W. Va. Code R. § 64-23-11

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 64-23-11 - Registration of Radioactive Materials

11.1. Purpose and Scope

11.1.a. This Section, and Sections 13. and 15. of this rule, provide for the registration of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized pursuant to this Section and Sections 13. and 15. of this rule, or as otherwise provided in these Sections.

11.1.b. In addition to the requirements of this Section, all registrants are subject to the requirements of Sections 1., 6., 13. and 15. of this rule. Furthermore, registrants engaged in industrial radiographic operations are subject to the requirements of Section 8 of this rule, registrants using radionuclides in the healing arts are subject to the requirements of Section 12. of this rule, and registrants engaged in wireline and subsurface tracer studies are subject to the requirements of Section 15. of this rule.

11.2. Source Material

11.2.a. Any person is exempt from this Section to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than one-twentieth (1/20) of one (1) percent (five one-hundredths [0.05] percent) of the mixture, compound, solution, or alloy.

11.2.b. Any person is exempt from this Section to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific registration, such person shall not refine or process such ore.

11.2.c. Any person is exempt from this Section to the extent that such person receives, possesses, uses, or transfers:

11.2.c.1. Any quantities of thorium contained in:

11.2.c.1.A. Incandescent gas mantles,

11.2.c.1.B. Vacuum tubes,

11.2.c.1.C. Welding rods,

11.2.c.1.D. Electric lamps for illuminating purposes provided that each lamp does not contain more than fifty (50) milligrams of thorium,

11.2.c.1.E. Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two (2) grams of thorium,

11.2.c.1.F. Rare earth metals and compounds, mixtures, and products containing not more than twenty five one-hundredths [0.25] percent by weight thorium, uranium, or any combination of these, or

11.2.c.1.G. Personnel neutron dosimeters, provided that each dosimeter does not contain more than fifty (50) milligrams of thorium;

11.2.c.2. Source material contained in the following products:

11.2.c.2.A. glazed ceramic Tableware, provided that the glaze contains not more than 20 percent by weight source material,

11.2.c.2.B. Glassware containing not more than ten (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,

11.2.c.2.C. Glass enamel or glass enamel frit containing not more than ten (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, or

11.2.c.2.D. Piezoelectric ceramic containing not more than two (2) percent by weight source material;

11.2.c.3. Photographic film, negatives, and prints containing uranium or thorium;

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

11.2.c.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:

11.2.c.5.A. The counterweights are manufactured in accordance with a specific registration issued by the U.S. Nuclear Regulatory Commission (NRC), authorizing distribution by the registrant pursuant to 10 CFR Part 40,

11.2.c.5.B. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM",⁷

11.2.c.5.C. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED",^1/ and

11.2.c.5.D. This exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;

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

11.2.c.6.A. The shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM", and

11.2.c.6.B. The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth (c) inch (three and two-tenths [3.2] mm);

11.2.c.7. Thorium contained in finished optical lenses, provided that each lens does not contain more than thirty (30) percent by weight of thorium, and that this exemption shall not be deemed to authorize either:

11.2.c.7.A. The shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or

11.2.c.7.B. The receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments;

11.2.c.8. Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than five one-thousandths (0.005) microcurie of uranium; or

11.2.c.9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

11.2.c.9.A. The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and

11.2.c.9.B. The thorium content in the nickel-thoria alloy does not exceed 4 percent by weight.

11.2.d. The exemptions in Subdivision 11.2.b. do not authorize the manufacture of any of the products described.

11.3. Radioactive Material Other Than Source Material

11.3.a. Exempt Concentrations

11.3.a.1. Except as provided in Paragraph 11.3.a.2., any person is exempt from this Section to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Table 64-23 Y.

11.3.a.2. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under Paragraph 11.3.a.1. or equivalent rules of the NRC, any agreement state or licensing state, except in accordance with a specific registration issued pursuant to Subdivision 11.17.a. or the general registrant provided in Subsection 11.28.

11.3.b. Exempt Quantities

11.3.b.1. Except as provided in Paragraphs 11.3.b.3. and 11.3.b.4., any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Table 64-23 Z.

11.3.b.2. Any person who possesses radioactive material received or acquired under the general registrant formerly provided in Subsection 11.7. is exempt from the requirements for a registrant set forth in this Section to the extent that such person possesses, uses, transfers or owns such radioactive material. Such exemption does not apply for Radium-226.

11.3.b.3. This Subdivision (11.3.b.) does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.

11.3.b.4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Table 64-3 Z, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under Subdivision 11.3.b. or equivalent rules of the NRC, any agreement state or licensing state, except in accordance with a specific registrant issued by the NRC pursuant to Section 32.18 of 10 CFR Part 32 or by the agency pursuant to Subdivision 11.17.b. which registrant states that the radioactive material may be transferred by the registrant to persons exempt under Subdivision 11.3.b. or the equivalent rules of the NRC, an agreement state, or licensing state.⁸

11.3.c. Exempt Items

11.3.c.1. Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from this rule to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products:⁸

11.3.c.1.A. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate:

11.3.c.1.A.1. Twenty five (25) millicuries (nine hundred twenty five [925] MBq) of tritium per timepiece.

11.3.c.1.A.2. Five (5) millicuries (one hundred eighty five [185] MBq) of tritium per hand.

11.3.c.1.A.3. Fifteen (15) millicuries (fife hundred fifty five [555] MBq) of tritium per dial (bezels when used shall be considered as part of the dial).

11.3.c.1.A.4. One hundred (100) microcuries (three and seven-tenths [3.7] MBq) of promethium-147 per watch or two hundred (200) microcuries (seven and four-tenths [7.4] MBq) of promethium-147 per any other timepiece.

11.3.c.1.A.5. Twenty (20) microcuries (seventy four one-hundredths [0.74] MBq) of promethium-147 per watch hand or forty (40) microcuries (one and forty eight one-hundredths [1.48] MBq) of Promethium-147 per other timepiece hand.

11.3.c.1.A.6. Sixty (60) microcuries (two and twenty two one-hundredths [2.22] MBq) of promethium-147 per watch dial or one hundred twenty (120) microcuries (four and forty four one-hundredths [4.44] MBq) of Promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).

11.3.c.1.A.7. The radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through fifty (50) milligrams per square centimeter of absorber:

11.3.c.1.A.7.(a) For wrist watches, one-tenth (0.1) millirad (one [1] :Gy) per hour at ten (10) centimeters from any surface.

11.3.c.1.A.7.(b) For pocket watches, one-tenth (0.1) millirad (one [1] :Gy) per hour at one (1) centimeter from any surface.

11.3.c.1.A.7.(c) For any other timepiece, 0.2 millirad (2 :Gy) per hour at 10 centimeters from any surface.

11.3.c.1.A.8. One microcurie (37 kBq) of Radium-226 per timepiece in timepieces acquired prior to July 1, 2001..

11.3.c.1.A.9. Lock illuminators containing not more than fifteen (15) millicuries (five hundred fifty five [555] MBq) of tritium or not more than two (2) millicuries (seventy [74] MBq) of Promethium-147 installed in automobile locks. The radiation dose rate from each lock illuminator containing Promethium-147 will not exceed one (1) millirad (ten [10] :Gy) per hour at one (1) centimeter from any surface when measured through fifty (50) milligrams per square centimeter of absorber.

11.3.c.1.B. Precision balances containing not more than one (1) millicurie (thirty seven (thirty seven [37] MBq) of tritium per balance or not more than five-tenths (0.5) millicurie (eighteen and five-tenths [18.5] MBq) of tritium per balance part.

11.3.c.1.C. Automobile shift quadrants containing not more than twenty five 25 millicuries (nine hundred twenty five [925] MBq) of tritium.

11.3.c.1.D. Marine compasses containing not more than seven hundred fifty (750) millicuries (twenty seven and eight-tenths [27.8] GBq) of tritium gas and other marine navigational instruments containing not more than two hundred fifty (250) millicuries (nine and twenty five one-hundredths [9.25] GBq) of tritium gas.

11.3.c.1.E. Thermostat dials and pointers containing not more than twenty five (25) millicuries (nine hundred twenty five [925] MBq) of tritium per thermostat.

11.3.c.1.F. Electron tubes; provided, that each tube does not contain more than one of the following specified quantities of radioactive material:

11.3.c.1.F.1. One hundred fifty (150) millicuries (five and fifty five one-hundredths [5.55] GBq) of tritium per microwave receiver protector tube or ten (10) millicuries (three hundred seventy [370] mBq) of tritium per any other electron tube.

