ε 1 that the Commission proposes to incorporate by reference. ASTM F2194-22 ε 1 is copyrighted. By permission of ASTM, the standard can be viewed as a read-only document during the comment period on this NPR, at http://www.astm.org/cpsc.htm. To download or print the standard, interested persons may purchase a copy of ASTM F2194-22 ε 1 from ASTM through its website ( http://www.astm.org ), or by mail from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428. Alternatively, interested parties may inspect a copy of the standard at CPSC's Office of the Secretary by contacting Alberta E. Mills, Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone: 301-504-7479; email: cpsc-os@cpsc.gov. VII. Effective Date The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). The Commission proposes a 180-day effective date for this rule. The rule would apply to all bassinets/cradles and after-market bassinet mattresses manufactured after the effective date. 15 U.S.C. 2058(g)(1). This amount of time is typical for durable infant or toddler rules promulgated under section 104 of the CPSIA. 70 Six months is also the period that the JPMA typically allows for products in their certification program to shift to a new standard once a new standard is published. Therefore, juvenile product manufacturers are accustomed to adjusting to new standards within this timeframe. 70 See, e.g., Safety Standard for Infant Swings, 77 FR 66713 (Nov. 7, 2012); Safety Standard for Crib Mattresses, 87 FR 8640 (Feb. 15, 2022). Moreover, although the NPR proposes to add requirements, the test methods and test equipment are not unique, in that other CPSC rules also use the same methods and equipment. For example, 41 third party laboratories are CPSC-accepted to test to part 1218. Eleven of 12 laboratories accepted to test to the crib mattress rule are also accredited for testing to the bassinet standard. Accordingly, the CPSC expects that these laboratories are competent to conduct the required testing and can have their International Organization for Standardization (ISO) accreditation and CPSC-acceptance updated in the normal course. The Commission invites comments, particularly from small businesses, regarding the proposed additional testing and the amount of time needed to come into compliance with a final rule. VIII. Regulatory Flexibility Act (RFA) The RFA requires that agencies review a proposed rule for the rule's potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency publishes an NPR. 5 U.S.C. 603. The IRFA must describe the impact of the proposed rule on small entities and identify significant alternatives that accomplish the statutory objectives and minimize any significant economic impact of the proposed rule on small entities. This proposed rule would have a significant economic impact on a substantial number of small U.S. entities, primarily from redesign costs in the first year that the final rule would be effective. A significant impact would occur for small companies whose products do not meet the proposed revised requirements, particularly suppliers of small bassinets and bassinet accessory products for strollers and play yards, as well as suppliers of cantilever style bassinets and after-market bassinet mattresses. Third party testing costs should not be a new significant cost for most small firms, given that bassinet suppliers should already be testing to the current mandatory standard in part 1218. However, for after-market bassinet mattress suppliers, the third party testing costs to comply with the final rule would be new, although these firms already incur costs for testing to establish compliance with other relevant CPSC regulations, including those for lead and phthalate content. A. Reason for Agency Action, NPR Objectives, Product Description, and Market Description Section I of this preamble explains why CPSC proposes to update the mandatory rule for bassinets/cradles and provides a statement of the objectives of, and legal basis for, the proposed rule. Section II of this preamble describes the types of products within the scope of the NPR, the market for bassinets/cradles, and the use of bassinets/cradles in the U.S. The requirements in the NPR are more stringent than the ASTM voluntary standard for bassinets/cradles, as described in sections IV and V of this preamble. The NPR addresses known hazards, discussed in section III of this preamble, that the current rule does not adequately address, as well as products on the market that were not common when the current rule was promulgated, such as products that resemble short play yards with canopies marketed for outdoor infant sleep. The scope of this proposed rule also includes after-market bassinet mattresses, which are not in scope of the current regulation in part 1218 or the crib mattress regulation in 16 CFR part 1241. Accordingly, the registration card already required for bassinets/cradles under section 14 of the CPSA (15 U.S.C. 2056a(d)) will now be required for after-market mattresses as well. Registration cards are exempt from PRA or RFA analysis, per section 104(d)(1) of the CPSIA. 