ML18236A299

Alabama Regulations Part 2

ML18236A299
Person / Time
Issue date:	08/21/2018
From:	Office of Nuclear Material Safety and Safeguards
To:
Beardsley M
Shared Package
ML18236A295	List: ML18236A296 ML18236A298 ML18236A299 ML18236A300 ML18236A302 ML18253A164 ML18253A178
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Download: ML18236A299 (117)

Text

420-3-26-.02 Licensing (1) Purpose.

(a) This Rule, 420-3-26-.02, provides for the licensing of radioactive material.

(b) In addition to the requirements of this Rule, 420-326-.02, all specific licensees are subject to the requirements of Rules 420-3-26-.01, 420-3-26-.03, 420-3-26-.10., and 420-3-26-.13. Licensees engaged in industrial radiographic operations are subject to the requirements of Rule 420-3-26-.04, licensees using radioactive material in the healing arts are subject to the requirements of Rule 420-3-26-.07, licensees using radioactive material for wireline service operation, subsurface tracer studies, or fishing operations are subject to Rule 420-3-26-.12, and licensees using radioactive material in irradiators are subject to the requirements of Rule 420-3-26-.14 of these Rules.

(c) General licensees are subject to the requirements of Rules 420-3-26-.01; 420-3-26-.02(4)(a)2; 420-3-26-.02(7)(a) through (h); 420-3-26-.02(12)(c), (e), and (g);

420-3-26-.02(18); 420-3-26-.02(19); 420-3-26-.03; 420-3-26-.10; and 420-3-26-.13.

(d) The regulations in this Rule 420-3-26-.02 also apply to any licensee authorized by specific or general license issued by the Agency to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Agency license, or transports that material on public highways.

(2) Scope. Except for persons exempt as provided in 420-3-26-.02(3) and (4), no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use radioactive material except as authorized in a specific or general license issued in accordance with the requirement of this rule.

Exemptions (3) Source Material.

(a) Any person is exempt from this Rule, 420-3-26-.02, to the extent that such person receives, possesses, uses, or transfers, or delivers 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 Rule, 420-3-26-.02, to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material, provided that the unrefined and unprocessed ore shall not be consolidated into a single physical location such that the quantity of source material exceeds the general license possession limits imposed in Rule 420-3-26-.02(6)(a). Except as authorized in a specific license, such person shall not refine or process such ore.

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(c) Any person is exempt from the requirements for a license set forth in this Rule, 420-3-26-.02, to the extent that such person receives, possesses, uses, or transfers:

1. Any quantities of thorium contained in:

(i) Incandescent gas mantles, (ii) Vacuum tubes, (iii) Welding rods, (iv) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium, (v) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium, (vi) Rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or (vii) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium.;

2. Source material contained in the following products:

(i) Glazed ceramic tableware manufactured before November 5, 2016, provided that the glaze contains not more than 20 percent by weight source material.;

(ii) Glassware, glass enamel, and glass enamel frit containing not more than 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or glass or ceramic used in construction; (ii) Piezoelectric ceramic containing not more than 2 percent by weight source Formatted: List Paragraph, Indent: Left: 0", First line: 0.5",

Numbered + Level: 1 + Numbering Style: i, ii, iii, + Start material. at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 1" Formatted: Font: 12 pt (iii) Glassware containing not more than 2 percent by weight source material or, for glassware manufactured before November 5, 2016, 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.,

(iv) 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.;

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4. Any finished product or part fabricated of, or containing, tungsten or magnesium-thorium alloys; providing that, the thorium content of the alloy does not exceed 4 percent by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.;

5. Uranium contained in counterweights installed in aircraft rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights:

provided that:,

(i) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM;1 (ii) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED; 31 and, (iii) The exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any counterweights other than repair or restoration of any plating or other covering.

6. Natural or depleted uranium metal used as shielding constituting part of any shipping containers provided, that:

(i) The shipping container is conspicuously and legibly impressed with the legend "CAUTION--RADIOACTIVE SHIELDING URANIUM" and (ii) The uranium metal is encased in milled steel, or equally fire resistant metal, of minimum wall thickness of one-eighth inch (3.2 mm).

7. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10 percent by weight of thorium or uranium or, for lenses manufactured before November 5, 2016, 30 percent by weight of thorium; and that the exemption contained in this subparagraph shall not be deemed to authorize either:

(i) The shaping, grinding, or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or 1

The requirements specified in subdivisions (i) and (ii) of the subparagraph need not 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 the rules.

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(ii) The receipt, possession, use, or transfer of uranium or 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 microcuries of uranium.

9.8. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

(i) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide) and (ii) The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.

9. The exemptions in 420-3-26-.02(3)(c) do not authorize the manufacture of any of the products described.

10. No person may initially transfer for sale or distribution a product containing source material to persons exempt under this subparagraph or equivalent regulations of the U. S.

Nuclear Regulatory Commission or an Agreement State, unless authorized by a license issued by the U. S. Nuclear Regulatory Commission pursuant to Section 40.5240.42 of 10 CFR Part 40 to initially transfer products for sale or distribution.

(i) Persons initially distributing source material in products covered by the exemptions in this subparagraph before November 5, 2016, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the U. S. Nuclear Regulatory Commission takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date.

(ii) Persons authorized to manufacture, process, or produce these materials or products containing source material by the Agency or another Agreement State, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued by the U. S. Nuclear Regulatory Commission pursuant to Section 40.42 of 10 CFR Part 40 for distribution only and are exempt from the requirements of Rules 420-3-26-.03, 420-3-26-.10, and 420-3-26-.02(9)(a) and (b).

(4) Radioactive Materials.

(a) Exempt Concentrations

1. Except as provided in paragraphs (a) 2. and 3. below, any person is exempt from this Rule, 420-3-26-.02, to the extent that such person receives, possesses, uses, transfers, owns, 4

or acquires products or materials containing radioactive material in concentrations not in excess of those listed in Schedule C.

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 under Rule 420-3-26-.02(4)(a)l.

or equivalent regulations of the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State, except in accordance with a license issued pursuant to 10 CFR 32.11.

3. A manufacturer, processor, or producer of a product or material is exempt from this Rule, 420-3-26-.02, to the extent that such person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule C and introduced into the product or material by a licensee holding a specific license issued by the Agency expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

4. Except as provided in Rule 420-3-26-.02(4)(e)2, any person is exempt from this Rule, 420-3-26-.02, to the extent that such person receives, possesses, uses, transfers, owns, or acquires property, structures, equipment, products, or materials containing radium such that the average concentration of the total of all radium isotopes present is less than 5.0 picocuries per gram.

5. Any person may, upon Agency review, be exempted from this Rule, 420-3-26-.02, provided the individual submits, and the Agency accepts, documentation indicating that the total radium content in the products, materials, property, structures, or equipment is not likely to result in an average member of the critical group receiving a total effective dose equivalent (TEDE) that exceeds 25 millirem (0.25 mSv) in any year, from all pathways.

6. The distribution, including custom blending, possession, and use of fertilizers containing naturally occurring radium is exempt from the requirements of this Rule, 420-3-26-.02.

7. Using purposeful dilution to lower radium concentrations to levels below 5 picocuries per gram in an attempt to render it exempt shall not be allowed without prior approval of the Agency.

8. This section shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

(b) 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 containing radioactive material, any person is exempt from these rules to the extent that he 5

receives, possesses, uses, transfers, owns, or acquires the following products:2

1. Timepieces or hands or dials containing radium or not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(i) 25 millicuries (925 MBq) of tritium per timepiece.;

(ii) 5 millicuries (185 MBq) of tritium per hand.;

(iii) 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial).;

(iv) 100 microcuries (3.7 MBq) of promethium 147 per watch or 200 microcuries (7.4 MBq) of promethium 147 per any other timepiece.;

(v) 20 microcuries (0.74 MBq) of promethium 147 per watch hand or 40 microcuries (1.48 MBq) of promethium 147 per other timepiece hand.;

(vi) 60 microcuries (2.22 MBq) of promethium 147 per watch dial or 120 microcuries (4.44 MBq) of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial).;

(vii) The levels of radiation from hands and dials containing promethium 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(I) For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface.;

(II) For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface.;

(III) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

(viii) 1.0 microcurie (0.037 MBq) of radium 226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

2. (i) Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device.

2 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material or 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. 20545.

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(ii) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device or of a total of not more than 50 millicuries (1.85 GBq) of hydrogen-3 (tritium) per device.

(iii) Such devices authorized before October 23, 2012, for use under the general license then provided in these rules or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Agency.

3. Balances of precision containing not more than 1 millicurie (37 MBq) of tritium per balance or not more than 0.5 millicuries of tritium per balance part manufactured prior to December 17, 2007.

4. Marine compasses containing not more than 750 millicuries (27.75 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured prior to December 17, 2007.

5. Ionization chamber smoke detectors containing not more than 1 microcurie (0.037 MBq) of americium 241 per detector in the form of a foil and designed to protect life and property from fires.

6. 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 of tritium per any other electronic tube.;

(ii) 1 microcurie (0.037 MBq) of cobalt 60.;

(iii) 5 microcuries (0.185 MBq)of nickel 63.;

(iv) 30 microcuries (1.11 MBq) of krypton 85.;

(v) 5 microcuries (0.185 MBq) of cesium 137.;

(vi) 30 microcuries (1.11 MBq) of promethium 147.;

Aand provided further, that the level of radiation due to radioactive material contained in each electron tube does not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeters of absorber.3 3

For the purpose of this subparagraph, electron tubes include spark gap tubes, power tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other complete sealed tube that is designed to conduct or control electrical currents.

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7. 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 Schedule B of this rRule., 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 Schedule B of this rule, provided that the sum of such fractions shall not exceed unity.

(iii) For americium 241, 0.05 microcurie (0.185 Bq) is considered an exempt quantity under Schedule B of this rRule.

8. Any person who desires to apply radioactive material to, or incorporate radioactive material into, the products exempted in this section, or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license pursuant to 10 CFR 32.14 of the U.S. Nuclear Regulatory Commission which states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to paragraph (b) of this section.

(c) Gas and Aerosol Detectors Containing Radioactive Material. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property, provided that:

1. Detectors containing byproduct material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR Part 32 which license authorizes the transfer of the detectors to persons who are exempt from regulatory requirements;

2. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under paragraph (c) of this section, should apply for a license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR Part 32 and for a certificate of registration in accordance with 10 CFR 32.210 of 10 CFR Part 32; or,

3. Detectors containing other than byproduct, source, or special nuclear material shall have been manufactured or initially transferred before November 30, 2007, in accordance with a specific license issued by the Agency, Licensing State, or any Agreement State pursuant to licensing requirements equivalent to those set forth in Section 32.26 of 10 CFR Part 32, which license authorizes the transfer of the detectors to persons who are exempt from regulatory 8

requirements.

(d) Self-luminous Products Containing Radioactive Material.

1. Tritium, Krypton 85, or Promethium 147. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton 85, or promethium 147, any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton 85, or promethium 147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements. The exemption in this paragraph does not apply to tritium, krypton 85, or promethium 147 used in products for frivolous purposes or in toys or adornments.

2. Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton 85, or promethium 147 for use under paragraph (d) of this section, should apply for a license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32 and for a certificate of registration in accordance with Section 32.210 of 10 CFR Part 32.

(e) Certain Industrial Devices. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in these rules to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.30 of 10 CFR Part 32, which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

1. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under paragraph (e) of this section, should apply for a license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.30 of 10 CFR Part 32 and for a certificate of registration in accordance with 10 CFR 32.210 of 10 CFR Part 32.

(f) Exempt Quantities.

1. Except as provided in subparagraphs 3., 4., and 5. of this paragraph, any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns, 9

or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Schedule B.

2. Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license formerly provided in Rule 420-3-26-.02 is exempt from the requirements for a license set forth in this Rule, 420-3-26-.02, to the extent that such person possesses, uses, transfers, or owns such radioactive material.

3. This paragraph (f) 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.

4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this paragraph or equivalent regulations of the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State, except in accordance with a specific license issued by the U.S.

Nuclear Regulatory Ccommission pursuant to Section 32.18 of 10 CFR Part 32 which license states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph (f) or the equivalent regulations of the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State.

5. No person may, for the purposes of producing an increased radiation level combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by these rules.

(g) Radioactive Drug: Capsules Containing Carbon-14 Urea for In Vivo Diagnostic Use in Humans.

1. Except as provided in paragraph 2. of this section, any person is exempt from the requirements for a license set forth in this rule provided that such person receives, possesses, uses, owns, transfers, or acquires capsules containing 1 microcurie (0.037 MBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for in vivo diagnostic use in humans.

2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to 420-3-26-.02(10)(e).

3. Nothing in this section relieves persons from complying with applicable FDA, other federal, and state requirements governing receipt, administration, and use of drugs.

(5) Types of Licenses. Licenses for radioactive materials are of two types: general and specific.

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(a) The Agency issues a specific license to a named person who has filed an application for a license under the provisions of this Rule, 420-3-26-.02.

(b) A general license is provided by rule, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the Agency or the issuance of a licensing document to a particular person. However, registration with the Agency may be required by the particular license.

(6) 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 receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:

1. No more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g.,

gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. Persons possessing source material in excess of these limits as of November 5, 2016, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time for 1 year beyond this date, or until the Agency takes final action on a pending application submitted on or before November 5, 2017, for a specific license for such material; and receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until December 31, 2017, or until the Agency takes final action on a pending application submitted on or before November 5, 2017, for a specific license for such material; and

2. No more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than 70 kg (154 lb) or uranium or thorium in any one calendar year. A person may not alter the chemical or physical form or the source material possessed under this paragraph until it is accounted for under the limits of subparagraph (a)1.; or

3. No more than 7 kg (15.4 lb) of uranium, removed from the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb) of uranium from drinking water during a calendar year under this paragraph; or

4. No more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lb) of source material in any one calendar year.

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(b) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in paragraph (a) of this section:

1. Are prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the Agency in a specific license.

2. Shall not abandon such material. Source material may be disposed of as follows:

(i) A cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this paragraph is exempt from the requirements to obtain a license under this rule to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under this rule; or (ii) In accordance with Rule 420-3-26-.03(33).

3. Are subject to the provisions of Rules 420-3-26-.02(2), (12), (17), (18), (29), and (30).

4. Shall not export such source material except in accordance with 10 CFR Part 110.

(c) Any person who receives, possesses, uses, or transfers source material in accordance with paragraph (a) of this section shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the Agency about such contamination and may consult with the Agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in Rule 420 26-.03(60).

(d) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in paragraph (a) of this section is exempt from the provisions of Rules 420-3-26-.01, 420-3-26-.03, and 420-3-26-10 to the extent that such receipt, possession, use, and transfer are within the terms of the general license, except that such person shall comply with the provisions of Rules 420-3-26-.03(33) and 420-3-26-.03(60) to the extent necessary to meet the provisions of paragraph (b)2. and (c) of this section. However, this exemption does not apply to any person who also holds a specific license issued under this rule.

(e) No person may initially transfer or distribute source material to persons generally licensed under paragraph (a)1. or (a)2. of this section, or equivalent regulations of the U.S.

Nuclear Regulatory Commission or another Agreement State unless authorized by a specific 12

license issued in accordance with Rule 420-3-26-.02(10)(v) or equivalent provisions of the U.S.

Nuclear Regulatory Commission or another Agreement State. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by paragraph (a) of this section before November 5, 2016, without specific authorization may continue for 1 year beyond this date. Distribution may also be continued until the Agency takes final action on a pending application for license or license amendment to specifically authorize distribution submitted on or before November 5, 2017.

(f) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. The general license under this paragraph does not authorize any person to receive, possess, use, or transfer source material.

(g) 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 420-3-26-.02(6)(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 420-3-26-.02(6)(d) 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 420-326-.02(10)(1) 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. (i) Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by 420-3-26-.02(6)(d) shall file Agency Form GLDU "Registration Certificate - Use of Depleted Uranium Under General License," with the Agency.

The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on Agency Form GLDU the following information and such other information as may be required by that form:

(I) Name and address of the registrant.;

(II) A statement that the registrant has developed and will maintain procedures de-signed to establish physical control over the depleted uranium described in 420-3-26-.02(6)(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 420-3-26-.02(6) (d)3.(i)(II).

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(ii) The registrant possessing or using depleted uranium under the general license established by 420-3-26-.02(6)(d)l. shall report in writing to the Agency any changes in information furnished by him in Agency Form GLDU "Registration Certificate - Use of Depleted Uranium." 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 420-3-26-.02(6)(d)l.:

(i) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.

(ii) Shall not abandon such depleted uranium.

(iii) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of 420-3-26-.02(18). In the case where the transferee receives the depleted uranium pursuant to the general license established by 420-3-26-.02(6)(d)l., the transferor shall furnish the transferee a copy of this Rule, 420-3-26-.02, and a copy of Agency Form GLDU. In cases where the transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Commission or Agreement State's regulation equivalent to 420-3-26-.02(6)(d)l., the transferor shall furnish the transferee a copy of the regulation and a copy of Agency Form GLDU 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 Rule 420-3-26-.02.

