TITLE 32: ENERGY CHAPTER II: DEPARTMENT OF NUCLEAR SAFETY SUBCHAPTER b: RADIATION PROTECTION PART 330 LICENSING OF RADIOACTIVE MATERIAL SUBPART A: GENERAL PROVISIONS Section 330.10 Purpose and Scope 330.30 License Exemption - Source Material 330.40 License Exemption - Radioactive Materials Other Than Source Material SUBPART B: TYPES OF LICENSES Section 330.200 Types of Licenses 330.210 General Licenses - Source Material 330.220 General Licenses - Radioactive Material Other Than Source Material SUBPART C: SPECIFIC LICENSES Section 330.240 Filing Application for Specific Licenses 330.250 General Requirements for the Issuance of Specific Licenses 330.260 Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials 330.270 Special Requirements for Specific Licenses of Broad Scope 330.280 Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material 330.300 Issuance of Specific Licenses 330.310 Specific Terms and Conditions of License 330.320 Expiration and Termination of Licenses 330.330 Renewal of Licenses 330.340 Amendment of Licenses at Request of Licensee 330.350 Department Action on Application to Renew or Amend 330.360 Persons Possessing a License for Source, Byproduct, or Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass on Effective Date of This Part 330.370 Persons Possessing Accelerator-Produced or Naturally-Occurring Radioactive Material on Effective Date of This Part (Repealed) 330.400 Transfer of Material 330.500 Modification and Revocation of Licenses 330.900 Reciprocal Recognition of Licenses SUBPART D: TRANSPORTATION (Repealed) Section 330.1000 Transportation of Radioactive Materials (Repealed) 330.APPENDIX A EXEMPT CONCENTRATIONS 330.APPENDIX B EXEMPT QUANTITIES 330.APPENDIX C GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIALS (Repealed) 330.TABLE A Group I (Repealed) 330.TABLE B Group II (Repealed) 330.TABLE C Group III (Repealed) 330.TABLE D Group IV (Repealed) 330.TABLE E Group V (Repealed) 330.TABLE F Group VI (Repealed) 330.APPENDIX D LIMITS FOR BROAD LICENSES (SECTION 330.270) 330.APPENDIX E Schedule E (Repealed) 330.APPENDIX F Schedule F (Repealed) 330.APPENDIX G FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(D)) 330.APPENDIX H WORDING OF FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(E)) AUTHORITY: Implementing and authorized by the Radiation Protection Act of 1990 (Ill. Rev. Stat. 1990 Supp., ch. 111«, pars. 210-1 et seq.). SOURCE: Filed April 20, 1974, by the Department of Public Health; transferred to the Department of Nuclear Safety by P.A. 81-1516, effective December 3, 1980; amended at 5 Ill. Reg. 9586, effective September 10, 1981; codified at 7 Ill. Reg. 17492; recodified at 10 Ill. Reg. 11268; amended at 10 Ill. Reg. 17315, effective September 25, 1986; amended at 15 Ill. Reg. 10632, effective July 15, 1991. SUBPART A: GENERAL PROVISIONS Section 330.10 Purpose and Scope a) This Part provides for the licensing of radioactive material. No person shall receive, possess, utilize, manufacture, distribute, transfer, own, or acquire radioactive material or devices or equipment utilizing or producing such materials except as authorized in a specific or general license issued pursuant to this Part or as otherwise provided in this Part. b) In addition to the requirements of subsection (a), all licensees are subject to the requirements of this Part, and 32 Ill. Adm. Code 310, 320, 331, 340, 341 and 400. Licensees engaged in industrial radiographic operations are subject to the requirements of 32 Ill. Adm. Code 350. Licensees using radioactive material in the healing arts are subject to the requirements of 32 Ill. Adm. Code 335 and licensees engaged in wireline and subsurface tracer studies are subject to the requirements of 32 Ill. Adm. Code 351. The requirements of this Part do not apply to carriers. Carriers are subject to the requirements of 32 Ill. Adm. Code 341. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.30 License Exemption - Source Material a) Any person is exempt from this Part 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 1 percent (0.05 percent) of the mixture, compound, solution, or alloy. b) Any person is exempt from this Part 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 Part to the extent that such person receives, possesses, uses, or transfers: 1) Any quantities of thorium contained in: A) Incandescent gas mantles, B) Vacuum tubes, C) Welding rods, D) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium, E) Germicidal lamps, sunlamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium, F) 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 G) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium. 2) Source material contained in the following products: A) Glazed ceramic tableware, provided that the glaze contains not more than 20 percent by weight source material, B) Piezoelectric ceramic containing not more than 2 percent by weight source material, C) Glassware containing not more than 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, and D) Glass enamel or glass enamel frit containing not more than 10 percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983. 