Safety Standard for Toys: Requirements for Water Beads, 73024-73050 [2024-19286]

Download as PDF 73024 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Paragraph 6002 Class E Airspace Areas Designated as a Surface Area. * * * * * ANM CO E2 Aurora, CO [Amended] Buckley Space Force Base, CO (Lat. 39°42′06″ N, long. 104°45′07″ W) Denver International Airport, CO (Lat. 39°51′42″ N, long. 104°40′23″ W) Centennial Airport, CO (Lat. 39°34′12″ N, long. 104°50′57″ W) That airspace extending upward from the surface to but not including 7,500 feet MSL within a 4.4-mile radius of the airport, within 2 miles northeast and 4 miles southwest of the airport’s 151° bearing extending to 7.1 miles southeast, and within 4 miles south and 4.4 miles north of the airport’s 270° bearing extending to 4.7 miles west, excluding that airspace within the Denver International Airport, CO, Class B and Centennial Airport, CO, Class D airspace areas. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement. * * * * * Paragraph 6004 Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area. * * * * * ANM CO E4 Aurora, CO [Removed] Aurora, Buckley ANG Base, CO (Lat. 39°42′06″ N, long. 104°45′07″ W) * * * * * Issued in Des Moines, Washington, August 30, 2024. B.G. Chew, Group Manager, Operations Support Group, Western Service Center. [FR Doc. 2024–20197 Filed 9–6–24; 8:45 am] BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1112 and 1250 [CPSC Docket No. CPSC–2024–0027] ddrumheller on DSK120RN23PROD with PROPOSALS1 Safety Standard for Toys: Requirements for Water Beads Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. AGENCY: The Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. This safety standard sets forth requirements SUMMARY: VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 for water bead toys and toys that contain water beads. The U.S. Consumer Product Safety Commission (CPSC) proposes to establish additional performance and labeling requirements for these products. The Commission also proposes to amend CPSC’s list of notice of requirements (NORs) to include water bead toys and toys that contain water beads. DATES: Submit comments by November 8, 2024. ADDRESSES: Submit all comments, identified by Docket No. CPSC–2024– 0027, 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. 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. CPSC typically does not accept comments submitted by email, except as described below. Mail/Hand Delivery/Courier/ Confidential Written Submissions: CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal. You may, however, submit comments by mail, hand delivery, or courier to: Office of the Secretary, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone: (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–2024–0027, into PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 the ‘‘Search’’ box, and follow the prompts. FOR FURTHER INFORMATION CONTACT: Matthew Kresse, Project Manager, Division of Mechanical Engineering, Directorate for Laboratory Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; Telephone 301–987–2222; email: mkresse@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Background and Statutory Authority Section 106(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) made ASTM International’s (ASTM) voluntary standard for toys, ASTM F963–07, Standard Consumer Safety Specification for Toy Safety (except section 4.2 and Annex 4), a mandatory safety standard for toys beginning 180 days after the enactment date of the CPSIA. 15 U.S.C. 2056b(a). The CPSIA states that ASTM F963 shall be considered a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (15 U.S.C. 2058). Since 2009, CPSC has enforced ASTM F963 as a mandatory standard for toys.1 2 In 2017, the Commission established 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, and it incorporated by reference the newly revised ASTM standard at that time, ASTM F963–16. 82 FR 8989 (Feb. 2, 2017). Most recently, on January 18, 2024, the Commission updated part 1250 to incorporate by reference a 2023 revision, ASTM F963–23. 89 FR 3344. Section 4.40 of ASTM F963–23 includes requirements for toys, including but not limited to water beads, that are made of ‘‘Expanding Materials.’’ 3 However, the requirements currently in ASTM F963–23 for this category of toys appear insufficient to address all known water bead hazards. Potential hazards for ‘‘Expanding Materials’’ in general include gastrointestinal tract blockage if a child ingests a product comprised of expanding materials. Hazard mitigation provisions in ASTM F963–23 include performance requirements, but do not include warnings or instructional literature specifically tailored to the 1 Since 2009, ASTM revised F963 five times: ASTM F963–08, ASTM F963–11, ASTM F963–16, ASTM F963–17, and ASTM F963–23 (approved August 1, 2023). 2 Section 3.1.91 of ASTM F963–23 (Toy): ‘‘Any object designed, manufactured, or marketed as a plaything for children under 14 years of age.’’ 3 Under ASTM F963, ‘‘Expanding Materials’’ are defined as ‘‘any material used in a toy which expands greater than 50% in any dimension from its as-received state.’’ E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules ‘‘Expanding Materials’’ requirements. While sections 5, 6, and 7 of ASTM F963–23 provide ‘‘Labeling Requirements,’’ ‘‘Instructional Literature’’ requirements, and ‘‘Producer’s Markings’’ requirements generally for toys under the standard, none of these requirements is directed to water beads specifically. Thus, the generalized warnings and instructional literature requirements do not address all known hazards. Incident data, described in section III of this preamble, demonstrate that children ingest water beads, aspirate and choke on them, or insert them into the nose or ear, and subsequently suffer injury or death. Staff’s testing of water beads, described in section IV of this preamble, further demonstrates that tested water beads that pass the performance requirements in ASTM F963–23 can still pose safety hazards. Accordingly, this notice of proposed rulemaking (NPR) under section 106 of the CPSIA proposes additional requirements in part 1250 to establish mandatory requirements specifically for water beads.4 Further, this NPR proposes revising the title of part 1250 from ‘‘Safety Standard Mandating ASTM F963 for Toys’’ to ‘‘Safety Standard for Toys,’’ to reflect the inclusion of proposed requirements that do not incorporate by reference existing requirements in ASTM F963.5 6 The Commission is authorized to issue this NPR pursuant to both section 106(c) and (d) of the CPSIA, 15 U.S.C. 2056b(c) and (d). Section 106(c) requires ddrumheller on DSK120RN23PROD with PROPOSALS1 4 https://www.cpsc.gov/content/FY-2024Operating-Plan. 5 On August 21, 2024, the Commission voted unanimously (5–0) to publish this NPR. 6 The information in this proposed rule is based in part on information and analysis in the July 31, 2024 Memorandum, Staff’s Draft Proposed Rule for Safety Standard for Toys: Requirements for Water Beads, available at: https://www.bing.com/ck/a?!& &p=fcf3dff1c5f81972JmltdHM9MTcyNDI4NDgw MCZpZ3VpZD0wMDlhOTVlYi01OTI3LTY wZDYtMzEzYy04MTY1NTg2ODYxNGMmaW5 zaWQ9NTIwNA&ptn=3&ver=2&hsh=3&fclid=009a9 5eb592760d6313c81655868614c&psq=Staff%e2% 80%99s+Draft+Proposed+Rule+for+Safety+ Standard+for+Toys%3a+Requirements+for+ Water+Beads&u=a1aHR0cHM6Ly93d3cu Y3BzYy5nb3YvczNmcy1wdWJsaWMvTm90a WNlLW9mLVByb3Bvc2VkLVJ1bGVtYWtpbmct UmVxdWlyZW1lbnRzLWZvci1XYXRlci1CZWF kcy5wZGY_VmVyc2lvbklkPTNreHZnemVN cElSSEphS1Eza25BNEczNnFWWjZFeVNp&ntb=1. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 the Commission to periodically review and revise its mandatory toy safety standards to ensure that such standards provide the highest level of safety for toys that is feasible. Section 106(d) further requires the Commission to examine and assess the effectiveness of its mandatory toy safety standards in protecting children from safety hazards, and then it must promulgate consumer product safety rules that are more stringent than the existing standards if the Commission determinates that more stringent standards would further reduce the risk of injury associated with such toys. Consistent with the consultation requirement in section 106(d)(1) of the CPSIA, staff has worked with the ASTM F15.22 subcommittee task group since 2009 to update the toy standard and discuss hazards associated with water beads. This consultation, including sharing staff’s assessment of hazards and suggested additional performance and labeling requirements, continued through revision and publication of ASTM F963–23. Building on staff’s continued collaboration with ASTM and in consideration of the incident data, the Commission is issuing this NPR to address four identified hazard patterns associated with water beads that are not adequately addressed by the current mandatory standard provisions addressing Expanding Materials: (1) ingestion of water beads, (2) insertion of water beads into the nose or ear, (3) aspiration due to water beads, and (4) choking due to water beads. The Commission proposes adding additional performance requirements to part 1250 to better address these risks. The NPR also proposes establishing acrylamide level limits for water beads, which may contain this toxic chemical, and implementing new testing for water beads under part 1250 to limit acrylamide in water beads in response to toxicity hazards when they enter the body. Finally, the Commission proposes labeling requirements for water beads under part 1250, including mandating warnings on products and instructional literature within scope of the rule. This NPR provides an overview of staff’s assessment and analysis, and it includes the Commission’s basis for issuing the proposed rule. For the PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 73025 reasons explained here, the Commission preliminarily determines that the proposed water bead requirements comply with section 106 of the CPSIA because they are more stringent than the current requirements in ASTM F963–23, would further reduce the risk of injury and death 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 seeks comment on these issues. II. The Product A. Description of the Product Water beads are various shaped, multi-colored or clear beads composed of water absorbing polymers, such as polyacrylamides and polyacrylates, which expand when soaked in liquid such as water. When first purchased, water beads are small and dehydrated, typically no larger than 7.0 mm diameter. The beads are often sold in large quantity packages that may contain up to thousands of beads (depending on original size) in one package. While in the dehydrated state, with all water content removed, water beads are typically either hard, solid beads, or soft-gelled beads. Water beads are designed to be soaked in water, which allows the beads to absorb the water and expand. After being soaked in water for periods as short as a few hours for smaller water beads or two to three days for larger water beads, water beads multiply in size, as demonstrated in Figure 1. Some water beads can expand, for example, from 2.0 mm diameter in their dehydrated state to 16.0 mm diameter when fully expanded (shown on the left in Figure 1), or from 7.0 mm diameter in the dehydrated state to 50.0 mm diameter when fully expanded (shown on the right in Figure 1). Thus, water beads have the potential to expand up to 800 percent of their original size. Once expanded, water beads remain moist even if removed from water but do not appear to have any adhesive properties that would cause them to stick together. When broken apart by hand or squeezing, expanded water beads tend to break into small, fragmented pieces (shown in Figure 2). E:\FR\FM\09SEP1.SGM 09SEP1 73026 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Figure 1: Water Beads, Before and After Expansion. Figure 2: Water Beads, After Being Squeezed and Breaking. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 of 72 hours, with the toy dimensions measured at 6-, 24-, 48- and 72-hour intervals in order to determine if the toy is an expanding material. CPSC proposes establishing a definition for ‘‘water bead(s)’’ under part 1250 as ‘‘various shaped, water absorbent polymers, such as, but not limited to polyacrylamides and polyacrylates, which expand when soaked in water.’’ CPSC proposes to incorporate ASTM’s process for conditioning water bead in the proposed rule test procedures. B. Scope of Products Within the NPR This NPR would apply both to water bead toys and toys that contain water beads. A toy is ‘‘any object designed, manufactured, or marketed as a plaything for children under 14 years of age.’’ 16 CFR 1250.2(a); section 3.1.92 of PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 ASTM F963–23. Water bead toys therefore are water beads marketed as a plaything for children under 14 years of age (consistent with the definition of a ‘‘toy’’ in 16 CFR 1250.2(a)), while toys that contain water beads are toys that encompass water beads within the toy and the water beads are not intended to be accessed, such as a squeeze ball (Figure 5). Commonly, water beads are included in a variety of toy products, such as toy experiment kits (Figure 3), toy sensory kits (Figure 4), toy squeeze/ sensory balls filled with water beads (Figure 5), and toy water pellet guns designed to shoot water bead projectiles (Figure 6). Each product would be subject to the proposed rule and would need to meet the requirements of a final rule. E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.008</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 Water beads are often sold in bulk or as part of other children’s toys, such as experiment kits and sensory kits, or can be contained within toy squeeze balls or stress balls. Some water beads are not marketed as children’s toys and are outside of the scope of this proposed rule. As noted, CPSC currently regulates water beads under section 4.40 of ASTM F963–23, Expanding Materials, and 16 CFR 1250.2(a). ASTM F963–23 does not define the term ‘‘water beads,’’ but it defines an ‘‘Expanding Material’’ in section 3.1.28 as ‘‘any material used in a toy which expands greater than 50% in any dimension from its as-received state when tested in accordance with 8.30.’’ Section 8.30 directs that the toy must be submerged in deionized water maintained at 37 °C ± 2 °C for a duration Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules 73027 Figure 3: Toy Experiment Kit. Figure 4: Toy Sensory Kit. Figure 6: Toy Water Bead Pellet Gun. Examples of products outside of the scope of this proposed rule are water beads that are not toys or are not contained in toys and are for various VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 non-toy uses, such as water beads used for decorative purposes (e.g., placement in candle holders), in vases or gardens for plant hydration, as air freshener PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 products or deodorizers for cat litter, and in first-aid cold packs. E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.009</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 Figure 5: Toy Squeeze/Sensory Ball. 73028 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules III. Incident Data and Hazard Patterns CPSC staff searched two CPSCmaintained databases to identify incidents and hazard patterns associated with water beads: the Consumer Product Safety Risk Management System (CPSRMS) 7 and the National Electronic Injury Surveillance System (NEISS).8 9 Due to data availability, the CPSRMS incidents occurred between January 1, 2017, and December 31, 2023, while the NEISS incidents occurred between January 1, 2017, and December 31, 2022. A. CPSRMS Data ddrumheller on DSK120RN23PROD with PROPOSALS1 From 2017 through 2023, CPSC identified 64 incidents in CPSRMS associated with the use of water beads. One incident resulted in a fatality, while 27 incidents led to hospitalization; 15 incidents led to emergency department (ED) treatment; and seven incidents led to care by a medical professional. The remaining 14 incident reports noted possible but uncertain medical treatment, or the level of care was unreported. Of the reported incidents that indicate a child’s age, children’s ages range from 9 months old to 11 years old, with one incident involving a 22-year-old woman with special needs. 7 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 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. 8 NEISS is the source of the injury estimates; it is a statistically valid injury surveillance system. NEISS injury data are gathered from emergency departments of a sample of hospitals, with 24-hour emergency departments and at least six beds, selected as a probability sample of all U.S. hospitals. The surveillance data gathered from the sample hospitals enable CPSC to make timely national estimates of the number of injuries associated with specific consumer products. 9 CPSC staff performed multiple searches consisting of a combination of product codes and narrative or manufacturer/model keyword searches to find water bead incidents. Staff extracted data coded under 1381 (Toys, not elsewhere classified), 1395 (Toys, not specified), 1413 (Greenhouse supplies or gardening supplies [excluding plant stands, tools, hoses, sprayers and chemicals]), 1616 (Jewelry [excluding watches]), 1682 (Hair curlers, curling irons, clips & hairpins), 5016 (Balls, other or not specified), 5020 (Pretend electronics, tools, housewares, and appliances), 9101 (No clerical coding—retailer report), and 9102 (No clerical coding—retailer report). VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 Staff identified the following incident data hazard patterns. 1. Ingestion In 52 reported incidents, a child ingested or likely ingested at least one water bead.10 Of those reports, 47 incidents involved a child ingesting at least one water bead, while five incidents involved a likely ingestion. Where reported, children between the ages of 9 months old and 5 years old ingested or likely ingested the water beads. Incidents included one death, 23 hospitalizations, 12 ED treatments, four visits to a medical professional, and 12 instances where the level of care was uncertain. The fatality involved a child swallowing at least one water bead. Specifically, in CPSC In-Depth Investigation (IDI) 11 230727CBB1846, a 10-month-old female was discovered unresponsive after consuming at least one water bead. The medical examiner determined that the child died from complications after a water bead expanded and caused a small intestine obstruction.12 In 22 reported incidents, an ingested water bead caused a bowel obstruction because the water bead expanded to a size that did not naturally pass through the gastrointestinal tract. After ingestion, water beads do not remain in the stomach for an extended period, which limits the potential for the water bead to expand in the stomach. Water beads can expand fully once they pass from the stomach and into the small intestine because water beads remain in the small intestine for a longer period and are able to absorb liquid like the water in which they are designed to absorb and expand. After expansion, water beads can become too large to pass from the small intestine to the large intestine and instead form a bowel obstruction. Swallowing a water bead presents different hazards than swallowing a smooth, solid object such as a marble because an object like a marble will not grow after being swallowed. Marbles and other smooth, solid objects can frequently also be located and identified by x-ray due to their density, unlike water beads, as discussed further below. Once located, marbles can be removed endoscopically if reported early enough, especially if they appear to be too large to pass through the stomach or the remainder of the digestive track, whereas water beads can remain small within the stomach and then grow larger, then causing a small bowel obstruction. Vomiting and coughing are commonly reported initial symptoms that occur after a water bead is first ingested.13 Lethargy, distress, dehydration, loss of appetite, fever, fatigue, and abdominal pain are also reported when an expanded water bead blocks the small intestine. Medical providers may misdiagnose water bead ingestion symptoms because the symptoms are ambiguous and may be attributable to medical conditions or sources other than water bead ingestion, such as gastrointestinal illness. Further, caregivers may be unaware a child ingested a water bead and, therefore, are unable to report the ingestion. Children commonly visit medical care providers multiple times before diagnosis of a water bead ingestion. For example, in IDI 220511HCC3859, a 14-month-old female was initially diagnosed with gastrointestinal illness after episodes of vomiting. The child was taken first to a pediatrician and then to a local ED where she was treated with intravenous fluids and released. Only after the child was taken to a second ED once her condition worsened was it discovered that she had ingested a water bead.14 In some cases, small water beads pass naturally, as can be the case when other small foreign objects are ingested, such as coins and small toy parts.15 For example, in IDI 230707CBB1698, a 3year-old female ingested approximately 1,200 small water beads (approximately 1 tablespoon before expansion). The child successfully passed all water beads through her digestive system with the aid of a mineral oil enema.16 Medical providers may also not know that ingested water beads can cause 10 In several cases where a child likely ingested water beads, a caregiver saw a child put a water bead in his or her mouth, yet the presumably ingested water bead was not found. The water bead could have passed naturally, or the child never swallowed the water bead. Still, medical intervention had been sought in some incidents. 11 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. 12 Water bead obstruction was measured to be ‘‘approximately 2.8 x 2.8 x 2.8 cm [or 28 x 28 x 28 mm].’’ 13 Forrester MB. Pediatric Orbeez Ingestions Reported to Texas Poison Centers. Pediatr Emerg Care. 2019 Jun;35(6):426–427. doi: 10.1097/ PEC.0000000000001227. PMID: 28697162. 14 Size of expanded water bead not provided. Samples of the product showed full expansion being between 45 mm and 50 mm in diameter. 15 Mehmetoğlu F. A Retrospective 10-Year Analysis of Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May 6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID: PMC5960561. 16 Size of expanded water beads not provided. However, samples of the product that staff collected for testing shows full expansion being between 9.32 mm and 15.20 mm in diameter. PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 bowel obstructions. Therefore, although a medical provider is aware that a child ingested a water bead, they may send a patient home to digest or naturally pass the water bead, not knowing that may be impossible and the ingestion may result in injury or death. Water beads that do not pass naturally through the digestive tract can sometimes be removed by endoscopy or colonoscopy. However, such medical procedures routinely require sedation or general anesthesia, which carry risks of side effects and complications. For example, in IDI 230613CBB1591, a 2-year-old male swallowed at least two water beads and was examined and released from an ED without intervention. The child was later admitted to a different hospital where a water bead was removed via endoscopy. The child required a third hospital visit to remove a second water bead via colonoscopy.17 Water beads that do not pass naturally or cannot be removed can result in small bowel obstructions. Children experiencing a small bowel obstruction have required invasive exploratory laparotomy with small intestine enterotomy 18 under general anesthesia to remove any ingested water beads. For example, in IDI 170802CCC3140, a 13month-old female became ill after ingesting a water bead. The water bead expanded in her small intestine, causing a blockage. She was transported to a hospital where the water bead was surgically removed under general anesthesia with an exploratory laparotomy and enterotomy.19 A delay between the time a caregiver or medical provider discovers that a child has ingested a water bead and when the child receives appropriate medical treatment may increase the risk of severe injury or death. Prompt recognition that a child has ingested a water bead enables swift medical treatment and removal of the water bead before the water bead expands, causing gastrointestinal blockages. However, due to the small size of individual water beads, caregivers may not know that a child has swallowed a water bead, so early intervention may not be possible. Even after a child begins to receive medical care, medical providers may have difficulty locating an ingested water bead inside the body because 17 Size of expanded water beads not provided. 18 An exploratory laparotomy is a general surgical operation where a surgeon opens the abdomen and examines the abdominal organs. This is coupled with a small intestine enterotomy, which is a surgical incision to the intestine wall to remove the foreign body. 19 Size of expanded water bead not provided. Samples of the product that staff collected for testing shows full expansion being between 13.0 mm and 17.50 mm in diameter. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 water beads are radiolucent.20 Radiolucent water beads are not easily identified using routine x-ray radiography because they are not dense, appearing dark or black and almost entirely transparent when the x-ray beam passes through the bead. Incident data and medical literature report children requiring serial x-rays, computer tomography (CT) scans, and ultrasounds to accurately diagnose a water bead bowel obstruction.21 Other possible medical outcomes that can occur from a child ingesting water beads include surgery site infection, sepsis, extended hospital stays, and follow up surgeries. For example: • In IDI 221107CFE0002, a 9-monthold child required five surgeries to remove the small bowel obstruction and treat complications from the initial surgery.22 • In IDI 220701HFE0002, a 14-monthold child required a second surgery and a small bowel resection at the site of the previous enterotomy after the initial surgery failed to remove all ingested water beads.23 When reviewing the incident data and conducting laboratory testing, CPSC staff has not identified evidence of water beads sticking together once fully expanded within the gastrointestinal tract to form a congealed water bead mass that is more difficult to pass than individual beads. In an effort to diligently address all potential water bead ingestion hazards, though, CPSC is requesting comment on whether any toy water bead products present adhesive properties that would allow water beads to stick together. 2. Ear Insertion CPSRMS contains five reports of victims presenting with water beads in the ear canal. All five of the incidents required medical intervention, while two of the five incidents required hospitalization. When reported, children’s ages ranged from 3 years old to 9 years old. One incident involved a 22-year-old woman with special needs. Ear canal insertions are not uncommon for healthcare providers to treat in hospital EDs. Common inserted objects include plastic beads, small toy parts, pebbles, and pieces of food. Many 20 Radiolucent is defined as being transparent to x-rays. 21 Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of ingested water beads diagnosed with point-of-care ultrasound. Clin Exp Emerg Med. 2020 Dec;7(4):330–333. doi: 10.15441/ceem.20.041. Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832. 22 The IDI confirms that ‘‘[m]edical imaging revealed a 2.4 cm [or 24 mm] foreign object blockage.’’ 23 Size of expanded water beads not provided. PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 73029 such cases are evaluated, then treated with irrigation or suction of the ear canal, or using surgical instrumentation, such as forceps or hooks.24 However, it is uniquely challenging to remove water beads from the ear canal.25 For example, water beads should not be removed using irrigation because exposure to water may cause the beads to expand. Medical providers may attempt to remove water beads with tools, but water beads can break during a removal attempt or if a removal attempt fails. Under those circumstances, surgery under sedation or general anesthesia may be necessary to remove water bead fragments. Further, because water beads are radiolucent (i.e., transparent to xrays) and thus difficult for medical providers to locate and identify, confirmation that a water bead is in the ear canal before attempting removal is difficult. Although medical providers can typically see that something is in the ear canal, x-ray or other imaging technology such as a CT scan are often used to attempt to confirm the object in the ear canal is in fact a water bead, as opposed to a cyst or other object. Because water beads can be difficult to identify on x-rays and the symptoms are ambiguous, cases of insertions into the ear canal have been misdiagnosed as ear infections and treated with topical antibiotics, which can lead to enlargement of the bead and further damage to the ear canal. For similar reasons regarding enlargement, irrigation efforts should be avoided. Early diagnosis of a suspected water bead insertion is critical for a good health outcome because water beads are highly damaging when they expand into middle ear structures.26 Young children or patients with certain special needs may not be able to communicate well 24 Lotterman S, Sohal M. Ear Foreign Body Removal. [Updated 2022 Nov 28]. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https:// www.ncbi.nlm.nih.gov/books/NBK459136/; Svider PF, Vong A, Sheyn A, et al. What are we putting in our ears? a consumer product analysis of aural foreign bodies. Laryngoscope. 2015;125(3):709–714. doi:10.1002/lary.24935.PubMedGoogle ScholarCrossref. 25 Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of Emergency Medicine, ISSN: 0736–4679, Vol: 56, Issue: 6, Page: e115-e117. 2019; Sterling M, Murnick J, Mudd P. Destructive Otologic Foreign Body: Dangers of the Expanding Bead. JAMA Otolaryngol Head Neck Surg. 2016;142(9):919–920. doi:10.1001/ jamaoto.2016.1870; Zalzal HG, Ryan M, Reilly B, Mudd P. Managing the Destructive Foreign Body: Water Beads in the Ear (A Case Series) and Literature Review. Annals of Otology, Rhinology & Laryngology. 2023;132(9):1090–1095. doi:10.1177/ 00034894221133768. 26 The middle ear is the portion of the ear that is responsible for transferring acoustic energy to the inner ear. E:\FR\FM\09SEP1.SGM 09SEP1 73030 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules enough to explain that a water bead is lodged in their ear, which leads to delayed diagnosis and a poor treatment outcome. For example, in I2410042A, a 22-year-old female with special needs visited multiple healthcare facilities before diagnosis of a water bead ear insertion.27 Once a water bead expands into the middle ear structure, children can experience ear pain, damage to ear structures, and hearing loss. For example, in IDI 210421HCC1751, a 5year-old female’s ear drum was injured after a water bead expanded in her ear canal.28 Similarly, a case report identifies a 4-year-old female who sustained a small ear drum perforation. The perforation was subsequently repaired during a follow up operation.29 Long-term or permanent hearing loss is possible after a water bead is inserted into the ear canal. For example, in IDI 230613CBB1590, a 3-year-old female reported ear pain for several days. She was initially presumed to have an ear infection and was treated with antibiotics. Thereafter, she began having seizures and was hospitalized. A water bead was removed from her middle ear after it expanded and ruptured the right ear drum.30 The child experienced ongoing seizures, hearing loss, and ear pain at least 14 months after the incident. Another case report describes a 10-year-old female who suffered permanent hearing loss after a water bead remained in her ear canal for at least 10 weeks.31 3. Nose Insertion Four injury incident reports identify children presenting with water beads in the nasal passage. One incident involved a required hospitalization. When a child’s age was reported, ages ranged from 3 years old to 11 years old. Water beads can cause severe tissue damage to the nasal mucosa 32 if left in the nasal cavity for prolonged periods of time, such as days or weeks.33 While it is not uncommon for children to insert foreign bodies into nasal cavities, 27 Size of expanded water bead not provided. of expanded water bead not provided. 29 Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of Emergency Medicine, ISSN: 0736–4679, Vol: 56, Issue: 6, Page: e115–e117. 2019. 30 The IDI confirms that the ‘‘[g]randmother described the extracted water bead as being the size of a pea.’’ 31 Schulze SL, Kerschner J, Beste D. Pediatric external auditory canal foreign bodies: a review of 698 cases. Otolaryngol Head Neck Surg. 2002 Jul;127(1):73–8. doi: 10.1067/mhn.2002.126724. PMID: 12161734. 32 The tissue that lines the nasal cavity. 33 Han S, Chen Y, Xian X, Teng Y. BMC Pediatrics (2021) 21:273 https://doi.org/10.1186/s12887-02102740-x. ddrumheller on DSK120RN23PROD with PROPOSALS1 28 Size VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 children may display significant symptoms from water beads that are not experienced after inserting other objects, such as pieces of food, into the nose. Water bead nasal cavity insertion symptoms include nasal congestion, bleeding, fever, runny nose, and nasal swelling. Because these symptoms can be related to many other causes, caregivers or doctors may not realize that they are due to water beads. While it may be possible to remove a water bead from a nasal cavity without professional medical intervention or for a water bead to pass naturally, children may still experience symptoms and negative side effects after water beads expand in the nose. For example, in I18C0277A, a 3-year-old male was eventually able to blow out a water bead that had been in his nose for up to two weeks.34 The child had not told his parents he had inserted the water bead into his nose, but the parents later described the child as having had a nosebleed, trouble sleeping, congestion, a small tear in the nasal cavity, and a low-grade fever lasting three days. Some water bead nose insertions require medical intervention to remove the water bead, sometimes using nasal endoscopy under general anesthesia or sedation.35 For example, in IDI 180104CBB1236, a 4-year-old male was placed under general anesthesia at a local hospital and underwent a nasal endoscopy. The child inserted an unknown number of water beads into his nose. He was successful in blowing out most of the water beads, but a nasal endoscopy revealed a single water bead in the nasal passages. Removal was unsuccessful due to bleeding, so the child was placed under general anesthesia to remove the remaining water bead.36 4. Aspiration Aspiration is the entry of a foreign body, excess saliva, food, or stomach contents from the upper respiratory tract into the lower respiratory tract, which includes the trachea, bronchi, bronchioles, and lungs. Two reported incidents of aspiration involved a child swallowing and inhaling a water bead that then entered and blocked the child’s airway. One incident required ED treatment and the other required hospitalization. Sudden inhalation of small objects can cause aspiration into the respiratory tract.37 Depending on the object’s size, 34 Size of expanded water bead not provided. 35 Id. 36 Size of expanded water bead not provided. O., Ebeid, A.M, Motaweh, M.M., Kleibo, I.S. Aspirated foreign bodies in the 37 Abdulmajid, PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 aspirated foreign bodies tend to pass through the trachea and bronchi mainstream and lodge in areas of the tracheobronchial tree.38 If a water bead becomes lodged in a child’s upper airway, particularly after expansion, the child may experience airway obstruction or acute respiratory distress, which may be fatal. Examples of aspirations include: • In I2310047A, a 20-month-old male aspirated a water bead, which obstructed his airway, necessitating medical intervention.39 • In IDI 201130CCC3196, an 18month-old male aspirated water beads, which led to an airway obstruction. The child was admitted to the hospital for a bronchoscopy 40 under general anesthesia, where several water beads were removed from his airway.41 When a child aspirates a water bead, the initial symptoms range from minor initial choking spells, coughing, or wheezing, to unconsciousness as the water bead obstructs more of the airway for a longer period of time, resulting in the child being unable to breathe and transmit oxygen to the brain. Death versus injury to the child after a water bead aspiration is dependent upon the degree of bronchial obstruction and the time interval between inhalation and extraction of the water bead. Early diagnosis of water bead aspiration allows for a greater likelihood of successful removal and better potential treatment outcome because the water bead may not have yet expanded. Because water beads are radiolucent, they can be difficult to locate within the body and thus difficult to remove, tracheobronchial tree. Thorax 31:365–640, 1976; Aytac, A. Ikizler, C. Inhalation of foreign bodies in children. J. Thoracic & Cardiovasc. Surgery 74(1):145–151, 1977; Blazer, S. Naveh, Y., Friedman, A. Foreign body in the airway—a review of 200 cases. Am. J. Diseases of Children 134(1):68– 71, 1980; Cohen, S.R., Herbert, W.I. Lewis, G.B. Geller, K.A. Foreign bodies in the airway—five-year retrospective study with special reference to management. Ann. Otol. 89:437–442, 1980. 38 The tracheobronial tree is composed of the trachea, the bronchi, and the bronchioles that transport air from the environment to the lungs for gas exchange. 39 Size of expanded water bead not provided. 40 A bronchoscopy is an endoscopic technique to visualize the inside of the airways for diagnostic and therapeutic purposes. 41 IDI included a photo of an expanded water bead from the toy alongside a dime coin to reflect the bead’s approximate size. While the expanded sizes of the removed beads are unknown, the mother provided a photo of before and after expansion in water. The photo shows an expanded bead with a diameter about the size of a dime, and much larger than an unexpanded bead next to it. As discussed in section IV of this preamble below, limiting the expansion potential of water bead toys to no more than 50 percent of the original size will help reduce damage from aspiration. E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules particularly when the airway obstruction is not complete. 5. Choking One reported incident identified that a child had choked on a water bead. Choking occurs when a foreign body fully or partially obstructs the airway to compromise oxygen supply to the lungs.42 Physical characteristics of objects that pose a choking hazard include, for example, large size, round shape, and smooth texture. The hazard pattern for choking does not depend upon expansion after the water bead enters the body. Caregivers commonly place water beads in water for prolonged periods of time so the beads can fully expand in advance of a child’s playtime. For example, in IDI 180104CBB1236, the child’s father placed a number of water beads in water so that they ‘‘would grow and be ready to use in the morning.’’ Children may then attempt to swallow the expanded beads. Large, expanded water beads pose a significant choking hazard because they are spherical objects, which can easily roll to the back of the throat and form an air-tight seal with the elastic lining of the airway, thereby causing a complete blockage of the air way and inability to breath.43 The throat muscles can contract and tightly grip a water bead, which can make removal difficult without medical intervention. If an object completely obstructs the airway at or above the level of the trachea, the rapid loss of oxygen to body tissues can cause irreversible brain damage or death within minutes. If the airway is not completely blocked, the gag reflex will force the object to the back of the throat (the opposite of swallowing) and the cough reflex will bring in air to force the object from the airway in response to choking. B. National Injury Estimates From NEISS ddrumheller on DSK120RN23PROD with PROPOSALS1 Based on NEISS data, CPSC estimates 6,300 injuries (sample size = 250, coefficient of variation = 0.27) related to water beads were treated in U.S. hospital EDs over the six-year period from 2017 through 2022.44 Of the 250 42 Baker, S.P. Childhood asphyxiation by choking or suffocation. JAMA 244(12):1343–1346, 1980. 