(iv) Shall, within 30 days of any transfer, report in writing to the Agency the name and address of the person receiving the depleted uranium pursuant to such transfer.

(v) Shall not export such depleted uranium except in accordance with a license issued by the U.S. Nuclear Regulatory Commission pursuant to 10 CFR Part 110.

5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by 420-3-26-.02(6)(d)l. is exempt from the requirements of Rules 420-3-26-.03 and 420-3-26-.10 of these rules with respect to the depleted uranium covered by that general license.

(7) General Licenses - Certain Detecting, Measuring, Gauging, or Controlling Devices and Certain Devices for Producing Light or an Ionized Atmosphere.

(a) 1. A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and federal, state, or local government agencies to acquire, receive, possess, use, or transfer, in accordance with the provisions of paragraphs 1., 2. and 3. of Rule 420-3-26-.02(7)(a),

radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, 14

radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(i) The general license in paragraph (a) of Rule 420-3-26-.02(7) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

(I) A specific license issued under Rule 420-3-26-.02(10)(g); or (II) An equivalent specific license issued by the U.S. Nuclear Regulatory Commission, another Agreement State, or Licensing State.

(ii) The devices must have been received from one of the specific licensees described in Rule 420-3-26-.02(7)(a)1.(i) or through a transfer made under paragraph 3(xi) of Rule 420-3-26-.02(7)(a) and which will be possessed and used at a single physical location.

(iii) The general license in paragraph 1. of Rule 420-3-26-.02(7)(a) applies only to radioactive material which will be possessed and used at a single physical location.

(iv) Notwithstanding the requirements listed in 420-3-26-.02(7)(a)1.(ii) and (iii), state and local emergency response agencies are exempt from requirements that devices described in 420-3-26-.02(7)(a)1. be possessed and used at a single location.

2. Any person who acquires, receives, possesses, uses, or transfers radioactive material in a device pursuant to the general license in paragraph 1 of Rule 420-3-26-.02(7)(a):

(i) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels.;

(ii) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six6-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 of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose.;

(iii) Shall assure that the tests required by paragraph 2.(ii) of Rule 420-3-26-.02(7)(a) and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

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(I) In accordance with the instructions provided by the labels; or (II) By a person holding a specific license issued by the Agency, another Agreement State, or the U.S. Nuclear Regulatory Commission to perform such activities.;

(iv) Shall maintain records showing compliance with the requirements of paragraphs 2.(ii) and 2.(iii) of Rule 420-3-26-.02(7)(a). The records must show the results of the tests. The records also must show the dates of performance of, and the names of persons performing testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(I) Each record of a test for leakage of radioactive material required by paragraph 2.(ii) of Rule 420-3-26-.02(7)(a) must be retained for 3 years after the next required leak test is performed or until the sealed source is transferred or disposed.

(II) Each record of a test of the off-on mechanism and indicator required by paragraph 2.(ii) of Rule 420-3-26-.02(7)(a) must be retained for three 3 years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed.

(III) Each record that is required by paragraph 2.(iii) of Rule 420-3-26-.02(7)(a) must be retained for three 3 years from the date of the recorded event or until the device is transferred orf disposed.

(v) Shall immediately suspend operation of the device if there is 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 (0.185 becquerel) or more of removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or another person holding a specific license to repair such devices that was issued by the Agency, another Agreement State, or the U.S. Nuclear Regulatory Commission. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the Agency. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie (0.185 kBq) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Director, Office of Radiation Control, P. O. Box 303017, Montgomery, Alabama 36130-3017 within 30 days. Under these circumstances, the criteria set out in Rule 420-3-26-.03(60),

Radiological Criteria for Unrestricted Use may be applicable, as determined by the Agency on a case-by-case basis.

(vi) Shall not abandon the device containing radioactive material.

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(vii) Shall not export the device containing radioactive material except in accordance with regulations of the U.S. Nuclear Regulatory Commission.

(viii) Shall transfer or dispose of the device containing radioactive material only by export as provided by paragraph 2.(vii) of Rule 420-3-26-.02(7)(a), by transfer to another general licensee as authorized in paragraph 2.(xi) of Rule 420-3-26-.02(7)(a), or to a person authorized to receive the device by a specific license issued under this Rule 420-3-26-.02, or to a person authorized to receive the device by a specific license issued under Rule 420-3-26-.02 that authorizes waste collection, or equivalent regulations of another Agreement State or the U.S.

Nuclear Regulatory Commission, or as otherwise approved under paragraph 2.(x) of Rule 420-3-26-.02(7)(a).

(ix) Shall, within 30 days after the transfer of a device to a specific licensee or export, furnish a report to the Director, Office of Radiation Control, P.O. Box 303017, Montgomery, Alabama 36130-3017. The report must contain:

(I) The identification of the device by manufacturers (or initial transferors) name, model number, and serial number.;

(II) The name, address, and license number of the person receiving the device (license number not applicable if exported).; and (III) The date of the transfer.

(x) Shall obtain written Agency approval before transferring the device to any specific licensee not specifically identified in paragraph 2.(viii) of Rule 420-3-26-.02(7)(a);

however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval if the holder:

(I) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use.;

(II) Removes, alters, covers, or clearly and unambiguously augments the existing label [otherwise required by Rule 420-3-26-.02(7)(a)2.(i)] so that the device is labeled in compliance with Rule 420-3-26-.03(30); however, the manufacturer model number and serial number must be retained.;

(III) Obtains manufacturers or initial transferors information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and.

(IV) Reports the transfer as required in Rule 420-3-26-.02(7)(a)2.(ix).

(xi) Shall transfer the device to another general licensee only if:

(I) The device remains in use at a particular location. In this case, the transferor shall 17

give the transferee a copy of this Rule 420-3-26-.02, a copy of Rule 420-3-26-.03, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to the Director, Office of Radiation Control, P.O. Box 303017-3017, Montgomery, Alabama 36130-3017:

I. The manufacturers (or initial transferors) name.;

II. The model number and the serial number of the device transferred.;

III. The transferees name, and mailing address for the location of use; and.

IV. The name, title, and phone number of the responsible individual identified by the licensee in accordance with paragraph 2.(xiv) of Rule 420-3-26-.02(7)(a) to have knowledge of and authority to take actions to ensure compliance with the appropriate rules and requirements; or (II) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(xii) Shall comply with the provisions of Rule 420-3-26-.03(51) and (52) for reporting stolen, lost, or missing sources or devices and reporting radiation incidents but shall be exempt, unless otherwise specified, from the other requirements of Rule 420-3-26-.03 and Rule 420-3-26-.10.

(xiii) Shall respond to written requests from the Agency to provide information relating to the general license within 30 calendar days of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Director, Office of Radiation Control, P.O. Box 303017, Montgomery, Alabama 36130-3017 a written justification for the request.

(xiv) Shall appoint an individual responsible for having knowledge of the appropriate rules and requirements and the authority for taking required actions to comply with appropriate rules and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate rules and requirements. This appointment does not relieve the general licensee of any responsibility in this regard.

(xv) Shall register, in accordance with paragraphs (7)(a)2.(xv)(I) and (II) of Rule 420-3-26-.02(7)(a), devices containing at least 10 millicuries (370MBq) of cesium-137, 0.1 millicurie (3.7MBq) of strontium-90, 1.0 millicurie (37 MBq.) of cobalt-60, 0.1 millicurie of radium-226, or 1.0 millicurie (37MBq) of americium-241 or any other transuranic [i.e., element with atomic number greater than uranium (92)], based on the activity indicated on the label. Each address for a location of use, as described in paragraph (7)(a)2.(xv)(II)IV of Rule 420-3 .02(7)(a), represents a separate general license and requires a separate registration.

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(I) If in possession of a device meeting the criteria of paragraph (a)2.(xv) of Rule 420-3-26-.02(7)(a), shall register these devices with the Agency. The registration information must be submitted to the Agency within 30 days of the date of receipt of the device(s) and annually thereafter. In addition, a general licensee holding devices meeting the criteria of paragraph (a)2.(xv) of Rule 420-3-26-.03(7)(a) is subject to the bankruptcy notification requirement in Rule 420-3-26-.02(12)(e).

(II) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Agency:

I. Name and mailing address of the general licensee.

II. Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label).

III. Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (a)2.(xiv) of Rule 420-3-26-.02(7)(a).

IV. Address or location at which the device(s) are used and/or stored.

V. Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.

VI. Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(xvi) Shall report changes to the mailing address for the location of use (including change in the name of licensee) to the Director, Office of Radiation Control, P.O. Box 303017, Montgomery, Alabama 36130-3017 within 30 days of the effective date of the change.

(xvii) May not hold devices that are not in use for longer than two 2 years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (a)2.(ii) of Rule 420-3-26-.02(7)(a) need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two2-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(xviii) Shall notify the Agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Ttitle 11 (Bankruptcy) of the United States by or against:

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(I) The licensee; (II) Any 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 (III) An affiliate [as that term is defined in 11 U.S.C. 101(2)] of the licensee.

3. The general license in paragraph (7)(a) of Rule 420-3-26-.02(7) does not authorize the manufacture or import of devices containing radioactive material.

(b) Certain Items and Self-Luminous Products Containing Radium 226.

1. A general license is hereby issued to any person to acquire, receive, possess, use, or transfer in accordance with the provisions of paragraphs 2., 3. and 4. of this section, radium 226 contained in the following products manufactured prior to September 1, 2010.

(i) Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanatory jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

(ii) Intact timepieces containing greater than 1 microcurie (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

(iii) Luminous items installed in air, marine, or land vehicles.

(iv) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

(v) Small radium sources containing no more than 1 microcurie (0.037 MBq) of radium 226. For the purposes of this paragraph, small radium sources means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the Agency or the U.S.

Nuclear Regulatory Commission.

2. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in Rule 420-3-26-.02(7)(b)1. are exempt from the provisions of this rule to the extent that the receipt, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under this rule.

3. Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with the general license in Rule 420-3-26-.02(7)(b)1.:

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(i) Shall notify the Agency should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the Agency within 30 days.

(ii) Shall not abandon products containing radium 226. The product, and any radioactive material from the product, may only be disposed of in accordance with Rule 420-3-26-.03 or by transfer to a person authorized by a specific license to receive the radium 226 in the product or as otherwise approved by the Agency.

(iii) Shall not export products containing radium 226 except in accordance with U.S.

Nuclear Regulatory Commission regulations.

(iv) Shall dispose of products containing radium 226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act of 2005, by transfer to a person authorized to receive radium 226 by a specific license issued under Rule 420-3-26-.02, or equivalent regulations of the U.S. Nuclear Regulatory Commission or another Agreement State, or as otherwise approved by the Agency.

(v) Shall respond to written requests from the Agency to provide information relating to the general license within 30 calendar days of the written request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Agency a written justification for the request.

4. The general license in Rule 420-3-26-.02(7)(b)1. does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium 226, except that timepieces may be disassembled and repaired.

(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:

(i) Each device contains not more than 10 curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium 147; and.

(ii) Each device has been manufactured, assembled, or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured or assembled in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Agency or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR Part 32 of the regulations of the U.S. Nuclear Regulatory 21

Commission.

2. Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in subparagraph 1.of this paragraph are exempt from the requirements of Rule 420-3-26-.03 and 420-3-26-.10 except that they shall comply with the provisions of 420-3-26-.02(23) and 420-3-26 -.02(24).

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. The general license provided in this paragraph is subject to the provisions of 420-3-26-.01(6), 420-3-26-.01(7), 420-3-26-.01(8), 420-3-26-.01(10), 420-3-26-.01(11),

420-3-26-.01(12), 420-3-26-.02(12), 420-3-26-.02(18), 420-3-26-.02(21), and Rule 420-3-26-.10.

(d) Calibration and Reference Sources.

1. A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of subparagraphs 3. and 4.

of this paragraph (d), americium 241 and radium 226 in the form of calibration or reference sources:

(i) Any person who holds a specific license issued by the Agency which authorizes him to receive, possess, use, and transfer radioactive material; and,.

(ii) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear material.

2. A general license is hereby issued to receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of subparagraphs 3. and 4. of this paragraph (d) to any person who holds a specific license issued by the Agency which authorizes him to receive, possess, use, and transfer radioactive material.

3. The general licenses in subparagraphs 1. and 2. of this paragraph apply only to calibration or reference sources which have been manufactured in accordance with specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S.

Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR Part 32 of Section 70.39 of 10 CFR Part 70, or which have been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued to the manufacturer by the Agency or any Agreement State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 of the regulations of the U.S. Nuclear Regulatory Commission.

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4. The general licenses in subparagraphs 1. and 2. of this paragraph are subject to the provisions of 420-3-26-.01(6), 420-3-26-.01(7), 420-3-26-.01(8), 420-3-26-.01(10),

420-3-26-.01(11), 420-3-26-.02 (12), and 420-3-26-.02(19), Rule 420-3-26-.03 and Rule 420-3-26-.10 of these rules. In addition, persons who own, receive, acquire, possess, use, and transfer one or more calibration or reference sources pursuant to these general licenses:

(i) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries (0.185 MBq) of americium 241, 5 microcuries (0.185 MBq) of radium 226, and 5 microcuries (0.185 MBq) of plutonium in such sources;.

(ii) Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:

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),

(RADIUM 226). (PLUTONIUM).4 DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

(Name of Manufacturer or Initial Transferor);

(iii) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to receive the source.;

(iv) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium 241, radium 226, or plutonium which might otherwise escape during storage.;

(v) Each person licensed under section Section 32.57 of U.S. Nuclear Regulatory Commission Rule 10 CFR Part 32 shall perform a dry wipe test on each source containing more than 0.1 microcurie (3.7 kilobecquerels) of americium 241 or radium 226 before transferring the source to a general licensee as authorized in Rule 420-3-26-.02(7)(d)1. or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. This test shall be performed by wiping the entire radioactive surface of the source using a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcuries (0.185 kilobecquerel) of americium 241 or radium 226. If this test discloses more than 0.005 microcuries 4

Showing only the name of the appropriate material.

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(0.185 kilobecquerel) of radioactive material, the source shall be deemed to be leaking americium 241 or radium 226 and shall not be transferred to a general licensee under Rule 420-3-26-.02(7)(d)1. or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State.

(vi) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

5. These general licenses do not authorize the manufacturer of calibration or reference sources containing americium 241, radium 226, or plutonium.

(e) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this rRule, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material.

(f) 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 no more than 50 (1.85 MBq) microcuries of strontium 90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license; or

2. Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in subparagraph 1. of this paragraph (f);

(i) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating 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 this Rule 420-3-26-.02.;

(ii) 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.;

(iii) Are exempt from the requirements of Rules 420-3-26-.03 and 420-3-26-.10 except that such persons shall comply with the provisions of 420-3-26-.03(38), 420-3-26-.03(51), and 420-3-26-.03(52) of these rules.;

(iv) Are exempt from the requirements of Rules 420-3-26-.02 and 420-3-26-.01 except that such persons shall comply with the provisions of 420-3-26-.02(12), 420-3-26-.02(18),

420-3-26-.02(19), 420-3-26-.02(21), 420-326-.01(6), 420-3-26-.01(7), 420-3-26-.01(8),

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420-3-26-.01(10), 420-3-26-.01(11) and 420-3-26-.01(12).

3. This general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices.

(g) General License for Use of Radioactive Material for certain Certain In Vitro Clinical or Laboratory Testing.

1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests5, in accordance with the provisions of subparagraphs 2., 3.,

4., 5., and 6. of this paragraph, the following radioactive materials in prepackaged units:

(i) Iodine 125, in units not exceeding 10 microcuries (0.37 MBq) each 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.

(ii) Iodine 131, in units not exceeding 10 microcuries (0.37 MBq) each 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.

(iii) Carbon-14, in units not exceeding 10 microcuries (0.37 MBq) each 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.

(iv) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each 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.

(v) Iron-59 in units not exceeding 20 microcuries (0.74 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive mate-rials, or the radiation therefrom, to human beings or animals.

(vi) Cobalt-57, in units not exceeding 10 microcuries (0.37 MBq) each, for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive materials, or the radiation therefrom, to human beings or animals.

(vii) Selenium-75, in units not exceeding 10 microcuries (0.37 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive materials, or the radiation therefrom, to human beings or animals.

(viii) Mock Iodine-125 reference or calibration sources, in units not exceeding 5

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.

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0.05 microcurie (1.85 kBq) of Iodine-129 and 0.005 (0.185 kBq) microcurie of americium 241 each 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.

2. No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by 420-3-26-.02(7)(g)l. until he has filed Agency Form IV-GL "Certificate - In Vitro Testing with Radioactive Material Under General License" with the Agency and received from the Agency a validated copy of Agency Form IV-GL with certification number assigned. The physician, clinical laboratory, or hospital shall furnish on Agency Form IV-GL the following information and such other information as may be required by that form:

(i) Name and address of the physician, clinical laboratory, or hospital.;

(ii) The location of use; and.