11.3.c.1.F.2. One (1) microcurie (thirty seven [37] kBq) of Cobalt-60.

11.3.c.1.F.3. Five (5) microcuries (one hundred eighty five [185] kBq) of nickel-63.

11.3.c.1.F.4. Thirty (30) microcuries (one and eleven one-hundredths [1.11] MBq) of krypton-85.

11.3.c.1.F.5. Five (5) microcuries (one hundred eighty five [185] kBq) of cesium-137.

11.3.c.1.F.6. Thirty (30) microcuries (one and eleven one-hundredths [1.11] MBq) of promethium-147.

11.3.c.1.G. And provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed one (1) millirad (ten [10] :Gy) per hour at one (1) centimeter from any surface when measured through seven (7) milligrams per square centimeter of absorber.

11.3.c.1.H. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

11.3.c.1.H.1. Each source contains no more than one exempt quantity set forth in Table 64-23 Z, and

11.3.c.1.H.2. Each instrument contains no more than ten (10) exempt quantities. For purposes of this requirement, an instrument's sources 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 Table 64-23 Z, provided that the sum of such fractions shall not exceed unity.

11.3.c.1.H.3. For Americium-241, five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) is considered an exempt quantity under Subdivision C.4c.i.(8).

11.3.c.1.I. Spark gap irradiators containing not more than 1 microcurie (37 kBq) of Cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three (3) gallons (eleven and four-tenths [11.4] l) per hour.

11.3.c.2. Self-Luminous Products Containing Radioactive Material

11.3.c.2.A. Tritium, Krypton-85, or Promethium-147. Except for persons who manufacture, process, or produce self-luminous products containing tritium, Krypton-85, or Promethium-147, any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, Krypton-85 or Promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific registrant issued by the NRC pursuant to Section 32.22 of 10 CFR Part 32, which registrant authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in Paragraph 11.3.c.2. does not apply to tritium, Krypton-85, or Promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

11.3.c.2.B. Radium-226. Any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than one-tenth (0.1) microcurie (3.7 kBq) of Radium-226 which were acquired prior to July 1, 2001.

11.3.c.3. Gas and Aerosol Detectors Containing Radioactive Material

11.3.c.3.A. Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported, or transferred in accordance with a specific registrant issued by the NRC⁹equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555 pursuant to Section 32.26 of 10 CFR Part 32; or a licensing state pursuant to Subdivision 11.3.a.3.A., which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.

11.3.c.3.B. Gas and aerosol detectors previously manufactured and distributed to general registrants in accordance with a specific registrant issued by an agreement state shall be considered exempt under Subparagraph 11.3.c.3.A., provided that the device is labeled in accordance with the specific registrant authorizing distribution of the generally registered device, and provided further that they meet the requirements of Subdivision 11.17.c.

11.3.c.3.C. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific registrant issued by a licensing state shall be considered exempt under Subparagraph 11.3.c.3.A., provided that the device is labeled in accordance with the specific registrant authorizing distribution, and provided further that they meet the requirements of Subdivision 11.17.c.

11.3.c.4. Resins Containing Scandium-46 and Designed for Sand Consolidation in Oil Wells. Any person is exempt from this rule to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific registrant issued by the NRC, or shall have been manufactured in accordance with the specifications contained in a specific registrant issued by the agency or any agreement state to the manufacturer of such resins pursuant to registration requirements equivalent to those in Sections 32.16 and 32.17 of 10 CFR Part 32 of the rules of the NRC. This exemption does not authorize the manufacture of any resins containing scandium-46.

11.4. Types of Registrants. Registrants for radioactive materials are of two types: general and specific.

11.4.a. General registrants provided in this Section are effective without the filing of applications with the agency or the issuance of registration documents to the particular persons, although the filing of a certificate with the agency may be required by the particular general registrant. The general registrant is subject to all other applicable portions of this rule and any limitations of the general registrant.

11.4.b. Specific registrants require the submission of an application to the agency and the issuance of a registration document by the agency. The registrant is subject to all applicable portions of this rule as well as any limitations specified in the registration document.

11.5. General Registrants - Source Material

11.5.a. A general registrant is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and state and local government agencies to use and transfer not more than fifteen (15) pounds (six and eighty two one-hundredths [6.82] kg) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, pursuant to this general registrant, may not receive more than a total of one hundred fifty (150) pounds (sixty eight and two-tenths [68.2] kg) of source material in any one (1) calendar year.

11.5.b. Persons who receive, possess, use, or transfer source material pursuant to the general registrant issued in Subdivision 11.15.a. are exempt from the provisions of Sections 6. and 14. of this rule to the extent that such receipt, possession, use, or transfer is within the terms of such general registrant; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific registrant issued pursuant to this Section.

11.5.c. Persons who receive, possess, use, or transfer source material pursuant to the general registrant in Subdivision 11.5.a. 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 registrant.

11.5.d. A general registrant is hereby issued authorizing the receipt of title to source material without regard to quantity. This general registrant does not authorize any person to receive, possess, use, or transfer source material.

11.6. Depleted Uranium in Industrial Products and Devices

11.6.a. A general registrant is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of Subdivisions 11.6.b., c., d., and e., 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.

11.6.b. The general registrant in Subdivision 11.6.a. applies only to industrial products or devices which have been manufactured either in accordance with a specific registrant issued to the manufacturer of the products or devices pursuant to Subdivision 11.17.1. or in accordance with a specific registration issued to the manufacturer by the NRC or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the NRC or an agreement state.

11.6.c. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general registrant established by Subdivision 11.6.a. shall file Agency Form W "certificate - use of depleted uranium under general registrant", with the agency. The form shall be submitted within thirty (30) days after the first receipt or acquisition of such depleted uranium. The general registrant shall furnish on Agency Form W the following information and such other information as may be required by that form:

11.6.c.1. Name and address of the general registrant;

11.6.c.2. A statement that the general registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in Subdivision 11.6.a. 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

11.6.c.2.A. Name and title, address, and telephone number of the individual duly authorized to act for and on behalf of the general registrant in supervising the procedures identified in Paragraph 11.6.c.2.

11.6.c.2.B. The general registrant possessing or using depleted uranium under the general registration established by Subdivision 11.6.a. shall report in writing to the agency any changes in information furnished by him in Agency Form W "Certificate - Use of Depleted Uranium Under General Registration". The report shall be submitted within thirty (30) days after the effective date of such change.

11.6.d. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general registration established by Subdivision 11.6.a.:

11.6.d.1. 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;

11.6.d.2. Shall not abandon such depleted uranium;

11.6.d.3. Shall transferor dispose of such depleted uranium only by transfer in accordance with the provisions of Subsection 11.26. In the case where the transferee receives the depleted uranium pursuant to the general registration established by Subdivision 11.6.a., the transferor shall furnish the transferee a copy of this rule and a copy of Agency Form W. In the case where the transferee receives the depleted uranium pursuant to a general registration contained in the NRC's or agreement state's rule equivalent to Subdivision 11.6.a., the transferor shall furnish the transferee a copy of this rule and a copy of Agency Form W accompanied by a note explaining that use of the product or device is regulated by the NRC or agreement state under requirements substantially the same as those in this rule;

11.6.d.4. Within thirty (30) days of any transfer, shall report in writing to the agency the name and address of the person receiving the depleted uranium pursuant to such transfer; and

11.6.d.5. Shall not export such depleted uranium except in accordance with a license issued by the NRC pursuant to 10 CFR Part 110.

11.6.e. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general registration established by Subdivision 11.6.a. is exempt from the requirements of Sections 6. and 14. of this rule with respect to the depleted uranium covered by that general registration.

11.7. General Registrations - Radioactive Material Other Than Source Material

11.7.a. Certain Devices and Equipment. A general registration is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific registration issued to the manufacturer by the NRC for use pursuant to Section 31.3 of 10 CFR Part 31. This general registration is subject to the provisions of Subsections 4.3 through 4.7, Paragraph 11.3.a.2., Subsections 11.19., 11.26., 11.27. and Sections 6., 14. and 15. of this rule.

11.7.a.1. Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than five hundred (500) microcuries (eighteen and five-tenths [18.5] MBq) of Polonium-210 per device.