15 U.S.C. 2056a(d)(1). B. Small Entities to Which the NPR Would Apply Section II of this preamble describes the products within the scope of the rule and an overview of the markets for bassinets/cradles and for after-market bassinet mattresses. This section XIII.B of the preamble provides additional detail on the market for products within the scope of the rule. Annual Units Sold: CPSC estimates the annual U.S. sales of new bassinets, including items with a bassinet mode or attachment, to be—rounded for the purposes of further analysis—3.1 million units per year. CPSC made this estimate using Centers for Disease Control (CDC) data on the number of newborns, 71 State Department data on adoptions from foreign countries, 72 and a survey by Statista 73 in 2017 on the estimated ownership of bassinets, play yards, and strollers, also taking into account the market for used items. 71 https://www.cdc.gov/nchs/nvss/births.htm. 72 https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/AnnualReports.html. 73 https://www.statista.com/forecasts/987681/ownership-of-baby-furniture-in-the-us. This data from 2017 is consistent with the Durable Nursery Products Exposure Survey that a contractor conducted for CPSC in 2013, which found that about 30% of families with children under age 6 owned a bassinet, cradle, or infant hammock. Specifically, CPSC estimates the total sales of new bassinets in the U.S. as the total of the sales of traditional bassinets and cradles, plus play yard bassinets, plus stroller bassinets, plus bedside sleepers with a bassinet mode, which is 3,080,942, rounded for the purposes of analysis to 3.1 million (see Table 3). While this may seem high (corresponding to roughly 80 percent of the number of newborns in the U.S. each year), it is consistent with the prevalence of multi-mode products with a bassinet mode or attachment. 74 The number of newborns is from CDC data on births and State Department data on adoptions from other countries; the data on product ownership is from the Statista survey. 75 https://www.statista.com/study/49911/baby-products-in-the-us/?locale=en. A survey by Statista in 2017 of parents with children under the age of 4. 76 https://www.statista.com/forecasts/987072/ownership-of-a-rocking-crib-amongst-parents-in-the-us. 77 A Statista report from the same survey group in 2017 found that 14 percent of parents bought a “rocking crib” second hand. CPSC assumes that the secondary market is similar for bassinets. If 14 percent of bassinet or cradle owners are used, then 86 percent are bought new. 78 Based on internet search in January 2023, seven of the top 20 best-selling play yards came with a bassinet attachment. Thus, approximately 35 percent. 79 The Statista survey also found that 17 percent of parents reported that their stroller had a “removable carrycot” feature (“bassinet” feature was not a survey item). 80 Based on a popular online general retail site in March 2023, fourteen of the top 20 best-selling beside sleepers came with a bassinet mode. Thus, approximately 70 percent. CPSC estimates the annual sales of used bassinets and products with bassinet mode to be 500,000 units per year, rounded for the purpose of analysis. Table 3 below displays the calculations, providing the sources in footnotes, for CPSC's estimation of sales for new and used bassinets and cradles. Table 3—Estimated Sales for New and Used Bassinets/Cradles Product 74 Number of newborns Families/caregivers who own this item 75 (percent) . . . and bought it new or received it new as a gift 76 77 Percentage of these items that include a bassinet (percent) Estimated annual unit new sales in scope of this rule Estimated annual unit used sales in scope of this rule (a) (b) (c) (d) (e) = (a) × (b) × (c) × (d) (f) = (a) × (b) × (1−c) × (d) Bassinet/cradle 3,666,077 38 86 percent 100 1,198,074 195,035 Play yard 66 78 35 728,303 118,561 Stroller 96 79 17 514,541 83,763 Bedside sleeper/bassinet 29 80 70 640,024 104,190 Total 3,080,942 501,549 Some families might have more than one newborn, some parents with a newborn might have separate residences, and non-parent caregivers also buy these items, so sales could be higher. However, because the expected product life and warranty for these items is typically several years, while the recommended use per infant is only five months, parents may use the same bassinet for subsequent children or obtain a used one through gift or purchase. CPSC estimates the size of the used market for all bassinet products, including products with bassinet attachments, at 501,549 units, rounded to 500,000 for the purposes of the cost analysis. CPSC assumes that at least a majority of consumers in the secondary market would choose to dispose of the used mattress and purchase a new after-market mattress. For this analysis, CPSC conservatively assumes that 75 percent of parents purchasing a used bassinet will buy a new after-market mattress. CPSC also assumes that roughly 10 percent of parents who buy a bassinet or product with bassinet attachment new will also purchase a new after-market mattress for use by a subsequent sibling, or for the same infant due to heavy soiling. Therefore, CPSC estimates the total annual market for after-market mattresses at 75 percent of the used sales (75% × 501,549 = 376,162) plus 10 percent of new sales (10% × 3,080,942 = 308,094), for a total of 684,256 units, rounded to 680,00 for the purpose of the cost analysis. The availability of hundreds of after-market bassinet mattresses online confirms that there is substantial demand for after-market mattresses, as well as a substantial volume of sales. The top seller by volume on Amazon currently sells more than 1,800 