Florida Regulations 64E-5.618: Requirements for Possession of Sealed Sources and Brachytherapy Sources
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(1) A licensee who possesses any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the department and shall maintain the instructions for the duration of source use in a legible form and convenient to users.
(2) A licensee in possession of a sealed source shall assure that:
(a) The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and,
(b) The source is tested for leakage at least every 6 months or at intervals approved by the department, another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission.
(c) Leak tests are capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample, or, in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 Bq) each 24 hours;
(d) Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and,
(e) Teletherapy and other device source samples are taken when the source is in the off position.
(f) Leak tests are analyzed by individuals who are licensed by the department, U.S. Nuclear Regulatory Commission, an agreement state or licensing state to perform leak test services.
(3) A licensee shall retain leak test records for 3 years. The records shall contain the model number and serial number if assigned of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (becquerels), the date of the test, and the name of the individual who performed the test analysis.
(4) If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall:
(a) Immediately withdraw the sealed source from use and cause it to be decontaminated and repaired or to be disposed of in accordance with these regulations; and,
(b) File a written report with the department within 5 days of receiving the leak test results describing the equipment involved, the test results, the action taken, the model number and serial number or the leaking source if assigned, the radioisotope and its estimated activity, and the date of the test.
(5) A leak test is not required on the following sources:
(a) Sources containing only radioactive material with a half-life of less than 30 days;
(b) Sources containing only radioactive material as a gas;
(c) Sources containing 100 microcuries (3.7 MBq) or less of beta or photon-emitting material or 10 microcuries (370 kBq) or less of alpha-emitting material; and,
(d) Seeds of iridium 192 encased in nylon ribbon.
(6) Leak tests are not required on calibration and reference sources stored and not being used. The licensee shall, however, clearly indicate on the inventory records that these sources are for storage only and the date placed in storage. The licensee shall test each such source for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.
(7) Leak tests are not required on brachytherapy and teletherapy sources that are listed on a department license for storage only. The licensee shall test each such source for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.
(8) A licensee who possesses sealed sources or brachytherapy sources, except gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all such sources at intervals not to exceed six months. The licensee shall retain each inventory record for 3 years. The inventory records shall contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, the date of the inventory, and the name of the individual who performed the inventory.
(9) A licensee who possesses a sealed source or brachytherapy source shall survey all areas where such sources are stored with a radiation survey instrument at least every 3 months. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
(10) A licensee shall retain a record of each survey required in subsection 64E-5.618(9), F.A.C., for 3 years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the model number and serial number of the survey instrument used to make the survey, and the name of the individual who performed the survey.
(11) Sealed sources designated as radioactive waste and held for decay in storage as in Fl. Admin. Code R. 64E-5.624, are not required to be leak tested or inventoried as required by this section.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Amended 5-12-93, Formerly 10D-91.724, Amended 2-11-10.
(a) The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and,
(b) The source is tested for leakage at least every 6 months or at intervals approved by the department, another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission.
(c) Leak tests are capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample, or, in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 Bq) each 24 hours;
(d) Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and,
(e) Teletherapy and other device source samples are taken when the source is in the off position.
(f) Leak tests are analyzed by individuals who are licensed by the department, U.S. Nuclear Regulatory Commission, an agreement state or licensing state to perform leak test services.
(3) A licensee shall retain leak test records for 3 years. The records shall contain the model number and serial number if assigned of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed in microcuries (becquerels), the date of the test, and the name of the individual who performed the test analysis.
(4) If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination, the licensee shall:
(a) Immediately withdraw the sealed source from use and cause it to be decontaminated and repaired or to be disposed of in accordance with these regulations; and,
(b) File a written report with the department within 5 days of receiving the leak test results describing the equipment involved, the test results, the action taken, the model number and serial number or the leaking source if assigned, the radioisotope and its estimated activity, and the date of the test.
(5) A leak test is not required on the following sources:
(a) Sources containing only radioactive material with a half-life of less than 30 days;
(b) Sources containing only radioactive material as a gas;
(c) Sources containing 100 microcuries (3.7 MBq) or less of beta or photon-emitting material or 10 microcuries (370 kBq) or less of alpha-emitting material; and,
(d) Seeds of iridium 192 encased in nylon ribbon.
(6) Leak tests are not required on calibration and reference sources stored and not being used. The licensee shall, however, clearly indicate on the inventory records that these sources are for storage only and the date placed in storage. The licensee shall test each such source for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.
(7) Leak tests are not required on brachytherapy and teletherapy sources that are listed on a department license for storage only. The licensee shall test each such source for leakage before any use or transfer unless it has been tested for leakage within 6 months before the date of use or transfer.
(8) A licensee who possesses sealed sources or brachytherapy sources, except gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all such sources at intervals not to exceed six months. The licensee shall retain each inventory record for 3 years. The inventory records shall contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, the date of the inventory, and the name of the individual who performed the inventory.
(9) A licensee who possesses a sealed source or brachytherapy source shall survey all areas where such sources are stored with a radiation survey instrument at least every 3 months. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
(10) A licensee shall retain a record of each survey required in subsection 64E-5.618(9), F.A.C., for 3 years. The record shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in millirems (microsieverts) per hour, the model number and serial number of the survey instrument used to make the survey, and the name of the individual who performed the survey.
(11) Sealed sources designated as radioactive waste and held for decay in storage as in Fl. Admin. Code R. 64E-5.624, are not required to be leak tested or inventoried as required by this section.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Amended 5-12-93, Formerly 10D-91.724, Amended 2-11-10.