197 Part 1117—Reporting of Chok- Ing Incidents
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Consumer Product Safety Commission § 1117.2 (b) A defect in the consumer product SOURCE: 60 FR 10493, Feb. 27, 1995, unless which was the subject of the civil ac- otherwise noted. tion; (c) A substantial product hazard; § 1117.1 Purpose. (d) An imminent hazard; or The purpose of this part is to set (e) Any other liability under any forth the Commission’s interpretative statute or any common law. regulations for reporting of choking in- cidents required by the Child Safety § 1116.12 Commission response to sec- tion 37 reports. Protection Act. The statute requires that each manufacturer, distributor, Upon receipt of a section 37 report, retailer, and importer of a marble, the Commission will evaluate the in- small ball, or latex balloon, or a toy or formation contained in the report and any relevant information contained in a game that contains a marble, small its files or data bases to determine ball, latex balloon, or other small part, what, if any, follow-up or remedial ac- shall report to the Commission any in- tion by the Commission is appropriate. formation obtained by such manufac- If the Commission requires additional turer, distributor, retailer, or importer information, it will notify the manu- which reasonably supports the conclu- facturer in writing of the specific infor- sion that an incident occurred in which mation to provide. In addition, the a child (regardless of age) choked on Commission will routinely review sec- such a marble, small ball, or latex bal- tion 37 reports to determine whether loon or on a marble, small ball, latex the reporting manufacturers have ful- balloon, or other small part contained filled their obligations under both sec- in such toy or game and, as a result of tions 37 and 15(b) in a timely manner. that incident the child died, suffered Such a review may also engender a re- serious injury, ceased breathing for quest for additional information, in- any length of time, or was treated by a cluding the dates on which final orders medical professional. were entered in each of the lawsuits re- ported under section 37. The Commis- § 1117.2 Definitions. sion will treat any subsequent submis- (a) Small part means any part, compo- sion of information by the manufac- nent, or piece of a toy or game, which, turer as a submission under section when tested in accordance with the 37(c)(2)(B) subject to the restrictions on procedures in 16 CFR 1501.4(a) and public disclosure contained in sections 6(a) and (b) of the Consumer Product 1501.4(b)(1), fits entirely within the cyl- Safety Act. inder shown in Figure 1 appended to 16 CFR 1501. PART 1117—REPORTING OF CHOK- (b) Small ball means any ball that under the influence of its own weight, ING INCIDENTS INVOLVING passes, in any orientation, entirely MARBLES, SMALL BALLS, LATEX through a circular hole with a diame- BALLOONS AND OTHER SMALL ter of 1.75 inches (4.445 cm) in a rigid PARTS template .25 inches (6 mm.) thick. For purposes of this designation, the term Sec. ‘‘ball’’ includes any spherical, ovoid, or 1117.1 Purpose. 1117.2 Definitions. ellipsoidal object that is designed or 1117.3 Reportable information. intended to be thrown, hit, kicked, 1117.4 Time for filing a report. rolled, or bounced, and is either not 1117.5 Information that must be reported permanently attached to another toy and to whom. or article, or is attached to such a toy 1117.6 Relation to section 15(b) of the or article by means of a string, elastic CPSA. 1117.7 Confidentiality of reports. cord, or similar tether. The term ball 1117.8 Effect of reports on liability. includes any multi-sided object formed 1117.9 Prohibited acts and sanctions. by connecting planes into a generally AUTHORITY: Section 102 of the Child Safety spherical, ovoid, or ellipsoidal shape Protection Act (Pub. L. No. 103–267), section that is designated or intended to be 16(b), 15 U.S.C. 2065(b) and 5 U.S.C. 553. used as a ball, and any novelty item of 197 VerDate Mar<15>2010 15:21 Feb 24, 2011 Jkt 223052 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Y:\SGML\223052.XXX 223052 WReier-Aviles on DSKGBLS3C1PROD with CFR § 1117.3 16 CFR Ch. II (1–1–11 Edition) a generally spherical, ovoid, or ellip- must not wait until they have inves- soidal shape that is designated or in- tigated the incident or conclusively re- tended to be used as a ball. solved whether the information is ac- (c) Choked means suffered an obstruc- curate or whether their product was in- tion of the airways. volved in the incident. Firms shall not (d) A latex balloon is a toy or decora- wait to determine conclusively the tive item consisting of a latex bag that cause of the death, injury, cessation of is designed to be inflated by air or gas. breathing or necessity for treatment. The term does not include inflatable An allegation that such a result fol- children’s toys that are used in aquatic lowed the choking incident is sufficient activities, such as rafts, water wings, to require a report. life rings, etc. (e) A marble is a ball made of a hard § 1117.4 Time for filing a report. material, such as glass, agate, marble (a) A subject firm must report within or plastic, that is used in various chil- 24 hours of obtaining information dren’s games, generally as a playing which reasonably supports the conclu- piece or marker. sion that an incident occurred in which (f) Serious injury includes not only a child (regardless of age) choked on a the concept of ‘‘grievous bodily injury’’ marble, small ball, or latex balloon or defined in the Commission’s rule for on a marble, small ball, latex balloon, Substantial Hazard Reports at 16 CFR or other small part contained in a toy 1115.12(d), but also any other signifi- or game and, as a result of that inci- cant injury. Injuries necessitating hos- dent the child died, suffered serious in- pitalization which require actual med- jury, ceased breathing for any length of ical or surgical treatment and injuries time, or was treated by a medical pro- necessitating absence from school or fessional. Section 1117.5 of this part work of more than one day are exam- sets forth the information that must be ples of situations in which the Commis- reported. sion shall presume that such a serious (b) The Commission will deem a sub- injury has occurred. ject firm to have obtained reportable (g) Subject firm means any manufac- information when the information has turer, distributor, retailer or importer been received by an official or em- of marbles, small balls, latex balloons, ployee who may reasonably be expected or a toy or game that contains a mar- to be capable of appreciating the sig- ble, small ball, latex balloon, or other nificance of the information. Under or- small part. dinary circumstances, 5 days shall be (h) Toy or game includes any toy or the maximum reasonable time for in- game, including those exempt under 16 formation to reach such an employee, CFR 1501.3 from the small parts ban- the Chief Executive Officer or the offi- ning provisions of 16 CFR 1500.18(a)(9). cial or employee responsible for com- [60 FR 10493, Feb. 27, 1995, as amended at 60 plying with the reporting requirements FR 41801, Aug. 14, 1995] of section 102 of the Child Safety Pro- tection Act. § 1117.3 Reportable information. A subject firm shall report any infor- § 1117.5 Information that must be re- mation it obtains which reasonably ported and to whom. supports the conclusion that a report- (a) Reports shall be directed to the able incident occurred. Generally, Division of Corrective Actions, Con- firms should report any information sumer Product Safety Commission, provided to the company, orally or in 4330 East West Highway, Bethesda, writing, which states that a child Maryland 20815 (Mailing Address: choked on a marble, small ball, latex Washington, D.C. 20207) (Phone: 301– balloon, or on a marble, small ball, 504–0608, facsimile: 301–504–0359). latex balloon or other small part con- (b) Subject firms must report as tained in a toy or game and, as a result much of the following information as is of that incident the child died, suffered known when the report is made: serious injury, ceased breathing for (1) The name, address, and title of any length of time, or was treated by a the person submitting the report to the medical professional. Subject firms Commission, 198 VerDate Mar<15>2010 15:21 Feb 24, 2011 Jkt 223052 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Y:\SGML\223052.XXX 223052 WReier-Aviles on DSKGBLS3C1PROD with CFR.