(iii) A statement that the physician, clinical laboratory, veterinarian, or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive materials as authorized under the general license in subparagraph 1. of this paragraph and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive materials.

3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by subparagraph 1. of this paragraph shall comply with the following:

(i) The general licensee shall not possess at any one time, pursuant to the general license in 420-3-26-.02(7)(g)l. at any one location of storage or use a total amount of iodine 125, iodine 131, iron 59, cobalt 57, and/or selenium 75 in excess of 200 microcuries (7.4 MBq).

(ii) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(iii) The general licensee shall use the radioactive material only for the uses authorized by subparagraph 1. of this paragraph.

(iv) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State, nor transfer the radioactive material in any manner other than in an unopened, labeled shipping container as received from the supplier.

4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to subparagraph 1. of this paragraph:

26

(i) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to 420-3-26-.02(10)(k) or in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State which authorizes the manufacture and distribution of iodine 125, iodine 131, carbon 14, hydrogen 3 (tritium), iron 59, cobalt 57, mock iodine 125, or selenium 75 for distribution to persons generally licensed pursuant to 420-3-26-.02(h) or its equivalent, and.

(ii) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom to human beings or animals: Its receipt, acquisition, possession, use, and transfer are subject to the regulations and general license of the U.S.

Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

Name of Manufacturer

5. The physician, clinical laboratory, or hospital possessing or using radioactive materials under the general license of subparagraph 1. of this paragraph shall report in writing to the Agency, any changes in the information furnished by him in Form IV-GL "Certificate - In Vitro Testing with Radioactive Material Under General License." The report shall be furnished within 30 days after the effective date of such change.

6. Any person using radioactive material pursuant to the general license of subparagraph 1. of this paragraph is exempt from the requirements of Rule 420-3-26-.03 and 420-3-26-.10 of these rules with respect to radioactive materials covered by that general license, except that such persons using the mock iodine-125 described in paragraph 1.(viii) of this section shall comply with the provisions of 420-3-26-.03(38), 420-3-26-.03(51), and 420-3-26-.03(52) of Rule 420-3-26-.03.

Specific License (8) Filing of Application for Specific Licenses.

(a) Applications for specific licenses shall be filed on a form prescribed by the Agency.

(b) The Agency 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 Agency to determine whether the application should be granted or denied or whether a license should be 27

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 for a license may include a request for a license authorizing one or more activities.

(e) In his application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Agency provided such references are clear and specific.

(f) Applications and documents submitted to the Agency may be made available for public inspection except that the Agency may withhold any document or part thereof from public inspection if disclosure of its contents is not required in the public interest and would adversely affect the interest of a person concerned.

(g) An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

1. Identify the source or device by manufacturer and model number as registered with the U.S. Nuclear Regulatory Commission, or with an Agreement State, in the Sealed Source and Device Registry; or

2. The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

3. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(9) General Requirements for the Issuance of Specific Licenses. A license application will be approved if the Agency determines that:

(a) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these rules in such a manner as to minimize danger to public health and safety or property.;

(b) The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety of property.;

28

(c) The issuance of the license will not be inimical to the health and safety of the public; and.

(d) The applicant satisfied any applicable special requirements in this Rule 420-3-26-.02.

(10) Special Requirements for Issuance of Specific Licenses for Radioactive Materials.

(a) Human Use of Radioactive Materials. In addition to the requirements set forth in 420-3-26-.02(9) above, a specific license for human use of radioactive material in institutions will be issued only if:

1. The applicant has appointed a medical isotope committee, in accordance with 420-3-26-.07(19) to evaluate all proposals for research, diagnostic, and therapeutic use of radioisotopes performed under the license. Membership and functions of the committee are described in 420-3-26-.07(19); and.

2. The applicant possesses adequate facilities for the clinical care of patients; and.

3. The physician designated on the application as the individual user has substantial experience in handling and administration of radioisotopes and, where applicable, the clinical management of radioactive patients; and,.

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

5. An application from a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for non-commercial transfer to itself for medical use under Rule 420-3-26-.07 shall include:

(i) A request for authorization for the production of PET radionuclides, or evidence of an existing license issued under Rule 420-3-26-.07 for a PET radionuclide production facility from which it receives PET radionuclides.

(ii) Evidence that the applicant is qualified to produce radioactive drugs for medical use.

(iii) Identification of individual(s) authorized to prepare PET radioactive drugs if the applicant is a pharmacy and documentation that each individual meets the requirements of authorized nuclear pharmacist as specified in Rule 420-3-26-.02(10)(t)5.

(iv) Information identified in Rule 420-3-26-.02(10)(t)1.(iii) on the PET radioactive drugs for medical use to be transferred to itself.

29

(b) Licensing of Individual Physicians for Human Use of Radioactive Materials.

1. An application by an individual physician or groups of physicians for a specific license for human use of radioactive material will be approved if:

(i) The applicant satisfies the general requirements specified in 420-3-26-.02(9) of this Rule, 420-3-26-.02.;

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

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

(iv) The applicant has extensive experience in the proposed use, the handling and administration of radioisotopes, and where applicable, the clinical management of radioactive patients. Physicians who wish to be named as authorized users for the medical use of radioactive material must submit documentation that they meet the appropriate training and experience as specified in Rule 420-3-26-.07.

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

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

(I) The administration of radiopharmaceuticals for diagnostic or therapeutic pur-poses; (II) The performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered; (III) The performance of in vitro diagnostic studies; or (IV) The calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation, and diagnostic instrumentation; (ii) The physician brings the radioactive material with him and removes the radioactive material when he departs. (The institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient); and.

(iii) The medical institution does not hold a radioactive material license under 30

420-3-26-.02 (10)(a).

(c) Calibration or Reference Sources Containing Americium-241 or Radium-226:

Requirements for License to Manufacture or Initially Transfer. An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under Rule 420-3-26-.02(7)(a) will be approved if:

1. The applicant satisfies the general requirements of 420-3-26-.02(9).;

2. The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(i) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source.;

(ii) Details of construction and design.;

(iii) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source.;

(iv) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use.;

(v) Details of quality control procedures to be followed in manufacture of the source.;

(vi) Description of labeling to be affixed to the source or the storage container for the source.;

(vii) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the source.

3. Each source will contain no more than 5 microcuries of americium-241 or radium-226.

4. The Agency determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that:

(i) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and.

(ii) The source has been subjected to and has satisfactorily passed the prototype tests 31

prescribed by subparagraph 5. of this section.

5. The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.005 microcurie of americium-241 or radium-226 to tests as follows:

(i) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source.

(ii) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.

(iii) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in subparagraph 5.(iv) of this section.

(iv) Source designs are rejected for which the following has been detected for any unit. Removal of more than 0.005 microcurie of americium-241 or radium-226 from the source or any other evidence of physical damage.

6. Each person licensed under paragraph (c) shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:

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 (or RADIUM-226). DO NOT TOUCH THE RADIOACTIVE PORTION OF THIS SOURCE.

Name of manufacturer or initial transferor (d) Human Use of Sealed Sources. In addition to the requirements set forth in 420-3-26-.02(9) above, a specific license for human use of sealed sources will be issued only if the applicant, or if the application is made by an institution, the individual user:;

1. Has specialized training in the therapeutic use of the sealed source considered (teletherapy unit, beta applicator, etc.) as specified in Rule 420-3-26-.07 or has experience equivalent to such training, and.

2. Is a physician.

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(e) Multiple Quantities or Types of Radioactive Material for Use in Research and Development. In addition to the requirements set forth in 420-3-26-.02(9) above, a specific license for multiple quantities or types of radioactive material for use in research and develop-ment will be issued only if:

1. The applicant's staff has substantial experience in the use of a variety of radioisotopes for a variety of research and development uses; and,.

2. The applicant has established an isotope committee (composed of such persons as a radiological safety officer, a representative of the business office, and one or more persons trained or experienced in the safe use of radioactive materials) which will review and approve, in advance of purchase of radioisotopes, proposals for such use; and.

3. The applicant has appointed a radiological safety officer who will advise and assist on radiological safety issues.

(f) Serialization of Nationally Tracked Sources. Each licensee who manufactures a nationally tracked source after September 1, 2010, shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alphanumeric characters.

(g) Licensing the Manufacture and Initial Transfer of Devices to Persons Generally Licensed Under Rule 420-3-26-.02(7)(a).

1. An application for a specific license to manufacture or initially transfer devices containing radioactive material, excluding special nuclear materials to persons generally licensed under Rule 420-3-26-.02(7)(a) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

(i) The applicant satisfies the general requirements of 420-3-26-.02(9);).

(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instruction, and potential hazards of the device to provide reasonable assurance that:

(I) The device can be safely operated by persons not having training in radiological protection,.

(II) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits specified in 420-3-26-.03(6)., and 33

(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 15 rems blood-forming organs; gonads; or lens of eye Hands and forearms; feet and ankles, 200 rems localized areas of skin averaged over areas no larger than 1 square centimeter Other organs 50 rems (iii) Each device bears a durable, legible, clearly visible label or labels approved by the Agency, which contain in a clearly identified and separate statement:

(I) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information).;

(II) The requirement, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and.

(III) The information called for in the following statement in the same or substantially similar form:

The receipt, possession, use, and transfer of this device, Model ___________6 , 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 initial transferor)

(iv) Each device having a separable source housing that provides the primary 6

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 devices.

34

shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, Caution - Radioactive Material, the radiation symbol described in Rule 420-3-26-.03(27)(a), and the name of the manufacturer and initial distributor.

(v) Each device meeting the criteria of Rule 420-3-26-.02(7)(a)2.(xv) bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, Caution -

Radioactive Material, and if practicable, the radiation symbol described in Rule 420-3-26-.03(27)(a).

(vi) The device has been registered in the Sealed Source and Device Registry.

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, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Agency will consider information which includes, but is not limited to:

(i) Primary containment (source capsule);).

(ii) Protection of primary containment;.

(iii) Method of sealing containment;.

(iv) Containment construction materials;.

(v) Form of contained radioactive material;.

(vi) Maximum temperature withstood during prototype tests;.

(vii) Maximum pressure withstood during prototype tests;.

(viii) Maximum quantity of contained radioactive material;.

(ix) Radiotoxicity of contained radioactive material; and.

(x) Operating experience with identical devices or similarly designed and constructed devices.

3. In the event the applicant desires that the general license under 420-3 35

.02(7)(a), or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator or remove the device from installation, he shall include in his application written instructions to be followed by the general licensee, estimated annual 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 dose in excess of 10 percent of the limits specified in 420-3-26-.03(6).

4. Conditions of licenses.

(i) If a device containing radioactive material is to be transferred for use under a general license contained in Rule 420-3-26-.02(7)(a), each person that is licensed under this rule shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

(I) A copy of the general license contained in Rule 420-3-26-.02(7)(a); if paragraphs (ii), (iii) and (iv) of Rule 420-3-26-.02(7)(a)3. do not apply to the particular device, those paragraphs may be omitted.

(II) A copy of Rule 420-3-26-.02(7)(a), Rule 420-3-26-.02(30), Rule 420-3 .03(51), and Rule 420-3-26-.03(52).

(III) A list of the services that can only be performed by the general licensee;.

(IV) Information on acceptable disposal options including estimated costs of disposal; and.

(V) An indication that the policy of the Agency, other Agreement States, and the U.S.

Nuclear Regulatory Commission is to issue civil penalties for improper disposal.

(ii) If radioactive material is to be transferred in a device for use under an equivalent general license of another Agreement State or the U.S. Nuclear Regulatory Commission, each person that is licensed under Rule 420-3-26-.02(10)(f) shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

(I) A copy of the appropriate Agreement State or U.S. Nuclear Regulatory 36

Commission rules or regulations equivalent to Agency Rules 420-3-26-.02(7)(a),

420-3-26-.02(30), 420-3-26-.03(51), and 420-3-26-.03(52). If certain paragraphs of the regulations do not apply to a particular device, those paragraphs may be omitted.

(II) A list of the services that can only be performed by a specific licensee;.

(III) Information on acceptable disposal options including estimated costs of disposal; and.

(IV) The name or title, address, and phone number of the contact at the Agreement State regulatory agency or U.S. Nuclear Regulatory Commission office from which additional information can be obtained.

(iii) An alternative approach to informing customers may be proposed by the licensee for approval by the Agency.

(iv) Each device that is transferred after the effective date of this Rule rule must meet the labeling requirements in Rule 420-3-26-.02(10)(g)1.(iii) through (v).

(v) If a notification of bankruptcy has been made under Rule 420-3-26-.02(12)(e) or the license is to be terminated, each person licensed under Rule 420-3-26-.02(10)(g) shall provide, upon request, to the Agency, to the U.S. Nuclear Regulatory Commission, and to any appropriate Agreement State, records of final disposition required under paragraph (10)(g)5.(ii) of Rule 420-3-26-.02(10).

5. Material Transfer Reports and Records. Each person licensed under Rule 420-3-26-.02(10)(g) to initially transfer devices to generally licensed persons shall comply with the requirements of this rule.

(i) The person shall report by letter to the Director, Office of Radiation Control, P.O. Box 303017, Montgomery, Alabama 36130-3017 all transfers of such devices to persons for use under the general license in Rule 420-3-26-.02(7)(a) and all receipts of devices from persons licensed under Rule 420-3-26-.02(7)(a).The report must be submitted on a quarterly basis on a form prescribed by the Agency or in a clear and legible report containing all the data required by the form prescribed by the Agency.

(I) The required information for transfers to general licensees includes:

I. The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

II. The name, title, and phone number of the person identified as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements.;

37

III. The date of transfer.;

IV. The type, model number, and serial number of the device transferred; and.

V. The quantity and type of radioactive material contained in the device.

(II) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(III) For devices received from a Rule 420-3-26-.02(7)(a) licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(IV) If the licensee makes changes to a device possessed by a Rule 420-3-26-.02(7)(a) general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(V) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(VI) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(VII) If no transfers have been made to or from persons generally licensed under Rule 420-3-26-.02(7)(a) during the reporting period, the report must so indicate.

(ii) The person shall report all transfers of devices to persons for use under a general license in an Agreement State or in a state subject to regulations of the U.S. Nuclear Regulatory Commission that are equivalent to Rule 420-3-26-.02(7)(a) to the responsible Agreement State agency or the U.S. Nuclear Regulatory Commission, as appropriate. The report must be submitted on a form prescribed by the Agreement State or on U.S. Nuclear Regulatory Commission Form 653 - Transfers of Industrial Devices or in a clear and legible report containing all of the data required by the form.

(I) The required information for transfers to general licensees includes:

I. The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

II. The name, title, and phone number of the person identified by the general licensee 38

as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements.;

III. The date of transfer.;

IV. The type, model number, and serial number of the device transferred; and.

V. The quantity and type of radioactive material contained in the device.

(II). If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(III) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(IV) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(V) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(VI) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

(VII) If no transfers have been made to or from a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State or the U.S. Nuclear Regulatory Commission upon request of the agency.

(iii) The person shall maintain all information concerning transfers and receipts of devices that support the reports required by this rule. Records required by this rule must be maintained for a period of 3 years following the date of the recorded event.

(h) Use of Sealed Sources in Industrial Radiography7. In addition to the requirements set forth in 420-3-26-.02(9) above, a specific license for use of sealed sources in industrial radiography will be issued only if:

1. The applicant submits an adequate program for training radiographers and 7

Industrial radiography for the purpose of this paragraph means the examination of the macroscopic structure of materials by nondestructive methods of utilizing sources of radiation.

39

radiographers assistants that meets the requirements of Rule 420-3-26-.04(16).

2. The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.

3. The applicant submits written operating and emergency procedures as described in Rule 420-3-26-.04(17).

4. The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographers assistant at intervals not to exceed six 6 months as described in Rule 420-3-26-.04(16)(e).

5. The applicant submits a description of the applicants overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation and responsibility.

6. The applicant identifies and lists the qualifications of the individual(s) designated as the Radiation Safety Officer [(420-3-26-.04(15)) )]and potential designees responsible for ensuring that the licensees radiation safety program is implemented in accordance with approved procedures.

7. If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe procedures for performing and the qualifications of the person(s) authorized to do the leak testing. If the applicant intends to analyze wipe samples, the application must include a description of the procedures to be followed. The description must include the following:

i. Instruments to be used.;

ii. Methods of performing the analysis; and.

iii. Pertinent experience of the person who will analyze the wipe samples.

8. If the applicant intends to perform in-house calibrations of survey instruments, the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 420-3-26-.04(8).

9. The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.

10. The applicant identifies the locations where all records required by these Rules rules will be maintained.

40

(i) Multiple Quantities or Types of Radioactive Material for Use in Processing. In addition to the requirements set forth in 420-3-26-.02(9), a specific license for multiple quantities or types of radioactive material for use in processing for distribution to other authorized persons will be issued only if:8

1. The applicant's staff has substantial experience in the use of a variety of radioisotopes for processing and distribution and.

