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AGENCY:
Consumer Product Safety Commission.
ACTION:
Notice of proposed rulemaking.
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: 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 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. 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.
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).
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.”
Section 4.40 of ASTM F963-23 includes requirements for toys, including but not limited to water beads, that are made of “Expanding Materials.” 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 “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.
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.”
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. 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.
On August 21, 2024, the Commission voted unanimously (5-0) to publish this NPR.
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.
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).
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 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.
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.
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) and the National Electronic Injury Surveillance System (NEISS). 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.
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.
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.
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).
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. 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) 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.
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.
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.
Water bead obstruction was measured to be “approximately 2.8 x 2.8 x 2.8 cm [or 28 x 28 x 28 mm].”
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. Lethargy, distress, dehydration, loss of appetite, fever, fatigue, and abdominal pain are also reported when an expanded water bead blocks the small intestine.
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.
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.
Size of expanded water bead not provided. Samples of the product showed full expansion being between 45 mm and 50 mm in diameter.
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. 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.
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.
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.
Medical providers may also not know that ingested water beads can cause 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.
Size of expanded water beads not provided.
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 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.
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.
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. 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.
Radiolucent is defined as being transparent to x-rays.
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.
- 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.
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. However, it is uniquely challenging to remove water beads from the ear canal. 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.
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.
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. Young children or patients with certain special needs may not be able to communicate well 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. 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. 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.
The middle ear is the portion of the ear that is responsible for transferring acoustic energy to the inner ear.
Size of expanded water bead not provided.
Size of expanded water bead not provided.
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. 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.
The IDI confirms that the “[g]randmother described the extracted water bead as being the size of a pea.”
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 if left in the nasal cavity for prolonged periods of time, such as days or weeks. 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.
The tissue that lines the nasal cavity.
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. 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.
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. 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.
Id.
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. 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. 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:
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.
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.
- 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 under general anesthesia, where several water beads were removed from his airway.
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, 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. Physical characteristics of objects that pose a choking hazard include, for example, large size, round shape, and smooth texture.
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. 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.
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. 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:
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. 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. Consumers reasonably may not know water beads are hazardous, particularly because they are marketed for children's play.
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.
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. 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. Children are prone to ingest or insert small, smooth, colorful objects, like water beads or toy parts. Unintentional foreign body ingestion is a leading causes for nonfatal ED visits in children younger than 9 years old. Management and treatment for childhood accidental ingestion is well documented in pediatric medical literature.
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.
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.
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.
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].
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 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 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.
A unilateral press release is a product-related safety warning issued by CPSC that is not issued jointly with a recalling company.
Table 1—Summary of Water Bead Announcements
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.
Table 2—Estimate of Number of Small Manufacturers and Importers
NAICS code | Description | SBA size standard for firms (# of employees) | Number of firms that meet size standard (based on SUSB data) |
---|---|---|---|
339930 | Doll, Toy, and Game Manufacturing | 700 | 7 |
326199 | All Other Plastic Product Manufacturing | 750 | 1 |
424610 | Plastics Materials and Basic Forms and Shapes Merchant Wholesalers | 150 | 4 |
423920 | Toy and Hobby Goods and Supplies Merchant Wholesalers | 175 | 19 |
Table 3—Estimate of Number of Small Retailers
NAICS code | Description | SBA size standard for firms (annual revenue) millions $ | Number of firms that meet size standard (based on SUSB data) |
---|---|---|---|
452210 | Department Stores | $40.0 | 15 |
452310 | General Merchandise Stores, Including Warehouse Clubs and Supercenters | 47.0 | 8,006 |
451120 | Hobby, Toy, and Game Stores | 35.0 | 4,660 |
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 |