43 Chang DT, Abdo K, Bhatt JM, Huoh KC, Pham NS, Ahuja GS. Persistence of choking injuries in children. Int J Pediatr Otorhinolaryngol. 2021 May;144:110685. doi: 10.1016/j.ijporl.2021.110685. Epub 2021 Mar 21. PMID: 33819896; Hayes NM, Chidekel A. Pediatric choking. Del Med J. 2004 Sep;76(9):335–40. PMID: 15510972. 44 The estimated injuries for this NPR are less than the estimate presented in the public guidance on water beads that can be found on the Commission’s website at https://www.cpsc.gov/ Safety-Education/Safety-Education-Centers/Water- VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 sample NEISS cases, none were fatal. About 42 percent of the estimated injuries involved children ages 2 through 4 years old, while about 15 percent of the estimated injuries involved children under the age of 2 years old. The youngest child was 7 months old. Forty-one (41) percent of those injured were male, while 59 percent were female. Regarding patient disposition, 95 percent were treated at the hospital ED and released; 3 percent were held for observation; 2 percent were admitted for hospitalization; and less than 1 percent left the hospital without care. The following hazard patterns were identified: • Ingestion (48 percent): the reports stated that the child ingested or swallowed a water bead, possibly ingested a water bead, or had put a water bead in his or her mouth. In all sample cases, the youngest child was 7 months old. Three (3) percent of all estimated injuries due to water bead ingestion involved hospitalizations. • Ear insertion (36 percent): the reports stated that the child either inserted a water bead into their ear or presented with a water bead stuck in the ear with uncertainty as to how the water bead became inserted. In all sample cases, the child was between the ages of two and 15 years old. • Nose insertion (15 percent): the reports stated that the child either inserted the water bead into their nose or presented with the water bead stuck in the nose with uncertainty as to how the water bead became inserted. In all sample cases, the child was between the ages of two and 10 years old. • Other (<1 percent): the remaining reports identified one injury from aspiration and one from eye insertion. C. Overview of Hazards in Relation to Child Supervision and Behavior Water bead ingestion, nasal and ear insertion, choking and aspiration can occur in seconds. Many incidents are not witnessed because the caregiver was not directly looking at the child when the ingestion, insertion, initial choking or aspiration occurred. Research indicates that toddlers and preschoolers (ages 2 years old through 5 years old) are out of view of a supervisor for about 20 percent of their awake time at home and are not within visual or hearing Beads-Information-Center#:∼:text=CPSC%20urges %20parents%20and%20caregivers, seek%20medical%20treatment%20right%20away. The difference is mainly due to the NPR excluding incidents with hazard patterns related to rashes or other allergic reactions and incidents involving water bead gel blaster projectiles, which commonly involve eye injury and some of which may not involve children’s toys in the scope of this proposed rule. PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 73031 range for about 4 percent of awake time at home.45 A study of 100 parents found that the mean amount of time parents were willing to leave a child unsupervised in low-risk areas, such as a living room, was six minutes before the child was old enough to crawl and four minutes after the child was old enough to crawl, before the child was 2 years old.46 Consumers reasonably may not know water beads are hazardous, particularly because they are marketed for children’s play. Research demonstrates that infants and toddlers are likely to mouth objects within reach. Mouthing of non-food items is a normal part of children’s exploratory behavior that contributes to incidents of choking and poisoning.47 This behavior is part of the reason for the ban on small parts for toys intended for children younger than 3 years of age, for example, and the mandatory smallparts warning for toys and games intended for children ages 3 years old to 6 years old. 16 CFR part 1501. Mouthing non-food items tends to decrease as a child’s age increases; however, it is not uncommon for children over the age of 3 years old to experience choking or ingestion episodes with objects other than food.48 Children are prone to ingest or insert small, smooth, colorful objects, like water beads or toy parts.49 Unintentional foreign body ingestion is a leading causes for nonfatal ED visits in children younger than 9 years old.50 45 Morrongiello, B. A., Corbett, M., McCourt, M., & Johnston, N. (2006). Understanding unintentional injury-risk in young children I. The nature and scope of caregiver supervision of children at home. Journal of Pediatric Psychology, 31(6): 529–539. 46 Garzon, D.L., Lee, Dr. R.K., and Homan, S.M. (2007) ‘‘There’s No Place Like Home: A Preliminary Study of Toddler Unintentional Injury.’’ Journal of Pediatric Nursing, 22, 368—375. 47 Tulve, N., Suggs, J., McCurdy, T., Cohen-Hubal, E., & Moya, J. (2002). Frequency of mouthing behavior in young children. Journal of Exposure Analysis and Environmental Epidemiology. 12, 259–264. 48 A-Kader. (2010) Foreign body ingestion: children like to put objects in their mouth. World J Pediatrics, Vol 6 No 4 . November 15, 2010. www.wjpch.com; Orsagh-Yentis D, McAdams RJ, Roberts KJ, et al. (2019). Foreign-Body Ingestions of Young Children Treated in US Emergency Departments: 1995–2015. Pediatrics. 143(5):e20181988; Reilly, J. (1992, Fall). Airway Foreign Bodies: Update and Analysis. Int Anesthesiol Clin.30(4):49–55; Altman, A., OzanneSmith, J. (1997). Non-fatal asphyxiation and foreign body ingestion in children 0–14 years. Injury Prevention. 3:176–182. 49 Svider, P.F., Vong, A., Sheyn, A., Bojrab, D.I., Hong, R. S., Eloy, J.A., and Folbe, A.J. (2015). What are we putting in our ears? A consumer product analysis of aural foreign bodies. The Laryngoscope. 125, 709–714; Heim, SW, & Maughan, K.L. (2007). Foreign Bodies in the ear, nose, and throat. American Academy of Family Physicians, 76, p.1186–1189. 50 Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting E:\FR\FM\09SEP1.SGM Continued 09SEP1 73032 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Management and treatment for childhood accidental ingestion is well documented in pediatric medical literature.51 D. Availability of Incident Data Upon publication of this NPR in the Federal Register, CPSC staff will make available for review and comment the CPSRMS and NEISS incident reports relied upon and discussed in the NPR, to the extent allowed by applicable law, along with the associated IDIs. The data will be made available by submitting a request to: https://forms.office.com/g/ gSZi1gHic8. You will then receive a website link to access the data at the email address you provided. If you do not receive a link within two business days, please contact mkresse@cpsc.gov. E. Recalls From December 2012 through March 2024, the Commission’s Office of Compliance and Field Operations conducted five recalls and issued two unilateral press release warnings 52 regarding water bead products. Table 1 below summarizes the seven announcements, including the announcement date, firm/brand, hazard(s), approximate number of units affected, number of reported incidents/ injuries, and press release number. The announcements involved one death and five reported injuries, and affected approximately 166,000 units. ddrumheller on DSK120RN23PROD with PROPOSALS1 TABLE 1—SUMMARY OF WATER BEAD ANNOUNCEMENTS Number of affected units Announcement date Firm/brand Hazard December 17, 2012 .... July 31, 2013 .............. September 10, 2013 ... December 12, 2013 .... September 14, 2023 ... Dunecraft Inc .............. Be Amazing! Toys ...... Eco-Novelty Corp ....... Doodlebutt .................. Buffalo Games, Inc ..... March 19, 2024 .......... Jangostor Brand ......... March 19, 2024 .......... Tuladuo Brand ............ Serious Ingestion Hazard ................................ Serious Ingestion Hazard ................................ Serious Ingestion Hazard ................................ Serious Ingestion Hazard ................................ Serious Ingestion, Choking and Obstruction Hazards. Chemical Toxicity Hazard—Violation of Federal Ban of Hazardous Substances. Chemical Toxicity Hazard—Violation of Federal Ban of Hazardous Substances. Number of incidents (injuries & deaths) 53 Press release No. 94,799 14,200 3,500 1,500 52,000 1 incident (1 injury, 0 deaths) ....... None Reported ............................. None Reported ............................. None Reported ............................. 2 incidents (1 injury, 1 death) ....... 54 13–071 Unknown 2 incidents (2 injuries, 0 deaths) .. 59 24–163 Unknown 1 incident (1 injury, 0 deaths) ....... 60 24–162 55 13–254 56 13–278 57 14–056 58 23–286 IV. Review of Voluntary Standards— ASTM F963 and EN 71–1 ASTM F963 includes performance requirements and test methods for toys, as well as requirements for warning labels and instructional literature, to reduce or prevent injury to children or death of children from mechanical, chemical, and other hazards associated with toy use. Toys must comply with this standard pursuant to 16 CFR part 1250. ASTM F963 defines ‘‘Expanding Materials’’ as ‘‘any material used in a toy which expands greater than 50% in any dimension from its as-received state.’’ Section 4.40 of ASTM F963–23 addresses potential hazards associated with expanding materials by requiring that toys and removable components of toys composed of expanding materials which, first, fit entirely within a small parts cylinder while in the toy’s asreceived size condition, then must, after expansion, completely pass through a 20.0 mm diameter gauge while applying a force of up to 4.5 lbf (pound-force). Water beads that expand up to 20.0 mm diameter would meet the ASTM F963–23 ‘‘Expanding Material’’ requirements because they would pass through the gauge, but water beads larger than 20.0 mm diameter would likely fail the requirements because the water beads would fragment once force is applied, as described below in more detail. Yet, as explained in section III of this preamble, incident data show that water beads both larger and smaller than 20.0 mm diameter are hazardous. Another voluntary standard used primarily in the European Union, EN 71–1, Safety of Toys—Part 1: Mechanical and Physical Properties, also provides requirements for expanding materials. Section 3.24 of EN 71–1 defines an ‘‘expanding material’’ as a ‘‘material, the volume of which expands when exposed to water.’’ Section 4.6 of EN 71–1 establishes performance requirements for expanding materials in toys or components of toys which fit entirely in a 31.7 mm diameter small parts cylinder, the same size as CPSC’s small parts cylinder reflected in Figure 9 below, and states they shall not expand more than 50 percent in any dimension when measured after being submerged in demineralized water for 24, 48 and 72 hours. If the expansion in any dimension is more than 50 percent, then the toy does not comply with the expanding material requirement. For example, water beads with an unexpanded diameter of 2.0 mm and expand larger than 3.0 mm diameter would pass through the small parts cylinder in their dehydrated state but expand by more than 50 percent, thus failing the EN 71–1 requirements. Additionally, EN 71–9, Safety of Toys— System (WISQARS) [Online]. (2003). National Center for Injury Prevention and Control, Centers for Disease Control and Prevention. Available from: URL: www.cdc.gov/ncipc/wisqars. [10/1/2022]. 51 Kay, M., & Wyllie, R. (2005). Pediatric foreign bodies and their management. 7(3):212–8; Lee, J.H., (2018) Foreign Body Ingestion in Children. Clinical Endoscopy, 51:129–136; Kramer et al., 2015; Conners GP,& Mohseni M. Pediatric Foreign Body Ingestion. [Updated 2021 Jul 18]. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https:// www.ncbi.nlm.nih.gov/books/NBK430915/— (accessed 4/12/22) Pediatric Foreign Body Ingestion—StatPearls—NCBI Bookshelf (nih.gov). 52 A unilateral press release is a product-related safety warning issued by CPSC that is not issued jointly with a recalling company. 53 When the 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. 54 https://www.cpsc.gov/Recalls/2012/dunecraftrecalls-water-balz-skulls-orbs-and-flower-toys-dueto-serious-ingestion. 55 https://www.cpsc.gov/Recalls/2013/BeAmazing-Toys-Recalls-Monster-Science-and-SuperStar-Science-Colossal-Water-Balls. 56 https://www.cpsc.gov/Recalls/2013/EcoNovelty-Recalls-Jumbo-Size-and-JumboMultipurpose-Cosmo-Beads-Toys. 57 https://www.cpsc.gov/Recalls/2014/DoodlebuttRecalls-Jelly-BeadZ-Jumbo-BeadZ-and-MagicGrowing-Fruity-Fun-Toys. 58 https://www.cpsc.gov/Recalls/2023/BuffaloGames-Recalls-Chuckle-Roar-Ultimate-WaterBeads-Activity-Kits-Due-to-Serious-IngestionChoking-and-Obstruction-Hazards-One-InfantDeath-Reported-Sold-Exclusively-at-Target. 59 https://www.cpsc.gov/Newsroom/NewsReleases/2024/CPSC-Warns-Consumers-toImmediately-Stop-Using-Jangostor-Water-BeadsDue-to-Chemical-Toxicity-Hazard-Violation-ofFederal-Ban-of-Hazardous-Substances-Sold-onAmazon-com. 60 https://www.cpsc.gov/Newsroom/NewsReleases/2024/CPSC-Warns-Consumers-toImmediately-Stop-Using-Tuladuo-Water-Bead-SetsDue-to-Chemical-Toxicity-Hazard-Violation-ofFederal-Ban-of-Hazardous-Substances-Sold-onAmazon-com. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 73033 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Part 9: Organic Chemical Compounds— Requirement 61 provides a test method and a concentration limit for a potentially hazardous chemical, called acrylamide, in toys. The EN standard states that the acrylamide concentration limit has been ‘‘calculated based on long-term licking, sucking and chewing of toys that are intended or likely to be mouthed for a significant amount of time. Examples are teethers, rattles and other hand-held soft plastic toys for young children.’’ Acrylamide limitations in EN 71–9 were developed to address acrylamide exposure following long-term licking, sucking and chewing of toys that are intended to be mouthed. In contrast, water bead toys addressed in this NPR are not intended to be mouthed, nor are they likely to be mouthed for a significant amount of time. The hazards this NPR works to address are ingestion, insertion, choking, and aspiration, not mouthing. Therefore, CPSC staff proposes mandating a different acrylamide limit and test method, intended to address the hazards outlined in the NPR, which is discussed in section V of this preamble. A. Assessment of Current ASTM F963– 23 Performance Requirements The test method for ‘‘Expanding Materials’’ described in section 8.30, Expanding Materials—Test Method of ASTM F963–23 requires that an expanding material, such as a water bead, first be submerged in deionized water for up to 72 hours in order to reach its largest expansion size. The product is then tested to check whether, at its largest expanded size, the water bead can pass through a gauge with a 20.0 mm (+0.0/¥0.1 mm) diameter hole, as is seen in Figure 7, when applying a force of 4.5 lbf (pound-force) to the water bead in the direction of the hole via a rod having a hemispherical end diameter of 10.0 mm. 20 mm (+0/·0,1 mm) {0,79in.) A A 6.4mm 20 Ill (4.$ lbf) ddrumheller on DSK120RN23PROD with PROPOSALS1 V Figure 7: Section 4.40 of ASTM F963-23 Test Gauge and Force Application. 62 CPSC staff assessed the current ASTM test method in section 8.30 of ASTM F963–23 and found that using a rod to apply force to an expanded water bead to determine whether the water bead can fit through a test gauge does not realistically represent the compression forces exerted on a water bead when it is swallowed. The use of a 10.0 mm diameter rod to apply a force when conducting the test causes fragmentation of the water bead (Figure 8), which would be considered a ‘‘pass’’ pursuant to the ASTM test standard. Yet, incident data confirms water beads remain whole after being swallowed, thus creating a gastrointestinal tract blockage.63 Because the force that the rod exerts can damage the expanded water bead and cause fragmentation, Commission staff has assessed that the current ASTM test method is inadequate to effectively test water beads for an ingestion hazard. 61 EN 71–9 provides requirements and test methods for organic chemical compounds, such as acrylamide. Previously cited EN 71–1 provides requirements and test methods for mechanical and physical properties, such as expansion limits. Both are part of the standard EN 71. 62 Reprinted, with permission, from ASTM F963– 23 Standard Consumer Safety Specification for Toy Safety, 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. A free, read-only copy of the standard is available for viewing on the ASTM website at https:// www.astm.org/READINGLIBRARY/. 63 Examples include the following IDIs: 230727CBB1846, 230707CBB1698, 230613CBB1591, 170802CCC3140 and 221107CFE0002. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.010</GPH> (+(l.1/-0mm) 73034 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Staff also analyzed the 20.0 mm (+0.0/ ¥0.1 mm) diameter gauge specified in section 4.40 of ASTM F963–23 and determined that in light of incident data demonstrating how ingestion hazards occur, the gauge diameter should be reduced. The 20.0 mm diameter gauge used in ASTM F963 was selected based on the dimension of the pyloric sphincter 64 within the gastrointestinal tract of an 18-month-old child because, at the time the ‘‘Expanding Materials’’ requirements were created, the pyloric sphincter was thought by the drafters to be the most likely site where the gastrointestinal blockage would occur. As explained below, however, objects that can cause a gastrointestinal blockage are more likely to occur at either the gastric outlet part of the stomach or the ileocecal valve at the end of the small intestine.65 Water beads, like other foreign bodies and food, do not remain in the stomach for long. Therefore, water beads generally do not expand fully in the stomach but pass through the pyloric sphincter and into the small intestine. Water beads continue to expand in the small intestine, where they spend more time and are exposed to liquid that facilitates expansion. After the water beads expand fully in the small intestine, they are unable to pass through the ileocecal valve and into the large intestine, therefore causing a gastrointestinal blockage. CPSC staff evaluated the relevant recent incident data and advises that because the ileocecal valve is often the site of the gastrointestinal blockage when a child ingests a water bead, the ileocecal valve is a more appropriate anatomical structure on which to base the diameter of the funnel test gauge than the pyloric sphincter. Literature on ileocecal valve size indicates valve size will vary based 64 The pyloric sphincter is the valve located at the bottom of the stomach which opens to allow food to pass from stomach to the small intestine. 65 The ileocecal valve is a sphincter muscle situated at the junction of the ileum (last portion of the small intestine) and the colon (first portion of the large intestine). VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 on age and natural variation within the population, 66 67 but the Commission has not identified reliable authorities providing ileocecal valve sizes for children between the ages of 9 months old and 3 years old. Accordingly, as explained in section V below, the Commission has based this proposed rule on incident data. Section 4.40 of ASTM F963–23 also requires that ‘‘[t]oys, and removable components of toys, which fit entirely inside the small parts cylinder in their as-received condition, and which are composed of an expanding material, shall completely pass through the gauge when tested.’’ The referenced small parts cylinder is from 16 CFR 1501.4 and section 4.6.1, Small Objects of ASTM F963–23, which provides general safety requirements. Under section 4.6.1, toys intended for children under 36 months of age, ‘‘including removable [components], liberated components, or fragments of toys[,] shall [not] be small enough without being compressed to fit entirely within [the small parts cylinder].’’ This requirement is to minimize choking, ingestion, or inhalation hazards. Most water bead products are intended for children older than 36 months of age, however, and therefore are not subject to requirements in section 4.6.1 of ASTM F963–23. Finally, to address the potential presence of toxic chemicals in toys, section 4.3 of ASTM F963–23 requires that all toys must comply with the Federal Hazardous Substances Act (FHSA) toxicity and hazardous substances standards. Though there is this generalized FHSA compliance requirement for all of ASTM F963–23, section 4.40, Expanding Materials of 66 Tang SJ, Wu R. Ilececum: A Comprehensive Review. Can J Gastroenterol Hepatol. 2019 Feb 3;2019:1451835. doi: 10.1155/2019/1451835. PMID: 30854348; PMCID: PMC6378086. 67 Silva AC, Beaty SD, Hara AK, Fletcher JG, Fidler JL, Menias CO, Johnson CD. Spectrum of normal and abnormal CT appearances of the ileocecal valve and cecum with endoscopic and surgical correlation. Radiographics. 2007 JulAug;27(4):1039–54. doi: 10.1148/rg.274065164. PMID: 17620466. PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 ASTM F963–23 does not specifically mandate testing for hazardous chemicals. Water beads are composed of absorbent polymers, which can contain acrylamide monomer—a chemical that can be hazardous when ingested.68 ASTM F963–23 does not have any test methods or limits for acrylamide monomer in water beads. Therefore, the current ASTM standard is inadequate to provide the highest level of safety feasible to ensure that the chemicals in water beads are non-toxic. Because water beads containing high levels of acrylamide monomer are toxic, the NPR proposes to establish content limits and test methods to address the toxicity hazard. B. Assessment of Current EN 71–1 Expanding Materials Requirements The test method for ‘‘Expanding Materials’’ described in section 8.14 of EN 71–1 requires that an expanding material, such as a water bead, that fits entirely in a small parts cylinder first be measured, using calipers,69 to determine its original size in each dimension. Next, the expanding material must be submerged in demineralized water for up to 72 hours to reach its largest expansion size. After expansion, the water bead must be measured again to determine if it has expanded more than 50 percent of its original size in any dimension. If the water bead has expanded more than 50 percent, the expanding material requirements are not met. The Commission preliminarily determines that the current EN 71–1 expanding material requirement is inadequate as a stand-alone requirement. Staff assesses that an additional maximum size requirement is 68 Per the Federal Hazardous Substances Act (FHSA) (16 CFR 1500.3(c)(2)(i)(A)), a substance with a median lethal dose (LD50) between 50 and 5000 mg/kg in rats is ‘‘toxic’’ for acute toxicity. The reported oral LD50 values for undiluted acrylamide in rats range from 150 to 413 mg/kg. See ATSDR Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf. 69 An instrument used to measure the dimensions of an object. E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.011</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 Figure 8: Expanded Water Bead After Being Fragmented by 10.0 mm Diameter Rod End. Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules necessary because as currently written, for example, the standard would allow for a water bead having a diameter of 9.0 mm to expand to 13.5 mm diameter. While this expansion would not be more than 50 percent of the water bead’s original size, therefore meeting the EN 71–1 expanding material requirements, the expanded water bead would likely cause a gastrointestinal block if a child ingested it. Indeed, as described in section III of this preamble,70 a water bead with 13.0 mm diameter is known to have caused a gastrointestinal block in a 13-month-old female. If the only limitation on compliant water beads was that they do not expand more than 50 percent, the ingestion hazard would still be present. The 50 percent expansion limit is, however, a beneficial additional safety provision when combined with staff’s proposed diameter limit for fully expanded beads. In particular, requiring a reduction in the maximum expansion of water beads reduces the potential damage to inner ear structures or nasal tissue if a child inserts a water bead into their ear or nose because more damage occurs when the water beads are intended to expand to bigger sizes and therefore exert more pressure on the body parts that contain them. Reducing expansion potential will also reduce the degree of bronchial obstruction created when a water bead is aspirated. ddrumheller on DSK120RN23PROD with PROPOSALS1 C. Assessment of Current ASTM F963– 23 Labeling Requirements Section 5.0, Labeling Requirements of ASTM F963–23 contains general labeling requirements that apply to toys, including water beads or toys containing water beads. Still, the requirements in section 5.0 are not specifically referenced in section 4.40, Expanding Materials. Only broad warning statements for small part choking hazards and small ball hazards are required for ‘‘Expanding Materials.’’ While the warning statements address general choking hazards, they do not address or inform about injuries (e.g., gastrointestinal blockage and nasal tissue damage) and deaths that have occurred when water beads expand after being swallowed or inserted. D. 2024 Proposed Draft Revisions to ASTM F963 On January 22, 2024, and March 25, 2024, CPSC staff met with the ASTM F15.22 Emerging Hazards Task Group to discuss a possible revision of ASTM F963 to include specific requirements for water beads. CPSC staff and ASTM discussed incident information and the 70 IDI 170802CC3140. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 ASTM 20.0 mm diameter test gauge compared to CPSC’s proposed funnel test gauge shown below in Figure 10 and Figure 11. On July 9, 2024, ASTM shared a draft proposal to revise section 4.40 of ASTM F963–23 to include water bead-specific requirements. On July 18, 2024, ASTM submitted a ballot for vote on the proposal, which is available until August 19, 2024. CPSC staff has reviewed the 2024 draft proposal, finding that it is inadequate to address all known water bead hazards. In the proposed revision, the draft would define a water bead as a ‘‘spherical or spheroid waterabsorbent object, intended to expand in size when immersed in a liquid.’’ This draft revision would apply to water beads intended to be accessible in dehydrated state and water beads in the expanded state. If the water bead is already expanded, the water bead would be given time to dehydrate before testing. These draft requirements would not apply to water beads that are not intended to be accessible, such as water beads within a squeeze ball. ASTM’s draft performance test proposal requires first measuring the diameter of a dehydrated water bead and then measuring the maximum amount of expansion after soaking the water bead in deionized water at 37 °C. If the maximum expansion is greater than 50 percent in diameter, then the water bead will be placed in a funnel gauge like that in Figure 10 to determine whether it can pass through the gauge under a certain external pressure. If the maximum expansion of the water bead is less than or equal to 50 percent in diameter, no further testing is required. Based on incident data, the ASTM draft proposes use of a funnel test gauge with a 12.0 mm diameter (+0.0/¥0.1 mm) as a performance requirement. When attempting to pass an expanded water bead, the proposed test includes applying a force of 0.1 lbf to the water bead in the direction of the 12.0 mm diameter hole with a 10.0 mm diameter rod having a flat end. The ASTM draft states that ‘‘a water bead material which breaks or loses integrity during this test is considered to be acceptable,’’ and therefore if the fragmented pieces pass through the funnel, the product still would meet the draft requirement even if the unbroken water bead was larger than 12.0 mm. The draft does not include acrylamide limits or revised labeling requirements. CPSC staff has reviewed the draft ASTM proposal and finds that a gauge size of 12.0 mm is inadequate to address known hazards from water beads. The draft proposes 12.0 mm in consideration PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 73035 of one incident,71 which describes a 13month-old female who was unable to pass a water bead presumed to be as small as 13.0 mm diameter. However, while staff knows a 13.0 mm sized bead can cause a blockage in a child, this incident does not establish the size of the largest water bead that can safely pass. Further, the draft ASTM requirements leave the potential for a dehydrated water bead of 13.0 mm diameter capable of expanding to 19.5 mm diameter without requiring testing because the water bead would not expand to more than 50 percent of its original size. As explained elsewhere in this preamble, fragmentation of the water bead during testing is not representative of incident data, and testing of water beads within toys, such as squeeze balls, appears necessary to address accessibility incidents. Therefore, while the draft ASTM proposal may be an improvement beyond the current ‘‘Expanding Materials’’ requirements, it would not adequately address known water bead hazards even if adopted. V. NPR Description of Proposed Provisions and Justification Based on incident data described in section III of this preamble and CPSC staff’s engineering, health sciences, and human factors assessments, the NPR proposes creating a new section 1250.4 to 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, adding performance and labeling requirements for water beads to better address the known water bead hazards and to provide the highest level of safety feasible for such products. Further, this NPR proposes revising the title of part 1250 from ‘‘Safety Standard Mandating ASTM F963 for Toys’’ to ‘‘Safety Standard for Toys,’’ to reflect the inclusion of proposed requirements that do not incorporate by reference existing requirements in the ASTM F963 voluntary standard. A. Performance Requirements To Address Ingestion, Choking, Aspiration, and Insertion Hazards Under the proposed rule, water beads in the pre-expanded state that fit entirely inside the small part cylinder from 16 CFR 1501.4 (Figure 9) must then, after full expansion, not grow more than 50 percent in any dimension and must remain whole while completely passing through the funnel test gauge depicted in Figure 10 and Figure 11. Instead of using the rod test in ASTM F963–23, the NPR proposes requiring the water bead to pass through 71 IDI E:\FR\FM\09SEP1.SGM 170802CCC3140. 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 a 9.0 mm (+0.0/¥0.1 mm) diameter funnel test gauge under its own weight to better reflect the lower range of the compression forces a water bead would experience while passing through a child’s gastrointestinal tract. In the absence of conclusive anatomical evidence, the Commission relies on incident data and CPSC staff’s analysis to propose that the funnel test gauge have a 9.0 mm diameter. IDI 170802CCC3140 describes a 13-monthold female who was unable to pass a water bead presumed to range from 13.0 mm to 17.5 mm diameter. Staff purchased a separate sample of the same product that the 13-month-old female ingested and tested the water beads according to the section 4.40 requirements. After testing, the water beads had a dehydrated, as-received diameter ranging between 2.0 mm and 2.50 mm. After hydration and expansion, the size ranged from between 13.0 mm to 17.5 mm diameter. IDI 230707CBB1698 describes a 3-yearold female who ingested but successfully passed approximately 1,200 water beads. The child successfully passed approximately 200 of the water beads naturally and then passed the remaining water beads with the aid of a mineral oil enema. Staff VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 purchased a separate sample of the same product that the 3-year-old female ingested and tested the water beads according to the requirements in section 4.40. After the testing was completed, the water beads had a dehydrated, asreceived diameter ranging between 2.20 mm and 2.40 mm. After hydration and expansion, the diameter of the water beads ranged from between 9.32 mm and 15.20 mm diameter. Based on these investigations, the NPR proposes requiring the use of a 9.0 mm diameter funnel test gauge to ensure the test methods provide the highest level of safety feasible by limiting the gauge size to the size of the smallest water bead that was known to pass through the body without causing an intestinal obstruction. The proposed 9.0 mm diameter funnel test gauge also would reduce the hazards associated with water beads that are inserted into children’s noses and ears. While nose and ear insertion incident data do not indicate the expanded water bead sizes, larger beads can grow further into the nasal cavity and middle ear, causing severe injuries and requiring invasive surgery with sedation and/or general anesthesia to completely remove. The larger water beads are more likely to be removable PO 00000 Frm 00034 Fmt 4702 Sfmt 4725 only in pieces, as opposed to as a whole, because the bead has expanded deeper into the nasal cavity or inner ear. Removal of smaller water beads tends to be less invasive because they can be removed in one piece by health care professionals, similar to removal efforts of other inserted small objects, like marbles, toy parts, and food. l.2Sin 31.7mm A L....-----.7. 1.ooin 25.4mm Figure 9: Small Parts Cylinder. E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.012</GPH> 73036 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules 73037 Figure 10: Funnel Test Gauge. A A L_ _ _J 0oo;&mm (2,0ln.) SECTtoNMJ.. 09.ll'tfrnm The NPR proposes including the ‘‘Expanding Materials’’ test method from section 8.30 of ASTM F963–23, with modifications, in the proposed rule for water beads under § 1250.4. The NPR proposes conditioning the water bead or toy containing the water bead at 20 ± 5 °C (68 ± 9 °F) and at a relative humidity of 40–65 percent for a minimum of seven hours prior to the test. This mirrors the ASTM test method but adds a requirement that if the water bead is partially expanded, or contained within a toy and partially expanded, the water bead should be removed and dehydrated before testing. This simulates the hazard that occurs when a water bead dislodges from the product and then dehydrates. Pursuant to the ASTM test method, the NPR proposes that the water bead should next be submerged in a test bath of deionized water maintained at 37 °C ± 2 °C (98.6 °F ± 3.6 °F) for the duration of immersion, VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 without agitation.72 For water beads that exhibit positive buoyancy, the test requires placing weight(s) with mass just sufficient to achieve complete submersion on top of the water bead. The test requires that test labs be careful to minimize contact of the test water bead with the sides or bottom of the container to minimize any interference with expansion. To ensure the water bead is fully expanded, the test requires submersion for 72 hours and to measure the bead’s expansion after 6 hours, 24 hours, 48 hours and then 72 hours. If the greatest expansion was observed at 72 hours, then the testing should proceed. If greatest expansion was observed at another time interval, then a new sample should be conditioned for 72 The largest expansion usually occurs in deionized water; therefore, the water bead can grow to its largest potential in deionized water when testing the product in a laboratory. This is a conservative approach, as beads may expand less in digestive fluids. PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 the time interval when greatest expansion was observed. Next, the NPR proposes adding a test step based on the ‘‘Expanding Materials’’ requirement from section 4.6 of EN 71–1, which limits water bead expansion to no more than 50 percent in any dimension. After the required period of submersion to reach greatest expansion, the water bead will be measured with calipers to determine whether it has expanded more than 50 percent. Setting this expansion limit will address potential damage to nasal passages and ear cavities, as well as prevent choking or aspiration hazards by limiting water bead growth. Thereafter, returning to the ASTM framework but instead of using the ASTM F963 rod test, the proposed test in the NPR would require placing the expanded water bead at the top surface of the 9.0 mm diameter gauge’s upper opening (Figure 11) in the orientation least likely to pass through, and releasing the bead to allow it to travel E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.013</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 Figure 11: Funnel Test Gauge. Material: Polytetrafluorethylene (PTFE). 73038 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules down until it reaches the lower opening, then observing if the expanded water bead is able to remain whole and completely pass through the lower opening. By testing to observe if the water bead can completely pass through the 9.0 mm diameter funnel test gauge without external force, the test can simulate what occurs in a child’s gastrointestinal tract to determine whether the bead will or will not cause a blockage in a child’s gastrointestinal tract or, specifically, at the child’s ileocecal valve located at the end of the small intestines. ddrumheller on DSK120RN23PROD with PROPOSALS1 B. Acrylamide Limits and Testing Water beads are composed of absorbent polymers, such as polyacrylamide and/or polyacrylate polymers. Polyacrylamide is a chemical compound composed of acrylamide monomer units linked together. The polymer form, polyacrylamide, is relatively non-toxic; however, acrylamide monomer alone can be toxic.73 Residual acrylamide monomer can remain after production of polyacrylamide, which can stay in water beads after manufacturing. Human exposure to acrylamide monomer is known to cause negative health effects depending on the amount and duration of exposure.74 Chronic, long-term exposure can adversely affect the nervous, gastrointestinal, and reproductive systems and is suspected to be a human carcinogen. Even shortterm or one-time exposures has caused acute negative effects in the nervous system.75 The United States Food and Drug Administration (FDA) limits the amount of residual acrylamide monomer allowed in polyacrylamide used in food production (21 CFR 176.170, 176.180), processing (21 CFR 173.5, 173.10, 173.315), and packaging (21 CFR 73 Per FHSA (16 CFR 1500.3(c)(2)(i)(A)), a substance with a median lethal dose (LD50) between 50 and 5000 mg/kg in rats is ‘‘toxic’’ for acute toxicity. The reported oral LD50 values for undiluted acrylamide in rats range from 150 to 413 mg/kg (source: ATSDR Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ ToxProfiles/tp203.pdf). 74 ATSDR Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/ tp203.pdf; Internationally Peer Reviewed Chemical Safety Information (INCHEM) Acrylamide Review, available at https://inchem.org/documents/pims/ chemical/pim652.htm; U.S. Environmental Protection Agency (EPA) Hazard Summary of Acrylamide, available at https://www.epa.gov/sites/ default/files/2016-09/documents/acrylamide.pdf; U.S. FDA Process Contaminants in Food— acrylamide, available at https://www.fda.gov/food/ process-contaminants-food/acrylamide. 75 Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ ToxProfiles/tp203.pdf. