Rule 391-3-17-.02 - Licensing of Radioactive Material(1)Purpose and Scope.(a) This Rule, 391-3-17-.02, provides for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a specific or general license issued pursuant to this Rule or as otherwise provided in this Chapter. However, nothing in this Rule shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.(b) In addition to the requirements of this Rule, all licensees are subject to the requirements of Rules .01, .03, .06, .07, .10, and .11 of this Chapter. Licensees engaged in industrial radiographic operations are subject to the requirements of Rule .04 of this Chapter. Licensees using radioactive material in the healing arts are also subject to the requirements of Rule .05 of this Chapter. Licensees engaged in the extrusion, mining, storage, beneficiating, processing, use, transfer, or disposal of NORM in such a manner as to alter the chemical properties or physical state of the NORM or its potential exposure pathways to humans are also subject to the requirements of Rule .08 of this Chapter. Licensees using irradiators whose dose rate exceeds 500 rads (5 Grays) per hour at one meter from the radioactive sealed sources are also subject to the requirements of Rule .09 of this Chapter. Note: All numbered and lettered references within this Rule refer to parts of this Rule, unless stated otherwise.
(2)Exemptions/Source Material.(a) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of one percent (0.05 percent) of the mixture, compound, solution, or alloy.(b) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.(c) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, or transfers: 1. Any quantities of thorium contained in: (i) Incandescent gas mantles,(iv) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium,(v) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium,(vi) Rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or(vii) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;2. Source material contained in the following products: (i) Glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20 percent by weight source material,(ii) Glassware containing not more than ten percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction,(iii) Glassware containing not more than 2 percent by weight source material, or for glassware manufactured before August 27, 2013, 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction, or(iv) Piezoelectric ceramic containing not more than two percent by weight source material;3. Photographic film, negatives, and prints containing uranium or thorium;4. Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that: (i) Each such counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM",(ii) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and(iii) This exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering; Note: The requirements specified in (2)(c)5.(i) and (ii) need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend: "CAUTION - RADIOACTIVE MATERIAL - URANIUM".
6. Natural or depleted uranium metal used as shielding constituting part of any shipping container which is conspicuously and legibly impressed with the legend: "CAUTION - RADIOACTIVE SHIELDING - URANIUM" and the uranium metal is encased in mild steel or equally fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm);7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight thorium or uranium or, for lenses manufactured before August 27, 2013, 30 percent by weight of thorium; and that this exemption contained in this subparagraph (c) does not authorize either: (i) The shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or(ii) The receipt, possession, use, or transfer of uranium or thorium contained in contact lenses, in spectacles, or in eyepieces in binoculars or other optical instruments;8. Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium; or9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that: (i) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and(ii) The thorium content in the nickel-thoria alloy does not exceed four percent by weight.10. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subparagraph (c), or equivalent regulations of an Agreement State or the U.S. Nuclear Regulatory Commission, unless authorized by a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.(i) Persons initially distributing source material in products covered by the exemptions in this subparagraph (c) before August 27, 2013, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the Commission takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date.(ii) Persons authorized to manufacture, process, or produce these materials or products containing source material by an Agreement State, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued under 10 CFR 40.52 for distribution only and are exempt from the requirements of 10 CFR 19 and 20, and 10 CFR 40.32(b) and (c).(d) The exemptions in paragraph (2)(c) do not authorize the manufacture of any of the products described.(3)Exemptions/Radioactive Material Other Than Source Material.(a) Exempt Concentrations. 1. Except as provided in (3)(a)3. and 4., any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires products containing radioactive material in concentrations not in excess of those listed in (21)(a), Schedule A.2. This section shall not be deemed to authorize the import of radioactive material or products containing radioactive material.3. A manufacturer, processor, or producer of a product or material is exempt from the requirements of this Rule to the extent that this person transfers products containing radioactive material in concentrations not in excess of those listed in (21)(a) Schedule A and introduced into the product or material by a licensee holding a specific license issued by the Director expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.4. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under (3)(a). or equivalent Regulations of the U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance with a specific license issued pursuant to 10 CFR 32.11.(b) Exempt Quantities. 1. Except as provided in (3)(b)3. through 5., any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in (21)(b), Schedule B.2. Any person, who possesses radioactive material received or acquired before September 25, 1971, under the general license then provided in 10 CFR 31.4, or similar general license of an Agreement State, is exempt from the requirements of this Chapter to the extent that this person possesses, uses, transfers, or owns byproduct material.3. Paragraph (3)(b) does not authorize the production, packaging, repackaging, or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in (21)(b), Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under (3)(b) or equivalent regulations of the U.S. Nuclear Regulatory Commission or any Agreement State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR, Part 32 , or by the Director pursuant to (11)(b) which license states that the radioactive material may be transferred by the licensee to persons exempt under (3)(b) or the equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State.5. No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in (21)(b), Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this Chapter.(c) Exempt Items. 1. Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or who incorporate radioactive material into, the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from the requirements for a license set forth in this Chapter to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products: Note: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive 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.
(i) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rates: (I) 25 millicuries (925 MBq) of tritium per timepiece.(II) 5 millicuries (185 MBq) of tritium per hand.(III) 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial).(IV) 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece.(V) 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand.(VI) 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).(VII) The levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber: I. For wrist watches, 0.1 millirad (1 µGy) per hour at ten centimeters from any surface.II. For pocket watches, 0.1 millirad (1 µGy) per hour at one centimeter from any surface.III. For any other timepiece, 0.2 millirad (2 µGy) per hour at ten centimeters from any surface.(VIII) One microcurie (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.(ii) Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device.(iii) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.(iv) Such devices authorized before October 23, 2012, for use under the general license then provided in Section 31.3 of 10 CFR, Part 31 and equivalent regulations of Agreement States and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Director.(v) Precision balances containing not more than one millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.(vii) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007.(ix) Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.(x) Electron tubes, provided that the levels of radiation from each electron tube containing radioactive material will not exceed one millirad (10 µGy) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber. Provided also, that each tube does not contain more than one of the following specified quantities of radioactive material: (I) 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or ten millicuries (370 MBq) of tritium per any other electron tube.(II) 1 microcurie (37 kBq) of cobalt-60.(III) 5 microcuries (185 kBq) of nickel-63.(IV) 30 microcuries (1.11 MBq) of krypton-85.(V) 5 microcuries (185 kBq) of cesium-137.(VI) 30 microcuries (1.11 MBq) of promethium-147. NOTE: For the purpose of .02(3)(c)1.(x), "Electron tubes" includes spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.
(xi) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that: (I) Each source contains no more than one exempt quantity set forth in (21)(b), Schedule B;(II) Each instrument contains no more than ten exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities specified in (21)(b), Schedule B, provided that the sum of such fractions shall not exceed unity; and(III) For purposes of .02(3)(c)1.(xi), 0.05 microcurie (1.85 kBq) of americium-241 is considered an exempt quantity under (21)(b), Schedule B.(xiii) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in 3(c)1., or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.14 of 10 CFR, Part 32, which license states that the product may be distributed by the licensee to persons exempt under (3)(c)1., or the equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State.2. Self-Luminous Products Containing Radioactive Material.(i) Tritium, krypton-85, or promethium-147. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR, Part 32, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements. This exemption does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.(ii) Radium-226. Any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 that were acquired prior to July 12, 1982.(iii) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under paragraph .02(3)(c)2.(i) should apply for a license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with Section 32.210 of 10 CFR Part 32.3. Gas and Aerosol Detectors Containing Radioactive Material.(i) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property provided that detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR, Part 32. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a State under comparable provisions to Section 32.26 of 10 CFR, Part 32 authorizing distribution to persons exempt from regulatory requirements.(ii) Gas and aerosol detectors containing naturally-occurring and accelerator-produced radioactive material (NARM) previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State shall be considered exempt under (3)(c)3.(i), provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of 10 CFR 32.26.(iii) Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or another Agreement State shall be considered exempt under (3)(c)3.(i), provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of 10 CFR 32.26.(iv) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under .02(3)(c)3.(i) should apply for a license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with Section 32.210 of 10 CFR, Part 32.4. Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans. (i) Except as provided in .02(3)(c)4.(ii) and .02(3)(c)4.(iii), any person is exempt from the requirements for a license set forth in O.C.G.A. Section 31-13-5(a)(9) (Georgia Radiation Control Act) and from the regulations in this Chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing one µCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.(ii) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Rule .02 and Rule .05 of this chapter.(iii) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to Rule .02 of this chapter.(iv) Nothing in .02(3)(c)4. relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.5. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under Section 32.30 of 10 CFR Part 32, which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.6. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under .02(3)(c)5. should apply for a license to the U.S. Nuclear Regulatory Commission pursuant to Section 32.30 of 10 CFR Part 32 and to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with § 32.210 of 10 CFR, Part 32.(4)Types of Licenses. Licenses for radioactive materials are of two types: general and specific. (a) General licenses provided in this Rule are effective without the filing of applications with the Division or the issuance of licensing documents to the particular persons, although the filing of a certificate with the Division may be required by the particular general license. The general licensee is subject to all other applicable portions of this Chapter and any limitations of the general license.(b) Specific licenses require the submission of an application to the Division and the issuance of a licensing document by the Director to a named person. The licensee is subject to all applicable portions of this Chapter as well as any limitations specified in the licensing document.(5)General Licenses - Source Material.(a) A general license is hereby issued authorizing persons to hold bare title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material.(b) A general license is hereby issued authorizing commercial and industrial firms; research, educational, and medical institutions; and Federal, State and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:1. No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this subparagraph may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. Persons possessing source material in excess of these limits as of August 27, 2013, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time for one year beyond this date, or until the Nuclear Regulatory Commission takes final action on a pending application submitted on or August 27, 2014, for a specific license for such material; and receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until December 31, 2014, or until the Nuclear Regulatory Commission takes final action on a pending application submitted on or before August 27, 2014, for a specific license for such material; and2. No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this subparagraph may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subparagraph unless it is accounted for under the limits of subparagraph (b)(1) of this section; or3. No more than 7 kg (15.4 lb) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this subparagraph; or4. No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this subparagraph may not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.(c) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in subparagraph (b) of this section. 1. Is prohibited from administering source material, or the radiation there from, either externally or internally, to human beings except as may be authorized by the NRC in a specific license.2. Shall not abandon such source material. Source material may be disposed of as follows: (i) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this subparagraph (c) is exempt from the requirements to obtain a license under paragraph (5) to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under 391-3-17-.02(7) through 391-3-17-.02(13); or(ii) In accordance with 391-3-17-.03(13) of this Chapter.3. Is subject to the provisions of 391-3-17-.03(13) of this Chapter.4. Is subject to the provisions in 391-3-17-.01(4), (5), (6) and (8), 391-3-17-.02(13), (18) and (19), and 391-3-17-.03(14) and (15).5. Shall not export such source material except in accordance with 10 CFR Part 110.(d) Depleted Uranium in Industrial Products and Devices.1. A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of (5)(d)2., 3., 4., and 5., depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.2. The general license in (5)(d)1. applies only to industrial products or devices which have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.3. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by (5)(d)1. shall: (i) File Division form "Registration Certificate - Use of Depleted Uranium Under General License" with the Division. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on the form the following information and such other information as may be required by that form: (I) Name and address of the registrant;(II) A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in (5)(d)1. and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and(III) Name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in (5)(d)3.(i)(II); and(ii) Report in writing to the Division any changes in information furnished by him in Division form "Registration Certificate - Use of Depleted Uranium Under General License". The report shall be submitted within 30 days after the effective date of such change.4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by (5)(d)1: (i) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;(ii) Shall not abandon such depleted uranium;(iii) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of (19). In the case where the transferee receives the depleted uranium pursuant to the general license established by (5)(d)1., the transferor shall furnish the transferee a copy of this Regulation and a copy of Division form "Registration Certificate - Use of Depleted Uranium Under General License". In the case where the transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to (5)(d)1., the transferor shall furnish the transferee a copy of this Regulation and a copy of Division form "Registration Certificate - Use of Depleted Uranium Under General License "accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or Agreement State under requirements substantially the same as those in this Regulation;(iv) Shall report in writing to the Division the name and address of the person receiving the depleted uranium pursuant to such transfer within 30 days of any transfer.5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by (5)(d)1. is exempt from the requirements of Rule .03 and Rule .07 of this Chapter with respect to the depleted uranium covered by that general license.(e) Any person who receives, possesses, uses, or transfers source material in accordance with subparagraph (b) of this section shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the Division about such contamination and may consult with the Division as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in 10 CFR 20.1402.(f) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in subparagraph (b) of this section is exempt from the provisions of 391-3-17-.03 and 391-3-17-.07 to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of 391-3-17-.03(7)(b) and 391-3-17-.03(13)(a) to the extent necessary to meet the provisions of subparagraphs (c)(2) and (e) of this section. However, this exemption does not apply to any person who also holds a specific license issued under this Chapter.(g) No person may initially transfer or distribute source material to persons generally licensed under subparagraph (b) of this section, or equivalent regulations of an Agreement State or NRC, unless authorized by a specific license issued in accordance with 391-3-17-.02(5)(h), 10 CFR 40.54, or equivalent provisions of an Agreement State. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample.(h) An application for a specific license to initially transfer source material for use under 391-3-17-.02 will be approved if: 1. The applicant satisfies the general requirements specified in this Chapter; and2. The applicant submits adequate information on, and the Division approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.(i) Each person licensed under 391-3-17-.02 shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."(j) Each person licensed under 391-3-17-.02 shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.(k) Each person licensed under 391-3-17-.02 shall report transfers as follows: 1. File a report with the Division. The report shall include the following information: (i) The name, address, and license number of the person who transferred the source material;(ii) For each general licensee under 391-3-17-.02, 10 CFR 40.22 and equivalent Agreement State regulations or provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and(iii) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.2. File a report with each responsible Agreement State agency or NRC that identifies all persons, operating under provisions equivalent to this Chapter, to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the Agreement State or NRC being reported to: (i) The name, address, and license number of the person who transferred the source material; and(ii) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.(iii) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the Agreement State or NRC.3. Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under 10 CFR Part 40.22 or equivalent Agreement State or NRC provisions during the current period, a report shall be submitted indicating so. If no transfers have been made to general licensees in a particular Agreement State or falling under the jurisdiction of the NRC, during the reporting period, this information shall be reported to the NRC or responsible Agreement State agency upon request of the agency or NRC.(l) Each person licensed under 391-3-17-.02 shall maintain all information that supports the reports required by this subparagraph concerning each transfer to a general licensee for a period of 1 year after the event is included in a report to the Division, Commission or to an Agreement State agency.(m) Each person licensed under 391-3-17-.02(5)(h) shall provide the information specified in this paragraph to each person to whom source material is transferred for use under 391-3-17-.02(5)(b). This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes: 1. A copy of 391-3-17-.02(5)(b) and .02(19) or relevant equivalent regulations of the NRC or an Agreement State.2. Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.(6)General Licenses - Radioactive Materials Other Than Source Material. Each general license issued under (6) has its own specific conditions and requirements. (a) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Rule, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material.(c) Certain Detecting, Measuring, Gauging, or Controlling Devices and Certain Devices for Producing Light or an Ionizing Atmosphere.1. A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and State or local government agencies to own, receive, acquire, possess, use, or transfer, in accordance with the provisions of (6)(c)2., 3., and 4., radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.2. The general license in (6)(c)1. applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained: (i) in a specific license issued by the Director pursuant to (11)(d); or(ii) in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State, which authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State. The devices must have been received from one of the specific licensees described in (i) or (ii) above or through a transfer made under (6)(c)3.(viii).
