[Federal Register: July 1, 1994] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1117 Proposed Rule; Requirements for Reporting Choking Incidents to the Consumer Product Safety Commission Pursuant to the Child Safety Protection Act AGENCY: Consumer Product Safety Commission (CPSC). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The ``Child Safety Protection Act'' requires manufacturers, distributors, retailers, and importers of marbles, small balls, latex balloons, and toys or games that contain such items or other small parts, to report to the Commission when they learn of certain choking incidents involving such products. The Commission is proposing a rule to implement this reporting requirement. DATES: Written comments in response to this notice must be received by the Commission no later than September 14, 1994. ADDRESSES: Comments, preferably in five (5) copies, should be mailed to the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207-0001, telephone (301) 504-0800, or delivered to room 502, East West Towers Building, 4330 East West Highway, Bethesda, MD. 20814. FOR FURTHER INFORMATION CONTACT: Eric L. Stone, Office of Compliance and Enforcement, at the above address, telephone (301) 504-0626, extension 1350. SUPPLEMENTARY INFORMATION: A. Background Section 101 of the Child Safety Protection Act, (Pub. L. No. 103- 267) (June 17, 1994) (the Act) adds a new Section 24 to the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1277, to be codified at 15 U.S.C. 1278. Section 24 of the FHSA requires the labeling of certain toys. The Commission's proposed amendments of 16 CFR Part 1500 implementing those labeling requirements are published elsewhere in this issue of the Federal Register. Section 102 of the Child Safety Protection Act also added a new reporting requirement: Each manufacturer, distributor, retailer and importer of a marble, small ball, or latex balloon, or a toy or game that contains a marble, small ball, latex balloon or other small part, shall report to the Commission any information obtained by such manufacturer, distributor, retailer, or importer which reasonably supports the conclusion that-- (A) an incident occurred in which a child (regardless of age) choked on such a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in such toy or game and (B) as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. (The full text of section 102 is published in the Appendix to this proposal because the language will not be codified in the United States Code.) Under the Act, a failure to report is a prohibited act under section 19(a)(3) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2068(a)(3), punishable by a civil penalty under section 20 of the CPSA, 15 U.S.C. 2069. The Act provides a high degree of confidentiality for such reports. In addition, the Act states that reports shall not be interpreted as admissions of liability or of the truth of the information in the reports. Several terms are not defined by the Act, and the text of the Act leaves other issues unresolved. For example, the Act does not say how soon a firm must report after it obtains reportable information. The Act is also silent as to what information must be reported. Applying the legislative history of the Act and the expertise developed over the last twenty years enforcing section 15(b) of the CPSA (15 U.S.C. 2064(b)), the Commission proposes these regulations to implement the new reporting provision. The Act provides that ``[f]or purposes of section 19(a)(3) of the Consumer Product Safety Act (15 U.S.C. 2068(a)(3)), the requirement to report information under this subsection is deemed to be a requirement under such Act.'' Section 16(b) of the CPSA (15 U.S.C. 2065(b)) authorizes the Commission to require manufacturers, private labelers and distributors to make reports and provide information reasonably required for the purposes of implementing the CPSA. A failure to make reports or provide information under section 16(b) of the CPSA (15 U.S.C. 2065(b)) is a prohibited act under section 190(a)(3) of the CPSA (15 U.S.C. 2068(a)(3)). The Commission proposes this rule under section 102 of the Act and section 16(b) of the CPSA (15 U.S.C. 2065(b)). The proposed rule specifies the information that should trigger a report, the timeframe for reporting, and the content of reports. Violations of this rule are prohibited acts under the CPSA. Since the statutory reporting obligation became effective on June 17, 1994 when the bill was signed into law, subject firms may use this proposal for guidance as to how to comply with their reporting obligation in the statute. Section 30(d) of the CPSA (15 U.S.C. 2079(d)) provides that ``[a] risk of injury which is associated with a consumer product and which could be eliminated or reduced to a sufficient extent by action under the Federal Hazardous Substances Act, the Poison Prevention Packaging Act of 1970, or the Flammable Fabrics Act may be regulated under this Act only if the Commission by rule finds that it is in the public interest to regulate such risk of injury under this Act.'' Such a finding is unnecessary for this rule because it does not regulate a risk of injury, but merely requires firms to report information about consumer products. B. Section by Section Discussion Section 1117.3 of the proposed rule emphasizes that subject firms must