D.C. Mun. Regs. tit. 22, r. 22-B10815

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10815 - REPORTING OF ACCIDENTAL RADIATION OCCURRENCES

10815.1

Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, immediately report to the Department all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by such manufacturer. Reasonable grounds include, but are not necessarily limited to, professional, scientific, or medical facts or opinions documented or otherwise, that concludes or leads to the conclusion that such an incident has occurred.

10815.2

Such reports shall be addressed to the Department, and the reports and their envelopes shall be distinctly marked "Report on 10815" and shall contain all of the following information where known to the manufacturer:

(a) The nature of the accidental radiation occurrence;

(b) The location at which the accidental radiation occurrence occurred;

(c) The manufacturer, type, and model number of the electronic product or products involved;

(d) The circumstances surrounding the accidental radiation occurrence, including causes;

(e) The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure or injuries and, if requested by the Department, the names of the persons involved;

(f) The actions, if any, which may have been taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence; and

(g) Any other pertinent information with respect to the accidental radiation occurrence.

10815.3

If a manufacturer is required to report to the Director under § 10815.1 and also is required to report under Chapter 104, the manufacturer shall report in accordance with Chapter 104. If a manufacturer is required to report to the Director under § 10815.1 and is not required to report under Chapter 104, the manufacturer shall report in accordance with § 10815.1 of this section. A manufacturer need not file a separate report under this section if an incident involving an accidental radiation occurrence is associated with a defect or noncompliance and is reported pursuant to § 10823.

D.C. Mun. Regs. tit. 22, r. 22-B10815

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.