Note: Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in Section 179.21 of the Code of Federal Regulations, Title 21.
3. Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in (6)(c)1.:(i) Shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;(ii) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on/off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however, (I) Devices containing only krypton need not be tested for leakage of radioactive material, and(II) Devices containing only tritium or not more than 100 microcuries (3.7 MBq) of other beta- and/or gamma-emitting material or ten microcuries (0.37 MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;(iii) Shall assure that the tests required by (6)(c)3.(ii) and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:(I) In accordance with the instructions provided by the labels, or(II) By a person holding an applicable specific license from the Director, the U.S. Nuclear Regulatory Commission or an Agreement State to perform such activities;(iv) Shall maintain records showing compliance with the requirements of (6)(c)3.(ii) and (iii). The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding, or containment. Records of tests for leakage of radioactive material required by (6)(c)3.(ii) shall be maintained for three years after the next required leak test is performed. Records of tests of the on/off mechanism and indicator required by (6)(c)3.(ii) shall be maintained for three years after the next required test of the on/off mechanism and indicator is performed. Records which are required by (6)(c)3.(iii) shall be maintained for three years. In case of transfer or disposal, records required by this paragraph (iv) shall be maintained for three years after the transfer or disposal.(v) Shall, upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on/off mechanism or indicator, or upon the detection of 0.005 microcurie (185 Bq) or more removable radioactive material, immediately suspend operation of the device. The device may not be operated until it has been repaired by the manufacturer or other person holding an applicable specific license from the Director, the U.S. Nuclear Regulatory Commission or an Agreement State to repair such devices. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device or as otherwise approved by the Division. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie (185 Bq) or more of removable radioactive material, or failure or damage to a source likely to result in contamination of the premises or environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Division within 30 days. Under these circumstances, the criteria set out in Rule .03(7)(b)"Radiological requirements for unrestricted use" may be applicable, as determined by the Division on a case-by-case basis;(vi) Shall not abandon the device containing radioactive material;(vii)(I) Shall transfer or dispose of the device containing radioactive material only by export as provided in (6)(c)3.(xiv), by transfer to another general licensee as specified in (6)(c)3.(viii) or equivalent regulations of the NRC or another Agreement State, by transfer to a specific licensee of the Director, the U.S. Nuclear Regulatory Commission or an Agreement State whose specific license authorizes him to receive the device or authorizes him to collect waste, or as otherwise approved under (6)(c)(3)(vii)(III).(II) Within 30 days after transfer of a device to a specific licensee or export, the licensee shall furnish to the Division a report containing identification of the device by manufacturer's (or initial transferor's) name, model number, serial number, the name and address and license number (license number not applicable if exported) of the person receiving the device and the date of transfer;(III) If transfer is to any other licensee not identified in (vii)(I), the licensee shall obtain written approval from the Division before transferring the device to any other person; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder: I. Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;II. Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by Rule .02(6)(c)3.(i) so that the device is labeled in compliance with Rule .03(12)(d); however the manufacturer, model number, and serial number must be retained;III. Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); andIV. Reports the transfer under Rule .02(6)(c)3.(vii)(viii) Shall transfer the device to another general licensee only: (I) Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this Regulation and any safety documents identified in the label on the device. Within 30 days of the transfer, report to the Division the manufacturer's (or initial transferor's) name, model number, serial number of the device transferred, the name and mailing address for place of use of the transferee, and the name, title and telephone number of a person identified by the transferee as the individual responsible for having knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or(II) Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee;(ix) Shall comply with the provisions of Rule .03(15) of this Chapter for reporting radiation incidents, or the theft or loss of licensed material, but shall be exempt from the other requirements contained in Rules .03 and .07 of this Chapter;(x) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard;(xi)(I) Shall register, in accordance with paragraphs (6)(c)3.(xi)(II) and (III), devices containing at least 10 mCi (370 Mbq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium 226, or 1 mCi (37 MBq) of americium-241 or any other transuranic [i.e., element with atomic number greater than uranium (92)], based on the activity indicated on the label. Each address for a location of use, as described under paragraph 3.(xi)(III)IV. of this section, represents a separate general licensee and requires a separate registration.(II) If in possession of a device meeting the criteria of paragraph (6)(c)3.(xi)(I), shall register these devices annually with the Division. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Division. The registration information must be submitted to the Division within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of (6)(c)3.(xi)(I) is subject to the bankruptcy notification requirement in (13)(e) of this rule.(III) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Division; I. Name and mailing address of the general licensee.II. Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label).III. Name, title, and telephone number of the responsible person designated as a representative of the general licensee under (6)(c)3.(x).IV. Address or location at which the device(s) are used and/or stored.V. Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.VI. Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.(IV) Persons generally licensed by the NRC or an Agreement State are not eligible for reciprocity.(xii) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Division within 30 days of the effective date of the change;(xiii) May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by (6)(c)3.(ii) need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.(xiv) Shall not export the device containing byproduct material except in accordance with the requirements of 10 CFR Part 110.(xv) Shall respond to written requests from the Program to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Program a written justification for the request.4. The general license in (6)(c)1. does not authorize the manufacture or import of devices containing radioactive material.5. The general license provided in (6)(c)1. is subject to the provisions of (13), (18), and (19) of this rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.(d) Luminous Safety Devices for Aircraft. 1. A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided: (i) Each device contains not more than ten Curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147; and(ii) Each device has been manufactured, assembled, or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Director or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR, Part 32, of the regulations of the U.S. Nuclear Regulatory Commission.2. Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in (6)(d) are exempt from the requirements of Rules .03 and .07 of this Chapter, except that they shall comply with the provisions of Rule .03(15) of this Chapter.3. This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147.4. This general license does not authorize the ownership, receipt, acquisition, possession, or use of promethium-147 contained in instrument dials.5. This general license is subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.(e) Ice-Detection Devices. 1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice-detection devices, provided each device contains not more than 50 microcuries (1.85 MBq) of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the Director or any Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR, Part 32, of the regulations of the U.S. Nuclear Regulatory Commission.2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice-detection devices pursuant to the general license in (6)(e)1.: (i) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license or equivalent licensing document from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of Rule .03(13) of this Chapter;(ii) Shall assure that all labels affixed to the device at the time of receipt and which bear a statement that prohibits removal of the labels are maintained thereon; and(iii) Are exempt from the requirements of Rules .03 and .07 of this Chapter except that such persons shall comply with the provisions of Rule .03(13) and (15) of this Chapter.3. This general license does not authorize the manufacture, assembly, disassembly, or repair of strontium-90 in ice-detection devices.4. This general license is subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.(f) Calibration and Reference Sources. 1. A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of (6)(f)4. and 5., americium-241 in the form of calibration or reference sources: (i) Any person who holds a specific license issued by the Director which authorizes him to receive, possess, use, and transfer radioactive material; and(ii) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear material.2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of (6)(f)4. and 5. to any person who holds a specific license issued by the Director which authorizes him to receive, possess, use, and transfer radioactive material.3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of (6)(f)4. and 5. to any person who holds a specific license issued by the Director which authorizes him to receive, possess, use, and transfer radioactive material.4. The general licenses in (6)(f)1., 2., and 3. apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR, Part 32, or Section 70.39 of 10 CFR, Part 70 , or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Director or any Agreement State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR, Part 32, or Section 70.39 of 10 CFR, Part 70, of the regulations of the U.S. Nuclear Regulatory Commission.5. The general licenses provided in (6)(f)1., 2., and 3. are subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rules .03, .06, and .07 of this Chapter. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses: (i) Shall not possess at any one time, at any one location of storage or use, more than five microcuries (185 kBq) of americium-241, five microcuries (185 kBq) of plutonium, or five microcuries (185 kBq) of radium-226 in such sources;(ii) Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label that includes the following statement, or a substantially similar statement that contains the information called for, as appropriate: (I) The receipt, possession, use, and transfer of this source, Model _____, Serial No. _____, are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION - RADIOACTIVE MATERIAL -
THIS SOURCE CONTAINS (AMERICIUM-241)*
(PLUTONIUM)*. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_______________________________________
(NAME OF MANUFACTURER OR IMPORTER)
*Note: Showing only the name of the appropriate material, i.e., either plutonium or americium.
(iii) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Director, the U.S. Nuclear Regulatory Commission or an Agreement State to receive the source;(iv) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 which might otherwise escape during storage; and(v) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.(g) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing. Note: The new drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specified diagnostic drugs in interstate commerce.
1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following radioactive material, in accordance with the provisions of (6)(g) 2., 3., 4., 5., and 6., the following radioactive materials in prepackaged units for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals: (i) Iodine-125, in units not exceeding ten microcuries (370 kBq) each.(ii) Iodine-131, in units not exceeding ten microcuries (370 kBq) each.(iii) Carbon-14, in units not exceeding ten microcuries (370 kBq) each.(iv) Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each.(v) Iron-59, in units not exceeding 20 microcuries (740 kBq) each.(vi) Cobalt-57, in units not exceeding ten microcuries (370 kBq) each.(vii) Selenium-75, in units not exceeding ten microcuries (370 kBq) each.(viii) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each.2. No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by (6)(g)1. until he has filed Division form, "Certificate - In-Vitro Testing with Radioactive Material Under General License" with the Division and received from the Division a validated copy of this form with certification number assigned or until he has been authorized pursuant to (9)(e)3. to use radioactive material under the general license in (6)(g). The physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital shall furnish on the form the following information and such other information as may be required by that form: (i) Name and address of the physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital;(ii) The location of use; and(iii) A statement that the physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in (6)(g)1. and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by (6)(g)1. shall comply with the following: (i) The general licensee shall not possess at any one time, pursuant to the general license in (6)(g)1., at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 microcuries (7.4 MBq).(ii) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing the equivalent amount of radiation protection.(iii) The general licensee shall use the radioactive material only as authorized by (6)(g)1.(iv) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Director, the U.S. Nuclear Regulatory Commission or any Agreement State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.(v) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in (6)(g)1.(viii) as required by Rule .03(13) of this Chapter.4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to (6)(g)1.:(i) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to (11)(g) or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission or any Agreement State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under (6)(g) or its equivalent, and(ii) Unless the following statement, or a statement which contains the information called for, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:(I) This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, 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)
5. The physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital possessing or using radioactive material under the general license of (6)(g)1. shall report in writing to the Division any changes in the information furnished by him in the "Certificate - In Vitro Testing with Radioactive Material Under General License". The report shall be furnished within 30 days after the effective date of such change.6. Any person using radioactive material pursuant to the general license of (6)(g)1. is exempt from the requirements of Rules .03 and .07 of this Chapter with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in (6)(g)1.(viii) shall comply with the provisions of (13) and (15) of Rule .03 of this Chapter.(7)Filing Application for Specific Licenses.(a) Applications for specific licenses shall be filed on forms supplied by the Georgia Department of Natural Resources, Environmental Protection Division, Radioactive Materials Program, 4244 International Parkway, Suite 120, Atlanta, Georgia, 30354, or current mailing address. The application shall set forth all applicable information called for by the form.(b) The Division may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Director to determine whether the application should be granted or denied or whether a license should be modified or revoked.(c) Each application shall be signed by the applicant or person duly authorized to act for and on his behalf.(d) An application for a license may include a request for a license authorizing one or more activities.(e) In his application, the applicant may incorporate, by reference, information contained in previous applications, statements, or reports filed with the Division, provided that such references are clear and specific by page, paragraph, and date.(f) Applications and documents submitted to the Division may be made available for public inspection except those documents described in Rule .01(5)(c) which may be withheld from public inspection or discovery.(g) The Division may verify information contained in applications and secure additional information deemed necessary to make a reasonable determination as to whether to issue a license and whether special conditions should be attached thereto by visiting the facility or location where radioactive materials would be possessed, or used, and by discussing details of proposed possession or use of the radioactive materials with the applicant or the applicant's designated representatives.(h) Emergency Plan for Large Quantity Users. 1. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities specified in (21)(e), Schedule E, must contain either: (i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed one rem (.01 Sv) effective dose equivalent or five rems (.05 Sv) to the thyroid; or(ii) An emergency plan for responding to a release of radioactive material.2. One or more of the following factors may be used to support an evaluation submitted under (7)(h)1.(i): (i) The radioactive material is physically separated so that only a portion could be involved in an accident;(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;(iii) The release fraction in the respirable size range would be lower than the release fraction shown in (21)(e), Schedule E, due to the chemical or physical form of the material;(iv) The solubility of the radioactive material would reduce the dose received;(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in (21)(e), Schedule E;(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in (21)(e), Schedule E; or(vii) Other factors appropriate for the specific facility.3. An emergency plan for responding to a release of radioactive material submitted under (7)(h)1.(ii) must include the following information: (i) Facility description - a brief description of the licensee's facility and the area near the site.(ii) Types of accidents - an identification of each type of radioactive materials accident for which protective actions may be needed.(iii) Classification of accidents - a classification system for classifying accidents as alerts or site area emergencies.(iv) Detection of accidents - identification of the means of detecting each type of accident in a timely manner.(v) Mitigation of consequences - a brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers on site, and a description of the program for maintaining the equipment.(vi) Assessment of releases - a brief description of the methods and equipment to assess releases of radioactive materials.(vii) Responsibilities - a brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Division; also responsibilities for developing, maintaining, and updating the plan.(viii) Notification and coordination - a commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established to prevent spreading of contamination during recovery activities. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Division immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. Note: This Chapter does not supersede or release licensees from complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L-99-499 or other State or Federal reporting requirements.