11.7.a.2. Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than five hundred (500) microcuries (eighteen and five-tenths [18.5] MBq) of Polonium-210 per device or a total of not more than fifty (50) millicuries (one and eighty five one-hundredths [1.85] GBq) of hydrogen-3 (tritium) per device.

11.7.b. Certain Measuring, Gauging or Controlling Devices

11.7.b.1. A general registration is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of Paragraph 11.7.b.2., 3. and 4., radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

11.7.b.2. The general registration in Paragraph 11.7.b.1. applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific registration issued by the agency pursuant to Subdivision 11.17.d. or in accordance with the specifications contained in a specific registration issued by the NRC, an agreement state or a licensing state, which authorizes distribution of devices to persons generally licensed by the NRC, an agreement state or a licensing state.

11.7.b.3. Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general registration in Paragraph 11.7.a.1. or 11.7.b.3.A. shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;

11.7.b.3.A. Shall assure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than six (6) month intervals or at such other intervals as are specified in the label, however,

11.7.b.3.A.1. Devices containing only krypton need not be tested for leakage of radioactive material, and

11.7.b.3.A.2. Devices containing only tritium or not more than one hundred (100) microcuries (three and seven-tenths [3.7] MBq) of other beta or beta-gamma-emitting material or ten (10) microcuries (thirty seven one-hundredths [0.37] MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

11.7.b.3.B. Shall assure that other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:

11.7.b.3.B.1. In accordance with the instructions provided by the labels, or

11.7.b.3.B.2. By a person holding an applicable specific registration from the agency, the NRC, an agreement state or a licensing state to perform such activities;

11.7.b.3.C. Shall maintain records showing compliance with the requirements of Subparagraph 11.7.b.3.A. and B. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by Subparagraph 11.7.b.3.A. shall be maintained for one (1) year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the "on-off" mechanism and indicator required by Subparagraph 11.7.b.3.A. shall be maintained for one (1) year after the next required test of the "on-off" mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by Subparagraph 11.7.b.3.A. shall be maintained for a period of two (2) years from the date of the recorded event or until the device is transferred or disposed of;

11.7.b.3.D. Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the "on-off" mechanism or indicator, or upon the detection of five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific registration from the agency, the NRC, an agreement state or a licensing state to repair such devices, or disposed of by transfer to a person authorized by an applicable specific registration to receive the radioactive material contained in the device and, within thirty (30) days, furnish to the agency a report containing a brief description of the event and the remedial action taken;

11.7.b.3.E. Shall not abandon the device containing radioactive material;

11.7.b.3.F. Except as provided in Subparagraph 11.7.b.3.G., shall transferor dispose of the device containing radioactive material only by transfer to a specific registrant of the agency, the NRC, an agreement state or a licensing state whose specific registration authorizes him to receive the device and within thirty (30) days after transfer of a device to a specific registrant shall furnish to the agency a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific registrant in order to obtain a replacement device;

11.7.b.3.G. Shall transfer the device to another general registrant only:

11.7.b.3.G.1. Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this rule and any safety documents identified in the label on the device and within thirty (30) days of the transfer, report to the agency the manufacturer's name and model number of device transferred, the name and address of the transferee, and the name and position of an individual who may constitute a point of contact between the agency and the transferee; or

11.7.b.3.G.2. Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general registration; and

11.7.b.3.H. Shall comply with the provisions of Sections 6.53. and 6.54. of this rule for reporting radiation incidents, theft, or loss of registered material, but shall be exempt from the other requirements of Sections 6. and 14. of this rule.

11.7.b.4. The general registration in Paragraph 11.7.b.1. does not authorize the manufacture of devices containing radioactive material.

11.7.b.5. The general registration provided in Paragraph 11.7.b.1. is subject to the provisions of Subsections 4.2 through 4.7., 11.19.,11.26.,11.27. and Section 15. of this rule.

11.8. Luminous Safety Devices for Aircraft

11.8.a. A general registration is hereby issued to own, receive, acquire, possess, and use tritium or Promethium-147 contained in luminous safety devices for use in aircraft, provided:

11.8.a.1. Each device contains not more than ten (10) curies (three hundred seventy [370] GBq) of tritium or three hundred 300 millicuries (eleven one-tenths [11.1] GBq) of promethium-147; and

11.8.a.2. Each device has been manufactured, assembled or imported in accordance with a specific license issued by the NRC, or each device has been manufactured or assembled in accordance with the specifications contained in a specific registration issued by the agency or any agreement state to the manufacturer or assembler of such device pursuant to registration requirements equivalent to those in Section 32.53 of 10 CFR Part 32.

11.8.b. Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general registration in Subdivision 11.8.a. are exempt from the requirements of Sections 6. and 14. of this rule except that they shall comply with the provisions of Sections 6.53. and 6.54.

11.8.c. This general registration does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or Promethium-147.

11.8.d. This general registration does not authorize the ownership, receipt, acquisition, possession or use of Promethium-147 contained in instrument dials.

11.8.e. This general registration is subject to the provisions of Subsections 4.3. through 4.7.,11.19., 11.26., 11.27., and Section 15. of this rule.

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

11.10. Calibration and Reference Sources

11.10.a. A general registration is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of Subdivisions 11.10.d. and e. and Americium-241 in the form of calibration or reference sources:

11.10.a.1. Any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material; and

11.10.a.2. Any person who holds a specific registration issued by the NRC which authorizes him to receive, possess, use, and transfer special nuclear material.

11.10.b. A general registration is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of Subdivisions 11.10.d and 11.10.e. to any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.

11.10.c. A general registration is hereby issued to own, receive, possess, use, and transfer Radium-226 in the form of calibration or reference sources in accordance with the provisions of Subdivisions 11.10.d. and 11.10.e. to any person who holds a specific registration issued by the agency which authorizes him to receive, possess, use, and transfer radioactive material.

11.10.d. The general registrations in Subdivisions 11.10.a., 11.10.b. and 11.10.c. apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific registration issued to the manufacturer or importer of the sources by the NRC pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific registration issued to the manufacturer by the agency, any agreement state or licensing state pursuant to registration requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70.

11.10.e. The general registrations provided in Subdivisions 11.10.a., 11.10.b. and 11.10.c. are subject to the provisions of Subsections 4.3 through 4.7., 11.19., 11.26., 11.27., and Sections 6., 14., and 15. of this rule. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general registrations:

11.10.e.1. Shall not possess at any one time, at any one location of storage or use, more than five (5) microcuries (one hundred eighty five [185] kBq) of Americium-241, five (5) microcuries (one hundred eighty five [185] kBq) of plutonium, five (5) microcuries (one hundred eighty five [185] kBq) of Radium-226 in such sources;

11.10.e.2. Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:

11.10.e.2.A. The receipt, possession, use and transfer of this source, Model ________, Serial No._____________, are subject to a general registration and the rules of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS (AMERICIUM-241).

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

_____________________________

Name of manufacturer or importer

11.10.e.2.B. The receipt, possession, use and transfer of this source, Mode ________, Serial No. ____________ , are subject to a general registration and the rules of a Licensing State. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL

THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

_____________________________

Name of manufacturer or importer

11.10.e.3. Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a registration from the agency, the NRC, an agreement state or a licensing state to receive the source;

11.10.e.4. Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain Americium-241, Plutonium, or Radium-226 which might otherwise escape during storage; and

11.10.e.5. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

11.10.f. These general registrations do not authorize the manufacture of calibration or reference sources containing Americium-241, Plutonium, or Radium-226.

11.11. General Registration for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.

11.11.a. A general registration is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transferor use, for any of the following stated tests, in accordance with the provisions of Subdivisions 11.11.b., 11.11.c., 11.11.d., 11.11.e., and 11.11.f., the following radioactive materials in prepackaged units for use in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:

11.11.a.1. Carbon-14, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.11.a.2. Cobalt-57, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.11.a.3. Hydrogen-3 (tritium), in units not exceeding fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) each.

11.11.a.4. Iodine-125, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.11.a.5. Mock Iodine-125 reference or calibration sources, in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths 1.85 kBq) of iodine-129 and five one-thousandths (0.005) microcurie (one and eighty five one-hundredths [1.85] Bq) of Americium-241 each.

11.11.a.6. Iodine-131, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.11.a.7. Iron-59, in units not exceeding twenty (20) microcuries (seven hundred forty [740] kBq) each.

