Tenn. Comp. R. & Regs. 0400-20-10-.04 - EXEMPTIONS: RADIOACTIVE MATERIALS OTHER THAN SOURCE MATERIAL

(1) Exempt concentrations.

(a) Except as provided in subparagraphs (b) and (d) of this paragraph, any person is exempt from these rules 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 Schedule RHS 8-4.

(b) 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 subparagraph (a) of this paragraph or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State except in accordance with a license issued pursuant 10 CFR 32.11.

(c) This paragraph shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

(d) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license set forth in these rules to the extent that this person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule RHS 8-4 in the Appendix to this chapter and introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(2) Certain items containing radioactive material other than source material.

(a) Except for persons who apply radioactive materials to or persons who incorporate radioactive material into the products listed in this paragraph, any person is exempt from these rules to the extent that he receives, possesses, uses, transfers, owns or acquires the following products2;

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

(i) 25 millicuries of tritium per timepiece;

(ii) 5 millicuries of tritium per hand;

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

(iv) 100 microcuries of promethium-147 per watch or 200 microcuries of promethium-147 per any other timepiece;

(v) 20 microcuries of promethium-147 per watch hand or 40 microcuries of promethium-147 per other timepiece hand;

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

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

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

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

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

(viii) One microcurie of radium-226 per timepiece in intact timepieces acquired prior to May 31, 1986.

2. Certain names devices and equipment

(i) Static elimination device. Devices designed for use as static eliminators that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device.

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

(iii) Such devices authorized before October 23, 2012 for use under the general license then provided in 10 CFR 31.3 and equivalent regulations of Agreement States and manufactured, tested, and labeled be the manufacturer in accordance with specifications contained in a specific license issued by the Nuclear Regulatory Commission.

3. Balances of precision containing not more than one millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part manufactured before December 17, 2007.

4. Reserved.

5. Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas manufactured before December 17, 2007.

6. Reserved.

7. Electron tubes3 containing not more than one of the following specified quantities of radioactive material per tube:

(i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

(ii) 1 microcurie of cobalt-60;

(iii) 5 microcuries of nickel-63;

(iv) 30 microcuries of krypton-85;

(v) 5 microcuries of cesium-137;

(vi) 30 microcuries of promethium-147; provided, the levels of radiation from each electron tube containing radioactive material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.

8. Reserved.

9. Reserved.

10. Reserved.

11. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material; provided that:

(i) Each source contains no more than one exempt quantity set forth in Schedule RHS 8-3;

(ii) Each instrument contains no more than 10 exempt quantities. For purposes of this part, an instrument's source(s) may contain either one type or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Schedule RHS 8-3, provided that the sum of such fractions shall not exceed unity; and

(iii) For purposes of this part, 0.05 microcuries of americium-241 is considered an exempt quantity under Schedule RHS 8-3.

12. Reserved.

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

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

(3) Exempt quantities.

(a) Except as provided in subparagraphs (c) through (e) of this paragraph, any person is exempt from these rules 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 Schedule RHS 8-3.

(b) Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license formerly provided in this chapter is exempt from the requirements for a license set forth in this chapter to the extent that such person possesses, uses, transfers, or owns such radioactive material.

(c) This paragraph 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.

(d) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule RHS 8-3, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this paragraph or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State, or any Licensing State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR Part 32 or by the Department pursuant to paragraph (14) of Rule 0400-20-10-.13 which license states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State.4

(e) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in Schedule RHS 8-3 in the Appendix to this chapter, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the rules in this chapter.

(4) Capsules containing carbon-14 urea for 'in vivo' diagnostic use for humans.

(a) Except as provided in subparagraphs (b) and (c) of this paragraph, any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns or acquires capsules containing 1 microcurie (37 kilobecquerels) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for 'in vivo' diagnostic use for humans.

(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license under this chapter.

(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to 10 CFR 32.21.

(d) Nothing in this paragraph relieves persons from complying with applicable FDA, other federal and state requirements governing receipt, administration and use of drugs.

(5) Gas and aerosol detectors containing radioactive material.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from the requirements of Chapters 0400-20-04, 0400-20-05, and 0400-20-10, to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property provided that detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred5 in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to section 32.26 of 10 CFR Part 32. This exemption also covers gas and aerosol detectors manufactured or distributed before December 8, 2011, in accordance with a specific license issued by an Agreement State under comparable provisions to 10 CFR 32.36 authorizing distribution to persons exempt from regulatory requirements.

(b) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under subparagraph (a) of this paragraph, should apply for a license under 10 CFR 32.26 and for a certificate of registration in accordance with 10 CFR 32.210.

(6) Self luminous products containing radioactive material.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, owns or acquires tritium, krypton-85, promethium-147 in self luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements.

(b) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under subparagraph (a) of this paragraph, should apply for license under 10 CFR 32.22 and for a certificate of registration in accordance with 10 CFR 21.210.

(c) The exemption in subparagraph (a) of this paragraph does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.

(d) Any person is exempt from these rules to the extent that such person receives, possesses, uses, transfers, or owns self luminous products containing less than 0.1 microcurie of radium-226 which were acquired prior to September 28, 1991.

(7) Certain Industrial Devices.

(a) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in Chapters 0400-20-05, 0400-20-07, 0400-20-08, 0400-20-10, and 0400-20-12 to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced in accordance with a specific license issued under 10 CFR 32.30, which license authorizes the initial transfer of the device for use under this paragraph. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

(b) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under subparagraph (a) of this paragraph, should apply for a license under 10 CFR 32.30 and for a certificate of registration in accordance with 10 CFR 32.210.

Notes

Tenn. Comp. R. & Regs. 0400-20-10-.04

Original rule filed February 22, 2012; effective May 22, 2012. Amendments to rules 0400-20-04.04, 0400-20-05-.70, 0400-20-10-.04, 0400-20-10-.10 through 044-20-10-.13, 0400-20-10-.21, 0400-2010-.33, 0400-20-10-.36, 0400-20-10-.38, and original rules 0400-20-13-.01 through 0400-20-13-.08 filed June 14, 2017; effective September 12, 2017. Amendments filed September 1, 2021; effective 11/30/2021.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity, or other product containing radioactive material, whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Electron tubes", as used in this subparagraph, include spark gap tubes, power tubes, gas tubes, including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity, or other product containing radioactive material, whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, DC 20555.

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity, or other product containing radioactive material, whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, DC 20555.