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 176.110). The FDA has also published guidance on reducing the amount of acrylamide in foods.76 Polyacrylamide is commonly used in water and wastewater treatment, and the EPA limits the amount of acrylamide permitted in drinking water.77 No CPSC mandatory standard sets acrylamide limits for water beads or any other product; however, toys subject to ASTM F963, including water beads, are subject to the toxicology safety requirements in section 4.3.1, Hazardous Substances of ASTM F963– 23. Section 4.3.1 stipulates that ‘‘[t]oys or materials used in toys shall conform to the FHSA and to the regulations promulgated under that act . . . The regulations define limits for substances that are toxic, corrosive, [or] an irritant . . . .’’ Section 8.2, Testing for Hazardous Substance Content in ASTM F963–23 directs readers to review the FHSA to determine whether a product is comprised of hazardous substances. Depending on exposure, acrylamide could be a hazardous substance per 16 CFR 1500.3(b)(4)(i), which defines a hazardous substance as ‘‘any substance or mixture of substances which is toxic . . . .’’ Per 16 CFR 1500.3(b)(5), the term ‘toxic’ refers to ‘‘any substance (other than a radioactive substance) which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface.’’ While CPSC does not have incident data reflecting acrylamide poisoning from water beads,78 the presence of acrylamide monomers in several water bead products that staff tested demonstrates a potential chemical hazard. CPSC has made efforts to address the potential chemical hazard outside of rulemaking. For example, in March 2024 CPSC announced unilateral warnings for two water bead products that contained levels of acrylamide in violation of the FHSA.79 If one of those water beads was ingested, it could pose 76 U.S. FDA Guidance for Industry Acrylamide in Foods, available at https://www.fda.gov/media/ 87150/download. 77 U.S. EPA National Primary Drinking Water Regulations, available at https://www.epa.gov/ ground-water-and-drinking-water/national-primarydrinking-water-regulations. 78 CPSC has not yet received data demonstrating chronic exposure to acrylamide from water beads. 79 https://www.cpsc.gov/Newsroom/NewsReleases/2024/CPSC-Warns-Consumers-toImmediately-Stop-Using-Jangostor-Water-BeadsDue-to-Chemical-Toxicity-Hazard-Violation-ofFederal-Ban-of-Hazardous-Substances-Sold-onAmazon-com; https://www.cpsc.gov/Newsroom/ News-Releases/2024/CPSC-Warns-Consumers-toImmediately-Stop-Using-Tuladuo-Water-Bead-SetsDue-to-Chemical-Toxicity-Hazard-Violation-ofFederal-Ban-of-Hazardous-Substances-Sold-onAmazon-com. PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 a risk of acute toxicity to children from the acrylamide exposure. Children’s possible exposures to acrylamide after ingesting water beads would likely be a single, infrequent event (possibly including multiple beads in a single event). Therefore, the exposure scenario would be acute rather than chronic. The Agency for Toxic Substances and Disease Registry (ATSDR) 80 created and published an acute-duration oral minimal risk level (MRL) of 0.01 mg/kg-day for acrylamide.81 The MRL is an acute exposure level at which an exposed person (including a child) is unlikely to experience an adverse health effect. The Commission proposes that acrylamide limits be set to ensure that if a child ingests multiple water beads, the child’s exposure levels would not exceed the acute duration oral MRL for children aged 6 months old.82 The NPR proposes that the limit be set to 65 mg acrylamide extractable from 100 small water beads (defined as <4 mm across the smallest diameter of the bead prior to hydration) or one large water bead (defined as ≥4 mm across the smallest diameter of the bead prior to hydration). The quantities of small and large beads assumed to be ingested are based on water bead ingestion incidents and published case reports. Incident data indicate that children tend to ingest only one or two large beads. CPSC therefore proposes an exposure scenario in which a 6-month-old child ingests one large water bead. Less information is available for incidents of children ingesting small beads. If small beads do not expand enough after ingestion to cause a blockage, a child may not receive medical care. However, two case reports describe a 12-month-old who ingested 12 small water beads 83 and a 2-year-old who ingested approximately 100 small beads.84 A review of 21 water bead ingestion cases over a 10-year period 80 ATSDR is a federal public health agency within the United States Department of Health and Human Services. More information about ATSDR is available at https://www.atsdr.cdc.gov. 81 ATSDR Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/ tp203.pdf. 82 Six months is the most sensitive age in this range by having the lowest body weights, so the proposed limit of extractable acrylamide from water beads is based on children of this age. 83 Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of ingested water beads diagnosed with point-of-care ultrasound. Clin Exp Emerg Med. 2020 Dec;7(4):330–333. doi: 10.15441/ceem.20.041. Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832. 84 Jackson J, Randell KA, Knapp JF. Two Year Old With Water Bead Ingestion. Pediatr Emerg Care. 2015 Aug;31(8):605–7. doi: 10.1097/ PEC.0000000000000520. PMID: 26241717. E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 (2008 to 2017) reported that the number of water beads swallowed ranged from one to ‘‘a handful.85 Although IDI 230707CBB1698 describes a 3-year-old who ingested approximately 1,200 small water beads, this scenario appears to be an extreme occurrence. CPSC therefore proposes for this NPR an exposure scenario in which a 6-month-old child ingests 100 small water beads. The 100 count is within the range of documented ingestion incidents, and it is consistent with the number of small beads that staff uses in the acrylamide extraction test method described below. An acrylamide exposure limit from ATSDR’s acute-duration oral MRL of 0.01 mg/kg would mean that a child should not be exposed to more than 0.01 mg of acrylamide for each kg of the child’s body weight. When assessing the appropriate limit, staff used the fifth percentile body weight for the youngest female child according to the National Center for Health Statistics.86 The fifth percentile body weight of a 6- to 8month-old female is 6.5 kg. By multiplying the acute-duration oral MRL by the body weight, staff recommends an exposure limit for acrylamide from water beads is 0.065 mg, which is equal to 65 mg of extractable arylamide. The calculation are: 1. Calculate Acrylamide Exposure Limit: 0.01 mg/kg × 6.5 kg = 0.065 mg 2. Convert mg unit to mg: 0.065 mg × 1000 mg/mg = 65 mg The amount of extractable acrylamide shall be tested in accordance with the test procedure specified in the proposed 16 CFR 1250.4(c)(2).87 The proposed 65 mg acrylamide exposure limit applies to an assumed ingestion of one large bead (defined as ≥4 mm across the smallest diameter of the bead prior to hydration) or 100 small beads (defined as <4 mm across the smallest diameter of the bead prior to hydration). Under the proposal, CPSC would consider less than 65 mg acrylamide extractable from water beads safe in children as young as 6 months old, while water beads containing more than 65 mg pose a risk of acute toxicity. Staff in CPSC’s Division of Chemistry and Directorate for Health Sciences 85 Mehmetoğlu F. A Retrospective 10-Year Analysis of Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May 6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID: PMC5960561. 86 U.S. Centers for Disease Control and Prevention (CDC) Anthropometric Reference Data for Children and Adults: United States, 2015–2018, available at https://www.cdc.gov/nchs/data/series/sr_03/sr03046-508.pdf. 87 Because the volume of the extraction fluid may be variable, the 65 mg acrylamide limit is the total mass of acrylamide extracted in 24 hours and not a concentration. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 developed a test method to determine the levels of extractable acrylamide in water beads. The NPR proposes the following extraction method: • Perform an extraction test on water beads to determine the amount of acrylamide that leaches from the water beads over a 24-hour period. • Place dehydrated water beads in a container with pH neutral deionized water and place the container in a shaker bath that heats the water beads to 37 °C while shaking them at 30 RPM for 24 hours. • For each water bead product, perform three separate extraction trials, or repetitions, concurrently to ensure that all results are reasonably consistent, given any bead-to-bead variation. For large water beads (defined as ≥4 mm across the smallest diameter of the bead prior to hydration), perform three trials using one large bead per trial. For small beads (defined as <4 mm across the smallest diameter of the bead prior to hydration), perform three trials using 100 small beads per trial. If a product contains different sizes of water beads, perform extraction testing for each size. • Use an appropriate extraction container and volume of deionized water so that all water beads remain covered by water for the duration of the extraction period. Because water beads absorb different volumes of water depending on their size, conduct additional tests before performing final acrylamide extractions, to determine what volume of water best allows for full bead growth without unnecessarily diluting the concentration of extracted acrylamide. Choose containers that will not compress the water beads at any point during the 24-hour extraction period. To prevent water evaporation during the extraction, cover the containers during the extraction. • Following the extraction period, determine the volume of remaining water for each trial, then analyze the water to determine the mass of acrylamide present using an instrument that is able to quantitate acrylamide at levels equal to or less than the proposed limit. Staff used a liquid chromatography-tandem mass spectrometer (LC–MS/MS) system,88 but other instruments may accurately quantify acrylamide at levels equal to or less than the proposed limit. C. Marking, Labeling, and Instructional Literature Requirements The ASTM F963–23 standard does not contain marking, warning, or 88 LC–MS/MS is an analytical chemistry technique that allows for the physical separation and subsequent identification and quantification of analytes of interest within a solution. PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 73039 labeling requirements specifically for water beads. While the standard provides broad warning requirements under section 5 of ASTM F963–23, such warnings do not adequately address the hazards associated with water beads. The Commission proposes requiring the following marking, labeling, and instructional literature requirements for all products within scope of the NPR and seeks comment on format, location, and content requirements of proposed warnings. 1. Packaging and Container Marking and Labeling Warning about a hazard is a less effective method of addressing the hazard, contrasted with either designing the hazard out of a product or guarding consumers from the hazard.89 Therefore, when a standard relies on warnings to address a hazard, it is particularly important that the warning statements are noticeable, understandable, and motivational. The primary U.S. voluntary consensus standard for product safety signs and labels, ANSI Z535.4, American National Standard for Product Safety Signs and Labels,90 recommends that on-product warnings include content that addresses the following three elements: • a description of the hazard; • information about the consequences of exposure to the hazard; and • instructions regarding appropriate hazard-avoidance behaviors. Providing explicit or detailed information in a warning can increase its effectiveness 91 by enhancing perception of injury severity and perceived hazard.92 Vividness of 89 Laughery, K.R., & Wogalter, M.S. (2011). The Hazard Control Hierarchy and its Utility in Safety Decisions about Consumer Products. In W. Karwowski, M.M. Soares, & N.A. Stanton (Eds.), Human Factors and Ergonomics in Consumer Product Design: Uses and Applications (pp. 33–39). Boca Raton, FL: CRC Press; Williams, D.J., & Noyes, J.M. (2011). Reducing the Risk to Consumers: Implications for Designing Safe Consumer Products. In W. Karwowski, M.M. Soares, & N.A. Stanton (Eds.), Human Factors and Ergonomics in Consumer Product Design: Uses and Applications (pp. 3–21). Boca Raton, FL: CRC Press; Vredenburgh, A.G., & Zackowitz, I.B. (2006). Expectations. In M.S. Wogalter (Ed.), Handbook of warnings (pp. 345–354). Mahwah, NJ: Lawrence Erlbaum Associates. 90 ANSI Z535.4, American National Standard for Product Safety Signs and Labels is the primary US. voluntary consensus standard for the design, application, use, and placement of on-product warning labels when developing or assessing the adequacy of warning labels. 91 Laughery, Sr., K.R., & Smith, D.P. (2006). Explicit Information in Warnings. In M.S. Wogalter (Ed.), Handbook of Warnings (pp. 419–428). Mahwah, NJ: Lawrence Erlbaum Associates. 92 DeJoy, D.M. (1999). Motivation. In M.S. Wogalter, D.M. DeJoy, & K.R. Laughery (Eds.), E:\FR\FM\09SEP1.SGM Continued 09SEP1 73040 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules message content can increase message salience by triggering motivation to act in consideration of the warning.93 The Commission proposes including the following warnings on water bead toys and packaging of toys that contain water beads. Specifically, packaging would be required to include the warning as shown in Figure 12: This product contains water beads that grow larger. Children have DIED after swallowing water beads because the beads blocked their Intestines. Your child can die too. • Keep away from babies and toddlers. • Never use as a sensory toy or bath toy. • Seek immediate medical attention if you think your child swallowed beads or inserted beads into their nose, ears, or other part of the body. Figure 12. Warning for Water Bead Toys and Packaging of Toys Containing Water Beads. Packaging of toys with contained water beads, such as squeeze balls filled with water beads, would be required to include the warnings as shown in Figure 13: This product contains water beads that grow larger. Discard if beads are coming out. Children have DIED after swallowing water beads because the beads blocked their intestines. Your child can die too. • Keep away from babies and toddlers. • Never use as a sensory toy or bath toy. • Seek immediate medical attention if you think your child swallowed beads or inserted beads into their nose, ears, or other part of the body. body, water beads pose a danger by expanding inside the body. The additional statements advise consumers how to avoid hazards and what to do if the consumer suspects a child has swallowed or inserted a water bead. The warning for toys with contained water beads (Figure 13) includes the wording, ‘‘This product contains water beads that grow larger. Discard if beads are coming out[,]’’ to ensure consumers are aware that water beads are within the toy, and that exposed water beads are hazardous. Incident data confirm that caregivers may be unaware that toy products purchased contain hazardous water beads.95 When developing or assessing the adequacy of a warning, one must consider not only the content of a warning, but also its design or form.96 CPSC commonly uses ANSI Z535.4 as a reference for warning formatting requirements. Human factors experts and warnings literature regularly cite ANSI Z535.4 when discussing the design and evaluation of on-product warning labels and generally consider the ANSI Z535 series of requirements as the state-of-the-art, benchmark standards against which warning labels should be evaluated for adequacy.97 The scope of ANSI Z535.4 is broad enough to encompass nearly all consumer Warnings and Risk Communication (pp. 221–243). Philadelphia: Taylor & Francis. 93 Murray-Johnson, L., & Witte, K. (2003). Looking Toward the Future: Health Message Design Strategies. In T.L. Thompson, A. Dorsey, K. I. Miller, & R. Parrott (Eds.), Handbook of Health Communication (pp. 473–495). New York: Routledge. 94 https://www.consumerreports.org/babies-kids/ toys/water-beads-pose-a-serious-safety-risk-tochildren-a6431187819/. 95 Such as incident 20230601–3657B–2147347238 found on saferproducts.gov. A 2-year-old child bit into a stress ball and swallowed the contents requiring medical treatment. The consumer claims to have been unaware that there were water beads inside. 96 Laughery, Sr., K.R., & Wogalter, M.S. (2006). The Warning Expert in Civil Litigation. In M.S. Wogalter (Ed.), Handbook of Warnings (pp. 605– 615). Mahwah, NJ: Lawrence Erlbaum Associates; Madden, M.S. (1999). The Law Relating to Warnings. In M.S. Wogalter, D.M. DeJoy, & K.R. Laughery (Eds.), Warnings and Risk Communication (pp. 315–330). Philadelphia: Taylor & Francis; Madden, M.S. (2006). The Duty to Warn in Products Liability. In M.S. Wogalter (Ed.), Handbook of Warnings (pp. 583–588). Mahwah, NJ: Lawrence Erlbaum Associates. 97 Vredenburgh, A.G., & Zackowitz, I.B. (2005). Human Factors Issues to be Considered by Product Liability Experts. In Y.I. Noy & W. Karwowski (Eds.), Handbook of Human Factors in Litigation (Chapter 26). Boca Raton, FL: CRC Press; Wogalter, M.S., & Laughery, K.R. (2005). Effectiveness of Consumer Product Warnings: Design and Forensic Considerations. In Y.I. Noy & W. Karwowski (Eds.), Handbook of Human Factors in Litigation (Chapter 31). Boca Raton, FL: CRC Press. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.015</GPH> The Commission further proposes that toys containing water beads that are not individually packaged (e.g., multiple squeeze balls sold in a bin/box) would be required to have a hangtag or sticker label affixed on each individual product with the warning shown in Figure 13. Because CPSC is aware of one death in the U.S. and additional deaths outside of the U.S.,94 both warnings labels state, ‘‘Children have DIED after swallowing water beads because the beads blocked their intestines. Your child can die too.’’ The purpose of this statement is to communicate to consumers the consequences of swallowing water beads, as well as clarify that once a water bead enters the EP09SE24.014</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 Figure 13. Warnings for Toys Containing Water Beads. Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules products, including children’s products and toys.98 Signal words, colors, graphics, and placement all increase conspicuity. The salience of a visual warning can be enhanced using large and bold print, high contrast, color, borders, pictorial symbols, and special effects like flashing lights. Therefore, the NPR proposes warning label design requirements for water bead toys and toys containing water beads that reflect the current recommendations from ASTM’s Ad Hoc Language Task Group (Ad Hoc Task Group).99 The recommendations provide permanent, conspicuous, and consistently formatted warning labels across juvenile products. Warnings that meet the recommendations address numerous format issues related to capturing consumer attention, improving readability, and increasing hazard perception and avoidance behavior. Such recommendations include requiring that the proposed warnings conform to ANSI NEMA Z535.4—2023, American National Standard for Product Safety Signs and Labels, sections 6.1–6.4, 7.2–7.6.3, and 8.1, with the following changes to the ANSI standard: • In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace the word ‘‘should’’ with ‘‘shall;’’ • In section 7.6.3, replace the phrase ‘‘should (when feasible)’’ with the word ‘‘shall;’’ and • Strike the word ‘‘safety’’ when used immediately before a color (e.g., replace ‘‘safety white’’ with ‘‘white’’). Further, certain text in the message panel must be in bold and in capital letters as shown in the example warning labels in Figure 12 and Figure 13, to provide emphasis and capture the reader’s attention. The signal word ‘‘WARNING’’ must appear in sans serif letters in upper case only, be at least 1⁄8 inch (3.2 mm) in height, and be centeror left-aligned. The height of the exclamation point inside the safety alert ddrumheller on DSK120RN23PROD with PROPOSALS1 98 Kalsher, M.J., & Wogalter, M.S. (2008). Warnings: Hazard Control Methods for Caregivers and Children. In R. Lueder & V.J.B. Rice (Eds.), Ergonomics for Children: Designing Products and Places for Toddlers to Teens (pp. 509–539). New York: Taylor & Francis; Rice, V.J.B. (2012). Designing for Children. In G. Salvendy (Ed.), Handbook of Human Factors and Ergonomics (4th ed.) (pp. 1472–1483). Hoboken, NJ: Wiley. 99 ASTM Ad Hoc Wording 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 nursery product voluntary standards. The latest version of the Ad Hoc-approved recommended language is published in the ‘‘Committee Documents’’ section of the Committee F15 ASTM website. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 symbol must be at least half the height of the triangle and be centered vertically inside the triangle, as shown in the example warnings. The message panel text capital letters are no less than 1⁄16″ (1.6mm) 100 and the message panel text is center- or left-aligned, in sans serif letters. Consistent with Ad Hoc, the text in each column should be arranged in list or outline format, with precautionary statements preceded by bullet points. Precautionary statements must be separated by bullet points if paragraph formatting is used. Warnings that are placed directly on a product and/or the packaging have a higher noticeability rate 101 because consumers are more likely to see such warnings when examining the product prior to purchase. ANSI Z535.4 provides general guidance on warning placement, stating that warnings must be ‘‘readily visible to the intended viewer’’ and will ‘‘alert the viewer to the hazard in time to take appropriate action.’’ 102 Similarly, both the Ad Hoc Task Group and section 5.3.6 of ASTM F963–23 require conspicuous warnings. The NPR proposes warning labels be placed on the principal display panel as defined in section 3.1.62 of ASTM F963–23. 2. Instructional Literature Some water bead toys or toys containing water beads provide instructional literature, such as manuals for use. Instructions or other literature accompanying a water bead product, when provided, shall include directions for use, including the relevant warnings from Figure 12 or Figure 13. The NPR proposes that instructional literature shall include the same warning labels that the NPR proposes for product packaging, with similar formatting requirements, though the literature does not need to be in color.103 Still, the Commission proposes that the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the warnings 100 1.6mm is the size dimension from the toy standard, 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, not from the Ad Hoc Task Group. 101 Wogalter, M.S., Godfrey, S.S., Fontenelle, G.A., Desaulniers, D.R., Rothstein, P., & Laughery, K.R. (1987). Effectiveness of warnings. Human Factors 29(5), 599–612; Frantz, J.P.; Rhoades, T.P. (1993). A Task-Analytic Approach to the Temporal and Spatial Placement of Product Warnings. Human Factors: The Journal of the Human Factors and Ergonomics Society, 35(4), pp. 719–730. 102 American National Standards Institute. (2011). ANSI Z535.4. American national standard: Product safety signs and labels. Rosslyn, VA: National Electrical Manufacturers Association, Section 9.1. 103 ANSI Z535.6, Product Safety Information in Product Manuals, Instructions and Other Collateral Materials, allows warning labels to be black and white whereas the NPR mandates color for warning labels packaging. PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 73041 shall contrast with the background of the instructional literature.104 VI. Feasibility of Proposed Requirements Pursuant to section 106(c) of the CPSIA, Congress directed the Commission to ‘‘periodically review and revise the rules set forth under this section to ensure that such rules provide the highest level of safety for such products that is feasible.’’ 15 U.S.C. 2056b(c). The Commission’s statutory obligation is to ensure that toys have the highest level of safety that the producers are capable of achieving, considering technological and economic ability. Based on the staff’s analysis provided in this NPR, the Commission preliminarily determines that the NPR is technically and economically feasible, and requests comment on this determination. A. Technological Feasibility A proposed rule is technically feasible if it is capable of being done. For example, compliant products might already be on the market; or the technology to comply with requirements might be commercially available; or existing products could be made compliant; or alternative practices, best practices, or operational changes would allow manufacturers to comply. See, e.g., 15 U.S.C. 1278a(d) (discussing lead limits). The Commission believes the NPR’s proposals meet technical feasibility criteria. For instance, products currently available on the market are within the proposed rule’s 9.0 mm size limitation, and there should be multiple means of producing and packaging water bead toys that expand by less than 50 percent. With respect to demonstrating compliance, the proposed funnel test gauge test does not require tools, like a push rod, to determine whether a water bead can pass through the gauge. Further, several testing tools in the NPR (e.g., a small parts cylinder) are already included in CPSC mandatory standards or come from the ASTM F963 standard. Accordingly, much of the technology is already used when testing to section 4.40 of ASTM F963–23 and is commercially available. B. Economic Feasibility The draft proposed rule is economically feasible because noncompliant toy products can be redesigned to be compliant, or be repurposed for non-toy uses. Based on CPSC staff’s analysis, the Commission expects manufacturers would, to comply with the proposed rule, incur 104 Ad E:\FR\FM\09SEP1.SGM Hoc section Y.6, Instructional Literature. 09SEP1 73042 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules material costs to redesign their product and retool their manufacturing processes to produce a compliant product. Staff expect the redesign and retooling costs to be significant for small firms involved in the water bead toy market, with the exception of the labeling requirements, which are negligible (i.e., less than $0.01 per product). A decline in sales is expected, as many currently available water bead toys would not be compliant with the draft proposed rule. However, while the impact of the proposed rule may be significant, firms could sell compliant water bead toys or sell non-compliant water beads for non-toy purposes, such as agricultural purposes. VII. Incorporation by Reference Proposed § 1250.4 would incorporate by reference ANSI Z535.4—2023. The Office of the Federal Register (OFR) has regulations regarding incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to a final rule, ways in which the material the agency incorporates by reference is reasonably available to interested parties, and how interested parties can obtain the material. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b)(3). In accordance with the OFR regulations, section V of this preamble summarizes the major provisions of ANSI Z535.4—2023 that the Commission proposes to incorporate by reference into proposed § 1250.4. The standard itself is reasonably available to interested parties. By permission of ANSI, the standard can be viewed as a read-only document during the comment period for this NPR, at: https://ibr.ansi.org/Standards/ nema.aspx. Interested parties can also schedule an appointment to inspect a copy of the standard at CPSC’s Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, telephone: (301) 504–7479; email: cpscos@cpsc.gov. Alternatively, interested parties can purchase a copy of the standard from ANSI, 1899 L Street NW, 11th Floor, Washington, DC 20036. ddrumheller on DSK120RN23PROD with PROPOSALS1 VIII. 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 90-day effective date for this rule. The rule would apply to all water beads manufactured after the effective date. 15 U.S.C. 2058(g)(1). VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 Although the NPR proposes to add new requirements, most of the test methods and test equipment are not unique, in that the current ASTM toy standard utilizes several similar methods and equipment. For example, as of July 12, 2024, 81 third-party laboratories were already CPSCaccepted to test expanding materials as provided in section 4.40 of ASTM F963–23, as incorporated into part 1250 on January 18, 2024. Additionally, as of July 12, 2024, 153 third-party laboratories were CPSC-accepted to test expanding materials as provided in section 4.40 of ASTM F963–17. While these third-party laboratories may not yet be CPSC-accepted for testing for acrylamide, 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 quickly in the normal course. Additionally, a 90-day effective date allows the proposed standard to coincide with the thirdparty testing requirements for children’s products under section 14(a)(3) of the CPSA, as an NOR date must be no later than 90 days before such rules or revisions take place. 15 U.S.C. 2063(a)(3). The Commission invites comments, particularly from small businesses, regarding the proposed testing and the amount of time needed to come into compliance with a final rule. IX. 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, unless the rule would not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603, 605(b). 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 requirements. Third-party testing costs PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 should not be a new significant cost for most small firms, given suppliers should already test to the current mandatory standard in part 1250. A. Reason for Action, NPR Objectives, Product Description, and Market Description Section I of this preamble explains why the Commission proposes to establish a mandatory rule for water bead toys 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 water beads, and the use of water beads in the U.S. The proposed requirements in the NPR are more stringent than ASTM F963–23, which the Commission incorporated into the mandatory rule 16 CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, as described in sections IV and V of this preamble. CPSC staff has not identified any other Federal rules that duplicate, overlap, or conflict with the draft proposed rule. The NPR addresses the known hazards presented by water beads, discussed in section III of this preamble, that the current rule does not adequately address. B. Small Entities To Which the Rule Would Apply Section II of this preamble describes the products within the scope of the rule and an overview of the market for water beads. This section provides additional details on the market for products within the scope of the rule. CPSC staff has found that a majority of the firms that sell water bead toys are wholesalers of hobby goods, toys, and plastic products.105 Retailers of water bead toy products are hobby and toy stores, department stores, and warehouse stores and supercenters.106 Some of these products may be sold by convenience stores, but staff estimates the number of units sold from such stores is negligible. Water bead toys are 105 The North American Industry Classification System (NAICS) defines product codes for U.S. firms. Firms advertise water bead products as toys and therefore water beads may be categorized under many NAICS product codes. These firms could be listed in NAICS code 339930 Doll, Toy, and Game Manufacturing but some may also be listed in code 326199 All Other Plastic Product Manufacturing. Importers of these products could also vary among different NAICS codes. A majority of the firms should be listed in the following NAICS codes as wholesalers; 423920 Toy and Hobby Goods and Supplies Merchant Wholesalers, and 424610 Plastics Materials and Basic Forms and Shapes Merchant Wholesalers. 106 Retailers consist of NAICS codes 459120 Hobby, Toy, and Game Stores, 455110 Department Stores, and 455211 Warehouse Clubs and Supercenters. E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules small, novelty products which can easily be stored and sold in varying retail channels and, therefore, the described retailers, importers, and manufacturers are not all inclusive but represent the most prominent sources for water bead toys. Currently, over 30 firms supply water bead toys to the U.S. market. Most of the U.S.-based manufacturers and importers are small companies based on Small Business Administration (SBA) size standards.107 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.108 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.109 There is no NAICS category 73043 specifically for water bead manufacturing or importing. Companies that manufacture water bead toy products may be categorized as doll, toy, and game manufacturing or under the category ‘‘All Other Plastic Product Manufacturing.’’ Importers are generally considered a type of merchant wholesaler. As seen in the tables below of applicable NAICS categories, the SBA small entity threshold for manufactures is generally 150 to 750 employees. TABLE 2—ESTIMATE OF NUMBER OF SMALL MANUFACTURERS AND IMPORTERS NAICS code 339930 326199 424610 423920 SBA size standard for firms (# of employees) Description ........... ........... ........... ........... Doll, Toy, and Game Manufacturing ................................................................... All Other Plastic Product Manufacturing ............................................................. Plastics Materials and Basic Forms and Shapes Merchant Wholesalers .......... Toy and Hobby Goods and Supplies Merchant Wholesalers ............................ Number of firms that meet size standard (based on SUSB data) 700 750 150 175 7 1 4 19 TABLE 3—ESTIMATE OF NUMBER OF SMALL RETAILERS NAICS code Description 452210 ........... 452310 ........... 451120 ........... Department Stores .............................................................................................. General Merchandise Stores, Including Warehouse Clubs and Supercenters .. Hobby, Toy, and Game Stores ........................................................................... Based on the Census Bureau’s 2021 Statistics of U.S. Businesses (SUSB) data and a review of publicly available data on annual revenues, staff estimates the number of firms classified as small for the aforementioned NAICS codes to be seven manufacturers, 23 importers, and 12,681 retailers. These firms could be considered small and supply water bead products. ddrumheller on DSK120RN23PROD with PROPOSALS1 SBA size standard for firms (annual revenue) millions $ C. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of the Proposed Rule The proposed rule would require suppliers (manufacturers and importers) of water bead toys to meet performance, warning label, and user instruction requirements, and to conduct thirdparty testing to demonstrate compliance. This section discusses the reporting and paperwork requirements. Compliance costs are analyzed in detail in section IX.E of this preamble. Manufacturers must demonstrate that they have met the performance 107 Under SBA standards, a manufacturer, importer, and retailer of a product is categorized as a small entity based on their associated NAICS code. SBA uses the number of employees to determine if a manufacturer or importer is a small entity while SBA uses the amount of annual revenues for retailers. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 $40.0 47.0 35.0 Number of firms that meet size standard (based on SUSB data) 15 8,006 4,660 requirements of the rule by providing a children’s product certificate. As specified in 16 CFR part 1109, suppliers who are not the original manufacturer, such as importers, may rely on the testing or certification suppliers provide, as long as the requirements in part 1109 are met. Manufacturers and importers are required to furnish certificates to retailers and distributors (section 14(g)(3) of the CPSA); retailers are not required to third-party test the children’s products that they sell unless they are also the manufacturer or importer. Under section 14 of the CPSA, manufacturers, importers, and private labelers of water bead products will be required to certify, based on a test of each product conducted by third-party conformity assessment body, that their products comply with the requirements of the proposed rule. Each children’s product certificate must identify the third-party conformity assessment body that conducted the testing upon which the certificate depends. 108 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. 