11.11.a.8. Selenium-75, in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.11.b. No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general registration established by Subdivision 11.11.a. until he has filed Agency Form F, "certificate - in vitro testing with radioactive material under general registration", with the agency and received from the agency a validated copy of Agency Form V with certification number assigned. The physician, veterinarian, clinical laboratory or hospital shall furnish on agency form v the following information and such other information as may be required by that form:

11.11.b.1. Name and address of the physician, veterinarian, clinical laboratory or hospital;

11.11.b.2. The location of use; and

11.11.b.3. A statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general registration in Subdivision 11.11.a. and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.

11.11.c. A person who receives, acquires, possesses or uses radioactive material pursuant to the general registration established by Subdivision 11.11.a. shall comply with the following:

11.11.c.1. The general registrant shall not possess at any one time, pursuant to the general registration in Subdivision 11.11.a., at any one location of storage or use, a total amount of Iodine-125, Iodine-131, Selenium-75, Iron-59, or Cobalt-57 in excess of two hundred (200) microcuries (seven and four-tenths [7.4] MBq).

11.11.c.2. The general registrant shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

11.11.c.3. The general registrant shall use the radioactive material only for the uses authorized by Subdivision 11.11.a.

11.11.c.4. The general registrant shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a registration issued by the agency, the NRC, any agreement state or licensing state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

11.11.c.5. The general registrant shall dispose of the mock Iodine-125 reference or calibration sources described in Paragraph 11.11.a.7. as required by Subsection 6.13. of this rule.

11.11.d. The general registrant shall not receive, acquire, possess, or use radioactive material pursuant to Subdivision 11.11.a.:

11.11.d.1. Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific registration issued pursuant to Subdivision 11.17.g. or in accordance with the provisions of a specific registration issued by the NRC, any agreement state or licensing state which authorizes the manufacture and distribution of Iodine-125, Iodine-131, Carbon-14, Hydrogen-3 (tritium), Iron-59, Selenium-75, Cobalt-57, or mock Iodine-125 to persons generally registered under Subparagraph 11.3.3.c.A. or its equivalent, and

11.11.d.2. Unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

11.11.d.2.A. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of the NRC or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

____________________

Name of manufacturer

11.11.d.2.B. This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the rules and a general registration of a licensing state.

____________________

Name of manufacturer

11.11.e. The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general registration of Subdivision 11.11.a. shall report in writing to the agency, any changes in the information furnished by him in the "Certificate - In Vitro Testing With Radioactive Material Under General Registration", Agency Form V. The report shall be furnished within thirty (30) days after the effective date of such change.

11.11.f. Any person using radioactive material pursuant to the general registration of Subdivision 11.11.a. is exempt from the requirements of Sections 6. and 14. of this rule with respect to radioactive material covered by that general registration, except that such persons using the mock Iodine-125 described in Paragraph 11.11.a.7. shall comply with the provisions of Subsections 6.13., 6.53. and 6.54. of this rule.

11.12. Ice Detection Devices

11.12.a. A general registration is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) of strontium-90 and each device has been manufactured or imported in accordance with a specific registration issued by the NRC or each device has been manufactured in accordance with the specifications contained in a specific registration issued by the agency or an agreement state to the manufacturer of such device pursuant to registration requirements equivalent to those in Section 32.61 of 10 CFR Part 32.

11.12.b. Persons who own, receive, acquire, possess, use, or transfer Strontium-90 contained in ice detection devices pursuant to the general registration in Subdivision 11.12.a.,

11.12.b.1. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific registration from the NRC or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of Subsection 6.13. of this rule;

11.12.b.2. Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and

11.12.b.3. Are exempt from the requirements of Sections 6. and 14. of this rule except that such persons shall comply with the provisions of Subsections 6.13., 6.53. and 6.54.

11.12.c. This general registration does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.

11.12.d. This general registration is subject to the provisions of Subsections 4.3 through 4.7., 11.19., 11.26., 11.27. and Section 15. of this rule.

11.13. Filing Application for Specific Registrations

11.13.a. Applications for specific registrations shall be filed on a form prescribed by the agency.

11.13.b. The agency may at any time after the filing of the original application, and before the expiration of the registration, require further statements in order to enable the agency to determine whether the application should be granted or denied or whether a registration should be modified or revoked.

11.13.c. Each application shall be signed by the applicant or registrant or a person duly authorized to act for and on his behalf.

11.13.d. An application for a registration may include a request for a registration authorizing one or more activities.

11.13.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.

11.13.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 content is not required in the public interest and would adversely affect the interest of a person concerned.

11.14. General Requirements for the Issuance of Specific Registrations. A registration application will be approved if the agency determines that:

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

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

11.14.c. The issuance of the registration will not be inimical to the health and safety of the public; and

11.14.d. The applicant satisfies any applicable special requirements in Subsections 11.15., 11.17., Sections 8.,13. or 15. of this rule.

11.14.e. Environmental Report, Commencement of Construction. In the case of an application for a registration to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity which the agency determines will significantly affect the quality of the environment, the agency, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed registration, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a registration to receive and possess radioactive material in such plant or facility. As used in this Paragraph the term "commencement of construction" is 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 roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

11.14.f. Financial Surety Arrangements for Site Reclamation

11.14.f.1. Financial surety arrangements for site reclamation which may consist of surety bonds, cash deposits, certificates of deposit, deposits of government securities, letters or lines of credit, or any combination of the above for the categories of registrations listed in Paragraph 11.14.f.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 registrant to meet the requirements of the act and this rule.

11.14.f.1.A. The amount of funds to be ensured by such surety arrangements shall be based on agency-approved cost estimates.

11.14.f.1.B. 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 registration requirements.

11.14.f.2. The arrangements required in Subdivision 11.14.f.1. shall be established prior to issuance of the registration to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility.

11.14.f.3. Amendments to registrations in effect on July 1, 2001. may be issued providing that the required surety arrangements are established within ninety (90) days .

11.14.f.4. The following specific registrations are required to make financial surety arrangements:

11.14.f.4.A. Major processors;

11.14.f.4.B. Waste handling registrants;

11.14.f.4.C. Former U.S. Atomic Energy Commission or NRC licensed facilities; and

11.14.f.4.D. All others except persons exempt pursuant to Paragraph 11.14.f.5.

11.14.f.5. The following persons are exempt from the requirements of 11.14.f.1.:

11.14.f.5.A. All state, local, or other government agencies, unless they are subject to Subparagraph 11.14.f.4.B.;

11.14.f.5.B. Persons authorized to possess no more than one thousand (1,000) times the quantity specified in Table 64-23 Z or combination of radioactive material listed therein as given in Table 64-23 Z, note 1;

11.14.f.5.C. Persons authorized to possess Hydrogen-3 contained as hydrogen gas in a sealed source; or

11.14.f.5.D. Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than thirty (30) days.

11.15. Special Requirements for Issuance of Certain Specific Registrations for Radioactive Material

11.15.a. Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in Subsection 11.14., a specific registration for use of sealed sources in industrial radiography will be issued if:

11.15.a.1. The applicant will have an adequate program for training radiographic personnel and submits to the agency a schedule or description of such program which specifies the:

11.15.a.1.A. Initial training,

11.15.a.1.B. Periodic training,

11.15.a.1.C. On-the-job training, and

11.15.a.1.D. Means to be used by the registrant to determine the radiographic personnel's knowledge and understanding of and ability to comply with agency rules and registration requirements, and the operating and emergency procedures of the applicant.

11.15.b. The applicant has established and submits to the agency satisfactory written operating and emergency procedures described in Subsection 8.15. of this rule;

11.15.c. The applicant will have an internal inspection system adequate to assure that this rule, registration provisions, and the applicant's operating and emergency procedures are followed by radiographic personnel; the inspection system shall include the performance of internal inspections at intervals not to exceed three (3) months and the retention of records of such inspections for two (2) years;

11.15.d. The applicant submits to the agency a description of the overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

11.15.e. The applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the agency a description of such procedures including:

11.15.e.1. Instrumentation to be used,

11.15.e.2. Method of performing tests, and

11.15.e.3. Pertinent experience of the individual who will perform the test; and

11.15.f. The registrant shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

11.16. Special Requirements for Specific Registrations of Broad Scope. This Section prescribes requirements for the issuance of specific registrations of broad scope for radioactive material and certain rules governing holders of such registrations.