(ix) Information to be communicated - a brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the Division.(x) Training - a brief description of the frequency, performance objectives, and plans for the training that the licensee will provide workers on how to respond to an emergency, including any special instruction and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.(xi) Safe shutdown - a brief description of the means of restoring the facility to a safe condition after an accident.(xii) Exercises - provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site, and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and the overall effectiveness of the response. These exercises must be documented and deficiencies found by the critiques must be corrected.(xiii) Hazardous chemicals - a certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.4. The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Division. The licensee shall provide any comments received within the 60 days to the Division with the emergency plan.(i) Except as provided in paragraphs 2., 3. and 4. of this section, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must:1. Identify the source or device by manufacturer and model number as registered with the Nuclear Regulatory Commission, an Agreement State, or for a source or a device containing radium-226 or accelerator produced radioactive material with a State under provisions comparable to Section 32.210 of 10 CFR Part 32.2. For sources or devices manufactured before October 23, 2012, that are not registered with the Commission under Section 32.210 of 10 CFR, Part 32 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in Section 32.210(c) of 10 CFR, Part 32, the application must include: (i) All available information identified in Section 32.210(c) of 10 CFR, Part 32 concerning the source, and, if applicable, the device; and(ii) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.3. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with Section 32.210(g)(1) of 10 CFR, Part 32, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.4. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Rule .05 or equivalent Nuclear Regulatory Commission or Agreement State requirements shall include: 1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under Rule .02, Nuclear Regulatory Commission or of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in .02(11)(i)2. of this Rule.3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in .02(11)(i)5. of this Rule.4. Information identified in Rule .02(11)(i)3. of this Rule on the PET drugs to be noncommercially transferred to members of its consortium.(8)General Requirements for the Issuance of Specific Licenses. A license application will be approved if the Division determines the following: (a) That the applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this Chapter in such a manner as to minimize danger to public health and safety or property;(b) That the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;(c) That the issuance of the license will not be inimical to the health and safety of the public; and(d) That the applicant satisfies any applicable special requirements in (9), (10), and (11).(e) Bonding Requirements. 1. Pursuant to Georgia Laws 1979, pp. 1059, 1060, a specific license will be issued to a Major Processor as defined in Rule .01(2) of this Chapter only if the applicant has posted a surety bond with, and made payable to, the Director, Environmental Protection Division, Department of Natural Resources, to ensure the protection of the public health and safety in the event of abandonment, insolvency, or other inability of the licensee to meet the requirements of the Act and this Chapter. (i) The bond provided shall be not less than $100,000.00, nor more than $5,000,000.00.(ii) The exact amount of the bond shall be determined by the Director, Environmental Protection Division, and shall be based on the probable extent of contamination, the amount of possible property damage, the costs of removal and disposal of sources of radiation used by the licensee, and the costs of reclamation of the property in the event of abandonment, insolvency, or other inability of the licensee to meet the requirements of the Act and this Chapter, including performing such services to the satisfaction of the Division.2. Persons licensed at the time the bonding requirements of this Chapter became effective, and upon notice by the Division, must, within a period of 90 days following such notice, provide the bond required by (8)(e)1. as a condition for continuation of the license.(f) Environmental Report, Commencement of Construction. In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the Division determines will significantly affect the quality of the environment, commencement of construction of the plant or facility in which the activity will be conducted shall not begin until the Director has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph, the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.(g) Financial assurance and record-keeping for decommissioning.1. The following are required to furnish financial assurance and record-keeping for decommissioning: (i) Each applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in Schedule F shall submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity Rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Schedule F.(ii) Each applicant for a specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities set forth in Schedule F shall submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 1012 is greater than 1 (unity Rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Schedule F.2. Each applicant for a specific license authorizing the possession and use of radioactive material of half-life greater than 120 days and in quantities specified in subparagraphs (8)(g)4. shall either:(i) Submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6.; or(ii) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by (8)(g)4. using one of the methods described in (8)(g)7. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but prior to the receipt of licensed material. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of (8)(g)7. is to be submitted to the Division. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements (8)(g)7. must be submitted to the Division before the receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the Division, as part of the certification a signed original of the financial instrument obtained to satisfy the requirements of (8)(g)7.3.(i) Each holder of a specific license issued on or after January 1, 1993, which is of a type described in (8)(g)1. or 2. shall provide financial assurance for decommissioning in accordance with the criteria set forth in this Rule.(ii) Each holder of a specific license issued before January 1, 1993, which is of a type described in (8)(g)1. shall submit, on or before January 1, 1993, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria set forth in this Rule. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal.(iii) Each holder of a specific license issued before January 1, 1993, and of a type described in (8)(g)2. shall submit, on or before January 1, 1993, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this .02(8)(g).(iv) Waste collectors and waste processors shall provide financial assurance in an amount based on a decommissioning funding plan as described in subparagraphs .02(8)(g)5 and (8)(g)6. The decommissioning funding plan must also include the cost of disposal of the maximum amount (curies) of radioactive material permitted by the license, and the cost of disposal of the maximum quantity, by volume, of radioactive material that could be present at the licensee's facility at any time, in addition to the cost to remediate the licensee's site to meet the license termination requirements in .02(18).4. Table of required amounts of financial assurance for decommissioning by quantity of material. Greater than 104 but less than or equal to 105 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1): $1,125,000
Greater than 103 but less than or equal to 104 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1): $225,000
Greater than 1010 times the applicable quantities of Schedule F in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in (8)(g), divided by 1010 is greater than 1): $113,000
5. Each decommissioning funding plan must be submitted for review and approval and must contain (i) A detailed cost estimate for decommissioning, in an amount reflecting:(I) The cost of an independent contractor to perform all decommissioning activities;(II) The cost of meeting the .03(7)(b) criteria for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of .03(7)(c), the cost estimate may be based on meeting the .03(7)(c) criteria;(III) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and(IV) An adequate contingency factor.(ii) Identification of and justification for using the key assumptions contained in the DCE;(iii) A description of the method of assuring funds for decommissioning from subparagraph 7 of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;(iv) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and(v) A signed original of the financial instrument obtained to satisfy the requirements of subparagraph 7 of this section (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).6. At the time of license renewal and at intervals not to exceed 3 years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs: (i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;(ii) Waste inventory increasing above the amount previously estimated;(iii) Waste disposal costs increasing above the amount previously estimated;(iv) Facility modifications;(v) Changes in authorized possession limits;(vi) Actual remediation costs that exceed the previous cost estimate;(vii) Onsite disposal; and(viii) Use of a settling pond.7. Financial assurance for decommissioning must be provided by one or more of the following methods: (i) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.(ii) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in (21)(d) Schedule D. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in (21)(g) Schedule G. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning: costs may be used if the guarantee and test are as contained in (21)(d) Schedule D. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in (21)(h) Schedule H. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions: (I) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically, unless 90 days or more prior to the renewal date the issuer notifies the Division, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Division within 30 days after receipt of notification of cancellation.(II) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Division. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.(III) The surety method or insurance must remain in effect until the Director has terminated the license.(iii) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in (8)(g)2.(iv) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in (8)(g)4., and indicating that funds for decommissioning will be obtained when necessary.8. Each person licensed under this Chapter shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the site is released for unrestricted use by the Division. Before licensed activities are transferred or assigned in accordance with .02(13)(b), licensees shall transfer all records described in (7)(i) through (iv) to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records of relevant information to the decommissioning of a facility are kept for other purposes, references to these records and their locations may be used. Information the Division considers important to decommissioning consists of:(i) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.(ii) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.(iii) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or radioactive materials having only half-lives of less than 65 days, or depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every two years, of the following: (I) All areas designated and formerly designated as restricted areas as defined under Rule 391-3-17-.01(2);(II) All areas outside of restricted areas that require documentation under (8)(g)8.(i);(III) All areas outside of restricted areas where current and previous wastes have been buried as documented under Rule .03(14)(i) of this Chapter; and(IV) All areas outside of restricted areas that contain materials such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under Rule .03(13)(b) of this Chapter.(iv) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.9. Teletherapy licensees are exempted from decommissioning financial assurance requirements for possession of licensed material in sealed sources in quantities greater than 1010 times the applicable quantities of Schedule F of this rule, for the purpose of source changes only. This exemption is granted for no more than 30 days for any one source change.(h) Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas. 1. Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the Director notifies the licensee in writing that the license is terminated. During this time, the licensee shall: (i) Limit actions involving radioactive material to those related to decommissioning; and(ii) Continue to control entry to restricted areas until they are suitable for release in accordance with Division requirements.2. Within 60 days of the occurrence of any of the following, each licensee shall provide notification to the Division in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with Division requirements, or submit within 12 months of notification a decommissioning plan, if required by (8)(h)5.(i), and begin decommissioning upon approval of that plan if: (i) The license has expired pursuant to (14) or (18)(c); or(ii) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Division requirements; or(iii) No principal activities under the license have been conducted for a period of 24 months; or(iv) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Division requirements.3. Coincident with the notification required by (8)(h)2., the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to (8)(g) in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to (8)(h)5.(iv)(V). (i) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective.(ii) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Director.4. The Division may grant a request to extend the time periods in (8)(h)2. if the Division determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to (8)(h)2. The schedule for decommissioning set forth in (8)(h)2. may not commence until the Director has made a determination on the request.5.(i) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Division and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:(I) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;(II) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;(III) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation or;(IV) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.(ii) The Division may approve an alternate schedule for submittal of a decommissioning plan required pursuant to (8)(h)2. if the Division determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.(iii) Procedures such as those listed in (8)(h)5.(i) with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.(iv) The proposed decommissioning plan for the site or separate building or outdoor area must include: (I) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;(II) A description of planned decommissioning activities;(III) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;(IV) A description of the planned final radiation survey; and(V) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.(VI) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in (8)(h)7.(v) The proposed decommissioning plan will be approved by the Division if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.6.(i) Except as provided in (8)(h)7., licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practical but no later than 24 months following the initiation of decommissioning.(ii) Except as provided in (8)(h)7. when decommissioning involves the entire site, the licensee shall request license termination as soon as practical but no later than 24 months following the initiation of decommissioning.7. The Division may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Division determines that the alternative is warranted by consideration for the following: (i) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;(ii) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;(iii) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;(iv) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and(v) Other site-specific factors which the Division may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.8. As the final step in decommissioning, the licensee shall follow the requirements of Rule .02(18)(d).(9)Special Requirements for Issuance of Certain Specific Licenses for Radioactive Material.(a) Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in (8), a specific license for the use of sealed sources in industrial radiography will be issued if the licensee meets all of the requirements of Rule .04 of this Chapter.(b) Human Use of Radioactive Materials in Institutions. In addition to the requirements set forth in (8), a specific license for the human use of radioactive material in an institution will be issued only if the licensee also meets all of the requirements of Rule .05 of this Chapter.(c) Specific Licenses to Individual Physicians for Human Use of Radioactive Material. 1. 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 (8), and all of the requirements of Rule .05 of this Chapter;(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.2. The Director 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:(I) The administration of radiopharmaceuticals for diagnostic or therapeutic purposes;(II) The performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;(III) The performance of in vitro diagnostic studies; or(IV) 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 (9)(b).(d) Human Use of Sealed Sources Containing Radioactive Material. In addition to the requirements set forth in (8), a specific license for the human use of sealed sources containing radioactive material will be issued only if the applicant, or, if the application is made by an institution, the individual user is a physician and either: 1. Has specialized training in the therapeutic use of the sealed source considered (e.g., teletherapy unit, beta applicator), or has experience equivalent to such training; or2. Has specialized training in the diagnostic use of the sealed source considered (e.g., bone mineral analyzer) or has experience equivalent to such training.(e) Specific Licenses for Certain Medical Uses of Radioactive Material.1. Subject to the provisions of (9)(e)2. and 3., an application for a specific license pursuant to (9)(b), (c), or (d), for any medical use or uses of radioactive material specified in Rule .05 of this Chapter, will be approved if: (i) The applicant satisfies the requirements of (9)(b), (c), or (d);(ii) The applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses specified in the application;(iii) The applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, has adequate training and experience in the handling of radioactive material appropriate to his participation in the uses specified in the application;(iv) The applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses specified in the application;(v) The applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses specified in the application; and(vi) For uses regulated by Rules .05(41) and (44) of this Chapter, any licensee using radioactive material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding: (I) Chemical and physical form,(II) Route of administration, and2. Any licensee who is authorized to use radioactive material pursuant to (9)(e) and to Rule .05 of this Chapter is subject to the following conditions: (i) For paragraphs (41), (44), and (48) of Rule .05 of this Chapter, no licensee shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, and labeled, packaged, and distributed in accordance with a specific license issued by the Director pursuant to (11)(i), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR, Part 32, or a specific license issued by an Agreement State pursuant to equivalent regulations.(ii) For Rule 391-3-17-.05(44), no licensee 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: (I) Reagent kits not containing radioactive material that are approved by the Division, the U.S. Nuclear Regulatory Commission or an Agreement State for use by persons licensed pursuant to (9)(d) and to Rule .05 of this Chapter or(II) Generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the Director pursuant to (11)(i), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.73 of 10 CFR, Part 32, or a specific license issued by an Agreement State pursuant to equivalent regulations; and(iii) For Brachytherapy, regulated by Rule .05 of this Chapter, no licensee 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 Director pursuant to (11)(j), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR, Part 32, or a specific license issued to the manufacturer by an Agreement State pursuant to equivalent regulations.3. Any licensee who is licensed pursuant to (9) for one or more of the medical uses regulated by Rule .05 of this Chapter also is authorized to use radioactive material under the general license in (6)(g) for in vitro uses without filing the Certificate as required by (6)(g)2, provided that the licensee is subject to the other provisions of (6)(g).(f) Use of Naturally-Occurring Radioactive Material (NORM). In addition to the requirements set forth in (8), a specific license for the use of NORM will be issued if the licensee meets all of the requirements of Rule .08 of this Chapter.(g) Use of Sealed Sources in Irradiators. In addition to the requirements set forth in (8), a specific license for the use of sealed sources in large irradiators will be issued if the licensee meets all of the requirements of Rule .09 of this Chapter.(10)Special Requirements for Specific Licenses of Broad Scope. These requirements are for the issuance of non-medical specific licenses of broad scope for radioactive material ("broad licenses") and contain certain regulations governing holders of such licenses. (The issuance of medical specific licenses of broad scope is addressed in (9).) Nota Bene: See Note, in (3)(c)1.