report whenever they obtain sufficient information to put a reasonable firm on notice of a reportable choking incident. The reporting provision originated in the Senate, and The Report of the Senate Committee on Commerce, Science and Transportation states this provision requires subject firms to ``report to the CPSC any information obtained that supports the conclusion that an incident occurred in which a child, regardless of age, choked on such a product and, as a result of such coking incident, the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional.'' (S. Rep. No. 195, 103d Cong., 2d Sess. 10 (1993).) The rule is intended to require firms to report incident information obtained after June 17, 1994, the effective date of the Child Safety Protection Act. The Commission has placed no limitations on the age of the child involved in the incident or on the intended ages for the toy or game involved. This approach is consistent with the Senate committee report which said ``reports are to be made regardless of the age of the child who chokes and regardless of the ages of the child for which the toy was intended.'' (S. Rep. No. 195, 103d Cong., 2d Sess. 10 (1993)). Section 1117.4 of the proposal requires firms to report within 24 hours of obtaining information about a reportable choking incident. Since the statute does not provide a time frame for reporting, the Commission believes the intent was that firms report as soon as they obtain ``information that supports the conclusion that an incident occurred.'' (S. Rep. No. 195, 103d Cong., 2d Sess. 10 (1993)). Moreover, immediate reporting is important to help the Commission prevent additional choking incidents to children. Proposed Sec. 1117.5 describes the information that firms must report. The Commission has limited the reporting requirements to information necessary to give the Commission staff sufficient information to understand the nature of, and the context for, the choking incident and to determine whether corrective measures may be necessary. Because these reports are limited to reduce the burden on reporting firms, the Commission anticipated that in some cases the staff may need to investigate further. Section 1117.6 of the proposed rule explains that this reporting provision is in addition to, but not a substitute for, the reporting requirements of section 15(b) of the CPSA (15 U.S.C. 2064(b)). Even if a report of a choking hazard is not required by the proposed rule, a report may be necessary under section 15(b) of the CPSA (15 U.S.C. 2064(b)) and 16 CFR Part 1115. The remaining provisions of this proposed regulation set forth the confidentiality, liability ad penalty provisions that would apply to reporting in accordance with the proposed regulation published below. C. Impact on Small Businesses In accordance with section 3(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), the Commission certifies that this regulation will not have a significant economic impact upon a substantial number of small entities if issued on a final basis. Any obligations imposed upon such entities arise under the express provisions of section 102 of the Child Protection Safety Act, Pub. L. No. 103-267, June 17, 1994. The proposed regulation simply implements the obligations imposed by that law. The regulation itself will not have a significant economic impact on small businesses, either beneficial or negative, beyond that which results from the statutory provisions. D. Environmental Considerations The proposed rule fall within the provisions of 16 CFR 1021.5(c), which designates categories of actions conducted by the Consumer Product Safety Commission that normally have little or no potential for affecting the human environment. The Commission does not believe that the rule contains any unusual aspects which may produce effects on the human environment, nor can the Commission foresee any circumstance in which the rule proposed below may produce such effects. For this reason, neither an environmental assessment nor an environmental impact statement is required. E. Proposed Effective Date This regulation is proposed to become effective 30 days after publication of the final regulation in the Federal Register. Subject firms should be aware, however, that the Child Safety Protection Act required reporting as of June 17, 1994. Firms may use this proposal for guidance as to how to comply with the law. List of Subjects in 16 CFR Part 1117 Administrative practice and procedure, Business and industry, Consumer Protection, Toy Safety, Penalties, Reporting and recordkeeping requirements, and Small Parts. Conclusion Therefore, pursuant to the authority of the Child Safety Protection Act [Pub. L. 103-267), section 16(b) of the CPSA (15 U.S.C. 2065(b)), and 5 U.S.C. 553, the CPSC proposes to amend Title 16 of the Code of Federal Regulations, Chapter II, Subchapter B by adding a new Part 1117 to read as follows: PART 1117--REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER SMALL PARTS. Sec. 1117.1 Purpose. 1117.2 Definitions. 1117.3 Reportable information. 1117.4 Time for filing a report. 1117.5 Information that must be reported and to whom. 1117.6 Relation to section 15(b) of the CPSA. 1117.7 Confidentiality of reports. 1117.8 Effect of reports on liability. 