109 https://www.census.gov/programs-surveys/ susb/data/tables.html. PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 D. Potential Impact on Small Entities Water beads that expand to larger than 9.0 mm or to more than 50 percent greater than their original size in diameter when tested pursuant to section 8.30, Expanding Materials Test Method of ASTM F963–23, with modifications proposed in the NPR, would require modification to meet the proposed rule or be taken off the market. Additionally, water beads toys that do not meet the proposed acrylamide limit would require modification or discontinuation. The Commission assesses it is likely that a substantial number of firms will incur significant costs from redesign, retooling, loss of sales, or the purchase and installation of new components. While some water bead toys are produced at sizes under the proposed maximum water bead diameter limit of 9.0 mm, CPSC staff has not identified E:\FR\FM\09SEP1.SGM 09SEP1 73044 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 water bead products that currently conform to the 50-percent-or-less growth limitation specified in the proposed rule. CPSC staff reviewed product descriptions for popular water bead retail packages and found that most are sold in mixed sizes with water beads that are both under and over the maximum size limit of the proposed rule. Staff estimates that water beads over the size limit are less than 5 percent of the market based on the range of sizes in these descriptions and an assumed distribution. Staff assesses water beads over the established limit can easily be replaced with sizes smaller than the limit to comply with the proposed rule. However, the 50 percent growth limitation requirement is expected to result in all or nearly all water bead toys needing to be redesigned. Given this requirement, and the likelihood that all currently available water bead toys would not be compliant, staff expects some small firms to no longer package and advertise their products as toys but instead as agricultural or decorative home products (although firms may be able to redesign toys with water beads that expand to less than 9.0 mm and/or be packaged at a size closer to the desired expanded size). Due to the uncertainty related to redesigning these products, CPSC staff cannot generate an estimate of the potential costs of the proposed rule. CPSC staff seeks comment on the number of water beads designated as toys that currently meet the requirements of the proposed rule, and on the technical feasibility of the proposed requirements and potential redesign/retooling costs. Firms might incur a small one-time additional cost from updating existing labels and/or adding labels. Generally, the costs associated with modifying or adding warning labels are low on a per unit basis because all manufacturers of children’s products are already required to provide labels with their product pursuant to section 14(a)(5) of the CPSA. The additional costs related to updating labels are less than $0.01 per unit of product sold, therefore, staff expect the incremental cost related to the labeling provision to be negligible. E. Impact on Small Manufacturers CPSC staff considers 1 percent of revenue to be a ‘‘significant’’ economic impact, consistent with other federal government agencies. Staff expect that small manufacturers would incur significant costs from redesign, retooling, loss of product sales, and material change to comply with the proposed rule. However, the labeling VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 costs per product are negligible (less than $0.01) and would have a de minimis impact on small firms. Overall, staff assess that a substantial number of small manufacturing firms will incur a significant cost from the proposed rule, although sale losses would be mitigated to the extent that manufacturers repurpose non-compliant water beads for non-toy uses (e.g., agricultural or decorative). F. Third-Party Testing Costs The NPR would require manufacturers and importers of water bead toys to comply with performance requirements and demonstrate compliance by required third-party testing. As specified in 16 CFR part 1109, entities that are not manufacturers of children’s products, such as importers, may rely on the certificate of compliance provided by others. Water bead manufacturers could incur some additional costs for certifying compliance with the proposed rule. The certification must be based on a test of each product performed by a third-party conformity assessment body. Based on quotes from testing laboratories for ASTM F963 mechanical services and chemistry testing services, the cost of certification testing would range from $300 to $500 per product sample. Some labs currently not performing acrylamide testing in other contexts may incur retooling costs to perform the necessary testing, which could result in higher prices per product sample. However, testing of products is already a requirement and only the incremental increase in expected price would be considered a cost for the proposed rule. CPSC staff do not expect a significant price increase for these testing services as a result of the proposed rule, particularly because they assess that laboratories tend to price testing by category (i.e., chemical testing vs. mechanical testing) and, therefore, such testing already has a price assigned that likely will not increase. G. Efforts To Minimize Impact, Alternatives Considered The Commission considered three alternatives to the proposed rule that could reduce the impact on small entities: (1) not establishing a mandatory standard for water beads, (2) establishing an information and education campaign, or (3) setting a later effective date. 1. Not Establishing a Mandatory Standard Section 106 of the CPSIA requires CPSC to periodically review and revise ASTM F963 to ensure that such PO 00000 Frm 00042 Fmt 4702 Sfmt 4702 standards provide the highest level of safety for such products that is feasible. Given CPSC’s statutory mandate, and continuing incidents associated with water bead toys as described in section III of this preamble, the Commission has determined that it must address the safety of children using water bead toys to ensure that the risks of ingestion and insertion into the body are mitigated. While failing to promulgate a mandatory standard for water beads would have no direct impact on U.S. small businesses, it would allow hazardous products to remain on the market and do nothing to reduce known hazards associated with water beads. This option might be selected if it were believed that the risk associated with these products is acceptable and that agency warning efforts have resulted or will result in the necessary market changes to address these injuries. As discussed immediately below, however, that is not the case. In addition, while there are no direct costs associated with this alternative, this alternative is unlikely to directly address the fatal and non-fatal injuries identified from water bead toys. 2. Information and Education Campaign CPSC could expand its information and education campaigns concerning the ingestion hazard associated with water bead toys. This would require consumer outreach efforts like advertising and marketing related to the hazards. This alternative could be implemented independent of regulatory action. Public awareness is a crucial component in making safe purchasing decisions and safely using water beads. CPSC issued the first warning about ingesting water beads in 2012 with a recall. Since then, there have been many announcements from government bodies, healthcare professionals and the media.110 Given the continuing 110 Dunecraft Recalls Water Balz, Skulls, Orbs and Flower Toys Due to Serious Ingestion Hazard | CPSC.gov (2012) https://www.cpsc.gov/Recalls/ 2012/dunecraft-recalls-water-balz-skulls-orbs-andflower-toys-due-to-serious-ingestion; ACCC warns of dangers of water expanding balls to kids | ACCC (2015) https://www.accc.gov.au/media-release/ accc-warns-of-dangers-of-water-expanding-balls-tokids; Are Water Beads Toxic?—poisonhelp.org https://www.poisonhelp.org/2024/03/26/waterbeads-toxic/; How High-Powered Magnetic Toys Can Harm Children—HealthyChildren.org (2023) https://www.healthychildren.org/English/safetyprevention/at-home/Pages/Dangers-of-MagneticToys-and-Fake-Piercings.aspx?ampnfstatus= 401&ampnftoken=00000000-0000-0000-0000000000000000&ampnfstatusdescription= ERROR%252525252525253A %252525252525252BNo%252525252525252B local%252525252525252Btoken; Water Beads: A Danger to Young Children & Can Be Deadly if Swallowed | CPSC.gov (2023) https://www.cpsc.gov/ Safety-Education/Safety-Guides/Toys-Crafts-WaterBeads/Water-Beads-A-Danger-to-Young-Children- E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules incidents associated with water beads, CPSC assesses that information and education campaigns have limited effectiveness in adequately addressing the hazard. Therefore, the Commission preliminarily finds that while an information campaign might be helpful, it would be inadequate to address water bead toy hazards. 3. Later Effective Date The Commission could propose a later effective date that would reduce the burden on entities of all sizes by allowing more time to remove products from the market, repackage, and test products. In addition, testing laboratories need to become accredited to the proposed rule before any product can be tested to the proposed rule. Smaller companies are less likely to have the resources to quickly come into compliance with the proposed rule than larger ones, and a minority of the small U.S. companies that have products in scope of this proposed rule have multiple products that do not appear to meet the new performance requirements. However, the Commission preliminarily finds that providing a longer effective date would allow the hazards of water bead toys to be unaddressed for a later period of time resulting in more deaths and injuries, and thus would unreasonably delay addressing the ingestion hazard associated with water beads. X. Environmental Consideration The Commission’s regulations address whether the agency is required to prepare an environmental assessment or an environmental impact statement. Under these regulations, certain categories of CPSC actions normally have ‘‘little or no potential for affecting the human environment,’’ and therefore do not require an environmental assessment or an environmental impact statement. Safety standards providing performance and labeling requirements for consumer products come under this categorical exclusion. 16 CFR 1021.5(c)(1). The NPR falls within the categorical exclusion. XI. Paperwork Reduction Act This proposed rule for water beads contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (‘‘OMB’’) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we set forth: • Title for the collection of information; • Summary of the collection of information; • Brief description of the need for the information and the proposed use of the information; 73045 • Description of the likely respondents and proposed frequency of response to the collection of information; • Estimate of the burden that shall result from the collection of information; and • Notice that comments may be submitted to the OMB. Title: Safety Standard for Toys: Requirements for Water Beads Description: As described in section V of this preamble, the proposed rule would require new labeling for water bead toys. CPSC will seek a new OMB control number for this rule in the next PRA update for Third Party Testing of Children’s Products. The NPR proposes that water bead toys meet the proposed requirements of § 1250.4, which are summarized in section V of this preamble. Section 5 of ASTM F963–23 contains requirements for marking, labeling, and instructional literature of children’s toys in general. These requirements fall within the definition of ‘‘collection of information,’’ as defined in 44 U.S.C. 3502(3). Description of Respondents: Persons who manufacture or import water bead toys or toys that contain water beads. Estimated Burden: We estimate the burden of this collection of information as follows: ddrumheller on DSK120RN23PROD with PROPOSALS1 TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN Burden type Number of respondents Frequency of responses Total annual responses Hours per response Total burden hours Labeling and instructions ............................................................. 30 1 30 2 60 This estimate is based on the following: CPSC estimates there are 30 suppliers that would respond to this collection annually, and that the majority of these entities would be considered small businesses. CPSC assumes that on average each respondent that reports annually would respond once, as product models for water beads are brought to market and new labeling and instruction materials are created, for a total of 30 responses annually (30 respondents × 1 responses per year). CPSC assumes that on average it will take 1 hour for each respondent to create the required label and one hour for them to create the required instructions, for an average response burden of 2 hours per response. Therefore, the total burden hours for the collection are estimated to be 60 hours annually (30 responses × 2 hours per response = 60 total burden hours). CPSC estimates the hourly compensation for the time required to create and update labeling and instructions is $41.55.111 Therefore, the estimated annual cost of the burden requirements is $2,493 ($41.55 per hour × 60 hours = $2,493). No operating, maintenance, or capital costs are associated with the collection. Based on this analysis, the proposed revisions to the standard would impose a burden to industry of 60 hours at a cost of $2,493 annually. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), CPSC has requested OMB approval of new information collection and recordkeeping requirements related to this proposed rule. CPSC invites comments on this new information collection. All comments received on this information collection will be summarized and included in the final request for OMB approval. Interested persons are requested to submit comments regarding information collection by November 8, 2024 (see the ADDRESSES section at the beginning of Can-Be-Deadly-if-Swallowed; Water Beads: Harmful if Swallowed, Put in Ears—HealthyChildren.org (2024) https://www.healthychildren.org/English/ safety-prevention/at-home/Pages/Water-BeadsHarmful.aspx?gad_source=1; Water Beads | CPSC.gov (2024) https://www.cpsc.gov/SafetyEducation/Safety-Education-Centers/Water-BeadsInformation-Center?language=en. 111 U.S. Bureau of Labor Statistics, ‘‘Employer Costs for Employee Compensation,’’ September 2023, Table 4, total compensation for all sales and office workers in goods-producing private industries: https://www.bls.gov/news.release/ archives/ecec_12152023.pdf. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 73046 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules this notice). Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on: • Whether the collection of information is necessary for the proper performance of the CPSC’s functions, including whether the information will have practical utility; • The accuracy of the CPSC’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Ways to enhance the quality, utility, and clarity of the information to be collected; • Ways to reduce the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology; and • The estimated burden hours to create and update labeling and instructions, including any alternative estimates. ddrumheller on DSK120RN23PROD with PROPOSALS1 XII. Preemption Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a standard or regulation that prescribes requirements for the performance, composition, contents, design, finish, construction, packaging, or labeling of such product dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 106(f) of the CPSIA deems rules issued under that provision ‘‘consumer product safety standards.’’ Therefore, once a rule issued under section 106 of the CPSIA takes effect, it will have preemptive effect in accordance with section 26(a) of the CPSA. XIII. Certification and Notice of Requirements Section 14(a) of the CPSA imposes the requirement that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the CPSA requires that certification of children’s products subject to a children’s product safety rule be based on testing conducted by a CPSCaccepted third-party conformity assessment body. Section 14(a)(3) of the CPSA requires the Commission to publish an NOR for the accreditation of third-party conformity assessment bodies (or laboratories) to assess conformity with a children’s product VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 safety rule to which a children’s product is subject. The proposed rule would create a new 16 CFR 1250.4 as part of 16 CFR part 1250. If issued as a final rule, the proposed rule would be a children’s product safety rule that requires the issuance of an NOR. 16 CFR part 1112 establishes requirements for accreditation of thirdparty conformity assessment bodies to test for conformity with a children’s product safety rule in accordance with section 14(a)(2) of the CPSA. Part 1112 also codifies all of the NORs issued previously by the Commission. To meet the requirement that the Commission issue an NOR for the proposed standard, the Commission proposes to add water beads to the list of children’s product safety rules for which CPSC has issued an NOR. Testing laboratories applying for acceptance as a CPSC-accepted thirdparty conformity assessment body to test to the new standard for water beads would be required to meet the thirdparty conformity assessment body accreditation requirements in part 1112. When a laboratory meets the requirements as a CPSC-accepted thirdparty conformity assessment body, the laboratory can apply to CPSC to have 16 CFR 1250.4, Safety Standard for Toys: Requirements for Water Beads, included within the laboratory’s scope of accreditation of CPSC safety rules listed for the laboratory on the CPSC website at: https://www.cpsc.gov/cgi-bin/ labsearch/. Testing laboratories should not be adversely impacted as a result of this rule. Approximately 67 third-party testing laboratories are CPSC-accepted to test compliance with ASTM F963–23. CPSC staff expects that these labs will become accredited and CPSC-accepted to test to this new standard in the normal course of business. CPSC expects that these laboratories will be able to test to a new rule in a short time period. Furthermore, no laboratory is required to provide testing services. The only laboratories that are expected to provide such services are those that anticipate receiving sufficient revenue from the mandated testing to justify procuring the testing equipment and obtaining accreditation. XIV. Request for Comments The Commission requests comments on the proposed rule to promulgate a mandatory standard for water beads under section 106 of the CPSIA. During the comment period, ASTM F963–23 is available as a read-only document at: https://www.astm.org/cpsc.htm. Comments should be submitted in accordance with the instructions in the PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 ADDRESSES section at the beginning of this document. CPSC requests comments on all aspects of this rulemaking and specifically requests comment on the following topics: A. Water Bead Definition The proposed rule defines ‘‘water bead(s)’’ as ‘‘various shaped, water absorbent polymers, such as, but not limited to polyacrylamides and polyacrylates, which expand when soaked in water.’’ Should the proposed rule use a different definition of water beads? B. NPR Scope 1. Which, if any, water pellet guns designed to shoot water bead projectiles are not children’s toys within the scope of the NPR? Please provide rationale supporting your comment. 2. How, if at all, should color(s) of the water beads factor into the determination of whether they are toys, and therefore within the scope of the proposed rule? Please provide support for your recommendation. C. Proposed Requirements To Address Ingestion Hazards 1. Are the proposed 9.0 mm diameter funnel test gauge and the 50 percent expansion limit adequate to address the hazards associated with ingestion of the product? If 9.0 mm diameter is not adequate, what size is adequate and why? If a 50 percent expansion limit is not adequate, what expansion limit is adequate and why? 2. Are there any other performance requirements CPSC should consider to address the hazards associated with water bead ingestion? D. Proposed Requirements To Address Ear Insertion Hazards 1. Is the proposed 9.0 mm diameter funnel test gauge along with the 50 percent expansion limit adequate to address the hazards associated with ear insertion? If 9.0 mm diameter is not adequate, what size is adequate and why? If a 50 percent expansion limit is not adequate, what percentage is adequate and why? 2. What size dehydrated bead is most attractive to children regarding the risk of ear insertions and why? 3. Are there any other performance requirements CPSC should consider to address the hazards associated with ear insertion? E. Proposed Requirements To Address Nose Insertion Hazards 1. Is the proposed 9.0 mm diameter funnel test gauge along with the 50 E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules percent expansion limit adequate to address the hazards associated with nose insertion? If 9.0 mm diameter is not adequate, what size is adequate and why? If a 50 percent expansion limit is not adequate, what percentage is adequate and why? 2. What size dehydrated bead is most attractive to children regarding the risk of nose insertions and why? 3. Are there any other performance requirements CPSC should consider to address the hazards associated with nose insertion? endpoint(s), and appropriate safety factors? 4. The chosen test value of 100 small water beads when testing for extractable acrylamide was within the range noted in incident case reports of children ingesting water beads. Is another test value for small water beads more appropriate? 5. Is CPSC’s acrylamide limit test method sufficient to evaluate extractable acrylamide in water beads? Are there other tests methods that CPSC should consider? F. Proposed Requirements To Address Aspiration Hazards 1. Is the proposed 9.0 mm diameter funnel test gauge along with the 50 percent expansion limit adequate to address the hazards associated with aspiration of the product? If the 9.0 mm diameter is not adequate, what size is adequate and why? If a limit of 50 percent expansion is not adequate, what percentage is adequate and why? 2. Are there any other performance requirements CPSC should consider to address the hazards associated with water bead aspiration? I. Proposed Warning Label Requirements for Water Beads ddrumheller on DSK120RN23PROD with PROPOSALS1 G. Water Beads Sticking Together 1. Is there evidence of water beads sticking together or are there specific water bead products that have tendency to stick together before, during, or after expansion? If so, please provide further details. 2. Is there an environment or scenario that has successfully caused expanded water beads to aggregate with themselves and/or any other substances, like food or mucus, to cause an obstruction? If so, please provide details. H. Proposed Acrylamide Limit and Test Method 1. Is the proposed limit of 65 mg extractable acrylamide monomer from 100 small water beads or from one large water bead appropriate to adequately address the hazard of acute toxicity for children who ingest water beads? 2. The 4.0 mm demarcation between the ‘‘small’’ and ‘‘large’’ designations for water beads was selected based on CPSC staff’s observations of water bead samples prior to hydration, which tended to have diameters of equal to or less than 3.0 mm, or equal to or greater than 5.0 mm. Is another metric or method more appropriate to distinguish small and large water beads? 3. Is there an alternative, more appropriate, acute oral toxicity reference value than ATSDR’s the acute-duration oral minimal risk level that is based on valid test methods, relevant health VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 1. Are the proposed warnings adequate to address hazards associated with water beads? Should other warnings be considered? Should other warning formats be considered? 2. Regarding the proposed warning for toys that contain water beads, will consumers know what ‘‘water beads’’ are when warned of the dangers of ‘‘water beads’’ that became dislodged from the toy? Is there another term aside from ‘‘water bead’’ that would help consumers better identify what part of the toy is a water bead? 3. Regarding the proposed warning for toys that contain water beads, will consumers know what the warning ‘‘Discard if beads are coming out’’ means? Is there another term aside from ‘‘coming out’’ that would help consumers understand the warning? J. Initial Regulatory Flexibility Analysis and Other Topics 1. Significant impact. Is CPSC’s estimated cost of redesign to achieve compliance accurate? If not, please provide additional information and support for your proposed correction. Also, do the estimated costs represent more than one percent of annual revenue for individual small U.S. manufacturers and importers? 2. Testing costs. Will third-party testing costs for water beads increase as a result of the requirements in this NPR, and if so, by how much? Are test labs that are currently accredited to test for ASTM F963–23 equipped to use LC– MS–MS to test for acrylamide in water beads? What other analytical test methods and equipment are appropriate for quantifying acrylamide content in the levels discussed in the NPR? 3. Effective date. How much time is required to come into compliance with a final rule (including product compliance and third-party testing), particularly for small businesses? Please provide supporting data with your comment. PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 73047 4. Alternatives to reduce the impact on small businesses. Are there any alternatives to the rule that could reduce the impact on small businesses without reducing safety? Please provide supporting data with your comment, particularly addressing small businesses. K. Feasibility Are the proposed requirements in this NPR feasible, both technically and economically? L. Water Bead Manufacturing Are manufacturers able to limit the growth of water beads to a specific diameter or specific percentage of growth? If so, what is the process of adjusting growth potential? List of Subjects 16 CFR Part 1112 Administrative practice and procedure, Audit, Consumer protection, Reporting and recordkeeping requirements, Third-party conformity assessment body. 16 CFR Part 1250 Consumer protection, Incorporation by reference, Infants and children, Labeling, Law enforcement, Toys. For the reasons discussed in the preamble, the Commission proposes to amend 16 CFR parts 1112 and 1250 as follows: PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 1. The authority citation for part 1112 is revised to read as follows: ■ Authority: 15 U.S.C. 2063. 2. Amend § 1112.15 by adding paragraph (b)(32)(ii)(LL) to read as follows: ■ § 1112.15 When can a third-party conformity assessment body apply for CPSC acceptance for a particular CPSC rule and/or test method? * * * * * (b) * * * (32) * * *. (ii) * * * (LL) 16 CFR 1250.4, Requirements for Water Beads. * * * * * PART 1250—SAFETY STANDARD FOR TOYS 3. Revise the heading of part 1250 to read as set forth above. ■ 4. The authority citation for part 1250 is revised to read as follows: ■ Authority: 15 U.S.C. 2056b. E:\FR\FM\09SEP1.SGM 09SEP1 73048 § 1250.1 Scope. This part establishes a consumer product safety standard for toys. ■ 6. Add § 1250.4 to read as follows: ddrumheller on DSK120RN23PROD with PROPOSALS1 § 1250.4 Figure 1 to Paragraph (c)(1)—Small Parts Cylinder. Requirements for water beads. (a) Scope and purpose. This section establishes performance and labeling requirements for water bead toys and toys containing water beads to minimize the risk of children ingesting, inserting, aspirating, and choking on water beads. The provisions of this part are intended to eliminate or adequately reduce the risk of injury and death to children from water bead toy hazards. This section adds requirements for water bead toys in addition to the requirements of § 1250.2. (b) Definitions. In addition to the definitions incorporated by reference in § 1250.2(a), the following definitions apply for purposes of this section: Aspiration hazard mean a hazard caused by a child inhaling a water bead whereby the water bead can become lodged in the respiratory tract and can potentially cause death or injury. Choking hazard means a hazard cause by a child attempting to swallow a water bead whereby the water bead can become lodged in the throat and can potentially cause death or injury. Ingestion hazard means a hazard caused by a child swallowing a water bead whereby the water bead can become lodged in the digestive tract and can potentially cause death or injury. Insertion hazard means a hazard caused by a child putting a water bead in the ear canal or nasal passage of the body and can potentially cause injury or death. Water bead means a various shaped water absorbent polymer, such as, but not limited to, polyacrylamide and polyacrylate, which expands when soaked in water. (c) Performance requirements. In addition to the requirements of § 1250.2, all water bead toys and toys containing water beads within the scope of the rule must meet the performance requirements in this section to minimize the risk of children ingesting, inserting, aspirating, and choking on water beads. (1) Water beads as received or water beads removed from a toy, which fit entirely inside the small parts cylinder in their dehydrated (pre-expanded) state as shown in Figure 1 to paragraph (c)(1) (16 CFR 1501.4) shall not expand more than 50 percent in any dimension and shall remain whole while also completely passing through the funnel test gauge as shown in Figure 2 to paragraph (c)(1), under its own weight VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 1.25 in 31,7mrn A Figure 2 to Paragraph (c)(1)—Funnel Test Gauge. Material: Polytetrafluorethylene (PTFE). A A L_ _ _J IIJ50.8mm (2.0ln.) 6AlJrrm (0.25ln,) (i) Test method. Condition the water bead or toy containing the water bead, at 20 ± 5 °C (68 ± 9 °F) and at a relative humidity of 40–65 percent for a minimum of seven hours prior to the test. (ii) If the water bead is partially expanded, or contained within a toy and partially expanded, remove the water bead for testing and allow 120 hours to dehydrate. (iii) Measure the bead using calipers to determine the dehydrated dimensions. If not spherical, measure in all dimensions. When measuring with calipers, do not compress the bead in a manner that will change its shape. (iv) Submerge the water bead under a test bath of deionized water maintained at 37 ± 2 °C (98.6 ± 3.6 °F) for the PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 duration of immersion, without agitation. For water beads that exhibit positive buoyancy, place weight(s) (with mass just sufficient to achieve complete submersion) atop the water bead. Care should be taken to minimize contact of the test water bead with the sides or bottom of the container. (v) Maintain submersion for 72 hours, measuring the water bead dimensions at 6 hours, 24 hours, 48 hours and 72 hours duration. If the greatest expansion was observed at 72 hours of submersion, proceed to immediately test the expanded water bead. If the greatest expansion was observed at another time interval, condition and submerge a new water bead per paragraph (c)(1)(i)–(iv) for the time interval at which the greatest expansion was observed. Then immediately test the expanded water bead. (vi) Remove the expanded water bead and using calipers, calculate the expansion amount in all dimensions as a percentage of the dehydrated dimensions and determine whether the bead has expanded more than 50 percent in any dimension. When measuring with calipers, do not compress the bead in a manner that will change its expanded shape. (vii) Place the expanded water bead at the top surface of the gauge’s upper opening in the orientation least likely to pass through, and release allowing it to travel down until it reaches the lower opening. The expanded water bead shall remain whole and completely pass through the lower opening. (2) Acrylamide Limit Requirements. Water beads shall not have more than 65 mg acrylamide extractable from 100 small water beads (defined as <4 mm across the smallest diameter of the bead prior to hydration) or from one large water bead (defined as ≥4 mm across the smallest diameter of the bead prior to hydration) in the test procedure described below: (i) Acrylamide test procedure. To determine the amount of extractable acrylamide in water beads, first place the water beads (one large water bead or 100 small water beads) as received in a container with pH neutral deionized water. (ii) Situate the container(s) in a shaker bath that can heat the water beads to 37 °C and shake them at a rate of 30 RPM. Leave the water beads untouched for 24 hours. (iii) Multiple concurrent trials, or sequential repetitions, must be performed to ensure that results are reasonably consistent, given any beadto-bead variation. For large water beads, perform three trials with one large bead per trial. For small water beads, perform E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.017</GPH> after expansion, when tested in accordance with the following test procedure: 5. Revise § 1250.1 to read as follows: EP09SE24.016</GPH> ■ Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules three trials with 100 small beads per trial. (iv) Use an extraction container and volume of deionized water so that all water beads remain covered by water for the duration of the extraction period. Because water beads absorb water differently depending on their various sizes, additional tests may need to be conducted before starting the extractions to determine a volume of water that allows for full growth and coverage of the water beads without unnecessarily diluting the concentration of extracted acrylamide. Select containers that will not compress the water beads at any point during the 24hour extraction period. (v) Cover the containers to prevent evaporation of the water during the extraction. (vi) Following the extraction, determine the volume of remaining water for each trial. Analyze the remaining water to determine the mass of acrylamide present using an instrument that can quantitate acrylamide at levels equal to or less than the limit. (d) Labeling requirements. All water bead toys and packaging of toys containing water beads within the scope 73049 of the rule must meet the marking, labeling, and instructional literature requirements in this section to minimize the risk of children ingesting, inserting, aspirating, and choking on water beads. (1) Requirements for Marking and Labeling. (i) Water bead toys, packaging of water bead toys, and the container of water beads, if provided, must include the safety alert symbol, signal word, and word message as shown in Figure 3 to paragraph (d)(1)(i). Figure 3 to Paragraph (d)(1)(i)— Warning for Water Bead Toys and Packaging. This product contains water beads that grow larger. Children have DIED after swallowing water beads because the beads blocked their Intestines. Your child can die too. Keep away from babies and toddlers. Never use as a sensory toy or bath toy. Seek immediate medical attention if you think your child swallowed beads or inserted beads into their nose, ears, or other part of the body. (ii) Products with contained water beads, such as balls filled with water beads, and the packaging must include the safety alert symbol, signal word, and word message as shown in Figure 4 to paragraph (d)(1)(ii): Figure 4 to Paragraph (d)(1)(ii)—Toys That Contain Water Beads. (vi) The warnings shall conform to ANSI Z535.4–2023, sections 6.1–6.4, 7.2–7.6.3, and 8.1, with the following changes: (A) In sections 6.2.2, 7.3, 7.5, and 8.1.2, of ANSI Z535.4–2023 replace the word ‘‘should’’ with the word ‘‘shall.’’ (B) In section 7.6.3 of ANSI Z535.4– 2023, replace the phrase ‘‘should (when feasible)’’ with the word ‘‘shall.’’ (C) In section X of ANSI Z535.4–2023, strike the word ‘‘safety’’ when used immediately before a color (for example, replace safety white’’ with ‘‘white’’). (vii) Certain text in the message panel must be in bold and in capital letters as shown in the example warning labels in figures 3 and 4 to paragraph (d)(1)(ii). Text must use black lettering on a white background or white lettering on a black background. (viii) The message panel text shall appear in sans serif letters and be center or left aligned. Text with precautionary (hazard avoidance) statements shall be preceded by bullet points. (ix) Multiple precautionary statements shall be separated by bullet points if paragraph formatting is used. EP09SE24.019</GPH> (iii) Products with contained water beads that do not have packaging must have a hangtag or sticker label with the full warnings. Multiple products sold in a package or bin must be individually labeled with a hangtag or sticker. (iv) The warnings shall be in the English language at a minimum. (v) The warnings shall be conspicuous and permanent on the principal display panel as defined in section 3.1.62 of the version of ASTM F963 incorporated by reference in § 1250.2(a) and in a distinct color contrasting to the background on which it appears. VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.018</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 This product contains water beads that grow larger. Discard if beads are coming out. Children have DIED after swallowing water beads because the beads blocked their intestines. Your child can die too. Keep away from babies and toddlers. Never use as a sensory toy or bath toy. Seek immediate medical attention if you think your child swallowed beads or inserted beads into their nose, ears, or other part of the body. 73050 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Proposed Rules (x) The safety alert symbol A and the signal word "WARNING" shall appear in sans serif letters and be at least 1/8" (3.2mm) high and be center or left aligned. The remainder of the text (xi) The safety alert symbol, an exclamation mark in a triangle, when used with the signal word, must precede the signal word. The base of the safety alert symbol must be on the same horizontal line as the base of the letters of the signal word. The height of the safety alert symbol must equal or exceed the signal word letter height. The exclamation mark must be at least half the size of the triangle centered vertically. (2) Requirements for Instructional Literature. Instructions shall have the same warning labels that must appear on the product packaging, with similar formatting requirements, but without the need to be in color. However, the signal word and safety alert symbol shall contrast with the background of the signal word panel, and the warnings shall contrast with the background of the instructional literature. (e) Incorporation by reference. The Director of the Federal Register approves the incorporation by reference of ANSI Z535.4–23, American National Standard for Product Safety Signs and Labels (approved December 14, 2023) in paragraph (d) of this section in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This material is available for inspection at the U.S. Consumer Product Safety Commission and at the National Archives and Records Administration (NARA). Contact the U.S. Consumer Product Safety Commission at: the Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 504–7479, email: cpscos@cpsc.gov. For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to: www.archives.gov/federal-register/cfr/ ibr-locations.html. A free, read-only copy of the standard is available for viewing on the ANSI website at https:// ibr.ansi.org/Standards/nema.aspx. You may also obtain a copy from American National Standards Institute (ANSI), 1899 L Street NW, 11th Floor, Washington, DC 20036, www.ansi.org. Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2024–19286 Filed 9–6–24; 8:45 am] BILLING CODE 6355–01–P VerDate Sep<11>2014 16:20 Sep 06, 2024 Jkt 262001 DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4, 5, 19, 24, 26, and 27 [Docket No. TTB–2022–0004; Notice No. 210A, Ref: Notice No. 210] RIN 1513–AC86 Standards of Fill for Wine and Distilled Spirits Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Supplemental notice of proposed rulemaking; reopening of comment period. AGENCY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) is reopening the comment period for a proposed rule (Notice No. 210) published on May 25, 2022, which proposed changes to the authorized standards of fill for wine and distilled spirits, to solicit comments on additional suggestions raised in public comments made in response to Notice No. 210 that go beyond the scope of the original proposal. In Notice No. 210, TTB proposed to add 10 authorized standards of fill to those already authorized for wine, and alternatively, eliminating all but a minimum standard of fill for wine containers and all but a minimum and maximum for distilled spirits containers. TTB did not propose any specific standards of fill for distilled spirits as an alternative to generally eliminating them. TTB received a number of comments in response to the notice of proposed rulemaking requesting that TTB add specific new standards of fill for distilled spirits, as well as for wine, and also requesting that TTB consider eliminating the distinction between the standards of fill for distilled spirits in cans and those for distilled spirits in containers other than cans. TTB is now reopening the public comment period based on these suggestions, to provide notice to stakeholders that TTB is considering these additional requests for potential inclusion in the final rule and to also provide an opportunity for stakeholders to submit additional information to assist TTB in assessing whether to incorporate some, all, or none of these proposals into the final rule. SUMMARY: PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 The comment period for the proposed rule published on May 25, 2022 (87 FR 31787), is reopened. TTB must receive your comments on or before October 9, 2024. ADDRESSES: You may electronically submit comments to TTB on this document, and view copies of this document, the original notice of proposed rulemaking, supporting materials, and any comments TTB receives on it within Docket No. TTB– 2022–0004 as posted at https:// www.regulations.gov. A direct link to that docket is available on the TTB website at https://www.ttb.gov/lawsregulations-and-public-guidance/lawsand-regulations/all-rulemaking under Notice No. 210A. Alternatively, you may submit comments via postal mail to the Director, Regulations and Ruling Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW, Box 12, Washington, DC 20005. Please see the Public Participation section of this document for further information on the comments requested regarding this proposal and on the submission, confidentiality, and public disclosure of comments. FOR FURTHER INFORMATION CONTACT: Caroline Hermann, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW, Box 12, Washington, DC 20005; phone 202–453–1039, ext. 175. SUPPLEMENTARY INFORMATION: DATES: I. Background A. Authority The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers regulations setting forth standards of fill for containers of beverage distilled spirits and wine products distributed within the United States. The authority to establish these standards is based on two provisions of law: (1) Section 5301(a) of the Internal Revenue Code of 1986 (IRC), codified at 26 U.S.C. 5301(a) in the case of distilled spirits,1 and (2) section 105(e) of the Federal Alcohol Administration Act (FAA Act), codified at 27 U.S.C. 205(e), for both distilled spirits and wine. 1 Sections 5041(e) and 5368 of the IRC also provide the Secretary the authority to set forth tax tolerances for containers of wine products. E:\FR\FM\09SEP1.SGM 09SEP1 EP09SE24.020</GPH> ddrumheller on DSK120RN23PROD with PROPOSALS1 shall be in characters whose upper case shall be at least 1/16" (1.6mm) high.

