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Persons Possessing Accelerator-Produced or Naturally-Occurring Radioactive Material on Effective Date of This Part (Repealed) 330.400 Transfer of Material 330.500 Modification and Revocation of Licenses 330.900 Reciprocal Recognition of Licenses SUBPART D: TRANSPORTATION (Repealed) Section 330.1000 Transportation of Radioactive Materials (Repealed) 330.APPENDIX A EXEMPT CONCENTRATIONS 330.APPENDIX B EXEMPT QUANTITIES 330.APPENDIX C GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIALS (Repealed) 330.TABLE A Group I (Repealed) 330.TABLE B Group II (Repealed) 330.TABLE C Group III (Repealed) 330.TABLE D Group IV (Repealed) 330.TABLE E Group V (Repealed) 330.TABLE F Group VI (Repealed) 330.APPENDIX D LIMITS FOR BROAD LICENSES (SECTION 330.270) 330.APPENDIX E Schedule E (Repealed) 330.APPENDIX F Schedule F (Repealed) 330.APPENDIX G FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(D)) 330.APPENDIX H WORDING OF FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(E))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 determination that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values; 2) 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. c) Financial Surety Arrangements for Reclaiming Sites. For purposes of this subsection, "reclaiming" shall mean returning property to a condition or state such that the property no longer presents a public health or safety hazard or threat to the environment. 1) Unless exempted by subsection (c)(4) or (c)(5), issuance or amendment of a license shall be dependent upon satisfactory financial surety arrangements to ensure the protection of the public health and safety in the event of abandonment, default, or other inability of the licensee to meet the requirements of the Act, this Part, 32 Ill. Adm. Code: Chapter II, Subparts b and d. Self insurance, or any arrangement which essentially constitutes self insurance, will not satisfy the surety requirements since such arrangement provides no further assurance than being without insurance. Determination of satisfactory surety arrangements shall be subject to the following conditions: A) Financial surety arrangements for site reclamation may consist of surety bonds, certificates of deposit, deposits of government securities, letters of credit, insurance policies, or any combination of the above for the categories of licenses listed in subsection (c)(3). The amount of funds to be ensured by such surety arrangements shall be based on Department- approved reclaiming cost estimates for disposal of all radioactive material authorized under the license, including removal of all radioactive contamination caused by authorized material to a level in conformance with 32 Ill. Adm. Code 340.Appendix C. The Department shall consider the following in approving the cost estimate of the financial surety requirements for each individual applicant or licensee: i) The probable extent of contamination through the use or possession of radioactive material at the facility or site and the probable cost of removal of such contamination to a level in con- formance with 32 Ill. Adm. Code 340.Appendix C. This consideration shall encompass probable contaminating events associated with licensee's methods or modes of operation and shall be based on factors such as quantities, half-lives, radiation hazards and toxicities, and chemical and physical forms; ii) The extent of possible off-site property damage caused by operation of the facility or site; iii) The cost of removal and disposal of sources of radiation, which are or would be generated, stored, processed, or otherwise present at the licensed facility or site; and iv) The costs involved in reclaiming the property on which the facility or site is located, and all other properties contaminated by radioactive material authorized under the license. B) The financial surety arrangements shall be filed with and maintained by the Chief, Division of Radioactive Materials of the Department (hereafter referred to as the Division Chief) in a dollar amount greater than or equal to the amount approved by the Department and determined necessary to provide for the protection of public health and safety in accordance with subsection (c)(1)(A). i) A licensee or applicant shall submit a cost estimate for approval by the Department in accordance with subsection (c)(1)(A). ii) The licensee's surety arrangements may be reviewed annually by the Department and be adjusted to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed and any other condition affecting costs for reclaiming to ensure that sufficient surety is retained to cover liability which remains until license termination. iii) When a change in activities not requiring a license amendment would raise the cost estimate for reclaiming to an amount greater than the amount of financial surety currently filed with the Division Chief, the licensee shall, within sixty (60) days after the increase, file additional financial surety at least equal to this increase. iv) When a license amendment would raise the cost estimate for reclaiming to an amount greater than the amount of financial surety currently filed with the Division Chief, the amendment shall not be issued until the required surety arrangements are established. v) When the current reclaiming cost estimate decreases, upon the written request of the licensee, and provided that the decrease is verified by the Division Chief, the Division Chief shall reduce the amount of financial surety required for the facility to the amount of the current reclaiming cost estimate. Upon such occurrence, the Division Chief shall, considering the financial surety arrangements on file, either cause to be released to the licensee collateral which has been deposited equal to this reduction or allow the licensee to substitute for the arrangements on file new arrangements in the reduced amount. vi) The term of the surety arrangement shall be for the period from issuance of the license until termination of the license by the Department in accordance with Section 330.320. vii) Upon termination of the license, the Division Chief will release all surety amounts not previously forfeited by the licensee. C) The Director: i) May order that any financial surety filed by a licensee pursuant to subsection (c) be forfeited to the State if the Director determines that the licensee has failed to perform reclaiming to assure health and safety from radiation hazards and comply with other license requirements or orders pertaining to reclaiming. Such forfeiture action shall follow the procedures provided in 32 Ill. Adm. Code 200. ii) Shall, upon the date of issuance of the final order described in subsection (c)(1)(C)(i), notify the Attorney General who shall collect the forfeiture if voluntary payment is not made within thirty (30) days of the date of issuance of the final order. iii) Shall deposit all funds from forfeited financial sureties in a temporary, locally-held trust fund to be administered by the Department for site reclaiming. D) The licensee or applicant must choose from the financial surety arrangements specified in Appendix G of this Part. E) The wording of the financial surety may be identical to the wording of the corresponding arrangement in Appendix H of this Part and must contain provisions described in Appendix G of this Part. F) Use of Multiple Financial Surety Arrangements. The licensee or applicant may utilize more than one financial surety arrangement per facility to satisfy the requirement specified in subsection (c)(1). These arrangements are limited to bonds supported by letters of credit, insurance and securities. The arrangement must be as specified in Appendix G of this Part, except that it is the combination of arrangements, rather than the single arrangement, which must provide financial surety for the necessary amount. G) Use of Financial Surety Arrangement for Multiple Facilities and/or Multiple Licensees at a Facility. The licensee or applicant may use a financial surety arrangement specified in Appendix G of this Part to meet the requirements of subsection (c)(1) for more than one license he holds, or more than one facility he owns, or operates in Illinois. The arrangement submitted to the Division Chief shall include a list indicating, for each facility, the license number(s), name(s), address(es) and amount(s) of funds for reclaiming assured by the arrangement. The amount of funds available through the arrangement shall not be less than the sum of the sureties that would be available if a separate arrangement had been filed and maintained for each license or facility. If more than one license exists for a facility, the amount of funds for each license shall be specified. H) Substitution of Alternate Financial Surety Arrangements. The licensee may substitute alternate financial surety arrangements specified in Appendix G of this Part meeting the requirements of subsection (c)(1) for the financial surety already filed with the Department for the facility. However, the existing arrangements shall not be released by the Division Chief until the substitute financial surety arrangements have been received and approved. I) Any applicant or licensee who fulfills the requirements of subsection (c)(1) by obtaining a surety bond, letter of credit, or insurance policy, will be deemed to be without the required financial surety in the event of bankruptcy of the issuing institution, or a suspension, or revocation of the authority of the institution issuing the surety bond, letter of credit, or insurance policy to issue such instruments. The applicant or licensee must establish other Department-approved financial surety within thirty (30) days after such an event. 2) The arrangements required in subsection (c)(1) shall be established prior to issuance or amendment of the license to assure that sufficient funds will be available for reclaiming; 3) The following specific licensees are required to make financial surety arrangements: A) Major processors as defined in 32 Ill. Adm. Code 310.20; B) Waste handling licensees as defined in 32 Ill. Adm. Code 310.20; C) Wet source storage irradiators; D) Ore processors which produce source material tailings or sludge; E) Possessors of source material tailings or sludge; F) Persons who use particle accelerators to manufacture radionuclides for distribution to other licensees or customers; G) Former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission licensed facilities that were licensed pursuant to 10 CFR 50, exclusive of subsequent amendments or additions unless exempted by subsection (c)(4). 4) The following persons are exempt from the requirements of subsection (c)(1): A) All State, local, or other government agencies, unless they are subject to subsection (c)(3)(A) or (c)(3)(B); AGENCY NOTE: For purposes of subsection (c), "government agencies" shall not include federal or state contractors, non-governmental recipients of government grants, or non-governmental medical institutions. B) All educational institutions; and AGENCY NOTE: An educational institution is a non- profit organization which has as its primary purpose the advancement of knowledge in one or more specific fields and which is accredited by the North Central Association of Colleges and Schools. C) Persons authorized to possess only those radioactive materials with half-lives of sixty-five (65) days or less. 5) Unless also described in subsection (c)(3), the following persons are exempt from the requirements of subsection (c)(1): A) Persons licensed to manufacture or possess, but not distribute, radioactive material for medical purposes, including veterinary medicine; B) Persons licensed to perform industrial radiography; C) Persons licensed to perform wireline service operations and subsurface tracer studies; D) Persons licensed to distribute radiopharmaceuticals, generators, or reagent kits as a nuclear pharmacy; E) Persons licensed to distribute, without processing, radioactive material or products containing radioactive material; F) Persons licensed to possess irradiators, other than wet source storage irradiators; G) Persons licensed to possess source material (depleted uranium) for shielding purposes; H) Persons licensed to possess radioactive material for use in analytical instruments; and I) Persons licensed to possess radioactive material in gauges or other measuring systems. d) Long-Term Care Requirements. 1) A license application will be approved only if the Department determines that a long-term care fund for monitoring and maintenance has been established by the waste handling licensee prior to the issuance of the license; or 2) The waste handling applicants may choose, at the time of the licensure, to provide a financial surety arrangement in lieu of a long-term care fund. AGENCY NOTE: Long-term care funding may also be required for former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission licensed facilities, or persons whose activities cause situations that significantly affect the public health and safety, or the environment by reason of exposure to radiation or radioactive materials. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.260 Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials a) Specific Licenses to Institutions for Human Use of Radioactive Material. A specific license for human use of radioactive material in institutions shall be issued only if the applicant has met the requirements of 32 Ill. Adm. Code 335 and the requirements set forth in Section 330.250. b) Specific Licenses to Individual Physicians for Human Use of Radioactive Material. An application by an individual physician or group of physicians for a specific license for human use of radioactive material shall be approved only if: 1) The applicant satisfies the general requirements specified in Section 330.250; 2) The application is for use in the applicant's practice in an office outside a medical institution; and 3) The applicant has met the requirements of 32 Ill. Adm. Code 335. c) Specific Licenses for Pharmacies Using Radioactive Material. In addition to the requirements set forth in Section 330.250, a specific license for a pharmacy shall meet the following additional requirements: 1) Radiopharmaceuticals dispensed and/or distributed for human use shall be either: A) Repackaged from prepared radiopharmaceuticals i) that are the subject of a U.S. Food and Drug Administration (FDA) approved "New Drug Application" (NDA), or ii) for which the FDA has accepted an "Investigational New Drug Application" (IND), or B) Prepared from generators and reagent kits that are the subject of an FDA-approved NDA or for which the FDA has accepted an IND. 2) Prepared radiopharmaceuticals for which FDA has accepted an IND and radiopharmaceuticals prepared from generators or reagent kits for which the FDA has accepted an IND shall be dispensed and/or distributed: A) In accordance with the directions provided by the sponsor of the IND, and B) Only to physicians who have been accepted by the sponsor of the IND to participate in clinical evaluation of the drug. 3) The licensee shall inform in writing each physician who participates in an IND evaluation that the physician is responsible to the sponsor of the IND for use of the drug in accordance with protocols established by the sponsor and for reporting to the sponsor the clinical information obtained through use of the drug. 4) The licensee shall procure biological products labeled with radionuclides or kits used to prepare such products from a supplier who holds an unsuspended or unrevoked license issued by either the U.S. Department of Health, Education and Welfare or the U.S. Department of Health and Human Services to propagate, manufacture, prepare, label, or distribute the products. 5) The licensee shall perform radiometric tests for molybdenum breakthrough upon each elution of a molybdenum-99/tech- netium-99m generator in accordance with the requirements of 32 Ill. Adm. Code 335.4020. 6) The licensee shall procure all radioactive drugs from a supplier who manufactures or repackages the product under appropriate pharmaceutical controls related to assay, identity, quality, purity, sterility and non-pyrogenicity. 7) The licensee shall dispense radioactive drugs only under the prescription of a specifically licensed physician who is authorized to possess and use the radioactive drugs or of a physician authorized under the provisions of a broad radioactive material license. The licensee shall maintain a copy of the radioactive material license of each customer physician and shall verify that the physician is authorized to receive the prescribed radiopharmaceutical prior to transferring the radiopharmaceutical. 8) The licensee may distribute in vitro test kits to customers but shall neither remove any package insert nor violate the packaging. 9) The licensee shall subject each batch of sulfur colloid to microscopic tests for particle size and chromatographic tests for free pertechnetate, and shall maintain records of such tests for inspection by the Department. Preparations which contain particles one micron or larger in diameter, have more than 10% free pertechnetate, or appear flocculent or aggregated shall not be dispensed to customers. 10) The licensee shall report to the Department, within ten days of occurrence, any irregularities pertaining to identifica- tion, labeling, quality, or assay of any radioactive drug received under the authority of this license. d) Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in Section 330.250, a specific license for use of sealed sources in industrial radiography will be issued if: 1) The applicant will have an adequate program for training radiographers and radiographer's assistants and submits to the Department a schedule or description of such program which specifies the: A) Initial training; B) Periodic training; C) On-the-job training; D) Means to be used by the licensee to determine the radiographer's knowledge and understanding of and ability to comply with the conditions of the license, the provisions of this Part and 32 Ill. Adm. Code 310, 320, 340, 341, 350 and 400 and the operating and emergency procedures of the applicant; and E) Means to be used by the licensee to determine the radiographer's assistants' knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant. 2) The applicant has established and submits to the Department satisfactory written operating and emergency procedures described in 32 Ill. Adm. Code 350.2020; 3) The applicant will have an internal inspection system to assure that the requirements of 32 Ill. Adm. Code 310, 320, 340, 341, 350, 400 and this Part, license provisions, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants; the inspection system shall include the performance of internal inspections at intervals not to exceed 3 months and the retention of records of such inspections for 2 years. The inspection records shall contain the date, name of the person performing the inspection, inspection findings and a description of any corrective action taken; 4) The applicant submits to the Department a description of the overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program; 5) The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the Department a description of such procedures, including: A) Instrumentation to be used; B) Method of performing tests; and C) Pertinent experience of the individual who will perform the test; 6) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.270 Special Requirements for Specific Licenses of Broad Scope This Section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of such licenses. 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) 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 Appendix D of this Part, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Appendix D, 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 Appendix D, 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 Appendix D of this Part, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Appendix D, 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 Appendix D, Column II, for that radionuclide. The sum of the ratios for all radio- nuclides 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 Section 330.250; 2) The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and 3) 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: A) 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; B) 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 C) 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, 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 subsection (b)(3)(C)(ii) prior to 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 Section 330.250; and 2) 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: A) 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 B) 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, 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 subsection (c)(2)(B)(ii) prior to 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 Section 330.250; 2) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received: A) A college degree at the bachelor level, or equivalent training and experience, in the physical, or biological sciences, or in engineering; and B) 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 pertinent to the type and forms of radioactive material to be used; and 3) 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 licenses of broad scope are subject to the following conditions: 1) Unless specifically authorized, persons licensed pursuant to this Section shall not: A) Conduct tracer studies in the environment involving direct release of radioactive material; B) 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; C) Conduct activities for which a specific license issued by the Department under Sections 330.260 or 330.280 is required; or D) 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 this Part 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 this Part 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 this Part 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 subsection (d). (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.280 Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material a) Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations. 1) In addition to the requirements set forth in Section 330.250, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the radioactive material to persons exempted from this Part pursuant to Sections 330.30 or 330.40(a) will be issued if: A) The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and B) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Appendix A of this Part, that reconcentration of the radioactive material in concentrations exceeding those in Appendix A is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being. 2) Each person licensed under subsection (a) is required to maintain records of transfer of material and shall file a report with the Department which shall identify the following: A) Type and quantity of each product or material into which radioactive material has been introduced during the reporting period; B) Name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; C) The type and quantity of radionuclide introduced into each product or material; and D) The initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. 3) The licensee shall file the report within 30 days following: A) Five years after filing the preceding report; or B) Filing an application for renewal of the license under Section 330.330; or C) Notifying the Department under Section 330.310(d) of the licensee's decision to permanently discontinue activities authorized under the license issued under subsection (a). 4) The report must cover the period between the filing of the preceding report and the occurrence specified in subsection (3) (A), (B) and (C) of this Section. If no transfers of radioactive material have been made under subsection (a) during the reporting period, the report shall so indicate. 5) The licensee shall maintain the record of a transfer for a period of one year after the event has been included in a report to the Department. b) Licensing the Distribution of Radioactive Material in Exempt Quantities. 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. 1) An application for a specific license to distribute NARM to persons exempted from this Part pursuant to Section 330.40(b) will be approved if: A) 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; B) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and C) The applicant submits copies of prototype labels and brochures and the Department approves such labels and brochures. 