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 4 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 counter- weights, provided that: A) The counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or the Atomic Energy Commission authorizing distribution by the licensee pursuant to 10 CFR 40.13(c)(5)(i), as in effect on June 30, 1969, B) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM", AGENCY NOTE: The requirement specified in subsection (c)(5)(B) does not need to be met by counterweights manufactured prior to December 31, 1969; provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM", as previously required by 10 CFR 40.13(c)(5)(ii), as in effect June 30, 1969, exclusive of subsequent amendments or additions. A copy of this rule is available for public inspection at the Department of Nuclear Safety (Department). C) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and AGENCY NOTE: The requirement specified in subsection (c)(5)(C) does not need to be met by counterweights manufactured prior to December 31, 1969; provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM", as previously required by 10 CFR 40.13(c)(5)(ii), as in effect June 30, 1969, exclusive of subsequent amendments or additions. A copy of this rule is available for public inspection at the Department. D) 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 covering. 6) Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that: A) The shipping container is conspicuously and legibly impressed with the legend, "CAUTION- RADIOACTIVE SHIELDING-URANIUM"; and B) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one- eighth inch (3.2mm). 7) Thorium contained in finished optical lenses, provided that each lens does not contain more than 30 percent by weight of thorium, and that this exemption shall not be deemed to authorize either: A) The shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or B) The receipt, possession, use, or transfer of thorium contained in contact lenses, or 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; or 9) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that: A) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and B) The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight. d) The exemptions in subsection (c) do not authorize the manufacture of any of the products described. e) Any licensee is exempt from the requirements of this Part to the extent that its activities are subject to the requirements of 32 Ill. Adm. Code 601, except as specifically provided for in 32 Ill. Adm. Code 601. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.40 License Exemption - Radioactive Materials Other Than Source Materials a) Exempt Concentrations. 1) Except as provided in Section 330.40(a)(2), any person is exempt from this Part to the extent that such person receives, possesses, uses, transfers, owns, or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Appendix A of this Part. This Section shall not be deemed to authorize the import of radioactive materials or products containing radioactive materials. 2) 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 Section 330.40(a)(1) or equivalent regulations of the U.S. Nuclear Regulatory Commission (10 CFR 30.14 revised as of January 1, 1985, exclusive of any subsequent amendments or editions), any Agreement State or Licensing State, except in accordance with a specific license issued pursuant to Section 330.280(a) or the general license provided in Section 330.900. b) Exempt Quantities. 1) Except as provided in Section 330.40(b)(2) and (3), any person is exempt from this Part 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 Appendix B of this Part. 2) This paragraph (Section 330.40(b)) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution. 3) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Appendix B of this Part, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under Section 330.40(b) or equivalent regulations of the United States Nuclear Regulatory Commission, any Agreement State or Licensing State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR 32 or by the Department pursuant to Section 330.280(b) which license states that the radioactive material may be transferred by the licensee to persons exempt under Section 330.40(b) or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State. AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. c) Exempt Items. 1) Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products or persons who initially transfer for sale or distribution the following products, any person is exempt from this Part to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products: AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. A) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate: 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 radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber: for wrist watches, 0.1 millirad (1 uGy) per hour at 10 centimeters from any surface; for pocket watches, 0.1 millirad (1 uGy) per hour at 1 centimeter from any surface; for any other timepiece, 0.2 millirad (2 uGy) per hour at 10 centimeters from any surface; or viii) one microcurie (37 kBq) of radium-226 per timepiece in timepieces acquired prior to May 1, 1974. B) Lock illuminators containing not more than 15 millicuries (555 MBq) of tritium or not more than 2 millicuries (74 MBq) of promethium-147 installed in automobile locks. The radiation dose rate from each lock illuminator containing promethium-147 will not exceed 1 millirad (10 uGy) per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber. C) Precision balances containing not more than 1 millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part. D) Automobile shift quadrants containing not more than 25 millicuries (925 MBq) of tritium. E) 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. F) Thermostat dials and pointers containing not more than 25 millicuries (925 MBq) of tritium per thermostat. G) Electron tubes; provided 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 10 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; or vi) 30 microcuries (1.11 MBq) of promethium-147. and provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed 1 millirad (10 uGy) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. AGENCY NOTE: For purposes of Section 330.40(c)(1)(G), "electron tubes" include 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. H) 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 