Agencies

[Federal Register Volume 89, Number 174 (Monday, September 9, 2024)]
[Proposed Rules]
[Pages 73024-73050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19286]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1250

[CPSC Docket No. CPSC-2024-0027]


Safety Standard for Toys: Requirements for Water Beads

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA) 
mandates that ASTM F963 shall be a mandatory toy safety standard. This 
safety standard sets forth requirements for water bead toys and toys 
that contain water beads. The U.S. Consumer Product Safety Commission 
(CPSC) proposes to establish additional performance and labeling 
requirements for these products. The Commission also proposes to amend 
CPSC's list of notice of requirements (NORs) to include water bead toys 
and toys that contain water beads.

DATES: Submit comments by November 8, 2024.

ADDRESSES: Submit all comments, identified by Docket No. CPSC-2024-
0027, 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. 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. CPSC typically does not accept comments 
submitted by email, except as described below.
    Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC 
encourages you to submit electronic comments by using the Federal 
eRulemaking Portal. You may, however, submit comments by mail, hand 
delivery, or courier to: Office of the Secretary, Consumer Product 
Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; 
telephone: (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: [email protected].
    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-2024-0027, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Matthew Kresse, Project Manager, 
Division of Mechanical Engineering, Directorate for Laboratory 
Sciences, Consumer Product Safety Commission, 5 Research Place, 
Rockville, MD 20850; Telephone 301-987-2222; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

    Section 106(a) of the Consumer Product Safety Improvement Act of 
2008 (CPSIA) made ASTM International's (ASTM) voluntary standard for 
toys, ASTM F963-07, Standard Consumer Safety Specification for Toy 
Safety (except section 4.2 and Annex 4), a mandatory safety standard 
for toys beginning 180 days after the enactment date of the CPSIA. 15 
U.S.C. 2056b(a). The CPSIA states that ASTM F963 shall be considered a 
consumer product safety standard issued by the Commission under section 
9 of the Consumer Product Safety Act (15 U.S.C. 2058). Since 2009, CPSC 
has enforced ASTM F963 as a mandatory standard for toys.1 2 
In 2017, the Commission established 16 CFR part 1250, Safety Standard 
Mandating ASTM F963 for Toys, and it incorporated by reference the 
newly revised ASTM standard at that time, ASTM F963-16. 82 FR 8989 
(Feb. 2, 2017). Most recently, on January 18, 2024, the Commission 
updated part 1250 to incorporate by reference a 2023 revision, ASTM 
F963-23. 89 FR 3344.
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    \1\ Since 2009, ASTM revised F963 five times: ASTM F963-08, ASTM 
F963-11, ASTM F963-16, ASTM F963-17, and ASTM F963-23 (approved 
August 1, 2023).
    \2\ Section 3.1.91 of ASTM F963-23 (Toy): ``Any object designed, 
manufactured, or marketed as a plaything for children under 14 years 
of age.''
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    Section 4.40 of ASTM F963-23 includes requirements for toys, 
including but not limited to water beads, that are made of ``Expanding 
Materials.'' \3\ However, the requirements currently in ASTM F963-23 
for this category of toys appear insufficient to address all known 
water bead hazards. Potential hazards for ``Expanding Materials'' in 
general include gastrointestinal tract blockage if a child ingests a 
product comprised of expanding materials. Hazard mitigation provisions 
in ASTM F963-23 include performance requirements, but do not include 
warnings or instructional literature specifically tailored to the

[[Page 73025]]

``Expanding Materials'' requirements. While sections 5, 6, and 7 of 
ASTM F963-23 provide ``Labeling Requirements,'' ``Instructional 
Literature'' requirements, and ``Producer's Markings'' requirements 
generally for toys under the standard, none of these requirements is 
directed to water beads specifically. Thus, the generalized warnings 
and instructional literature requirements do not address all known 
hazards.
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    \3\ Under ASTM F963, ``Expanding Materials'' are defined as 
``any material used in a toy which expands greater than 50% in any 
dimension from its as-received state.''
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    Incident data, described in section III of this preamble, 
demonstrate that children ingest water beads, aspirate and choke on 
them, or insert them into the nose or ear, and subsequently suffer 
injury or death. Staff's testing of water beads, described in section 
IV of this preamble, further demonstrates that tested water beads that 
pass the performance requirements in ASTM F963-23 can still pose safety 
hazards. Accordingly, this notice of proposed rulemaking (NPR) under 
section 106 of the CPSIA proposes additional requirements in part 1250 
to establish mandatory requirements specifically for water beads.\4\ 
Further, this NPR proposes revising the title of part 1250 from 
``Safety Standard Mandating ASTM F963 for Toys'' to ``Safety Standard 
for Toys,'' to reflect the inclusion of proposed requirements that do 
not incorporate by reference existing requirements in ASTM 
F963.5 6
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    \4\ https://www.cpsc.gov/content/FY-2024-Operating-Plan.
    \5\ On August 21, 2024, the Commission voted unanimously (5-0) 
to publish this NPR.
    \6\ The information in this proposed rule is based in part on 
information and analysis in the July 31, 2024 Memorandum, Staff's 
Draft Proposed Rule for Safety Standard for Toys: Requirements for 
Water Beads, available at: https://www.bing.com/ck/a?!&&p=fcf3dff1c5f81972JmltdHM9MTcyNDI4NDgwMCZpZ3VpZD0wMDlhOTVlYi01OTI3LTYwZDYtMzEzYy04MTY1NTg2ODYxNGMmaW5zaWQ9NTIwNA&ptn=3&ver=2&hsh=3&fclid=009a95eb592760d6313c81655868614c&psq=Staff%e2%80%99s+Draft+Proposed+Rule+for+Safety+Standard+for+Toys%3a+Requirements+for+Water+Beads&u=a1aHR0cHM6Ly93d3cuY3BzYy5nb3YvczNmcy1wdWJsaWMvTm90aWNlLW9mLVByb3Bvc2VkLVJ1bGVtYWtpbmctUmVxdWlyZW1lbnRzLWZvci1XYXRlci1CZWFkcy5wZGY_VmVyc2lvbklkPTNreHZnemVNcElSSEphS1Eza25BNEczNnFWWjZFeVNp&ntb=1.
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    The Commission is authorized to issue this NPR pursuant to both 
section 106(c) and (d) of the CPSIA, 15 U.S.C. 2056b(c) and (d). 
Section 106(c) requires the Commission to periodically review and 
revise its mandatory toy safety standards to ensure that such standards 
provide the highest level of safety for toys that is feasible. Section 
106(d) further requires the Commission to examine and assess the 
effectiveness of its mandatory toy safety standards in protecting 
children from safety hazards, and then it must promulgate consumer 
product safety rules that are more stringent than the existing 
standards if the Commission determinates that more stringent standards 
would further reduce the risk of injury associated with such toys. 
Consistent with the consultation requirement in section 106(d)(1) of 
the CPSIA, staff has worked with the ASTM F15.22 subcommittee task 
group since 2009 to update the toy standard and discuss hazards 
associated with water beads. This consultation, including sharing 
staff's assessment of hazards and suggested additional performance and 
labeling requirements, continued through revision and publication of 
ASTM F963-23.
    Building on staff's continued collaboration with ASTM and in 
consideration of the incident data, the Commission is issuing this NPR 
to address four identified hazard patterns associated with water beads 
that are not adequately addressed by the current mandatory standard 
provisions addressing Expanding Materials: (1) ingestion of water 
beads, (2) insertion of water beads into the nose or ear, (3) 
aspiration due to water beads, and (4) choking due to water beads. The 
Commission proposes adding additional performance requirements to part 
1250 to better address these risks. The NPR also proposes establishing 
acrylamide level limits for water beads, which may contain this toxic 
chemical, and implementing new testing for water beads under part 1250 
to limit acrylamide in water beads in response to toxicity hazards when 
they enter the body. Finally, the Commission proposes labeling 
requirements for water beads under part 1250, including mandating 
warnings on products and instructional literature within scope of the 
rule.
    This NPR provides an overview of staff's assessment and analysis, 
and it includes the Commission's basis for issuing the proposed rule. 
For the reasons explained here, the Commission preliminarily determines 
that the proposed water bead requirements comply with section 106 of 
the CPSIA because they are more stringent than the current requirements 
in ASTM F963-23, would further reduce the risk of injury and death 
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 seeks comment on these issues.

II. The Product

A. Description of the Product

    Water beads are various shaped, multi-colored or clear beads 
composed of water absorbing polymers, such as polyacrylamides and 
polyacrylates, which expand when soaked in liquid such as water. When 
first purchased, water beads are small and dehydrated, typically no 
larger than 7.0 mm diameter. The beads are often sold in large quantity 
packages that may contain up to thousands of beads (depending on 
original size) in one package. While in the dehydrated state, with all 
water content removed, water beads are typically either hard, solid 
beads, or soft-gelled beads. Water beads are designed to be soaked in 
water, which allows the beads to absorb the water and expand. After 
being soaked in water for periods as short as a few hours for smaller 
water beads or two to three days for larger water beads, water beads 
multiply in size, as demonstrated in Figure 1. Some water beads can 
expand, for example, from 2.0 mm diameter in their dehydrated state to 
16.0 mm diameter when fully expanded (shown on the left in Figure 1), 
or from 7.0 mm diameter in the dehydrated state to 50.0 mm diameter 
when fully expanded (shown on the right in Figure 1). Thus, water beads 
have the potential to expand up to 800 percent of their original size. 
Once expanded, water beads remain moist even if removed from water but 
do not appear to have any adhesive properties that would cause them to 
stick together. When broken apart by hand or squeezing, expanded water 
beads tend to break into small, fragmented pieces (shown in Figure 2).

[[Page 73026]]

[GRAPHIC] [TIFF OMITTED] TP09SE24.008

    Water beads are often sold in bulk or as part of other children's 
toys, such as experiment kits and sensory kits, or can be contained 
within toy squeeze balls or stress balls. Some water beads are not 
marketed as children's toys and are outside of the scope of this 
proposed rule.
    As noted, CPSC currently regulates water beads under section 4.40 
of ASTM F963-23, Expanding Materials, and 16 CFR 1250.2(a). ASTM F963-
23 does not define the term ``water beads,'' but it defines an 
``Expanding Material'' in section 3.1.28 as ``any material used in a 
toy which expands greater than 50% in any dimension from its as-
received state when tested in accordance with 8.30.'' Section 8.30 
directs that the toy must be submerged in deionized water maintained at 
37 [deg]C  2 [deg]C for a duration of 72 hours, with the 
toy dimensions measured at 6-, 24-, 48- and 72-hour intervals in order 
to determine if the toy is an expanding material. CPSC proposes 
establishing a definition for ``water bead(s)'' under part 1250 as 
``various shaped, water absorbent polymers, such as, but not limited to 
polyacrylamides and polyacrylates, which expand when soaked in water.'' 
CPSC proposes to incorporate ASTM's process for conditioning water bead 
in the proposed rule test procedures.

B. Scope of Products Within the NPR

    This NPR would apply both to water bead toys and toys that contain 
water beads. A toy is ``any object designed, manufactured, or marketed 
as a plaything for children under 14 years of age.'' 16 CFR 1250.2(a); 
section 3.1.92 of ASTM F963-23. Water bead toys therefore are water 
beads marketed as a plaything for children under 14 years of age 
(consistent with the definition of a ``toy'' in 16 CFR 1250.2(a)), 
while toys that contain water beads are toys that encompass water beads 
within the toy and the water beads are not intended to be accessed, 
such as a squeeze ball (Figure 5). Commonly, water beads are included 
in a variety of toy products, such as toy experiment kits (Figure 3), 
toy sensory kits (Figure 4), toy squeeze/sensory balls filled with 
water beads (Figure 5), and toy water pellet guns designed to shoot 
water bead projectiles (Figure 6). Each product would be subject to the 
proposed rule and would need to meet the requirements of a final rule.

[[Page 73027]]

[GRAPHIC] [TIFF OMITTED] TP09SE24.009

    Examples of products outside of the scope of this proposed rule are 
water beads that are not toys or are not contained in toys and are for 
various non-toy uses, such as water beads used for decorative purposes 
(e.g., placement in candle holders), in vases or gardens for plant 
hydration, as air freshener products or deodorizers for cat litter, and 
in first-aid cold packs.

[[Page 73028]]

III. Incident Data and Hazard Patterns

    CPSC staff searched two CPSC-maintained databases to identify 
incidents and hazard patterns associated with water beads: the Consumer 
Product Safety Risk Management System (CPSRMS) \7\ and the National 
Electronic Injury Surveillance System (NEISS).8 9 Due to 
data availability, the CPSRMS incidents occurred between January 1, 
2017, and December 31, 2023, while the NEISS incidents occurred between 
January 1, 2017, and December 31, 2022.
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    \7\ 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 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.
    \8\ NEISS is the source of the injury estimates; it is a 
statistically valid injury surveillance system. NEISS injury data 
are gathered from emergency departments of a sample of hospitals, 
with 24-hour emergency departments and at least six beds, selected 
as a probability sample of all U.S. hospitals. The surveillance data 
gathered from the sample hospitals enable CPSC to make timely 
national estimates of the number of injuries associated with 
specific consumer products.
    \9\ CPSC staff performed multiple searches consisting of a 
combination of product codes and narrative or manufacturer/model 
keyword searches to find water bead incidents. Staff extracted data 
coded under 1381 (Toys, not elsewhere classified), 1395 (Toys, not 
specified), 1413 (Greenhouse supplies or gardening supplies 
[excluding plant stands, tools, hoses, sprayers and chemicals]), 
1616 (Jewelry [excluding watches]), 1682 (Hair curlers, curling 
irons, clips & hairpins), 5016 (Balls, other or not specified), 5020 
(Pretend electronics, tools, housewares, and appliances), 9101 (No 
clerical coding--retailer report), and 9102 (No clerical coding--
retailer report).
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A. CPSRMS Data

    From 2017 through 2023, CPSC identified 64 incidents in CPSRMS 
associated with the use of water beads. One incident resulted in a 
fatality, while 27 incidents led to hospitalization; 15 incidents led 
to emergency department (ED) treatment; and seven incidents led to care 
by a medical professional. The remaining 14 incident reports noted 
possible but uncertain medical treatment, or the level of care was 
unreported. Of the reported incidents that indicate a child's age, 
children's ages range from 9 months old to 11 years old, with one 
incident involving a 22-year-old woman with special needs. Staff 
identified the following incident data hazard patterns.

1. Ingestion

    In 52 reported incidents, a child ingested or likely ingested at 
least one water bead.\10\ Of those reports, 47 incidents involved a 
child ingesting at least one water bead, while five incidents involved 
a likely ingestion. Where reported, children between the ages of 9 
months old and 5 years old ingested or likely ingested the water beads. 
Incidents included one death, 23 hospitalizations, 12 ED treatments, 
four visits to a medical professional, and 12 instances where the level 
of care was uncertain. The fatality involved a child swallowing at 
least one water bead. Specifically, in CPSC In-Depth Investigation 
(IDI) \11\ 230727CBB1846, a 10-month-old female was discovered 
unresponsive after consuming at least one water bead. The medical 
examiner determined that the child died from complications after a 
water bead expanded and caused a small intestine obstruction.\12\
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    \10\ In several cases where a child likely ingested water beads, 
a caregiver saw a child put a water bead in his or her mouth, yet 
the presumably ingested water bead was not found. The water bead 
could have passed naturally, or the child never swallowed the water 
bead. Still, medical intervention had been sought in some incidents.
    \11\ 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.
    \12\ Water bead obstruction was measured to be ``approximately 
2.8 x 2.8 x 2.8 cm [or 28 x 28 x 28 mm].''
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    In 22 reported incidents, an ingested water bead caused a bowel 
obstruction because the water bead expanded to a size that did not 
naturally pass through the gastrointestinal tract. After ingestion, 
water beads do not remain in the stomach for an extended period, which 
limits the potential for the water bead to expand in the stomach. Water 
beads can expand fully once they pass from the stomach and into the 
small intestine because water beads remain in the small intestine for a 
longer period and are able to absorb liquid like the water in which 
they are designed to absorb and expand. After expansion, water beads 
can become too large to pass from the small intestine to the large 
intestine and instead form a bowel obstruction.
    Swallowing a water bead presents different hazards than swallowing 
a smooth, solid object such as a marble because an object like a marble 
will not grow after being swallowed. Marbles and other smooth, solid 
objects can frequently also be located and identified by x-ray due to 
their density, unlike water beads, as discussed further below. Once 
located, marbles can be removed endoscopically if reported early 
enough, especially if they appear to be too large to pass through the 
stomach or the remainder of the digestive track, whereas water beads 
can remain small within the stomach and then grow larger, then causing 
a small bowel obstruction.
    Vomiting and coughing are commonly reported initial symptoms that 
occur after a water bead is first ingested.\13\ Lethargy, distress, 
dehydration, loss of appetite, fever, fatigue, and abdominal pain are 
also reported when an expanded water bead blocks the small intestine.
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    \13\ Forrester MB. Pediatric Orbeez Ingestions Reported to Texas 
Poison Centers. Pediatr Emerg Care. 2019 Jun;35(6):426-427. doi: 
10.1097/PEC.0000000000001227. PMID: 28697162.
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    Medical providers may misdiagnose water bead ingestion symptoms 
because the symptoms are ambiguous and may be attributable to medical 
conditions or sources other than water bead ingestion, such as 
gastrointestinal illness. Further, caregivers may be unaware a child 
ingested a water bead and, therefore, are unable to report the 
ingestion. Children commonly visit medical care providers multiple 
times before diagnosis of a water bead ingestion. For example, in IDI 
220511HCC3859, a 14-month-old female was initially diagnosed with 
gastrointestinal illness after episodes of vomiting. The child was 
taken first to a pediatrician and then to a local ED where she was 
treated with intravenous fluids and released. Only after the child was 
taken to a second ED once her condition worsened was it discovered that 
she had ingested a water bead.\14\
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    \14\ Size of expanded water bead not provided. Samples of the 
product showed full expansion being between 45 mm and 50 mm in 
diameter.
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    In some cases, small water beads pass naturally, as can be the case 
when other small foreign objects are ingested, such as coins and small 
toy parts.\15\ For example, in IDI 230707CBB1698, a 3-year-old female 
ingested approximately 1,200 small water beads (approximately 1 
tablespoon before expansion). The child successfully passed all water 
beads through her digestive system with the aid of a mineral oil 
enema.\16\
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    \15\ Mehmeto[gbreve]lu F. A Retrospective 10-Year Analysis of 
Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May 
6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID: 
PMC5960561.
    \16\ Size of expanded water beads not provided. However, samples 
of the product that staff collected for testing shows full expansion 
being between 9.32 mm and 15.20 mm in diameter.
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    Medical providers may also not know that ingested water beads can 
cause

[[Page 73029]]

bowel obstructions. Therefore, although a medical provider is aware 
that a child ingested a water bead, they may send a patient home to 
digest or naturally pass the water bead, not knowing that may be 
impossible and the ingestion may result in injury or death. Water beads 
that do not pass naturally through the digestive tract can sometimes be 
removed by endoscopy or colonoscopy. However, such medical procedures 
routinely require sedation or general anesthesia, which carry risks of 
side effects and complications. For example, in IDI 230613CBB1591, a 2-
year-old male swallowed at least two water beads and was examined and 
released from an ED without intervention. The child was later admitted 
to a different hospital where a water bead was removed via endoscopy. 
The child required a third hospital visit to remove a second water bead 
via colonoscopy.\17\
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    \17\ Size of expanded water beads not provided.
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    Water beads that do not pass naturally or cannot be removed can 
result in small bowel obstructions. Children experiencing a small bowel 
obstruction have required invasive exploratory laparotomy with small 
intestine enterotomy \18\ under general anesthesia to remove any 
ingested water beads. For example, in IDI 170802CCC3140, a 13-month-old 
female became ill after ingesting a water bead. The water bead expanded 
in her small intestine, causing a blockage. She was transported to a 
hospital where the water bead was surgically removed under general 
anesthesia with an exploratory laparotomy and enterotomy.\19\
---------------------------------------------------------------------------

    \18\ An exploratory laparotomy is a general surgical operation 
where a surgeon opens the abdomen and examines the abdominal organs. 
This is coupled with a small intestine enterotomy, which is a 
surgical incision to the intestine wall to remove the foreign body.
    \19\ Size of expanded water bead not provided. Samples of the 
product that staff collected for testing shows full expansion being 
between 13.0 mm and 17.50 mm in diameter.
---------------------------------------------------------------------------

    A delay between the time a caregiver or medical provider discovers 
that a child has ingested a water bead and when the child receives 
appropriate medical treatment may increase the risk of severe injury or 
death. Prompt recognition that a child has ingested a water bead 
enables swift medical treatment and removal of the water bead before 
the water bead expands, causing gastrointestinal blockages. However, 
due to the small size of individual water beads, caregivers may not 
know that a child has swallowed a water bead, so early intervention may 
not be possible. Even after a child begins to receive medical care, 
medical providers may have difficulty locating an ingested water bead 
inside the body because water beads are radiolucent.\20\ Radiolucent 
water beads are not easily identified using routine x-ray radiography 
because they are not dense, appearing dark or black and almost entirely 
transparent when the x-ray beam passes through the bead. Incident data 
and medical literature report children requiring serial x-rays, 
computer tomography (CT) scans, and ultrasounds to accurately diagnose 
a water bead bowel obstruction.\21\
---------------------------------------------------------------------------

    \20\ Radiolucent is defined as being transparent to x-rays.
    \21\ Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of 
ingested water beads diagnosed with point-of-care ultrasound. Clin 
Exp Emerg Med. 2020 Dec;7(4):330-333. doi: 10.15441/ceem.20.041. 
Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832.
---------------------------------------------------------------------------

    Other possible medical outcomes that can occur from a child 
ingesting water beads include surgery site infection, sepsis, extended 
hospital stays, and follow up surgeries. For example:
     In IDI 221107CFE0002, a 9-month-old child required five 
surgeries to remove the small bowel obstruction and treat complications 
from the initial surgery.\22\
---------------------------------------------------------------------------

    \22\ The IDI confirms that ``[m]edical imaging revealed a 2.4 cm 
[or 24 mm] foreign object blockage.''
---------------------------------------------------------------------------

     In IDI 220701HFE0002, a 14-month-old child required a 
second surgery and a small bowel resection at the site of the previous 
enterotomy after the initial surgery failed to remove all ingested 
water beads.\23\
---------------------------------------------------------------------------

    \23\ Size of expanded water beads not provided.
---------------------------------------------------------------------------

    When reviewing the incident data and conducting laboratory testing, 
CPSC staff has not identified evidence of water beads sticking together 
once fully expanded within the gastrointestinal tract to form a 
congealed water bead mass that is more difficult to pass than 
individual beads. In an effort to diligently address all potential 
water bead ingestion hazards, though, CPSC is requesting comment on 
whether any toy water bead products present adhesive properties that 
would allow water beads to stick together.
2. Ear Insertion
    CPSRMS contains five reports of victims presenting with water beads 
in the ear canal. All five of the incidents required medical 
intervention, while two of the five incidents required hospitalization. 
When reported, children's ages ranged from 3 years old to 9 years old. 
One incident involved a 22-year-old woman with special needs.
    Ear canal insertions are not uncommon for healthcare providers to 
treat in hospital EDs. Common inserted objects include plastic beads, 
small toy parts, pebbles, and pieces of food. Many such cases are 
evaluated, then treated with irrigation or suction of the ear canal, or 
using surgical instrumentation, such as forceps or hooks.\24\ However, 
it is uniquely challenging to remove water beads from the ear 
canal.\25\ For example, water beads should not be removed using 
irrigation because exposure to water may cause the beads to expand. 
Medical providers may attempt to remove water beads with tools, but 
water beads can break during a removal attempt or if a removal attempt 
fails. Under those circumstances, surgery under sedation or general 
anesthesia may be necessary to remove water bead fragments. Further, 
because water beads are radiolucent (i.e., transparent to x-rays) and 
thus difficult for medical providers to locate and identify, 
confirmation that a water bead is in the ear canal before attempting 
removal is difficult. Although medical providers can typically see that 
something is in the ear canal, x-ray or other imaging technology such 
as a CT scan are often used to attempt to confirm the object in the ear 
canal is in fact a water bead, as opposed to a cyst or other object. 
Because water beads can be difficult to identify on x-rays and the 
symptoms are ambiguous, cases of insertions into the ear canal have 
been misdiagnosed as ear infections and treated with topical 
antibiotics, which can lead to enlargement of the bead and further 
damage to the ear canal. For similar reasons regarding enlargement, 
irrigation efforts should be avoided.
---------------------------------------------------------------------------

    \24\ Lotterman S, Sohal M. Ear Foreign Body Removal. [Updated 
2022 Nov 28]. In: StatPearls [internet]. Treasure Island (FL): 
StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459136/; Svider PF, Vong A, Sheyn A, 
et al. What are we putting in our ears? a consumer product analysis 
of aural foreign bodies. Laryngoscope. 2015;125(3):709-714. 
doi:10.1002/lary.24935.PubMedGoogle ScholarCrossref.
    \25\ Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile 
Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of 
Emergency Medicine, ISSN: 0736-4679, Vol: 56, Issue: 6, Page: e115-
e117. 2019; Sterling M, Murnick J, Mudd P. Destructive Otologic 
Foreign Body: Dangers of the Expanding Bead. JAMA Otolaryngol Head 
Neck Surg. 2016;142(9):919-920. doi:10.1001/jamaoto.2016.1870; 
Zalzal HG, Ryan M, Reilly B, Mudd P. Managing the Destructive 
Foreign Body: Water Beads in the Ear (A Case Series) and Literature 
Review. Annals of Otology, Rhinology & Laryngology. 
2023;132(9):1090-1095. doi:10.1177/00034894221133768.
---------------------------------------------------------------------------

    Early diagnosis of a suspected water bead insertion is critical for 
a good health outcome because water beads are highly damaging when they 
expand into middle ear structures.\26\ Young children or patients with 
certain special needs may not be able to communicate well

[[Page 73030]]

enough to explain that a water bead is lodged in their ear, which leads 
to delayed diagnosis and a poor treatment outcome. For example, in 
I2410042A, a 22-year-old female with special needs visited multiple 
healthcare facilities before diagnosis of a water bead ear 
insertion.\27\ Once a water bead expands into the middle ear structure, 
children can experience ear pain, damage to ear structures, and hearing 
loss. For example, in IDI 210421HCC1751, a 5-year-old female's ear drum 
was injured after a water bead expanded in her ear canal.\28\ 
Similarly, a case report identifies a 4-year-old female who sustained a 
small ear drum perforation. The perforation was subsequently repaired 
during a follow up operation.\29\
---------------------------------------------------------------------------

    \26\ The middle ear is the portion of the ear that is 
responsible for transferring acoustic energy to the inner ear.
    \27\ Size of expanded water bead not provided.
    \28\ Size of expanded water bead not provided.
    \29\ Ramgopal S, Ramprasad V, Manole M, Maguire R. Expansile 
Superabsorbent Polymer Ball Foreign Body in the Ear. The Journal of 
Emergency Medicine, ISSN: 0736-4679, Vol: 56, Issue: 6, Page: e115-
e117. 2019.
---------------------------------------------------------------------------

    Long-term or permanent hearing loss is possible after a water bead 
is inserted into the ear canal. For example, in IDI 230613CBB1590, a 3-
year-old female reported ear pain for several days. She was initially 
presumed to have an ear infection and was treated with antibiotics. 
Thereafter, she began having seizures and was hospitalized. A water 
bead was removed from her middle ear after it expanded and ruptured the 
right ear drum.\30\ The child experienced ongoing seizures, hearing 
loss, and ear pain at least 14 months after the incident. Another case 
report describes a 10-year-old female who suffered permanent hearing 
loss after a water bead remained in her ear canal for at least 10 
weeks.\31\
---------------------------------------------------------------------------

    \30\ The IDI confirms that the ``[g]randmother described the 
extracted water bead as being the size of a pea.''
    \31\ Schulze SL, Kerschner J, Beste D. Pediatric external 
auditory canal foreign bodies: a review of 698 cases. Otolaryngol 
Head Neck Surg. 2002 Jul;127(1):73-8. doi: 10.1067/mhn.2002.126724. 
PMID: 12161734.
---------------------------------------------------------------------------

3. Nose Insertion
    Four injury incident reports identify children presenting with 
water beads in the nasal passage. One incident involved a required 
hospitalization. When a child's age was reported, ages ranged from 3 
years old to 11 years old.
    Water beads can cause severe tissue damage to the nasal mucosa \32\ 
if left in the nasal cavity for prolonged periods of time, such as days 
or weeks.\33\ While it is not uncommon for children to insert foreign 
bodies into nasal cavities, children may display significant symptoms 
from water beads that are not experienced after inserting other 
objects, such as pieces of food, into the nose. Water bead nasal cavity 
insertion symptoms include nasal congestion, bleeding, fever, runny 
nose, and nasal swelling. Because these symptoms can be related to many 
other causes, caregivers or doctors may not realize that they are due 
to water beads.
---------------------------------------------------------------------------

    \32\ The tissue that lines the nasal cavity.
    \33\ Han S, Chen Y, Xian X, Teng Y. BMC Pediatrics (2021) 21:273 
https://doi.org/10.1186/s12887-021-02740-x.
---------------------------------------------------------------------------

    While it may be possible to remove a water bead from a nasal cavity 
without professional medical intervention or for a water bead to pass 
naturally, children may still experience symptoms and negative side 
effects after water beads expand in the nose. For example, in 
I18C0277A, a 3-year-old male was eventually able to blow out a water 
bead that had been in his nose for up to two weeks.\34\ The child had 
not told his parents he had inserted the water bead into his nose, but 
the parents later described the child as having had a nosebleed, 
trouble sleeping, congestion, a small tear in the nasal cavity, and a 
low-grade fever lasting three days.
---------------------------------------------------------------------------

    \34\ Size of expanded water bead not provided.
---------------------------------------------------------------------------

    Some water bead nose insertions require medical intervention to 
remove the water bead, sometimes using nasal endoscopy under general 
anesthesia or sedation.\35\ For example, in IDI 180104CBB1236, a 4-
year-old male was placed under general anesthesia at a local hospital 
and underwent a nasal endoscopy. The child inserted an unknown number 
of water beads into his nose. He was successful in blowing out most of 
the water beads, but a nasal endoscopy revealed a single water bead in 
the nasal passages. Removal was unsuccessful due to bleeding, so the 
child was placed under general anesthesia to remove the remaining water 
bead.\36\
---------------------------------------------------------------------------

    \35\ Id.
    \36\ Size of expanded water bead not provided.
---------------------------------------------------------------------------

4. Aspiration
    Aspiration is the entry of a foreign body, excess saliva, food, or 
stomach contents from the upper respiratory tract into the lower 
respiratory tract, which includes the trachea, bronchi, bronchioles, 
and lungs. Two reported incidents of aspiration involved a child 
swallowing and inhaling a water bead that then entered and blocked the 
child's airway. One incident required ED treatment and the other 
required hospitalization.
    Sudden inhalation of small objects can cause aspiration into the 
respiratory tract.\37\ Depending on the object's size, aspirated 
foreign bodies tend to pass through the trachea and bronchi mainstream 
and lodge in areas of the tracheobronchial tree.\38\ If a water bead 
becomes lodged in a child's upper airway, particularly after expansion, 
the child may experience airway obstruction or acute respiratory 
distress, which may be fatal. Examples of aspirations include:
---------------------------------------------------------------------------

    \37\ Abdulmajid, O., Ebeid, A.M, Motaweh, M.M., Kleibo, I.S. 
Aspirated foreign bodies in the tracheobronchial tree. Thorax 
31:365-640, 1976; Aytac, A. Ikizler, C. Inhalation of foreign bodies 
in children. J. Thoracic & Cardiovasc. Surgery 74(1):145-151, 1977; 
Blazer, S. Naveh, Y., Friedman, A. Foreign body in the airway--a 
review of 200 cases. Am. J. Diseases of Children 134(1):68-71, 1980; 
Cohen, S.R., Herbert, W.I. Lewis, G.B. Geller, K.A. Foreign bodies 
in the airway--five-year retrospective study with special reference 
to management. Ann. Otol. 89:437-442, 1980.
    \38\ The tracheobronial tree is composed of the trachea, the 
bronchi, and the bronchioles that transport air from the environment 
to the lungs for gas exchange.
---------------------------------------------------------------------------

     In I2310047A, a 20-month-old male aspirated a water bead, 
which obstructed his airway, necessitating medical intervention.\39\
---------------------------------------------------------------------------

    \39\ Size of expanded water bead not provided.
---------------------------------------------------------------------------

     In IDI 201130CCC3196, an 18-month-old male aspirated water 
beads, which led to an airway obstruction. The child was admitted to 
the hospital for a bronchoscopy \40\ under general anesthesia, where 
several water beads were removed from his airway.\41\
---------------------------------------------------------------------------

    \40\ A bronchoscopy is an endoscopic technique to visualize the 
inside of the airways for diagnostic and therapeutic purposes.
    \41\ IDI included a photo of an expanded water bead from the toy 
alongside a dime coin to reflect the bead's approximate size. While 
the expanded sizes of the removed beads are unknown, the mother 
provided a photo of before and after expansion in water. The photo 
shows an expanded bead with a diameter about the size of a dime, and 
much larger than an unexpanded bead next to it. As discussed in 
section IV of this preamble below, limiting the expansion potential 
of water bead toys to no more than 50 percent of the original size 
will help reduce damage from aspiration.
---------------------------------------------------------------------------

    When a child aspirates a water bead, the initial symptoms range 
from minor initial choking spells, coughing, or wheezing, to 
unconsciousness as the water bead obstructs more of the airway for a 
longer period of time, resulting in the child being unable to breathe 
and transmit oxygen to the brain. Death versus injury to the child 
after a water bead aspiration is dependent upon the degree of bronchial 
obstruction and the time interval between inhalation and extraction of 
the water bead. Early diagnosis of water bead aspiration allows for a 
greater likelihood of successful removal and better potential treatment 
outcome because the water bead may not have yet expanded. Because water 
beads are radiolucent, they can be difficult to locate within the body 
and thus difficult to remove,

[[Page 73031]]

particularly when the airway obstruction is not complete.
5. Choking
    One reported incident identified that a child had choked on a water 
bead. Choking occurs when a foreign body fully or partially obstructs 
the airway to compromise oxygen supply to the lungs.\42\ Physical 
characteristics of objects that pose a choking hazard include, for 
example, large size, round shape, and smooth texture.
---------------------------------------------------------------------------

    \42\ Baker, S.P. Childhood asphyxiation by choking or 
suffocation. JAMA 244(12):1343-1346, 1980.
---------------------------------------------------------------------------

    The hazard pattern for choking does not depend upon expansion after 
the water bead enters the body. Caregivers commonly place water beads 
in water for prolonged periods of time so the beads can fully expand in 
advance of a child's playtime. For example, in IDI 180104CBB1236, the 
child's father placed a number of water beads in water so that they 
``would grow and be ready to use in the morning.'' Children may then 
attempt to swallow the expanded beads. Large, expanded water beads pose 
a significant choking hazard because they are spherical objects, which 
can easily roll to the back of the throat and form an air-tight seal 
with the elastic lining of the airway, thereby causing a complete 
blockage of the air way and inability to breath.\43\ The throat muscles 
can contract and tightly grip a water bead, which can make removal 
difficult without medical intervention. If an object completely 
obstructs the airway at or above the level of the trachea, the rapid 
loss of oxygen to body tissues can cause irreversible brain damage or 
death within minutes. If the airway is not completely blocked, the gag 
reflex will force the object to the back of the throat (the opposite of 
swallowing) and the cough reflex will bring in air to force the object 
from the airway in response to choking.
---------------------------------------------------------------------------

    \43\ Chang DT, Abdo K, Bhatt JM, Huoh KC, Pham NS, Ahuja GS. 
Persistence of choking injuries in children. Int J Pediatr 
Otorhinolaryngol. 2021 May;144:110685. doi: 10.1016/
j.ijporl.2021.110685. Epub 2021 Mar 21. PMID: 33819896; Hayes NM, 
Chidekel A. Pediatric choking. Del Med J. 2004 Sep;76(9):335-40. 
PMID: 15510972.
---------------------------------------------------------------------------

B. National Injury Estimates From NEISS

    Based on NEISS data, CPSC estimates 6,300 injuries (sample size = 
250, coefficient of variation = 0.27) related to water beads were 
treated in U.S. hospital EDs over the six-year period from 2017 through 
2022.\44\ Of the 250 sample NEISS cases, none were fatal. About 42 
percent of the estimated injuries involved children ages 2 through 4 
years old, while about 15 percent of the estimated injuries involved 
children under the age of 2 years old. The youngest child was 7 months 
old. Forty-one (41) percent of those injured were male, while 59 
percent were female. Regarding patient disposition, 95 percent were 
treated at the hospital ED and released; 3 percent were held for 
observation; 2 percent were admitted for hospitalization; and less than 
1 percent left the hospital without care. The following hazard patterns 
were identified:
---------------------------------------------------------------------------

    \44\ The estimated injuries for this NPR are less than the 
estimate presented in the public guidance on water beads that can be 
found on the Commission's website at https://www.cpsc.gov/Safety-
Education/Safety-Education-Centers/Water-Beads-Information-
Center#:~:text=CPSC%20urges%20parents%20and%20caregivers, 
seek%20medical%20treatment%20right%20away. The difference is mainly 
due to the NPR excluding incidents with hazard patterns related to 
rashes or other allergic reactions and incidents involving water 
bead gel blaster projectiles, which commonly involve eye injury and 
some of which may not involve children's toys in the scope of this 
proposed rule.
---------------------------------------------------------------------------

     Ingestion (48 percent): the reports stated that the child 
ingested or swallowed a water bead, possibly ingested a water bead, or 
had put a water bead in his or her mouth. In all sample cases, the 
youngest child was 7 months old. Three (3) percent of all estimated 
injuries due to water bead ingestion involved hospitalizations.
     Ear insertion (36 percent): the reports stated that the 
child either inserted a water bead into their ear or presented with a 
water bead stuck in the ear with uncertainty as to how the water bead 
became inserted. In all sample cases, the child was between the ages of 
two and 15 years old.
     Nose insertion (15 percent): the reports stated that the 
child either inserted the water bead into their nose or presented with 
the water bead stuck in the nose with uncertainty as to how the water 
bead became inserted. In all sample cases, the child was between the 
ages of two and 10 years old.
     Other (<1 percent): the remaining reports identified one 
injury from aspiration and one from eye insertion.