1117.9 Prohibited acts and sanctions. Appendix to Part 1117--Sec. 102 of the Child Safety Reporting Act Authority: Section 102 of the Child Safety Protection Act [Pub. L. No. 103-267), section 16(b), 15 U.S.C. 2065(b), and 5 U.S.C. 553. Sec. 1117.1 Purpose. The purpose of this part is to set forth the Commission's regulations for reports of choking incidents required by the Child Safety Protection Act. The statute requires that each manufacturer, distributor, retailer, and importer of a marble, small ball, or latex balloon, or a toy or a game that contains a marble, small ball, latex balloon, or other small part, shall report to the Commission any information obtained by such manufacturer, distributor, retailer, or importer which reasonably supports the conclusion that an incident occurred in which a child (regardless of age) choked on such a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in such toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. Sec. 1117.2 Definitions. (a) Small part means any component of a toy or game which, when tested in accordance with the procedures in 16 CFR 1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in Figure 1 appended to 16 CFR 1501. (b) Small ball means any ball with a diameter of 1.75 inches (4.445 cm) or less when measured in the manner set forth in 16 CFR 1500.18(a)(17)(iii) & (iv). For purposes of this designation, the term ``ball'' includes any spherical, ovoid, or ellipsoidal object that is designed or intended to be thrown, hit, kicked, rolled, or bounced, and is either not permanently attached to another toy or article, or is attached to such toy or article by means of a string, elastic cord, or similar tether. The term ``ball'' includes any multi-sided object formed by connecting planes into a generally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball, and any novelty item of a generally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball. (c) Choked means suffered an obstruction of the airways. (d) A latex balloon is a toy or decorative item consisting of a latex bag that is designed to be inflated by air or gas. The term does not include inflatable children's toys that are used in aquatic activities, such as rafts, water wings, life rings, etc. (e) A marble is a ball made of a hard material, such as glass, agate, marble or plastic, that is used in various children's games, generally as a playing piece or marker. (f) Serious injury includes not only the concept of ``grievous bodily injury'' defined in the Commission's rule for Substantial Hazard Reports at 16 CFR 1115.12(d), but also any other significant injury. Injuries necessitating hospitalization which require actual medical or surgical treatment, fractures, lacerations requiring sutures, concussions, injuries to the eye, ear, or internal organs requiring medical treatment, and injuries necessitating absence from school or work or more than one day are examples of situations in which the Commission shall presume that such a serious injury has occurred. (g) Subject firm means any manufacturer, distributor, retailer or importer of marbles, small balls, latex balloons, or a toy or game that contains a marble, small ball, latex balloon, or other small part. Sec. 1117.3 Reportable information. A subject firm shall report any information it obtains which reasonably supports the conclusion that a reportable incident occurred. Generally, firms should report any information provided to the company, orally or in writing, which states that a child choked on a marble, small ball, latex balloon, or on a marble, small ball, latex balloon or other small part contained in a toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. Subject firms must not wait until they have investigated the incident or conclusively resolved whether the information is accurate or whether their product was involved in the incident. Firms shall not wait to determine conclusively the cause of the death, injury, cessation of breathing or necessity for treatment. An allegation that such a result followed the choking incident is sufficient to require a report. Sec. 1117.4 Time for filing a report. A subject firm must report within 24 hours of obtaining information which reasonably supports the conclusion that an incident occurred in which a child (regardless of age) choked on a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in a toy or game and, as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. Section 1117.5 sets forth the information that must be reported. Sec. 1117.5 Information that must be reported and to whom. (a) Reports shall be directed to the Division of Corrective Actions, Consumer Products Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814 (Mailing Address: Washington, D.C. 20207) (Phone: 301-504-0608, facsimile: 301-504-0359). (b) Subject firms must report as much of the following information as is known when the report is made: (1) The name, address, and title of the person submitting the report to the Commission, (2) The name and address of the subject firm, (3) The name and address of the child who choked and the person(s) who notified the subject firm of the choking incident, (4) Identification of the product involved including the date(s) of distribution, model or style number, a description of the product (including any labeling and warnings), a description of the marble, small ball, latex balloon or other small part involved, and