2) The license issued under subsection (b)(1) is subject to the following conditions: A) No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided the sum of the fractions shall not exceed unity. B) Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to Section 330.40(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 uSv) per hour. C) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which: i) Identifies the radionuclide and the quantity of radioactivity, and ii) Bears the words "Radioactive Material". D) In addition to the labeling information required by subsection (b)(2)(C), the label affixed to the immediate container, or an accompanying brochure, shall: i) State that the contents are exempt from Licensing 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 subsection (b) is required to maintain records and file reports as follows: A) Records of transfer of material identifying, by name and address, each person to whom radioactive material is transferred for use under Section 330.40(b) or the equivalent regulations of an Agreement State, or Licensing State and stating the kinds and quantities of radioactive material transferred. The licensee shall maintain the record of a transfer for a period of one year after the event is included in a summary report to the Department. B) The licensee shall file a summary report stating the total quantity of each radioisotope transferred under the specific license with the Department. C) The licensee shall file the summary report within 30 days following: i) Five years after filing the preceding report; or ii) Filing an application for renewal of the license under Section 330.330; or iii) Notifying the Department under Section 330.310(a) of the licensee's decision to permanently discontinue activities authorized under the license issued under subsection (b). D) The report must cover the period between the filing of the preceding report and the occurrences specified in subsections (C)(i), (ii), or (iii) of this Section. If no transfers of radioactive material have been made under subsection (b) during the reporting period, the report must so indicate. c) Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under Section 330.40(c)(3) will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR 32, revised as of January 1, 1990. The maximum quantity of radium-226 in each device shall not exceed 0.1 microcurie (3.7 kBq). AGENCY NOTE: Licensing requirements contained in subsequent amendments or editions of 10 CFR 32 are not incorporated into this Part. A copy of 10 CFR 32 is available for public inspection at the Department of Nuclear Safety. d) Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed Under Section 330.220(b). 1) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under Section 330.220(b) or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State will be approved if: A) The applicant satisfies the general requirements of Section 330.250; B) 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 1 calendar quarter a dose in excess of 10 percent of the limits specified in the table in 32 Ill. Adm. Code 340.2010(a); 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: Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye ............. 15 rems (150 mSv) Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter ........................ 200 rems (2 Sv) Other organs ................ 50 rems (500 mSv); and C) Each device bears a durable, legible, clearly visible label or labels approved by the Department, 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 one of the following statements, as appropriate, in the same or substantially similar form: Devices Containing Radioactive Material Other Than Naturally Occurring Radioactive Material The receipt, possession, use and transfer of this device, Model , Serial No. , are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION - RADIOACTIVE MATERIAL Name of Manufacturer or Distributor AGENCY NOTE: The model, serial number and name of the manufacturer, or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. Devices Containing Naturally-Occurring Radioactive Material The receipt, possession, use and transfer of this device, Model , Serial No. , are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION - RADIOACTIVE MATERIAL Name of Manufacturer or Distributor AGENCY NOTE: The model, serial number and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. 2) In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider information which includes, but is not limited to: A) Primary containment or source capsule; B) Protection of primary containment; C) Method of sealing containment; D) Containment construction materials; E) Form of contained radioactive material; F) Maximum temperature withstood during prototype tests; G) Maximum pressure withstood during prototype tests; H) Maximum quantity of contained radioactive material; I) Radiotoxicity of contained radioactive material; and J) Operating experience with identical devices or similarly designed and constructed devices. 3) In the event the applicant desires that the general licensee under Section 330.220(b) or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the limits specified in the table in 32 Ill. Adm. Code 340.2010(a). 4) Each person licensed under subsection (d) to distribute devices to generally licensed persons shall: A) Furnish a copy of the general license contained in Section 330.220(b) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in Section 330.220(b); B) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's, Agreement State's, or Licensing State's regulation equivalent to Section 330.220 (b), or alternatively, furnish a copy of the general license contained in Section 330.220(b) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the Agreement State, or the Licensing State. If a copy of the general license in Section 330.220(b) is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State under requirements substantially the same as those in Section 330.220(b); C) Report to the Department all transfers of such devices to persons for use under the general license in Section 330.220(b). 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 Department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact and relationship to the intended user. If no transfers have been made to persons generally licensed under Section 330.220(b) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter; D) Furnish reports to other agencies. 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 31. ii) Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to subsection (d) for use under a general license in that State's regulations equivalent to Section 330.220(b). iii) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person. iv) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission. v) If no transfers have been made to general licensees within a particular State during the reporting period, this information shall be reported to the responsible State agency upon request of that agency; and E) Keep records showing the name, address and the point of contact for each general licensee to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in Section 330.220(b), or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subsection (d)(4). The records required by this paragraph shall be maintained for a period of five years from the date of the recorded event. e) Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. 1) An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under Section 330.220(c) will be approved if: A) The applicant satisfies the general requirements specified in Section 330.250; and B) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 32.101 of 10 CFR 32, revised as of January 1, 1990, exclusive of subsequent amendments or editions, or their equivalent. A copy of 10 CFR 32 is available for public inspection at the Department of Nuclear Safety. 2) Each person licensed under this subsection shall file an annual report with the Department which shall state the total quantity of tritium or promethium-147 transferred to persons generally licensed under Section 330.220(c) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The report shall identify each general licensee by name and address, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report shall cover the year ending June 30 and shall be filed within thirty (30) days thereafter. f) Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium, or Radium-226 for Distribution to Persons Generally Licensed Under Section 330.220(e). An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium, or radium-226 for distribution to persons generally licensed under Section 330.220(e) will be approved if: 1) The applicant satisfies the general requirements of Section 330.250; and 2) The applicant satisfies the requirements of 10 CFR 32.57, 10 CFR 70.39 and certifies that he will satisfy, and subsequently satisfies, the requirements of 10 CFR 32.58, 10 CFR 32.59 and 10 CFR 32.102, revised as of January 1, 1990, exclusive of subsequent amendments or editions. 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 Section 330.220(f), or equivalent regulations of an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission, will be approved if: 1) The applicant satisfies the general requirements specified in Section 330.250. 2) The radioactive material is to be prepared for distribution in prepackaged units of: 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 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. 3) Each prepackaged unit bears a durable, clearly visible label: A) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 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 B) Displaying the radiation caution symbol described in 32 Ill. Adm. Code 340.2030(a)(1) and the words, "CAUTION - RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals". 4) One of the following statements, 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: A) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Name of Manufacturer B) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State. Name of Manufacturer 5) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains information about the precautions to be followed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the manufacturer shall state in the directions that this item shall be disposed of in compliance with 32 Ill. Adm. Code 340.3010. h) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under Section 330.220(g) will be approved if: 1) The applicant satisfies the general requirements of Section 330.250; and 2) The criteria of Section 32.61, 32.62, and 32.103 of 10 CFR 32, as in effect January 1, 1990, exclusive of subsequent amendments or editions, are met. AGENCY NOTE: A copy of 10 CFR 32 is available for public inspection at the Department. i) Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Specific Licenses. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to Section 330.260(a) for the uses listed in 32 Ill Adm. Code 335.3010, 335.4010, or 335.5010 will be approved if: 1) The applicant satisfies the general requirements specified in Section 330.250; 2) The applicant submits information showing that: A) The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a New Drug Application (NDA) approved by the Food and Drug Administration (FDA), or an "Investigational New Drug Application" (IND) that has been accepted by the FDA; or B) The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; 3) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by specific licensees; and 4) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the Department for distribution to persons licensed pursuant to Section 330.260(a) for radioactive material specified in 32 Ill. Adm. Code 335.3010, 335.4010, or 335.5010, as appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The labels, leaflets, or brochures required by this subsection are in addition to the labeling required by the Food and Drug Administration (FDA) and may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. j) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material. AGENCY NOTE: Although the Department does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have such reagent kits approved by the Department for use by persons licensed pursuant to Section 330.260(a) for generators or reagent kits specified in 32 Ill. Adm. Code 335.4010 may submit the pertinent information specified in this subsection. An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to Section 330.260(a) for the uses specified in 32 Ill. Adm. Code 335.4010 will be approved if: 1) The applicant satisfies the general requirements specified in Section 330.250; 2) The applicant submits evidence that: A) The generator or reagent kit is to be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a New Drug Application (NDA) approved by the Food and Drug Administration (FDA), or an "Investigational New Drug Application" (IND) that has been accepted by the FDA, or B) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; 3) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit; 4) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity and date of assay; and 5) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains: A) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and B) A statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the Department pursuant to Section 330.260(a) and 32 Ill. Adm. Code 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The labels, leaflets, or brochures required by this subsection are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. k) 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 Section 330.260 (a) for use as a calibration or reference source or for the uses listed in 32 Ill. Adm. Code 335.7010 will be approved if: 1) The applicant satisfies the general requirements in Section 330.250; 2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: A) The radioactive material contained, its chemical and physical form, and amount; B) Details of design and construction of the source or device; C) 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; D) For devices containing radioactive material, the radiation profile of a prototype device; E) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; F) Procedures and standards for calibrating sources and devices; G) Legend and methods for labeling sources and devices as to their radioactive content; and H) 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; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label; 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 Department for distribution to persons licensed pursuant to Section 330.260(a) and 32 Ill. Adm. Code 335.7010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, provided, that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source; 4) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and 5) In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to: A) Primary containment or source capsule; B) Protection of primary containment; C) Method of sealing containment; D) Containment construction materials; E) Form of contained radioactive material; F) Maximum temperature withstood during prototype tests; G) Maximum pressure withstood during prototype tests; H) Maximum quantity of contained radioactive material; I) Radiotoxicity of contained radioactive material; and J) Operating experience with identical sources or devices or similarly designed and constructed sources or devices. l) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to Section 330.210(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if: 1) The applicant satisfies the general requirements specified in Section 330.250. 