11.16.a. The different types of broad scope registrations are set forth below:

11.16.a.1. A "Type A specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the registration, but not exceeding quantities specified in the registration, for any authorized purpose. The quantities specified are usually in the multicurie range.

11.16.a.2. A "Type B specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Table 64-23 Aa, for any authorized purpose. The possession limit for a Type B registration of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Table 64-23 Aa, column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Table 64-23 Aa, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the registration shall not exceed unity.

11.16.a.3. A "Type C specific registration of broad scope" is a specific registration authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in Table 64-23 Aa, for any authorized purpose. The possession limit for a Type C registration of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Table 64-23 Aa, column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Table 64-23 Aa, column ii, for that radionuclide. The sum of the ratios for all radionuclides possessed under the registration shall not exceed unity.

11.16.b. An application for a Type A specific registration of broad scope will be approved if:

11.16.b.1. The applicant satisfies the general requirements specified in Subsection 11.14.;

11.16.b.2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

11.16.b.3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

11.16.b.3.A. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

11.16.b.3.B. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

11.16.b.3.C. The establishment of appropriate administrative procedures to assure:

11.16.b.3.C.1. Control of procurement and use of radioactive material;

11.16.b.3.C.2. Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

11.16.b.3.C.3. Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with Part 11.16.b.3.C.2. prior to use of the radioactive material.

11.16.c. An application for a Type B specific registration of broad scope will be approved if:

11.16.c.1. The applicant satisfies the general requirements specified in Subsection 11.14.; and

11.16.c.2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

11.16.c.2.A. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and

11.16.c.2.B. The establishment of appropriate administrative procedures to assure,

11.16.c.2.B.1. Control of procurement and use of radioactive material,

11.16.c.2.B.2. Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures, and

11.16.c.2.B.3. Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with Part 11.16.c.2.B.2. prior to use of the radioactive material.

11.16.d. An application for a type c specific registration of broad scope will be approved if:

11.16.d.1. The applicant satisfies the general requirements specified in Subsection 11.14.;

11.16.d.2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

11.16.d.2.A. A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and

11.16.d.2.B. At least forty (40) hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

11.16.d.3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

11.16.e. Specific registrations of broad scope are subject to the following conditions:

11.16.e.1. Unless specifically authorized, persons registered pursuant to Subsection 11.16. shall not:

11.16.e.1.A. Conduct tracer studies in the environment involving direct release of radioactive material;

11.16.e.1.B. Receive, acquire, own, possess, use, or transfer devices containing one hundred thousand (100,000) curies (three and seven-tenths (3.7) PBq) or more of radioactive material in sealed sources used for irradiation of materials;

11.16.e.1.C. Conduct activities for which a specific registration issued by the agency under Subsections 11.15., 11.17., or Section 12. of this rule is required; or

11.16.e.1.D. Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

11.16.e.2. Each Type A specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals approved by the registrant's radiation safety committee.

11.16.e.3. Each Type B specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals approved by the registrant's radiation safety officer.

11.16.e.4. Each type c specific registration of broad scope issued under this Section shall be subject to the condition that radioactive material possessed under the registration may only be used by, or under the direct supervision of, individuals who satisfy the requirements of Subdivision 11.16.d.

11.17. Special Requirements for a Specific Registration to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices Which Contain Radioactive Material

11.17.a. Registration of the Introduction of Radioactive Material into Products in Exempt Concentrations

11.17.a.1. In addition to the requirements set forth in Subsection 11.14., a specific registration authorizing the introduction of radioactive material into a product or material owned by or in the possession of the registrant or another to be transferred to persons exempt under Paragraph 11.3.a.1. will be issued if:

11.17.a.1.A. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

11.17.a.1.B. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Table 64-23 Y, that reconcentration of the radioactive material in concentrations exceeding those in Table 64-23 Y is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

11.17.a.1.C. Each person registered under Subdivision 11.17.a. shall file an annual report with the agency which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the registrant. If no transfers of radioactive material have been made pursuant to Subdivision 11.17.a. during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty (30) days thereafter.

11.17.b. Registration of the Distribution of Radioactive Material in Exempt Quantities.

11.17.b.1. An application for a specific registration to distribute NARM to persons exempted from this rule pursuant to Subdivision 11.3.b. will be approved if:

11.17.b.1.A. The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

11.17.b.1.B. The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

11.17.b.1.C. The applicant submits copies of prototype labels and brochures and the agency approves such labels and brochures.

11.17.b.2. The registration issued under Paragraph 11.17.b.1. is subject to the following conditions:

11.17.b.2.A. No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

11.17.b.2.B. Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to Subdivision 11.3.b. The outer package shall be such that the dose rate at the external surface of the package does not exceed five-tenths (0.5) millirem (five [5] :Sv) per hour.

11.17.b.2.C. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

11.17.b.2.C.1. Identifies the radionuclide and the quantity of radioactivity, and

11.17.b.2.C.2. Bears the words "radioactive material".

11.17.b.2.D. In addition to the labeling information required by Subparagraph 11.17.b.2.C., the label affixed to the immediate container, or an accompanying brochure, shall:

11.17.b.2.D.1. State that the contents are exempt from registration requirements,

11.17.b.2.D.2. 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

11.17.b.2.D.3. Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

11.17.b.3. Each person registered under Subdivision 11.17.b. shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under Subdivision 11.17.b. or the equivalent rules of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific registration shall be filed with the agency. Each report shall cover the year ending June 30, and shall be filed within thirty (30) days thereafter. If no transfers of radioactive material have been made pursuant to Subdivision 11.17.b. during the reporting period, the report shall so indicate.

11.17.c. Registration of the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors. An application for a specific registration authorizing the incorporation of narm into gas and aerosol detectors to be distributed to persons exempt under Paragraph 11.3.c.3. will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32. The maximum quantity of radium-226 in each device shall not exceed one-tenth (0.1) microcurie (three and seven-tenths [3.7] kBq).

11.17.d. Registration of the Manufacture and Distribution of Devices to Persons Generally Registered Under Subdivision 11.7.b.

11.17.d.1. An application for a specific registration to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally registered under Subdivision 11.7.b. or equivalent rules of the NRC, an agreement state, or a licensing state will be approved if:

11.17.d.1.A. The applicant satisfies the general requirements of Subsection 11.14.;

11.17.d.1.B. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

11.17.d.1.B.1. The device can be safely operated by persons not having training in radiological protection,

11.17.d.1.B.2. 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 (1) calendar quarter a dose in excess of ten (10) percent of the limits specified in Subsection 6.4.a. of this rule, and

11.17.d.1.B.3. 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 organ doses listed in Table 64-23 Ll column III: and

11.17.d.1.C. Each device bears a durable, legible, clearly visible label or labels approved by the agency, which contain in a clearly identified and separate statement:

11.17.d.1.C.1. 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,

11.17.d.1.C.2. 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

11.17.d.1.C.3. The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

11.17.d.1.C.3.(a) The receipt, possession, use, and transfer of this device, Model___________, Serial No.____________¹⁰, are subject to a general registration or the equivalent and the rules of the NRC or a state with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

______________________________________________________

Name of manufacturer or distributor

11.17.d.1.C.3.(b) The receipt, possession, use, and transfer of this device, Model__________, Serial No.___________^4/, are subject to a general registration or the equivalent, and the rules of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

______________________________________________________

Name of manufacturer or distributor

___________________________

11.17.d.2. In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the agency will consider information which includes, but is not limited to:

11.17.d.2.A. Primary containment or source capsule;

11.17.d.2.B. Protection of primary containment;

11.17.d.2.C. Method of sealing containment;

11.17.d.2.D. Containment construction materials;

11.17.d.2.E. Form of contained radioactive material;

11.17.d.2.F. Maximum temperature withstood during prototype tests;

11.17.d.2.G. Maximum pressure withstood during prototype tests;

11.17.d.2.H. Maximum quantity of contained radioactive material;

11.17.d.2.I. Radiotoxicity of contained radioactive material; and

11.17.d.2.J. Operating experience with identical devices or similarly designed and constructed devices.

11.17.d.3. In the event the applicant desires that the general registration under Subdivision 11.7.b. , or under equivalent rules of the NRC, an agreement state, or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific registration for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general registration, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general registration, is unlikely to cause that individual to receive a calendar quarter dose in excess of ten (10) percent of the limits specified in Subsection 6.4. of this rule.