(a) The different types of broad scope licenses are set forth below:1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.2. A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in (21)(c), Schedule C, for any authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in (21)(c), Schedule C, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in (21)(c), Schedule C, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in (21)(c), Schedule C, for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in (21)(c), Schedule C, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in (21)(c), Schedule C, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.(b) An application for a Type A specific license of broad scope will be approved if:1. The applicant satisfies the general requirements specified in (8);2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record-keeping, material control and accounting, and management review that are necessary to assure safe operations, including: (i) The establishment of a Radiation Safety Committee composed of such persons as a Radiation Safety Officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;(ii) The appointment of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and(iii) The establishment of appropriate administrative procedures to assure:(I) Control of procurement and use of radioactive material;(II) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, the training and experience of the user, and the operating or handling procedures; and(III) Review, approval, and recording by the Radiation Safety Committee of safety evaluations of proposed uses prepared in accordance with (10)(b)3.(iii)(II) prior to the use of the radioactive material.(c) An application for a Type B specific license of broad scope will be approved if:1. The applicant satisfies the general requirements specified in (8); and2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record-keeping, material control and accounting, and management review that are necessary to assure safe operations, including: (i) The appointment of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and(ii) The establishment of appropriate administrative procedures to assure: (I) Control of procurement and use of radioactive material,(II) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, the training and experience of the user, and the operating or handling procedures, and(III) Review, approval, and recording by the Radiation Safety Officer of safety evaluations of proposed uses prepared in accordance with (10)(c)2.(ii)(II) prior to the use of the radioactive material.(d) An application for a Type C specific license of broad scope will be approved if: 1. The applicant satisfies the general requirements specified in (8);2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received: (i) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and(ii) At least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record-keeping, material control and accounting, and management review necessary to assure safe operations.(e) Specific non-medical licenses of broad scope are subject to the following conditions: 1. Unless specifically authorized, persons licensed pursuant to (10) shall not:(i) Conduct tracer studies in the environment involving direct release of radioactive material;(ii) Receive, acquire, own, possess, use, or transfer devices containing 100,000 Curies (3.7 PBq) or more of radioactive material in sealed sources used for irradiation of materials;(iii) Conduct activities for which a specific license issued by the Division under (9) or (11) is required; or(iv) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.2. Each Type A specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Committee.3. Each Type B specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Officer.4. Each Type C specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of (10)(d).(11)Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material.(b) Licensing the Distribution of Naturally-Occurring and Accelerator-Produced Radioactive Material (NARM) in Exempt Quantities. Nota Bene: See Note, in (3)(c)1.
1. An application for a specific license to distribute NARM to persons exempted from this Chapter pursuant to (3)(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, 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 Division approves such labels and brochures.2. The license issued under (11)(b)1. is subject to the following conditions: (i) No more than ten 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 quantities provided the sum of the fractions shall not exceed unity.(ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to (3)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 µSv) per hour.(iii) The immediate container of each quantity or separately- packaged fractional quantity of radioactive material shall bear a durable and legible label which: (I) Identifies the radionuclide and the quantity of radioactivity, and(II) Bears the words "Radioactive Material".(iv) In addition to the labeling information required by (11)(b)2.(iii), the label affixed to the immediate container, or an accompanying brochure, shall:(I) State that the contents are exempt from applicable U.S. Nuclear Regulatory Commission or Agreement State requirements,(II) 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(III) 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 (11)(b) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under (3)(b) or the equivalent regulations of the U.S. Nuclear Regulatory Commission or another Agreement 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 Division. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to (11)(b) during the reporting period, the report shall so indicate.(d) Licensing the Manufacture and Initial Transfer of Devices to Persons Generally Licensed Under (6)(c). 1. An application for a specific license to initially transfer devices containing radioactive material to persons generally licensed under (6)(c) 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 of (8);(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: (I) The device can be safely operated by persons not having training in radiological protection,(II) 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 year a dose in excess of ten percent of the annual limits specified in Rule .03(5)(a)1. of this Chapter, and(III) 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: I. Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rem (150 mSv);
II. Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter 200 rem (2 Sv);
III. Other Organs 50 rem (500 mSv); and
(iii) Each device bears a durable, legible, and clearly visible label or labels approved by the Division, which contain in a clearly identified and separate statement: (I) 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);(II) 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(III) The information called for in the following statement, in the same or substantially similar form: I. The receipt, possession, use, and transfer of this device, Model ____, Serial No.____, are subject to a general license or the equivalent and to the regulations of the U.S. Nuclear Regulatory Commission or of 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 INITIAL TRANSFEROR)
Note: The model, serial number, and name of the manufacturer or distributor may be omitted from the appropriate label provided the information is elsewhere specified in labeling affixed to the device. Devices distributed pursuant to Regulations equivalent to (11)(d) prior to January 1, 1981, may bear labels authorized by the Regulations in effect on January 1, 1980. Devices distributed on or after January 1, 1981, including devices redistributed upon radioactive sources exchange, shall bear labels authorized in (11)(d).
(iv) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in Rule .03(12), and the name of the manufacturer or initial distributor.(v) Each device meeting the criteria of (6)(c)3.(xii), bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material," and, if practical, the radiation symbol described in Rule .03(12).(vi) The device has been registered in the Sealed Source and Device Registry.2. In the event the applicant desires that the device 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 his 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 Division will consider information that includes, but is not limited to: (i) Primary containment (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 devices or similarly designed and constructed devices.3. In the event the applicant desires that the general licensee under (6)(c), or under equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement 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 his application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the basis for such estimates. The submitted information shall demonstrate that the 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 dose in excess of ten percent of the annual limits specified in Rule .03(5)(a)1. of this Chapter.4. Each person licensed under (11)(d) shall provide the information specified in (11)(d)4.(i) to each generally licensed recipient to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person.(i) The required information includes: (I) A copy of the general license contained in (6)(c); if (6)(c)3.(ii) through (iv) or (6)(c)3.(xii) do not apply to the particular device, these rules may be omitted.(II) A copy of Rule .01(4), (5), (6), (7), (8), (9) and (10), Rule .02(13), (18), and (19), Rule .03(15)(a) and (b) and Rule .06;(III) A list of the services that can only be performed by a specific licensee;(IV) Information on acceptable disposal options including estimated costs of disposal; and(V) An indication that improper disposal can result in high civil penalties.(ii) If a device containing radioactive material is to be transferred for use under a general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to (6)(c), the licensee shall provide the information specified in (11)(d)4.(ii) to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:(I) A copy of this equivalent regulation or, alternatively, furnish a copy of the general license contained in (6)(c) 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 or the Agreement State. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. If a copy of the general license in (6)(c) 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 or the Agreement State under requirements substantially the same as those in (6)(c); if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;(II) A list of the services that can only be performed by a specific licensee;(III) Information on acceptable disposal options including estimated costs of disposal;(IV) An indication that improper disposal can result in high civil penalties; and(V) The name or title, address, and telephone number of the contact at the appropriate NRC Regional Office or Agreement State from which additional information may be obtained.(iii) An alternative approach to informing customers may be proposed by the licensee for approval by the Division.5. Each device that is transferred after January 1, 2003, must meet the labeling requirements of (11)(d)1.(iii) through (v).6. If a notification of bankruptcy has been made under (13)(e) or the license is to be terminated, each person licensed under (11)(d) shall provide, upon request, to the Division and as appropriate to any Agreement State or the NRC, records of final disposition required under (11)(d)4.(viii).7. The licensee shall report to the Division all transfers of such devices to persons for use under the general license in (6)(c) and report all receipts of such devices from persons licensed under (6)(c).(i) Such report shall identify each general licensee by the following:(I) The name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use;(II) The name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;(III) The date of the transfer;(IV) The type, model number, and serial number of the device transferred; and(V) The quantity and type of radioactive material contained in the device.(ii) 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 the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).(iii) For devices received from a (6)(c) general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.(iv) If the licensee makes changes to a device possessed by a (6)(c) general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.(v) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.(vi) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.(vii) If no transfers have been made to or from persons generally licensed under (6)(c) during the reporting period, the report shall so indicate.8. The licensee shall furnish reports to other agencies as follows:(i) 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 and all receipts of devices from U.S. Nuclear Regulatory Commission Section 31.5 general licensees;(ii) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to (11)(d) for use under a general license in that state's regulations equivalent to (6)(c) and all receipts of devices from general licensees in the state agency's jurisdiction;(iii) The reports identified in 8.(i) and 8.(ii) shall identify each general licensee by the following:(I) The name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.(II) The name, title and telephone number the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;(III) The date of the transfer;(IV) The type, model, and serial number of the device transferred; and(V) The quantity and type of radioactive material contained in the device.(iv) 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 the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).(v) For devices received from a (6)(c) general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.(vi) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.(vii) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.(viii) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.(ix) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, report this information to the U.S. Nuclear Regulatory Commission; and(x) If no transfers have been made to general licensees within a particular state during the reporting period, report this information to the responsible state agency upon request of that agency.9. Each person licensed under (11)(d) to distribute devices to generally licensed persons shall maintain all information concerning transfers and receipts of devices that supports the reports required by (11)(d)4. These records shall be maintained for a period of three years following the date of the recorded event.(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, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, and for distribution to persons generally licensed under (6)(d), will be approved subject to the following conditions: 1. The applicant satisfies the general requirements specified in (8), and2. The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 32.56 of 10 CFR, Part 32, or their equivalent.