Florida Regulations 64E-5.344: Notification of Incidents
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(1) Immediate Notification. Regardless of 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 might have caused or threatens to cause any of the following conditions:
(a) An individual to receive:
1. A total effective dose equivalent of 25 rem (0.25 sievert) or more,
2. A lens dose equivalent of 75 rem (0.75 sievert) or more, or
3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rad (2.5 gray) or more, or
(b) The release of radioactive material inside or outside of a restricted area so that if an individual had 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 report to the department within 24 hours of discovery of the event each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that might have caused or threatens to cause any of the following conditions:
(a) An individual to receive in a period of 24 hours:
1. A total effective dose equivalent exceeding 5 rem (0.05 sievert),
2. A lens dose equivalent exceeding 15 rem (0.15 sievert), or
3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rem (0.5 sievert), or
(b) The release of radioactive material inside or outside of a restricted area so that if an individual had 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 as specified Fl. Admin. Code R. 64E-5.344, 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 subsections 64E-5.344(1) and (2), F.A.C., to the department by telephone, telegram, mailgram, or facsimile to the department.
(5) The provisions of Fl. Admin. Code R. 64E-5.344, do not apply to doses that result from planned special exposures if such doses are within the limits for planned special exposures and are reported as specified in Fl. Admin. Code R. 64E-5.346
(6) Immediate notification. In addition to the other reporting requirements in these regulations, each licensee shall notify the department as soon as possible but not later than 4 hours after the discovery of an event, such as a fire, explosion, or toxic gas release, that prevents immediate protective actions necessary to avoid exposure to radiation or radioactive materials that could exceed regulatory limits or to avoid releases of licensed material that could exceed regulatory limits.
(7) Twenty-four hour report. Each licensee shall notify the Department within 24 hours after the discovery of any of 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 of materials as specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 (see 64E-5.101, F.A.C.); 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 exposure 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 when 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 materials when:
1. The quantity of material involved is five times the lowest annual limit on intake for material specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012; and,
2. The damage affects the integrity of the licensed material or its container.
(e) Dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user as defined in Fl. Admin. Code R. 64E-5.6011
(f) Dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that meets one of the following:
1. Greater than 50 mSv (5 rem) total effective dose equivalent, or
2. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
(8) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:
(a) Licensees shall make reports required by subsections 64E-5.344(6) and (7), F.A.C., by telephone to the department. If the information is available at the time of notification, the information provided in these reports must include:
1. The caller’s name and call back telephone number,
2. A description of the event, including date and time,
3. The exact location of the event,
4. The isotopes, quantities, and chemical and physical forms of the licensed material involved; and,
5. Any personnel radiation exposure data available.
(b) Written report. Each licensee who makes a report required by subsections 64E-5.344(6) and (7), F.A.C., shall submit a written follow-up report within 30 days of the initial report. Written reports prepared as required by other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information. The reports must include the following:
1. A description of the event, including the probable cause and the manufacturer and model number of any equipment that failed or malfunctioned,
2. The exact location of the event,
3. The isotopes, quantities, and chemical and physical form of the licensed material involved,
4. Date and time of the event,
5. Corrective actions taken or planned and the results of any evaluations or assessments; and,
6. The extent of exposure of individuals to radiation or to radioactive materials without identification of the individuals by name.
Rulemaking Authority 404.051 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History-New 1-1-94, Amended 5-15-96, Formerly 10D-91.481, Amended 10-8-00, 2-11-10, 12-26-13.
Terms Used In Florida Regulations 64E-5.344
- Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
- Probable cause: A reasonable ground for belief that the offender violated a specific law.
1. A total effective dose equivalent of 25 rem (0.25 sievert) or more,
2. A lens dose equivalent of 75 rem (0.75 sievert) or more, or
3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 250 rad (2.5 gray) or more, or
(b) The release of radioactive material inside or outside of a restricted area so that if an individual had 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 report to the department within 24 hours of discovery of the event each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that might have caused or threatens to cause any of the following conditions:
(a) An individual to receive in a period of 24 hours:
1. A total effective dose equivalent exceeding 5 rem (0.05 sievert),
2. A lens dose equivalent exceeding 15 rem (0.15 sievert), or
3. A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 50 rem (0.5 sievert), or
(b) The release of radioactive material inside or outside of a restricted area so that if an individual had 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 as specified Fl. Admin. Code R. 64E-5.344, 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 subsections 64E-5.344(1) and (2), F.A.C., to the department by telephone, telegram, mailgram, or facsimile to the department.
(5) The provisions of Fl. Admin. Code R. 64E-5.344, do not apply to doses that result from planned special exposures if such doses are within the limits for planned special exposures and are reported as specified in Fl. Admin. Code R. 64E-5.346
(6) Immediate notification. In addition to the other reporting requirements in these regulations, each licensee shall notify the department as soon as possible but not later than 4 hours after the discovery of an event, such as a fire, explosion, or toxic gas release, that prevents immediate protective actions necessary to avoid exposure to radiation or radioactive materials that could exceed regulatory limits or to avoid releases of licensed material that could exceed regulatory limits.
(7) Twenty-four hour report. Each licensee shall notify the Department within 24 hours after the discovery of any of 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 of materials as specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 (see 64E-5.101, F.A.C.); 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 exposure 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 when 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 materials when:
1. The quantity of material involved is five times the lowest annual limit on intake for material specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012; and,
2. The damage affects the integrity of the licensed material or its container.
(e) Dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user as defined in Fl. Admin. Code R. 64E-5.6011
(f) Dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that meets one of the following:
1. Greater than 50 mSv (5 rem) total effective dose equivalent, or
2. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
(8) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:
(a) Licensees shall make reports required by subsections 64E-5.344(6) and (7), F.A.C., by telephone to the department. If the information is available at the time of notification, the information provided in these reports must include:
1. The caller’s name and call back telephone number,
2. A description of the event, including date and time,
3. The exact location of the event,
4. The isotopes, quantities, and chemical and physical forms of the licensed material involved; and,
5. Any personnel radiation exposure data available.
(b) Written report. Each licensee who makes a report required by subsections 64E-5.344(6) and (7), F.A.C., shall submit a written follow-up report within 30 days of the initial report. Written reports prepared as required by other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information. The reports must include the following:
1. A description of the event, including the probable cause and the manufacturer and model number of any equipment that failed or malfunctioned,
2. The exact location of the event,
3. The isotopes, quantities, and chemical and physical form of the licensed material involved,
4. Date and time of the event,
5. Corrective actions taken or planned and the results of any evaluations or assessments; and,
6. The extent of exposure of individuals to radiation or to radioactive materials without identification of the individuals by name.
Rulemaking Authority 404.051 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History-New 1-1-94, Amended 5-15-96, Formerly 10D-91.481, Amended 10-8-00, 2-11-10, 12-26-13.