pictures or sample if available, (5) A description of the choking incident and any injuries that resulted or medical treatment that was necessary, (6) Copies of any information obtained about the choking incident, (7) Any information about changes made to the product or its labeling or warnings with the intention of avoiding such choking incidents, including, but no limited to, the date(s) of the change and its implementation, and a description of the change. Copies of any engineering drawings or product and label samples that depict the change(s). (8) The details of any public notice or other corrective action planned by the firm, (9) Such other information as appropriate. (c) Subject firms must immediately supplement their reports when they obtain further information specified in section (b). Sec. 1117.6 Relation to section 15(b) of the CPSA. Section 15(b) of the CPSA requires subject firms to report when they obtain information which reasonably supports the conclusion that products they distributed in commerce fail to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA, contain a defect which could create a substantial product hazard, or create an unreasonable risk of serious injury or death. The Commission's rules interpreting this provision are set forth at 16 CFR 1115. The requirements of section 102 of the CPSA and this Part are in addition to, but not to the exclusion of, the requirements in section 15(b) and Part 1115. To comply with section 15(b), subject firms must continue to evaluate safety information they obtain about their products. Subject firms may have an obligation to report under section 15(b) of the CPSA whether or not they obtain information about choking incidents. Firms must also comply with the lawsuit reporting provisions of section 37 of the CPSA, interpreted at 16 CFR 1116. Sec. 1117.7 Confidentiality of reports. The confidentiality provisions of section 6 of the CPSA, 15 U.S.C. 2055, apply to reports submitted under this Part. The Commission shall afford information submitted under this Part the protection afforded to information submitted under section 15(b), in accordance with section 6(b)(5) of the CPSA and subpart G of Part 1101 of Title 16 of the CFR. Sec. 1117.8 Effect of reports on liability. A report by a manufacturer, distributor, retailer, or importer under this Part shall not be interpreted, for any purpose, as an admission of liability or of the truth of the information contained in the report. Sec. 1117.9 Prohibited acts and sanctions. (a) Whoever knowingly and willfully falsifies or conceals a material fact in a report submitted under this Part is subject to criminal penalties under 18 U.S.C. 1001. (b) A failure to report to the Commission in a timely fashion as required by this Part is a prohibited act under section 19(a)(3) of the CPSA, 15 U.S.C. 2068(a)(3). (c) A subject firm that knowingly fails to report is subject to civil penalties under section 20 of the CPSA, 15 U.S.C. 2069. ``Knowing'' means the having of actual knowledge or the presumed having of knowledge deemed to be possessed by a reasonable person who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations. Section 20(d) of the CPSA, 15 U.S.C. 2069(d). (d) Any person who knowingly and willfully violates section 19 of this Act after having received notice of noncompliance from the Commission may be subject to criminal penalties under section 21 of the CPSA, 15 U.S.C. 2070. Appendix to Part 1117--Sec. 102 of the Child Safety Reporting Act Sec. 102 Reporting Requirements. (a) Reports to Consumer Product Safety Commission.-- (1) Requirement to Report.--Each manufacturer, distributor, retailer, and importer of a marble, small ball, or latex balloon, or a toy or game that contains a marble, small ball, latex balloon, or other small part, shall report to the Commission any information obtained by such manufacturer, distributor, retailer, or importer which reasonably supports the conclusion that-- (A) an incident occurred in which a child (regardless of age) choked on such a marble, small ball, or latex balloon or on a marble, small ball, latex balloon, or other small part contained in such toy or game; and (B) as a result of that incident the child died, suffered serious injury, ceased breathing for any length of time, or was treated by a medical professional. (2) Treatment Under CPSA.--For purposes of section 19(a)(3) of the Consumer Product Safety Act (15 U.S.C. 2068(a)(3)), the requirement to report information under this subsection is deemed to be a requirement under such Act. (3) Effect on Liability.--A report by a manufacturer, distributor, retailer, or importer under paragraph (1) shall not be interpreted, for any purpose, as an admission of liability or of the truth of the information contained in the report. (b) Confidentiality Protections.--The confidentiality protections of section 6(b) of the Consumer Product Safety Act (15 U.S.C. 2055(b)) apply to any information reported to the Commission under subsection (a) of this section. For purposes of section 6(b)(5) of such Act, information so reported shall be treated as information submitted pursuant to section 15(b) of such Act respecting a consumer product. Dated: June 28, 1994. Sadye E. Dunn, Secretary, Consumer Product Safety Commission. [FR Doc. 94-16083 Filed 6-30-94; 8:45 am] BILLING CODE 6355-01-M