11.17.d.4. Each person registered under Subdivision 11.17.d. to distribute devices to generally registered persons shall:

11.17.d.4.A. Furnish a copy of the general registration contained in Subdivision 11.7.d. to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general registration contained in Subdivision 11.7.d.;

11.17.d.4.B. Furnish a copy of the general registration contained in the NRC's, agreement state's, or licensing state's rule equivalent to Subdivision 11.7.d., or alternatively, furnish a copy of the general registration contained in Subdivision 11.7.d. to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general registration of the NRC, the agreement state, or the licensing state. If a copy of the general registration in use of the device is regulated by the NRC, agreement state, or licensing state under requirements Subdivision 11.7.d. is furnished to such a person, it shall be accompanied by a note explaining that the substantially the same as those in Subdivision 11.7.d.;

11.17.d.4.C. Report to the agency all transfers of such devices to persons for use under the general registration in Subdivision 11.7.d. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally registered under Subdivision 11.7.d. during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within thirty (30) days thereafter;

11.17.d.4.D. Furnish reports to other agencies.

11.17.d.4.D.1. Report to the NRC all transfers of such devices to persons for use under the NRC general registration in Section 31.5 of 10 CFR Part 31.

11.17.d.4.D.2. Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to Subdivision 11.17.d. for use under a general registration in that state's rules equivalent to Subdivision 11.7.d.

11.17.d.4.D.3. Such reports shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such a device is transferred to the generally registered person.

11.17.d.4.D.4. If no transfers have been made to NRC registrants during the reporting period, this information shall be reported to the NRC.

11.17.d.4.D.5. If no transfers have been made to general registrations within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of that agency; and

11.17.d.4.E. Keep records showing the name, address, and the point of contact for each general registration to whom he directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general registration provided in Subdivision 11.7.b., or equivalent rules of the NRC, an agreement state, or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subpart 11.17.d.1.C.

11.17.e. Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific registration to manufacture, assemble, or repair luminous safety devices containing tritium or Promethium-147 for use in aircraft, for distribution to persons generally registered under Subsection 11.8. will be approved if:

11.17.e.1. The applicant satisfies the general requirements specified in Subsection 11.14.; and

11.17.e.2. The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, and 32.101 of 10 CFR Part 32, or their equivalent.

11.17.f. Special Requirements for Registration to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Generally Registered Under Subsection 11.10. An application for a specific registration to manufacture calibration and reference sources containing Americium-241, plutonium or Radium-226 to persons generally registered under Subsection 11.10. will be approved if:

11.17.f.1. The applicant satisfies the general requirement of Subsection 11.14.; and

11.17.f.2. The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, and 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

11.17.g. Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General Registration. An application for a specific registration to manufacture or distribute radioactive material for use under the general registration of Subsection 11.11. will be approved if:

11.17.g.1. The applicant satisfies the general requirements specified in Subsection 11.14.

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

11.17.g.2.A. Carbon-14 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.17.g.2.B. Cobalt-57 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.17.g.2.C. Hydrogen-3 (tritium) in units not exceeding fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) each.

11.17.g.2.D. Iodine-125 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.17.g.2.E. Mock iodine-125 in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) of iodine-129 and five one-thousandths (0.005) microcurie (one hundred eighty five one-hundredths [185] Bq) of americium-241 each.

11.17.g.2.F. Iodine-131 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

11.17.g.2.G. Iron-59 in units not exceeding twenty (20) microcuries (seven hundred forty [740] kBq) each.

11.17.g.2.H. Selenium-75 in units not exceeding ten (10) microcuries (three hundred seventy [370] kBq) each.

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

11.17.g.3.A. Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed ten (10) microcuries (three hundred seventy [370] kBq) of Iodine-125, Iodine-131, Carbon-14, Cobalt-57, or Selenium-75; fifty (50) microcuries (one and eighty five one-hundredths [1.85] MBq) of Hydrogen-3 (tritium); twenty (20) microcuries (seven hundred forty [740] kBq) of Iron-59; or mock Iodine-125 in units not exceeding five one-hundredths (0.05) microcurie (one and eighty five one-hundredths [1.85] kBq) of Iodine-129 and five one-thousandths (0.005) microcurie (one hundred eighty five [185] Bq) of Americium-241 each; and

11.17.g.3.B. Displaying the radiation caution symbol described in Subsection 6.7. and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

11.17.g.4. One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

11.17.g.4.A. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority.

______________________

Name of manufacturer

11.17.g.4.B. This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the rules and a general registration of a licensing state.

______________________

Name of manufacturer

11.17.g.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 registrant regarding the waste disposal requirements set out in Subsection 6.7. of this rule.

11.17.h. Registration of the Manufacture and Distribution of Ice Detection Devices. An application for a specific registration to manufacture and distribute ice detection devices to persons generally registered under Subsection 11.12. will be approved if:

11.17.h.1. The applicant satisfies the general requirements of Subsection 11.14.; and

11.17.h.2. The criteria of Sections 32.61, 32.62, and 32.103 of 10 CFR Part 32 are met.

11.17.i. Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under Group Registrants. An application for a specific registration to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons registered pursuant to this Section for the uses listed in Subsections 11.30., 11.32., and 11.36. of this rule will be approved if:

11.17.i.1. The applicant satisfies the general requirements specified in Subsection 11.14. of this Section;

11.17.i.2. The applicant submits evidence that:

11.17.i.2.A. The radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or

11.17.i.2.B. The manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;

11.17.i.3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by group registrations; and

11.17.i.3.A. 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 registered by the agency for distribution to persons registered pursuant to this Section for the uses listed in 11.17.i.

11.17.i.3.B. The labels, leaflets, or brochures required by Paragraph 11.17.i.3.A. 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.

11.17.j. Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material.¹¹ An application for a specific registration to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons registered pursuant to this Section for the uses listed in Subsection 11.32. of this rule will be approved if:

11.17.j.1. The applicant satisfies the general requirements specified in Subsection 11.25.;

11.17.j.2. The applicant submits evidence that:

11.17.j.2.a. The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or

11.17.j.2.B. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;

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

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

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

11.17.j.5.A. Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and

11.17.j.5.B. A statement that this generator or reagent kit, as appropriate, is approved for use by persons registered by the agency pursuant to Subsection 11.32. of this rule or under equivalent licenses of the NRC, an agreement state, or a licensing state. The labels, leaflets, or brochures required by Subdivision 11.17.j. 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.

11.17.k. Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific registration to manufacture and distribute sources and devices containing radioactive material to persons registered pursuant to Section 12. for use as a calibration or reference source or for the uses listed in Subsections 12.40 and 12.42. of this rule will be approved if:

11.17.k.1. The applicant satisfies the general requirements in Subsection 11.14. of this Section;

11.17.k.2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

11.17.k.2.A. The radioactive material contained, its chemical and physical form, and amount,

11.17.k.2.B. Details of design and construction of the source or device,

11.17.k.2.C. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,

11.17.k.2.D. For devices containing radioactive material, the radiation profile of a prototype device,

11.17.k.2.E. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

11.17.k.2.F. Procedures and standards for calibrating sources and devices,

11.17.k.2.G. Legend and methods for labeling sources and devices as to their radioactive content, and

11.17.k.2.H. Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

11.17.k.3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is registered by the agency for distribution to persons registered pursuant to Section 12. and Subsections 12.40. and 12.42. of this rule or under equivalent licenses of the NRC, an agreement state, or a licensing state, provided that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source;

11.17.k.4. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six (6) months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

11.17.k.5. In determining the acceptable interval for test of leakage of radioactive material, the agency will consider information that includes, but is not limited to:

11.17.k.5.A. Primary containment or source capsule,

11.17.k.5.B. Protection of primary containment,

11.17.k.5.C. Method of sealing containment,

11.17.k.5.D. Containment construction materials,

11.17.k.5.E. Form of contained radioactive material,

11.17.k.5.F. Maximum temperature withstood during prototype tests,

11.17.k.5.G. Maximum pressure withstood during prototype tests,

11.17.k.5.H. Maximum quantity of contained radioactive material,

11.17.k.5.I. Radiotoxicity of contained radioactive material, and

11.17.k.5.J. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

11.17.l. Requirements for Registration to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications

11.17.l.1. An application for a specific registration to manufacture industrial products and devices containing depleted uranium for use pursuant to Subdivision 11.5.d. equivalent rules of the NRC or an agreement state will be approved if:

11.17.l.1.A. The applicant satisfies the general requirements specified in Subsection 11.14.;

11.17.l.1.B. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one (1) calendar quarter a radiation dose in excess of ten (10) percent of the limits specified in Subsection 6.4. of this rule; and

11.17.l.1.C. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

11.17.l.2. In the case of an industrial product or device whose unique benefits are questionable, the agency will approve an application for a specific registration under Subdivision 11.17.l. 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.