(f) Special Requirements for License to Manufacture or Initially Transfer Calibration Sources Containing Americium-241, Plutonium, or Radium-226 for Distribution to Persons Generally Licensed Under (6)(f). An application for a specific license to manufacture or initially transfer calibration and reference sources containing americium-241, plutonium, or radium-226 to persons generally licensed under (6)(f) will be approved subject to the following conditions: 1. The applicant satisfies the general requirement of (8), and2. The applicant satisfies the requirements of Sections 32.57, 32.58, and 32.59 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 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 (6)(g) will be approved subject to the following conditions: 1. The applicant satisfies the general requirements specified in (8);2. The radioactive material is to be prepared for distribution in prepackaged units of: (i) Iodine-125 in units not exceeding ten microcuries (370 kBq) each,(ii) Iodine-131 in units not exceeding ten microcuries (370 kBq) each,(iii) Carbon-14 in units not exceeding ten microcuries (370 kBq) each,(iv) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each,(v) Iron-59 in units not exceeding 20 microcuries (740 kBq) each,(vi) Cobalt-57 in units not exceeding ten microcuries (370 kBq) each,(vii) Selenium-75 in units not exceeding ten microcuries (370 kBq) each,(viii) Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each;3. Each prepackaged unit bears a durable and clearly visible label: (i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed ten microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries (1.85 Mbq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each; and(ii) Displaying the radiation caution symbol described in Rule 391-3-17-.03, of this Chapter, and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals";4. The following statement, as appropriate, or a substantially similar statement which contains the information called for in the following statement, 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 in the practice of veterinary medicine, 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 of and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. ___________________________________
(NAME OF MANUFACTURER)
and
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 Rule .03(13) of this Chapter.(h) Licensing the Manufacture and Distribution of Ice-Detection Devices. An application for a specific license to manufacture and initially transfer ice-detection devices to persons generally licensed under (6)(e) will be approved subject to the following conditions: 1. The applicant satisfies the general requirements of (8), and2. The criteria of Sections 32.61 and 32.62 of 10 CFR, Part 32, are met.(i) Manufacture, Preparation, or Transfer, for Commercial Distribution of Pharmaceuticals Containing Radioactive Material for Medical Use. An application for a specific license to manufacture, prepare, or transfer for commercial distribution pharmaceuticals containing radioactive material for use by persons licensed pursuant to (9) for the uses listed in (41), (44), and (48) of Rule .05 of this Chapter will be approved subject to the following conditions: 1. The applicant satisfies the general requirements specified in (8);2. The applicant submits evidence that the applicant is at least one of the following: (i) Registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);(ii) Registered or licensed with a State Agency as a drug manufacturer;(iii) Licensed as a pharmacy by the Georgia State Board of Pharmacy;(iv) Operating as a nuclear pharmacy within a Federal medical institution; or(v) A Positron Emission Tomography (PET) drug production facility registered with a State agency.3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per vial, syringe, generator, or other container of the radiopharmaceutical, and shielding provided by the packaging to show it is appropriate for safe handling and storage of radiopharmaceuticals by licensees; and4. The applicant commits to the following labeling requirements: (i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radiopharmaceutical to be transferred for commercial distribution. The label must include the radiation symbol and words "Caution, Radioactive Material" or "Danger Radioactive Material"; the name of the radiopharmaceutical or its abbreviation, and quantity of radioactivity at a specified date and time. For radiopharmaceuticals with a half-life greater than 100 days, the time may be omitted.(ii) A label is affixed to each syringe, vial, or other container used to hold a radiopharmaceutical to be transferred for commercial distribution. The label must include the words "Caution, Radioactive Material" or "Danger Radioactive Material" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label, leaflet, or brochure.5. A licensee described by (11)(i)2.(iii) or (iv): (i) May prepare radiopharmaceuticals for medical use, as defined in Rule .05(2)(s) provided that the radiopharmaceutical is prepared by either an authorized nuclear pharmacist, as specified in (ii) and (iv) or an individual under the supervision of an authorized nuclear pharmacist as specified in Rule .05(18)(b).(ii) May allow a pharmacist to work as an authorized nuclear pharmacist if this individual: (I) Qualifies as an authorized nuclear pharmacist as defined in .05(2)(e),(II) Meets the requirements specified in Rule .05(24)(b) and .05(27) and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or has notified the Division in accordance with Rule .05(11), or(III) Is designated as an authorized nuclear pharmacist in accordance with (iv).(iii) The actions authorized in (i) and (ii) are permitted not withstanding more restrictive language in license conditions.(iv) May designate a nuclear pharmacist in accordance with Rule .05(26) as an authorized nuclear pharmacist if the individual is identified as of December 31, 1996, as an "authorized user" on a license issued by the Director, the NRC, or an Agreement State, under this rule or equivalent requirements, or if the individual was a nuclear pharmacist preparing only radiopharmaceuticals containing accelerator produced radioactive material and the individual practiced at a Government Agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC.(v) Shall provide to the Division a copy of each individual's certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in 391-3-17-.05(24), or a Division, NRC, or Agreement State issued license, or permit issued by a licensee of broad scope, or documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, and a copy of the individual's license to practice pharmacy in the State of Georgia issued by the Secretary of State's office, no later than 30 days after the date that the licensee allows pursuant to (ii) and (iii), the individual to work as an authorized nuclear pharmacist.6. A licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceuticals. The licensee shall measure, by direct measurements or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceuticals prior to transfer for commercial distribution. In addition, the licensee shall: (i) Perform test before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and(ii) Check each instrument for constancy and proper operation at the beginning of each day of use.7. A licensee shall satisfy the labeling requirements in subparagraph (11)(i)4.8. Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, or other State requirements governing radiopharmaceuticals.(j) 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 Rule .05 of this chapter for use as a calibration, transmission, or reference source or for medical uses regulated by Rule .05(55), (65), or (67) of this Chapter will be approved subject to the following conditions:1. The applicant satisfies the general requirements of (8);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) Instructions 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. Instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label.)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 source or device is licensed by the Director for distribution to persons licensed pursuant to (9) and to Rule .05(55), (65), or (67) of this Chapter or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State;4. The source or device has been registered in the Sealed Source and Device Registry;5. 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;6. In determining the acceptable interval for test of leakage of radioactive material, the Division will consider information that includes, but is not limited to, that which is listed in (11)(d)2.(k) 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 (5)(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved subject to the following conditions:(i) The applicant satisfies the general requirements specified in (8);(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 1 year a radiation dose in excess of ten percent of the annual limits specified in Rule .03(5)(a)1. of this Chapter; 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 Director will approve an application for a specific license under (11)(k) 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 Director may deny any application for a specific license under (11)(k) if the end use(s) of the industrial product or device cannot be reasonably foreseen.4. Each person licensed pursuant to (11)(k)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:(I) 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(II) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and to 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) Furnish a copy of the general license contained in:(I) (5)(d) and a copy of Division form "Registration Certificate - Use of Depleted Uranium Under General License" to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in (5)(d), or(II) The U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to (5)(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 (5)(d) and a copy of Division form "Registration Certificate - Use of Depleted Uranium Under General License" 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 (5)(d);(v) Report to the Division all transfers of industrial products or devices to persons for use under the general license in (5)(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 Division 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 (5)(d) during the reporting period, the report shall so indicate;(vi) Report to other agencies as follows: (I) To the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Regulatory Commission general license in Section 40.25 of 10 CFR, Part 40 ;(II) To the responsible state agency all transfers of devices manufactured and distributed pursuant to 10CFR 32.210 for use under a general license in that state's regulations equivalent to (5)(d);(III) Have such reports 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;(IV) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, report this information to the U.S. Nuclear Regulatory Commission; and(V) If no transfers have been made to general licensees within a particular Agreement State during the reporting period, report this information to the responsible Agreement State agency upon the request of that agency; and(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 (5)(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of two 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 (11).(12)Issuance of Specific Licenses.(a) Upon a determination that an application meets the requirements of the Act and the Rules of the Division, the Director may issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary to effectuate the purposes of the Act.(b) The Director may incorporate in any license at the time of issuance, or thereafter, such additional requirements and conditions, as authorized by the Act or Rules, or Order, with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this Chapter as necessary in order to: 1. Minimize danger to public health and safety or property;2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as necessary to effectuate the purposes of the Act; and3. Prevent loss or theft of material subject to this Rule.(13)Specific Terms and Conditions of Licenses.(a) Each license issued pursuant to this Rule shall be subject to all the provisions of the Act, and to all Rules of the Division and Orders of the Director.(b) No license issued or granted under this Rule and no right to possess or utilize radioactive material granted by any license issued pursuant to this Rule shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the Division, after securing full information, finds that the transfer is in accordance with the provisions of the Act, and gives its consent in writing. 1. An application for transfer of license must include:(i) The identity, technical and financial qualification of the proposed transferee; and(ii) Financial assurance for decommissioning information required by .02(8)(g).(c) Each person licensed by the Director pursuant to this Rule shall confine use and possession of the material licensed to the locations and purposes authorized in the license.(d) Each licensee shall notify the Division in writing immediately and request termination of his license when the licensee decides to terminate all activities involving radioactive materials authorized under the license. This notification and request for termination must include the information specified in (18)(d).(e) Each general licensee required to register by (6)(c)3.(xi) and each specific licensee shall notify the Division in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against: 2. An entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or3. An affiliate (as that term is defined in 11 U.S.C. 101(2) of the licensee.(f) The notification specified in (13)(e) shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.(g) Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.(h) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with Rule .05(45)(a)(b) and (c). The licensee shall record the results of each test and retain each record for 3 years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in 391-3-17-.05(45) at the time of generator elution, in accordance with 391-3-17-.05(120).(i) Authorization under .02(7)(j) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.1. Each licensee authorized under .02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall: (i) Satisfy the labeling requirements in .02(11)(i)4. of this Rule for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in .02(11)(i)6. of this Rule.2. A licensee that is a pharmacy authorized under .02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be: (i) an authorized nuclear pharmacist that meets the requirements in .02(11)(i)5. of this Rule, or(ii) an individual under the supervision of an authorized nuclear pharmacist as specified in Rule .05(18).3. A pharmacy, authorized under .02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of .02(11)(i)5.