after-market bassinet mattresses per month. The Commission requests comments from the public on the estimated annual sales volume, including any information that would validate a different estimate on the rate of after-market mattress sales (number of units sold per year). While other possible outlets for bassinet and after-market bassinet mattress sales exist that are not included in this estimate (specifically, sales to hotels, daycares, and hospitals), they are likely to be minimal. Hotels generally provide a sleep space that can accommodate larger children, typically cribs or play yards without a bassinet. Similarly, daycare centers typically purchase cribs and play yards rather than traditional bassinets; and major daycare and hospitality child furniture suppliers do not sell bassinets or cradles, although daycares may use consumer grade play yards with bassinet attachments. Hospital ownership of bassinets is small, reported as only 55,085 units in 2019, 81 and hospital bassinets are medical devices regulated by the Food and Drug Administration (FDA), and thus out of scope of this NPR. 81 https://www.statista.com/statistics/824751/total-hospital-bassinet-numbers-in-the-us/. Prices and Features: Prices for traditional bassinets range from under $50 to more than $1,500, with most products in the $50 to $125 range. The least expensive products tend to be under 30 inches high and come with legs rather than a stand or base. The more expensive products tend to be larger and come with features that include canopies, motorized sounds or vibrations, attached toy bars, and pouches or shelves for storing diapers and bottles. Prices for cradles range from $100 to more than $1,000, with most products in the $100 to $200 range. Solid hardwood cradles are available for more than $1,000. Some products advertised as “rocking bassinets” are physically identical to cradles, with a curved rocker base. Combination bedside sleeper/bassinets typically sell from $75 to more than $600, with most products in the $125 to $200 range. Attachments to play yards are usually not priced or sold separately. Some stroller bassinet attachments are sold separately, with most such products in the $100 to $200 range. Play yard and stroller bassinet attachments are designed to attach to a specific model or set of models from one manufacturer, and/or to a stand sold separately by that manufacturer. The stands typically sell for $125 to $175. The wide range of prices and features reflect that parents and other caregivers buy bassinets for different purposes. Some people buy a large bassinet with a non-folding stand as a primary sleep space for the nursery, while others buy small portable items for travel, napping, or occasional care by a non-parent. No one best-selling size, price range, or set of features exists for bassinets. For example, the ten best-selling bassinets on Amazon in February 2023 ranged in price from $42 to $200 and included two small traditional bassinets that fold for transport, five bassinet/bedside sleeper combination products, two large cantilever bassinets, and an “infant lounger” with a rigid frame. Prices and features on Walmart.com had a similar variety, with prices of the ten best-selling bassinets ranging from $50 to $150. The best-selling products there included small portable bassinets, traditional bassinets on a stand that do not fold for transport, a combination bassinet/play yard, and several combination bassinet/bedside sleepers. With approximately 3.1 million new bassinets sold per year, including items with a bassinet mode, at an average price of approximately $100 per unit, CPSC estimates the total U.S. bassinet market is approximately $310 million in sales per year. This total does not include the market for used items. Based on this IRFA's estimate of approximately 500,000 used units per year (see previous section), and an estimated used price of $40 based on observed prices of used bassinets on Ebay and Mercari as a percentage of original retail prices, the used market would represent approximately $20 million dollars in sales per year. Prices for after-market bassinet mattresses range from $20 to $180, with most products in the $30 to $40 range, which is also the price range for replacement mattresses from the original bassinet supplier. The high end of the price range for after-market mattresses are hand-crafted items with a specialty fill and/or cover, such as natural rubber or organic fiber. Most after-market mattresses are sold online by small importers and foreign direct shippers. Several hundred U.S.-based crafters sell after-market mattresses that appear to have been hand-cut from upholstery foam. With a typical price of $35 and annual sales of 680,000 units per year, the after-market bassinet mattress market is approximately $23.8 million per year. Bassinet and Bassinet Mattress Suppliers: Many manufacturers and importers, as well as foreign direct shippers, supply bassinets and cradles. CPSC identified more than 120 suppliers in March of 2023, including suppliers that sell play yards or strollers with bassinet attachments. Most companies that supply bassinets also supply a variety of other infant and children's products; bassinets are typically not their only or main product line. JPMA currently has 22 member companies that are certified for bassinet/cradles, 82 including companies that manufacture or import stroller bassinets and play yard bassinet attachments, although one of the 22 does not appear to currently have any products on the U.S. market. 