Appendix B of this Part; and ii) Each instrument contains no more than 10 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 in Appendix B of this Part, provided that the sum of such fractions shall not exceed unity. AGENCY NOTE: For purposes of Section 330.40(c)(1)(H), 0.05 microcurie (1.85 kBq) of americium-241 is considered an exempt quantity. I) Spark gap irradiators containing not more than 1 microcurie (37 kBq) of cobalt-60 per spark gap irradiator for use in electrically-ignited fuel oil burners having a firing rate of at least 3 gallons (11.4 l) per hour. 2) Self-Luminous Products Containing Radioactive Material. A) Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, or produce self- luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from this Part 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, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in Section 330.40(c)(2) does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments. The U. S. Nuclear Regulatory Commission shall make this determination of exemption. B) Radium-226. Any person is exempt from this Part 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 which were acquired prior to May 1, 1974. 3) Gas and Aerosol Detectors Containing Radioactive Material. A) Except for persons who manufacture, process, produce, or initially transfer for sale and distribution gas and aerosol detectors containing radioactive material, any person is exempt from 32 Ill. Adm. Code 320, 330, 331, 340, 350, 351, 370, 400 and 601 to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported, 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 32; or a Licensing State pursuant to Section 330.280(c), which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. AGENCY NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. B) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State shall be considered exempt under Section 330.40(c)(3)(a), 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 Section 330.280(c). C) Gas and aerosol detectors containing naturally- occurring or accelerator-produced radioactive material (NARM) previously manufactured and distributed in accordance with a specific license issued by a Licensing State shall be considered exempt under Section 330.40(c)(3)(a), provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of Section 330.280(c). 4) Resins Containing Scandium-46 and Designed for Sand Consolidation in Oil Wells. Any person is exempt from this Part to the extent that such person receives, possesses, uses, transfers, owns, or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer of such resins pursuant to licensing requirements equivalent to those in Section 32.17 of 10 CFR 32, revised as of January 1, 1985, of the regulations of the U.S. Nuclear Regulatory Commission. This exemption does not authorize the manufacture of any resins containing scandium-46. AGENCY NOTE: Licensing requirements contained in subsequent amendments or editions of 10 CFR 32 are not incorporated into this rule. A copy of 10 CFR 32 is available for public inspection at the Department of Nuclear Safety. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) SUBPART B: TYPES OF LICENSES Section 330.200 Types of Licenses Licenses for radioactive materials are of two types: general and specific. a) "General license" means a license, set forth in this Part and 32 Ill. Adm. Code 341, which is effective without the filing of an application to transfer, acquire, own, possess, or use quantities of, or devices or equipment utilizing radioactive material (Ill. Rev. Stat. 1990 Supp., ch. 111«, par. 210-4(d)), although the filing of a certificate with the Department may be required by the particular general license. The general licensee is subject to all other applicable portions of 32 Ill. Adm. Code: Chapter II and any limitations of the general license. b) "Specific license" means a license, as set forth in this Part, issued after application to use, manufacture, produce, transfer, receive, acquire, own, or possess quantities of, or devices or equipment utilizing radioactive material (Ill. Rev. Stat. 1990 Supp., ch. 111«, par. 210-4(m)). The licensee is subject to all applicable portions of 32 Ill. Adm. Code: Chapter II as well as any limitations specified in the licensing document. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.210 General Licenses - Source Material a) A general license is hereby issued authorizing commercial and industrial firms, research, educational, and medical institutions, and State and local government agencies to use and transfer not more than 15 pounds (6.82 kg) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, pursuant to this general license, may not receive more than a total of 150 pounds (68.2 kg) of source material in any one calendar year. b) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in Section 330.210(a) are exempt from the provisions of 32 Ill. Adm. Code 340 and 400 to the extent that such receipt, possession, use, or transfer is within the terms of such general license; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to this Part. c) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material. 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 Section 330.210(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 Section 330.210(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 pursuant to Section 330.280(m) or 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 Section 330.210(d)(1) shall: A) file the form, "Registration Certificate - Use of Depleted Uranium Under General License," with the Department. 