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Rule Title: SPECIFIC LICENSES: SPECIAL REQUIREMENTS FOR ISSUANCE OF CERTAIN SPECIFIC LICENSES FOR RADIOACTIVE MATERIAL
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Department: PUBLIC HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Chapter: RADIATION CONTROL
Subchapter: Licensing of Radioactive Material
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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37.14.540    SPECIFIC LICENSES: SPECIAL REQUIREMENTS FOR ISSUANCE OF CERTAIN SPECIFIC LICENSES FOR RADIOACTIVE MATERIAL

(1) In addition to the requirements set forth in ARM 37.14.521, a specific license for human use of radioactive material in institutions will be issued if:

(a) the applicant has appointed a medical isotopes committee of at least 3 members to evaluate all proposals for research, diagnostic, and therapeutic use of radioactive material within that institution. Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in assay of radioactive material and protection against radiation;

(b) the applicant possesses adequate facilities for the clinical care of patients;

(c) the physician designated on the application as the individual user has substantial experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients; and

(d) if the application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses.

(2) (a) An application by an individual physician or group of physicians for a specific license for human use of radioactive material will be approved if:

(i) the applicant satisfies the general requirements specified in ARM 37.14.521;

(ii) the application is for use in the applicant's practice in an office outside a medical institution;

(iii) the applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable; and

(iv) the applicant has extensive experience in the proposed use, the handling and administration of radionuclides, and where applicable, the clinical management of radioactive patients.

(b) The department will not approve an application by an individual physician or group of physicians for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:

(i) the use of radioactive material is limited to:

(A) the administration of radiopharmaceuticals for diagnostic or therapeutic purposes,

(B) the performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered,

(C) the performance of in vitro diagnostic studies, or

(D) the calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

(ii) the physician brings the radioactive material with him and removes the radioactive material when he departs. (The institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient) ; and

(iii) the medical institution does not hold a radioactive material license under (1) of this rule.

(3) (a) Subject to the provisions of (b) , (c) , and (d) below, an application for a specific license pursuant to (1) , (2) , or (4) of this rule for any medical use or uses of radioactive material specified in 1 or more of Groups I to VI, inclusive, of Schedule C of this subchapter will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

(i) the applicant satisfies the requirements of (1) , (2) , or (4) of this rule;

(ii) the applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

(iii) the applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups;

(iv) the applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups; and

(v) the applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

(b) Any licensee or registrant who is authorized to use radioactive material pursuant to 1 or more groups in (a) above and Schedule C of this subchapter is subject to the following conditions:

(i) For groups I, II, IV, and V, no licensee or registrant shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(10) , a specific license issued by the US nuclear regulatory commission, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(ii) For Group III, no licensee or registrant shall receive, possess, or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:

(A) reagent kits not containing radioactive material that are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state for use by persons licensed pursuant to (3) and Schedule C of this subchapter or equivalent regulations; or

(B) generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(11) , a specific license issued by the US nuclear regulatory commission, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(iii) For Group VI, no licensee or registrant shall receive, possess, or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(12) , a specific license issued by the US nuclear regulatory commission, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(iv) For Group III, any licensee or registrant who uses generators or reagent kits shall elute the generator or process radioactive material with the reagent kit in accordance with instructions which are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and are furnished by the manufacturer on the label attached to or in the leaflet or brochure which accompanies the generator or reagent kit.

(v) For Group VI any licensee who possesses and uses sources or devices containing radioactive material shall:

(A) cause each source or device containing more than 100 microcuries of radioactive material with a half-life greater than 30 days, except iridium-192 seeds encased in nylon ribbon, to be tested for contamination and/or leakage at intervals not to exceed 6 months or at such other intervals as are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and described by the manufacturer on the label attached to the source, device, or permanent container thereof, or in the leaflet or brochure which accompanies the source or device. Each source or device shall be so tested prior to its first use unless the supplier furnishes a certificate that the source or device has been so tested within 6 months prior to the transfer;

(B) assure that the test required by (A) above shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample or in the case of radium, the escape of radon at the rate of 0.001 microcurie per 24 hours. The test sample shall be taken from the source or from the surfaces of the device in which the source is permanently or semi-permanently mounted or stored on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department;

(C) if the test required by (A) above reveals the presence of 0.005 microcurie or more of removable contamination or in the case of radium, the escape of radon at the rate of 0.001 microcurie per 24 hours, immediately withdraw the source from use and cause it to be decontaminated and repaired or to be disposed of in accordance with department rules. A report shall be filed within 5 days of the test with the department, describing the equipment involved, the test results, and the corrective action taken;

(D) follow the radiation safety and handling instructions approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, device or permanent container thereof, or in the leaflet or brochure which accompanies the source or device, and maintain such instruction in a legible and conveniently available form;

(E) conduct a quarterly physical inventory to account for all sources and devices received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include the quantities and kinds of radioactive material, location of sources and devices, and the date of the inventory;

(F) assure that needles or standard medical applicator cells containing radium-226, or cobalt-60 as wire are not opened while in the licensee's possession unless specifically authorized by a license issued to him by the department; and

(G) assure that patients containing cobalt-60, cesium-137, iridium-192 and/or radium-226 implants shall remain hospitalized until the implants are removed.