(v) of this Rule.(14)Expiration of Licenses. Except as provided in (15)(b), each specific license shall expire at the end of the day, in the month and year stated therein.(15)Renewal of Licenses.(a) No less than 30 days before the expiration date specified in a specific license, the licensee shall either: 1. Submit an application for license renewal filed in accordance with (7), or2. Notify the Division in writing in accordance with (13)(d) and (15)(c) if the licensee decides not to renew the license.(b) In any case in which a licensee, not less than 30 days prior to the expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the Division.(c) If a licensee does not submit an application for license renewal on or before the expiration date specified in the license, then the licensee shall, on or before that expiration date: 1. Terminate the use of radioactive material,2. Remove radioactive contamination to the extent practicable,3. Properly dispose of the radioactive material, and4. Submit the information specified in (18)(d).(16)Amendment of Licenses at Request of Licensee. Applications for amendment of a license shall be filed in accordance with (7) and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.(17)Action on Applications to Renew or Amend. In considering an application by a licensee to renew or amend the license, the Director will apply the criteria set forth in (8), (9), (10), or (11), as applicable.(18)Modification, Revocation, and Termination of Licenses.(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to the Act, or by reason of Rules, and Orders issued by the Director.(b) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act or of this Rule, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Director to refuse to grant a license on an original application, or for violation of, or failure to observe, any of the terms and conditions of the Act, of the license, or of any Rule or Order of the Director.(c) Each specific license revoked by the Director expires at the end of the day on the date of the Director's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Order of the Director.(d) The Director may terminate a specific license upon request submitted by the licensee to the Division in writing provided the following:1. The licensee certifies the disposition of all licensed material, including accumulated wastes, by submitting a completed "Request to Terminate Radioactive Materials License" form or equivalent information; and2. The licensee conducts a radiation survey of the premises where the licensed activities were carried out and submits a report of the results of the survey unless the licensee demonstrates that the premises are suitable for release in accordance with the requirements for decommissioning in Rule .03(7). As appropriate, the licensee shall: (i) Report levels of gamma radiation in units of microroentgen (millisieverts) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of disintegrations per minute or microcuries (megabecquerels) per 100 square centimeters - removable and fixed - for surfaces, microcuries (megabecquerels) per milliliter for water, and picocuries (becquerels) per gram for solids such as soils or concrete; and(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.3. If detectable levels of residual radioactive contamination are found, the license continues to be in effect, even beyond the expiration date if necessary, with respect to possession of residual radioactive material as contamination until the Division notifies the licensee in writing that the license is terminated. Each licensee who possesses residual radioactive material under this paragraph shall initiate decommissioning activities as required by (8)(h).4. If no residual radioactive contamination is detected, the licensee shall submit a certification that no detectable radioactive contamination was found. If the information submitted is found to be adequate, the Director will notify the licensee in writing that the license is terminated.(e) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Director determines that: 1. Radioactive material has been properly disposed;2. Reasonable effort has been made to eliminate residual radioactive contamination, if present; and3.(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with Division requirements for decommissioning in Rule .03(7); or(ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with Division requirements for decommissioning in Rule .03(7).4. Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Division: (i) Records of disposal of licensed material made under Rule .03(13)(b) (including burials authorized before January 28, 1982),.03(13)(c), .03(13)(d), .03(13)(e); and(ii) Records required by Rule .03(14)(c)2.(iv).5. If licensed activities are transferred or assigned in accordance with Rule .02(13)(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated: (i) Records of disposal of licensed material made under Rule .03(13)(b) (including burials authorized before January 28, 1982), .03(13)(c), .03(13)(d), .03(13)(e); and(ii) Records required by Rule .03(14)(c)2.(iv).6. Prior to license termination, each licensee shall forward the records required by Rule .02(8)(g)8. to the Division.(19)Transfer of Material.(a) Authorization for Transfer. No licensee shall transfer radioactive material except as authorized pursuant to (19)(b).(b) Condition of Transfer. Any licensee may transfer radioactive material, subject to acceptance by the transferee, to: 1. The Division, after receiving prior approval from the Division;2. The United States Department of Energy or any successor thereto;3. Any person exempt from this Rule to the extent permitted under such exemption;4. Any person licensed to receive such material under terms of a general license or its equivalent, or specific license or equivalent licensing document issued by the Director, the U.S. Nuclear Regulatory Commission or any Agreement State, to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Division or any Agreement State; or5. Any person authorized by the Division in writing.(c) Before transferring radioactive material to a specific licensee of the Director, the U.S. Nuclear Regulatory Commission or an Agreement State or to a general licensee who is required to register with the Division, the U.S. Nuclear Regulatory Commission or an Agreement State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.(d) The following methods for the verification required by (19)(c) are acceptable: 1. The transferor may possess, and read, a current copy of the transferee's specific license or registration certificate.2. The transferor may have in his possession a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date.3. For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided that the oral certification is confirmed in writing within ten days.4. The transferor may obtain other sources of information compiled by a reporting service from official records of the Division, the U.S. Nuclear Regulatory Commission or the licensing agency of an Agreement State regarding the identity of licensees and the scope and expiration date of licenses and registration.5. When none of the methods of verification described in paragraphs (19)(d)1., 2., 3., and 4. is readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Division, the U.S. Nuclear Regulatory Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the radioactive material.(e) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of Rule .06 of this Chapter.(f) Each person who receives source or byproduct material pursuant to a license issued pursuant to the regulations in Rule 391-3-17-.02 shall keep records showing the receipt, transfer, and disposal of this source or byproduct material as specified in 10 CFR 40.61.(20)Reciprocity.(a) Persons licensed by other Agencies. Subject to the provisions of this Chapter, any person who holds a specific license from the U.S. Nuclear Regulatory Commission or any Agreement State, other than this State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State, except in areas of exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year provided that: 1. The licensing document does not limit the activity authorized by such document to specified installations or locations;2. The out-of-state licensee notifies the Division in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the State, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the 3-day period would impose an undue hardship on the out-of-state licensee, he may, upon application to the Division, obtain permission to proceed sooner;3. The out-of-state licensee complies with all applicable Rules of the Division, and with all the terms and conditions of his licensing document except any such terms and conditions that may be inconsistent with applicable Rules of the Division;4. Provided further that the Division may require the out-of-state licensee to supply such other information as the Division may reasonably request; and5. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in (20)(a) except by transfer to a person who is: (i) Specifically licensed by the Director or the U.S. Nuclear Regulatory Commission to receive such material; or(ii) Exempt from the requirements for a license for such material under (3)(a).(b) Notwithstanding the provisions of (20)(a), any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in (6)(c)1. within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such device in this State provided that:1. Such person shall file a report with the Division within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each such report shall identify each general licensee to whom such a device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;2. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State;3. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed the manufacturing of the device bear a statement that "Removal of This Label is Prohibited"; and4. The holder of the specific license shall furnish to each general licensee to whom he transfers such a device or on whose premises he installs such a device a copy of the general license contained in (6)(c).(c) The Division may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety, to property, or to the environment.(21)Schedules.(a) Schedule A. SCHEDULE A
EXEMPT CONCENTRATIONS
Exempt Concentrations Element (Atomic Number) | Schedule A Isotope | Column I Gas Concentration (µCi/mL) (1) | Column II Liquid and Solid Concentration (µCi/mL) (2) |
Antimony (51) | Sb 122 | 3 x 10-4 |
Sb 124 | 2 x 10-4 |
Sb 125 | 1 x 10-3 |
Argon (18) | Ar 37 | 1 x 10-3 |
Ar 41 | 4 x 10-7 |
Arsenic (33) | As 73 | 5 x 10-3 |
As 74 | 5 x 10-4 |
As 76 | 2 x 10-4 |
As 77 | 8 x 10-4 |
Barium (56) | Ba 131 | 2 x 10-3 |
Ba 140 | 3 x 10-4 |
Beryllium (4) | Be 7 | 2 x 10-2 |
Bismuth (83) | Bi 206 | 4 x 10-4 |
Bromine (35) | Br 82 | 4 x 10-7 | 3 x 10-3 |
Cadmium (48) | Cd 109 | 2 x 10-3 |
Cd 115m | 3 x 10-4 |
Cd 115 | 3 x 10-4 |
Calcium (20) | Ca 45 | 9 x 10-5 |
Ca 47 | 5 x 10-4 |
Carbon (6) | C 14 | 1 x 10-6 | 8 x 10-3 |
Cerium (58) | Ce 141 | 9 x 10-4 |
Ce 143 | 4 x 10-4 |
Ce 144 | 1 x 10-4 |
Cesium (55) | Cs 131 | 2 x 10-2 |
Cs 134m | 6 x 10-2 |
Cs 134 | 9 x 10-5 |
Chlorine (17) | Cl 38 | 9 x 10-7 | 4 x 10-3 |
Chromium (24) | Cr 51 | 2 x 10-2 |
Cobalt (27) | Co 57 | 5 x 10-3 |
Co 60 | 5 x 10-4 |
Copper (29) | Cu 64 | 3 x 10-3 |
Dysprosium (66) | Dy 165 | 4 x 10-3 |
Dy 166 | 4 x 10-4 |
Erbium (68) | Er 169 | 9 x 10-4 |
Er 171 | 1 x 10-3 |
Europium (63) | Eu 152 | 6 x 10-4 |
(T0.5 = 9.2 h) |
Eu 155 | 2 x 10-3 |
Fluorine (9) | F 18 | 2 x 10-6 | 8 x 10-3 |
Gadolinium (64) | Gd 153 | 2 x 10-3 |
Gd 159 | 8 x 10-4 |
Gallium (31) | Ga 72 | 4 x 10-4 |
Germanium (32) | Ge 71 | 2 x 10-2 |
Gold (79) | Au 196 | 2 x 10-3 |
Au 198 | 5 x 10-4 |
Au 199 | 2 x 10-3 |
Hafnium (72) | Hf 181 | 7 x 10-4 |
Hydrogen (1) | H 3 | 5 x 10-6 | 3 x 10-2 |
Indium (49) | In 113m | 1 x 10-2 |
In 114m | 2 x 10-4 |
Iodine (53) | I 126 | 3 x 10-9 | 2 x 10-5 |
I 131 | 3 x 10-9 | 2 x 10-5 |
I 132 | 8 x 10-8 | 6 x 10-4 |
I 133 | 1 x 10-8 | 7 x 10-5 |
I 134 | 2 x 10-7 | 1 x 10-3 |
Iridium (77) | Ir 190 | 2 x 10-3 |
Ir 192 | 4 x 10-4 |
Ir 194 | 3 x 10-4 |
Iron (26) | Fe 55 | 8 x 10-3 |
Fe 59 | 6 x 10-4 |
Krypton (36) | Kr 85m | 1 x 10-6 |
Kr 85 | 3 x 10-6 |
Lanthanum (57) | La 140 | 2 x 10-4 |
Lead (82) | Pb 203 | 4 x 10-3 |
Lutetium (71) | Lu 177 | 1 x 10-3 |
Manganese (25) | Mn 52 | 3 x 10-4 |
Mn 54 | 1 x 10-3 |
Mn 56 | 1 x 10-3 |
Mercury (80) | Hg 197m | 2 x 10-3 |
Hg 197 | 3 x 10-3 |
Hg 203 | 2 x 10-4 |
Molybdenum (42) | Mo 99 | 2 x 10-3 |
Neodymium (60) | Nd 147 | 6 x 10-4 |
Nd 149 | 3 x 10-3 |
Nickel (28) | Ni 65 | 1 x 10-3 |
Niobium | Nb 95 | 1 x 10-3 |
(columbium) (41) |
Nb 97 | 9 x 10-3 |
Osmium (76) | Os 185 | 7 x 10-4 |
Os 191m | 3 x 10-2 |
Os 191 | 2 x 10-3 |
Os 193 | 6 x 10-4 |
Palladium (46) | Pd 103 | 3 x 10-3 |
Pd 109 | 9 x 10-4 |
Phosphorus (15) | P 32 | 2 x 10-4 |
Platinum (78) | Pt 191 | 1 x 10-3 |
Pt 193m | 1 x 10-2 |
Pt 197m | 1 x 10-2 |
Pt 197 | 1 x 10-3 |
Polonium (84) | Po 210 | 7 x 10-6 |
Potassium (19) | K 42 | 3 x 10-3 |
Praseodymium | Pr 142 | 3 x 10-4 |
(59) |
Pr 143 | 5 x 10-4 |
Promethium (61) | Pm 147 | 2 x 10-3 |
Pm 149 | 4 x 10-4 |
Radium (88) | Ra 226 | 1 x 10-7 |
Ra 228 | 3 x 10-7 |
Rhenium (75) | Re 183 | 6 x 10-3 |
Re 186 | 9 x 10-4 |
Re 188 | 6 x 10-4 |
Rhodium (45) | Rh 103m | 1 x 10-1 |
Rubidium (37) | Rb 86 | 7 x 10-4 |
Ruthenium (44) | Ru 97 | 4 x 10-3 |
Ru 103 | 8 x 10-4 |
Ru 105 | 1 x 10-3 |
Ru 106 | 1 x 10-4 |
Samarium (62) | Sm 153 | 8 x 10-4 |
Scandium (21) | Sc 46 | 4 x 10-4 |
Sc 47 | 9 x 10-4 |
Sc 48 | 3 x 10-3 |
Selenium (34) | Se 75 | 3 x 10-3 |
Silicon (14) | Si 31 | 9 x 10-3 |
Silver (47) | Ag 105 | 1 x 10-3 |
Ag 110m | 3 x 10-4 |
Ag 111 | 4 x 10-4 |
Sodium (11) | Na 24 | 2 x 10-3 |
Strontium (38) | Sr 85 | 1 x 10-3 |
Sr 89 | 1 x 10-4 |
Sr 91 | 7 x 10-4 |
Sr 92 | 7 x 10-4 |
Sulfur (16) | S 35 | 9 x 10-8 | 6 x 10-4 |
Tantalum (73) | Ta 182 | 4 x 10-4 |
Technetium (43) | Tc 96m | 1 x 10-1 |
Tc 96 | 1 x 10-3 |
Tellurium (52) | Te 125m | 2 x 10-3 |
Te 127m | 6 x 10-4 |
Te 127 | 3 x 10-3 |
Te 129m | 3 x 10-4 |
Te 131m | 6 x 10-4 |
Te 132 | 3 x 10-4 |
Terbium (65) | Tb 160 | 4 x 10-4 |
Thallium (81) | Tl 200 | 4 x 10-3 |
Tl 201 | 3 x 10-3 |
Tl 202 | 1 x 10-3 |
Tl 204 | 1 x 10-3 |
Thulium (69) | Tm 170 | 5 x 10-4 |
Tin (50) | Sn 113 | 9 x 10-4 |
Sn 125 | 2 x 10-4 |
Tungsten | W 181 | 4 x 10-3 |
(wolfram) (74) |
W 187 | 7 x 10-4 |
Vanadium (23) | V 48 | 3 x 10-4 |
Xenon (54) | Xe 131m | 4 x 10-6 |
Xe 133 | 3 x 10-6 |
Xe 135 | 1 x 10-6 |
Ytterbium (70) | Yb 175 | 1 x 10-3 |
Yttrium (39) | Y 90 | 2 x 10-4 |
Y 91m | 3 x 10-2 |
