Section 410 IAC 5-3-13 - Specific licenses to manufacture, repair, or distribute products containing radioactive materialsAuthority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Sec. 13.
(a) Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations. (1) In addition to the requirements set forth in 410 IAC 5-3-10, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under 410 IAC 5-3-4(a)(1) will be issued if: (i) The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and(ii) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Schedule A, 410 IAC 5-3-26, that reconcentration of the radioactive material in concentrations exceeding those in Schedule A is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.(2) Each person licensed under 410 IAC 5-3-13(a) shall file an annual report with the board which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to 410 IAC 5-3-13(a) during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.(b) Licensing the Distribution of Radioactive Material in Exempt Quantities.10/(1) An application for a specific license to distribute NARM to persons exempted from 410 IAC 5 pursuant to 410 IAC 5-3-4(b) will be approved if: (i) The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;(ii) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and(iii) The applicant submits copies of prototype labels and brochures and the board approves such labels and brochures.(2) The license issued under 410 IAC 5-3-13(b)(1) is subject to the following conditions: (i) No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.(ii) Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to 410 IAC 5-3-4(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which: (A) Identifies the radionuclide and the quantity of radioactivity, and(B) Bears the words "Radioactive Material."(iv) In addition to the labeling information required by 410 IAC 5-3-13(b)(2)(iii), the label affixed to the immediate container, or an accompanying brochure, shall: (A) State that the contents are exempt from licensing state requirements;(B) Bear the words "Radioactive Material-Not for Human Use-Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited-Exempt Quantities Should Not Be Combined;" and(C) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.(3) Each person licensed under 410 IAC 5-3-13(b) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under 410 IAC 5-3-4 or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the board. Each report shall cover the year ending June 30, and shall be filed within thirty (30) days thereafter. If no transfers of radioactive material have been made pursuant to 410 IAC 5-3-13(b) during the reporting period, the report shall so indicate. 10/ Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
(c) Licensing the Incorporation of Naturally-Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under 410 IAC 5-3-4(c)(3) will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32. The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie.(d) Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under 410 IAC 5-3-7(d). (1) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 410 IAC 5-3-7(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state will be approved if: (i) The applicant satisfies the general requirements of 410 IAC 5-3-10;(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: (A) The device can be safely operated by persons not having training in radiological protection;(B) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits specified in the table in 410 IAC 5-4-2(a); and(C) Under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses: Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rems
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rems
Other organs 50 rems; and
(iii) Each device bears a durable, legible, clearly visible label or labels approved by the board, which contain in a clearly identified and separate statement: (A) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information;(B) The requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and(C) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:(aa) The receipt, possession, use, and transfer of this device, Model _____, Serial No. _____ 11/, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION-RADIOACTIVE MATERIAL
_______________________________________
Name of manufacturer or distributor
(bb) The receipt, possession, use, and transfer of this device, Model _____, Serial No. _____ 11/, are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION-RADIOACTIVE MATERIAL
_______________________________________
Name of manufacturer or distributor
(2) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the board will consider information which includes, but is not limited to:(i) Primary containment or source capsule;(ii) Protection of primary containment;(iii) Method of sealing containment;(iv) Containment construction materials;(v) Form of contained radioactive material;(vi) Maximum temperature withstood during prototype test;(vii) Maximum pressure withstood during prototype tests; (viii) Maximum quantity of contained radioactive material;(ix) Radiotoxicity of contained radioactive material; and(x) Operating experience with identical devices or similarly designed and constructed devices.(3) In the event the applicant desires that the general licensee under 410 IAC 5-3-7(d), or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the limits specified in the table in 410 IAC 5-4-2(a).(4) Each person licensed under 410 IAC 5-3-13(d) to distribute devices to generally licensed persons shall: (i) Furnish a copy of the general license contained in 410 IAC 5-3-7(d) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in 410 IAC 5-3-7(d);(ii) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's, agreement state's or licensing state's regulation equivalent to 410 IAC 5-3-7(d), or alternatively, furnish a copy of the general license contained in 410 IAC 5-3-7(d) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the agreement state or the licensing state. If a copy of the general license in 410 IAC 5-3-7(d) is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, agreement state or licensing state under requirements substantially the same as those in 410 IAC 5-3-7(d);(iii) Report to the board all transfers of such devices to persons for use under the general license in 410 IAC 5-3-7(d). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the board and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to the persons generally licensed under 410 IAC 5-3-7(d) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter;(iv) Furnish reports to other agencies: (A) Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31;(B) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to 410 IAC 5-3-13(d) for use under a general license in that state's regulations equivalent to 410 IAC 5-3-7(d);(C) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the board and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person;(D) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission;(E) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of that agency.(v) Keep records showing the name, address, and the point of contact for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in 410 IAC 5-3-7(d), or equivalent regulations of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state. The records should show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person and compliance with the report requirements of 410 IAC 5-3-13(d)(4). 11/ The model, serial number, and name of manufacturer or distributor may be omitted from this label provided the information is elsewhere specified and labeling affixed to the device.