2. The applicant has appointed a radiological safety officer who will advise and assist on radiological safety matters.

(j) 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 420-3-26-.02(7)(g) will be approved if:

1. The applicant satisfies the general requirements specified in 420-3-26-.02(9).

2. The radioactive material is to be prepared for distribution in prepackaged units of:

(i) Iodine-125 in units not exceeding 10 microcuries (0.37 MBq) each.

(ii) Iodine-131 in units not exceeding 10 microcuries (0.37 MBq) each.

(iii) Carbon-14 in units not exceeding 10 microcuries (0.37 MBq) each.

(iv) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each.

(v) Iron-59 in units not exceeding 20 microcuries (0.74 MBq) each.

(vi) Cobalt-57 in units not exceeding 10 microcuries (0.37 MBq) each.

(vii) Selenium-75 in units not exceeding 10 microcuries (0.37 MBq) each.

(viii) Mock Iodine-125 in units not exceeding 0.05 microcuries (1.85 kBq) of Iodine-129 and 0.005 microcuries (0.185 kBq) of americium-241 each.

3. Each prepackaged unit bears a durable, clearly visible label:

8 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material, intended for use by the general public may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20545.

41

(i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (0.37 MBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75, 50 microcuries (1.85 MBq) of hydrogen-3 (tritium); 20 microcuries (0.74 MBq) of iron-59, or Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (0.185kBq) of americium-241 each; and.

(ii) Displaying the radiation caution symbol described in 420-3-26-.03(27) and the words, "CAUTION, RADIOACTIVE MATERIAL" and "NOT FOR INTERNAL OR EXTERNAL USE IN HUMANS OR ANIMALS."

4. The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

This radioactive material may be received, acquired, possessed, and used only by physi-cians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a General License of the U.S.

Nuclear Regulatory Commission or a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)

5. The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in 420-3-26-.03(38) of these rules.

(k) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Application.

1. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 420-3-26-.02(6)(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

(i) The applicant satisfies the general requirements specified in 420-3-26-.02(9);).

(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling and marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use 42

and transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar year a radiation dose in excess of 10 percent of the limits specified in 420-3-26-.03(6).

(iii) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium or a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

2. In the case of an industrial product or device whose unique benefits are questionable, the Agency will approve an application for a specific license under 420-3-26-.02(10)(k) only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

3. The Agency may deny any application for a specific license under 420-3-26-.02(10)(k) if the end use of the industrial product or device cannot be reasonably foreseen.

4. Each person licensed pursuant to 420-3-26-.02(10)(k) shall:

(i) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device.;

(ii) Label or mark each unit to:

(I) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device.;

(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 of an Agreement State; and.

(iii) Assure that the depleted uranium, before being installed in each product or device, has been impressed with the following legend clearly legible through any plating of other covering: "Depleted Uranium;"

(iv) (I) Furnish a copy of the general license contained in 420-3-26-.02(6)(d) and a copy of Agency Form GLDU to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in 420-3-26-.02(6)(d); or (II) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission or Agreement State's regulation equivalent to 420-3-26-.02(6)(d) and a copy of the 43

U.S. Nuclear Regulatory Commission or Agreement State's certificate; or alternatively, furnish a copy of the general license contained in 420-3-26-.02(6)(d) and a copy of Agency Form GLDU 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 420-3-26-.02(6)(d).

(v) Report to the Agency all transfers of industrial products or devices to persons for use under the general license in 420-326-.02(6)(d). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under 420-3-26-.02(6)(d) during the reporting period, the report shall so indicate.;

(vi) (I) Report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 40-25 of 10 CFR Part 40.

(II) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to 420-3 .02(10)(k) for use under a general license in that states regulations equivalent to 420-3-26-.02(6)(d).

(III) Such report shall identify each general licensee by name and address, an indi-vidual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.

(IV) If no transfers have been made to the 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 Agreement State during the reporting period, this information shall be reported to the responsible Agreement State.

(vii) Keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 420-3-26-.02(6)(d) or equivalent regulations of the U.S.

Nuclear Regulatory Commission or of an Agreement State. The records shall be maintained for 44

a period of 3 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.

(l) Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to 420-3-26-.02(10)(a) or (b) will be approved if:

1. The applicant satisfies the general requirements specified in 420-3-26-.02(9) of this Rule, 420-3-26-.02.;

2. The applicant submits evidence that:

(i) The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), a biologic product license issued by FDA; or (ii) The manufacture and distribution of the radioactive pharmaceutical 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; and.

4. (i) The label affixed to each package of the radiopharmaceutical-contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the Agency for distribution to persons licensed pursuant to 420-3-26-.02(10)(a) or (b) or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State.

(ii) The labels, leaflets or brochures required by 420-3-26-.02(10)(l)4.(i) 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.

(m) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive materialMaterial. 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 420-3-26-.02(10)(a) or (b) will be approved if:

1. The applicant satisfies the general requirements specified in 420-3-26-.02(9).;

45

2. The applicant submits evidence that:

(i) The generator or reagent kit is to be manufactured, labeled, and packaged in accordance with the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a biologic product license issued by FDA; or (ii) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.;

3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kits.;

4. The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and.

5. The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

(i) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and.

(ii) A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the Agency pursuant to 420-3-26-.02(10)(a) or (b) or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State. The labels, leaflets, or brochures required by 420-3-26-.02(10)(m) are in addition to the labeling required by FDA and they may be separate from or with the approval of FDA may be combined with the labeling required by FDA.

(n) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use.

1. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under 420-3-26-.07 for use as a calibration, transmission, or reference sources, or for the uses listed in Rules 420-3-26-.07(60),

(70), (72), and (90) will be approved if:

(i) The applicant satisfies the general requirements in Rule 420-3-26-.02(9).;

(ii) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

46

(I) The radioactive material contained, its chemical and physical form, and amount.;

(II) Details of design and construction of the source or device;.

(III) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;.

(IV) For devices containing radioactive material, the radiation profile of a prototype device;.

(V) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;.

(VI) Procedures and standards for calibrating sources and devices;.

(VII) Legend and methods for labeling sources and devices as to their radioactive content;.

(VIII) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: 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;.

(iii) 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 Agency has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in Rules 420-3-26-.07(35), (60), (70), and (72) as appropriate, and to persons who hold an equivalent license issued by the Agency, the NRC or an Agreement State.

(iv) The source or device has been registered in the Sealed Source and Device Registry.

2. (i) 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, the application shall include 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.

(ii) In determining the acceptable interval for test of leakage of radioactive material, the Agency will consider information that includes, but is not limited to:

47

(I) Primary containment (source capsule);).

(II) Protection of primary containment;.

(III) Method of sealing containment;.

(IV) Containment construction materials;.

(V) Form of contained radioactive material;.

(VI) Maximum temperature withstood during prototype tests;.

(VII) Maximum pressure withstood during prototype tests;.

(VIII) Maximum quantity of contained radioactive material;.

(IX) Radiotoxicity of contained radioactive material;.

(X) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(o) Licensing the Distribution of NARM in Exempt Quantities9

1. An application for a specific license to distribute NARM to persons exempted from these Rules rules pursuant to 420-3-26-.02(4)(e) will be approved if:

(i) The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to a human being;.

(ii) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity product, or device intended for commercial distribution, and.

(iii) The applicant submits copies of prototype labels and brochures and the Agency approves such labels and brochures.

2. The license issued under 420-3-26-.02(10)(o) is subject to the following 9

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 who are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C.

48

conditions:;

(i) No more than 10 ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

(ii) Each exempt quantity shall be separately and individually packaged. No more than 10 ten such packaged exempt quantities' shall be contained in any outer package for transfer to persons exempt pursuant to 420-3-26-.02(4)(e). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(I) Identifies the radionuclide and the quantity of radioactivity, and.

(II) Bears the words "Radioactive Material."

(iv) In addition to the labeling information required by 420-3-26-.02(10)(o)2.(iii), the label affixed to the immediate container, or an accompanying brochure shall:

(I) State that the contents are exempt from Agreement State requirements.,

(II) Bear the words, "Radioactive Material-Not for Human Use--Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited--Exempt Quantities Should Not Be Combined," ." and (III) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

3. Each person licensed under 420-3-26-.02(10)(o) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under 420-3-26-.02(4)(e) or the equivalent regulations of an Agreement State, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Agency. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to 420-3-26-.02(10)(o) during the reporting period, the report shall so indicate.

(p) Commercial Waste Disposal by Land Burial. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, source material milling, or for the conduct of any other activity which the Agency determines will significantly affect the quality of the environment, the Agency shall weigh the environmental, economic, technical, and other benefits against environmental costs and consider available alternatives. The Agency shall conclude that the issuance of the proposed license, with 49

any appropriate conditions to protect environmental values, justified before commencement of construction of the plant or facility in which the activity will be conducted. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant 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 site or the protection of environmental values.

(q) Special Financial Surety Requirements. In the case of an application for a license or an amendment to a license listed in subparagraph 4 below, financial surety arrangements must be made for site reclamation as follows:

1. Pursuant to Act 582, and as otherwise provided, financial surety arrangements for site reclamation which may consist of surety or performance bonds, cash deposits, certificate of deposit, deposits of government securities, letters or lines of credit, or any combination of the above for the categories of licensees listed in 420-3-26-.02(10)(q)4. shall be established 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 act and these Rulesrules.

(i) The amount of funds to be ensured by such surety arrangements shall be based on Agency approved cost estimates.

(ii) Self insurance, or any arrangement which essentially constitutes self insurance, will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through license requirements.

2. The arrangements required in 420-3-26-.02(10)(q)l. shall be established prior to issuance of the license to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility.

3. (Deleted 1998)

4. The following specific licensees are required to make financial surety arrangements:

(i) Major processors.;

(ii) Waste handling licensees; and.

(iii) Former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission licensed production and utilization facilities.

5. The following persons are exempt from the requirements of 50

420-3-26-.02(10) (q) 1.

(i) All Statestate, local, or other government agencies unless they are subject to 420-3-26-.02(10)(q)4.,.

(ii) Persons authorized to possess no more than 1,000 times the quantity specified in Schedule B of 420-3-26-.02 or combination of radioactive material listed therein as given in Schedule B, of 420-3-26-.02,.

(iii) Persons authorized to possess hydrogen-3 contained as hydrogen gas in a sealed source, or (iv) Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half life greater than 30 days.

(r) Long Term Care Requirements. Pursuant to Act 82-328 Code of Alabama and as otherwise provided, a long-term care fund shall be established by the following specific licensees prior to the issuance of the license or prior to the termination of the license if the applicant chooses at the time of the licensure to provide a surety in lieu of a long-term care fund:10

1. Waste handling licensees, and.

2. Source material milling licensees.

(s) Licensing Wireline Service Operations and Subsurface Studies. In addition to the requirements set forth in 420-3-26-.02(9) above, a specific license authorizing the use of radioactive material for wireline service operations and/or subsurface tracer studies will be issued only if:

1. The applicant has developed an adequate program for training logging supervisors and logging assistants and such program specifies the:

(i) Initial training.,

(ii) On-the-job training,.

(iii) Annual safety reviews provided by the licensee,.

(iv) Methods the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Agency Rules and the applicant's operating and emergency procedures, and.

10 Long-term care funding may also be required for former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission licensed facilities.

51

(v) Methods the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the Agency's Rules and the applicant's operating and emergency procedures;.

2. The applicant has developed and submitted to the Agency written operating and emergency procedures as described in 420-3-26-.12(16);).

3. The applicant has established and submits his program for annual inspections of the job performance of each logging supervisor to ensure that Agency Rules, license requirements, and the applicant's operating and emergency procedures are followed. Records of these inspections must be maintained for 3 years;.

4. The applicant submitted a description of his overall organizational structure as it applies to the radiation safety responsibilities in wireline service operations and in subsurface tracer studies, including specific delegations of authority;.

5. The applicant has or can contract for personnel with experience in the recovery of equipment lodged in wells;.

6. Evidence of a liability insurance policy for $1,000,000.00 to cover any liability as a result of any operations; and,.

7. If the applicant wishes to perform leak testing of sealed sources, he shall identify the manufacturers and model numbers of the leak test kit(s) to be used. If the applicant wishes to analyze his own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures including:;

(i) Instruments to be used,.

(ii) Methods of performing the analysis, and.

(iii) Pertinent experience of the person who will analyze the wipe samples.

(t) Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs Containing Radioactive Material for Medical Use Under Rule 420-3-26-.02(10)(a) or (b).

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to 420-3-26-.02(10)(a) or (b) and 420-3-26-.07 will be approved if:

(i) The applicant satisfies the general requirements specified in 420-3-26-.02(9),).

(ii) The applicant submits evidence that the applicant is at least one of the following:

(I) Registered with the U.S. Food and Drug Administration (FDA) as the owner or 52

operator of a drug establishment that engages in manufacture, preparation, propagation, compounding or processing of a drug under 21 CFR 207.20(a),).

(II) Registered or licensed with the Alabama Board of Pharmacy as a drug manufacturer, .

(III) Licensed as a pharmacy by the Alabama Board of Pharmacy,.

(IV) Operating as a nuclear pharmacy within a federal medical institution; or.

(V) A positron Emission Tomography (PET) drug production facility registered with the Agency.

(iii) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and.

(iv) The applicant satisfies the following labeling requirements:

(I) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL, the name of the radioactive drug or its abbreviation, and the quantity of radioactivity at a specified date and time.

For radioactive drugs with a half life greater than one hundred (100) days, the time may be omitted.

(II) A label is affixed to each syringe, vial or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee described in paragraph 1.(ii)(III), (IV) and (V) of this Rulerule:

(i) May prepare radioactive drugs for medical use as defined in 420-3-26-.07(2) provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraph 2.(ii) and (iii) of this section, or an individual under the supervision of an authorized nuclear pharmacist as described in 420-3-26-.07(22).

(ii) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(I) The individual qualifies as an authorized nuclear pharmacist as defined in 420-3-26-.07(2).

53

(II) The individual meets the requirements in 420-3-26-.07(28)(b) and 420-3-26-.07(30) and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or (III) The individual is authorized as an authorized nuclear pharmacist in accordance with paragraph (iii) of this section.

(iii) May allow a pharmacist to act as an authorized nuclear pharmacist if the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material at a pharmacy, at a government agency, or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009.

3. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement, or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta- or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition the licensee shall:

(i) As specified in 420-3-26-.07(32), perform tests on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary and.

(ii) Check each instrument for constancy and proper operation at the beginning of each day of use.

4. Nothing in this section relieves the licensee from applying with applicable FDA other Federal federal and State state requirements governing radioactive drugs.

5. To meet the requirements of Rule 420-3-26-.07(28), the licensee shall provide to the Agency:

(i) A copy of each individuals certification by a specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State with the written attestation signed by a preceptor as required by 420-3 .07(28)(b)2.; or (ii) The Agency, U.S. Nuclear Regulatory Commission, or an Agreement State license; or (iii) A U.S. Nuclear Regulatory Commission master material licensee permit; or (iv) The permit issued by a U.S. Nuclear Regulatory Commission master material permitee of broad scope or the authorization from a commercial nuclear pharmacy authorized to 54

list its own authorized nuclear pharmacists; or (v) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009; and (vi) A copy of the Alabama State Board of Pharmacy license.

6. A pharmacy authorized under Rule 420-3-26-.02(10)(a)5. to produce PET radioactive drugs for non-commercial transfer to itself that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of subparagraph 5.

(u) Licensing of Irradiators. A specific license for the use of radioactive material in an irradiator will be issued if the applicant satisfies the general requirements of 420-3-26-.02(9) and the following requirements:

1. The applicant must describe the training provided to irradiator operators including:

(i) Classroom training and on-the-job simulator training.;

(ii) Safety reviews.;

(iii) Means employed by the applicant to test each operators understanding of Agency rules, licensing requirements, and the operating, safety, and emergency procedures for the irradiator; and.

(iv) Minimum training and experience of personnel who provide training.

2. The application must include a copy of the written operating and emergency procedures listed in 420-3-26-.14(18) that describes the radiation safety aspects of the procedures.

3. The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authority of the radiation safety officer and those management personnel who have radiation safety responsibility or authority. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer.

4. The application must include a description of the access control systems required by 420-3-26-.12(7), the radiation monitors described by 420-3-26-.14(10), the method of detecting leaking sources required by 420-3-26-.14(21), including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

55

5. If the applicant intends to perform leak testing, the applicant shall establish procedures for performing leak testing of dry-source-storage sealed sources and submit a copy of these procedures to the Agency. The procedures must include:

(i) Methods of collecting leak test samples;.

(ii) Qualifications of the individual who collects the samples;.

(iii) Instruments to be used; and.

(iv) Methods of analyzing the samples.

6. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading and unloading at its facility, the loading or unloading must be done by persons specifically authorized by the Agency, the U.S. Nuclear Regulatory Commission, or an Agreement State to load or unload irradiator sources.