2) The applicant submits sufficient information relating to the design (including blueprints), manufacture (construction materials and methods), prototype testing (description of testing that will be done and the acceptance criteria), quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to assure that possession, use, or transfer of the depleted uranium in the product or device will not cause any individual to receive in any period of 1 calendar quarter a radiation dose in excess of 10 percent of the limits specified in 32 Ill. Adm. Code 340.1010(a). 3) The applicant submits information assuring that the presence of depleted uranium for a mass-volume application in the product or device will provide a unique benefits to the public, i.e., a benefit which could not be achieved but for the use of depleted uranium. The applicant's methods for use and handling of the product or device will not result in uncontrolled disposal or dispersal of depleted uranium into the environment. 4) The Department will deny any application for a specific license under this subsection if the end use(s) of the industrial product or device cannot be reasonably foreseen. 5) Each person licensed pursuant to subsection (l)(1) shall: A) 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; B) 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 the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State; C) 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"; D) Furnish: i) A copy of the general license contained in Section 330.210(d) and a copy of the 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 Section 330.210(d); or ii) A copy of the general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to Section 330.210(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 Section 330.210(d) and a copy of the 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 Section 330.210(d); E) Report to the Department all transfers of industrial products or devices to persons for use under the general license in Section 330.210(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 Department 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 thirty (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 Section 330.210(d) during the reporting period, the report shall so indicate; F) File a report which identifies each general licensee by name and address, an individual by name and/or position who constitutes 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 thirty (30) days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. The licensee shall report: i) To the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 40.25 of 10 CFR 40; ii) To the responsible State agency all transfers of devices manufactured and distributed pursuant to subsection (l) for use under a general license in that State's regulations equivalent to Section 330.210(d); iii) To the U.S. Nuclear Regulatory Commission if no transfers have been made by the licensees during the reporting period; iv) To the responsible Agreement State Agency upon the request of that Agency if no transfers have been made to general licensees within a particular Agreement State during the reporting period; and G) 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 Section 330.210(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred and compliance with the report requirements of this Section. m) Special Requirements for License to Manufacture, Import, or Initially Distribute Sealed Sources or Devices Containing Sealed Sources to Persons having a Specific License. 1) An application for license to manufacture, import, or initially distribute sealed sources or devices containing sealed sources for initial transfer to persons having a specific license to receive such sealed sources or devices will be approved subject to the following conditions: A) The applicant satisfies the general requirements specified in Section 330.250; B) The licensee subject to this subsection shall not transfer a sealed source or device containing a sealed source to any person except in accordance with the requirements of Section 330.400. 2) Any manufacturer, importer, or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the Department for evaluation of radiation safety information about its product and for filing 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". A) A request for evaluation of a sealed source or device containing a sealed source must be submitted in duplicate and shall include information required by subsections (m)(2)(B) or (C), as applicable, demonstrating that the radiation safety properties of such source or device will not endanger public health and safety or property. B) A request for evaluation of a sealed source must include the following radiation safety information: i) Proposed uses for the sealed source; ii) Chemical and physical form and maximum quantity of radioactive material in the sealed source; iii) Details of design of the sealed source, radiation and its shielding including blueprints, engineering drawings or annotated drawings; iv) Details of construction of the sealed source including a description of materials used in construction; v) Radiation profile of a prototype sealed source; vi) Procedures for and results of prototype testing; vii) Details of quality control procedures to be followed in manufacture; viii) A description or facsimile of labeling to be affixed to the sealed source; ix) Leak testing procedures; and x) Any additional information, including experimental studies and tests, required by the Department to facilitate a determination of the safety of the sealed source, as required by Section 330.250. C) A request for evaluation of a device containing a sealed source must include the following radiation safety information: i) Proposed uses for the device; ii) Manufacturer, model number, chemical and physical form and maximum quantity of radioactivity in the sealed source or sources to be used in the device; iii) Details of design of the sealed source, including blueprints, engineering drawings or annotated drawings; iv) Details of construction of the sealed source including a description of materials used in construction; v) Radiation profile of a prototype device; vi) Procedures for and results of prototype testing; vii) Details of quality control procedures to be followed in manufacture; viii) A description or facsimile of labeling to be affixed to the device; ix) Leak testing procedures; x) A description of potential hazards in installation, service, maintenance, handling, use and operation of the device; xi) Information about installation, service and maintenance procedures; xii) Handling, operating and safety instructions; and xiii) Any additional information, including experimental studies and tests, required by the Department to facilitate a determination of the safety of the device as required by Section 330.250. D) When evaluating a sealed source or device, the Department will apply the radiation safety criteria described in subsection 32.210(d) of 10 CFR 32, revised as of January 1, 1990, exclusive of subsequent amendments or editions. A copy of 10 CFR 32 is available for public inspection at the Department. E) The person submitting a request for evaluation of a product shall manufacture and distribute the product in accordance with: i) The statements and representations, including the quality control program, described in the request; and ii) The provisions of the evaluation sheet prepared by the Department and submitted to the U.S. Department of Health and Human Services, for filing in the "Radioactive Material Reference Manual" or in the U.S. Nuclear Regulatory Commission, for filing in the "Registry of Radioactive Sealed Sources and Devices". n) Manufacture and Distribution of Radioactive Material for Medical Use Under General License. A specific license authorizing the distribution of radioactive material for diagnostic medical use by a physician under a general license shall be issued only if the applicant for the specific license satisfies the requirements of Section 330.250 and: 1) The applicant submits evidence that the radioactive material is to be manufactured, labeled, and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration, has approved, or in accordance with a license for a biologic product issued by the Secretary, U.S. Department of Health and Human Services; and 2) One of the following statements, as appropriate, or a statement which contains the information called for in one of the following statements, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package: A) This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use, and transfer are subject to the regulations and a general license or its equivalent of the U.S. Nuclear Regulatory Commission, or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority. Name of Manufacturer B) This radioactive drug may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use, and transfer are subject to the regulations and a general license or its equivalent of a Licensing State. Name of Manufacturer (Source: Amended at 15 Ill. Reg.10632, effective July 15, 1991) Section 330.300 Issuance of Specific Licenses a) Upon a determination that an application meets the requirements of the Act and the regulations of the Department, the Department will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary. b) The Department may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this Part as it deems appropriate or 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 may be appropriate or necessary; and 3) prevent loss or theft of material subject to this Part. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.310 Specific Terms and Conditions of License a) Each license issued pursuant to this Part shall be subject to all applicable provisions, of the Radiation Protection Act of 1990 (The Act) (Ill. Rev. Stat. 1990 Supp., ch. 111«, par. 210-1 et seq.), now or hereafter in effect, and to all applicable rules, regulations, and orders of the Department. b) No license issued or granted under this Part and no right to possess or utilize radioactive material granted by any license issued pursuant to this Part 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 Department shall, after securing full information find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing. c) Each person licensed by the Department pursuant to this Part shall confine use and possession of the material licensed to the locations and purposes authorized in the license. d) Each licensee shall notify the Department in writing prior to commencing activities to reclaim the licensed facility. e) Notification of Bankruptcy. 1) Each licensee shall notify the Department, 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; A) The licensee; B) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or C) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee. 2) This notification must indicate: A) The bankruptcy court in which the petition for bankruptcy was filed; and B) The date of the filing of the petition. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.320 Expiration and Termination of Licenses a) Except as provided in Section 330.330(b), the authority to engage in licensed activities as specified in the specific license shall expire at the end of the specified day in the month and year stated therein. Any expiration date on a specific license applies only to the authority to engage in licensed activities. Expiration of a specific license shall not relieve the licensee of responsibility for decommissioning his facility and terminating the specific license. b) Each licensee shall notify the Department immediately, in writing, and request termination of the license when the licensee decides to terminate all activities involving radioactive materials authorized under the license. This notification and request for termination shall include the documents required by subsection (d) and shall otherwise substantiate that the licensee has met all of the requirements in subsection (d). c) No less than 30 days before the expiration date specified in the license, the licensee shall either: 1) submit an application for license renewal under Section 330.330; or 2) notify the Department, in writing, if the licensee decides not to renew the license. The licensee requesting termination of a license shall comply with the requirements of subsection (d). d) Termination of Licenses. 1) If a licensee does not submit an application for license renewal under Section 330.330, the licensee shall, on or before the expiration date specified in the license: A) terminate use of radioactive material; B) remove radioactive contamination to the level outlined in 32 Ill. Adm. Code 340.Appendix C, to the extent practicable; C) properly dispose of radioactive material; D) submit a completed Department Form KLM.007; and E) submit a radiation survey report to confirm the absence of radioactive materials or to establish the levels of residual radioactive contamination, unless the licensee demonstrates the absence of residual radioactive contamination in some other manner. The licensee shall, as applicable: i) report levels of radiation in units of microrads per hour of beta and gamma radiation at 1 centi- meter and gamma radiation at 1 meter from sur- faces and report levels of radioactivity in units of transformations per minute (or micro- curies) per 100 square centimeters removable and fixed on surfaces; microcuries per milliliter in water, and picocuries per gram in contaminated solids such as soils or concrete; and ii) specify the instrumentation used and certify that each instrument was properly calibrated and tested. 2) If no residual radioactive contamination attributable to activities conducted under the license is detected, the licensee shall submit a certification that no detectable radioactive contamination was found. The Department will notify the licensee, in writing, of the termination of the license. 3) If detectable levels or residual radioactive contamination attributable to activities conducted under the license are found: A) the license continues in effect beyond the expiration date, if necessary, with respect to possession of residual radioactive material present as contamination until the Department notifies the licensee in writing that the license is terminated. During this time the licensee is subject to the provisions of subsection (e). B) in addition to the information submitted under subsections (d)(1)(D) and (E), the licensee shall submit a plan for decontamination, if required, as regards residual radioactive contamination remaining at the time the license expires. e) Each licensee who possesses residual radioactive material under subsection (d)(3), following the expiration date specified in the license, shall: 1) limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and 2) continue to control entry to restricted areas until they are suitable for release for unrestricted use and the Department notifies the licensee in writing that the license is terminated. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.330 Renewal of Licenses a) Applications for renewal of specific licenses shall be filed in accordance with Section 330.240. b) In any case in which a licensee, not less than 30 days prior to 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 final action has been taken by the Department. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.340 Amendment of Licenses at Request of Licensee Applications for amendment of a license shall be filed in accordance with Section 330.240 and shall specify the purpose for which the licensee desires the license to be amended and the grounds for such amendment. The Department shall not issue amendments to licenses that were issued before June 1, 1987, for naturally occurring or accelerator produced radioactive material to authorize use, possession, or receipt of source, byproduct, or special nuclear material. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.350 Department Action on Application to Renew and Amend In considering an application by a licensee to renew or amend the license, the Department will apply the criteria set forth in Sections 330.250, 330.260, 330.270 or 330.280 as applicable. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 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 Any person who, on the effective date of this Part, possesses a general or specific license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the U.S. Nuclear Regulatory Commission, shall be deemed to possess a like license issued under this Part and the Act. Such license shall expire on the date of expiration specified in the U.S. Nuclear Regulatory Commission license. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.370 Persons Possessing Accelerator-Produced or Naturally- Occurring Radioactive Material on Effective Date of This Part (Repealed) (Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.400 Transfer of Material a) No licensee shall transfer radioactive material except as authorized pursuant to this Section. b) Except as otherwise provided in his license and subject to the provisions of subsections (c) and (d), any licensee may transfer radioactive material: 1) To the Department; AGENCY NOTE: A licensee may transfer material to the Department only after receiving prior approval from the Department. 2) To the U.S. Department of Energy; 3) To any person exempt from the regulations in this Part to the extent permitted under such exemption; 4) To any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or any Licensing State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Department, an Agreement State, or a Licensing State; or 5) As otherwise authorized by the Department in writing. c) Before transferring radioactive material to a specific licensee of the Department, or to a general licensee who is required to register with the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing 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) Any of the following methods for the verification required by subsection (c) is acceptable: 1) The transferor may possess a current copy of the transferee's specific license or registration certificate authorizing the transferee to receive the type, form and quantity of radioactive material to be transferred; 2) The transferor may possess 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 10 days; 4) The transferor may obtain other information compiled by a reporting service from official records of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State regarding the identity of licensees and the scope and expiration dates of licenses and registration; or 5) When none of the methods of verification described in subsections (d)(1) through (4) are 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 Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State that the transferee is licensed to receive the radioactive material. e) Shipment and transport of radioactive material shall be in accordance with the provisions of 32 Ill. Adm. Code 341. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.500 Modification and Revocation 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, regulations, and orders issued by the Department in accordance with 32 Ill. Adm. Code 200. b) In accordance with 32 Ill. Adm. Code 200, 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 because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Department 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, or of the license, or of any rule, regulation, or order of the Department. c) Except in cases of willfulness or those in which the public health, interest, or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements. (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.900 Reciprocal Recognition of Licenses a) Licenses of Byproduct, Source, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass. 1) Subject to this Part, any person who holds a specific license from the U.S. Nuclear Regulatory Commission or an Agreement 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 for a period not in excess of 180 days in any 12 month period, provided that: A) A current copy of the licensing document is on file with the Department and the activities authorized by such document are not limited to specified installations or locations; B) The out-of-state licensee notifies the Department by telephone, telegraph, or letter prior to engaging in such activities. Such notification shall indicate the location, period, and type of proposed possession and use within the State. If initial notification was by telephone, the out-of-state licensee shall submit to the Department within ten (10) days following such telephone notification a telegram or letter which contains the above information. Upon receipt from the out-of-state licensee of a written request which contains a schedule of activities to be conducted within Illinois, the Department will waive the requirement for additional notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in subsection (a)(1); C) The out-of-state licensee complies with 32 Ill. Adm. Code: Chapter II and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with 32 Ill. Adm. Code: Chapter II; D) The out-of-state licensee supplies such other information as the Department may request; and E) The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subsection (a)(1) except by transfer to a person: i) Specifically licensed by the Department or by the U.S. Nuclear Regulatory Commission to receive such material, or ii) Exempt from the requirements for a license for such material under Section 330.40(a). 2) Notwithstanding the provisions of subsection (a)(1), 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 Section 330.220(b)(1) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this State provided that: A) Such person shall file a report with the Department within thirty (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 device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device; B) 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; C) Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and D) The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in Section 330.220(b) or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device. 3) The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by a Licensing State, or any product distributed pursuant to such licensing document, if the Department determines that had the individual been licensed in Illinois by the Department, the license would have been subject to action under Section 330.500 or 32 Ill. Adm. Code 310.90. b) Licenses of Naturally Occurring and Accelerator-Produced Radioactive Material. 1) Subject to this Part, any person who holds a specific license from a Licensing 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 for a period not in excess of 180 days in any 12 month period, provided that: A) A current copy of the licensing document is on file with the Department and the activities authorized by such document are not limited to specified installations or locations; B) The out-of-state licensee notifies the Department by telephone, telegraph, or letter prior to engaging in such activities. Such notification shall indicate the location, period, and type of proposed possession and use within the State. If initial notification was by telephone, the out-of-state licensee shall submit to the Department within ten (10) days following such telephone notification a telegram or letter which contains the above information. Upon receipt from the out-of-state licensee of a written request which contains a schedule of activities to be conducted within Illinois, the Department will waive the requirement for additional notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in subsection (a)(1); C) The out-of-state licensee complies with 32 Ill. Adm. Code: Chapter II and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with 32 Ill. Adm. Code: Chapter II; D) The out-of-state licensee supplies any other information necessary to show compliance with 32 Ill. Adm. Code: Chapter II; and E) The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subsection (b)(1) except by transfer to a person: i) Specifically licensed by the Department or by another Licensing State to receive such material, or ii) Exempt from the requirements for a license for such material under Section 330.40. 