11.17.l.3. The agency may deny any application for a specific registration under Subdivision 11.17.l. if the end uses of the industrial product or device cannot be reasonably foreseen.

11.17.l.4. Each person registered pursuant to Subdivision 11.17.l. shall:

11.17.l.4.A. Maintain the level of quality control required by the registration in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

11.17.l.4.B. Label or mark each unit to:

11.17.l.4.B.1. Identify the manufacturer of the product or device and the number of the registration under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

11.17.l.4.B.2. State that the receipt, possession, use, and transfer of the product or device are subject to a general registration or the equivalent and the rules of the NRC or an agreement state;

11.17.l.4.C. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "depleted uranium";

11.17.l.4.C.1. Furnish a copy of the general registration contained in Subdivision 11.5.d. and a copy of Agency Form W to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general registration contained in Subdivision 11.5.d., or

11.17.l.4.C.2. Furnish a copy of the general registration contained in the NRC's or agreement state's rule equivalent to Subdivision 11.5.d. and a copy of the NRC's or agreement state's certificate, or alternatively, furnish a copy of the general registration contained in Subdivision 11.5.d. and a copy of Agency Form W to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general registration of the NRC or an agreement state, with a note explaining that use of the product or device is regulated by the NRC or an agreement state under requirements substantially the same as those in Subdivision 11.5.d.;

11.17.l.4.D. Report to the agency all transfers of industrial products or devices to persons for use under the general registration in Subdivision 11.5.d. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such a product or device is transferred to the generally registered person. If no transfers have been made to persons generally registered under Subdivision 11.5.d. during the reporting period, the report shall so indicate;

11.17.l.4.D.1. Report to the NRC all transfers of industrial products or devices to persons for use under the NRC general registration in Section 40.25 of 10 CFR Part 40,

11.17.l.4.D.2. Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to Subdivision 11.17.l. for use under a general registration in that state's rules equivalent to Subdivision 11.5.d.,

11.17.l.4.D.3. Such report shall identify each general registration by name and address, an individual by name and position who may constitute a point of contact between the agency and the general registration, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty (30) days after the end of each calendar quarter in which such product or device is transferred to the generally registered person,

11.17.l.4.D.4. If no transfers have been made to NRC registrants during the reporting period, this information shall be reported to the NRC, and

11.17.l.4.D.5. If no transfers have been made to general registrations within a particular agreement state during the reporting period, this information shall be reported to the responsible agreement state agency upon the request of that agency; and

11.17.l.4.D.6. Keep records showing the name, address, and point of contact for each general registration to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general registration provided in Subdivision 11.5.d. or equivalent rules of the NRC or an agreement state. The records shall be maintained for a period of two (2) years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this Section.

11.18. Issuance of Specific Registrations

11.18.a. Upon a determination that an application meets the requirements of this rule and the rules of the agency, the agency will issue a specific registration authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.

11.18.b. The agency may incorporate in any registration at the time of issuance, or thereafter by appropriate rule, or order, such additional requirements and conditions with respect to the registration's receipt, possession, use, and transfer of radioactive material subject to this Section as it deems appropriate or necessary in order to:

11.18.b.1. Minimize danger to public health and safety or property;

11.18.b.2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the registration as may be appropriate or necessary; and

11.18.b.3. Prevent loss or theft of material subject to this Section.

11.19. Specific Terms and Conditions of Registrations

11.19.a. Each registration issued pursuant to this Section shall be subject to all the provisions of this rule, now or hereafter in effect, and to all rules, and orders of the agency.

11.19.b. No registration issued or granted under this Section and no right to possess or utilize radioactive material granted by any registration issued pursuant to this Section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any registration to any person unless the agency shall, after securing full information find that the transfer is in accordance with the provisions of the act, now or hereafter in effect, and to all valid rules, and orders of the agency, and shall give its consent in writing.

11.19.c. Each person registered by the agency pursuant to this Section shall confine use and possession of the material registered to the locations and purposes authorized in the registration.

11.19.d. Each registrant shall notify the agency in writing when the registrant decides to permanently discontinue all activities involving materials authorized under the registration.

11.19.e. Each registrant 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:

11.19.e.1. The registrant;

11.19.e.2. An entity (as that term is defined in 11 U.S.C. 101(14) ) controlling the registrant or listing the registration or registrant as property of the estate; or

11.19.e.3. An affiliate (as that term is defined in 11 U.S.C. 101(2) ) of the registrant.

11.19.f. The notification specified in Subdivision 11.19.e. shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

11.20. Expiration and Termination of Registrations

11.20.a. Except as provided in Subdivision 11.21.b., each specific registration shall expire at the end of the specified day in the month and year stated therein.

11.20.b. Each registrant shall notify the agency immediately, in writing, and request termination of the registration when the registrant decides to terminate all activities involving radioactive material authorized under the registration. This notification and request for termination of the registration must include the reports and information specified in Paragraphs 11.20.d.4. and 5.

11.20.c. No less than thirty (30) days before the expiration date specified in the registration, the registrant shall either:

11.20.c.1. Submit an application for registration renewal under Subsection 11.21.; or

11.20.c.2. Notify the agency, in writing, if the registrant decides not to renew the registration.

11.20.d. If a registrant does not submit an application for registration renewal under Subsection 11.21., the registrant shall, on or before the expiration date specified in the registration:

11.20.d.1. Terminate use of radioactive material;

11.20.d.2. Remove radioactive contamination to the extent practicable;

11.20.d.3. Properly dispose of radioactive material;

11.20.d.4. Submit a completed agency form t; and

11.20.d.5. Submit a radiation survey report to confirm the absence of radioactive material or to establish the levels of residual radioactive contamination, unless the registrant demonstrates the absence of residual radioactive contamination in some other manner. The registrant shall, as appropriate:

11.20.d.5.A. Report levels of radiation in units of microrads per hour of beta and gamma radiation at 1 centimeter and gamma radiation at 1 meter from surfaces and report levels of radioactivity, including alpha, in units of transformations per minute (or microcuries) per one hundred (100) square centimeters removable and fixed on surfaces, microcuries per milliliter in water, and picocuries per gram in contaminated solids such as soils or concrete; and

11.20.d.5.B. Specify the instrumentation used and certify that each instrument was properly calibrated and tested.

11.20.d.6. If no residual radioactive contamination attributable to activities conducted under the registration is detected, the registrant shall submit a certification that no detectable radioactive contamination was found. The agency will notify the registrant, in writing, of the termination of the registration.

11.20.d.7. If detectable levels of residual radioactive contamination attributable to activities conducted under the registration are found, the registration continues in effect beyond the expiration date, if necessary, with respect to possession of residual radioactive material present as contamination until the agency notifies the registrant in writing that the registration is terminated. During this time the registrant is subject to the provisions of Subdivision 11.20.e.

11.20.d.8. In addition to the information submitted under Paragraphs 11.20.d.4. and 11.20.d.5., the registrant shall submit a plan for decontamination, if required, as regards residual radioactive contamination remaining at the time the registration expires.

11.20.e. Each registrant who possesses residual radioactive material under Paragraph 11.20.d.7., following the expiration date specified in the registration shall:

11.20.e.1. Limit actions involving radioactive material to those related to decontamination and other activities related to preparation for release for unrestricted use; and

11.20.e.2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the agency notifies the registrant in writing that the registration is terminated.

11.21. Renewal of Registrations

11.21.a. Applications for renewal of specific registrations shall be filed in accordance with Subsection 11.13.

11.21.b. In any case in which a registrant, not less than thirty (30) days prior to expiration of his existing registration, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing registration shall not expire until final action by the agency.

11.22. Amendment of Registrations at Request of Registrant. Applications for amendment of a registration shall be filed in accordance with Subsection 11.13. and shall specify the respects in which the registrant desires the registration to be amended and the grounds for such amendment.

11.23. Agency Action on Applications to Renew or Amend. In considering an application by a registrant to renew or amend the registration, the agency will apply the criteria set forth in Subsections 11.14., 11.15.,11.16., and 11.17 and in Sections 8., 12. and 15. this rule, as applicable.

