N.Y. Comp. Codes R. & Regs. tit. 12 § 38.29

Current through Register Vol. 46, No. 50, December 11, 2024

Section 38.29 - Reports

(a)Reports of stolen, lost, or missing licensed or registered sources of radiation.

(1) Telephone reports. Each licensee or registrant shall report any stolen, lost or missing licensed or registered source of radiation to the commissioner by telephone immediately (as soon as possible but not more than four hours after discovery) after its occurrence becomes known.

(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 commissioner 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; and

(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 (as soon as possible but not more than four hours after discovery) 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

(d) a dose to any organ in which the total of the deep dose equivalent and the committed dose equivalent is 2.5 Sv (250 rem) 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 hotcells or process enclosures; or

(iii) the inability or failure to implement immediate protective actions necessary to avoid exposures to radiation or radioactive materials which could exceed regulatory limits, or releases of radioactive material which could exceed regulatory limits.

(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

(d) a dose to any organ in which the total of the deep dose equivalent and the committed dose equivalent exceeds 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;

(iii) the following events involving licensed material:

(a) an unplanned contamination event that:

(1) 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;

(2) involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix A-13 of section 38.41 of this Part (rule) for the material; and

(3) 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:

(1) 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;

(2) the equipment is required to be available and operable at the time it is disabled or fails to function; and

(3) 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:

(1) the quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix A-13 of section 38.41 of this Part (rule) for the material; and

(2) the damage affects the integrity of the licensed material or its container.

(3) The licensee or registrant shall prepare each report filed with the commissioner 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 commissioner and shall include the following information to the extent that it is available at the time of the report:

(i) the reporting person's name and contact telephone number;

(ii) a description of the event, including date and time;

(iii) the exact location of the event;

(iv) the radioactive materials involved, including quantities and chemical and physical form; and

(v) any personnel radiation exposure data available.

(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 subdivision (d) of this section.

(c)Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits.

(1) Reportable events. In addition to the notification required by subdivision (b) of this section, 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 subdivision (b) of this section;

(ii) doses in excess of any of the following:

(a) the occupational dose limits for adults in section 38.18(a) of this Part (rule);

(b) the occupational dose limits for a minor in section 38.18(g) of this Part (rule);

(c) the limits for an embryo/fetus of a declared pregnant woman in section 38.18(h) of this Part (rule);

(d) the limits for an individual member of the public in section 38.19(a) of this Part (rule);

(e) any applicable limit in the license or registration;

(f) the ALARA constraint on air emissions established under section 38.17(d) of this Part; 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 this Part (rule) or in the license or registration, whether or not involving exposure of any individual in excess of the limits in section 38.19(a) of this Part (rule).

(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) a description of the incident or event, including the exact location, date and time, the probable cause, and a description of any equipment that failed or malfunctioned;

(b) estimates of each individual's dose; and

(c) the levels of radiation and concentrations of radioactive material involved; and

(d) the cause of any elevated exposures, dose rates, or concentrations; and

(e) corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints 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 38.18(h) of this Part (rule), 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 commissioner.

(d)Reports of planned special exposures.

The licensee or registrant shall submit a written report to the commissioner within 30 days following any planned special exposure conducted in accordance with section 38.18(f) of this Part (rule), informing the commissioner that a planned special exposure was conducted and indicating the date the exposure occurred and the information required by section 38.28(e) of this Part (rule).

(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 38.27 of this Part (rule).

(2) When a licensee or registrant is required pursuant to subdivision (c) of this section to report to the commissioner 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 commissioner, and shall comply with the provisions of section 38.27 of this Part (rule).

(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 commissioner describing the equipment involved, the test results and the corrective action taken.

(g)Reports of filing petitions for bankruptcy.

(1) Each holder of a specific and general license shall report immediately by certified mail to the commissioner following the filing of voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:

(i) the holder of a specific or general license,

(ii) an entity (i.e., person, estate, trust, governmental unit, or United States trustee) controlling the holder of a specific or general license or listing the license or holder thereof as property of the bankrupt estate; or

(iii) an affiliate (as defined in 11 USC section 101 [2]) of the holder of a specific or general license.

(2) The bankruptcy notification shall indicate the:

(i) bankruptcy court in which the petition for bankruptcy was filed;

(ii) the date on which the petition was filed.

N.Y. Comp. Codes R. & Regs. Tit. 12 § 38.29