2) Notwithstanding the provisions of subsection (b)(1), any person who holds a specific license issued by a Licensing State authorizing the holder to manufacture, transfer, install, or service a device described in Section 330.220 (b)(1) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such a device in this State provided that: A) Such person shall file a report with the Department within thirty (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 device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device; B) The device has been manufactured, labeled, installed and serviced in accordance with applicable provisions of the specific license issued to such person by a Licensing State; C) Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and D) The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such a copy of the general license contained in Section 330.220(b) or in equivalent regulations of the agency having jurisdiction over the manufacture and distribution of the device. 3) The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by a Licensing State, or any product distributed pursuant to such licensing document, if the Department determines that had the out-of-state licensee been licensed by Illinois, the licensee's license would have been subject to action under Section 330.500 or 32 Ill. Adm. Code 310.90. (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) SUBPART D: TRANSPORTATION (Repealed) Section 330.1000 Transportation of Radioactive Material (Repealed) (Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.APPENDIX A Exempt Concentrations Column II Column I Liquid and Gas Con- Solid Con- Element (atomic centration centration number) Isotope uCi/ml 1 uCi/ml 2 Antimony (51) Sb-122 3XlO-4 Sb-124 2XlO-4 Sb-125 lXlO-3 Argon (18) Ar-37 lXlO-3 Ar-41 4XlO-7 Arsenic (33) As-73 5XlO-3 As-74 5XlO-4 As-76 2XlO-4 As-77 8XlO-4 Barium (56) Ba-131 2XlO-3 Ba-140 3XlO-4 Beryllium (4) Be-7 2XlO-2 Bismuth (83) Bi-206 4XlO-4 Bromine (35) Br-82 4XlO-7 3XlO-3 Cadmium (48) Cd-109 2XlO-3 Cd-115m 3XlO-4 Cd-115 3XlO-4 Calcium (20) Ca-45 9XlO-5 Ca-47 5XlO-4 Carbon (6) C-14 lXlO-6 8XlO-3 Cerium (58) Ce-141 9XlO-4 Ce-143 4X10-4 Ce-144 lXlO-4 Cesium (55) Cs-131 2XlO-2 Cs-134m 6XlO-2 Cs-134 9XlO-5 Chlorine (17) Cl-38 9XlO-7 4XlO-3 Chromium (24) Cr-51 2XlO-2 Column II Column I Liquid and Gas Con- Solid Con- Element (atomic centration centration number) Isotope uCi/ml 1 uCi/ml 2 Cobalt (27) Co-57 5XlO-3 Co-58 lXlO-3 Co-60 5XlO-4 Copper (29) Cu-64 3XlO-3 Dysprosium (66) Dy-165 4XlO-3 Dy-166 4XlO-4 Erbium (68) Er-169 9XlO-4 Er-171 lXlO-3 Europium (63) Eu-152 (9.2 h) 6XlO-4 Eu-155 2XlO-3 Fluorine (9) F-18 2XlO-6 8XlO-3 Gadolinium (64) Gd-153 2XlO-3 Gd-159 8XlO-4 Gallium (31) Ga-72 4XlO-4 Germanium (32) Ge-71 2XlO-2 Gold (79) Au-196 2XlO-3 Au-198 5XlO-4 Au-199 2XlO-3 Hafnium (72) Hf-181 7XlO-4 Hydrogen (1) H-3 5XlO-6 3XlO-2 Indium (49) In-113m lXlO-2 In-114m 2XlO-4 Iodine (53) I-126 3XlO-9 2XlO-5 1-131 3XlO-9 2XlO-5 I-132 8XlO-8 6XlO-4 I-133 lXlO-8 7XlO-5 I-134 2XlO-7 lXlO-3 Iridium (77) Ir-190 2XlO-3 Ir-192 4XlO-4 Ir-194 3XlO-4 Iron (26) Fe-55 8XlO-3 Fe-59 6XlO-4 Column II Column I Liquid and Gas Con- Solid Con- Element (atomic centration centration number) Isotope uCi/ml 1 uCi/ml 2 Krypton (36) Kr-85m lXlO-6 Kr-85 3XlO-6 Lanthanum (57) La-140 2XlO-4 Lead (82) Pb-203 4XlO-3 Lutetium (71) Lu-177 lXlO-3 Manganese (25) Mn-52 3XlO-4 Mn-54 lXlO-3 Mn-56 lXlO-3 Mercury (80) Hg-197m 2XlO-3 Hg-197 3XlO-3 Hg-203 2XlO-4 Molybdenum (42) Mo-99 2XlO-3 Neodymium (60) Nd-147 6XlO-4 Nd-149 3XlO-3 Nickel (28) Ni-65 lXlO-3 Niobium (Columbium) (41) Nb-95 lXlO-3 Nb-97 9XlO-3 Osmium (76) Os-185 7XlO-4 Os-191m 3XlO-2 Os-191 2XlO-3 Os-193 6XlO-4 Palladium (46) Pd-103 3XlO-3 Pd-109 9XlO-4 Phosphorus (15) P-32 2XlO-4 Platinum (78) Pt-191 lXlO-3 Pt-193m lXlO-2 Pt-197m lXlO-2 Pt-197 lXlO-3 Potassium (19) K-42 3XlO-3 Praseodymium (59) Pr-142 3XlO-4 Pr-143 5XlO-4 Column II Column I Liquid and Gas Con- Solid Con- Element (atomic centration centration number) Isotope uCi/ml 1 uCi/ml 2 Promethium (61) Pm-147 2XlO-3 Pm-149 4XlO-4 Rhenium (75) Re-183 6XlO-3 Re-186 9XlO-4 Re-188 6XlO-4 Rhodium (45) Rh-103m lXlO-1 Rh 105 lXlO-3 Rubidium (37) Rb-86 7XlO-4 Ruthenium (44) Ru-97 4XlO-3 Ru-103 8XlO-4 Ru-105 lXlO-3 Ru-106 lXlO-4 Samarium (62) Sm-153 8XlO-4 Scandium (21) Sc-46 4XlO-4 Sc-47 9XlO-4 Sc-48 3XlO-4 Selenium (34) Se-75 3XlO-3 Silicon (14) Si-31 9XlO-3 Silver (47) Ag-105 lXlO-3 Ag-llOm 3XlO-4 Ag-111 4XlO-4 Sodium (11) Na-24 2XlO-3 Strontium (38) Sr-85 lXlO-3 Sr-89 lXlO-4 Sr-91 7XlO-4 Sr-92 7XlO-4 Sulfur (16) S-35 9XlO-8 6XlO-4 Tantalum (73) Ta-182 4XlO-4 Technetium (43) Tc-96m lXlO-1 Tc-96 lXlO-3 Column II Column I Liquid and Gas Con- Solid Con- Element (atomic centration centration number) Isotope uCi/ml 1 uCi/ml 2 Tellurium (52) Te-125m 2XlO-3 Te-127m 6XlO-4 Te-127 3XlO-3 Te-129m 3XlO-4 Te-131m 6XlO-4 Te-132 3XlO-4 Terbium (65) Tb-160 4XlO-4 Thallium (81) Tl-200 4XlO-3 Tl-201 3XlO-3 Tl-202 lXlO-3 Tl-204 lXlO-3 Thulium (69) Tm-170 5XlO-4 Tm-171 5XlO-3 Tin (50) Sn-113 9XlO-4 Sn-125 2XlO-4 Tungsten (Wolfram) (74) W-181 4XlO-3 W-187 7XlO-4 Vanadium (23) V-48 3XlO-4 Xenon (54) Xe-131m 4XlO-6 Xe-133 3XlO-6 Xe-135 lXlO-6 Ytterbium (70) Yb-175 lXlO-3 Yttrium (39) Y-90 2XlO-4 Y-91m 3XlO-2 Y-91 3XlO-4 Y-92 6XlO-4 Y-93 3XlO-4 Zinc (30) Zn-65 lXlO-3 Zn-69m 7XlO-4 Zn-69 2XlO-2 Zirconium (40) Zr-95 6XlO-4 Zr-97 2XlO-4 Beta- and/or gamma-emitting radioactive material not listed above with half-life of less than 3 years. lXlO-10 1X10-6 1 Values are given in Column I only for those materials normally used as gases. 2 uCi/g for solids. NOTE 1: Many radioisotopes transform into isotopes which are also radio- active. In expressing the concentrations in Appendix A of this Part, the activity stated is that of the parent isotope and takes into account the daughters. NOTE 2: For purposes of Section 330.40 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 radioactivity concentration present in the product and the exempt radioactivity concentration established in Appendix A for the specific isotope when not in combination. The sum of such ratios may not exceed "1". EXAMPLE: Concentration of Isotope A in Product + Exempt Concentration of Isotope A Concentration of Isotope B in Product is less Exempt Concentration of Isotope B than or equal to 1 NOTE 3: To convert uCi/ml to SI units of megabecquerels per liter, multiply the above values by 37. EXAMPLE: Zirconium (40) Zr-97 (2xlO-4 uCi/ml multiplied by 37 is equivalent to 74 x 10-4 MBq/l). (Source: Amended at 10 Ill. Reg. 17315, effective September 25, 1986) SECTION 330.APPENDIX B EXEMPT QUANTITIES Radioactive Micro- Material curies 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 Radioactive Micro- Material curies 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 Radioactive Micro- Material curies 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 Sulfur-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 Radioactive Micro- Material curies 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 NOTE 1: To convert microcuries (uCi) to SI units of kilobecquerels (kBq), multiply the above values by 37. EXAMPLE: Zirconium-97 (10 uCi multiplied by 37 is equivalent to 370 kBq). (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) SECTION 330.APPENDIX C GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIALS (Repealed) (Source: Repealed at 15 Ill. Reg. 10632, effective July 15, 1991) SECTION 330.APPENDIX D LIMITS FOR BROAD LICENSES (SECTION 330.270) COL. I COL. II RADIOACTIVE MATERIAL CURIES CURIES Antimony-122 1 0.01 Antimony-124 1 0.01 Antimony-125 1 0.01 Arsenic-73 10 0.1 Arsenic-74 1 0.01 Arsenic-76 1 0.01 Arsenic-77 10 0.1 Barium-131 10 0.1 Barium-140 1 0.01 Beryllium-7 10 0.1 Bismuth-210 0.1 0.001 Bromine-82 10 0.1 Cadmium-109 1 0.01 Cadmium-115m 1 0.01 Cadmium-115 10 0.1 Calcium-45 1 0.01 Calcium-47 10 0.1 Carbon-14 100 1. Cerium-141 10 0.1 Cerium-143 10 0.1 Cerium-144 0.1 0.001 Cesium-131 100 1. Cesium-134m 100 1. Cesium-134 0.1 0.001 Cesium-135 1 0.01 Cesium-136 10 0.1 Cesium-137 0.1 0.001 Chlorine-36 1 0.01 Chlorine-38 100 1. Chromium-51 100 1. Cobalt-57 10 0.1 Cobalt-58m 100 1. Cobalt-58 1 0.01 Cobalt-60 0.1 0.001 Copper-64 10 0.1 Dysprosium-165 100 1. Dysprosium-166 10 0.1 Erbium-169 10 0.1 Erbium-171 10 0.1 Europium-152 (9.2 h) 10 0.1 Europium-152 (13 y) 0.1 0.001 Europium-154 0.1 0.001 Europium-155 1 0.01 Fluorine-18 100 1. Gadolinium-153 1 0.01 Gadolinium-159 10 0.1 Gallium-72 10 0.1 COL. I COL. II RADIOACTIVE MATERIAL CURIES CURIES Germanium-71 100 1. Gold-198 10 0.1 Gold-199 10 0.1 Hafnium-181 1 0.01 Holmium-166 10 0.1 Hydrogen-3 100 1. Indium-113m 100 1. Indium-114m 1 0.01 Indium-115m 100 1. Indium-115 1 0.01 Iodine-125 0.1 0.001 Iodine-126 0.1 0.001 Iodine-129 0.1 0.001 Iodine-131 0.1 0.001 Iodine-132 10 0.1 Iodine-133 1 0.01 Iodine-134 10 0.1 Iodine-135 1 0.01 Iridium-192 1 0.01 Iridium-194 10 0.1 Iron-55 10 0.1 Iron-59 1 0.01 Krypton-85 100 1. Krypton-87 10 0.1 Lanthanum-140 1 0.01 Lutetium-177 10 0.1 Manganese-52 1 0.01 Manganese-54 1 0.01 Manganese-56 10 0.1 Mercury-197m 10 0.1 Mercury-197 10 0.1 Mercury-203 1 0.01 Molybdenum-99 10 0.1 Neodymium-147 10 0.1 Neodymium-149 10 0.1 Nickel-59 10 0.1 Nickel-63 1 0.01 Nickel-65 10 0.1 Niobium-93m 1 0.01 Niobium-95 1 0.01 Niobium-97 100 1. Osmium-185 1 0.01 Osmium-191m 100 1. Osmium-191 10 0.1 Osmium-193 10 0.1 Palladium-103 10 0.1 Palladium-109 10 0.1 Phosphorus-32 1 0.01 Platinum-191 10 0.1 COL. I COL. II RADIOACTIVE MATERIAL CURIES CURIES Platinum-193m 100 1. Platinum-193 10 0.1 Platinum-197m 100 1. Platinum-197 10 0.1 Polonium-210 0.01 0.0001 Potassium-42 1 0.01 Praseodymium-142 10 0.1 Praseodymium-143 10 0.1 Promethium-147 1 0.01 Promethium-149 10 0.1 Radium-226 0.01 0.0001 Rhenium-186 10 0.1 Rhenium-188 10 0.1 Rhodium-103m 1,000 10. Rhodium-105 10 0.1 Rubidium-86 1 0.01 Rubidium-87 1 0.01 Ruthenium-97 100 1. Ruthenium-103 1 0.01 Ruthenium-105 10 0.1 Ruthenium-106 0.1 0.001 Samarium-151 1 0.01 Samarium-153 10 0.1 Scandium-46 1 0.01 Scandium-47 10 0.1 Scandium-48 1 0.01 Selenium-75 1 0.01 Silicon-31 10 0.1 Silver-105 1 0.01 Silver-110m 0.1 0.001 Silver-111 10 0.1 Sodium-22 0.1 0.001 Sodium-24 1 0.01 Strontium-85m 1,000 10. Strontium-85 1 0.01 Strontium-89 1 0.01 Strontium-90 0.01 0.0001 Strontium-91 10 0.1 Strontium-92 10 0.1 Sulfur-35 10 0.1 Tantalum-182 1 0.01 Technetium-96 10 0.1 Technetium-97m 10 0.1 Technetium-97 10 0.1 Technetium-99m 100 1. Technetium-99 1 0.01 Tellurium-125m 1 0.01 Tellurium-127m 1 0.01 Tellurium-127 10 0.1 COL. I COL. II RADIOACTIVE MATERIAL CURIES CURIES Tellurium-129m 1 0.01 Tellurium-129 100 1. Tellurium-131m 10 0.1 Tellurium-132 1 0.01 Terbium-160 1 0.01 Thallium-200 10 0.1 Thallium-201 10 0.1 Thallium-202 10 0.1 Thallium-204 1 0.01 Thulium-170 1 0.01 Thulium-171 1 0.01 Tin-113 1 0.01 Tin-125 1 0.01 Tungsten-181 1 0.01 Tungsten-185 1 0.01 Tungsten-187 10 0.1 Vanadium-48 1 0.01 Xenon-131m 1,000 10. Xenon-133 100 1. Xenon-135 100 1. Ytterbium-175 10 0.1 Yttrium-90 1 0.01 Yttrium-91 1 0.01 Yttrium-92 10 0.1 Yttrium-93 1 0.01 Zinc-65 1 0.01 Zinc-69m 10 0.1 Zinc-69 100 1. Zirconium-93 1 0.01 Zirconium-95 1 0.01 Zirconium-97 1 0.01 Any radioactive material other than source material, special nuclear material, or alpha emitting radio- active material not listed above. 