Y 91 | 3 x 10-4 |
Y 92 | 6 x 10-4 |
Y 93 | 3 x 10-4 |
Zinc (30) | Zn 65 | 1 x 10-3 |
Zn 69m | 7 x 10-4 |
Zn 69 | 2 x 10-2 |
Zirconium (40) | Zr 95 | 6 x 10-4 |
Zr 97 | 2 x 10-4 |
Beta- and/or gamma-emitting radioactive material not listed above with halflife less than three years | 1 x 10-10 | 1 x 10-6 |
Note: Many radioisotopes disintegrate into isotopes that are also radioactive. In expressing the concentrations in Schedule A, the activity stated is that of the parent isotope and takes into account the daughters. For purposes of (3)(a) where there is involved a combination of isotopes, the limit for the combination should be derived as follows:
Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).
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(b) Schedule B. SCHEDULE B
EXEMPT QUANTITIES
Schedule B - Exempt Quantities |
Radioactive Material | Exempt Quantity (Microcuries) |
Antimony-122 (Sb 122) | 100 |
Antimony-124 (Sb 124) | 10 |
Antimony-125 (Sb 125) | 10 |
Arsenic-73 (As 73) | 100 |
Arsenic-74 (As 74) | 10 |
Arsenic-76 (As 76) | 10 |
Arsenic-77 (As 77) | 100 |
Barium-131 (Ba 131) | 10 |
Barium-133 (Ba 133) | 10 |
Barium-140 (Ba 140) | 10 |
Bismuth-210 (Bi 210) | 1 |
Bromine-82 (Br 82) | 10 |
Cadmium-109 (Cd 109) | 10 |
Cadmium-115m (Cd 115m) | 10 |
Cadmium-115 (Cd 115) | 100 |
Calcium-45 (Ca 45) | 10 |
Calcium-47 (Ca 47) | 10 |
Carbon-14 (C 14) | 100 |
Cerium-141 (Ce 141) | 100 |
Cerium-143 (Ce 143) | 100 |
Cerium-144 (Ce 144) | 1 |
Cesium-129 (Cs 129) | 100 |
Cesium-131 (Cs 131) | 1,000 |
Cesium-134m (Cs 134m) | 100 |
Cesium-134 (Cs 134) | 1 |
Cesium-135 (Cs 135) | 10 |
Cesium-136 (Cs 136) | 10 |
Cesium-137 (Cs 137) | 10 |
Chlorine-36 (Cl 36) | 10 |
Chlorine-38 (Cl 38) | 10 |
Chromium-51 (Cr 51) | 1,000 |
Cobalt-57 (Co 57) | 100 |
Cobalt-58m (Co 58m) | 10 |
Cobalt-58 (Co 58) | 10 |
Cobalt-60 (Co 60) | 1 |
Copper-64 (Cu 64) | 100 |
Dysprosium-165 (Dy 165) | 10 |
Dysprosium-166 (Dy 166) | 100 |
Erbium-169 (Er 169) | 100 |
Erbium-171 (Er 171) | 100 |
Europium-152 (Eu 152) 9.2h | 100 |
Europium-152 (Eu 152) 13 yr | 1 |
Europium-154 (Eu 154) | 1 |
Europium-155 (Eu 155) | 10 |
Fluorine-18 (F 18) | 1,000 |
Gadolinium-153 (Gd 153) | 10 |
Gadolinium-159 (Gd 159) | 100 |
Gallium-67 (Ga 67) | 100 |
Gallium-72 (Ga 72) | 10 |
Germanium-68 (Ge 68) | 10 |
Germanium-71 (Ge 71) | 100 |
Gold-195 (Au 195) | 10 |
Gold-198 (Au 198) | 100 |
Gold-199 (Au 199) | 100 |
Hafnium-181 (Hf 181) | 10 |
Holmium-166 (Ho 166) | 100 |
Hydrogen-3 (H 3) | 1,000 |
Indium-111 (In 111) | 100 |
Indium-113m (In 113m) | 100 |
Indium-114m (In 114m) | 10 |
Indium-115m (In 115m) | 100 |
Indium-115 (In 115) | 10 |
Iodine-123 (I 123) | 100 |
Iodine-125 (I 125) | 1 |
Iodine-126 (I 126) | 1 |
Iodine-129 (I 129) | 0.1 |
Iodine-131 (I 131) | 1 |
Iodine-132 (I 132) | 10 |
Iodine-133 (I 133) | 1 |
Iodine-134 (I 134) | 10 |
Iodine-135 (I 135) | 10 |
Iridium-192 (Ir 192) | 10 |
Iridium-194 (Ir 194) | 100 |
Iron-52 (Fe 52) | 10 |
Iron-55 (Fe 55) | 100 |
Iron-59 (Fe 59) | 10 |
Krypton-85 (Kr 85) | 100 |
Krypton-87 (Kr 87) | 10 |
Lanthanum-140 (La 140) | 10 |
Lutetium-177 (Lu 177) | 100 |
Manganese-52 (Mn 52) | 10 |
Manganese-54 (Mn 54) | 10 |
Manganese-56 (Mn 56) | 10 |
Mercury-197m (Hg 197m) | 100 |
Mercury-197 (Hg 197) | 100 |
Mercury-203 (Hg 203) | 10 |
Molybdenum-99 (Mo 99) | 100 |
Neodymium-147 (Nd 147) | 100 |
Neodymium-149 (Nd 149) | 100 |
Nickel-59 (Ni 59) | 100 |
Nickel-63 (Ni 63) | 10 |
Nickel-65 (Ni 65) | 100 |
Niobium-93m (Nb 93m) | 10 |
Niobium-95 (Nb 95) | 10 |
Niobium-97 (Nb 97) | 10 |
Osmium-185 (Os 185) | 10 |
Osmium-191m (Os 191m) | 100 |
Osmium-191 (Os 191) | 100 |
Osmium-193 (Os 193) | 100 |
Palladium-103 (Pd 103) | 100 |
Palladium-109 (Pd 109) | 100 |
Phosphorus-32 (P 32) | 10 |
Platinum-191 (Pt 191) | 100 |
Platinum-193m (Pt 193m) | 100 |
Platinum-193 (Pt 193) | 100 |
Platinum-197m (Pt 197m) | 100 |
Platinum-197 (Pt 197) | 100 |
Polonium-210 (Po 210) | 0.1 |
Potassium-42 (K 42) | 10 |
Potassium-43 (K 43) | 10 |
Praseodymium-142 (Pr 142) | 100 |
Praseodymium-143 (Pr 143) | 100 |
Promethium-147 (Pm 147) | 10 |
Promethium-149 (Pm 149) | 10 |
Rhenium-186 (Re 186) | 100 |
Rhenium-188 (Re 188) | 100 |
Rhodium-103m (Rh 103m) | 100 |
Rhodium-105 (Rh 105) | 100 |
Rubidium-81 (Rb 81) | 10 |
Rubidium-86 (Rb 86) | 10 |
Rubidium-87 (Rb 87) | 10 |
Ruthenium-97 (Ru 97) | 100 |
Ruthenium-103 (Ru 103) | 10 |
Ruthenium-105 (Ru 105) | 10 |
Ruthenium-106 (Ru 106) | 1 |
Samarium-151 (Sm 151) | 10 |
Samarium-153 (Sm 153) | 100 |
Scandium-46 (Sc 46) | 10 |
Scandium-47 (Sc 47) | 100 |
Scandium-48 (Sc 48) | 10 |
Selenium-75 (Se 75) | 10 |
Silicon-31 (Si 31) | 100 |
Silver-105 (Ag 105) | 10 |
Silver-110m (Ag 110m) | 1 |
Silver-111 (Ag 111) | 100 |
Sodium-22 (Na 22) | 10 |
Sodium-24 (Na 24) | 10 |
Strontium-85 (Sr 85) | 10 |
Strontium-89 (Sr 89) | 1 |
Strontium-90 (Sr 90) | 0.1 |
Strontium-91 (Sr 91) | 10 |
Strontium-92 (Sr 92) | 10 |
Sulphur-35 (S 35) | 100 |
Tantalum-182 (Ta 182) | 10 |
Technetium-96 (Tc 96) | 10 |
Technetium-97m (Tc 97m) | 100 |
Technetium-97 (Tc 97) | 100 |
Technetium-99m (Tc 99m) | 100 |
Technetium-99 (Tc 99) | 10 |
Tellurium-125m (Te 125m) | 10 |
Tellurium-127m (Te 127m) | 10 |
Tellurium-127 (Te 127) | 100 |
Tellurium-129m (Te 129m) | 10 |
Tellurium-129 (Te 129) | 100 |
Tellurium-131m (Te 131m) | 10 |
Tellurium-132 (Te 132) | 10 |
Terbium-160 (Tb 160) | 10 |
Thallium-200 (Tl 200) | 100 |
Thallium-201 (Tl 201) | 100 |
Thallium-202 (Tl 202) | 100 |
Thallium-204 (Tl 204) | 10 |
Thulium-170 (Tm 170) | 10 |
Thulium-171 (Tm 171) | 10 |
Tin 113-(Sn 113) | 10 |
Tin 125-(Sn 125) | 10 |
Tungsten-181 (W 181) | 10 |
Tungsten-185 (W 185) | 10 |
Tungsten-187 (W 187) | 100 |
Vanadium-48 (V 48) | 10 |
Xenon-131m (Xe 131m) | 1,000 |
Xenon-133 (Xe 133) | 100 |
Xenon-135 (Xe 135) | 100 |
Ytterbium-175 (Yb 175) | 100 |
Yttrium-87 (Y 87) | 10 |
Yttrium-88 (Y 88) | 10 |
Yttrium-90 (Y 90) | 10 |
Yttrium-91 (Y 91) | 10 |
Yttrium-92 (Y 92) | 100 |
Yttrium-93 (Y 93) | 100 |
Zinc-65 (Zn 65) | 10 |
Zinc-69m (Zn 69m) | 100 |
Zinc-69 (Zn 69) | 1,000 |
Zirconium-93 (Zr 93) | 10 |
Zirconium-95 (Zr 95) | 10 |
Zirconium-97 (Zr 97) | 10 |
Any radioactive material not listed above other than alpha- emitting radioactive material | 0.1 |
(c) Schedule C. SCHEDULE C
LIMITS FOR BROAD LICENSES
Schedule C - Limits For Broad Licenses |
Radioactive Materials | Column I (Curies) | Column II (Curies) |
Antimony-122 (Sb 122) | 1 | 0.01 |
Antimony-124 (Sb 124) | 1 | 0.01 |
Antimony-125 (Sb 125) | 1 | 0.01 |
Arsenic-73 (As 73) | 10 | 0.1 |
Arsenic-74 (As 74) | 1 | 0.01 |
Arsenic-76 (As 76) | 1 | 0.01 |
Arsenic-77 (As 77) | 10 | 0.1 |
Barium-131 (Ba 131) | 10 | 0.1 |
Barium-140 (Ba 140) | 1 | 0.01 |
Beryllium-7 (Be 7) | 10 | 0.1 |
Bismuth-210 (Bi 210) | 0.1 | 0.001 |
Bromine-82 (Br 82) | 10 | 0.1 |
Cadmium-109 (Cd 109) | 1 | 0.01 |
Cadmium-115m (Cd 115m) | 1 | 0.01 |
Cadmium-115 (Cd 115) | 10 | 0.1 |
Calcium-45 (Ca 45) | 1 | 0.01 |
Calcium-47 (Ca 47) | 10 | 0.1 |
Carbon-14 (C 14) | 100 | 1.0 |
Cerium-141 (Ce 141) | 10 | 0.1 |
Cerium-143 (Ce 143) | 10 | 0.1 |
Cerium-144 (Ce 144) | 0.1 | 0.001 |
Cesium-131 (Cs 131) | 100 | 1.0 |
Cesium-134m (Cs 134m) | 100 | 1.0 |
Cesium-134 (Cs 134) | 0.1 | 0.001 |
Cesium-135 (Cs 135) | 1 | 0.01 |
Cesium-136 (Cs 136) | 10 | 0.1 |
Cesium-137 (Cs 137) | 0.1 | 0.001 |
Chlorine-36 (Cl 36) | 0.01 | 0.001 |
Chlorine-38 (Cl 38) | 100 | 1.0 |
Chromium-51 (Cr 51) | 100 | 1.0 |
Cobalt-57 (Co 57) | 10 | 0.1 |
Cobalt-58m (Co 58m) | 100 | 1.0 |
Cobalt-58 (Co 58) | 1 | 0.01 |
Cobalt-60 (Co 60) | 0.1 | 0.001 |
Copper-64 (Cu 64) | 10 | 0.1 |
Dysprosium-165 (Dy 165) | 100 | 1.0 |
Dysprosium-166 (Dy 166) | 10 | 0.1 |
Erbium-169 (Er 169) | 10 | 0.1 |
Erbium-171 (Er 171) | 10 | 0.1 |
Europium-152 (Eu 152) 9.2h | 10 | 0.1 |
Europium-152 (Eu 152) 13 yr | 0.1 | 0.001 |
Europium-154 (Eu 154) | 0.1 | 0.001 |
Europium-155 (Eu 155) | 1 | 0.01 |
Fluorine-18 (F 18) | 100 | 1.0 |
Gadolinium-153 (Gd 153) | 1 | 0.01 |
Gadolinium-159 (Gd 159) | 10 | 0.1 |
Gallium-72 (Ga 72) | 10 | 0.1 |
Germanium-71 (Ge 71) | 100 | 1.0 |
Gold-198 (Au 198) | 10 | 0.1 |
Gold-199 (Au 199) | 10 | 0.1 |
Hafnium-181 (Hf 181) | 1 | 0.01 |
Holmium-166 (Ho 166) | 10 | 0.1 |
Hydrogen-3 (H 3) | 100 | 1.0 |
Indium-113m (In 113m) | 100 | 1.0 |
Indium-114m (In 114m) | 1 | 0.01 |
Indium-115m (In 115m) | 100 | 1.0 |
Indium-115 (In 115) | 1 | 0.01 |
Iodine-125 (I 125) | 0.1 | 0.001 |
Iodine-126 (I 126) | 0.1 | 0.001 |
Iodine-129 (I 129) | 0.1 | 0.001 |
Iodine-131 (I 131) | 0.1 | 0.001 |
Iodine-132 (I 132) | 10 | 0.1 |
Iodine-133 (I 133) | 1 | 0.01 |
Iodine-134 (I 134) | 10 | 0.1 |
Iodine-135 (I 135) | 1 | 0.01 |
Iridium-192 (Ir 192) | 1 | 0.01 |
Iridium-194 (Ir 194) | 10 | 0.1 |
Iron-55 (Fe 55) | 10 | 0.1 |
Iron-59 (Fe 59) | 1 | 0.01 |
Krypton-85 (Kr 85) | 100 | 1.0 |
Krypton-87 (Kr 87) | 10 | 0.1 |
Lanthanum-140 (La 140) | 1 | 0.01 |
Lutetium-177 (Lu 177) | 10 | 0.1 |
Manganese-52 (Mn 52) | 1 | 0.01 |
Manganese-54 (Mn 54) | 1 | 0.01 |
Manganese-56 (Mn 56) | 10 | 0.1 |
Mercury-197m (Hg 197m) | 10 | 0.1 |
Mercury-197 (Hg 197) | 10 | 0.1 |
Mercury-203 (Hg 203) | 1 | 0.01 |
Molybdenum-99 (Mo 99) | 10 | 0.1 |
Neodymium-147 (Nd 147) | 10 | 0.1 |
Neodymium-149 (Nd 149) | 10 | 0.1 |
Nickel-59 (Ni 59) | 10 | 0.1 |
Nickel-63 (Ni 63) | 1 | 0.01 |
Nickel-65 (Ni 65) | 10 | 0.1 |
Niobium-93m (Nb 93m) | 1 | 0.01 |
Niobium-95 (Nb 95) | 1 | 0.01 |
Niobium-97 (Nb 97) | 100 | 1.0 |
Osmium-185 (Os 185) | 1 | 0.01 |
Osmium-191m (Os 191m) | 100 | 1.0 |
Osmium-191 (Os 191) | 10 | 0.1 |
Osmium-193 (Os 193) | 10 | 0.1 |
Palladium-103 (Pd 103) | 10 | 0.1 |
Palladium-109 (Pd 109) | 10 | 0.1 |
Phosphorus-32 (P 32) | 1 | 0.01 |
Platinum-191 (Pt 191) | 10 | 0.1 |
Platinum-193m (Pt 193m) | 100 | 1.0 |
Platinum-193 (Pt 193) | 10 | 0.1 |
Platinum-197m (Pt 197m) | 100 | 1.0 |
Platinum-197 (Pt 197) | 10 | 0.1 |
Polonium-210 (Po 210) | 0.01 | 0.0001 |
Potassium-42 (K 42) | 1 | 0.01 |
Praseodymium-142 (Pr 142) | 10 | 0.1 |
Praseodymium-143 (Pr 143) | 10 | 0.1 |
Promethium-147 (Pm 147) | 1 | 0.01 |
Promethium-149 (Pm 149) | 10 | 0.1 |
Radium-226 | 0.01 | 0.0001 |
Rhenium-186 (Re 186) | 10 | 0.1 |
Rhenium-188 (Re 188) | 10 | 0.1 |
Rhodium-103m (Rh 103m) | 1,000 | 0 |
Rhodium-105 (Rh 105) | 10 | 0.1 |
Rubidium-86 (Rb 86) | 1 | 0.01 |
Rubidium-87 (Rb 87) | 1 | 0.01 |
Ruthenium-97 (Ru 97) | 100 | 1.0 |
Ruthenium-103 (Ru 103) | 1 | 0.01 |
Ruthenium-105 (Ru 105) | 10 | 0.1 |
Ruthenium-106 (Ru 106) | 0.1 | 0.001 |
Samarium-151 (Sm 151) | 1 | 0.01 |
Samarium-153 (Sm 153) | 10 | 0.1 |
Scandium-46 (Sc 46) | 1 | 0.01 |
Scandium-47 (Sc 47) | 10 | 0.1 |
Scandium-48 (Sc 48) | 1 | 0.01 |
Selenium-75 (Se 75) | 1 | 0.01 |
Silicon-31 (Si 31) | 10 | 0.1 |
Silver-105 (Ag 105) | 1 | 0.01 |
Silver-110m (Ag 110m) | 0.1 | 0.001 |
Silver-111 (Ag 111) | 10 | 0.1 |
Sodium-22 (Na 22) | 0.1 | 0.001 |
Sodium-24 (Na 24) | 1 | 0.01 |
Strontium-85m (Sr 85m) | 1,000 | 10.0 |
Strontium-85 (Sr 85) | 1 | 0.01 |
Strontium-89 (Sr 89) | 1 | 0.01 |
Strontium-90 (Sr 90) | 0.01 | 0.0001 |
Strontium-91 (Sr 91) | 10 | 0.1 |
Strontium-92 (Sr 92) | 10 | 0.1 |
Sulphur-35 (S 35) | 10 | 0.1 |
Tantalum-182 (Ta 182) | 1 | 0.01 |
Technetium-96 (Tc 96) | 10 | 0.1 |
Technetium-97m (Tc 97m) | 10 | 0.1 |
Technetium-97 (Tc 97) | 10 | 0.1 |
Technetium-99m (Tc 99m) | 100 | 1.0 |
Technetium-99 (Tc 99) | 1 | 0.01 |
Tellurium-125m (Te 125m) | 1 | 0.01 |
Tellurium-127m (Te 127m) | 1 | 0.01 |
Tellurium-127 (Te 127) | 10 | 0.1 |
Tellurium-129m (Te 129m) | 1 | 0.01 |
Tellurium-129 (Te 129) | 100 | 1.0 |
Tellurium-131m (Te 131m) | 10 | 0.1 |
Tellurium-132 (Te 132) | 1 | 0.01 |
Terbium-160 (Tb 160) | 1 | 0.01 |
Thallium-200 (Tl 200) | 10 | 0.1 |
Thallium-201 (Tl 201) | 10 | 0.1 |
Thallium-202 (Tl 202) | 10 | 0.1 |
Thallium-204 (Tl 204) | 1 | 0.01 |
Thulium-170 (Tm 170) | 1 | 0.01 |
Thulium-171 (Tm 171) | 1 | 0.01 |
Tin 113-(Sn 113) | 1 | 0.01 |
Tin 125-(Sn 125) | 1 | 0.01 |
Tungsten-181 (W 181) | 1 | 0.01 |
Tungsten-185 (W 185) | 1 | 0.01 |
Tungsten-187 (W 187) | 10 | 0.1 |
Vanadium-48 (V 48) | 1 | 0.01 |
Xenon-131m (Xe 131m) | 1,000 | 0 |
Xenon-133 (Xe 133) | 100 | 1.0 |
Xenon-135 (Xe 135) | 100 | 1.0 |
Ytterbium-175 (Yb 175) | 10 | 0.1 |
Yttrium-90 (Y 90) | 1 | 0.1 |
Yttrium-91 (Y 91) | 1 | 0.1 |
Yttrium-92 (Y 92) | 10 | 0.1 |
Yttrium-93 (Y 93) | 1 | 0.01 |
Zinc-65 (Zn 65) | 1 | 0.01 |
Zinc-69m (Zn 69m) | 10 | 0.1 |
Zinc-69 (Zn 69) | 100 | 1.0 |
Zirconium-93 (Zr 93) | 1 | 0.01 |
Zirconium-95 (Zr 95) | 1 | 0.01 |
Zirconium-97 (Zr 97) | 1 | 0.01 |
Any radioactive material other than source material, or alpha-emitting radioactive material not listed above. | 0.1 | 0.001 |
(d) Schedule D. Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning. 1. Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This schedule establishes criteria for passing the financial test and for obtaining the parent company guarantee.2. Financial Test. To pass the financial test, the parent company must meet the criteria of either (21)(d)2.(i) or (21)(d)2.(ii) as follows: (i) The parent company must have: (I) two of the following three ratios: a ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5;(II) Net working capital and tangible net worth each at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used);(III) Tangible net worth of at least $10 million; and(IV) Assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used).(ii) The parent company must have: (I) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as issued by Moody's;(II) Tangible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used);(III) Tangible net worth of at least $10 million; and(IV) Assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used).(iii) The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently-audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure the licensee shall inform the Director and Division within 90 days of any matters coming to the auditor's attention that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.(iv) After the initial financial test, the parent company must repeat the passage of the test within 120 days after the close of each succeeding fiscal year. If the parent company no longer meets the requirements, as appropriate, of either (21)(d)2.(i) or (21)(d)2.(ii), the licensee must send notice to the Director and Division of intent to establish alternate financial assurance as specified in the Division's Rules. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year-end financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.3. Parent Company Guarantee. The terms of a parent company guarantee which an applicant or licensee obtains must provide that:(i) The parent company guarantee shall remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Director and Division. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Director, as evidenced by the return receipts;(ii) If the licensee fails to provide alternate financial assurance as specified in the Division's Rules within 90 days after receipt by the licensee and the Director and Division of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor shall provide such alternative financial assurance in the name of the licensee;(iii) The parent company guarantee and financial test provisions must remain in effect until the Department has terminated the license; and(iv) If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.(e) Schedule E. SCHEDULE E
QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN FOR RESPONDING TO A RELEASE
Schedule E - Emergency Plan ForResponding to a Release |
Radioactive Material (1) | Release Fraction | Quantity (Curies) |
Actinium-228 | 0.001 | 4,000 |
Americium-241 | 0.001 | 2 |
Americium-242 | 0.001 | 2 |
Americium-243 | 0.001 | 2 |
Antimony-124 | 0.01 | 4,000 |
Antimony-126 | 0.01 | 6,000 |
Barium-133 | 0.01 | 10,000 |
Barium-140 | 0.01 | 30,000 |
Bismuth-207 | 0.01 | 5,000 |
Bismuth-210 | 0.01 | 600 |
Cadmium-109 | 0.01 | 1,000 |
Cadmium-113 | 0.01 | 80 |
Calcium-45 | 0.01 | 20,000 |
Californium-252 | 0.001 | 9 (20 mg) |
Carbon-14 (Non Carbon dioxide) | 0.01 | 50,000 |
Cerium-141 | 0.01 | 10,000 |
Cerium-144 | 0.01 | 300 |
Cesium-134 | 0.01 | 2,000 |
Cesium-137 | 0.01 | 3,000 |
Chlorine-36 | 0.5 | 100 |
Chromium-51 | 0.01 | 300,000 |
Cobalt-60 | 0.001 | 5,000 |
Copper-64 | 0.01 | 200,000 |
Curium-242 | 0.001 | 60 |
Curium-243 | 0.001 | 3 |
Curium-244 | 0.001 | 4 |
Curium-245 | 0.001 | 2 |
Europium-152 | 0.01 | 500 |
Europium-154 | 0.01 | 400 |
Europium-155 | 0.01 | 3,000 |
Germanium-68 | 0.01 | 2,000 |
Gadolinium-153 | 0.01 | 5,000 |
Gold-198 | 0.01 | 30,000 |
Hafnium-172 | 0.01 | 400 |
Hafnium-181 | 0.01 | 7,000 |
Holmium-166m | 0.01 | 100 |
Hydrogen-3 | 0.5 | 20,000 |
Iodine-125 | 0.5 | 10 |
Iodine-131 | 0.5 | 10 |
Indium-114m | 0.01 | 1,000 |
Iridium-192 | 0.001 | 40,000 |
Iron-55 | 0.01 | 40,000 |
Iron-59 | 0.01 | 7,000 |
Krypton-85 | 1.0 | 6,000,000 |
Lead-210 | 0.01 | 8 |
Manganese-56 | 0.01 | 60,000 |
Mercury-203 | 0.01 | 10,000 |
Molybdenum-99 | 0.01 | 30,000 |
Neptunium-237 | 0.001 | 2 |
Nickel-63 | 0.01 | 20,000 |
Niobium-94 | 0.01 | 300 |
Phosphorus-32 | 0.5 | 100 |
Phosphorus-33 | 0.5 | 1,000 |
Polonium-210 | 0.01 | 10 |
Potassium-42 | 0.01 | 9,000 |
Promethium-145 | 0.01 | 4,000 |
Promethium-147 | 0.01 | 4,000 |
Radium-226 | 0.001 | 100 |
Ruthenium-106 | 0.01 | 200 |
Samarium-151 | 0.01 | 4,000 |
Scandium-46 | 0.01 | 3,000 |
Selenium-75 | 0.01 | 10,000 |
Silver-110m | 0.01 | 1,000 |
Sodium-22 | 0.01 | 9,000 |
Sodium-24 | 0.01 | 10,000 |
Strontium-89 | 0.01 | 3,000 |
Strontium-90 | 0.01 | 90 |
Sulfur-35 | 0.5 | 900 |
Technetium-99 | 0.01 | 10,000 |
Technetium-99m | 0.01 | 400,000 |
Tellurium-127m | 0.01 | 5,000 |
Tellurium-129m | 0.01 | 5,000 |
Terbium-160 | 0.01 | 4,000 |
Thulium-170 | 0.01 | 4,000 |
Tin-13 | 0.01 | 10,000 |
Tin-123 | 0.01 | 3,000 |
Tin-126 | 0.01 | 1,000 |
Titanium-44 | 0.01 | 100 |
Vanadium-48 | 0.01 | 7,000 |
Xenon-133 | 1.0 | 900,000 |
Yttrium-91 | 0.01 | 2,000 |
Zinc-65 | 0.01 | 5,000 |
Zirconium-93 | 0.01 | 400 |
Zirconium-95 | 0.01 | 5,000 |
Any other beta-/gamma-emitter | 0.01 | 10,000 |
Mixed fission products | 0.01 | 1,000 |
Mixed Corrosion Products | 0.01 | 10,000 |
Contaminated equipment, beta/gamma | 0.001 | 10,000 |
Irradiated material, any form other than solid noncombustible | 0.01 | 1,000 |
Irradiated material, solid noncombustible | 0.001 | 10,000 |
Mixed radioactive waste, beta/gamma | 0.01 | 1,000 |
Packaged mixed waste, beta/gamma2 | 0.001 | 10,000 |
Any other alpha-emitter | 0.001 | 2 |
Contaminated equipment, alpha | 0.0001 | 20 |
Packaged waste, alpha(2) | 0.0001 | 20 |
(f) Schedule F SCHEDULE F
QUANTITIES FOR USE WITH DECOMMISSIONING
Schedule F - Quantities for Use With Decommissioning |
Radioactive Material | Quantity (Microcurie (a)/) |
Americium-241 | 0.01 |
Antimony-122 | 100 |
Antimony-124 | 10 |
Antimony-125 | 10 |
Arsenic-73 | 100 |
Arsenic-74 | 10 |
Arsenic-76 | 10 |
Arsenic-77 | 100 |
Barium-131 | 10 |
Barium-133 | 10 |
Barium-140 | 10 |
Bismuth-210 | 1 |
Bromine-82 | 10 |
Cadmium-109 | 10 |
Cadmium-115m | 10 |
Cadmium-115 | 100 |
Calcium-45 | 10 |
Calcium-47 | 10 |
Carbon-14 | 100 |
Cerium-141 | 100 |
Cerium-143 | 100 |
Cerium-144 | 1 |
Cesium-131 | 1,000 |
Cesium-134m | 100 |
Cesium-134 | 1 |
Cesium-135 | 10 |
Cesium-136 | 10 |
Cesium-137 | 10 |
Chlorine-36 | 10 |
Chlorine-38 | 10 |
Chromium-51 | 1,000 |
Cobalt-58m | 10 |
Cobalt-58 | 10 |
Cobalt-60 | 1 |
Copper-64 | 100 |
Dysprosium-165 | 10 |
Dysprosium-166 | 100 |
Erbium-169 | 100 |
Erbium-171 | 100 |
Europium-152 (9.2 h) | 100 |
Europium-152 (13 yr) | 1 |
Europium-154 | 1 |
Europium-155 | 10 |
Florine-18 | 1,000 |
Gadolinium-153 | 10 |
Gadolinium-159 | 100 |
Gallium-72 | 10 |
Germanium-71 | 0 |
Hafnium-181 | 10 |
Holmium-166 | 100 |
Hydrogen-3 | 1,000 |
Indium-113m | 100 |
Indium-114m | 10 |
Indium-115m | 100 |
Indium-115 | 10 |
Iodine-125 | 1 |
Iodine-126 | 1 |
Iodine-129 | 0.1 |
Iodine-131 | 1 |
Iodine-132 | 10 |
Iodine-133 | 1 |
Iodine-134 | 10 |
Iodine-135 | 10 |
Iridium-192 | 10 |
Iridium-194 | 100 |
Iron-55 | 100 |
Iron-59 | 10 |
Krypton-85 | 100 |
Krypton-87 | 10 |
Lanthanum-140 | 10 |
Lutetium-177 | 100 |
Manganese-52 | 10 |
Manganese-54 | 10 |
Manganese-56 | 10 |
Mercury-197m | 100 |
Mercury-197 | 100 |
Mercury-203 | 10 |
Molybdenum-99 | 100 |
Neodymium-147 | 100 |
Neodymium-149 | 100 |
Nickel-59 | 100 |
Nickel-63 | 10 |
Nickel-65 | 100 |
Niobium-93m | 10 |
Niobium-95 | 10 |
Niobium-97 | 10 |
Osmium-185 | 10 |
Osmium-191m | 100 |
Osmium-191 | 100 |
Osmium-193 | 100 |
Palladium-103 | 100 |
Palladium-109 | 100 |
Phosphorus-32 | 10 |
Platinum-191 | 100 |
Platinum-193m | 100 |
Platinum-193 | 100 |
Platinum-197m | 100 |
Platinum-197 | 100 |
Plutonium-239 | 0.01 |
Polonium-210 | 0.1 |
Potassium-42 | 10 |
Praseodymium-142 | 100 |
Praseodymium-143 | 100 |
Promethium-147 | 10 |
Promethium-149 | 10 |
Radium-226 | 0.01 |
Rhenium-186 | 100 |
Rhenium-188 | 100 |
Rhodium-103m | 100 |
Rhodium-105 | 100 |
Rubidium-86 | 10 |
Rubidium-87 | 10 |
Ruthenium-97 | 100 |
Ruthenium-103 | 10 |
Ruthenium-105 | 10 |
Ruthenium-106 | 1 |
Samarium-151 | 10 |
Samarium-153 | 100 |
Scandium-46 | 10 |
Scandium-47 | 100 |
Scandium-48 | 10 |
Selenium-75 | 10 |
Silicon-31 | 100 |
Silver-105 | 10 |
Silver-110m | 1 |
Silver-111 | 100 |
Sodium-22 | 1 |
Sodium-24 | 10 |
Strontium-85 | 10 |
Strontium-89 | 1 |
Strontium-90 | 0.1 |
Strontium-91 | 10 |
Strontium-92 | 10 |
Sulfur-35 | 100 |
Tantalum-182 | 10 |
Technetium-96 | 10 |
Technetium-97m | 100 |
Technetium-97 | 100 |
Technetium-99m | 100 |
Technetium-99 | 10 |
Tellurium-125m | 10 |
Tellurium-127m | 10 |
Tellurium-127 | 100 |
Tellurium-129m | 10 |
Tellurium-129 | 100 |
Tellurium-131m | 10 |
Tellurium-132 | 10 |
Terbium-160 | 10 |
Thallium-200 | 100 |
Thallium-201 | 100 |
Thallium-202 | 100 |
Thallium-204 | 10 |
Thorium (natural)b/ | 100 |
Thulium-170 | 10 |
Thulium-171 | 10 |
Tin-113 | 10 |
Tin-125 | 10 |
Tungsten-181 | 10 |
Tungsten-185 | 10 |
Tungsten-187 | 100 |
Uranium (natural)c/ | 100 |
Uranium-233 | 0.01 |
Uranium-234 | 0.01 |
Uranium-235 | 0.01 |
Vanadium-48 | 10 |
Xenon-131m | 1,000 |
Xenon-133 | 100 |
Xenon-135 | 100 |
Ytterbium-175 | 100 |
Yttrium-90 | 10 |
Yttrium-91 | 10 |
Yttrium-92 | 100 |
Yttrium-93 | 100 |
Zinc-65 | 10 |
Zinc-69m | 100 |
Zinc-69 | 1,000 |
Zirconium-93 | 10 |
Zirconium-95 | 10 |
Zirconium-97 | 10 |
Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition. | 0.01 |
Any radionuclide other than alpha emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition. | 0.10 |
(g) Schedule G. Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning. 1. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of (21)(g)2. The terms of the self-guarantee are in (21)(g)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
2. Financial Test (i) To pass the financial test, a company must meet all of the following criteria: (I) Tangible net worth at least ten times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee.(II) Assets located in the United States amounting to at least 90 percent of total decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee.(III) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.(ii) To pass the financial test, a company must meet all of the following additional requirements: (I) The company must have at least one class of equity securities registered under the Security Exchange Act of 1934.(II) The company's independent certified public accountant must have compared the data used by the company in the financial test, which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Director and Division within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.(III) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.(iii) If the licensee no longer meets the requirements of (21)(g)2.(i), the licensee must send immediate notice to the Director and Division of its intent to establish alternate financial assurance as specified in the Division's Rules within 120 days of such notice.3. Company Self-Guarantee The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
(i) The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Director and Division. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Director, as evidence by the return receipt.(ii) The licensee shall provide alternative financial assurance as specified in the Division's Rules within 90 days following receipt by the Director of a notice of cancellation of the guarantee.(iii) The guarantee and financial test provisions must remain in effect until the Director has terminated the license or until another financial assurance method acceptable to the Director has been put in effect by the licensee.(iv) The licensee will promptly forward to the Department, the Division and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of Section 13 of the Securities and Exchange Act of 1934.(v) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Director and Division within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of (21)(g)2.(i).(vi) The applicant or licensee must provide to the Director and Division a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Director, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.(h) Schedule H. Criteria Relating to Use of Financial Tests and Self-Guarantee For Providing Reasonable Assurance of Funds For Decommissioning by Nonprofit Colleges, Universities, and Hospitals. 1. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of (h)2. The terms of the self-guarantee are in (h)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.
2. Financial Test (i) For colleges and universities, to pass the financial test a college or university must meet either the criteria in (h)2.(i)(I) or the criteria in (h)2.(i)(II). (I) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.(II) For applicants or licensees that do not issue bonds, unrestricted endowment consisting of assets located in the United States of at least $50 million, or at least 30 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.(ii) For hospitals, to pass the financial test a hospital must meet either the criteria in (h)2.(ii)(I) or the criteria in (h)2.(ii)(II): (I) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.(II) For applicants or licensees that do not issue bonds, all the following tests must be met: I. (Total Revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04.II. Long term debt divided by net fixed assets must be less than or equal to 0.67.III. (Current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55.IV. Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as a self-guaranteeing license.(iii) In addition, to pass the financial test, a licensee must meet all the following requirements: (I) The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year-end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Director and Division within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the licensee no longer passes the test.(II) After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year.(III) If the licensee no longer meets the requirements of (h)1., the licensee must send notice to the Director and Division of its intent to establish alternative financial assurance as specified in Division's Rules. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year-end financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.3. Self-Guarantee The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
(i) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, and/or return receipt requested, to the Director and Division. Cancellation may not occur unless an alternative financial assurance mechanism is in place.(ii) The licensee shall provide alternative financial assurance as specified in the Division's Rules within 90 days following receipt by the Director of a notice of cancellation of the guarantee.(iii) The guarantee and financial test provisions must remain in effect until the Director has terminated the license or until another financial assurance method acceptable to the Director has been put in effect by the licensee.(iv) The applicant or licensee must provide to the Director and Division a written guarantee (a written commitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Director, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.(v) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poors or Moodys, the licensee shall provide notice in writing of such fact to the Director and Division within 20 days after publication of the change by the rating service. Footnotes: (1) Values are given only for those materials normally used as gases.
(2) µCi/gm for solids.
Footnotes:
(1) For combinations of radioactive materials listed above, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule E exceeds one.
(2) Waste packaged in Type B containers does not require an emergency plan.
a/ To convert µCi to kBq, multiply the µCi value by 37.
b/ Based on alpha disintegration rate of Th-232, Th-230 and their daughter products.
c/ Based on alpha disintegration rate of U-238, U-234, and U-235.
Ga. Comp. R. & Regs. R. 391-3-17-.02
O.C.G.A. § 31-13-1 et seq., as amended.
Original Rule entitled "Licensing of Radioactive Material" adopted. F. May 2, 1991; eff. May 22, 1991.Amended: F. Feb. 24, 1994; eff. Mar. 16, 1994.Amended: F. Oct. 4, 1994; eff. Oct. 24, 1994.Amended: F. Apr. 16, 1997; eff. May 6, 1997.Amended: F. Mar. 29, 2002; eff. Apr. 18, 2002.Amended: F. May 30, 2003; eff. July 1, 2003, as specified by the Agency.Amended: F. Oct. 17, 2008; eff. Nov. 6, 2008.Amended: F. Jan. 8, 2014; eff. Jan. 28, 2014.Note: Correction of non-substantive typographical error in History, 'Original Rule entitled "Standards for Protection Against Radiation" adopted.' corrected to 'Original Rule entitled "Licensing of Radioactive Material" adopted.' Effective May 1, 2016.Amended: F. Apr. 11, 2016; eff. May 1, 2016.Amended: New title "Licensing of Radioactive Material." F. May 11, 2016; eff. May 31, 2016.Amended: F. June 1, 2017; eff. June 21, 2017.Amended: F. Dec. 14, 2017; eff. Jan. 3, 2018.Amended: F. Jan. 28, 2019; eff. Feb. 17, 2019.Amended: F. Feb. 26, 2020; eff. Mar. 17, 2020.Amended: F. Mar. 24, 2021; eff. Apr. 13, 2021.