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 "Registration Certificate - Use of Depleted Uranium Under General License," the following information: 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 Section 330.210(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 Section 330.210(d)(3)(A)(ii). B) report in writing to the Department any changes in information furnished by him in the 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 Section 330.210(d)(1): A) 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; B) shall not abandon such depleted uranium; C) shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of Section 330.400. In the case where the transferee receives the depleted uranium pursuant to the general license established by Section 330.210(d)(1), the transferor shall furnish the transferee a copy of this Part and a copy of the 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 regulation, (10 CFR 40.25(a) revised as of July 1, 1985, exclusive of any subsequent amendments or editions) or Agreement State's regulation equivalent to Section 330.210(d)(1), the transferor shall furnish the transferee a copy of this Part and a copy of the 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 Part; D) within 30 days of any transfer, shall report in writing to the Department the name and address of the person receiving the depleted uranium pursuant to such transfer; and E) shall not export such depleted uranium except in accordance with a license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR 110. 5) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by Section 330.210(d)(1) is exempt from the requirements of 32 Ill. Adm. Code 340 and 400 with respect to the depleted uranium covered by that general license. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.220 General Licenses - Radioactive Material Other Than Source Material a) Certain Devices and Equipment. A general license is hereby issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission for use pursuant to Section 31.3 of 10 CFR 31. This general license is subject to the provisions of 32 Ill. Adm. Code 310.40 through 310.90, 340, 341, 400, and Sections 330.40(a)(2), 330.310, 330.400, and 330.500 of this Part. AGENCY NOTE: Attention is directed particularly to the provisions of 32 Ill. Adm. Code 340 which relate to the labeling of containers. 1) Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device. 2) Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device or a total of not more than 50 millicuries (1.85 GBq) of hydrogen-3 (tritium) per device. b) Certain Measuring, Gauging or Controlling Devices. 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 subsection (b)(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 subsection (b)(1) applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifica- tions contained in a specific license issued by the Department pursuant to Section 330.280(d) or in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, which authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. AGENCY 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 21 CFR 179.21. 3) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in subsection (b)(1): A) 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; B) 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 6-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 10 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; C) Shall assure that testing (including testing required by subsection (b)(3)(B)), 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 Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform such activities; D) Shall maintain records showing compliance with the requirements of subsections (b)(3)(B) and (3)(C). The records shall show the results of tests concerning the installation, leakage testing, servicing and removal of radioactive material, its shielding or containment. The records also shall show the dates of performance of, and the names of persons performing these tests. Records of tests for leakage of radioactive material required by subsection (b)(3)(B) shall be maintained for 1 year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the "on-off" mechanism and indicator required by subsection (b)(3)(B) shall be maintained for 1 year after the next required test of the "on-off" mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by subsection (b)(3)(C), other than records of tests for leakage of radioactive material, shall be maintained for a period of 2 years from the date of the recorded event or until the device is transferred or disposed of; E) 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 radio- active material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the Department a report containing a brief descrip- tion of the event and the remedial action taken; F) Shall not abandon the device containing radioactive material; G) Except as provided in subsection (b)(3)(H), shall transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State whose specific license authorizes him to receive the device and within 30 days after transfer of a device to a specific licensee shall furnish to the Department a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific licensee in order to obtain a replacement device; H) 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 subsection (b) and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Department the manufacturer's name and model number of device transferred, the name and address of the transferee and the name and/or position of an individual who may constitute a point of contact between the Department and the transferee; or ii) Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee; I) Shall comply with the provisions of 32 Ill. Adm. Code 340.4020 and 340.4030 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of 32 Ill. Adm. Code 340 and 400. 4) The general license in subsection (b)(1) does not authorize the manufacture of devices containing radioactive material. 