7. The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 420-3-26-.14(22).

(v) Initial Transfer of Source Material for Use Under Small Quantities of Source Material General License.

1. An application for a specific license to initially transfer source for use under Rule 420-3-26-.02(6), or equivalent regulations of the U.S. Nuclear Regulatory Commission or another Agreement State, will be approved if:

(i) The applicant satisfies the general requirements of Rule 420-3-26-.02(9):).

(ii) The applicant submits sufficient information on, and the Agency approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.

2. Each person licensed under paragraph (v)1. shall:

(i) Label the immediate container of each quantity of source material with the type of source material and quantity of material and the words radioactive material; . and (ii) Ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records; and.

(iii) Provide the information specified in this paragraph to each person to whom source material is transferred for use under Rule 420-3-26-.02(6) or equivalent provisions in U.S.

56

Nuclear Regulatory Commission or another State regulation. This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

(I) A copy of Rules 420-3-26-.02(6) and 420-3-26-.02(18) or equivalent regulations of the U.S. Nuclear Regulatory Commission or another Agreement States; and.

(II) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

(iv) Report transfers as follows:

(I) File a report with the Agency. The report shall include the following information:

I. The name, address, and license number of the person who transferred the source material; .

II. For each general licensee under Rule 420-3-26-.02(6) or equivalent U.S. Nuclear Regulatory Commission or another Agreement State provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar year, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and.

III. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

(II) File a report with the U.S. Nuclear Regulatory Commission or each responsible Agreement State that identifies all persons, operating under provisions equivalent to Rule 420 26-.02(6), to whom greater than 50 grams (0.11lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers to U.S. Nuclear Regulatory Commission jurisdiction or the Agreement State being reported to:

I. The name, address, and license number of the person who transferred the source material: and.

II. The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.

III. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within U.S. Nuclear Regulatory Commission and other Agreement State jurisdictions.

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(III) Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under Rule 420-3-26-.02(6) during the current period, a report shall be submitted to the Agency indicating so. If no transfers have been made to general licensees in U.S. Nuclear Regulatory Commission jurisdiction or a particular Agreement State during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission or the responsible Agreement State agency upon their request.

3. Each person licensed under paragraph (v)1. shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of 1 year after the event is included in a report to the Agency, U.S. Nuclear Regulatory Commission, or another Agreement State.

(w) Licensing of Radium in Property, Products, or Material Containing Radium in Concentrations Sufficient to Cause an Individual to Receive a Total Effective Dose Equivalent (TEDE) in Excess of 25 Millirem (0.25 mSv) in One 1 Year.

1. Except as provided by Rule 420-3-26-.02(4)(a)4. and 5., any individual who receives, possesses, uses, transfers, owns, or acquires property, structures, products, or materials containing radium in concentrations exceeding 5 picocuries/gram (0.185 Bq/g), excluding background, shall make application to the Agency for a radioactive material license which authorizes the receipt, possession, transfer, and use of such property, structures, equipment, products, or materials.

(x) Requirements for Licensing the Manufacture, Assembly, Repair or Initial Transfer of Luminous Safety Devices for Use in Aircraft.

1. An application for a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 420-3-26-.02(7)(c), will be approved if all the following are met:

(i) The applicant satisfies the general requirements specified in 420-3-26-.02(9) of this chapter.;

(ii) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(I) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device.;

(II) Details of construction and design.;

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(III) Details of the method of binding or containing the tritium or promethium-147.;

(IV) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;.

(V) Quality assurance procedures to be followed that are sufficient to ensure compliance with the requirements of this section; and.

(VI) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the safety of the device.

(iii) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad (5 microgray) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.

(iv) The Agency determines that:

(I) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions that are likely to be encountered in normal use and handling of the device;.

(II) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;.

(III) The device is so designed that it cannot easily be disassembled; and.

(IV) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (v) of this section.

(v) The applicant shall subject at least five prototypes of the device to tests as follows:

(I) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(II) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (v)(III) of this section.

(III) Device designs are rejected for which the following has been detected for any unit:

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I. A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; or II. Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or III. Any other evidence of physical damage.

(vi) The device has been registered in the Sealed Source and Device Registry.

2. Each person licensed under 420-3-26-.02(10)(x) shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147.

3. Each person licensed under this paragraph shall:

(i) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and.

(ii) Subject inspection lots to acceptance sampling procedures, by procedures specified in 420-3-26-.02(10)(x)4. of this section and in the license issued under 420-3 .02(10)(x), to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

4. The licensee shall subject each inspection lot to:

(i) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.

(ii) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria:

(I) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device;.

(II) Levels of radiation in excess of 0.5 millirad (5 microgray) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and.

(III) Any other criteria specified in the license issued under this paragraph.

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5. No person licensed under this paragraph shall transfer to persons generally licensed under 420-3-25-.02, or an equivalent general license of the U.S. Nuclear Regulatory Commission or an Agreement State:

(i) Any luminous safety device tested and found defective under any condition of a license issued under 420-3-26-.02(10)(x) unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (ii) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in 420-3-26-.02(10)(x)3.(ii) of this section, unless:

(I) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under 420-3-26-.02(10)(x); and.

(II) Each individual sub-lot is sampled, tested, and accepted in accordance with 420-3-26-.02(10)(x)3.(ii) and 5.(ii)(I) and any other criteria that may be required as a condition of the license issued under this paragraph.

6. Each person licensed under 420-3-26-.02(10)(x) shall file an annual report with Agency, by method specified in 420-3-26-.01(12), which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under this paragraph. The report must identify each general licensee by name, 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 must cover the year ending December 31 and must be filed within 30 days thereafter. If no transfers have been made to persons generally licensed under this paragraph during the reporting period, the report must so indicate.

7. Each person licensed under this paragraph shall report annually all transfers of devices to persons in another Agreement State or the U.S. Nuclear Regulatory Commission for use under general license regulations that are equivalent to this rule. Reports shall be sent to the responsible Agreement State agency or the U.S. Nuclear Regulatory Commission. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made into a particular Agreement State or the U.S. Nuclear Regulatory Commission jurisdiction during the reporting period, this information must be reported to the responsible Agreement State agency or the U.S. Nuclear Regulatory Commission upon request.

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(y) Ice Detection Devices Containing Strontium-90; Requirements for License to Manufacture or Initially Transfer.

1. An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under 420-3-26-.02(7) of this chapter will be approved if all the following are met:

(i) The applicant satisfies the general requirements specified in 420-3-26-.02(9) of this chapter.;

(ii) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(I) Chemical and physical form and maximum quantity of strontium-90 in the device;.

(II) Details of construction and design of the source of radiation and its shielding;.

(III) Radiation profile of a prototype device;.

(IV) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use; (V) Details of quality control procedures to be followed in manufacture of the device;.

(VI) Description of labeling to be affixed to the device;.

(VII) Instructions for handling and installation of the device; and,.

(VIII) Any additional information, including experimental studies and tests required by the Agency to facilitate a determination of the safety of the device;.

(iii) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;.

(iv) Each device will bear durable, legible labeling that includes the radiation caution symbol prescribed by 420-3-26-.03(27) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;.

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(v) The Agency determines that:

(I) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions that are likely to be encountered in normal use and handling of the device;.

(II) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;.

(III) The device is so designed that it cannot be easily disassembled;.

(IV) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by 420-3-26-.02(10)(y)1.(vi).

(V) Quality control procedures have been established to satisfy the requirements of this section.

(vi) The applicant shall subject at least five prototypes of the device to tests as follows:

(I) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(II) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in 420-3-26-.02(10)(y)1.(vi)(III).

(III) Device designs are rejected for which the following has been detected for any unit:

I. A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or II. Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or III. Any other evidence of physical damage.

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(vii) The device has been registered in the Sealed Source and Device Registry.

(viii) Each person licensed under this paragraph shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(ix) Each person licensed under this paragraph shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(x) Each person licensed under this paragraph shall:

(I) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and.

(II) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph 420-3-26-.02(10)(y)1.(xi) and in the license issued under 420-3 .02(10)(y), to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded.

(xi) Each person licensed under 420-3-26-.02(10)(y) shall subject each inspection lot to:

(I) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(II) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under 420-3-26-.02(10)(y).

(xii) No person licensed under this paragraph shall transfer to persons generally licensed under 420-3-26-.02(7)(f) of this chapter, or under an equivalent general license of an Agreement State:

(I) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under this paragraph, unless the defective ice 64

detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (II) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph 420-3 .02(10)(y) 1.(x)(II) of this section, unless:

I. A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under this paragraph; and.

II. Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs 420-3-26-.02(10)(y)1.(x)(II) and 420-3-26-.02(10)(y)1.(xii)(II)I. and any other criteria as may be required as a condition of the license issued under 420-3-26-.02(10)(y).

(z) Registration of product information.

1. Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the Agency for evaluation of radiation safety information about its product and for its registration.

2. The request for review must be sent to the Agency at the address specified in 420-3-26-.01(12).

3. The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses, and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

4. The Agency normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Agency formulates reasonable standards and criteria with the help of the manufacturer or distributor. The Agency shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

5. After completion of the evaluation, the Agency issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

6. The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

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(i) The statements and representations, including quality control program, contained in the request; and.

(ii) The provisions of the registration certificate.

7. Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(i) Calibration and reference sources containing no more than:

(I) 1 millicurie (37 MBq), for beta and/or gamma emitting radionuclides; or (II) 0.01 millicurie (0.37 MBq), for alpha emitting radionuclides; or (ii) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and (I) The intended recipients are licensed under this chapter or comparable provisions of the U.S. Nuclear Regulatory Commission or an Agreement State; or (II) The recipients are authorized for research and development; or (III) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 20 curies (740 GBq) of tritium or 200 millicuries (7.4 GBq) of any other radionuclide.

8. After the certificate is issued, the Agency may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Agency will complete its evaluation in accordance with criteria specified in this section. The Agency may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

9. A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Agency shall request inactivation of the registration certificate. Such a request must be sent to the Agency at the address specified in 420-3-26-.01(12), and must normally be made no later than 2 years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased.

However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than 2 years after that transfer, the certificate holder shall request inactivation of 66

the certificate within 90 days of this determination and briefly describe the circumstances of the delay.

10. If a distribution license is to be terminated in accordance with 420-3-25-.02(13),

the licensee shall request inactivation of its registration certificates associated with that distribution license before the Agency will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

11. A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, even if the certificate is inactive.

(11) Issuance of Specific Licenses.

(a) Upon a determination that an application meets the requirements of the Act and the rules of the Agency, the Agency 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 Agency may refuse to issue a license to any person who has been refused issuance or renewal of a license, by authority of the Agency, another Agreement State, Licensing State, or the Nuclear Regulatory Commission, or whose license has been revoked, suspended, or restricted by such licensing authority, if such suspension, revocation, or restriction has occurred within 1 calendar year. If it is a repeat suspension, revocation, or restriction, then the period for refusal is 2 years.

(12) Specific Terms and Conditions of Licenses.

(a) Each license issued pursuant to this Rule, 420-3-26-.02, shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations, and orders of the Agency.

(b) 1. No license issued or granted pursuant to this Rule rule nor any right under a license shall be transferred, assigned, or in any manner disposed of, either voluntarily, directly or indirectly, through transfer of control of any license to any person, unless the Agency shall, after securing full information, find that the transfer is in accordance with the provisions of the Act act and shall give consent in writing.

2. An application for transfer of license must include:

(i) The identity, technical, and financial qualifications of the proposed transferee; and.

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(ii) Financial assurance for decommissioning information required by 420-3-26-.02(26).

(c) Each person licensed by the Agency pursuant to this Rule, 420-3-26-.02, shall confine his use and possession of the material licensed to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to this Rule rule shall carry with it the right to receive, acquire, own, and possess radioactive material.

Preparation for shipment and transport of radioactive material shall be in accordance with transportation requirements specified in Rules 420-3-.02(21), (22), (23), and (24).

(d) Each licensee shall notify the Agency in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

(e) 1. Each licensee, including licensees required to register by Rule 420-3-26-.02(7)(a)2.(xv), shall notify the Agency, 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:

(i) The licensee;.

(ii) 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 (iii) An affiliate [as that term is defined in 11 U.S.C. 101 (2)] of the licensee.

2. This notification must indicate:

(i) The bankruptcy court in which the petition for bankruptcy was filed; and,.

(ii) The date of the filing of the petition.

(f) Licensees required to submit emergency plans by 420-3-6-.02(27)(a) shall follow the emergency plan approved by the Agency. The licensee may change the approved plan only if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the Agency and to affected offsite response organizations within 6 months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Agency.

(g) Each portable gauge licensee shall use, at a minimum, two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(h) The Agency may incorporate, in any license issued pursuant to this Rulerule, at the time of issuance, or thereafter by appropriate rule, license condition, or order, such additional 68

requirements with respect to the receipt, possession, use, and transfer of radioactive material as it deems appropriate or necessary in order to:

1. Protect health or to minimize danger to life or property.;

2. Require such reports and the keeping of such records and to provide for such inspections as may be necessary or appropriate to effectuate the purpose of the Act act and the Rules rules thereunder.

(i) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with 420-3-26-.07(49). The licensee shall record the results of each test and retain each record for 3 years after the record is made.

(j) Deliberate misconduct

1. This section applies to any:

(i) Licensee;.

(ii) Certificate holder;.

(iii) Quality assurance program approval holder;.

(iv) Applicant for a license, certificate, or quality assurance program approval;.

(v) Contractor (including a supplier or consultant) or subcontractor to any person identified in paragraph (j)1. of this section; or.

(vi) Employees of any person identified in paragraph (j)1. of this section.

2. A person identified in paragraph 1. of this section who knowingly provides to any entity, listed in paragraph 1. of this section, any components, materials, or other goods or services that relate to a licensee's, certificate holder's, quality assurance program approval holder's, or applicant's activities subject to this part may not:

(i) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate holder, quality assurance program approval holder, or any applicant to be in violation of any rule, regulation, or order; or any term, condition or limitation of any license, certificate, or approval issued by the Agency; or (ii) Deliberately submit to the Agency, a licensee, a certificate holder, quality assurance program approval holder, an applicant for a license, certificate or quality assurance program approval, or a licensee's, applicant's, certificate holder's, or quality assurance program 69

approval holder's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Agency.

3. A person who violates paragraph 2.(i) or 2.(ii) of this section may be subject to enforcement action in accordance with the procedures in 420-3-26-.13.

4. For the purposes of paragraph (ii)(I) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:

(i) Would cause a licensee, certificate holder, quality assurance program approval holder, or applicant for a license, certificate, or quality assurance program approval to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license or certificate issued by the Agency; or (ii) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate holder, quality assurance program approval holder, applicant, or the contractor or subcontractor of any of them.

(13) Renewal, Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas.

(a) Each specific license expires at the end of the day on the expiration date stated in the license, unless the licensee has filed an application for renewal in accordance with 420-3-26-.02(8) not less than 30 days before the expiration date stated in the existing license. If an application for renewal has been filed at least 30 days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the Agency makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(b) Each specific license revoked by the Agency expires at the end of the day on the date of the Agency's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Agency Order.

(c) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the Agency notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

1. Limit actions involving radioactive material to those related to decommissioning; and.

2. Continue to control entry to restricted areas until they are suitable for release in accordance with Agency requirements.

(d) Within 60 days of the occurrence of any of the following each licensee shall provide notification to the Agency in writing of such occurrence, and either begin 70

decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with Agency requirements, or submit within 12 months of notification a decommissioning plan, if required by 420-3-26-.02(13)(g)1., and begin decommissioning upon approval of that plan if:

1. The license has expired pursuant to 420-3-26-.02(13)(a) or (b) of this section; or

2. The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Agency requirements; or

3. No principal activities under the license have been conducted for a period of 24 months; or

4. No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Agency requirements.

(e) Coincident with the notification required by 420-3-26-.02(13)(d), the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to Rule 420-3-26-.02 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to 420-3-26-.02(13)(g)(4)(v).

1. Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective.

2. Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Commission.

(f) The Agency may grant a request to extend the time periods established in 420-3-26-.02(13)(d) if the Agency determines that this relief is not detrimental to public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to 420-3-26-.02(13)(d). The schedule for decommissioning set forth in 420-3-26-.02(13)(d) may not commence until the Agency has made a determination on the request.

(g) 1. A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Agency and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

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(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; (ii) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; (iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or (iv) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

2. The Agency may approve an alternate schedule for submittal of a decommissioning plan required pursuant to 420-3-26-.02(13)(d) if the Agency determines that the alternative schedule is necessary for the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

3. Procedures such as those listed in 420-3-26-.02(13)(g)(1) with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.

4. The proposed decommissioning plan for the site or separate building or outdoor area must include:

(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;.

(ii) A description of planned decommissioning activities;.

(iii) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;.

(iv) A description of the planned final radiation survey; and.

(v) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(vi) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in 420-3-26-.02(13)(h)2.

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5. The proposed decommissioning plan will be approved by the Agency if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

(h) 1. Except as provided in paragraph 420-3-26-.02(13)(h)2.(i), licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.