0.1 0.001 NOTE 1: To convert curies (Ci) to SI units of gigabecquerels (GBq), multiply the above values by 37. EXAMPLE: Zirconium-97 (Col. II) (0.01 Ci multiplied by 37 is equivalent to 0.37 GBq) (Source: Amended at 15 Ill. Reg. 10632, effective July 15, 1991) Section 330.APPENDIX E Schedule E, Unimportant Quantities of Source Material (Repealed) (Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.APPENDIX F Schedule F, Certain Items Containing Byproduct Material (Repealed) (Source: Repealed at 10 Ill. Reg. 17315, effective September 25, 1986) Section 330.APPENDIX G FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250 (c)(1)(D)) a) Surety Bond - If an applicant or licensee elects to satisfy the requirements of Section 330.250(c)(1) by filing a surety bond, that bond shall conform to the following requirements: 1) The surety company issuing the bond must, at a minimum, be among those listed as acceptable sureties or reinsurers on federal bonds in Circular 570 of the U.S. Department of Treasury, entitled "Surety Companies Acceptable On Federal Bonds", 52 Fed. Reg. 24601, revised as of July 1, 1987. A copy of this document is available for inspection at the Department of Nuclear Safety; 2) The wording of the surety bond must contain the provisions specified in subsection (1) of Appendix H of this Part. Additional conditions may be agreed to between the applicant or licensee and the surety company so long as no requirement of this Part nor other required provision is avoided or altered; 3) The surety bond guarantees that: A) Funds will be available to perform reclaiming in accordance with 32 Ill. Adm. Code 340.Appendix C to assure health and safety from radiation hazards and other requirements of the license for the facility whenever required by the Department; B) Surety waives notification of amendments to licenses, applicable laws, statutes, rules and regulations and agrees that no such amendment shall in any way alleviate its obligation on the bond; and C) The licensee will provide alternate financial surety as specified in Section 330.250(c)(1) and obtain the Division Chief's written approval of the assurance provided within ninety (90) days of receipt by both the licensee and the Division Chief of a notice of cancellation of the bond from the surety; 4) Under the terms of the bond the surety shall become liable on the bond obligation when the licensee fails to perform as guaranteed by the bond. Following a determination by the Division Chief that the licensee has failed to so perform, under the terms of the bond the surety shall perform reclaiming to the satisfaction of the State as guaranteed by the bond or shall forfeit the amount of the penal sum, as provided in Section 330.250(c)(1)(C); 5) The penal sum of the bond shall be in an amount at least adequate to provide the necessary financial surety; 6) Under the terms of the bond, the surety may cancel the bond by sending notice of cancellation by certified mail return receipt requested to the licensee and to the Division Chief. Cancellation shall not occur, however, during the 180 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Division Chief, as evidenced by the return receipts; 7) The surety shall not be liable for the deficiency in the performance of reclaiming after the Division Chief has determined satisfactory reclaiming has occurred; 8) Licensee may terminate the bond by sending written notice to the surety, provided, however, that no such notice shall become effective until the surety receives written authorization from the Division Chief for the termination of the bond. b) Personal Bond Supported by a Letter of Credit. If an applicant or licensee elects to satisfy the surety requirements of Section 330.250(c)(1) by filing his personal performance guarantee accompanied by collateral in the form of an irrevocable standby letter of credit, he must guarantee funds to perform reclaiming in accordance with 32 Ill. Adm. Code 340.Appendix C for protection of health and safety and other requirements of the license for the facility. In addition, the irrevocable standby letter of credit supporting this guarantee must conform to the following requirements: 1) The institution issuing the letter of credit must be an entity which has the authority to issue letters of credit and whose letter of credit operations are regulated and examined by a Federal or Illinois agency; 2) The wording of the letter of credit must contain the provisions specified in subsection (a)(2) of Appendix H of this Part. Additional conditions may be agreed to between the applicant or licensee and the issuing institution so long as no requirement of this Part nor required provision is avoided or altered; 3) The letter of credit must be accompanied by a letter from the licensee referring to the letter of credit by number, issuing institution and date and providing the following information: the radioactive material license number(s), name(s) and address(es) of the facility(ies) and the amount of funds for each license assured for reclaiming of the facility(ies) by the letter of credit; 4) The letter of credit must be irrevocable and issued for a period of at least one year. The letter of credit shall provide that the expiration date shall be automatically extended for a period of at least one year unless, at least 180 days before the current expiration date, the issuing institution notifies both the licensee and the Division Chief by certified mail of a decision not to extend the expiration date. Under the terms of a letter of credit, the 180 days will begin on the date when both the licensee and the Division Chief have received the notice, as evidenced by the return receipts; 5) The letter of credit must be issued in an amount at least adequate to provide the necessary financial surety; and 6) The Director may draw on the letter of credit upon forfeiture as provided in Section 330.250(c)(1)(C). The Director shall also draw on the letter of credit if the licensee does not establish alternate financial surety as specified in this Part and obtain written approval of such alternate assurance from the Division Chief within ninety (90) days after receipt by both the licensee and the Division Chief of a notice from the issuing institution that it has decided not to extend the letter of credit beyond the current expiration date. The Division Chief shall delay the drawing if the issuing institution grants an extension of the term of the credit. During the last thirty (30) days of any extension, the Director will draw on the letter of credit if the licensee has failed to provide alternate financial surety as specified in subsection 330.250(c)(1) and obtain written approval of such surety from the Division Chief. c) Personal Bond Supported by Insurance. If an applicant or licensee elects to satisfy the surety requirements of Section 330.250(c)(1) by filing his personal performance guarantee accompanied by collateral in the form of an insurance policy, he must guarantee funds sufficient to perform reclaiming in accordance with 32 Ill. Adm. Code 340.Appendix C for protection of health and safety and other requirements of the licensee for the facility. In addition, the insurance policy supporting this guarantee must conform to the following requirements: 1) The insurer must be licensed to transact the business of insurance or be eligible to provide insurance as an excess or surplus lines insurer; 2) The insurance policy shall be accompanied by a certificate of insurance in which the wording contains the provisions specified in subsection (3) of Appendix H of this Part. Additional conditions may be agreed to between the applicant or licensee and the insurer so long as no requirement of this Part nor required provision is avoided or altered; 3) The insurance policy must be for a face amount at least adequate to provide the necessary financial surety. The term "face amount" means the total amount the insurer is obligated to pay under the policy. Actual payments by the insurer shall not change the face amount, although the insurer's future liability shall be lowered by the amount of the payments; 4) The insurance policy must guarantee that funds will be available for reclaiming the facility whenever reclaiming is necessary as determined by the Division Chief; 5) Upon forfeiture of financial surety as provided in Section 330.250(c)(1)(C), the Director shall direct the insurer to pay the full face amount to the State as specified in Section 330.250(c)(1)(C); 6) The licensee shall maintain the policy in full force and effect until license termination or substitution of alternate financial surety as specified in Section 330.250(c)(1). Failure to pay the premium without substitution of alternate financial surety as specified in Section 330.250(c)(1) shall constitute a violation of this Part. Such violation shall be considered to begin upon receipt by the Division Chief of a notice of future cancellation, termination, or failure to renew due to nonpayment of the premium, rather than upon the date of expiration; 7) The policy shall provide that the insurer shall not cancel, terminate or fail to renew the policy except for failure to pay the premium. The automatic renewal of the policy must, at a minimum, provide the insured with the option of renewal at the face amount of the expiring policy. If there is a failure to pay the premium, the insurer may elect to cancel, terminate or fail to renew the policy by sending notice by certified mail to the licensee and the Division Chief. Cancellation, termination or failure to renew shall not occur, however, during the 180 days beginning with the date of receipt of the notice by both the Division Chief and the licensee, as evidenced by the return receipts. Cancellation, termination or failure to renew shall not occur and the policy shall remain in full force and effect in the event that on or before the date of expiration: A) The Division Chief considers the facility abandoned; B) The license is terminated or revoked or renewal is denied; C) Closure is ordered by the Director or a court of competent jurisdiction; D) The licensee is named as debtor in a voluntary or involuntary proceeding under Title 11, U.S. Code (Bankruptcy); or E) The premium due is paid. 8) Commencing on the date that liability to make payments pursuant to the policy accrues, the insurer will thereafter annually increase the face amount of the policy. Such increase must be equivalent to the face amount of the policy, less any payments made, multiplied by an amount equivalent to 85 percent of the most recent investment rate or of the equivalent coupon-issue yield announced by the U.S. Treasury for 26-week Treasury securities; and 9) Any provision of the policy inconsistent with any or all regulations in this Part will be deemed to be amended to eliminate such inconsistency. d) Personal Bond Supported by Securities. If an applicant or licensee elects to satisfy the surety requirements of Section 330.250(c)(1) by filing his personal performance guarantee accompanied by collateral in the form of securities, he must guarantee sufficient funds to perform reclaiming in accordance with 32 Ill. Adm. Code 340.Appendix C for protection of health and safety and other requirements of the license(s) for the facility(ies). In addition, the securities supporting this guarantee must be fully registered as to principal and interest in such manner as to identify the State and the Department as holder of such collateral and also identifying that person filing such collateral. The securities shall be accompanied by a certificate whose wording contains the provisions specified in subsection (4) of Appendix H, identifying the State and the Department as holder of such collateral and to also identify that person filing such collateral. These securities must have a current market value at least adequate to provide the necessary financial surety and must be included among the following types: 1) Negotiable United States Treasury securities assigned irrevocably to the State; or 2) Negotiable general obligation municipal or corporate bonds which have at least an "A" rating by Moody's and/or Standard and Poor's rating services and which are assigned irrevocably to the State. e) Personal Bond Supported by Certificate of Deposit. If an applicant or licensee elects to satisfy the surety requirements of Section 330.250(c)(1) by filing his personal performance guarantee accompanied by a Certificate of Deposit in an amount at least adequate to provide necessary financial surety, the irrevocable certificate of deposit supporting this guarantee must conform to the following requirements: 1) The institution issuing the certificate of deposit must be an entity which has the authority to issue certificates of deposit and whose certificate of deposit operations are regulated and examined by a Federal or State agency; 2) The certificate of deposit must be accompanied by a letter from the licensee referring to the certificate of deposit by number, issuing institution and date and providing the following information: A) The radioactive material license number(s), name(s) and address(es) of the facility(ies) and the amount of funds assured for reclaiming of the facility(ies) by the certificate of deposit. Such certificate of deposit must also include a statement signed by an officer of the issuing financial institution which waives all rights of lien which the institution has or might have against the certificate; B) This letter must contain the applicable provisions specified in subsection (5) of Appendix H of this Part. Additional provisions may be agreed to between the applicant or licensee and the issuing institution so long as no requirement of this Part or required provision is avoided or altered; 3) The certificate of deposit must be assigned irrevocably to the State and issued for a period of at least one year. The certificate of deposit must provide that the expiration date will be automatically extended for a period of at least one year unless, at least 180 days before the current expiration date, the issuing institution notifies both the licensee and the Division Chief by certified mail of a decision not to extend the expiration date. Under the terms of the certificate of deposit, the 180 days will begin on the date when both the licensee and the