Effective Date: 01/08/97
Title: Section 16.15 - Reports
16.15 Reports. (a) Reports of stolen, lost, or missing licensed or registered sources of radiation.
(1) Telephone reports. Each licensee or registrant shall report to the Department by telephone as follows:
(i) Immediately after its occurrence becomes known to the licensee or registrant, stolen, lost, or missing licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix 16-A, Table 9, infra, under such circumstances that it appears to the licensee or registrant that an exposure could result to individuals in unrestricted areas;
(ii) Within 30 days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than 10 times the quantity specified in Appendix 16-A, Table 9, infra, that is still missing;
(iii) Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation equipment; or
(iv) Immediately after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive materials which could exceed the regulatory limits, or releases of radioactive mateial which could exceed regulatory limits; due to an event such as an explosion, or toxic gas release.
(2) Written reports. Each licensee or registrant required to make a report pursuant to this subdivision shall, within 30 days after making the telephone report, make a written report to the Department setting forth the following information:
(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation equipment, the manufacturer, model and serial number, type and maximum energy of radiation emitted;
(ii) A description of the circumstances under which the loss or theft occurred; and
(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved; and
(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; and
(v) Actions that have been taken, or will be taken, to recover the source of radiation; and
(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.
(3) After filing the written report, the licensee or registrant shall also report any additional substantive information on the loss or theft within 30 days after the discovery of such information.
(4) The names of individuals who may have received exposure to radiation must be stated only in a separate and detachable portion of the report.
(b) Notification of incidents.
(1) Immediate notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:
(i) An individual to receive:
(a) A total effective dose equivalent of 0.25 Sv (25 rem) or more; or
(b) An eye dose equivalent of 0.75 Sv (75 rem) or more; or
(c) A shallow dose equivalent to the skin or extremities of 2.5 Gy (250 rad) or more; or
(ii) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
(2) Twenty-four hour notification. Each licensee or registrant shall, within 24 hours of discovery of the event, report each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:
(i) An individual to receive, in a period of 24 hours;
(a) A total effective dose equivalent exceeding 0.05 Sv (5 rem); or
(b) An eye dose equivalent exceeding 0.15 Sv (15 rem); or
(c) A shallow dose equivalent to the skin or extremities exceeding 0.5 Sv (50 rem); or
(ii) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures. (3) The licensee or registrant shall prepare each report filed with the Department pursuant to this subdivision so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.
(4) Licensees or registrants shall make the reports required by paragraphs (1) and (2) of this subdivision by telephone, telegram, mailgram, or facsimile to the Department.
(5) The provisions of this subdivision do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures, and are reported pursuant to section 16.15(d).
(c) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits.
(1) Reportable events. In addition to the notification required by section 16.15(b), each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:
(i) Incidents for which notification is required by section 16.15(b);
(ii) Doses in excess of any of the following:
(a) The occupational dose limits for adults in section 16.6(a);
(b) The occupational dose limits for a minor in section 16.6(g);
(c) The limits for an embryo/fetus of a declared pregnant woman in section 16.6(h);
(d) The limits for an individual member of the public in section 16.7(a);
(e) Any applicable limit in the license or registration; or
(iii) Levels of radiation or concentrations of radioactive material in:
(a) A restricted area in excess of applicable limits in the license or registration;
(b) An unrestricted area in excess of 10 times the applicable limit set forth in Part 16 or in the license or registration, whether or not involving exposure of any individual in excess of the limits in section 16.7(a).
(2) Contents of reports.
(i) Each report required by this subdivision shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
(a) Estimates of each individual's dose; and
(b) The levels of radiation and concentrations of radioactive material involved; and
(c) The cause of the elevated exposures, dose rates, or concentrations; and
(d) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, generally applicable environmental standards, and associated license or registration conditions.
(ii) Each report filed pursuant to paragraph (1) of this subdivision shall include for each individual exposed: the name, social security account number, and date of birth. With respect to the limit for the embryo/fetus in section 16.6(h), the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.
(3) All licensees or registrants who make reports pursuant to this subdivision shall submit the report in writing to the Department.
(d) Reports of planned special exposures. The licensees or registrant shall submit a written report to the Department within 30 days following
any planned special exposure conducted in accordance with section 16.6(f), informing the Department that a planned special exposure was conducted and indicating the date the planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by section 16.14(e).
(e) Notifications and reports to individuals.
(1) Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in section 16.13 of these regulations.
(2) When a licensee or registrant is required pursuant to section 16.15(c) to report to the Department any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the Department, and shall comply with the provisions of section 16.13 of these regulations.
(f) Reports of leaking or contaminated sealed sources. If a sealed source is determined to be leaking or contaminated, a report shall be filed within five days with the Department describing the equipment involved, the test results and the corrective action taken.
(g) Each professional practitioner who treats or diagnoses any suspected radiation illness shall report in writing to the Department within seven days after such treatment or diagnoses, the fact thereof and the full name, address and age of the individual. Included in this reporting requirement are patients who have developed clinical symptoms as a result of contact with radioactive (gold) jewelry.