2. Except as provided in paragraph 420-3-26-.02(13)(h)2.(i) of this section, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.

(i) The Agency may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Agency determines that the alternative is warranted by consideration of the following:

1. Whether it is technically feasible to complete decommissioning within the allotted 24-month period;.

2. Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;.

3. Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;.

4. Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and.

5. Other site-specific factors which the Agency may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(j) As the final step in decommissioning, the licensee shall:

1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed Agency Form DRM or equivalent information; and.

2. Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in Rule 420-3-26-.03(60) and (61). The licensee shall, as appropriate:

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(i) Report levels of gamma radiation in units of microroentgen (millisieverts) per hour at one 1 meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of disintegrations per minute or microcuries (megabecquerels) per 100 square centimeters (removable and fixed) for surfaces, microcuries (megabecquerels) per milliliter for water, and picocuries (becquerels) per gram for solids such as soils or concrete; and.

(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(k) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Agency determines that:

1. Radioactive material has been properly disposed;.

2. Reasonable effort has been made to eliminate residual radioactive contamination, if present; and.

3. (i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 420-3-26-.03; or (ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 420-3-26-.03.

4. Records required by 420-3-26-.02(30)(d) and (f) have been received.

(14) Reserved.

(15) Amendment of Licenses at Request of Licensee. Applications for amendment of a license shall be filed in accordance with 420-3-26-.02(8) and shall specify the respects in which the licensee desires his license to be amended and the grounds for such amendment.

(16) Agency Action on Applications to Renew or Amend. In considering an application by a licensee to renew or amend his license, the Agency will apply criteria set forth in 420-3-26-.02(9) and 420-3-26-.02(10), as applicable.

(17) Inalienability of Licenses.

(a) No license issued or granted under this Rule rule and no right to possess or utilize radioactive material granted by any license issued pursuant to this Rule 420-3-26-.02 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 Agency 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.

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(b) An application for transfer of license must include:

1. The identity, technical, and financial qualifications of the proposed transferee and.

2. Financial assurance for decommissioning information required by Rule 420-3 .03, as applicable.

(18) Transfer of Material.

(a) No licensee shall transfer radioactive material except as authorized pursuant to this section.

(b) Any licensee may transfer radioactive material:

1. To the Agency;.

2. To the U.S. Department of Energy;.

3. To any person exempt from the regulations in this Rule 420-3-26-.02 to the extent permitted under such exemption;.

4. To any person authorized to receive such material under the terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or any Agreement State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Agency, or any Agreement State; or

5. As otherwise authorized by the Agency in writing.

(c) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of 420-3-26-.02(21).

(d) Before transferring radioactive material to a specific license of the Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State, or to a general licensee who is required to register with the Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

(e) The following methods for verification required by 420-3-26-.02(18)(d) are acceptable:

1. The transferor may have in his possession and read, a current copy of the transferee's specific license; 75

2. The transferor may have in his possession a written certificate by the transferee that he is authorized by license to receive the type, form, and quantity of radioactive material to be transferred, specifying the license number, issuing agency, and expiration date;

3. For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license to receive the type, form, and quantity of radioactive material to be transferred, specifying the license number, issuing agency, and expiration date; provided that the oral certification is confirmed in writing within 10 days;

4. The transferor may obtain other sources of information compiled by a reporting service from official records of the Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State as to 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 420-3-26-.02(18)(e)l.

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 Agency, the U.S. Nuclear Regulatory Commission, Licensing State, or the licensing agency of an Agreement State that the transferee is licensed to receive the radioactive material.

(19) Modification, Revocation, and Termination of Licenses.

(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the Agency.

(b) Any license may be revoked, suspended, or modified in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by application or statement of fact of any report, record, or inspection or other means which would warrant the Agency 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 the license, or of any rule, regulation, or order of the Agency.

(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 therefore, the 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.

(d) The Agency may terminate a specific license upon request submitted by the licensee to the Agency in writing.

(e) The Agency may suspend, revoke, or amend any license in the event that the 76

person to whom such license was granted has a license revoked, suspended, or restricted by a licensing authority of another Agreement State or the U.S. Nuclear Regulatory Commission.

(f) The Agency may cause the withholding or recall of radioactive material from any licensee who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Agency, or who uses such materials in violation of law or regulation of the Agency, or in a manner other than disclosed in the application therefore or approved by the Agency.

(20) Reciprocal Recognition of Licenses.

(a) Subject to these Rulesrules, any person who holds a specific license from the U.S.

Nuclear Regulatory Commission, Licensing State, or any 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 with this state for a period not in excess of 30 days in any calendar year provided that:

1. The licensing document does not limit the activity authorized by such document to specified installations or locations; and.

2. The out-of-state licensee notifies the Agency in writing at least 3 days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the 3- day period would impose an undue hardship on the out-of-state licensee, he may, upon application to the Agency, obtain permission to proceed sooner. The Agency may waive the requirement for filing additional written 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 this section, and,.

3. The out-of-state licensee complies with the applicable rules of the Agency and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable rules of the Agency; and.

4. The out-of-state licensee supplies such other information as the Agency may request; and,.

5. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in this section except by transfer to a person;:

(i) Specifically licensed by the Agency or by the U.S. Nuclear Regulatory Commission, Licensing State, to receive such material; or 77

(ii) Exempt from the requirements for such material under 420-3-26-.02(4)(a).

(b) Notwithstanding the provisions of paragraph (a) of this section, any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State to authorize the holder to manufacture, transfer, install, or service a device described in Rule 420-3-26-.02(7)(a). within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, or service such a device in this State state provided that:

1. Such person shall file a report with the Agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general license 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.

2. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission, Licensing State, or an Agreement State.

3. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement the "Removal of this label is prohibited.; and,

4. 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 Rule 420-3-26-.02(7)(a).

(c) The Agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another Agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazards to public health and safety or property.

(21) Transportation of Radioactive Material.

(a) Incorporation by reference.

1. Except as provided in this chapter, the requirements of 10 CFR Part 71 (relating to packaging and transportation of radioactive material) are incorporated by reference.

2. Notwithstanding the requirements incorporated by reference, 10 CFR 71.2, 71.6, 71.11, 71.14(b), 71.19, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.70, 71.71, 71.73, 71.74, 71.75, 71.77, 71.85(a),(b),

and (c), 71.91(b), 71.99, 71.100, 71.101(c)(2), (d) and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125 are not incorporated by reference.

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(b) Effect of incorporation of 10 CFR Part 71.

1. To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 71 (relating to packaging and transportation of radioactive material), the following words and phrases shall be substituted for the language in 10 CFR Part 71 as follows:

(i) A reference to NRC or Commission means Agency.

(ii) A reference to NRC or Agreement State means Agency, NRC, or Agreement State.

(iii) Notifications, reports, and correspondence referenced in the incorporated parts of 10 CFR Part 71 shall be directed to the Agency.

(c) Communications. Notwithstanding the incorporation by reference of 10 CFR 71.1 (relating to communications and records), all communications concerning the requirements of this chapter should be sent to the Alabama Office of Radiation Control, P.O. Box 303017, Montgomery, Alabama 36130-3017.

(d) In addition to the incorporation by reference of 10 CFR Part 71 (relating to packaging and transportation of radioactive material), if Chapter 420-3-26-.02 (relating to transportation) or the regulations of the United States Department of Transportation in 49 CFR Parts 171180 and 388397 do not apply to a shipment of licensed material, the licensee shall conform to the standards and requirements of those regulations to the same extent as if the shipment was subject to the regulations.

(22) Exemptions.

(a) On application of any interested person or on its own initiative, the Agency may grant any exemption from the requirements of the regulations in this part that it determines is authorized by law and will not endanger life or property nor the common defense and security.

(b) Common and contract carriers, freight forwarders, and warehousemen are exempt from these rules to the extent that they transport or store radioactive material in the regular course of their carriage for another or storage incident thereto.

(c) Any licensee who delivers radioactive material to a carrier for transport, where such transport is subject to the regulations of the U.S. Postal Service, is exempt from the provisions of 420-3-26-.02(21).

(23) Intrastate Transport.

(a) A general license is hereby issued to any common or contract carrier to receive, possess, transport, and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with 79

the applicable requirements of the regulations appropriate to the mode of transport, of the U.S.

Department of Transportation and incorporated sections of 10 CFR Part 71 (relating to packaging and transportation of radioactive material) of the U.S. Nuclear Regulatory Commission insofar as such regulations relate to the loading and storage of packages, shipping papers, placarding of the transporting vehicle, and incident reporting.11 (b) A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the U.S. Department of Transportation and incorporated sections of 10 CFR Part 71 (relating to packaging and transportation of radioactive material) of the U.S. Nuclear Regulatory Commission insofar as such regulations relate to the loading and storage of packages, shipping papers, placarding of the transporting vehicle, and incident reporting.11 (c) Persons who transport radioactive material pursuant to the general licenses in 420-3-26-.02(23)(a) or (b) are exempt from the requirements of Rule 420-3-26-.03 and Rule 420-3-26-.10 of these rules to the extent that they transport radioactive material.

(24) Preparation of Radioactive Material for Transport. A general license is hereby issued to a licensee to deliver radioactive material to a carrier12 for transport provided that:

(a) The licensee complies with the applicable requirements of the regulation, appropriate to the mode of transport, of the U.S. Department of Transportation and incorporated sections of 10 CFR Part 71 (relating to packaging and transportation of radioactive material) of the U.S. Nuclear Regulatory Commission insofar as such regulations relate to the packaging of radioactive material, providing shipping papers, and to the monitoring, marking, and labeling of those packages.

(b) The licensee has established procedures for safely opening and closing packages in which radioactive material is transported and to assure that prior to the delivery to a carrier for transport, each package is properly closed for transport.

(c) Prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee.

(25) Reserved.

11 Any notification of incidents referred to in those requirements shall be filed with, or made to, the Agency.

12 For the purpose of this rule, a licensee who transports his own licensed material as a private carrier is considered to have delivered such material to a carrier for transport.

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(26) Financial Assurance and Recordkeeping for Decommissioning.

Notwithstanding and in addition to the financial requirements specified in this Rule, 420-3-26-.02, the following shall apply with regard to decommissioning fund requirements:

(a) Each applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in Appendix F to Rule 420-3-26-.03 shall submit a decommissioning funding plan as described in 420-3-26-.02(26)(f). The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Appendix F to Rule 420-3-26-.03.

(b) Each holder of, or applicant for any specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities specified in Appendix F of Rule 420-3-26-.03 (or when a combination of isotopes are involved if R, as defined in 420-3-26-.02(26)(a), divided by 1012 is greater than 1) shall submit a decommissioning funding plan as described in 420-3-26-.02 (26)(g).

(c) Each applicant for a specific license authorizing the possession and use of radioactive material of half-life greater than 120 days and in quantities specified in 420-3-26-.02(26)(e) shall either:

1. Submit a decommissioning funding plan as described in 420-3-26-.02(26)(f); or

2. Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by 420-3-26-.02(26)(e) using one of the methods described in 420-3-26-.02(26)(g). For an applicant, this certification may state that the appropriate assurance will be obtained after the applicant has been approved and the license issued but prior to the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirement of paragraph (g) of this section must be submitted to the Agency before receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the Agency a signed original of the financial instrument obtained to satisfy the requirements of paragraph (g) of this section.

(d) 1. Each holder of a specific license issued on or after October 1, 1991, which is of a type described in 420-3-26-.02(26)(a) or (b), shall provide financial assurance for decommissioning in accordance with the criteria set forth in this Rule 420-3-26-.02(26).

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2. Each holder of a specific license issued before October 1, 1991, and of a type described in 420-3-26-.02(26)(a) shall submit, on or before January 1, 1992, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount equal to

$1,125,000 in accordance with the criteria set forth in this Rule 420-3-26-.02(26). If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal.

3. Each holder of a specific license issued before October 1, 1991, and of the type described in 420-3-26-.02(26)(b) shall submit, on or before January 1, 1992, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this Rule, 420-3-26-.02(26).

4. Any licensee who has submitted an application before October 1, 1991, for renewal of license in accordance with 420-3-26-.02(14) shall provide financial assurance for decommissioning in accordance with this Rule 420-3-26-.02(26). This assurance must be submitted when this rule becomes effective October 1, 1991.

5. Waste collectors and waste processors, as defined in Appendix G to Rule 420 26-.03 must provide financial assurance in an amount based on a decommissioning funding plan as described in Rule 420-3-26-.02(26). The decommissioning funding plan must include the cost of disposal of the maximum amount (curies) of radioactive material permitted by license, and the cost of the disposal of the maximum quantity, by volume, of radioactive material which could be present at the licensees facility at any time, in addition to the cost to remediate the licensees site to meet the criteria of Rule 420-3-26-.03. The decommissioning funding plan must be submitted by December 2, 2006.

(e) Table of required amounts of financial assurance for decommissioning by quantity of material. Licensees required to submit the $1,125,000 amount must do so by December 2, 2006. Licensees required to submit the $113,000 or $225,000 amount must do so by June 2, 2007. Licensees having possession limits exceeding the upper bounds of this table must base financial assurance on a decommissioning funding plan. For quantities:

1. Greater than 104 but less than or equal to 105 times $1,125,000 the applicable quantities of Appendix F of 420-3-26-.03 in unsealed form. (For a combination of isotopes, if R, as defined in 420-3-26-.02(26)(a), divided by 104, is greater than 1 but R divided by 105 is less or equal to 1)

2. Greater than 103 but less than or equal to 104 times $225,000 the applicable quantities of Appendix F of 420-3-26-.03 in unsealed form. (For a combination of isotopes, if R, as defined in 420-3-26-.02(26)(a), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1) 82

3. Greater than 1010 but less than or equal to 1012 times $113,000 the applicable quantities of Appendix F of 420-3-26-.03 in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in 420-3-26-.02(26)(a) divided by 1010 is greater than 1, but R divided by 1012 is less than or equal to 1)

(f) 1. Each decommissioning funding plan must be submitted for review and approval and must contain:

(i) A detailed cost estimate for decommissioning, in an amount reflecting:

I. The cost of an independent contractor to perform all decommissioning activities;.

II. The cost of meeting the criteria for unrestricted use specified in 420-3-26-.03(60),

provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 420-3-26-.03(60), the cost estimate may be based on meeting the 420-3-26-.03(60) criteria;.

III. The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and.

IV. An adequate contingency factor.

(ii) Identification of and justification for using the key assumptions contained in the detailed cost estimate;.

(iii) A description of the method of assuring funds for decommissioning from paragraph (g) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;.

(iv) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and.

(v) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (g) of this section (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

2. At the time of license renewal and at intervals not to exceed 3 years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

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(i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;.

(ii) Waste inventory increasing above the amount previously estimated;.

(iii) Waste disposal costs increasing above the amount previously estimated;.

(iv) Facility modifications;.

(v) Changes in authorized possession limits;.

(vi) Actual remediation costs that exceed the previous cost estimate;.

(vii) Onsite disposal; and.

(viii) Use of a settling pond.

(g) The financial instrument must include the licensee's name, license number, and docket number, and the name, address, and other contact information of the issuer, and, if a trust is used, the trustee. When any of the foregoing information changes, the licensee must, within 30 days, submit financial instruments reflecting such changes. The financial instrument submitted must be a signed original or signed original duplicate, except where a copy of the signed original is specifically permitted. Financial assurance for decommissioning must be provided by one or more of the following methods:

1. Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs.

Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

2. A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid should the licensee default. A surety method may be in the form of a surety bond, letter of credit, or a line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix A to this Rulerule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this Rule rule for commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on financial tests may be used if the guarantee and tests are as contained in Appendix B of this Rulerule. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and tests are as contained in Appendix C of this Rulerule. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and tests are as contained in Appendix D to this Rulerule. A guarantee by the applicant or licensee may not be used in 84

combination with any other financial methods to satisfy the requirements of this rule or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:

(i) The surety method or insurance must be open-ended or, if written for a specified term, such as 5 years, must be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Agency, the beneficiary, and the licensee of its intention not to renew.

The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Agency within 30 days after receipt of notification of cancellation.

(ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and the trust must be acceptable to the Agency. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as trustee and whose trust operations are regulated and examined by a federal or state agency.

(iii) The surety method or insurance must remain in effect until the Agency has terminated the license.

3. An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provision must be as stated in 420-3-26-.02(26)(g)2.

4. In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in 420-3-26-.02(26)(e), and indicating that funds for decommissioning will be obtained when necessary.

5. When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.

(h) Each person licensed under this Rule, 420-3-26-.02, shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the site is released for unrestricted use by the Agency. Before licensed activities are transferred or assigned in accordance with 420-3-26-.02(12)(b), licensees shall transfer all records described in this rule to the new licensee. In this case, the new licensee will be 85

responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their location may be used. Information the Agency considers important to decommissioning consists of:

1. Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

2. As built drawings and modifications of structures and equipment in restricted areas where radioactive materials are being used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

3. Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or radioactive materials having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:

(i) All areas designated and formerly designated restricted areas as defined in 420-3-26-.01(2)(a)93;.