5) The general license provided in subsection (b)(1) is subject to the provisions of 32 Ill. Adm. Code 310.40 through 310.90, 341 and Sections 330.310, 330.400 and 330.500 of this Part. c) 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: A) Each device contains not more than 10 curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147; and B) 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 Department 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 32, revised as of January 1, 1990, exclusive of any subsequent amendments or editions. A copy of 10 CFR 32 is available for public inspection at the Department of Nuclear Safety. 2) Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in subsection (c)(1) are exempt from the requirements of 32 Ill. Adm. Code 340 and 400, except that they shall comply with the provisions of 32 Ill. Adm. Code 340.4020 and 340.4030. 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 32 Ill. Adm. Code 310.40 through 310.90, 341 and Sections 330.310, 330.400 and 330.500 of this Part. d) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Part, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material. e) Calibration and References 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 subsections (e)(4) and (5), americium-241 in the form of calibration or reference sources: A) Any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material; and B) 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 subsections (e)(4) and (5) to any person who holds a specific license issued by the Department 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 subsections (e)(4) and (5) to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material. 4) The general licenses in subsections (e)(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 32 or Section 70.39 of 10 CFR 70, revised as of January 1, 1990, or which have been manufactured in accordance with the specifications contained in a specific license issued by the Department, any Agreement State, or Licensing State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR 32 or Section 70.39 of 10 CFR 70, revised as of January 1, 1990, exclusive of subsequent amendments or additions. Licensing requirements contained in subsequent amendments or editions of 10 CFR 32 or 10 CFR 70 are not incorporated into this Part. Copies of 10 CFR 32 and 10 CFR 70 are available for public inspection at the Department of Nuclear Safety. 5) The general licenses provided in subsections (e)(1), (2) and (3) are subject to the provisions of 32 Ill. Adm. Code 310.40 through 310.90, 340, 341, 400 and Sections 330.310, 330.400 and 330.500 of this Part. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses: A) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries (185 kBq) of americium-241, 5 microcuries (185 kBq) of plutonium, or 5 microcuries (185 kBq) of radium-226 in such sources; B) Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a statement which contains the information called for in one of the following statements, 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 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 AGENCY NOTE: Showing only the name of the appropriate material. ii) The receipt, possession, use and transfer of this source, Model , Serial No. , are subject to a general license and the regulations of a Licensing State. Do not remove this label. CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. Name of Manufacturer or Importer C) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to receive the source; D) 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 E) 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. f) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing. AGENCY NOTE: The New Drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce. 1) A general license is hereby issued to any physician, veterinarian, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of subsections (f)(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: A) Carbon-14, in units not exceeding 10 microcuries (370 kBq) each. B) Cobalt-57, in units not exceeding 10 microcuries (370 kBq) each. C) Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each. D) Iodine-125, in units not exceeding 10 microcuries (370 kBq) each. E) 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. F) Iodine-131, in units not exceeding 10 microcuries (370 kBq) each. G) Iron-59, in units not exceeding 20 microcuries (740 kBq) each. H) Selenium-75, in units not exceeding 10 microcuries (370 kBq) each. 2) No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by subsection (f)(1) until he has: A) Filed Department Form KLM.006, "Certificate - In Vitro Testing with Radioactive Material Under General License", with the Department and received from the Department a validated copy of Department Form KLM.006 with certification number assigned. B) The physician, veterinarian, clinical laboratory, or hospital requesting general licensure pursuant to subsection (f)(2)(A) shall furnish on Department Form KLM.006 the following information and such other information as may be required by that form: i) Name and address of the physician, veterinarian, clinical laboratory, or hospital; ii) The location of use; and iii) A statement that the physician, veterinarian, 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 subsection (f)(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 subsection (f)(1) shall comply with the following: A) The general licensee shall not possess at any one time, pursuant to the general license in subsection (f)(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). B) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection. C) The general licensee shall use the radioactive material only for the uses authorized by subsection (f)(1). D) 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 Department, the U.S. Nuclear Regulatory Commission, any Agreement State, or Licensing State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier. E) The general licensee shall dispose of the mock iodine- 125 reference or calibration sources described in subsection (f)(1)(E) as required by 32 Ill. Adm. Code 340.3010. 