82 JPMA runs a certification program for members, which includes third party testing to current ASTM and CPSC standards. See https://www.jpma.org/page/certification. Bassinets and cradles are available from online general retail sites, online baby product sites, and brick and mortar general retail stores, including “big box” stores. Two brick and mortar specialty chain stores for infants and children sell bassinets. Multiple online furniture stores associated with religious communities sell traditional solid hardwood cradles made in the U.S. A few woodworkers from foreign countries sell carved wooden cradles on a prominent online site for hand-crafted items. Hundreds of suppliers, including importers and U.S.-based hand crafters, supply after-market bassinet mattresses. These products are sold almost exclusively online, although a few are available to pick up in local big box stores after ordering online. While replacement mattresses from the original supplier are also sold primarily online, a few are similarly available for pick up in a big box or children's specialty store after ordering online. Small Entities to Which the Proposed Rule Would Apply: Currently, over 120 firms supply more than 250 models of bassinets to the U.S. market. Large U.S. business and foreign businesses of all sizes constitute the majority of the suppliers of the available models. Most of the U.S.-based manufacturers and importers are small companies based on Small Business Administration (SBA) size standards. Of the identified 50 U.S-based suppliers to the U.S. market, 43 are small importers or small manufacturers, five are large U.S. manufacturers, and two are large U.S. importers. The rest of the market is foreign direct shippers 83 and foreign manufacturers. Eight foreign manufacturers have U.S. distribution/warehouse operations that would meet the SBA size standard for a small importer if considered separately. 84 83 CPSC uses this term to refer to sellers who ship directly to the consumer from an address in a foreign country. 84 The SBA regulations in 13 CFR 121.105 specify that a U.S. small business for the purposes of SBA program eligibility is “a business entity organized for profit, with a place of business located in the United States, and which operates primarily within the United States or which makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials or labor.” Consistent with this definition, CPSC considered a company to be a U.S. manufacturer if they have a headquarters and design products in the U.S., and market products with their own brand name, although production may take place overseas. Similarly, we considered a U.S. company affiliated with a foreign company, such as a licensed distributor, to be a U.S. importer if they ship from a U.S. address, because shipping from a U.S. address would require “use of American products, materials or labor.” The total number of suppliers estimated here is approximate because online third party sellers (primarily small importers and foreign direct shippers) sell a wide variety of products, and can enter and exit the market quickly. In addition, as noted, multiple online furniture stores associated with religious communities sell wooden bassinets and cradles manufactured in the U.S.; CPSC was unable to estimate how many individual small manufacturers each of these furniture distributors might represent. The SBA size standards for small entities are based on the number of employees or the annual revenue of the firm, and there is a specific size standard for each 6-digit North American Industry Classification Series (NAICS) category. 85 The U.S. Census Bureau conducts an annual survey of small businesses in the U.S. and counts how many large and small businesses are in each NAICS category. 86 85 The North American Industry Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy. For more information, see https://www.census.gov/naics/. Some programs use 6-digit NAICS codes, which provide more specific information than programs that use more general 3- or 4-digit NAICS codes. 86 https://www.census.gov/programs-surveys/susb/data/tables.html. A NAICS category specifically for bassinet manufacturing or importing does not exist. Companies that manufacture bassinets may be categorized as furniture, textile product, toy and game, or apparel manufacturers. Importers are generally considered a type of merchant wholesaler, as are furniture wholesale distributors. Other NAICS categories may apply to companies that manufacture or import bassinets, but for whom bassinets are not their main product line. As seen in the table below of applicable NAICS categories, the SBA small entity threshold for manufacturers is generally 500 to 1000 employees, while it is generally 100 to 150 employees for importers and wholesalers. Companies that manufacture or import bassinets would fit into the NAICS categories shown in Table 4. As shown in Table 4, the majority of the U.S. businesses in the applicable categories for manufacturing and importing bassinets are small businesses, and there are thousands of such small businesses. Table 4—NAICS Categories for Manufacturers and Im [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2024-07706. Public record. Not legal advice.