(ii) All areas outside of restricted areas that require decontamination under 420-3-26-.02(26)(h)3.(i).

(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 420-3-26-.03(48); and.

(iv) All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in 420-3-26 -.03(60) or apply for approval for disposal under 420-3-26-.03(34).

4. Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

(27) Emergency Plan for Large Quantities.

(a) Each application to possess radioactive material in an unsealed or a sealed form, 86

on foils or plated sources, or sealed in glass in excess of the quantities in "Schedule E-Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan, must contain either:

1. An evaluation showing that the maximum dose to a person off site due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or

2. An emergency plan responding to a release of radioactive material.

(b) One or more of the following factors may be used to support an evaluation submitted under 420-3-26-.02(27)(a)(1):

1. The radioactive material is physically separated so that only a portion could be involved in an accident;

2. All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

3. The release fraction in the respirable size range would be lower than the release fraction shown in Schedule E due to the chemical or physical form of the material;

4. The solubility of the material would reduce the dose received;

5. Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Schedule E;

6. Operating restrictions or procedures would prevent a release fraction as large as shown in Schedule E; or

7. Other factors appropriate for the specific facility.

(c) An emergency plan for responding to a release of radioactive material submitted under 420-3-26-.02(27)(a)(2) must include the following information:

1. Facility description. A brief description of the licensee's facility and area near the site.

2. Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.

3. Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

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4. Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

5. Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers on site, and a description of the program for maintaining the equipment.

6. Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

7. Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying off site response organizations and the Agency; also responsibilities for developing, maintaining, and updating the plan.

8. Notification and coordination. A commitment to and a brief description of the means to promptly notify off site organizations and request off site assistance for the treatment of contaminated injured on site workers when appropriate. A control point must be established.

The notification and coordination must be planned so that availability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Agency immediately after notification of the appropriate off site response organizations and not later than 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> after the licensee declares an emergency.

9. Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to off site response organizations and to the Agency.

10. Training. A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instruction and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

11. Restoration of safe conditions. A brief description of the means of restoring the facility to safe condition after an accident.

12. Exercises. Provisions for conducting quarterly communications checks with off site response organizations and biennial on site exercises to test response to simulated emergencies. Quarterly communications checks with off site response organizations must include the check and update of all necessary phone numbers. The licensee shall invite off site response organizations to participate in the biennial exercises. Participation of off site response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be 88

known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

13. Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L.99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.

(d) The licensee shall allow the off site response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Agency. The licensee shall provide any comments received within the 60 days to the Agency with the emergency plan.

(28) Emergency Plan Reporting Requirements.

(a) Immediate report. Each licensee shall notify the Agency as soon as possible but no later than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.)

(b) Twenty-four hour report. Each licensee shall notify the Agency within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:

1. An unplanned event that:

(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> by imposing additional radiological controls or by prohibiting entry into the area;.

(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of Rule 420-3-26-.03; and.

(iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior to decontamination.

2. An event in which equipment is disabled or fails to function as designed when:

(i) The equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;.

89

(ii) The equipment is required to be available and operable when it is disabled or fails to function; and.

(iii) No redundant equipment is available and operable to perform the required safety function.

3. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

4. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(i) The quantity of material involved is greater than 5 times the lowest annual limit on intake on the material specified in Appendix B of Rule 420-3-26-.03; and.

(ii) The damage affects the licensed material or its container.

(c) Preparation and submission of reports. Reports made by the licensee in response to the requirements of this section must be made as follows:

1. Licensees shall make reports required by 420-3-26-.02(28)(a) and (b) by telephone to the Agency to the extent that the information is available at the time of notification.

The information provided in these reports must include:

(i) The caller's name and call back telephone number; .

(ii) A description of the event, including date and time;.

(iii) The exact location of the event;.

(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and.

(v) Any personnel exposure data available.

2. Written report. Each licensee who makes a report required by 420-3-26-.02(28)(a) and (b) shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other rules may be submitted to fulfill this requirement if the reports contain all the necessary information and appropriate distribution is made. These reports must be sent to the Director, Office of Radiation Control, Alabama Department of Public Health, P.O. Box 303017, Montgomery, Alabama 36130. The reports must include the following:

(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;.

90

(ii) The exact location of the event;.

(iii) The isotopes, quantities, and chemical and physical form of the material involved;.

(iv) Date and time of the event;.

(v) Corrective actions taken or planned and the results of any evaluations or assessments; and.

(vi) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(29) Reporting Requirements.

(a) Immediate Report. Each licensee shall notify the Agency as soon as possible but no later than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the discovery of an event that prevents immediate protective actions necessary to avoid exposure to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(b) Twenty four hour report. Each licensee shall notify the Agency within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:

1. An unplanned contamination event that:

(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> by imposing additional radiological controls or by prohibiting entry into the area;.

(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in Appendix B of Rule 420-3-26-.03 for the material; and.

(iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior to decontamination.

2. An event in which equipment is disabled or fails to function as designed when:

(i) The equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident.

(ii) The equipment is required to be available and operable when it is disabled or fails to function; and.

91

(iii) No redundant equipment is available and operable to perform the required safety function.

3. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable contamination on the individuals clothing or body.

4. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment involving radioactive material when:

(i) The quantity of material involved is greater than five times the lowest annual limit on intake specified in Appendix B of Rule 420-3-26-.03 for the material; and.

(ii) The damage affects the integrity of the licensed material or its container.

(c) Preparation and submission of reports. Reports made by licensees in response to the requirements of this section must be made as follows:

1. Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the Agency. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(i) The caller's name and call back number;.

(ii) A description of the event, including date and time;.

(iii) The exact location of the event;.

(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and.

(v) Any personal radiation exposure data available.

2. Written report. Each licensee who makes a report required by paragraphs (a) and (b) of this section shall submit a written follow-up report within 30 days of the initial report.

Written reports prepared pursuant to other rules may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made.

These reports must be sent to the Agency at the address specified in Rule 420-3-26-.01(12). The reports must include the following:

(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;.

(ii) The exact location of the event; 92

(iii) The isotopes, quantities, and chemical and physical form of the licensed material involved; (iv) Date and time of the event;.

(v) Corrective actions taken or planned and the results of any evaluations or assessments; and.

(vi) The extent of exposures of individuals to radiation or to radioactive materials without identification of individuals by name.

(30) Records.

(a) Each person who receives radioactive material pursuant to a license issued pursuant to these Rules rules shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

1. The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for 3 years following transfer or disposal of the material.

2. The licensee who transferred the material shall retain each record of transfer for 3 years after each transfer unless a specific requirement in other rules of this Rule dictate otherwise.of radioactive material until the Agency terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

3. The licensee who disposed of the material shall retain each record of disposal of radioactive material until the Agency terminates each license that authorizes disposal of the material.

(b) The licensee shall retain each record that is required by this Rule rule for the period specified by the appropriate rule or license condition. If a retention period is not otherwise specified by rule or license condition, the record must be retained until the Agency terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(c) Records which must be maintained pursuant to this Rule rule may be the original or a reproduced copy. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(d) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Agency:

93

1. Records of disposal of licensed material made under 420-3-26-.03(34) (including burials authorized before January 28, 1981), 420-3-26-.03(35), 420-3-26-.03(36),

420-3-26-.03(37); and.

2. Records required by 420-3-26-.03(42)(b)4.

(e) If licensed activities are transferred or assigned in accordance with 420-3-26-.02(12)(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

1. Records of disposal of licensed material made under 420-3-26-.03(34) (including burials authorized before January 28, 1981), 420-3-26-.03(35), 420-3-26-.03(36),

420-3-26-.03(37); and.

2. Records required by 420-3-26-.03(42)(b)4.

(f) Prior to license termination, each licensee shall forward the records required by 420-3-26-.02(11)(b) to the Agency.

SCHEDULE A (OMITTED)

Author: Karl David Walter Authority: §§ 22-14-4, 22-14-6, 22-14-7, 22-14-8, 22-14-9, 22-14-11, 22-14-12, 22-14-13, and 22-14-14, also 22-2-1, 22-2-2, 22-2-5, and 22-2-6, (Code of Alabama, 1975). Act 82-328 Section 5.b.l.

History: New June 15 1966; Revised June 17, 1968, March 18, 1970, March 17, 1970, September 19, 1973; Repromulgated August 21, 1974; Revised May 21, 1975, September 15, 1976, January 18, 1978; Recodified June 11, 1978; Revised November 21, 1979; Revised October 21, 1981. Revised and effective December 31, 1983; Revised and effective January 31, 1990; Revised and effective October 1, 1991; Revised and effective April 22, 1994; Revised and effective March 18, 1998; Revised effective May 25, 2000; Amended and filed May 19, 2006, Effective June 23, 2006; Amended and filed July 27, 2010, Effective September 1, 2010; Amended October 20, 2014, Effective December 1, 2014; Amended September 21, 2016, Effective November 5, 2016, Amended XX-XX-2018.

94

SCHEDULE B EXEMPT QUANTITIES Radioactive Material Microcuries Antimony-122 (Sb 122) 100 Antimony-124 (Sb 124) 10 Antimony-125 (Sb 125) 10 Arsenic-73 (As 73) 100 Arsenic-74 (As 74) 10 Arsenic-76 (As 76) 10 Arsenic-77 (As 77) 100 Barium-131 (Ba 131) 10 Barium-133 (Ba 133) 10 Barium-140 (Ba 140) 10 Bismuth-210 (Bi 210) 1 Bromine-82 (Br 82) 10 Cadmium-109 (Cd 109) 10 Cadmium-115m (Cd 115m) 10 Cadmium-115 (Cd 115) 100 Calcium-45 (Ca 45) 10 Calcium-47 (Ca 47) 10 Carbon-14 (C 14) 100 Cerium-141 (Ce 141) 100 Cerium-143 (Ce 143) 100 Cerium-144 (Ce 144) 1 Cesium-129 (Cs 129) 100 Cesium-131 (Cs 131) 1,000 Cesium-134m (Cs 134m) 100 Cesium-134 (Cs 134) 1 Cesium-135 (Cs 135) 10 Cesium-136 (Cs 136) 10 Cesium-137 (Cs 137) 10 Chlorine-36 (Cl 36) 10 Chlorine-38 (Cl 38) 10 Chromium-51 (Cr 51) 1,000 Cobalt-57 (Co 57) 100 Cobalt-58m (Co 58m) 10 Cobalt-60 (Co 60) 1 Copper-64 (Cu 64) 100 Dysprosium-165 (Dy 165) 10 Dysprosium-166 (Dy 166) 100 Erbium-169 (Er 169) 100 95

Radioactive Material Microcuries Erbium-171 (Er 171) 100 Europium-152 (Eu 152)9.2h 100 Europium-152 (Eu 152)13 yr 1 Europium-154 (Eu 154) 1 Europium-155 (Eu 155) 10 Fluorine-18 (F 18) 1,000 Gadolinium-153 (Gd 153) 10 Gadolinium-159 (Gd 159) 100 Gallium-67 (Ga 67) 100 Gallium-72 (Ga 72) 10 Germanium-68 (Ge 68) 10 Germanium-71 (Ge 71) 100 Gold-195 (Au 195) 10 Gold-198 (Au 198) 100 Gold-199 (Au 199) 100 Hafnium-181 (Hf 181) 10 Holmium-166 (Ho 166) 100 Hydrogen-3 (H 3) 1,000 Indium-111 (In 111) 100 Indium-113m (In 113m) 100 Indium-114m (In 114m) 10 Indium-115m (In 115m) 100 Indium-115 (In 115) 10 Iodine-123 (I 123) 100 Iodine-125 (I 125) 1 Iodine-126 (I 126) 1 Iodine-129 (I 129) 0.1 Iodine-131 (I 131) 1 Iodine-132 (I 132) 10 Iodine-133 (I 133) 1 Iodine-134 (I 134) 10 Iodine-135 (I 135) 10 Iridium-192 (Ir 192) 10 Iridium-194 (Ir 194) 100 Iron-52 (Fe 52) 10 Iron-55 (Fe 55) 100 Iron-59 (Fe 59) 10 Krypton-85 (Kr 85) 100 Krypton-87 (Kr 87) 10 Lanthanum-140 (La 140) 10 96

Radioactive Material Microcuries Lutetium-177 (Lu 177) 100 Manganese-52 (Mn 52) 10 Manganese-54 (Mn 54) 10 Manganese-56 (Mn 56) 10 Mercury-197m (Hg 197m) 100 Mercury-197 (Hg 197) 100 Mercury-203 (Hg 203) 10 Molybdenum-99 (Mo 99) 100 Neodymium-147 (Nd 147) 100 Neodymium-149 (Nd 149) 100 Nickel-59 (Ni 59) 100 Nickel-63 (Ni 63) 10 Nickel-65 (Ni 65) 100 Niobium-93m (Nb 93m) 10 Niobium-95 (Nb 95) 10 Niobium-97 (Nb 97) 10 Osmium-185 (Os 185) 10 Osmium-191M (Os 191m) 100 Osmium-191 (Os 191) 100 Osmium-193 (Os 193) 100 Palladium-103 (Pd 103) 100 Palladium-109 (Pd 109) 100 Phosphorus-32 (P 32) 10 Platinum-191 (Pt 191) 100 Platinum-193m (Pt 193m) 100 Platinum-193 (Pt 193) 100 Platinum-197m (Pt 197m) 100 Platinum-197 (Pt 197) 100 Polonium-210 (Po 210) 0.1 Potassium-42 (K 42) 10 Potassium-43 (K 43) 10 Praseodymium-142 (Pr 142) 100 Praseodymium-143 (Pr 143) 100 Promethium-147 (Pm 147) 10 Promethium-149 (Pm 149) 10 Rhenium-186 (Re 186) 100 Rhenium-188 (Re 188) 100 Rhodium-103m (Rh 103m) 100 Rhodium-105 (Rh 105) 100 Rubidium-81 (Rb 81) 10 97

Radioactive Material Microcuries 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- 9 0(Sr 90) 0.1 Strontium-91 (Sr 91) 10 Strontium-92 (Sr 92) 10 Sulphur-35 (S 35) 100 Tantalum-182 (Ta 182) 10 Technetium-96 (Tc 96) 10 Technetium-97m (Tc 97m) 100 Technetium-99m (Tc 99m) 100 Technetium-99 (Tc 99) 10 Tellurium-125m (Te 125m) 10 Tellurium-127m (Te 127m) 10 Tellurium-127 (Te 127) 100 Tellurium-129m (Te 129m) 10 Tellurium-129 (Te 129) 100 Tellurium-131m (Te 131m) 10 Tellurium-132 (Te 132) 10 Terbium-160 (Tb 160) 10 Thallium-200 (Tl 200) 100 Thallium-201 (Tl 201) 100 Thallium-202 (Tl 202) 100 98

Radioactive Material Microcuries 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 0.1 not listed above other than alpha-emitting radioactive material 99

SCHEDULE C EXEMPT CONCENTRATIONS Column II Column I Liquid and solid Gas concentration concentration Element (atomic number) Isotope Ci/ml 1/ Ci/ml 2/

Antimony (51) Sb-122 3x10-4 Sb-124 2x10-4 Sb-125 1x10-3 Argon (18) Ar-37 1x10-3 Ar-41 4x10-7 Arsenic (33) As-73 5x10-3 As-74 5x10-4 As-76 2x10-4 As-77 8x10-4 Barium (56) Ba-131 2x10-3 Ba-140 3x10-4 Beryllium (4) Be-7 2x10-2 Bismuth (83) Bi-206 4x10-4 Bromine (35) Br-82 4x10-7 3x10-3 Cadmium (48) Cd-109 2x10-3 Cd-115m 3x10-4 Cd-115 3x10-4 Calcium (20) Ca-45 9x10-5 Ca-47 5x10-4 Carbon (6) C-14 1x10-6 8x10-3 Cerium (58) Ce-141 9x10-4 Ce-143 4x10-4 Ce-144 1x10-4 Cesium (55) Cs-131 2x10-2 Cs-134m 6x10-2 Cs-134 9x10-5 Chlorine (17) Cl-38 9x10-7 4x10-3 Chromium (24) Cr-51 2x10-2 Cobalt (27) Co-57 5x10-3 Co-58 1x10-3 Co-60 5x10-4 Copper (29) Cu-64 3x10-3 Dysprosium (66) Dy-165 4x10-3 Dy-166 4x10-4 1/ Values are given in Column I only for those materials normally used as gases.

2/ Ci/g for solids.