Division Chief have received the notice, as evidenced by the return receipts; and 4) The Director may draw on the certificate of deposit upon forfeiture as provided in Section 330.250(c)(1)(C). The Director will also draw on the certificate of deposit if the licensee does not establish alternate financial surety as specified in this Part and obtain written approval of such alternate assurance from the Division Chief within ninety (90) days after receipt by both the licensee and the Division Chief of a notice from the issuing institution that it has decided not to extend the certificate of deposit beyond the current expiration date. The Director may delay the drawing if the issuing institution grants an extension of the term of the certificate of deposit. During the last thirty (30) days of any such extension, the Director will draw on the certificate of deposit if the licensee has failed to provide alternate financial surety as specified in this Part and obtain written approval of such surety from the Division Chief. (Source: Added at 15 Ill. Reg. 10632, effective July 15, 1991) SECTION 330.APPENDIX H - WORDING OF FINANCIAL SURETY ARRANGEMENTS (SECTION 330.250(c)(1)(E)) 1) A surety bond guaranteeing funds for reclaiming as specified in subsection (a) of Appendix G of this Part must contain the following provisions except that the instructions in parentheses are to be replaced with the relevant information and the parentheses deleted: SURETY BOND Date bond executed: Effective date: Principal: (legal name and business address of applicant or licensee) Type of organization: (insert "individual," "joint venture," "partnership" or "corporation") State of incorporation: Surety(ies): (Name(s) and business address(es)) License Number(s), name, address and reclaiming cost for each facility guaranteed by this bond: Total penal sum of bond: $ Surety's bond number: KNOW ALL PERSONS BY THESE PRESENTS, That we, the Principal and Surety(ies) hereto are firmly bound to the Illinois Department of Nuclear Safety, 1035 Outer Park Drive, Springfield, Illinois 62704, (hereinafter called Department), in the above penal sum for the payment of which we bind ourselves, our heirs, executors, administrators, successors and assigns jointly and severally; provided that, where the Surety(ies) are corporations acting as co- sureties, we, the Sureties, bind ourselves in such sum "jointly and severally" only for the purpose of allowing a joint action or actions against any or all of us, and for all other purposes each Surety binds itself, jointly and severally with the Principal, for the payment of such sum only as is set forth opposite the name of such Surety, but if no limit of liability is indicated, the limit of liability shall be the full amount of the penal sum. WHEREAS said Principal is required, under the Radiation Protection Act, as amended, to have a license in order to receive, possess, store and use radioactive material at the facility identified above, and WHEREAS said Principal is required to provide financial assurance for reclaiming as a condition of the license; NOW, THEREFORE, the conditions of this obligation are such that if the Principal shall faithfully perform reclaiming, whenever required to do so, of each facility for which this bond guarantees funds for reclaiming, to the satisfaction of the Director, Illinois Department of Nuclear Safety, in accordance with acceptable practices for protection of health and safety pursuant to all applicable laws, statutes, rules and regulations, as such laws, statutes, rules and regulations may be amended. OR, if the Principal shall provide alternate financial assurance as specified in Section 330.250(c)(1)(H), and obtain the written approval of such assurance from the Chief, Division of Radioactive Materials (hereinafter called the Division Chief), within ninety (90) days after the date notice of cancellation is received by both the Principal and the Division Chief from the Surety(ies), then this obligation shall be null and void; otherwise, it is to remain in full force and effect. The Surety(ies) shall become liable on this bond obligation only when the Principal has failed to fulfill the conditions described above. Upon notification by the Division Chief that the Principal has been found in violation of the reclaiming requirements of the Department, for a facility for which this bond guarantees funds for performance of reclaiming, the Surety(ies) shall forfeit the reclaiming cost amount guaranteed for the facility to the Department as directed by the Director. Upon notification by the Division Chief that the Principal has failed to provide alternate financial assurance as specified in Section 330.250(c)(1)(H), and obtain written approval of such assurance from the Division Chief during the thirty (30) days following receipt by both the Principal and the Director of a notice of cancellation of the bond, the Surety(ies) shall forfeit funds in the amount guaranteed for the facility(ies) to the Department as directed by the Director. The Surety(ies) hereby waive(s) notification of amendments to licenses, applicable laws, statutes, rules and regulations and agree(s) that no such amendment shall in any way alleviate its (their) obligation on this bond. The liability of the Surety(ies) shall not be discharged by any payment or succession of payments hereunder, unless and until such payment or payments shall amount in the aggregate to the penal sum of the bond, but in no event shall the obligation of the Surety(ies) hereunder exceed the amount of said penal sum. The Surety(ies) may cancel the bond by sending notice of cancellation by certified mail to the applicant or licensee and to the Division Chief; provided, however, that cancellation shall not occur during the 180 days beginning on the date of receipt of the notice of cancellation by both the Principal and the Division Chief, as evidenced by the return receipts. The Principal may terminate this bond by sending written notice to the Surety(ies); provided, however, that no such notice shall become effective until the Surety(ies) receive(s) written authorization for termination of the bond by the Division Chief. IN WITNESS WHEREOF, the Principal and Surety(ies) have executed this SURETY BOND and have affixed their seals on the date set forth above. The persons whose signatures appear below hereby certify that they are authorized to execute this surety bond on behalf of the Principal and Surety(ies). PRINCIPAL (Signature(s)) (Name(s)) (Title(s)) Corporate seal: CORPORATE SURETY(IES) (Name and address) State of incorporation: Liability limit: $ (Signature(s)) (Name(s)) (Title(s)) Corporate seal: (For every co-surety, provide signature(s), corporate seal and other information in the same manner as for the Surety above.) Bond premium: $ 2) A letter of credit, as specified in subsection (b) of Appendix G of this Part, must contain the following provisions except that instructions in parentheses are to be replaced with the relevant information and the parentheses deleted: IRREVOCABLE STANDBY LETTER OF CREDIT Chief Date: Division of Radioactive Materials Illinois Department of Nuclear Safety Dear Sir or Madam: We hereby establish our Irrevocable Standby Letter of Credit No. _______ in your favor, at the request and for the account of (applicant's or licensee's name and address) up to the aggregate amount of (in words) U.S. dollars $ , available upon presentation of: A) your sight draft, bearing reference to this letter of credit No. _______, and B) your signed statement reading as follows: "I certify that the amount of the draft is payable pursuant to regulations issued under authority of the Illinois Radiation Protection Act, as amended." This letter of credit is effective as of (date) and shall expire on (date at least 1 year later), but such expiration date shall be automatically extended for a period of (at least 1 year) on (date) and on each successive expiration date, unless, at least 180 days before the current expiration date, we notify both you and (applicant's or licensee's name) by certified mail that we have decided not to extend this letter of credit beyond the current expiration date. In the event you are so notified, any unused portion of the credit shall be available upon presentation of your sight draft for 180 days after the date of receipt by both you and (licensee's name), as shown on the signed return receipts. Whenever this letter of credit is drawn on, under and in compliance with the terms of this credit, we shall duly honor such draft upon presentation to us, and we shall forfeit the amount of the draft to the State of Illinois in accordance with your instructions. (Signature(s) and title(s) of official(s) of issuing institution) (Date) This credit is subject to (the most recent edition of the Uniform Customs and Practice for Documentary Credits, published by the International Chamber of Commerce, or the Uniform Commercial Code). 3) A certificate of insurance, as specified in subsection (c) of Appendix G of this Part, must contain the following provisions except that instructions in parentheses are to be replaced with the relevant information and the parentheses deleted: CERTIFICATE OF INSURANCE FOR RECLAIMING Name and Address of Insurer (herein called the "Insurer"): Name and Address of Insured (herein called the "Insured"): Facilities Covered: (List for each facility: The License Number, name, address and the amount of insurance for reclaiming (these amounts for all facilities covered must total the face amount shown below)). Face Amount: Policy Number: Effective Date: The Insurer hereby certifies that it has issued to the Insured the policy of insurance identified above to provide financial surety for reclaiming the facilities identified above. The Insurer further warrants that such policy conforms in all respects with the require- ments of subsection (c) of Appendix G of this Part, as applicable and as such regulations were constituted on the date shown immediately below. It is agreed that any provision of the policy inconsistent with such regulation is hereby amended to eliminate such inconsistency. Whenever requested by the Chief, Division of Radioactive materials, Illinois Department of Nuclear Safety, the Insurer agrees to furnish to the Chief, Division of Radioactive Materials, a duplicate original of the policy listed above, including all endorsements thereon. (Authorized signature for Insurer) (Name of person signing) (Title of person signing) Signature of witness or notary: (Date) 4) A personal bond supported by securities, as specified in subsection (d) of Appendix G of this Part, must be accompanied by a document which contains the following provisions except that the instructions in parentheses are to be replaced with relevant information and the parentheses deleted: ASSIGNMENT OF SECURITIES Pursuant to 32 Ill. Adm. Code 330.250(c), (licensee or applicant's name) hereby transfers ( Dollars) ($ ) in negotiable United States Treasury Securities unto Illinois Department of Nuclear Safety, including interest which thereby accrues, represented by Certificate No. ( ), herewith and does hereby agree that such securities shall be used for purposes of ensuring reclamation of ( name of facility ) site. 5) A certificate of deposit, as specified in subsection (e) of Appendix G of this Part, must contain the following provisions except that instructions in parentheses are to be replaced with the relevant information and the parentheses deleted: Name and address of Bank Certificate of Deposit , 19 No. $ (Licensee name and address) has deposited not subject to check ( ) Dollars ($ ) payable to the order of Illinois Department of Nuclear Safety, Chief, Division of Radioactive Materials, ( ) days after notice in writing of intended with- drawal shall have been given to the bank and upon surrender of this certificate properly endorsed, with interest as herein provided. This certificate shall be automatically renewed at maturity for successive periods of 1 year each. The bank reserves the right not to renew this certificate at the expiration of any 1 year's period upon mailing to the payee, at least 180 days prior to the expiration date, a notice of its election not to renew the certificate. (Cashier) Dated , 19 . (Licensee or Applicant) Signature Guaranteed By: (Title) ASSIGNMENT OF CORPORATE OR MUNICIPAL BOND Pursuant to 32 Ill. Adm. Code 330.250(c), (licensee or applicant's name) hereby transfers to Illinois Department of Nuclear Safety bonds of the (Corporation or Municipality's name) for ( ) Dollars ($ ), No. ( ) herewith standing in the name of the undersigned on the books of said (Corporation or Municipality) and does hereby agree that such bonds shall be used for purposes of ensuring reclaiming of ( name of facility ) site. Dated , 19 . (Licensee or Applicant) Signature Guaranteed By: (Title) (Source: Added at 15 Ill. Reg. 10632, effective July 15, 1991)