11.24. Persons Possessing a Registration for Source, Byproduct, or Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass on Effective Date of This rule. Any person who, on the effective date of this rule, possesses a general or specific registration for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the NRC, shall be deemed to possess a like registration issued under this Section and this rule, such registration to expire either ninety (90) days after receipt from the agency of a notice of expiration of such registration, or on the date or expiration specified in the NRC registration, whichever is earlier.

11.25. Persons Possessing Naturally Occurring and Accelerator-Produced Radioactive Material (NARM) on Effective Date of This rule. Any person who, on the effective date of this rule, possesses narm for which a specific registration is required by this rule or this Section shall be deemed to possess such a registration issued under this rule and this Section. Such registration shall expire ninety (90) days after the effective date of this rule; provided, however, that if within the ninety (90) days the person possessing such material files an application in proper form for a registration, such existing registration shall not expire until the application has been finally determined by the agency.

11.26. Transfer of Material

11.26.a. No registrant shall transfer radioactive material except as authorized pursuant to Subsection 11.26.

11.26.b. Except as otherwise provided in his registration and subject to the provisions of Subdivisions 11.26.c. and 11.26.d., any registrant may transfer radioactive material:

11.26.b.1. To the agency;

11.26.b.2. To the U.S. department of energy;

11.26.b.3. To any person exempt from this rule to the extent permitted under such exemption;

11.26.b.4. To any person authorized to receive such material under terms of a general registration or its equivalent, or a specific registration or equivalent registration document, issued by the agency, the NRC, any agreement state or any licensing state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the agency, an agreement state or a licensing state; or

11.26.b.5. As otherwise authorized by the agency in writing.

11.26.c. Before transferring radioactive material to a specific registration of the agency, the NRC, an agreement state or a licensing state, or to a general registration who is required to register with the agency, the NRC, an agreement state or a licensing state prior to receipt of the radioactive material, the registrant transferring the material shall verify that the transferee's registration authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

11.26.d. Any of the following methods for the verification required by Subdivision 11.26.c. is acceptable:

11.26.d.1. The transferor may possess and read a current copy of the transferee's specific registration or registration certificate.

11.26.d.2. The transferor may possess a written certification by the transferee that the transferee is authorized by registration or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the registration or registration certificate number, issuing agency, and expiration date.

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

11.26.d.4. The transferor may obtain other information compiled by a reporting service from official records of the agency, the NRC, an agreement state, or a licensing state regarding the identity of registrants and the scope and expiration dates of licenses and registration.

11.26.d.5. When none of the methods of verification described in Paragraphs 11.26.d.1. through 4. are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the agency, the NRC, or an agreement state, or a licensing state that the transferee is registered to receive the radioactive material.

11.26.e. Shipment and transport of radioactive material shall be in accordance with the provisions of Section 15. of this rule.

11.27. Modification and Revocation of Registrations

11.27.a. The terms and conditions of all registrations shall be subject to amendment, revision, or modification or the registration may be suspended or revoked by reason of amendments to this rule, or by reason of rules, rules, and orders issued by the agency.

11.27.b. Any registration 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 this rule, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the agency to refuse to grant a registration on an original application, or for violation of, or failure to observe any of the terms and conditions of this rule, or of the registration, or of any rule, or order of the agency.

11.27.c. Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no registration shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

11.28. Reciprocal Recognition of Registrations

11.28.a. Registrations of Byproduct, Source, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass

11.28.a.1. Subject to this rule, any person who holds a specific registration from the NRC or an agreement state, and issued by the agency having jurisdiction where the registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, is hereby granted a general registration to conduct the activities authorized in such registration document within this state for a period not in excess of one hundred eighty (180) days in any calendar year provided that:

11.28.a.1.A. The registration document does not limit the activity authorized by such document to specified installations or locations;

11.28.a.1.B. The out-of-state registrant notifies the agency in writing at least three (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 registration document. If, for a specific case, the three (3) day period would impose an undue hardship on the out-of-state registrant, the registrant 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 registration provided in Paragraph 11.28.a.1.;

11.28.a.1.C. The out-of-state registrant complies with all applicable rules of the agency and with all the terms and conditions of the registration document, except any such terms and conditions which may be inconsistent with applicable rules of the agency;

11.28.a.1.D. The out-of-state registrant supplies such other information as the agency may request; and

11.28.a.1.E. The out-of-state registrant shall not transferor dispose of radioactive material possessed or used under the general registration provided in Paragraph 11.28.a.1. except by transfer to a person:

11.28.a.1.E.1. Specifically registered by the agency or by the NRC to receive such material, or

11.28.a.1.E.2. Exempt from the requirements for a registration for such material under Subdivision 11.3.a.

11.28.a.2. Notwithstanding the provisions of Paragraph 11.28.a.1., any person who holds a specific registration issued by the NRC or an agreement state authorizing the holder to manufacture, transfer, install, or service a device described in Paragraph 11.7.b.1. within areas subject to the jurisdiction of the registration body is hereby granted a general registration to install, transfer, demonstrate, or service such a device in this state provided that:

11.28.a.2.A. Such person shall file a report with the agency within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general registration 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;

11.28.a.2.B. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific registration issued to such person by the NRC or an agreement state;

11.28.a.2.C. Such person shall assure that any labels required to be affixed to the device under rules of the authority which registered manufacture of the device bear a statement that "removal of this label is prohibited"; and

11.28.a.2.D. The holder of the specific registration shall furnish to each general registration to whom he transfers such device or on whose premises he installs such device a copy of the general registration contained in Subdivision 11.7.b. in equivalent rules of the agency having jurisdiction over the manufacture and distribution of the device.

11.28.a.3. The agency may withdraw, limit, or qualify its acceptance of any specific registration or equivalent registration document issued by the NRC or an agreement state, or any product distributed pursuant to such registration document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

11.28.b. Registrations of Naturally Occurring and Accelerator-Produced Radioactive Material

11.28.b.1. Subject to this rule, any person who holds a specific registration from a licensing state, and issued by the agency having jurisdiction where the registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, is hereby granted a general registration to conduct the activities authorized in such registration document within this state for a period not in excess of one hundred eighty (180) days in any calendar year provided that:

11.28.b.1.A. The registration document does not limit the activity authorized by such document to specified installations or locations;

11.28.b.1.B. The out-of-state registrant notifies the agency in writing at least three (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 registration document. If, for a specific case, the three (3) day period would impose an undue hardship on the out-of-state registrant, the registrant 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 registration provided in Paragraph 11.28.b.1;

11.28.b.1.C. The out-of-state registrant complies with all applicable rules of the agency and with all the terms and conditions of the registration document, except any such terms and conditions which may be inconsistent with applicable rules of the agency;

11.28.b.1.D. The out-of-state registrant supplies such other information as the agency may request; and

11.28.b.1.E. The out-of-state registrant shall not transferor dispose of radioactive material possessed or used under the general registration provided in 11.28.b.1. except by transfer to a person:

11.28.b.1.E.1. Specifically registered by the agency or by another licensing state to receive such material, or

11.28.b.1.E.2. Exempt from the requirements for a registration for such material under Subsection 11.3.

11.28.b.2. Notwithstanding the provisions of Paragraph 11.28.b.1., any person who holds a specific registration issued by a licensing state authorizing the holder to manufacture, transfer, install, or service a device described in Paragraph 11.7.b.1. within areas subject to the jurisdiction of the registration body is hereby granted a general registration to install, transfer, demonstrate or service such a device in this state provided that:

11.28.b.2.A. Such person shall file a report with the agency within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general registration 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;

11.28.b.2.B. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific registration issued to such person by a licensing state;

11.28.b.2.C. Such person shall assure that any labels required to be affixed to the device under rules of the authority which registered manufacture of the device bear a statement that "removal of this label is prohibited"; and

11.28.b.2.D. The holder of the specific registration shall furnish to each general registration to whom he transfers such device or on whose premises he installs such device a copy of the general registration contained in Subdivision 11.7.b. or in equivalent rules of the agency having jurisdiction over the manufacture and distribution of the device.

11.28.b.3. The agency may withdraw, limit, or qualify its acceptance of any specific registration or equivalent registration document issued by a licensing state, or any product distributed pursuant to such registration document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

W. Va. Code R. § 64-23-11