OAR 333-102-0350: Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reporting Requirements

(1) Immediate report. Each licensee must notify the Authority as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, or other manmade and natural events). (2) Twenty-four hour report. Each licensee must notify the Authority within 24 hours after the discovery of any of the following events involving licensed material: (a) An unplanned contamination event that: (A) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (B) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix B of Secs. 20.1001–20.2401 of 10 CFR part 20 for the material; and (C) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination. (b) An event in which equipment is disabled or fails to function as designed when: (A) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; (B) The equipment is required to be available and operable when it is disabled or fails to function; and (C) No redundant equipment is available and operable to perform the required safety function. (c) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body. (d) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when: (A) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix B of Secs. 20.1001–20.2401 of 10 CFR part 20 for the material; and (B) The damage affects the integrity of the licensed material or its container. (3) Preparation and submission of reports. Reports made by licensees in response to the requirements of this rule must be made as follows: (a) Licensees must make reports required by sections (1) and (2) of this rule by telephone to the Authority. To the extent that the information is available at the time of notification, the information provided in these reports must include: NOTE: The 24-hour telephone number for the Authority is 1-800-452-0311. (A) The caller's name and call back telephone number; (B) A description of the event, including date and time; (C) The exact location of the event; (D) The isotopes, quantities, and chemical and physical form of the licensed material involved; and (E) Any personnel radiation exposure data available. (b) Written report. Each licensee who makes a report required by sections (1) or (2) of this rule must submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be mailed to the Authority with Attention to Manager, Radiation Protection Services, Center for Health Protection, 800 NE Oregon Street, Suite 640, Portland, OR 97232. The reports must include the following: (A) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; (B) The exact location of the event; (C) The isotopes, quantities, and chemical and physical form of the licensed material involved; (D) Date and time of the event; (E) Corrective actions taken or planned and the results of any evaluations or assessments; and (F) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name. (4) The provisions of this rule apply to licensees subject to the notification requirements in OAR 333-102-0200(5).