C. Overview of Hazards in Relation to Child Supervision and Behavior

    Water bead ingestion, nasal and ear insertion, choking and 
aspiration can occur in seconds. Many incidents are not witnessed 
because the caregiver was not directly looking at the child when the 
ingestion, insertion, initial choking or aspiration occurred. Research 
indicates that toddlers and preschoolers (ages 2 years old through 5 
years old) are out of view of a supervisor for about 20 percent of 
their awake time at home and are not within visual or hearing range for 
about 4 percent of awake time at home.\45\ A study of 100 parents found 
that the mean amount of time parents were willing to leave a child 
unsupervised in low-risk areas, such as a living room, was six minutes 
before the child was old enough to crawl and four minutes after the 
child was old enough to crawl, before the child was 2 years old.\46\ 
Consumers reasonably may not know water beads are hazardous, 
particularly because they are marketed for children's play.
---------------------------------------------------------------------------

    \45\ Morrongiello, B. A., Corbett, M., McCourt, M., & Johnston, 
N. (2006). Understanding unintentional injury-risk in young children 
I. The nature and scope of caregiver supervision of children at 
home. Journal of Pediatric Psychology, 31(6): 529-539.
    \46\ Garzon, D.L., Lee, Dr. R.K., and Homan, S.M. (2007) 
``There's No Place Like Home: A Preliminary Study of Toddler 
Unintentional Injury.'' Journal of Pediatric Nursing, 22, 368--375.
---------------------------------------------------------------------------

    Research demonstrates that infants and toddlers are likely to mouth 
objects within reach. Mouthing of non-food items is a normal part of 
children's exploratory behavior that contributes to incidents of 
choking and poisoning.\47\ This behavior is part of the reason for the 
ban on small parts for toys intended for children younger than 3 years 
of age, for example, and the mandatory small-parts warning for toys and 
games intended for children ages 3 years old to 6 years old. 16 CFR 
part 1501. Mouthing non-food items tends to decrease as a child's age 
increases; however, it is not uncommon for children over the age of 3 
years old to experience choking or ingestion episodes with objects 
other than food.\48\ Children are prone to ingest or insert small, 
smooth, colorful objects, like water beads or toy parts.\49\ 
Unintentional foreign body ingestion is a leading causes for nonfatal 
ED visits in children younger than 9 years old.\50\

[[Page 73032]]

Management and treatment for childhood accidental ingestion is well 
documented in pediatric medical literature.\51\
---------------------------------------------------------------------------

    \47\ Tulve, N., Suggs, J., McCurdy, T., Cohen-Hubal, E., & Moya, 
J. (2002). Frequency of mouthing behavior in young children. Journal 
of Exposure Analysis and Environmental Epidemiology. 12, 259-264.
    \48\ A-Kader. (2010) Foreign body ingestion: children like to 
put objects in their mouth. World J Pediatrics, Vol 6 No 4 . 
November 15, 2010. www.wjpch.com; Orsagh-Yentis D, McAdams RJ, 
Roberts KJ, et al. (2019). Foreign-Body Ingestions of Young Children 
Treated in US Emergency Departments: 1995-2015. Pediatrics. 
143(5):e20181988; Reilly, J. (1992, Fall). Airway Foreign Bodies: 
Update and Analysis. Int Anesthesiol Clin.30(4):49-55; Altman, A., 
Ozanne-Smith, J. (1997). Non-fatal asphyxiation and foreign body 
ingestion in children 0-14 years. Injury Prevention. 3:176-182.
    \49\ Svider, P.F., Vong, A., Sheyn, A., Bojrab, D.I., Hong, R. 
S., Eloy, J.A., and Folbe, A.J. (2015). What are we putting in our 
ears? A consumer product analysis of aural foreign bodies. The 
Laryngoscope. 125, 709-714; Heim, SW, & Maughan, K.L. (2007). 
Foreign Bodies in the ear, nose, and throat. American Academy of 
Family Physicians, 76, p.1186-1189.
    \50\ Centers for Disease Control and Prevention. Web-based 
Injury Statistics Query and Reporting System (WISQARS) [Online]. 
(2003). National Center for Injury Prevention and Control, Centers 
for Disease Control and Prevention. Available from: URL: 
www.cdc.gov/ncipc/wisqars. [10/1/2022].
    \51\ Kay, M., & Wyllie, R. (2005). Pediatric foreign bodies and 
their management. 7(3):212-8; Lee, J.H., (2018) Foreign Body 
Ingestion in Children. Clinical Endoscopy, 51:129-136; Kramer et 
al., 2015; Conners GP,& Mohseni M. Pediatric Foreign Body Ingestion. 
[Updated 2021 Jul 18]. In: StatPearls [internet]. Treasure Island 
(FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430915/--(accessed 4/12/22) Pediatric 
Foreign Body Ingestion--StatPearls--NCBI Bookshelf (nih.gov).
---------------------------------------------------------------------------

D. Availability of Incident Data

    Upon publication of this NPR in the Federal Register, CPSC staff 
will make available for review and comment the CPSRMS and NEISS 
incident reports relied upon and discussed in the NPR, to the extent 
allowed by applicable law, along with the associated IDIs. The data 
will be made available by submitting a request to: https://forms.office.com/g/gSZi1gHic8. You will then receive a website link to 
access the data at the email address you provided. If you do not 
receive a link within two business days, please contact 
[email protected].

E. Recalls

    From December 2012 through March 2024, the Commission's Office of 
Compliance and Field Operations conducted five recalls and issued two 
unilateral press release warnings \52\ regarding water bead products. 
Table 1 below summarizes the seven announcements, including the 
announcement date, firm/brand, hazard(s), approximate number of units 
affected, number of reported incidents/injuries, and press release 
number. The announcements involved one death and five reported 
injuries, and affected approximately 166,000 units.
---------------------------------------------------------------------------

    \52\ A unilateral press release is a product-related safety 
warning issued by CPSC that is not issued jointly with a recalling 
company.
    \53\ When the 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.
    \54\ https://www.cpsc.gov/Recalls/2012/dunecraft-recalls-water-balz-skulls-orbs-and-flower-toys-due-to-serious-ingestion.
    \55\ https://www.cpsc.gov/Recalls/2013/Be-Amazing-Toys-Recalls-Monster-Science-and-Super-Star-Science-Colossal-Water-Balls.
    \56\ https://www.cpsc.gov/Recalls/2013/Eco-Novelty-Recalls-Jumbo-Size-and-Jumbo-Multipurpose-Cosmo-Beads-Toys.
    \57\ https://www.cpsc.gov/Recalls/2014/Doodlebutt-Recalls-Jelly-BeadZ-Jumbo-BeadZ-and-Magic-Growing-Fruity-Fun-Toys.
    \58\ https://www.cpsc.gov/Recalls/2023/Buffalo-Games-Recalls-Chuckle-Roar-Ultimate-Water-Beads-Activity-Kits-Due-to-Serious-Ingestion-Choking-and-Obstruction-Hazards-One-Infant-Death-Reported-Sold-Exclusively-at-Target.

                                                      Table 1--Summary of Water Bead Announcements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Number of
           Announcement date                    Firm/brand                     Hazard                affected      Number of incidents     Press release
                                                                                                      units     (injuries & deaths) \53\        No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
December 17, 2012.....................  Dunecraft Inc............  Serious Ingestion Hazard......       94,799  1 incident (1 injury, 0      \54\ 13-071
                                                                                                                 deaths).
July 31, 2013.........................  Be Amazing! Toys.........  Serious Ingestion Hazard......       14,200  None Reported...........     \55\ 13-254
September 10, 2013....................  Eco-Novelty Corp.........  Serious Ingestion Hazard......        3,500  None Reported...........     \56\ 13-278
December 12, 2013.....................  Doodlebutt...............  Serious Ingestion Hazard......        1,500  None Reported...........     \57\ 14-056
September 14, 2023....................  Buffalo Games, Inc.......  Serious Ingestion, Choking and       52,000  2 incidents (1 injury, 1     \58\ 23-286
                                                                    Obstruction Hazards.                         death).
March 19, 2024........................  Jangostor Brand..........  Chemical Toxicity Hazard--          Unknown  2 incidents (2 injuries,     \59\ 24-163
                                                                    Violation of Federal Ban of                  0 deaths).
                                                                    Hazardous Substances.
March 19, 2024........................  Tuladuo Brand............  Chemical Toxicity Hazard--          Unknown  1 incident (1 injury, 0      \60\ 24-162
                                                                    Violation of Federal Ban of                  deaths).
                                                                    Hazardous Substances.
--------------------------------------------------------------------------------------------------------------------------------------------------------

IV. Review of Voluntary Standards--ASTM F963 and EN 71-1
---------------------------------------------------------------------------

    \59\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
    \60\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Tuladuo-Water-Bead-Sets-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
---------------------------------------------------------------------------

    ASTM F963 includes performance requirements and test methods for 
toys, as well as requirements for warning labels and instructional 
literature, to reduce or prevent injury to children or death of 
children from mechanical, chemical, and other hazards associated with 
toy use. Toys must comply with this standard pursuant to 16 CFR part 
1250.
    ASTM F963 defines ``Expanding Materials'' as ``any material used in 
a toy which expands greater than 50% in any dimension from its as-
received state.'' Section 4.40 of ASTM F963-23 addresses potential 
hazards associated with expanding materials by requiring that toys and 
removable components of toys composed of expanding materials which, 
first, fit entirely within a small parts cylinder while in the toy's 
as-received size condition, then must, after expansion, completely pass 
through a 20.0 mm diameter gauge while applying a force of up to 4.5 
lbf (pound-force).
    Water beads that expand up to 20.0 mm diameter would meet the ASTM 
F963-23 ``Expanding Material'' requirements because they would pass 
through the gauge, but water beads larger than 20.0 mm diameter would 
likely fail the requirements because the water beads would fragment 
once force is applied, as described below in more detail. Yet, as 
explained in section III of this preamble, incident data show that 
water beads both larger and smaller than 20.0 mm diameter are 
hazardous.
    Another voluntary standard used primarily in the European Union, EN 
71-1, Safety of Toys--Part 1: Mechanical and Physical Properties, also 
provides requirements for expanding materials. Section 3.24 of EN 71-1 
defines an ``expanding material'' as a ``material, the volume of which 
expands when exposed to water.'' Section 4.6 of EN 71-1 establishes 
performance requirements for expanding materials in toys or components 
of toys which fit entirely in a 31.7 mm diameter small parts cylinder, 
the same size as CPSC's small parts cylinder reflected in Figure 9 
below, and states they shall not expand more than 50 percent in any 
dimension when measured after being submerged in demineralized water 
for 24, 48 and 72 hours. If the expansion in any dimension is more than 
50 percent, then the toy does not comply with the expanding material 
requirement. For example, water beads with an unexpanded diameter of 
2.0 mm and expand larger than 3.0 mm diameter would pass through the 
small parts cylinder in their dehydrated state but expand by more than 
50 percent, thus failing the EN 71-1 requirements. Additionally, EN 71-
9, Safety of Toys--

[[Page 73033]]

Part 9: Organic Chemical Compounds--Requirement \61\ provides a test 
method and a concentration limit for a potentially hazardous chemical, 
called acrylamide, in toys. The EN standard states that the acrylamide 
concentration limit has been ``calculated based on long-term licking, 
sucking and chewing of toys that are intended or likely to be mouthed 
for a significant amount of time. Examples are teethers, rattles and 
other hand-held soft plastic toys for young children.''
---------------------------------------------------------------------------

    \61\ EN 71-9 provides requirements and test methods for organic 
chemical compounds, such as acrylamide. Previously cited EN 71-1 
provides requirements and test methods for mechanical and physical 
properties, such as expansion limits. Both are part of the standard 
EN 71.
---------------------------------------------------------------------------

    Acrylamide limitations in EN 71-9 were developed to address 
acrylamide exposure following long-term licking, sucking and chewing of 
toys that are intended to be mouthed. In contrast, water bead toys 
addressed in this NPR are not intended to be mouthed, nor are they 
likely to be mouthed for a significant amount of time. The hazards this 
NPR works to address are ingestion, insertion, choking, and aspiration, 
not mouthing. Therefore, CPSC staff proposes mandating a different 
acrylamide limit and test method, intended to address the hazards 
outlined in the NPR, which is discussed in section V of this preamble.

A. Assessment of Current ASTM F963-23 Performance Requirements

    The test method for ``Expanding Materials'' described in section 
8.30, Expanding Materials--Test Method of ASTM F963-23 requires that an 
expanding material, such as a water bead, first be submerged in 
deionized water for up to 72 hours in order to reach its largest 
expansion size. The product is then tested to check whether, at its 
largest expanded size, the water bead can pass through a gauge with a 
20.0 mm (+0.0/-0.1 mm) diameter hole, as is seen in Figure 7, when 
applying a force of 4.5 lbf (pound-force) to the water bead in the 
direction of the hole via a rod having a hemispherical end diameter of 
10.0 mm.
---------------------------------------------------------------------------

    \62\ Reprinted, with permission, from ASTM F963-23 Standard 
Consumer Safety Specification for Toy Safety, 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. A free, read-only copy of the standard 
is available for viewing on the ASTM website at https://www.astm.org/READINGLIBRARY/.
[GRAPHIC] [TIFF OMITTED] TP09SE24.010

    CPSC staff assessed the current ASTM test method in section 8.30 of 
ASTM F963-23 and found that using a rod to apply force to an expanded 
water bead to determine whether the water bead can fit through a test 
gauge does not realistically represent the compression forces exerted 
on a water bead when it is swallowed. The use of a 10.0 mm diameter rod 
to apply a force when conducting the test causes fragmentation of the 
water bead (Figure 8), which would be considered a ``pass'' pursuant to 
the ASTM test standard. Yet, incident data confirms water beads remain 
whole after being swallowed, thus creating a gastrointestinal tract 
blockage.\63\ Because the force that the rod exerts can damage the 
expanded water bead and cause fragmentation, Commission staff has 
assessed that the current ASTM test method is inadequate to effectively 
test water beads for an ingestion hazard.
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    \63\ Examples include the following IDIs: 230727CBB1846, 
230707CBB1698, 230613CBB1591, 170802CCC3140 and 221107CFE0002.

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[[Page 73034]]

[GRAPHIC] [TIFF OMITTED] TP09SE24.011

    Staff also analyzed the 20.0 mm (+0.0/-0.1 mm) diameter gauge 
specified in section 4.40 of ASTM F963-23 and determined that in light 
of incident data demonstrating how ingestion hazards occur, the gauge 
diameter should be reduced. The 20.0 mm diameter gauge used in ASTM 
F963 was selected based on the dimension of the pyloric sphincter \64\ 
within the gastrointestinal tract of an 18-month-old child because, at 
the time the ``Expanding Materials'' requirements were created, the 
pyloric sphincter was thought by the drafters to be the most likely 
site where the gastrointestinal blockage would occur. As explained 
below, however, objects that can cause a gastrointestinal blockage are 
more likely to occur at either the gastric outlet part of the stomach 
or the ileocecal valve at the end of the small intestine.\65\
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    \64\ The pyloric sphincter is the valve located at the bottom of 
the stomach which opens to allow food to pass from stomach to the 
small intestine.
    \65\ The ileocecal valve is a sphincter muscle situated at the 
junction of the ileum (last portion of the small intestine) and the 
colon (first portion of the large intestine).
---------------------------------------------------------------------------

    Water beads, like other foreign bodies and food, do not remain in 
the stomach for long. Therefore, water beads generally do not expand 
fully in the stomach but pass through the pyloric sphincter and into 
the small intestine. Water beads continue to expand in the small 
intestine, where they spend more time and are exposed to liquid that 
facilitates expansion. After the water beads expand fully in the small 
intestine, they are unable to pass through the ileocecal valve and into 
the large intestine, therefore causing a gastrointestinal blockage. 
CPSC staff evaluated the relevant recent incident data and advises that 
because the ileocecal valve is often the site of the gastrointestinal 
blockage when a child ingests a water bead, the ileocecal valve is a 
more appropriate anatomical structure on which to base the diameter of 
the funnel test gauge than the pyloric sphincter. Literature on 
ileocecal valve size indicates valve size will vary based on age and 
natural variation within the population, 66 67 but the 
Commission has not identified reliable authorities providing ileocecal 
valve sizes for children between the ages of 9 months old and 3 years 
old. Accordingly, as explained in section V below, the Commission has 
based this proposed rule on incident data.
---------------------------------------------------------------------------

    \66\ Tang SJ, Wu R. Ilececum: A Comprehensive Review. Can J 
Gastroenterol Hepatol. 2019 Feb 3;2019:1451835. doi: 10.1155/2019/
1451835. PMID: 30854348; PMCID: PMC6378086.
    \67\ Silva AC, Beaty SD, Hara AK, Fletcher JG, Fidler JL, Menias 
CO, Johnson CD. Spectrum of normal and abnormal CT appearances of 
the ileocecal valve and cecum with endoscopic and surgical 
correlation. Radiographics. 2007 Jul-Aug;27(4):1039-54. doi: 
10.1148/rg.274065164. PMID: 17620466.
---------------------------------------------------------------------------

    Section 4.40 of ASTM F963-23 also requires that ``[t]oys, and 
removable components of toys, which fit entirely inside the small parts 
cylinder in their as-received condition, and which are composed of an 
expanding material, shall completely pass through the gauge when 
tested.'' The referenced small parts cylinder is from 16 CFR 1501.4 and 
section 4.6.1, Small Objects of ASTM F963-23, which provides general 
safety requirements. Under section 4.6.1, toys intended for children 
under 36 months of age, ``including removable [components], liberated 
components, or fragments of toys[,] shall [not] be small enough without 
being compressed to fit entirely within [the small parts cylinder].'' 
This requirement is to minimize choking, ingestion, or inhalation 
hazards. Most water bead products are intended for children older than 
36 months of age, however, and therefore are not subject to 
requirements in section 4.6.1 of ASTM F963-23.
    Finally, to address the potential presence of toxic chemicals in 
toys, section 4.3 of ASTM F963-23 requires that all toys must comply 
with the Federal Hazardous Substances Act (FHSA) toxicity and hazardous 
substances standards. Though there is this generalized FHSA compliance 
requirement for all of ASTM F963-23, section 4.40, Expanding Materials 
of ASTM F963-23 does not specifically mandate testing for hazardous 
chemicals. Water beads are composed of absorbent polymers, which can 
contain acrylamide monomer--a chemical that can be hazardous when 
ingested.\68\ ASTM F963-23 does not have any test methods or limits for 
acrylamide monomer in water beads. Therefore, the current ASTM standard 
is inadequate to provide the highest level of safety feasible to ensure 
that the chemicals in water beads are non-toxic. Because water beads 
containing high levels of acrylamide monomer are toxic, the NPR 
proposes to establish content limits and test methods to address the 
toxicity hazard.
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    \68\ Per the Federal Hazardous Substances Act (FHSA) (16 CFR 
1500.3(c)(2)(i)(A)), a substance with a median lethal dose 
(LD50) between 50 and 5000 mg/kg in rats is ``toxic'' for 
acute toxicity. The reported oral LD50 values for 
undiluted acrylamide in rats range from 150 to 413 mg/kg. See ATSDR 
Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------

B. Assessment of Current EN 71-1 Expanding Materials Requirements

    The test method for ``Expanding Materials'' described in section 
8.14 of EN 71-1 requires that an expanding material, such as a water 
bead, that fits entirely in a small parts cylinder first be measured, 
using calipers,\69\ to determine its original size in each dimension. 
Next, the expanding material must be submerged in demineralized water 
for up to 72 hours to reach its largest expansion size. After 
expansion, the water bead must be measured again to determine if it has 
expanded more than 50 percent of its original size in any dimension. If 
the water bead has expanded more than 50 percent, the expanding 
material requirements are not met.
---------------------------------------------------------------------------

    \69\ An instrument used to measure the dimensions of an object.
---------------------------------------------------------------------------

    The Commission preliminarily determines that the current EN 71-1 
expanding material requirement is inadequate as a stand-alone 
requirement. Staff assesses that an additional maximum size requirement 
is

[[Page 73035]]

necessary because as currently written, for example, the standard would 
allow for a water bead having a diameter of 9.0 mm to expand to 13.5 mm 
diameter. While this expansion would not be more than 50 percent of the 
water bead's original size, therefore meeting the EN 71-1 expanding 
material requirements, the expanded water bead would likely cause a 
gastrointestinal block if a child ingested it. Indeed, as described in 
section III of this preamble,\70\ a water bead with 13.0 mm diameter is 
known to have caused a gastrointestinal block in a 13-month-old female. 
If the only limitation on compliant water beads was that they do not 
expand more than 50 percent, the ingestion hazard would still be 
present.
---------------------------------------------------------------------------

    \70\ IDI 170802CC3140.
---------------------------------------------------------------------------

    The 50 percent expansion limit is, however, a beneficial additional 
safety provision when combined with staff's proposed diameter limit for 
fully expanded beads. In particular, requiring a reduction in the 
maximum expansion of water beads reduces the potential damage to inner 
ear structures or nasal tissue if a child inserts a water bead into 
their ear or nose because more damage occurs when the water beads are 
intended to expand to bigger sizes and therefore exert more pressure on 
the body parts that contain them. Reducing expansion potential will 
also reduce the degree of bronchial obstruction created when a water 
bead is aspirated.

C. Assessment of Current ASTM F963-23 Labeling Requirements

    Section 5.0, Labeling Requirements of ASTM F963-23 contains general 
labeling requirements that apply to toys, including water beads or toys 
containing water beads. Still, the requirements in section 5.0 are not 
specifically referenced in section 4.40, Expanding Materials. Only 
broad warning statements for small part choking hazards and small ball 
hazards are required for ``Expanding Materials.'' While the warning 
statements address general choking hazards, they do not address or 
inform about injuries (e.g., gastrointestinal blockage and nasal tissue 
damage) and deaths that have occurred when water beads expand after 
being swallowed or inserted.

D. 2024 Proposed Draft Revisions to ASTM F963

    On January 22, 2024, and March 25, 2024, CPSC staff met with the 
ASTM F15.22 Emerging Hazards Task Group to discuss a possible revision 
of ASTM F963 to include specific requirements for water beads. CPSC 
staff and ASTM discussed incident information and the ASTM 20.0 mm 
diameter test gauge compared to CPSC's proposed funnel test gauge shown 
below in Figure 10 and Figure 11. On July 9, 2024, ASTM shared a draft 
proposal to revise section 4.40 of ASTM F963-23 to include water bead-
specific requirements. On July 18, 2024, ASTM submitted a ballot for 
vote on the proposal, which is available until August 19, 2024.
    CPSC staff has reviewed the 2024 draft proposal, finding that it is 
inadequate to address all known water bead hazards. In the proposed 
revision, the draft would define a water bead as a ``spherical or 
spheroid water-absorbent object, intended to expand in size when 
immersed in a liquid.'' This draft revision would apply to water beads 
intended to be accessible in dehydrated state and water beads in the 
expanded state. If the water bead is already expanded, the water bead 
would be given time to dehydrate before testing. These draft 
requirements would not apply to water beads that are not intended to be 
accessible, such as water beads within a squeeze ball.
    ASTM's draft performance test proposal requires first measuring the 
diameter of a dehydrated water bead and then measuring the maximum 
amount of expansion after soaking the water bead in deionized water at 
37 [deg]C. If the maximum expansion is greater than 50 percent in 
diameter, then the water bead will be placed in a funnel gauge like 
that in Figure 10 to determine whether it can pass through the gauge 
under a certain external pressure. If the maximum expansion of the 
water bead is less than or equal to 50 percent in diameter, no further 
testing is required. Based on incident data, the ASTM draft proposes 
use of a funnel test gauge with a 12.0 mm diameter (+0.0/-0.1 mm) as a 
performance requirement. When attempting to pass an expanded water 
bead, the proposed test includes applying a force of 0.1 lbf to the 
water bead in the direction of the 12.0 mm diameter hole with a 10.0 mm 
diameter rod having a flat end. The ASTM draft states that ``a water 
bead material which breaks or loses integrity during this test is 
considered to be acceptable,'' and therefore if the fragmented pieces 
pass through the funnel, the product still would meet the draft 
requirement even if the unbroken water bead was larger than 12.0 mm. 
The draft does not include acrylamide limits or revised labeling 
requirements.
    CPSC staff has reviewed the draft ASTM proposal and finds that a 
gauge size of 12.0 mm is inadequate to address known hazards from water 
beads. The draft proposes 12.0 mm in consideration of one incident,\71\ 
which describes a 13-month-old female who was unable to pass a water 
bead presumed to be as small as 13.0 mm diameter. However, while staff 
knows a 13.0 mm sized bead can cause a blockage in a child, this 
incident does not establish the size of the largest water bead that can 
safely pass. Further, the draft ASTM requirements leave the potential 
for a dehydrated water bead of 13.0 mm diameter capable of expanding to 
19.5 mm diameter without requiring testing because the water bead would 
not expand to more than 50 percent of its original size. As explained 
elsewhere in this preamble, fragmentation of the water bead during 
testing is not representative of incident data, and testing of water 
beads within toys, such as squeeze balls, appears necessary to address 
accessibility incidents. Therefore, while the draft ASTM proposal may 
be an improvement beyond the current ``Expanding Materials'' 
requirements, it would not adequately address known water bead hazards 
even if adopted.
---------------------------------------------------------------------------

    \71\ IDI 170802CCC3140.
---------------------------------------------------------------------------

V. NPR Description of Proposed Provisions and Justification

    Based on incident data described in section III of this preamble 
and CPSC staff's engineering, health sciences, and human factors 
assessments, the NPR proposes creating a new section 1250.4 to 16 CFR 
part 1250, Safety Standard Mandating ASTM F963 for Toys, adding 
performance and labeling requirements for water beads to better address 
the known water bead hazards and to provide the highest level of safety 
feasible for such products. Further, this NPR proposes revising the 
title of part 1250 from ``Safety Standard Mandating ASTM F963 for 
Toys'' to ``Safety Standard for Toys,'' to reflect the inclusion of 
proposed requirements that do not incorporate by reference existing 
requirements in the ASTM F963 voluntary standard.

A. Performance Requirements To Address Ingestion, Choking, Aspiration, 
and Insertion Hazards

    Under the proposed rule, water beads in the pre-expanded state that 
fit entirely inside the small part cylinder from 16 CFR 1501.4 (Figure 
9) must then, after full expansion, not grow more than 50 percent in 
any dimension and must remain whole while completely passing through 
the funnel test gauge depicted in Figure 10 and Figure 11. Instead of 
using the rod test in ASTM F963-23, the NPR proposes requiring the 
water bead to pass through

[[Page 73036]]

a 9.0 mm (+0.0/-0.1 mm) diameter funnel test gauge under its own weight 
to better reflect the lower range of the compression forces a water 
bead would experience while passing through a child's gastrointestinal 
tract.
    In the absence of conclusive anatomical evidence, the Commission 
relies on incident data and CPSC staff's analysis to propose that the 
funnel test gauge have a 9.0 mm diameter. IDI 170802CCC3140 describes a 
13-month-old female who was unable to pass a water bead presumed to 
range from 13.0 mm to 17.5 mm diameter. Staff purchased a separate 
sample of the same product that the 13-month-old female ingested and 
tested the water beads according to the section 4.40 requirements. 
After testing, the water beads had a dehydrated, as-received diameter 
ranging between 2.0 mm and 2.50 mm. After hydration and expansion, the 
size ranged from between 13.0 mm to 17.5 mm diameter. IDI 230707CBB1698 
describes a 3-year-old female who ingested but successfully passed 
approximately 1,200 water beads. The child successfully passed 
approximately 200 of the water beads naturally and then passed the 
remaining water beads with the aid of a mineral oil enema. Staff 
purchased a separate sample of the same product that the 3-year-old 
female ingested and tested the water beads according to the 
requirements in section 4.40. After the testing was completed, the 
water beads had a dehydrated, as-received diameter ranging between 2.20 
mm and 2.40 mm. After hydration and expansion, the diameter of the 
water beads ranged from between 9.32 mm and 15.20 mm diameter. Based on 
these investigations, the NPR proposes requiring the use of a 9.0 mm 
diameter funnel test gauge to ensure the test methods provide the 
highest level of safety feasible by limiting the gauge size to the size 
of the smallest water bead that was known to pass through the body 
without causing an intestinal obstruction.
    The proposed 9.0 mm diameter funnel test gauge also would reduce 
the hazards associated with water beads that are inserted into 
children's noses and ears. While nose and ear insertion incident data 
do not indicate the expanded water bead sizes, larger beads can grow 
further into the nasal cavity and middle ear, causing severe injuries 
and requiring invasive surgery with sedation and/or general anesthesia 
to completely remove. The larger water beads are more likely to be 
removable only in pieces, as opposed to as a whole, because the bead 
has expanded deeper into the nasal cavity or inner ear. Removal of 
smaller water beads tends to be less invasive because they can be 
removed in one piece by health care professionals, similar to removal 
efforts of other inserted small objects, like marbles, toy parts, and 
food.
[GRAPHIC] [TIFF OMITTED] TP09SE24.012


[[Page 73037]]


[GRAPHIC] [TIFF OMITTED] TP09SE24.013

    The NPR proposes including the ``Expanding Materials'' test method 
from section 8.30 of ASTM F963-23, with modifications, in the proposed 
rule for water beads under Sec.  1250.4. The NPR proposes conditioning 
the water bead or toy containing the water bead at 20  5 
[deg]C (68  9 [deg]F) and at a relative humidity of 40-65 
percent for a minimum of seven hours prior to the test. This mirrors 
the ASTM test method but adds a requirement that if the water bead is 
partially expanded, or contained within a toy and partially expanded, 
the water bead should be removed and dehydrated before testing. This 
simulates the hazard that occurs when a water bead dislodges from the 
product and then dehydrates. Pursuant to the ASTM test method, the NPR 
proposes that the water bead should next be submerged in a test bath of 
deionized water maintained at 37 [deg]C  2 [deg]C (98.6 
[deg]F  3.6 [deg]F) for the duration of immersion, without 
agitation.\72\ For water beads that exhibit positive buoyancy, the test 
requires placing weight(s) with mass just sufficient to achieve 
complete submersion on top of the water bead. The test requires that 
test labs be careful to minimize contact of the test water bead with 
the sides or bottom of the container to minimize any interference with 
expansion. To ensure the water bead is fully expanded, the test 
requires submersion for 72 hours and to measure the bead's expansion 
after 6 hours, 24 hours, 48 hours and then 72 hours. If the greatest 
expansion was observed at 72 hours, then the testing should proceed. If 
greatest expansion was observed at another time interval, then a new 
sample should be conditioned for the time interval when greatest 
expansion was observed.
---------------------------------------------------------------------------

    \72\ The largest expansion usually occurs in deionized water; 
therefore, the water bead can grow to its largest potential in 
deionized water when testing the product in a laboratory. This is a 
conservative approach, as beads may expand less in digestive fluids.
---------------------------------------------------------------------------

    Next, the NPR proposes adding a test step based on the ``Expanding 
Materials'' requirement from section 4.6 of EN 71-1, which limits water 
bead expansion to no more than 50 percent in any dimension. After the 
required period of submersion to reach greatest expansion, the water 
bead will be measured with calipers to determine whether it has 
expanded more than 50 percent. Setting this expansion limit will 
address potential damage to nasal passages and ear cavities, as well as 
prevent choking or aspiration hazards by limiting water bead growth.
    Thereafter, returning to the ASTM framework but instead of using 
the ASTM F963 rod test, the proposed test in the NPR would require 
placing the expanded water bead at the top surface of the 9.0 mm 
diameter gauge's upper opening (Figure 11) in the orientation least 
likely to pass through, and releasing the bead to allow it to travel

[[Page 73038]]

down until it reaches the lower opening, then observing if the expanded 
water bead is able to remain whole and completely pass through the 
lower opening. By testing to observe if the water bead can completely 
pass through the 9.0 mm diameter funnel test gauge without external 
force, the test can simulate what occurs in a child's gastrointestinal 
tract to determine whether the bead will or will not cause a blockage 
in a child's gastrointestinal tract or, specifically, at the child's 
ileocecal valve located at the end of the small intestines.