4) The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to subsection (f)(1): A) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to Section 330.280(g) or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, any Agreement State, or Licensing 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 subsection (f) or its equivalent, and B) Unless one of the following statements, as appropriate, or a statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: i) This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Name of Manufacturer ii) This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State. Name of Manufacturer 5) The physician, veterinarian, clinical laboratory, or hospital possessing or using radioactive material under the general license of subsection (f)(1) shall report in writing to the Department, any changes in the information furnished by him in the "Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form KLM.006. 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 subsection (f)(1) is exempt from the requirements of 32 Ill. Adm. Code 340 and 400 with respect to radioactive material covered by that general license, except that such persons shall comply with the provisions of 32 Ill. Adm. Code 340.3010. In addition, persons using mock iodine-125 described in subsection (f)(1)(E) shall also comply with the provisions of 32 Ill. Adm. Code 340.4020 and 340.4030. g) 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 initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured or initially transferred in accordance with the specifications contained in a specific license issued by the Department or an Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR 32. 2) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in subsection (g)(1): A) 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 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 32 Ill. Adm. Code 340.3010; B) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and C) Are exempt from the requirements of 32 Ill. Adm. Code 340 and 400 except that such persons shall comply with the provisions of 32 Ill. Adm. Code 340.3010, 340.4020 and 340.4030. 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 32 Ill. Adm. Code 310.40 through 310.90, 341 and Sections 330.310, 330.400 and 330.500 of this Part. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) SUBPART C: SPECIFIC LICENSES Section 330.240 Filing Application for Specific Licenses a) Applications for specific licenses shall be filed in duplicate on forms prescribed by the Department. b) The Department 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 Department to determine whether the application should be granted or denied or whether an existing license should be modified or revoked. c) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf. d) An application may include a request for a license authorizing one or more activities. The Department will not grant the request if the proposed activities are not under the control of the same facility, administrator and radiation safety officer. In addition, when evaluating the request, the Department will consider complexity, similarity and proximity of the proposed activities. e) In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Department provided such references are clear and specific. f) Public inspection of applications and other documents submitted to the Department pursuant to this Section shall be in accordance with 2 Ill. Adm. Code 1076 and the requirements of the Freedom of Information Act (Ill. Rev. Stat. 1989, ch. 116, par. 201 et seq.). g) An application for a specific license to authorize receipt, possession, or use of radioactive material in the form of a sealed source or in a device that contains a sealed source must either: 1) Identify the sealed source or device that contains a sealed source by manufacturer and model number as filed in an evaluation sheet in the U.S. Department of Health and Human Services "Radioactive Material Reference Manual" or in the U.S. Nuclear Regulatory Commission "Registry of Radioactive Sealed Sources and Devices"; or 2) Contain the information identified in Section 330.280(m). (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.250 General Requirements for the Issuance of Specific Licenses a) A license application will be approved only if the Department determines that: 1) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this Part in such a manner as to minimize danger to public health and safety or property; 2) The applicant's proposed equipment, facilities and procedures are adequate to minimize danger to public health and safety or property; 3) The issuance of the license will not be inimical to the health and safety of the public; and 4) The applicant satisfies any applicable special requirements in Sections 330.260, 330.270, or 330.280. b) Environmental Report, Commencement of Construction. 1) In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity which the Department determines will significantly affect the quality of the environment, a license application must be reviewed and approved by the Department before commencement of construction of the plant or facility in which the activity will be conducted. Issuance of the license shall be based upon a consideration by the Department of the environmental, economic, technical and other benefits in comparison with the environmental costs and available alternatives, and a de