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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.251Exemptions, General Licenses, and General License Acknowledgements

    (F) 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 subsection (l)(2) of this section, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the requirements in this title.

  (3) Exempt items.

    (A) Certain items containing radioactive material.

      (i) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from this chapter if that person receives, possesses, uses, transfers, or acquires the following products:

        (I) timepieces, hands, or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

          (-a-) 25 millicuries (mCi) (925 megabecquerels (MBq)) of tritium per timepiece;

          (-b-) 5 mCi (185 MBq) of tritium per hand;

          (-c-) 15 mCi (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial);

          (-d-) 100 µCi (3.7 MBq) of promethium-147 per watch or 200 µCi (7.4 MBq) of promethium-147 per any other timepiece;

          (-e-) 20 µCi (0.74 MBq) of promethium-147 per watch hand or 40 µCi (1.48 MBq) of promethium-147 per other timepiece hand;

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

          (-g-) the levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter (mg/cm2) of absorber:

            (-1-) for wrist watches, 0.1 millirad per hour (mrad/hr) at 10 centimeters (cm) from any surface;

            (-2-) for pocket watches, 0.1 mrad/hr at 1 cm from any surface; and

            (-3-) for any other timepiece, 0.2 mrad/hr at 10 cm from any surface; or

          (-h-) 1 µCi (0.037 MBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007;

        (II) static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device;

        (III) ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 µCi (18.5 MBq) of polonium-210 per device or of a total of not more than 50 mCi (1.85 gigabecquerels (GBq)) of hydrogen-3 (tritium) per device;

        (IV) such devices authorized before October 23, 2012, for use under a general license issued under this section or equivalent regulations of the NRC or any agreement state and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the NRC;

        (V) balances of precision containing not more than 1 mCi (37 MBq) of tritium per balance or not more than 0.5 mCi (18.5 MBq) of tritium per balance part manufactured before December 17, 2007;

        (VI) marine compasses containing not more than 750 mCi (27.75 MBq) of tritium gas and other marine navigational instruments containing not more than 250 mCi (9.25 GBq) of tritium gas manufactured before December 17, 2007;

        (VII) electron tubes, provided that each tube does not contain more than one of the following specified quantities of radioactive material and that the levels of radiation from each electron tube containing radioactive material do not exceed 1 mrad/hr at 1 cm from any surface when measured through 7 mg/cm2 of absorber (For purposes of this clause, "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube designed to control electrical currents):

          (-a-) 150 mCi (5.55 GBq) of tritium per microwave receiver protector tube or 10 mCi (0.37 GBq) of tritium per any other electron tube;

          (-b-) 1 µCi (0.037 MBq) of cobalt-60;

          (-c-) 5 µCi (0.185 GBq) of nickel-63;

          (-d-) 30 µCi (1.11 GBq) of krypton-85;

          (-e-) 5 µCi (0.185 GBq) of cesium-137; or

          (-f-) 30 µCi (1.11 GBq) of promethium-147;

        (VIII) ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material not exceeding:

          (-a-) the applicable quantity set forth in subsection (l)(2) of this section or 0.05 µCi (1.85 kilobecquerels (kBq)) of americium-241; and

          (-b-) each instrument contains no more than 10 exempt quantities. For purposes of this subclause, an instrument's source(s) shall contain either one type or different types of radionuclides and an individual exempt quantity shall be composed of fractional parts of one or more of the exempt quantities in accordance with subsection (l)(2) of this section, provided that the sum of such fractions shall not exceed unity.

        (IX) ionization chamber smoke detectors containing not more than 1 µCi (37 kBq) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

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

      (iii) Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in clause (i) of this subparagraph, or who desires to initially transfer for sale or distribution such products containing radioactive material, shall apply for a specific license issued by the NRC in accordance with Title 10, CFR, §32.14, which license states that the product may be distributed by the licensee to persons exempt from the regulations pursuant to clause (i) of this subparagraph.

    (B) Self-luminous products containing tritium, krypton-85, or promethium-147.

      (i) Except for persons who manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in clause (iii) of this subparagraph, any person is exempt from this chapter if that person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.22, which authorizes the initial transfer of the product to persons who are exempt from regulatory requirements.

      (ii) 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 clause (i) of this subparagraph, should apply for:

        (I) a specific license to be issued by the NRC in accordance with Title 10, CFR, §32.22; and

        (II) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210.

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

    (C) Gas and aerosol detectors containing radioactive material.

      (i) 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 this chapter 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.

        (I) Detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.26.

        (II) The specific license issued by the NRC in accordance with Title 10, CFR, §32.26, authorizes the initial transfer of the product for use to persons who are exempt from regulatory requirements.

        (III) This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued in accordance with §289.252 of this title or under comparable provisions to Title 10, CFR, §32.26 authorizing distribution to persons exempt from regulatory requirements.

        (IV) 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 this clause, shall apply for:

          (-a-) a specific license to be issued by the NRC in accordance with Title 10, CFR, §32.26; and

          (-b-) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210.

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

      (iii) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by any agreement state shall be considered exempt in accordance with clause (i) of this subparagraph, provided that the devices are labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of §289.252 of this title.

    (D) Certain industrial devices. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements of this chapter 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.

      (i) Devices containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued under Title 10, CFR, §32.30.

      (ii) The specific license issued by the NRC in accordance with Title 10, CFR, §32.30, authorizes the initial transfer of the device for use under Title 10, CFR, §32.30.

      (iii) This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

      (iv) Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under this subparagraph, shall apply for:

        (I) a license to be issued by the NRC under Title 10, CFR, §32.30; and

        (II) a certificate of registration to be issued by the NRC in accordance with Title 10, CFR, §32.210.

  (4) Exemption for capsules containing carbon-14 urea for "in vivo" diagnostic use in humans.

    (A) Except as provided in subparagraphs (B) and (C) of this paragraph, a person is exempt from the requirements of this section and §289.256 of this title provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 1 µCi (37 kBq) or less of carbon-14 urea each (allowing for nominal variation that may occur during the manufacturing process), for "in vivo" diagnostic use in humans.

    (B) A person desiring to use the capsules for research involving human subjects shall apply for and receive a specific license in accordance with §289.256 of this title.

    (C) A person desiring to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license in accordance with Title 10, CFR, §32.21.

Cont'd...

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