B. Acrylamide Limits and Testing

    Water beads are composed of absorbent polymers, such as 
polyacrylamide and/or polyacrylate polymers. Polyacrylamide is a 
chemical compound composed of acrylamide monomer units linked together. 
The polymer form, polyacrylamide, is relatively non-toxic; however, 
acrylamide monomer alone can be toxic.\73\ Residual acrylamide monomer 
can remain after production of polyacrylamide, which can stay in water 
beads after manufacturing. Human exposure to acrylamide monomer is 
known to cause negative health effects depending on the amount and 
duration of exposure.\74\ Chronic, long-term exposure can adversely 
affect the nervous, gastrointestinal, and reproductive systems and is 
suspected to be a human carcinogen. Even short-term or one-time 
exposures has caused acute negative effects in the nervous system.\75\
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    \73\ Per FHSA (16 CFR 1500.3(c)(2)(i)(A)), a substance with a 
median lethal dose (LD50) between 50 and 5000 mg/kg in 
rats is ``toxic'' for acute toxicity. The reported oral 
LD50 values for undiluted acrylamide in rats range from 
150 to 413 mg/kg (source: ATSDR Toxicological Profile for 
Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf).
    \74\ ATSDR Toxicological Profile for Acrylamide, available at 
https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf; Internationally 
Peer Reviewed Chemical Safety Information (INCHEM) Acrylamide 
Review, available at https://inchem.org/documents/pims/chemical/pim652.htm; U.S. Environmental Protection Agency (EPA) Hazard 
Summary of Acrylamide, available at https://www.epa.gov/sites/default/files/2016-09/documents/acrylamide.pdf; U.S. FDA Process 
Contaminants in Food--acrylamide, available at https://www.fda.gov/food/process-contaminants-food/acrylamide.
    \75\ Agency for Toxic Substances and Disease Registry (ATSDR) 
Toxicological Profile for Acrylamide, available at https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------

    The United States Food and Drug Administration (FDA) limits the 
amount of residual acrylamide monomer allowed in polyacrylamide used in 
food production (21 CFR 176.170, 176.180), processing (21 CFR 173.5, 
173.10, 173.315), and packaging (21 CFR 176.110). The FDA has also 
published guidance on reducing the amount of acrylamide in foods.\76\ 
Polyacrylamide is commonly used in water and wastewater treatment, and 
the EPA limits the amount of acrylamide permitted in drinking 
water.\77\
---------------------------------------------------------------------------

    \76\ U.S. FDA Guidance for Industry Acrylamide in Foods, 
available at https://www.fda.gov/media/87150/download.
    \77\ U.S. EPA National Primary Drinking Water Regulations, 
available at https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations.
---------------------------------------------------------------------------

    No CPSC mandatory standard sets acrylamide limits for water beads 
or any other product; however, toys subject to ASTM F963, including 
water beads, are subject to the toxicology safety requirements in 
section 4.3.1, Hazardous Substances of ASTM F963-23. Section 4.3.1 
stipulates that ``[t]oys or materials used in toys shall conform to the 
FHSA and to the regulations promulgated under that act . . . The 
regulations define limits for substances that are toxic, corrosive, 
[or] an irritant . . . .'' Section 8.2, Testing for Hazardous Substance 
Content in ASTM F963-23 directs readers to review the FHSA to determine 
whether a product is comprised of hazardous substances. Depending on 
exposure, acrylamide could be a hazardous substance per 16 CFR 
1500.3(b)(4)(i), which defines a hazardous substance as ``any substance 
or mixture of substances which is toxic . . . .'' Per 16 CFR 
1500.3(b)(5), the term `toxic' refers to ``any substance (other than a 
radioactive substance) which has the capacity to produce personal 
injury or illness to man through ingestion, inhalation, or absorption 
through any body surface.''
    While CPSC does not have incident data reflecting acrylamide 
poisoning from water beads,\78\ the presence of acrylamide monomers in 
several water bead products that staff tested demonstrates a potential 
chemical hazard. CPSC has made efforts to address the potential 
chemical hazard outside of rulemaking. For example, in March 2024 CPSC 
announced unilateral warnings for two water bead products that 
contained levels of acrylamide in violation of the FHSA.\79\ If one of 
those water beads was ingested, it could pose a risk of acute toxicity 
to children from the acrylamide exposure.
---------------------------------------------------------------------------

    \78\ CPSC has not yet received data demonstrating chronic 
exposure to acrylamide from water beads.
    \79\ https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Jangostor-Water-Beads-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com; https://www.cpsc.gov/Newsroom/News-Releases/2024/CPSC-Warns-Consumers-to-Immediately-Stop-Using-Tuladuo-Water-Bead-Sets-Due-to-Chemical-Toxicity-Hazard-Violation-of-Federal-Ban-of-Hazardous-Substances-Sold-on-Amazon-com.
---------------------------------------------------------------------------

    Children's possible exposures to acrylamide after ingesting water 
beads would likely be a single, infrequent event (possibly including 
multiple beads in a single event). Therefore, the exposure scenario 
would be acute rather than chronic. The Agency for Toxic Substances and 
Disease Registry (ATSDR) \80\ created and published an acute-duration 
oral minimal risk level (MRL) of 0.01 mg/kg-day for acrylamide.\81\ The 
MRL is an acute exposure level at which an exposed person (including a 
child) is unlikely to experience an adverse health effect.
---------------------------------------------------------------------------

    \80\ ATSDR is a federal public health agency within the United 
States Department of Health and Human Services. More information 
about ATSDR is available at https://www.atsdr.cdc.gov.
    \81\ ATSDR Toxicological Profile for Acrylamide, available at 
https://www.atsdr.cdc.gov/ToxProfiles/tp203.pdf.
---------------------------------------------------------------------------

    The Commission proposes that acrylamide limits be set to ensure 
that if a child ingests multiple water beads, the child's exposure 
levels would not exceed the acute duration oral MRL for children aged 6 
months old.\82\ The NPR proposes that the limit be set to 65 [micro]g 
acrylamide extractable from 100 small water beads (defined as <4 mm 
across the smallest diameter of the bead prior to hydration) or one 
large water bead (defined as >=4 mm across the smallest diameter of the 
bead prior to hydration). The quantities of small and large beads 
assumed to be ingested are based on water bead ingestion incidents and 
published case reports. Incident data indicate that children tend to 
ingest only one or two large beads. CPSC therefore proposes an exposure 
scenario in which a 6-month-old child ingests one large water bead.
---------------------------------------------------------------------------

    \82\ Six months is the most sensitive age in this range by 
having the lowest body weights, so the proposed limit of extractable 
acrylamide from water beads is based on children of this age.
---------------------------------------------------------------------------

    Less information is available for incidents of children ingesting 
small beads. If small beads do not expand enough after ingestion to 
cause a blockage, a child may not receive medical care. However, two 
case reports describe a 12-month-old who ingested 12 small water beads 
\83\ and a 2-year-old who ingested approximately 100 small beads.\84\ A 
review of 21 water bead ingestion cases over a 10-year period

[[Page 73039]]

(2008 to 2017) reported that the number of water beads swallowed ranged 
from one to ``a handful.\85\ Although IDI 230707CBB1698 describes a 3-
year-old who ingested approximately 1,200 small water beads, this 
scenario appears to be an extreme occurrence. CPSC therefore proposes 
for this NPR an exposure scenario in which a 6-month-old child ingests 
100 small water beads. The 100 count is within the range of documented 
ingestion incidents, and it is consistent with the number of small 
beads that staff uses in the acrylamide extraction test method 
described below.
---------------------------------------------------------------------------

    \83\ Kim HB, Kim YB, Ko Y, Choi YJ, Lee J, Kim JH. A case of 
ingested water beads diagnosed with point-of-care ultrasound. Clin 
Exp Emerg Med. 2020 Dec;7(4):330-333. doi: 10.15441/ceem.20.041. 
Epub 2020 Dec 31. PMID: 33440112; PMCID: PMC7808832.
    \84\ Jackson J, Randell KA, Knapp JF. Two Year Old With Water 
Bead Ingestion. Pediatr Emerg Care. 2015 Aug;31(8):605-7. doi: 
10.1097/PEC.0000000000000520. PMID: 26241717.
    \85\ Mehmeto[gbreve]lu F. A Retrospective 10-Year Analysis of 
Water Absorbent Bead Ingestion in Children. Emerg Med Int. 2018 May 
6;2018:5910527. doi: 10.1155/2018/5910527. PMID: 29854461; PMCID: 
PMC5960561.
---------------------------------------------------------------------------

    An acrylamide exposure limit from ATSDR's acute-duration oral MRL 
of 0.01 mg/kg would mean that a child should not be exposed to more 
than 0.01 mg of acrylamide for each kg of the child's body weight. When 
assessing the appropriate limit, staff used the fifth percentile body 
weight for the youngest female child according to the National Center 
for Health Statistics.\86\ The fifth percentile body weight of a 6- to 
8-month-old female is 6.5 kg. By multiplying the acute-duration oral 
MRL by the body weight, staff recommends an exposure limit for 
acrylamide from water beads is 0.065 mg, which is equal to 65 [micro]g 
of extractable arylamide. The calculation are:
---------------------------------------------------------------------------

    \86\ U.S. Centers for Disease Control and Prevention (CDC) 
Anthropometric Reference Data for Children and Adults: United 
States, 2015-2018, available at https://www.cdc.gov/nchs/data/series/sr_03/sr03-046-508.pdf.

1. Calculate Acrylamide Exposure Limit: 0.01 mg/kg x 6.5 kg = 0.065 mg
2. Convert mg unit to [micro]g: 0.065 mg x 1000 [micro]g/mg = 65 
[micro]g

    The amount of extractable acrylamide shall be tested in accordance 
with the test procedure specified in the proposed 16 CFR 
1250.4(c)(2).\87\ The proposed 65 [micro]g acrylamide exposure limit 
applies to an assumed ingestion of one large bead (defined as >=4 mm 
across the smallest diameter of the bead prior to hydration) or 100 
small beads (defined as <4 mm across the smallest diameter of the bead 
prior to hydration). Under the proposal, CPSC would consider less than 
65 [micro]g acrylamide extractable from water beads safe in children as 
young as 6 months old, while water beads containing more than 65 
[micro]g pose a risk of acute toxicity. Staff in CPSC's Division of 
Chemistry and Directorate for Health Sciences developed a test method 
to determine the levels of extractable acrylamide in water beads. The 
NPR proposes the following extraction method:
---------------------------------------------------------------------------

    \87\ Because the volume of the extraction fluid may be variable, 
the 65 [micro]g acrylamide limit is the total mass of acrylamide 
extracted in 24 hours and not a concentration.
---------------------------------------------------------------------------

     Perform an extraction test on water beads to determine the 
amount of acrylamide that leaches from the water beads over a 24-hour 
period.
     Place dehydrated water beads in a container with pH 
neutral deionized water and place the container in a shaker bath that 
heats the water beads to 37 [deg]C while shaking them at 30 RPM for 24 
hours.
     For each water bead product, perform three separate 
extraction trials, or repetitions, concurrently to ensure that all 
results are reasonably consistent, given any bead-to-bead variation. 
For large water beads (defined as >=4 mm across the smallest diameter 
of the bead prior to hydration), perform three trials using one large 
bead per trial. For small beads (defined as <4 mm across the smallest 
diameter of the bead prior to hydration), perform three trials using 
100 small beads per trial. If a product contains different sizes of 
water beads, perform extraction testing for each size.
     Use an appropriate extraction container and volume of 
deionized water so that all water beads remain covered by water for the 
duration of the extraction period. Because water beads absorb different 
volumes of water depending on their size, conduct additional tests 
before performing final acrylamide extractions, to determine what 
volume of water best allows for full bead growth without unnecessarily 
diluting the concentration of extracted acrylamide. Choose containers 
that will not compress the water beads at any point during the 24-hour 
extraction period. To prevent water evaporation during the extraction, 
cover the containers during the extraction.
     Following the extraction period, determine the volume of 
remaining water for each trial, then analyze the water to determine the 
mass of acrylamide present using an instrument that is able to 
quantitate acrylamide at levels equal to or less than the proposed 
limit. Staff used a liquid chromatography-tandem mass spectrometer (LC-
MS/MS) system,\88\ but other instruments may accurately quantify 
acrylamide at levels equal to or less than the proposed limit.
---------------------------------------------------------------------------

    \88\ LC-MS/MS is an analytical chemistry technique that allows 
for the physical separation and subsequent identification and 
quantification of analytes of interest within a solution.
---------------------------------------------------------------------------

C. Marking, Labeling, and Instructional Literature Requirements

    The ASTM F963-23 standard does not contain marking, warning, or 
labeling requirements specifically for water beads. While the standard 
provides broad warning requirements under section 5 of ASTM F963-23, 
such warnings do not adequately address the hazards associated with 
water beads. The Commission proposes requiring the following marking, 
labeling, and instructional literature requirements for all products 
within scope of the NPR and seeks comment on format, location, and 
content requirements of proposed warnings.
1. Packaging and Container Marking and Labeling
    Warning about a hazard is a less effective method of addressing the 
hazard, contrasted with either designing the hazard out of a product or 
guarding consumers from the hazard.\89\ Therefore, when a standard 
relies on warnings to address a hazard, it is particularly important 
that the warning statements are noticeable, understandable, and 
motivational. The primary U.S. voluntary consensus standard for product 
safety signs and labels, ANSI Z535.4, American National Standard for 
Product Safety Signs and Labels,\90\ recommends that on-product 
warnings include content that addresses the following three elements:
---------------------------------------------------------------------------

    \89\ Laughery, K.R., & Wogalter, M.S. (2011). The Hazard Control 
Hierarchy and its Utility in Safety Decisions about Consumer 
Products. In W. Karwowski, M.M. Soares, & N.A. Stanton (Eds.), Human 
Factors and Ergonomics in Consumer Product Design: Uses and 
Applications (pp. 33-39). Boca Raton, FL: CRC Press; Williams, D.J., 
& Noyes, J.M. (2011). Reducing the Risk to Consumers: Implications 
for Designing Safe Consumer Products. In W. Karwowski, M.M. Soares, 
& N.A. Stanton (Eds.), Human Factors and Ergonomics in Consumer 
Product Design: Uses and Applications (pp. 3-21). Boca Raton, FL: 
CRC Press; Vredenburgh, A.G., & Zackowitz, I.B. (2006). 
Expectations. In M.S. Wogalter (Ed.), Handbook of warnings (pp. 345-
354). Mahwah, NJ: Lawrence Erlbaum Associates.
    \90\ ANSI Z535.4, American National Standard for Product Safety 
Signs and Labels is the primary US. voluntary consensus standard for 
the design, application, use, and placement of on-product warning 
labels when developing or assessing the adequacy of warning labels.
---------------------------------------------------------------------------

     a description of the hazard;
     information about the consequences of exposure to the 
hazard; and
     instructions regarding appropriate hazard-avoidance 
behaviors.
    Providing explicit or detailed information in a warning can 
increase its effectiveness \91\ by enhancing perception of injury 
severity and perceived hazard.\92\ Vividness of

[[Page 73040]]

message content can increase message salience by triggering motivation 
to act in consideration of the warning.\93\
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    \91\ Laughery, Sr., K.R., & Smith, D.P. (2006). Explicit 
Information in Warnings. In M.S. Wogalter (Ed.), Handbook of 
Warnings (pp. 419-428). Mahwah, NJ: Lawrence Erlbaum Associates.
    \92\ DeJoy, D.M. (1999). Motivation. In M.S. Wogalter, D.M. 
DeJoy, & K.R. Laughery (Eds.), Warnings and Risk Communication (pp. 
221-243). Philadelphia: Taylor & Francis.
    \93\ Murray-Johnson, L., & Witte, K. (2003). Looking Toward the 
Future: Health Message Design Strategies. In T.L. Thompson, A. 
Dorsey, K. I. Miller, & R. Parrott (Eds.), Handbook of Health 
Communication (pp. 473-495). New York: Routledge.
---------------------------------------------------------------------------

    The Commission proposes including the following warnings on water 
bead toys and packaging of toys that contain water beads. Specifically, 
packaging would be required to include the warning as shown in Figure 
12:
[GRAPHIC] [TIFF OMITTED] TP09SE24.014

    Packaging of toys with contained water beads, such as squeeze balls 
filled with water beads, would be required to include the warnings as 
shown in Figure 13:
[GRAPHIC] [TIFF OMITTED] TP09SE24.015

    The Commission further proposes that toys containing water beads 
that are not individually packaged (e.g., multiple squeeze balls sold 
in a bin/box) would be required to have a hangtag or sticker label 
affixed on each individual product with the warning shown in Figure 13.
    Because CPSC is aware of one death in the U.S. and additional 
deaths outside of the U.S.,\94\ both warnings labels state, ``Children 
have DIED after swallowing water beads because the beads blocked their 
intestines. Your child can die too.'' The purpose of this statement is 
to communicate to consumers the consequences of swallowing water beads, 
as well as clarify that once a water bead enters the body, water beads 
pose a danger by expanding inside the body. The additional statements 
advise consumers how to avoid hazards and what to do if the consumer 
suspects a child has swallowed or inserted a water bead. The warning 
for toys with contained water beads (Figure 13) includes the wording, 
``This product contains water beads that grow larger. Discard if beads 
are coming out[,]'' to ensure consumers are aware that water beads are 
within the toy, and that exposed water beads are hazardous. Incident 
data confirm that caregivers may be unaware that toy products purchased 
contain hazardous water beads.\95\
---------------------------------------------------------------------------

    \94\ https://www.consumerreports.org/babies-kids/toys/water-beads-pose-a-serious-safety-risk-to-children-a6431187819/.
    \95\ Such as incident 20230601-3657B-2147347238 found on 
saferproducts.gov. A 2-year-old child bit into a stress ball and 
swallowed the contents requiring medical treatment. The consumer 
claims to have been unaware that there were water beads inside.
---------------------------------------------------------------------------

    When developing or assessing the adequacy of a warning, one must 
consider not only the content of a warning, but also its design or 
form.\96\ CPSC commonly uses ANSI Z535.4 as a reference for warning 
formatting requirements. Human factors experts and warnings literature 
regularly cite ANSI Z535.4 when discussing the design and evaluation of 
on-product warning labels and generally consider the ANSI Z535 series 
of requirements as the state-of-the-art, benchmark standards against 
which warning labels should be evaluated for adequacy.\97\ The scope of 
ANSI Z535.4 is broad enough to encompass nearly all consumer

[[Page 73041]]

products, including children's products and toys.\98\
---------------------------------------------------------------------------

    \96\ Laughery, Sr., K.R., & Wogalter, M.S. (2006). The Warning 
Expert in Civil Litigation. In M.S. Wogalter (Ed.), Handbook of 
Warnings (pp. 605-615). Mahwah, NJ: Lawrence Erlbaum Associates; 
Madden, M.S. (1999). The Law Relating to Warnings. In M.S. Wogalter, 
D.M. DeJoy, & K.R. Laughery (Eds.), Warnings and Risk Communication 
(pp. 315-330). Philadelphia: Taylor & Francis; Madden, M.S. (2006). 
The Duty to Warn in Products Liability. In M.S. Wogalter (Ed.), 
Handbook of Warnings (pp. 583-588). Mahwah, NJ: Lawrence Erlbaum 
Associates.
    \97\ Vredenburgh, A.G., & Zackowitz, I.B. (2005). Human Factors 
Issues to be Considered by Product Liability Experts. In Y.I. Noy & 
W. Karwowski (Eds.), Handbook of Human Factors in Litigation 
(Chapter 26). Boca Raton, FL: CRC Press; Wogalter, M.S., & Laughery, 
K.R. (2005). Effectiveness of Consumer Product Warnings: Design and 
Forensic Considerations. In Y.I. Noy & W. Karwowski (Eds.), Handbook 
of Human Factors in Litigation (Chapter 31). Boca Raton, FL: CRC 
Press.
    \98\ Kalsher, M.J., & Wogalter, M.S. (2008). Warnings: Hazard 
Control Methods for Caregivers and Children. In R. Lueder & V.J.B. 
Rice (Eds.), Ergonomics for Children: Designing Products and Places 
for Toddlers to Teens (pp. 509-539). New York: Taylor & Francis; 
Rice, V.J.B. (2012). Designing for Children. In G. Salvendy (Ed.), 
Handbook of Human Factors and Ergonomics (4th ed.) (pp. 1472-1483). 
Hoboken, NJ: Wiley.
---------------------------------------------------------------------------

    Signal words, colors, graphics, and placement all increase 
conspicuity. The salience of a visual warning can be enhanced using 
large and bold print, high contrast, color, borders, pictorial symbols, 
and special effects like flashing lights. Therefore, the NPR proposes 
warning label design requirements for water bead toys and toys 
containing water beads that reflect the current recommendations from 
ASTM's Ad Hoc Language Task Group (Ad Hoc Task Group).\99\ The 
recommendations provide permanent, conspicuous, and consistently 
formatted warning labels across juvenile products. Warnings that meet 
the recommendations address numerous format issues related to capturing 
consumer attention, improving readability, and increasing hazard 
perception and avoidance behavior. Such recommendations include 
requiring that the proposed warnings conform to ANSI NEMA Z535.4--2023, 
American National Standard for Product Safety Signs and Labels, 
sections 6.1-6.4, 7.2-7.6.3, and 8.1, with the following changes to the 
ANSI standard:
---------------------------------------------------------------------------

    \99\ ASTM Ad Hoc Wording 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 nursery 
product voluntary standards. The latest version of the Ad Hoc-
approved recommended language is published in the ``Committee 
Documents'' section of the Committee F15 ASTM website.
---------------------------------------------------------------------------

     In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace the word 
``should'' with ``shall;''
     In section 7.6.3, replace the phrase ``should (when 
feasible)'' with the word ``shall;'' and
     Strike the word ``safety'' when used immediately before a 
color (e.g., replace ``safety white'' with ``white'').
    Further, certain text in the message panel must be in bold and in 
capital letters as shown in the example warning labels in Figure 12 and 
Figure 13, to provide emphasis and capture the reader's attention. The 
signal word ``WARNING'' must appear in sans serif letters in upper case 
only, be at least \1/8\ inch (3.2 mm) in height, and be center- or 
left-aligned. The height of the exclamation point inside the safety 
alert symbol must be at least half the height of the triangle and be 
centered vertically inside the triangle, as shown in the example 
warnings. The message panel text capital letters are no less than \1/
16\'' (1.6mm) \100\ and the message panel text is center- or left-
aligned, in sans serif letters. Consistent with Ad Hoc, the text in 
each column should be arranged in list or outline format, with 
precautionary statements preceded by bullet points. Precautionary 
statements must be separated by bullet points if paragraph formatting 
is used.
---------------------------------------------------------------------------

    \100\ 1.6mm is the size dimension from the toy standard, 16 CFR 
part 1250, Safety Standard Mandating ASTM F963 for Toys, not from 
the Ad Hoc Task Group.
---------------------------------------------------------------------------

    Warnings that are placed directly on a product and/or the packaging 
have a higher noticeability rate \101\ because consumers are more 
likely to see such warnings when examining the product prior to 
purchase. ANSI Z535.4 provides general guidance on warning placement, 
stating that warnings must be ``readily visible to the intended 
viewer'' and will ``alert the viewer to the hazard in time to take 
appropriate action.'' \102\ Similarly, both the Ad Hoc Task Group and 
section 5.3.6 of ASTM F963-23 require conspicuous warnings. The NPR 
proposes warning labels be placed on the principal display panel as 
defined in section 3.1.62 of ASTM F963-23.
---------------------------------------------------------------------------

    \101\ Wogalter, M.S., Godfrey, S.S., Fontenelle, G.A., 
Desaulniers, D.R., Rothstein, P., & Laughery, K.R. (1987). 
Effectiveness of warnings. Human Factors 29(5), 599-612; Frantz, 
J.P.; Rhoades, T.P. (1993). A Task-Analytic Approach to the Temporal 
and Spatial Placement of Product Warnings. Human Factors: The 
Journal of the Human Factors and Ergonomics Society, 35(4), pp. 719-
730.
    \102\ American National Standards Institute. (2011). ANSI 
Z535.4. American national standard: Product safety signs and labels. 
Rosslyn, VA: National Electrical Manufacturers Association, Section 
9.1.
---------------------------------------------------------------------------

2. Instructional Literature
    Some water bead toys or toys containing water beads provide 
instructional literature, such as manuals for use. Instructions or 
other literature accompanying a water bead product, when provided, 
shall include directions for use, including the relevant warnings from 
Figure 12 or Figure 13. The NPR proposes that instructional literature 
shall include the same warning labels that the NPR proposes for product 
packaging, with similar formatting requirements, though the literature 
does not need to be in color.\103\ Still, the Commission proposes that 
the signal word and safety alert symbol shall contrast with the 
background of the signal word panel, and the warnings shall contrast 
with the background of the instructional literature.\104\
---------------------------------------------------------------------------

    \103\ ANSI Z535.6, Product Safety Information in Product 
Manuals, Instructions and Other Collateral Materials, allows warning 
labels to be black and white whereas the NPR mandates color for 
warning labels packaging.
    \104\ Ad Hoc section Y.6, Instructional Literature.
---------------------------------------------------------------------------

VI. Feasibility of Proposed Requirements

    Pursuant to section 106(c) of the CPSIA, Congress directed the 
Commission to ``periodically review and revise the rules set forth 
under this section to ensure that such rules provide the highest level 
of safety for such products that is feasible.'' 15 U.S.C. 2056b(c). The 
Commission's statutory obligation is to ensure that toys have the 
highest level of safety that the producers are capable of achieving, 
considering technological and economic ability. Based on the staff's 
analysis provided in this NPR, the Commission preliminarily determines 
that the NPR is technically and economically feasible, and requests 
comment on this determination.

A. Technological Feasibility

    A proposed rule is technically feasible if it is capable of being 
done. For example, compliant products might already be on the market; 
or the technology to comply with requirements might be commercially 
available; or existing products could be made compliant; or alternative 
practices, best practices, or operational changes would allow 
manufacturers to comply. See, e.g., 15 U.S.C. 1278a(d) (discussing lead 
limits). The Commission believes the NPR's proposals meet technical 
feasibility criteria. For instance, products currently available on the 
market are within the proposed rule's 9.0 mm size limitation, and there 
should be multiple means of producing and packaging water bead toys 
that expand by less than 50 percent. With respect to demonstrating 
compliance, the proposed funnel test gauge test does not require tools, 
like a push rod, to determine whether a water bead can pass through the 
gauge. Further, several testing tools in the NPR (e.g., a small parts 
cylinder) are already included in CPSC mandatory standards or come from 
the ASTM F963 standard. Accordingly, much of the technology is already 
used when testing to section 4.40 of ASTM F963-23 and is commercially 
available.

B. Economic Feasibility

    The draft proposed rule is economically feasible because non-
compliant toy products can be redesigned to be compliant, or be 
repurposed for non-toy uses. Based on CPSC staff's analysis, the 
Commission expects manufacturers would, to comply with the proposed 
rule, incur

[[Page 73042]]

material costs to redesign their product and retool their manufacturing 
processes to produce a compliant product. Staff expect the redesign and 
retooling costs to be significant for small firms involved in the water 
bead toy market, with the exception of the labeling requirements, which 
are negligible (i.e., less than $0.01 per product). A decline in sales 
is expected, as many currently available water bead toys would not be 
compliant with the draft proposed rule. However, while the impact of 
the proposed rule may be significant, firms could sell compliant water 
bead toys or sell non-compliant water beads for non-toy purposes, such 
as agricultural purposes.

VII. Incorporation by Reference

    Proposed Sec.  1250.4 would incorporate by reference ANSI Z535.4--
2023. The Office of the Federal Register (OFR) has regulations 
regarding incorporation by reference. 1 CFR part 51. Under these 
regulations, agencies must discuss, in the preamble to a final rule, 
ways in which the material the agency incorporates by reference is 
reasonably available to interested parties, and how interested parties 
can obtain the material. In addition, the preamble to the final rule 
must summarize the material. 1 CFR 51.5(b)(3).
    In accordance with the OFR regulations, section V of this preamble 
summarizes the major provisions of ANSI Z535.4--2023 that the 
Commission proposes to incorporate by reference into proposed Sec.  
1250.4. The standard itself is reasonably available to interested 
parties. By permission of ANSI, the standard can be viewed as a read-
only document during the comment period for this NPR, at: https://ibr.ansi.org/Standards/nema.aspx. Interested parties can also schedule 
an appointment to inspect a copy of the standard at CPSC's Office of 
the Secretary, U.S. Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected]. Alternatively, interested parties can purchase a copy of 
the standard from ANSI, 1899 L Street NW, 11th Floor, Washington, DC 
20036.

VIII. 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 90-day effective 
date for this rule. The rule would apply to all water beads 
manufactured after the effective date. 15 U.S.C. 2058(g)(1).
    Although the NPR proposes to add new requirements, most of the test 
methods and test equipment are not unique, in that the current ASTM toy 
standard utilizes several similar methods and equipment. For example, 
as of July 12, 2024, 81 third-party laboratories were already CPSC-
accepted to test expanding materials as provided in section 4.40 of 
ASTM F963-23, as incorporated into part 1250 on January 18, 2024. 
Additionally, as of July 12, 2024, 153 third-party laboratories were 
CPSC-accepted to test expanding materials as provided in section 4.40 
of ASTM F963-17. While these third-party laboratories may not yet be 
CPSC-accepted for testing for acrylamide, 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 quickly in the normal course. 
Additionally, a 90-day effective date allows the proposed standard to 
coincide with the third-party testing requirements for children's 
products under section 14(a)(3) of the CPSA, as an NOR date must be no 
later than 90 days before such rules or revisions take place. 15 U.S.C. 
2063(a)(3). The Commission invites comments, particularly from small 
businesses, regarding the proposed testing and the amount of time 
needed to come into compliance with a final rule.

IX. 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, unless the rule would not have a significant economic impact on 
a substantial number of small entities. 5 U.S.C. 603, 605(b). 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 requirements. Third-party testing costs should 
not be a new significant cost for most small firms, given suppliers 
should already test to the current mandatory standard in part 1250.

A. Reason for Action, NPR Objectives, Product Description, and Market 
Description

    Section I of this preamble explains why the Commission proposes to 
establish a mandatory rule for water bead toys 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 water beads, and the use of water beads in the 
U.S. The proposed requirements in the NPR are more stringent than ASTM 
F963-23, which the Commission incorporated into the mandatory rule 16 
CFR part 1250, Safety Standard Mandating ASTM F963 for Toys, as 
described in sections IV and V of this preamble. CPSC staff has not 
identified any other Federal rules that duplicate, overlap, or conflict 
with the draft proposed rule. The NPR addresses the known hazards 
presented by water beads, discussed in section III of this preamble, 
that the current rule does not adequately address.

B. Small Entities To Which the Rule Would Apply

    Section II of this preamble describes the products within the scope 
of the rule and an overview of the market for water beads. This section 
provides additional details on the market for products within the scope 
of the rule.
    CPSC staff has found that a majority of the firms that sell water 
bead toys are wholesalers of hobby goods, toys, and plastic 
products.\105\ Retailers of water bead toy products are hobby and toy 
stores, department stores, and warehouse stores and supercenters.\106\ 
Some of these products may be sold by convenience stores, but staff 
estimates the number of units sold from such stores is negligible. 
Water bead toys are

[[Page 73043]]

small, novelty products which can easily be stored and sold in varying 
retail channels and, therefore, the described retailers, importers, and 
manufacturers are not all inclusive but represent the most prominent 
sources for water bead toys.
---------------------------------------------------------------------------

    \105\ The North American Industry Classification System (NAICS) 
defines product codes for U.S. firms. Firms advertise water bead 
products as toys and therefore water beads may be categorized under 
many NAICS product codes. These firms could be listed in NAICS code 
339930 Doll, Toy, and Game Manufacturing but some may also be listed 
in code 326199 All Other Plastic Product Manufacturing. Importers of 
these products could also vary among different NAICS codes. A 
majority of the firms should be listed in the following NAICS codes 
as wholesalers; 423920 Toy and Hobby Goods and Supplies Merchant 
Wholesalers, and 424610 Plastics Materials and Basic Forms and 
Shapes Merchant Wholesalers.
    \106\ Retailers consist of NAICS codes 459120 Hobby, Toy, and 
Game Stores, 455110 Department Stores, and 455211 Warehouse Clubs 
and Supercenters.
---------------------------------------------------------------------------

    Currently, over 30 firms supply water bead toys to the U.S. market. 
Most of the U.S.-based manufacturers and importers are small companies 
based on Small Business Administration (SBA) size standards.\107\ 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.\108\ 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.\109\ There is no NAICS 
category specifically for water bead manufacturing or importing. 
Companies that manufacture water bead toy products may be categorized 
as doll, toy, and game manufacturing or under the category ``All Other 
Plastic Product Manufacturing.'' Importers are generally considered a 
type of merchant wholesaler. As seen in the tables below of applicable 
NAICS categories, the SBA small entity threshold for manufactures is 
generally 150 to 750 employees.
---------------------------------------------------------------------------

    \107\ Under SBA standards, a manufacturer, importer, and 
retailer of a product is categorized as a small entity based on 
their associated NAICS code. SBA uses the number of employees to 
determine if a manufacturer or importer is a small entity while SBA 
uses the amount of annual revenues for retailers.
    \108\ 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.
    \109\ https://www.census.gov/programs-surveys/susb/data/tables.html.

                        Table 2--Estimate of Number of Small Manufacturers and Importers
----------------------------------------------------------------------------------------------------------------
                                                                      SBA size standard    Number of firms that
            NAICS code                        Description              for firms (# of      meet size standard
                                                                         employees)        (based on SUSB data)
----------------------------------------------------------------------------------------------------------------
339930............................  Doll, Toy, and Game                             700                        7
                                     Manufacturing.
326199............................  All Other Plastic Product                       750                        1
                                     Manufacturing.
424610............................  Plastics Materials and Basic                    150                        4
                                     Forms and Shapes Merchant
                                     Wholesalers.
423920............................  Toy and Hobby Goods and                         175                       19
                                     Supplies Merchant Wholesalers.
----------------------------------------------------------------------------------------------------------------


                                 Table 3--Estimate of Number of Small Retailers
----------------------------------------------------------------------------------------------------------------
                                                                      SBA size standard
                                                                      for firms (annual    Number of firms that
            NAICS code                        Description             revenue) millions     meet size standard
                                                                              $            (based on SUSB data)
----------------------------------------------------------------------------------------------------------------
452210............................  Department Stores..............               $40.0                       15
452310............................  General Merchandise Stores,                    47.0                    8,006
                                     Including Warehouse Clubs and
                                     Supercenters.
451120............................  Hobby, Toy, and Game Stores....                35.0                    4,660
----------------------------------------------------------------------------------------------------------------

    Based on the Census Bureau's 2021 Statistics of U.S. Businesses 
(SUSB) data and a review of publicly available data on annual revenues, 
staff estimates the number of firms classified as small for the 
aforementioned NAICS codes to be seven manufacturers, 23 importers, and 
12,681 retailers. These firms could be considered small and supply 
water bead products.

C. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of 
the Proposed Rule

    The proposed rule would require suppliers (manufacturers and 
importers) of water bead toys to meet performance, warning label, and 
user instruction requirements, and to conduct third-party testing to 
demonstrate compliance. This section discusses the reporting and 
paperwork requirements. Compliance costs are analyzed in detail in 
section IX.E of this preamble.
    Manufacturers must demonstrate that they have met the performance 
requirements of the rule by providing a children's product certificate. 
As specified in 16 CFR part 1109, suppliers who are not the original 
manufacturer, such as importers, may rely on the testing or 
certification suppliers provide, as long as the requirements in part 
1109 are met. Manufacturers and importers are required to furnish 
certificates to retailers and distributors (section 14(g)(3) of the 
CPSA); retailers are not required to third-party test the children's 
products that they sell unless they are also the manufacturer or 
importer. Under section 14 of the CPSA, manufacturers, importers, and 
private labelers of water bead products will be required to certify, 
based on a test of each product conducted by third-party conformity 
assessment body, that their products comply with the requirements of 
the proposed rule. Each children's product certificate must identify 
the third-party conformity assessment body that conducted the testing 
upon which the certificate depends.

D. Potential Impact on Small Entities

    Water beads that expand to larger than 9.0 mm or to more than 50 
percent greater than their original size in diameter when tested 
pursuant to section 8.30, Expanding Materials Test Method of ASTM F963-
23, with modifications proposed in the NPR, would require modification 
to meet the proposed rule or be taken off the market. Additionally, 
water beads toys that do not meet the proposed acrylamide limit would 
require modification or discontinuation.
    The Commission assesses it is likely that a substantial number of 
firms will incur significant costs from redesign, retooling, loss of 
sales, or the purchase and installation of new components. While some 
water bead toys are produced at sizes under the proposed maximum water 
bead diameter limit of 9.0 mm, CPSC staff has not identified

[[Page 73044]]

water bead products that currently conform to the 50-percent-or-less 
growth limitation specified in the proposed rule.
    CPSC staff reviewed product descriptions for popular water bead 
retail packages and found that most are sold in mixed sizes with water 
beads that are both under and over the maximum size limit of the 
proposed rule. Staff estimates that water beads over the size limit are 
less than 5 percent of the market based on the range of sizes in these 
descriptions and an assumed distribution. Staff assesses water beads 
over the established limit can easily be replaced with sizes smaller 
than the limit to comply with the proposed rule. However, the 50 
percent growth limitation requirement is expected to result in all or 
nearly all water bead toys needing to be redesigned. Given this 
requirement, and the likelihood that all currently available water bead 
toys would not be compliant, staff expects some small firms to no 
longer package and advertise their products as toys but instead as 
agricultural or decorative home products (although firms may be able to 
redesign toys with water beads that expand to less than 9.0 mm and/or 
be packaged at a size closer to the desired expanded size). Due to the 
uncertainty related to redesigning these products, CPSC staff cannot 
generate an estimate of the potential costs of the proposed rule. CPSC 
staff seeks comment on the number of water beads designated as toys 
that currently meet the requirements of the proposed rule, and on the 
technical feasibility of the proposed requirements and potential 
redesign/retooling costs.
    Firms might incur a small one-time additional cost from updating 
existing labels and/or adding labels. Generally, the costs associated 
with modifying or adding warning labels are low on a per unit basis 
because all manufacturers of children's products are already required 
to provide labels with their product pursuant to section 14(a)(5) of 
the CPSA. The additional costs related to updating labels are less than 
$0.01 per unit of product sold, therefore, staff expect the incremental 
cost related to the labeling provision to be negligible.

E. Impact on Small Manufacturers

    CPSC staff considers 1 percent of revenue to be a ``significant'' 
economic impact, consistent with other federal government agencies. 
Staff expect that small manufacturers would incur significant costs 
from redesign, retooling, loss of product sales, and material change to 
comply with the proposed rule. However, the labeling costs per product 
are negligible (less than $0.01) and would have a de minimis impact on 
small firms. Overall, staff assess that a substantial number of small 
manufacturing firms will incur a significant cost from the proposed 
rule, although sale losses would be mitigated to the extent that 
manufacturers repurpose non-compliant water beads for non-toy uses 
(e.g., agricultural or decorative).

F. Third-Party Testing Costs

    The NPR would require manufacturers and importers of water bead 
toys to comply with performance requirements and demonstrate compliance 
by required third-party testing. As specified in 16 CFR part 1109, 
entities that are not manufacturers of children's products, such as 
importers, may rely on the certificate of compliance provided by 
others.
    Water bead manufacturers could incur some additional costs for 
certifying compliance with the proposed rule. The certification must be 
based on a test of each product performed by a third-party conformity 
assessment body. Based on quotes from testing laboratories for ASTM 
F963 mechanical services and chemistry testing services, the cost of 
certification testing would range from $300 to $500 per product sample. 
Some labs currently not performing acrylamide testing in other contexts 
may incur retooling costs to perform the necessary testing, which could 
result in higher prices per product sample. However, testing of 
products is already a requirement and only the incremental increase in 
expected price would be considered a cost for the proposed rule. CPSC 
staff do not expect a significant price increase for these testing 
services as a result of the proposed rule, particularly because they 
assess that laboratories tend to price testing by category (i.e., 
chemical testing vs. mechanical testing) and, therefore, such testing 
already has a price assigned that likely will not increase.

G. Efforts To Minimize Impact, Alternatives Considered

    The Commission considered three alternatives to the proposed rule 
that could reduce the impact on small entities: (1) not establishing a 
mandatory standard for water beads, (2) establishing an information and 
education campaign, or (3) setting a later effective date.
1. Not Establishing a Mandatory Standard
    Section 106 of the CPSIA requires CPSC to periodically review and 
revise ASTM F963 to ensure that such standards provide the highest 
level of safety for such products that is feasible. Given CPSC's 
statutory mandate, and continuing incidents associated with water bead 
toys as described in section III of this preamble, the Commission has 
determined that it must address the safety of children using water bead 
toys to ensure that the risks of ingestion and insertion into the body 
are mitigated. While failing to promulgate a mandatory standard for 
water beads would have no direct impact on U.S. small businesses, it 
would allow hazardous products to remain on the market and do nothing 
to reduce known hazards associated with water beads. This option might 
be selected if it were believed that the risk associated with these 
products is acceptable and that agency warning efforts have resulted or 
will result in the necessary market changes to address these injuries. 
As discussed immediately below, however, that is not the case. In 
addition, while there are no direct costs associated with this 
alternative, this alternative is unlikely to directly address the fatal 
and non-fatal injuries identified from water bead toys.
2. Information and Education Campaign
    CPSC could expand its information and education campaigns 
concerning the ingestion hazard associated with water bead toys. This 
would require consumer outreach efforts like advertising and marketing 
related to the hazards. This alternative could be implemented 
independent of regulatory action. Public awareness is a crucial 
component in making safe purchasing decisions and safely using water 
beads. CPSC issued the first warning about ingesting water beads in 
2012 with a recall. Since then, there have been many announcements from 
government bodies, healthcare professionals and the media.\110\ Given 
the continuing

[[Page 73045]]

incidents associated with water beads, CPSC assesses that information 
and education campaigns have limited effectiveness in adequately 
addressing the hazard. Therefore, the Commission preliminarily finds 
that while an information campaign might be helpful, it would be 
inadequate to address water bead toy hazards.
---------------------------------------------------------------------------

    \110\ Dunecraft Recalls Water Balz, Skulls, Orbs and Flower Toys 
Due to Serious Ingestion Hazard [verbar] CPSC.gov (2012) https://www.cpsc.gov/Recalls/2012/dunecraft-recalls-water-balz-skulls-orbs-and-flower-toys-due-to-serious-ingestion; ACCC warns of dangers of 
water expanding balls to kids [verbar] ACCC (2015) https://www.accc.gov.au/media-release/accc-warns-of-dangers-of-water-expanding-balls-to-kids; Are Water Beads Toxic?--poisonhelp.org 
https://www.poisonhelp.org/2024/03/26/water-beads-toxic/; How High-
Powered Magnetic Toys Can Harm Children--HealthyChildren.org (2023) 
https://www.healthychildren.org/English/safety-prevention/at-home/Pages/Dangers-of-Magnetic-Toys-and-Fake-Piercings.aspx?ampnfstatus=401&nftoken=00000000-0000-0000-0000-000000000000&nfstatusdescription=ERROR%252525252525253A%252525252525252BNo%252525252525252Blocal%252525252525252Btoken; Water Beads: A 
Danger to Young Children & Can Be Deadly if Swallowed [verbar] 
CPSC.gov (2023) https://www.cpsc.gov/Safety-Education/Safety-Guides/Toys-Crafts-Water-Beads/Water-Beads-A-Danger-to-Young-Children-Can-Be-Deadly-if-Swallowed; Water Beads: Harmful if Swallowed, Put in 
Ears--HealthyChildren.org (2024) https://www.healthychildren.org/English/safety-prevention/at-home/Pages/Water-Beads-Harmful.aspx?gad_source=1; Water Beads [verbar] CPSC.gov (2024) 
https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Water-Beads-Information-Center?language=en.
---------------------------------------------------------------------------

3. Later Effective Date
    The Commission could propose a later effective date that would 
reduce the burden on entities of all sizes by allowing more time to 
remove products from the market, repackage, and test products. In 
addition, testing laboratories need to become accredited to the 
proposed rule before any product can be tested to the proposed rule. 
Smaller companies are less likely to have the resources to quickly come 
into compliance with the proposed rule than larger ones, and a minority 
of the small U.S. companies that have products in scope of this 
proposed rule have multiple products that do not appear to meet the new 
performance requirements. However, the Commission preliminarily finds 
that providing a longer effective date would allow the hazards of water 
bead toys to be unaddressed for a later period of time resulting in 
more deaths and injuries, and thus would unreasonably delay addressing 
the ingestion hazard associated with water beads.

X. Environmental Consideration

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

XI. Paperwork Reduction Act

    This proposed rule for water beads contains information collection 
requirements that are subject to public comment and review by the 
Office of Management and Budget (``OMB'') under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). In this document, pursuant to 44 
U.S.C. 3507(a)(1)(D), we set forth:
     Title for the collection of information;
     Summary of the collection of information;
     Brief description of the need for the information and the 
proposed use of the information;
     Description of the likely respondents and proposed 
frequency of response to the collection of information;
     Estimate of the burden that shall result from the 
collection of information; and
     Notice that comments may be submitted to the OMB.
    Title: Safety Standard for Toys: Requirements for Water Beads
    Description: As described in section V of this preamble, the 
proposed rule would require new labeling for water bead toys. CPSC will 
seek a new OMB control number for this rule in the next PRA update for 
Third Party Testing of Children's Products. The NPR proposes that water 
bead toys meet the proposed requirements of Sec.  1250.4, which are 
summarized in section V of this preamble. Section 5 of ASTM F963-23 
contains requirements for marking, labeling, and instructional 
literature of children's toys in general. These requirements fall 
within the definition of ``collection of information,'' as defined in 
44 U.S.C. 3502(3).
    Description of Respondents: Persons who manufacture or import water 
bead toys or toys that contain water beads.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

                                   Table 4--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                        Number of       Frequency of    Total annual    Hours per   Total burden
            Burden type                respondents        responses       responses     response        hours
----------------------------------------------------------------------------------------------------------------
Labeling and instructions.........               30                 1            30             2            60
----------------------------------------------------------------------------------------------------------------

    This estimate is based on the following: CPSC estimates there are 
30 suppliers that would respond to this collection annually, and that 
the majority of these entities would be considered small businesses. 
CPSC assumes that on average each respondent that reports annually 
would respond once, as product models for water beads are brought to 
market and new labeling and instruction materials are created, for a 
total of 30 responses annually (30 respondents x 1 responses per year). 
CPSC assumes that on average it will take 1 hour for each respondent to 
create the required label and one hour for them to create the required 
instructions, for an average response burden of 2 hours per response. 
Therefore, the total burden hours for the collection are estimated to 
be 60 hours annually (30 responses x 2 hours per response = 60 total 
burden hours).
    CPSC estimates the hourly compensation for the time required to 
create and update labeling and instructions is $41.55.\111\ Therefore, 
the estimated annual cost of the burden requirements is $2,493 ($41.55 
per hour x 60 hours = $2,493). No operating, maintenance, or capital 
costs are associated with the collection. Based on this analysis, the 
proposed revisions to the standard would impose a burden to industry of 
60 hours at a cost of $2,493 annually.
---------------------------------------------------------------------------

    \111\ U.S. Bureau of Labor Statistics, ``Employer Costs for 
Employee Compensation,'' September 2023, Table 4, total compensation 
for all sales and office workers in goods-producing private 
industries: https://www.bls.gov/news.release/archives/ecec_12152023.pdf.
---------------------------------------------------------------------------

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
chapter 35), CPSC has requested OMB approval of new information 
collection and recordkeeping requirements related to this proposed 
rule. CPSC invites comments on this new information collection. All 
comments received on this information collection will be summarized and 
included in the final request for OMB approval. Interested persons are 
requested to submit comments regarding information collection by 
November 8, 2024 (see the ADDRESSES section at the beginning of

[[Page 73046]]

this notice). Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments 
on:
     Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
     The accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
     Ways to enhance the quality, utility, and clarity of the 
information to be collected;
     Ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology; and
     The estimated burden hours to create and update labeling 
and instructions, including any alternative estimates.

XII. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a 
consumer product safety standard is in effect and applies to a product, 
no state or political subdivision of a state may either establish or 
continue in effect a standard or regulation that prescribes 
requirements for the performance, composition, contents, design, 
finish, construction, packaging, or labeling of such product dealing 
with the same risk of injury unless the state requirement is identical 
to the federal standard. Section 106(f) of the CPSIA deems rules issued 
under that provision ``consumer product safety standards.'' Therefore, 
once a rule issued under section 106 of the CPSIA takes effect, it will 
have preemptive effect in accordance with section 26(a) of the CPSA.

XIII. Certification and Notice of Requirements

    Section 14(a) of the CPSA imposes the requirement that products 
subject to a consumer product safety rule under the CPSA, or to a 
similar rule, ban, standard, or regulation under any other act enforced 
by the Commission, must be certified as complying with all applicable 
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the 
CPSA requires that certification of children's products subject to a 
children's product safety rule be based on testing conducted by a CPSC-
accepted third-party conformity assessment body. Section 14(a)(3) of 
the CPSA requires the Commission to publish an NOR for the 
accreditation of third-party conformity assessment bodies (or 
laboratories) to assess conformity with a children's product safety 
rule to which a children's product is subject. The proposed rule would 
create a new 16 CFR 1250.4 as part of 16 CFR part 1250. If issued as a 
final rule, the proposed rule would be a children's product safety rule 
that requires the issuance of an NOR.
    16 CFR part 1112 establishes requirements for accreditation of 
third-party conformity assessment bodies to test for conformity with a 
children's product safety rule in accordance with section 14(a)(2) of 
the CPSA. Part 1112 also codifies all of the NORs issued previously by 
the Commission. To meet the requirement that the Commission issue an 
NOR for the proposed standard, the Commission proposes to add water 
beads to the list of children's product safety rules for which CPSC has 
issued an NOR.
    Testing laboratories applying for acceptance as a CPSC-accepted 
third-party conformity assessment body to test to the new standard for 
water beads would be required to meet the third-party conformity 
assessment body accreditation requirements in part 1112. When a 
laboratory meets the requirements as a CPSC-accepted third-party 
conformity assessment body, the laboratory can apply to CPSC to have 16 
CFR 1250.4, Safety Standard for Toys: Requirements for Water Beads, 
included within the laboratory's scope of accreditation of CPSC safety 
rules listed for the laboratory on the CPSC website at: https://www.cpsc.gov/cgi-bin/labsearch/.
    Testing laboratories should not be adversely impacted as a result 
of this rule. Approximately 67 third-party testing laboratories are 
CPSC-accepted to test compliance with ASTM F963-23. CPSC staff expects 
that these labs will become accredited and CPSC-accepted to test to 
this new standard in the normal course of business. CPSC expects that 
these laboratories will be able to test to a new rule in a short time 
period. Furthermore, no laboratory is required to provide testing 
services. The only laboratories that are expected to provide such 
services are those that anticipate receiving sufficient revenue from 
the mandated testing to justify procuring the testing equipment and 
obtaining accreditation.

XIV. Request for Comments

    The Commission requests comments on the proposed rule to promulgate 
a mandatory standard for water beads under section 106 of the CPSIA. 
During the comment period, ASTM F963-23 is available as a read-only 
document at: https://www.astm.org/cpsc.htm. Comments should be submitted 
in accordance with the instructions in the ADDRESSES section at the 
beginning of this document.
    CPSC requests comments on all aspects of this rulemaking and 
specifically requests comment on the following topics:

A. Water Bead Definition

    The proposed rule defines ``water bead(s)'' as ``various shaped, 
water absorbent polymers, such as, but not limited to polyacrylamides 
and polyacrylates, which expand when soaked in water.'' Should the 
proposed rule use a different definition of water beads?

B. NPR Scope

    1. Which, if any, water pellet guns designed to shoot water bead 
projectiles are not children's toys within the scope of the NPR? Please 
provide rationale supporting your comment.
    2. How, if at all, should color(s) of the water beads factor into 
the determination of whether they are toys, and therefore within the 
scope of the proposed rule? Please provide support for your 
recommendation.

C. Proposed Requirements To Address Ingestion Hazards

    1. Are the proposed 9.0 mm diameter funnel test gauge and the 50 
percent expansion limit adequate to address the hazards associated with 
ingestion of the product? If 9.0 mm diameter is not adequate, what size 
is adequate and why? If a 50 percent expansion limit is not adequate, 
what expansion limit is adequate and why?
    2. Are there any other performance requirements CPSC should 
consider to address the hazards associated with water bead ingestion?

D. Proposed Requirements To Address Ear Insertion Hazards

    1. Is the proposed 9.0 mm diameter funnel test gauge along with the 
50 percent expansion limit adequate to address the hazards associated 
with ear insertion? If 9.0 mm diameter is not adequate, what size is 
adequate and why? If a 50 percent expansion limit is not adequate, what 
percentage is adequate and why?
    2. What size dehydrated bead is most attractive to children 
regarding the risk of ear insertions and why?
    3. Are there any other performance requirements CPSC should 
consider to address the hazards associated with ear insertion?

E. Proposed Requirements To Address Nose Insertion Hazards

    1. Is the proposed 9.0 mm diameter funnel test gauge along with the 
50

[[Page 73047]]

percent expansion limit adequate to address the hazards associated with 
nose insertion? If 9.0 mm diameter is not adequate, what size is 
adequate and why? If a 50 percent expansion limit is not adequate, what 
percentage is adequate and why?
    2. What size dehydrated bead is most attractive to children 
regarding the risk of nose insertions and why?
    3. Are there any other performance requirements CPSC should 
consider to address the hazards associated with nose insertion?

F. Proposed Requirements To Address Aspiration Hazards

    1. Is the proposed 9.0 mm diameter funnel test gauge along with the 
50 percent expansion limit adequate to address the hazards associated 
with aspiration of the product? If the 9.0 mm diameter is not adequate, 
what size is adequate and why? If a limit of 50 percent expansion is 
not adequate, what percentage is adequate and why?
    2. Are there any other performance requirements CPSC should 
consider to address the hazards associated with water bead aspiration?

G. Water Beads Sticking Together

    1. Is there evidence of water beads sticking together or are there 
specific water bead products that have tendency to stick together 
before, during, or after expansion? If so, please provide further 
details.
    2. Is there an environment or scenario that has successfully caused 
expanded water beads to aggregate with themselves and/or any other 
substances, like food or mucus, to cause an obstruction? If so, please 
provide details.

H. Proposed Acrylamide Limit and Test Method

    1. Is the proposed limit of 65 [mu]g extractable acrylamide monomer 
from 100 small water beads or from one large water bead appropriate to 
adequately address the hazard of acute toxicity for children who ingest 
water beads?
    2. The 4.0 mm demarcation between the ``small'' and ``large'' 
designations for water beads was selected based on CPSC staff's 
observations of water bead samples prior to hydration, which tended to 
have diameters of equal to or less than 3.0 mm, or equal to or greater 
than 5.0 mm. Is another metric or method more appropriate to 
distinguish small and large water beads?
    3. Is there an alternative, more appropriate, acute oral toxicity 
reference value than ATSDR's the acute-duration oral minimal risk level 
that is based on valid test methods, relevant health endpoint(s), and 
appropriate safety factors?
    4. The chosen test value of 100 small water beads when testing for 
extractable acrylamide was within the range noted in incident case 
reports of children ingesting water beads. Is another test value for 
small water beads more appropriate?
    5. Is CPSC's acrylamide limit test method sufficient to evaluate 
extractable acrylamide in water beads? Are there other tests methods 
that CPSC should consider?

I. Proposed Warning Label Requirements for Water Beads

    1. Are the proposed warnings adequate to address hazards associated 
with water beads? Should other warnings be considered? Should other 
warning formats be considered?
    2. Regarding the proposed warning for toys that contain water 
beads, will consumers know what ``water beads'' are when warned of the 
dangers of ``water beads'' that became dislodged from the toy? Is there 
another term aside from ``water bead'' that would help consumers better 
identify what part of the toy is a water bead?
    3. Regarding the proposed warning for toys that contain water 
beads, will consumers know what the warning ``Discard if beads are 
coming out'' means? Is there another term aside from ``coming out'' 
that would help consumers understand the warning?

J. Initial Regulatory Flexibility Analysis and Other Topics

    1. Significant impact. Is CPSC's estimated cost of redesign to 
achieve compliance accurate? If not, please provide additional 
information and support for your proposed correction. Also, do the 
estimated costs represent more than one percent of annual revenue for 
individual small U.S. manufacturers and importers?
    2. Testing costs. Will third-party testing costs for water beads 
increase as a result of the requirements in this NPR, and if so, by how 
much? Are test labs that are currently accredited to test for ASTM 
F963-23 equipped to use LC-MS-MS to test for acrylamide in water beads? 
What other analytical test methods and equipment are appropriate for 
quantifying acrylamide content in the levels discussed in the NPR?
    3. Effective date. How much time is required to come into 
compliance with a final rule (including product compliance and third-
party testing), particularly for small businesses? Please provide 
supporting data with your comment.
    4. Alternatives to reduce the impact on small businesses. Are there 
any alternatives to the rule that could reduce the impact on small 
businesses without reducing safety? Please provide supporting data with 
your comment, particularly addressing small businesses.

K. Feasibility

    Are the proposed requirements in this NPR feasible, both 
technically and economically?

L. Water Bead Manufacturing

    Are manufacturers able to limit the growth of water beads to a 
specific diameter or specific percentage of growth? If so, what is the 
process of adjusting growth potential?

List of Subjects

16 CFR Part 1112

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

16 CFR Part 1250

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

    For the reasons discussed in the preamble, the Commission proposes 
to amend 16 CFR parts 1112 and 1250 as follows:

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

0
1. The authority citation for part 1112 is revised to read as follows:

    Authority:  15 U.S.C. 2063.

0
2. Amend Sec.  1112.15 by adding paragraph (b)(32)(ii)(LL) to read as 
follows:


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

* * * * *
    (b) * * *
    (32) * * *.
    (ii) * * *
    (LL) 16 CFR 1250.4, Requirements for Water Beads.
* * * * *

PART 1250--SAFETY STANDARD FOR TOYS

0
3. Revise the heading of part 1250 to read as set forth above.
0
4. The authority citation for part 1250 is revised to read as follows:

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


[[Page 73048]]


0
5. Revise Sec.  1250.1 to read as follows:


Sec.  1250.1  Scope.

    This part establishes a consumer product safety standard for toys.
0
6. Add Sec.  1250.4 to read as follows:


Sec.  1250.4  Requirements for water beads.

    (a) Scope and purpose. This section establishes performance and 
labeling requirements for water bead toys and toys containing water 
beads to minimize the risk of children ingesting, inserting, 
aspirating, and choking on water beads. The provisions of this part are 
intended to eliminate or adequately reduce the risk of injury and death 
to children from water bead toy hazards. This section adds requirements 
for water bead toys in addition to the requirements of Sec.  1250.2.
    (b) Definitions. In addition to the definitions incorporated by 
reference in Sec.  1250.2(a), the following definitions apply for 
purposes of this section:
    Aspiration hazard mean a hazard caused by a child inhaling a water 
bead whereby the water bead can become lodged in the respiratory tract 
and can potentially cause death or injury.
    Choking hazard means a hazard cause by a child attempting to 
swallow a water bead whereby the water bead can become lodged in the 
throat and can potentially cause death or injury.
    Ingestion hazard means a hazard caused by a child swallowing a 
water bead whereby the water bead can become lodged in the digestive 
tract and can potentially cause death or injury.
    Insertion hazard means a hazard caused by a child putting a water 
bead in the ear canal or nasal passage of the body and can potentially 
cause injury or death.
    Water bead means a various shaped water absorbent polymer, such as, 
but not limited to, polyacrylamide and polyacrylate, which expands when 
soaked in water.
    (c) Performance requirements. In addition to the requirements of 
Sec.  1250.2, all water bead toys and toys containing water beads 
within the scope of the rule must meet the performance requirements in 
this section to minimize the risk of children ingesting, inserting, 
aspirating, and choking on water beads.
    (1) Water beads as received or water beads removed from a toy, 
which fit entirely inside the small parts cylinder in their dehydrated 
(pre-expanded) state as shown in Figure 1 to paragraph (c)(1) (16 CFR 
1501.4) shall not expand more than 50 percent in any dimension and 
shall remain whole while also completely passing through the funnel 
test gauge as shown in Figure 2 to paragraph (c)(1), under its own 
weight after expansion, when tested in accordance with the following 
test procedure:

Figure 1 to Paragraph (c)(1)--Small Parts Cylinder.
[GRAPHIC] [TIFF OMITTED] TP09SE24.016

Figure 2 to Paragraph (c)(1)--Funnel Test Gauge. Material: 
Polytetrafluorethylene (PTFE).
[GRAPHIC] [TIFF OMITTED] TP09SE24.017

    (i) Test method. Condition the water bead or toy containing the 
water bead, at 20  5 [deg]C (68  9 [deg]F) and 
at a relative humidity of 40-65 percent for a minimum of seven hours 
prior to the test.
    (ii) If the water bead is partially expanded, or contained within a 
toy and partially expanded, remove the water bead for testing and allow 
120 hours to dehydrate.
    (iii) Measure the bead using calipers to determine the dehydrated 
dimensions. If not spherical, measure in all dimensions. When measuring 
with calipers, do not compress the bead in a manner that will change 
its shape.
    (iv) Submerge the water bead under a test bath of deionized water 
maintained at 37  2 [deg]C (98.6  3.6 [deg]F) 
for the duration of immersion, without agitation. For water beads that 
exhibit positive buoyancy, place weight(s) (with mass just sufficient 
to achieve complete submersion) atop the water bead. Care should be 
taken to minimize contact of the test water bead with the sides or 
bottom of the container.
    (v) Maintain submersion for 72 hours, measuring the water bead 
dimensions at 6 hours, 24 hours, 48 hours and 72 hours duration. If the 
greatest expansion was observed at 72 hours of submersion, proceed to 
immediately test the expanded water bead. If the greatest expansion was 
observed at another time interval, condition and submerge a new water 
bead per paragraph (c)(1)(i)-(iv) for the time interval at which the 
greatest expansion was observed. Then immediately test the expanded 
water bead.
    (vi) Remove the expanded water bead and using calipers, calculate 
the expansion amount in all dimensions as a percentage of the 
dehydrated dimensions and determine whether the bead has expanded more 
than 50 percent in any dimension. When measuring with calipers, do not 
compress the bead in a manner that will change its expanded shape.
    (vii) Place the expanded water bead at the top surface of the 
gauge's upper opening in the orientation least likely to pass through, 
and release allowing it to travel down until it reaches the lower 
opening. The expanded water bead shall remain whole and completely pass 
through the lower opening.
    (2) Acrylamide Limit Requirements. Water beads shall not have more 
than 65 [micro]g acrylamide extractable from 100 small water beads 
(defined as <4 mm across the smallest diameter of the bead prior to 
hydration) or from one large water bead (defined as >=4 mm across the 
smallest diameter of the bead prior to hydration) in the test procedure 
described below:
    (i) Acrylamide test procedure. To determine the amount of 
extractable acrylamide in water beads, first place the water beads (one 
large water bead or 100 small water beads) as received in a container 
with pH neutral deionized water.
    (ii) Situate the container(s) in a shaker bath that can heat the 
water beads to 37 [deg]C and shake them at a rate of 30 RPM. Leave the 
water beads untouched for 24 hours.
    (iii) Multiple concurrent trials, or sequential repetitions, must 
be performed to ensure that results are reasonably consistent, given 
any bead-to-bead variation. For large water beads, perform three trials 
with one large bead per trial. For small water beads, perform

[[Page 73049]]

three trials with 100 small beads per trial.
    (iv) Use an extraction container and volume of deionized water so 
that all water beads remain covered by water for the duration of the 
extraction period. Because water beads absorb water differently 
depending on their various sizes, additional tests may need to be 
conducted before starting the extractions to determine a volume of 
water that allows for full growth and coverage of the water beads 
without unnecessarily diluting the concentration of extracted 
acrylamide. Select containers that will not compress the water beads at 
any point during the 24-hour extraction period.
    (v) Cover the containers to prevent evaporation of the water during 
the extraction.
    (vi) Following the extraction, determine the volume of remaining 
water for each trial. Analyze the remaining water to determine the mass 
of acrylamide present using an instrument that can quantitate 
acrylamide at levels equal to or less than the limit.
    (d) Labeling requirements. All water bead toys and packaging of 
toys containing water beads within the scope of the rule must meet the 
marking, labeling, and instructional literature requirements in this 
section to minimize the risk of children ingesting, inserting, 
aspirating, and choking on water beads.
    (1) Requirements for Marking and Labeling. (i) Water bead toys, 
packaging of water bead toys, and the container of water beads, if 
provided, must include the safety alert symbol, signal word, and word 
message as shown in Figure 3 to paragraph (d)(1)(i).

Figure 3 to Paragraph (d)(1)(i)--Warning for Water Bead Toys and 
Packaging.
[GRAPHIC] [TIFF OMITTED] TP09SE24.018

    (ii) Products with contained water beads, such as balls filled with 
water beads, and the packaging must include the safety alert symbol, 
signal word, and word message as shown in Figure 4 to paragraph 
(d)(1)(ii):

Figure 4 to Paragraph (d)(1)(ii)--Toys That Contain Water Beads.
[GRAPHIC] [TIFF OMITTED] TP09SE24.019

    (iii) Products with contained water beads that do not have 
packaging must have a hangtag or sticker label with the full warnings. 
Multiple products sold in a package or bin must be individually labeled 
with a hangtag or sticker.
    (iv) The warnings shall be in the English language at a minimum.
    (v) The warnings shall be conspicuous and permanent on the 
principal display panel as defined in section 3.1.62 of the version of 
ASTM F963 incorporated by reference in Sec.  1250.2(a) and in a 
distinct color contrasting to the background on which it appears.
    (vi) The warnings shall conform to ANSI Z535.4-2023, sections 6.1-
6.4, 7.2-7.6.3, and 8.1, with the following changes:
    (A) In sections 6.2.2, 7.3, 7.5, and 8.1.2, of ANSI Z535.4-2023 
replace the word ``should'' with the word ``shall.''
    (B) In section 7.6.3 of ANSI Z535.4-2023, replace the phrase 
``should (when feasible)'' with the word ``shall.''
    (C) In section X of ANSI Z535.4-2023, strike the word ``safety'' 
when used immediately before a color (for example, replace safety 
white'' with ``white'').
    (vii) Certain text in the message panel must be in bold and in 
capital letters as shown in the example warning labels in figures 3 and 
4 to paragraph (d)(1)(ii). Text must use black lettering on a white 
background or white lettering on a black background.
    (viii) The message panel text shall appear in sans serif letters 
and be center or left aligned. Text with precautionary (hazard 
avoidance) statements shall be preceded by bullet points.
    (ix) Multiple precautionary statements shall be separated by bullet 
points if paragraph formatting is used.

[[Page 73050]]

[GRAPHIC] [TIFF OMITTED] TP09SE24.020

    (xi) The safety alert symbol, an exclamation mark in a triangle, 
when used with the signal word, must precede the signal word. The base 
of the safety alert symbol must be on the same horizontal line as the 
base of the letters of the signal word. The height of the safety alert 
symbol must equal or exceed the signal word letter height. The 
exclamation mark must be at least half the size of the triangle 
centered vertically.
    (2) Requirements for Instructional Literature. Instructions shall 
have the same warning labels that must appear on the product packaging, 
with similar formatting requirements, but without the need to be in 
color. However, the signal word and safety alert symbol shall contrast 
with the background of the signal word panel, and the warnings shall 
contrast with the background of the instructional literature.
    (e) Incorporation by reference. The Director of the Federal 
Register approves the incorporation by reference of ANSI Z535.4-23, 
American National Standard for Product Safety Signs and Labels 
(approved December 14, 2023) in paragraph (d) of this section in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This material is 
available for inspection at the U.S. Consumer Product Safety Commission 
and at the National Archives and Records Administration (NARA). Contact 
the U.S. Consumer Product Safety Commission at: the Office of the 
Secretary, U.S. Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814, telephone (301) 504-7479, email: [email protected]. For information on the availability of this material at 
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. A free, read-only copy of the standard 
is available for viewing on the ANSI website at https://ibr.ansi.org/Standards/nema.aspx. You may also obtain a copy from American National 
Standards Institute (ANSI), 1899 L Street NW, 11th Floor, Washington, 
DC 20036, www.ansi.org.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-19286 Filed 9-6-24; 8:45 am]
BILLING CODE 6355-01-P
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