(e) Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 410 IAC 5-3-7(e) will be approved if: (1) The applicant satisfies the general requirements specified in 410 IAC 5-3-10, and(2) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32 or their equivalent.(f) Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium, or Radium-226 for Distribution to Persons Generally Licensed Under 410 IAC 5-3-7(g). An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under 410 IAC 5-3-7(g) will be approved if: (1) The applicant satisfies the general requirement of 410 IAC 5-3-10, and(2) The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.(g) Manufacture and Distribution of Radioactive Material for Medical Use Under General License. In addition to requirements set forth in 410 IAC 5-3-10, a specific license authorizing the distribution of radioactive material for use by physicians under the general license in 410 IAC 5-3-7(h) will be issued if: (1) The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration, has approved, or in accordance with a license for a biologic product issued by the Secretary, U.S. Department of Health and Human Services; and(2) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package: (i) This radioactive drug may be received, possessed, and used only by physicians licensed (to dispense drugs) in the practice of medicine. Its receipt, possession, use, and transfer are subject to the regulations and a general license or its equivalent of the U.S. Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority, ________________________________________
Name of manufacturer
(ii) This radioactive drug may be received, possessed, and used only by physicians licensed (to dispense drugs) in the practice of medicine. Its receipt, possession, use, and transfer are subject to the regulations and a general license or its equivalent of a licensing state. ________________________________________
Name of manufacturer
(h) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of 410 IAC 5-3-7(i) will be approved if: (1) The applicant satisfies the general requirements specified in 410 IAC 5-3-10;(2) The radioactive material is to be prepared for distribution in prepackaged units of: (i) Carbon-14 in units not exceeding 10 microcuries each;(ii) Cobalt-57 in units not exceeding 10 microcuries each;(iii) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each;(iv) Iodine-125 in units not exceeding 10 microcuries each;(v) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcuries of americium-241 each;(vi) Iodine-131 in units not exceeding 10 microcuries each;(vii) Iron-59 in units not exceeding 20 microcuries each;(viii) Selenium-75 in units not exceeding 10 microcuries each;(3) Each prepackaged unit bears a durable, clearly visible label:(i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, iodine-131, selenium-75, cobalt-57, or carbon-14; 50 microcuries of hydrogen-3 (tritium); 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and(ii) Displaying the radiation caution symbol described in 410 IAC 5-4-11(a)(1) and the words, "CAUTION, RADIOACTIVE MATERIAL," and "Not for Internal or External Use in Humans or Animals."(4) One of the following statements, or a substantially similar statement which contains the information called for in the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: (i) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. ________________________________________
Name of manufacturer
(ii) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only in in vitro clinical or laboratory tests not involving internal or external administration of the material or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a licensing state. ________________________________________
Name of manufacturer
(5) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source, must also contain directions to the licensee regarding the waste disposal requirements set out in 410 IAC 5-4-16.(i) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 410 IAC 5-3-10 will be approved if: (1) The applicant satisfies the general requirements of 410 IAC 5-3-10, and(2) The criteria of Sections 32.61, 32.62, and 32.103 of 10 CFR Part 32 are met.(j) Manufacture and Distribution of Radiopharmaceuticials [sic.] Containing Radioactive Material for Medical Use Under Group Licenses. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to 410 IAC 5-3-11(c) for the uses listed in Group I, Group II, IV, or V of Schedule C, 410 IAC 5-3-28, will be approved if: (1) The applicant satisfies the general requirements specified in 410 IAC 5-3-10;(2) The applicant submits evidence that: (i) The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA, or(ii) The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;(3) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and(4)(i) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the board for distribution to persons licensed pursuant to 410 IAC 5-3-11(c) and Schedule C, 410 IAC 5-3-28, Group I, Group II, Group IV, and Group V, as appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state.(ii) The labels, leaflets, or brochures required by 410 IAC 5-3-13(j)(4)(i) are in addition to the labeling required by the Food and Drug Administration and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.(k) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material.12/ An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to 410 IAC 5-3-11(c) for the uses listed in Group III of Schedule C, 410 IAC 5-3-28, will be approved if: (1) The applicant satisfies the general requirements specified in 410 IAC 5-3-10;(2) The applicant submits evidence that: (i) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application approved by the Food and Drug Administration or a "Notice of Claimed Investigational Exemption for a New Drug" that has been accepted by the FDA, or(ii) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;(3) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;(4) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and(5) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains: (i) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and(ii) A statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the board pursuant to 410 IAC 5-3-11(c) and Schedule C, 410 IAC 5-3-28, Group III or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state. The labels, leaflets or brochures required by 410 IAC 5-3-13(k) are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. 