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Column II Column I Liquid and solid Gas concentration concentration Element (atomic number) Isotope Ci/ml 1/ Ci/ml 2/

Erbium (68) Er-69 9x10-4 Er-171 1x10-3 Europium (63) Eu-152 (.2h) 6x10-4 Eu-155 2x10-3 Fluorine (9) F-18 2x10-6 8x10-3 Gadolinium (64) Gd-153 2x10-3 Gd-159 8x10-4 Gallium (31) Ga-72 4x10-4 Germanium (32) Ge-71 2x10-2 Gold (79) Au-196 2x10-3 Au-198 5x10-4 Au-199 2x10-3 Hafnium (72) Hf-181 7x10-4 Hydrogen (1) H-3 5x10-6 3x10-2 Indium (49) In-113m 1x10-2 In-114m 2x10-4

-9 Iodine (53) I-126 3x10 2x10-5 I-131 3x10-9 2x10-5 I-132 8x10-8 6x10-4 I-133 1x10-8 7x10-5 I-134 2x10-7 1x10-3 Iridium (77) Ir-190 2x10-3 Ir-192 4x10-4 Ir-194 3x10-4 Iron (26) Fe-55 8x10-3 Fe-59 6x10-4 Krypton (36) Kr-85m 1x10-6 Kr-85 3x10-6 Lanthanum (57) La-140 2x10-4 Lead (82) Pb-203 4x10-3 Lutetium (71) Lu-177 1x10-3 Manganese (25) Mn-52 3x10-4 Mn-54 1x10-3 Mn-56 1x10-3 Mercury (80) Hg-197m 2x10-3 Hg-197 3x10-3 Hg-203 2x10-4 1/ Values are given in Column I only for those materials normally used as gases.

2/ Ci/g for solids.

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Column II Column I Liquid and solid Gas concentration concentration Element (atomic number) Isotope Ci/ml 1/ Ci/ml 2/

Molybdenum (42) Mo-99 2x10-3 Neodymium (60) Nd-147 6x10-4 Nd-149 3x10-3 Nickel (28) Ni-65 1x10-3 Niobium (Columbium) (41) Nb-95 1x10-3 Nb-97 9x10-3 Osmium (76) Os-185 7x10-4 Os-191m 3x10-2 Os-191 2x10-3 Os-193 6x10-4 Palladium (46) Pd-103 3x10-3 Pd-109 9x10-4 Phosphorus (15) P-32 2x10-4 Platinum (78) Pt-191 1x10-3 Pt-193m 1x10-2 Pt-197m 1x10-2 Pt-197 1x10-3 Potassium (19) K-42 3x10-3 Praseodymium (59) Pr-142 3x10-4 Pr-143 5x10-4 Promethium (61) Pm-147 2x10-3 Pm-149 4x10-4 Rhenium (75) Re-183 6x10-3 Re-186 9x10-4 Re-188 6x10-4 Rhodium (45) Rh-103m 1x10-1 Rh-105 1x10-3 Rubidium (37) Rb-86 7x10-4 Ruthenium (44) Ru-97 4x10-3 Ru-103 8x10-4 Ru-105 1x10-3 Ru-106 1x10-4 Samarium (62) Sm-153 8x10-4 Scandium (21) Sc-46 4x10-4 Sc-47 9x10-4 Sc-48 3x10-4 Selenium (34) Se-75 3x10-3 1/ Values are given in Column I only for those materials normally used as gases.

2/ Ci/g for solids.

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Column II Column I Liquid and solid Gas concentration concentration Element (atomic number) Isotope Ci/ml 1/ Ci/ml 2/

Silicon (14) Si-31 9x10-3 Silver (47) Ag-105 1x10-3 Ag-110m 3x10-4 Ag-111 4x10-4 Sodium (11) Na-24 2x10-3 Strontium (38) Sr-85 1x10-3 Sr-89 1x10-4 Sr-91 7x10-4 Sr-92 7x10-4 Sulfur (16) S-35 9x10-8 6x10-4 Tantalum (73) Ta-182 4x10-4 Technetium (43) Tc-96m 1x10-1 Tc-96 1x10-3 Tellurium (52) Te-125m 2x10-3 Te-127m 6x10-4 Te-127 3x10-3 Te-129m 3x10-4 Te-131m 6x10-4 Te-132 3x10-4 Terbium (65) Tb-160 4x10-4 Thallium (81) Tl-200 4x10-3 Tl-201 3x10-3 Tl-202 1x10-3 Tl-204 1x10-3 Thulium (69) Tm-170 5x10-4 Tm-171 5x10-3 Tin (50) Sn-113 9x10-4 Sn-125 2x10-4 Tungsten (Wolfram) (74) W-181 4x10-3 W-187 7x10-4 Vanadium (23) V-48 3x10-4 Xenon (54) Xe-131m 4x10-6 Xe-133 3x10-6 Xe-135 1x10-6 Ytterbium (70) Yb-175 1x10-3 1/ Values are given in Column I only for those materials normally used as gases.

2/ Ci/g for solids.

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Column II Column I Liquid and solid Gas concentration concentration Element (atomic number) Isotope Ci/ml 1/ Ci/ml 2/

Yttrium (39) Y-90 2x10-4 Y-91m 3x10-2 Y-91 3x10-4 Y-92 6x10-4 Y-93 3x10-4 Zinc (30) Zn-65 1x10-3 Zn-69m 7x10-4 Zn-69 2x10-2 Zirconium (40) Zr-95 6x10-4 Zr-97 2x10-4 Beta- and/or gamma emitting radioactive material not listed above with half-life of less than 3 years. 1x10-10 1x10-6 NOTE 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule C, the activity stated is that of the parent isotope and takes into account the daughters.

NOTE 2: For purposes of 420-3-26-.02(4) 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 concentrations present in the product and the exempt concentration established in Schedule C for the specific isotope when not in combination. The sum of such ratios may not exceed 1" (i.e., unity).

EXAMPLE:

Concentration of Isotope A in Product + Concentration of Isotope B in Product =1 Exempt concentration of Isotope A Exempt concentration of Isotope B 1/ Values are given only for those materials normally used as gases.

2/ Ci/gm for solids.

SCHEDULE D (Deleted 1998) 104

SCHEDULE E QUANTITIES OF RADIOACTIVE MATERIAL REQUIRING CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN Radioactive Material Release Fraction Quantity (Curies)

Actinium-228 0.001 4,000 Americium-241 .01 2 Americium-242 .001 2 Americium-243 .001 2 Antimony-124 .01 4,000 Antimony-126 .01 6,000 Barium-133 .01 10,000 Barium-140 .01 30,000 Bismuth-207 .01 5,000 Bismuth-210 .01 600 Cadmium-109 .01 1,000 Cadmium-113 .01 80 Calcium-45 .01 20,000 Californium-252 .001 9 (20 mg)

Carbon-14 .01 50,000 Non CO Cerium-141 .01 10,000 Cerium-144 .01 300 Cesium-134 .01 2,000 Cesium-137 .01 3,000 Chlorine-36 .5 100 Chromium-51 .01 300,000 Cobalt-60 .001 5,000 Copper-64 .01 20,000 Curium-242 .001 60 Curium-243 .001 3 Curium-244 .001 4 Curium-245 .001 2 Europium-152 .01 500 Europium-154 .01 400 Europium-155 .01 3,000 Germanium-68 .01 2,000 Gadolinium-153 .01 5,000 Gold-198 .01 30,000 Hafnium-172 .01 400 Holmium-166m .01 7,000 105

Radioactive Material Release Fraction Quantity (Curies)

Hydrogen-3 .5 100 Iodine-125 .5 20,000 Iodine-131 .5 10 Indium-114m .01 1,000 Iridium-192 .001 40,000 Iron-55 .01 40,000 Krypton-85 1.01 6,000,000 Lead-210 .01 8 Manganese-56 .01 60,000 Mercury-203 .01 10,000 Molybdenum-99 .01 30,000 Neptunium-237 .001 2 Nickel-63 .01 20,000 Niobium-94 .01 300 Phosphorus-32 .5 100 Phosphorus-33 .5 1,000 Polonium-32 .01 10 Potassium-42 .01 9,000 Promethium-145 .01 4,000 Promethium-147 .01 4,000 Radium-226 .001 100 Ruthenium-106 .01 200 Samarium-151 .01 4,000 Scandium-46 .01 3,000 Selenium-75 .01 10,000 Silver-110m .01 1,000 Sodium-22 .01 9,000 Sodium-24 .01 10,000 Strontium-89 .01 3,000 Strontium-90 .01 90 Sulfur-35 .5 900 Technetium-99 .01 10,000 Technetium-99m .01 400,000 Tellurium-127m .01 5,000 Tellurium-129m .01 5,000 Terbium-160 .01 4,000 Thulium-170 .01 4,000 Tin-113 .01 10,000 Tin-123 .01 3,000 Tin-126 .01 1,000 Titanium-44 .01 100 Vanadium-48 .01 7,000 106

Radioactive Material Release Fraction Quantity (Curies)

Xenon-133 1.0 900,000 Yttrium-91 .01 2,000 Zinc-65 .01 5,000 Zirconium-63 .01 400 Zirconium-95 .01 5,000 Any other beta/gamma emitter .01 10,000 Mixed fission products .01 1,000 Decontaminated equipment, beta/gamma .001 10,000 Irradiated material, any form other than solid combustible .01 1,000 Mixed radioactive waste, beta/gamma .01 1,000 Packaged mixed waste, beta/gamma2 .001 10,000 Any other alpha emitter .001 2 Contaminated equipment, alpha .0001 20 Packaged waste, alpha2 .0001 20 Combinations of radioactive materials listed above1

1. For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule C exceeds one.

2. Waste packaged in Type B containers does not require an emergency plan.

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APPENDIX A Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning I.

Introduction:

An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial tests of Section II of this appendix. The terms of the self guarantee are in Section III of this appendix.

This appendix establishes criteria for passing the financial test and establishes the terms for obtaining the parent company guarantee.

II. Financial Test:

A. To pass the financial test, the parent company must meet the criteria of either A.1 or A. 2 of this appendix:

1. The parent company must have:

(i) Two of the following three ratios: A ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5; and.

(ii) Net working capital and tangible net worth each at least 6 six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used); and.

(iii) Tangible net worth of at least $10 million; and.

(iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least 6 timessix times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used).

2. The parent company must have:

(i) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poors or Aaa, Aa, A, or Baa as issued by Moodys; and.

(ii) Tangible net worth at least 6 six times the total current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used); and.

(iii) Tangible net worth of at least $10 million; and.

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(iv) Assets located in the United States amounting to at least 90 percent of the total assets or at least 6 six times the current decommissioning cost estimates for all facilities or parts thereof (or prescribed amount if certification is used).

B. The parent companys independent certified public accountant must have compared the data used by the parent company in the financial test which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Agency within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

C. 1. After the initial financial test, the parent company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.

2. If the parent company no longer meets the requirements of Section A. of this appendix, the licensee must send immediate notice to the Agency of its intent to establish alternate financial assurance as specified in Agency Rules within 120 days of such notice.

III. Parent Company Guarantee:

The terms of a parent company guarantee which an applicant or licensee obtains must provide that:

A. The parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the Agency. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Agency, as evidenced by the return receipt.

B. If the licensee fails to provide alternative financial assurance as specified in Agency Rules within 90 days following receipt by the licensee and Agency of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide such alternative financial assurance in the name of the licensee.

C. The parent company guarantee and financial test provisions must remain in effect until the Agency has terminated the license or until another financial assurance method acceptable to the Agency has been put into effect by the licensee.

D. If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Agency. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal federal or State state agency.

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E. The licensee will promptly forward to the Agency and the licensees independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of Section 13 of the Securities and Exchange Act of 1934.

F. If, at any time, the licensees most recent bond issuance ceases to be rated in any category of A or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Agency within 20 days after publication of the change by the rating service. If the licensees most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of Section II.A. of this appendix.

G. The applicant or licensee must provide to the Agency a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Agency, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

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APPENDIX B Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix.

This appendix establishes criteria for passing the financial test for the self guarantee and establishes the terms for a self-guarantee.

II. A. To pass the financial test, a company must meet all of the following criteria:

(1) Tangible net worth at least 10 ten times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used).

(2) Assets located in the United States amounting to at least 90 percent of total assets or at least 10 ten times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used).

(3) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S & P), or Aaa, Aa, or A as issued by Moodys.

B. To pass the financial test, a company must meet all of the following additional requirements:

(1) The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934.

(2) The companys independent certified public accountant must have compared the data used by the company in the financial test which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Agency within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

(3) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.

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C. If the licensee no longer meets the requirements of Section II.A. of this appendix, the licensee must send immediate notice to the Agency of its intent to establish alternate financial assurance as specified in Agency rules within 120 days of such notice.

III. Company Self-Guarantee. The terms of a self guarantee which an applicant or licensee furnishes must provide that:

A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Agency. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Agency, as evidenced by the return receipt.

B. The licensee shall provide alternative financial assurance as specified in Agency rules within 90 days following receipt by the Agency of a notice of cancellation of the guarantee.

C. The guarantee and financial test provisions must remain in effect until the Agency has terminated the license or until another financial assurance method acceptable to the Agency has been put in effect by the licensee.

D. The licensee will promptly forward to the Agency and the licensees independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of Section 13 of the Securities and Exchange Act of 1934.

E. If, at any time, the licensees most recent bond issuance ceases to be rated in any category of A or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Agency within 20 days after publication of the change by the rating service. If the licensees most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of Section II.A. of this appendix.

F. The applicant or licensee must provide to the Agency a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Agency, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

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APPENDIX C Criteria Relating to Use of Financial Tests and Self-Guarantee for Providing Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have No Outstanding Rated Bonds I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based of furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial tests of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix.

This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms of a self-guarantee.

II. Financial Test A. To pass the financial test, a company must meet the following criteria:

(1) Tangible net worth greater than $10 million, or at least 10 ten times the current decommissioning cost estimate (or the current amount required if certification is used),

whichever is greater, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

(2) Assets located in the United States amounting to at least 10 ten times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.

(3) A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities divided by net worth less than 1.5.

B. In addition, to pass the financial test, a company must meet all of the following requirements:

(1) The companys independent certified public accountant must have compared the data used by the company in the financial test, which is required to be derived from the independently audited year end financial statement based on United States generally accepted accounting practices for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Agency within 90 days of any matters that may cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.

(2) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.

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(3) If the licensee no longer meets the requirements of paragraph II.A. of this appendix, the licensee must send notice to the Agency of intent to establish alternative financial assurance as specified in Agency rules. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternative financial assurance within 120 days after the end of such fiscal year.

III. Company Self-Guarantee The terms of a self-guarantee which an applicant or licensee furnishes must provide that:

A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Agency. Cancellation may not occur until an alternative financial assurance mechanism is in place.

B. The licensee shall provide alternative financial assurance as specified in the rules within 90 days following receipt by the Agency of a notice of cancellation of the guarantee.

C. The guarantee and financial test provisions must remain in effect until the Agency has terminated the license or until another financial assurance method acceptable to the Agency has been put in effect by the licensee.

D. The applicant or licensee must provide to the Agency a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Agency, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

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APPENDIX D Criteria Relating to Use of Financial Tests and Self-Guarantee for Providing Reasonable Assurance for Decommissioning by Nonprofit Colleges, Universities, and Hospitals I. Introduction An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of Section II of this appendix. The terms of the self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

II. Financial Test A. For colleges and universities, to pass the financial test a college or university must meet either the criteria in paragraph II.A.(1) or the criteria in paragraph II.A.(2) of this appendix.

(1) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.

(2) For applicants or licensees that do not issue bonds, unrestricted endowment consisting of assets located within the United States of at least $50 million, or at least 30 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.

B. For hospitals, to pass the financial test a hospital must meet either the criteria in paragraph II.B.(1) or the criteria in paragraph II.B.(2) of this appendix:

(1) For applicants or licensees that issue bonds, a current rating for its most current uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.

(2) For applicants or licensees that do not issue bonds, all of the following tests must be met:

(a) (Total revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04.

(b) Long term debt divided by net fixed assets must be less than or equal to 0.67.

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(c) (Current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55.

(d) Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as a self-guaranteeing license.

C. In addition, to pass the financial test, a licensee must meet all of the following requirements:

1. The licensees independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial statement. In connection with procedure, the licensee shall inform the Agency within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the licensee no longer passes the test.

2. After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year.

3. If the licensee no longer meets the requirements of Section I of this appendix, the licensee must send notice to the Agency of its intent to establish alternative financial assurance as specified in Agency rules. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year end financial data show that the licensee no longer meets the financial data requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.

III. Self-Guarantee The terms of a self-guarantee which an applicant or licensee furnishes must provide that:

A. The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the Agency. Cancellation may not occur unless an alternative financial assurance mechanism is in place.

B. The licensee shall provide alternative financial assurance as specified in Agency rules within 90 days following receipt by the Agency of a notice of cancellation of the guarantee.

C. The guarantee and financial test provisions must remain in effect until the Agency has terminated the license or until another financial assurance method acceptable to the Agency has been put in effect by the licensee.

D. The applicant or licensee must provide to the Agency a written guarantee (a written commitment by a corporate officer or officer of the institution) which states that the 116

licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Agency, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.

E. If, at any time, the licensees most recent bond issuance ceases to be rated in any category of A or above by either Standard and Poors or Moodys, the licensee shall provide notice in writing of such fact to the Agency within 20 days after publication of the change by the rating service.

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