(c) Any licensee who is licensed pursuant to (3) (a) above for 1 or more of the medical use groups in Schedule C of this subchapter also is authorized to use radioactive material under the general license in ARM 37.14.512(9) for the specified in vitro uses without filing department form MRH-11 as required in ARM 37.14.512(9) (b) ; provided, that the licensee is subject to the other provisions of ARM 37.14.512(9) .

(d) Any licensee who is licensed pursuant to (3) (a) above for 1 or more of the medical use groups in Schedule C of this subchapter also is authorized, subject to the provisions of (d) and (e) below, to receive, possess, and use for calibration and reference standards:

(i) any radioactive material listed in Group I, Group II, or Group III of Schedule C of this subchapter with a half-life not longer than 100 days, in amounts not to exceed 15 millicuries total;

(ii) any radioactive material listed in Group I, Group II, or Group III of Schedule C of this subchapter with half-life greater than 100 days in amounts not to exceed 200 microcuries total;

(iii) technetium-99m in amounts not to exceed 30 millicuries; and

(iv) any radioactive material, in amounts not to exceed 3 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(12) , a specific license issued by the US nuclear regulatory commission, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(e) (i) Any licensee or registrant who possesses sealed sources as calibration or reference sources pursuant to (d) above shall cause each sealed source containing radioactive material, other than hydrogen-3, with a half-life greater than 30 days in any form other than gas to be tested for leakage and/or contamination at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, the sealed sources should not be used until tested, provided, however, that no leak tests are required when:

(A) the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material, or

(B) the sealed source is stored and is not being used; such sources shall, however, be tested for leakage prior to any use or transfer unless they have been leak tested within 6 months prior to the date of use or transfer.

(ii) The leak test shall be capable of detecting the presence of 0.005 microcuries of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department.

(iii) If the leak test reveals the presence of 0.005 microcuries or more of removable contamination, the licensee or registrant shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with ARM Title 37, chapter 14, subchapters 5 and 7. A report shall be filed within 5 days of the test with the department describing the equipment involved, the test results, and the corrective action taken.

(f) Any licensee or registrant who possesses and uses calibration and reference sources pursuant to (d) (iv) above shall:

(i) follow the radiation safety and handling instructions approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and

(ii) conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include the quantities and kinds of radioactive material, location of sources, and the date of the inventory.

(4) In addition to the requirements set forth in ARM 37.14.521, a specific license for human use of sealed sources will be issued only if the applicant or, if the application is made by an institution, the individual user:

(a) has specialized training in the diagnostic or therapeutic use of the sealed source considered, or has experience equivalent to such training, and

(b) is a physician.

(5) In addition to the requirements set forth in ARM 37.14.521, a specific license for use of sealed sources in industrial radiography will be issued if:

(a) the applicant will have an adequate program for training radiographers and radiographer's assistants and submits to the department a schedule or description of such program which specifies the:

(i) initial training,

(ii) periodic training,

(iii) on-the-job training,

(iv) means to be used by the licensee to determine the radiographer's knowledge and understanding of an ability to comply with department rules and licensing requirements, and the operating and emergency procedures of the applicant, and

(v) means to be used by the licensee to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant;

(b) the applicant has established and submits to the department satisfactory written operating and emergency procedures;

(c) the applicant will have an adequate internal inspection system, or other management control, to assure that license provisions, rules, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants;

(d) the applicant submits to the department a description of his overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

(e) the applicant who desires to conduct his own leak tests has established adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination and submits to the department a description of such procedures including:

(i) instrumentation to be used,

(ii) method of performing tests, e.g., points on equipment to be smeared and method of taking smear, and

(iii) pertinent experience of the person who will perform the test; and

(f) the licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

History: Sec. 75-3-202, MCA; IMP, Sec. 75-3-202, MCA; NEW, 1980 MAR p. 1069, Eff. 3/28/80; TRANS, from DHES, 1996 MAR p. 433; TRANS, from DEQ, 2000 MAR p. 189.


 

 
MAR Notices Effective From Effective To History Notes
3/28/1980 Current History: Sec. 75-3-202, MCA; IMP, Sec. 75-3-202, MCA; NEW, 1980 MAR p. 1069, Eff. 3/28/80; TRANS, from DHES, 1996 MAR p. 433; TRANS, from DEQ, 2000 MAR p. 189.
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