12/ Although the board does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the board for use by persons licensed pursuant to 410 IAC 5-3-11(c) and Group III of Schedule C, 410 IAC 5-3-28, may submit the pertinent information specified in 410 IAC 5-3-13(k).(l) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to 410 IAC 5-3-11(c) for use as a calibration or reference source or for the uses listed in Group VI of Schedule C, 410 IAC 5-3-28, will be approved if: (1) The applicant satisfies the general requirements in 410 IAC 5-3-10;(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: (i) The radioactive material contained, its chemical and physical form, and amount,(ii) Details of design and construction of the source or device,(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,(iv) For devices containing radioactive material, the radiation profile of a prototype device,(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,(vi) Procedures and standards for calibrating sources and devices,(vii) Legend and methods for labeling sources and devices as to their radioactive content, and(viii) Instruction for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label; and(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the name of source or device is licensed by the board for distribution to persons licensed pursuant to 410 IAC 5-3-11(c) and Schedule C, 410 IAC 5-3-28, Group VI or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state, provided, that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source.(4) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and(5) In determining the acceptable interval for test of leakage of radioactive material, the board will consider information that includes, but is not limited to: (i) Primary containment or source capsule; (ii) Protection of primary containment;(iii) Method of sealing containment; (iv) Containment construction materials;(v) Form of contained radioactive material;(vi) Maximum temperature withstood during prototype tests;(vii) Maximum pressure withstood during prototype tests;(viii) Maximum quantity of contained radioactive material;(ix) Radiotoxicity of contained radioactive material; and(x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.(m) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications. (1) An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 410 IAC 5-3-6(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state will be approved if: (i) The applicant satisfies the general requirements specified in 410 IAC 5-3-10;(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar quarter a radiation dose in excess of 10 percent of the limits specified in 410 IAC 5-4-2(a); and(iii) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.(2) In the case of an industrial product or device whose unique benefits are questionable, the board will approve an application for a specific license under 410 IAC 5-3-13(m) only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.(3) The board may deny any application for a specific license under 410 IAC 5-3-13(m) if the end use(s) of the industrial product or device cannot be reasonably foreseen.(4) Each person licensed pursuant to 410 IAC 5-3-13(m)(1) shall: (i) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;(ii) Label or mark each unit to:(A) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and(B) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an agreement state;(iii) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";(iv)(A) Furnish a copy of the general license contained in 410 IAC 5-3-6(d) and a copy of board form "W," 410 IAC 5-3-32, to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in 410 IAC 5-3-6(d); or(B) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's or agreement state's regulation equivalent to 410 IAC 5-3-6(d) and a copy of the U.S. Nuclear Regulatory Commission's or agreement state's certificate; or alternatively, furnish a copy of the general license contained in 410 IAC 5-3-6(d) and a copy of board form "W," 410 IAC 5-3-32, to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an agreement state, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an agreement state under requirements substantially the same as those in 410 IAC 5-3-6(d).(v) Report to the board all transfers of industrial products or devices to persons for use under the general license in 410 IAC 5-3-6(d). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the board and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under 410 IAC 5-3-6(d) during the reporting period, the report shall so indicate;(vi)(A) Report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 40.25 of 10 CFR Part 40.(B) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to 410 IAC 5-3-13(m) for use under a general license in that state's regulations equivalent to 410 IAC 5-3-6(d).(C) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.(D) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission.(E) If no transfers have been made to general licensees within a particular agreement state during the reporting period, this information shall be reported to the responsible agreement state agency upon the request of that agency.(vii) Keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 410 IAC 5-3-6(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.Indiana State Department of Health; Rule HRH-2,PT C,Sec C.28; filed May 26, 1978, 3:30 pm: 1 IR 154; filed Feb 29, 1984, 10:10 am: 7 IR 865; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFAReadopted filed 11/13/2019, 3:14 p.m.: 20191211-IR-410190391RFA