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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

(a) Purpose. This section provides for exemptions to licensing requirements, general licensing of radioactive material, and acknowledgement of general licenses.

(b) Scope. Except as otherwise authorized, no person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a general license or general license acknowledgement issued in accordance with this section, or in a specific license issued in accordance with §289.252 of this title (relating to Licensing of Radioactive Material), §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material), §289.258 of this title (relating to Licensing and Radiation Safety Requirements for Irradiators), or §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM).

(c) Definitions. The following words and terms when used in this section shall have the following meanings unless the context clearly indicates otherwise.

  (1) General license--An authorization in accordance with this section that grants authority to a person for certain activities involving radioactive material, and is effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons. The general licensee is subject to all other applicable portions of this chapter and any limitations of the general license.

  (2) General license acknowledgement--A written recognition of a general license issued in accordance with this section. The issuance of a general license acknowledgement requires the submission of an application to the agency. A written acknowledgement of a general license granted in accordance with this section is issued by the agency. The holder of a general license acknowledgement is subject to all other applicable portions of this chapter as well as any conditions specified in the acknowledgement document.

(d) Exemptions for source material.

  (1) Any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1.0% (0.05%) of the mixture, compound, solution, or alloy.

  (2) Any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore. This exemption does not apply to the mining of ore containing source material.

  (3) Any person is exempt from this section and §289.252 of this title to the extent that such person receives, possesses, uses, or transfers:

    (A) any quantities of thorium contained in:

      (i) incandescent gas mantles;

      (ii) vacuum tubes;

      (iii) welding rods;

      (iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams (mg) of thorium;

      (v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium;

      (vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these; or

      (vii) personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 mg of thorium;

    (B) source material contained in the following products:

      (i) glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material;

      (ii) glassware containing not more than 2% by weight source material or, for glassware manufactured before August 27, 2013, 10% by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction;

      (iii) glass enamel or glass enamel frit containing not more than 10% 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

      (iv) piezoelectric ceramic containing not more than 2.0% by weight source material;

    (C) photographic film, negatives, and prints containing uranium or thorium;

    (D) any finished product or part fabricated of, or containing, metal-thorium alloys, provided that the thorium content of the alloy does not exceed 4% by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;

    (E) uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:

      (i) each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM" (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM," required at that time);

      (ii) each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED" (The requirements specified in this clause need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, "CAUTION - RADIOACTIVE MATERIAL - URANIUM" required at that time); and

      (iii) the exemption contained in this subparagraph 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;

    (F) natural or depleted uranium used as shielding constituting part of any shipping container, provided that:

      (i) the shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM;" and

      (ii) the uranium metal is encased in a one-eighth inch minimum wall thickness of mild steel or equally fire resistant material;

    (G) thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight of thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained in this subparagraph shall not be deemed to authorize either:

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

      (ii) the receipt, possession, use, or transfer of uranium or thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or in other optical instruments;

    (H) uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie (µCi) (185 becquerels (Bq) of uranium; or

    (I) thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

      (i) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

      (ii) the thorium content in the nickel-thoria alloy does not exceed 4.0% by weight.

  (4) The exemptions in subsection (d)(3) of this section do not authorize the manufacture of any of the products described.

  (5) No person may initially transfer for sale or distribution a product containing source material to persons exempt under subsection (d)(3) of this section, Title 10, CFR, §40.13(c), or equivalent regulations of an agreement state, unless authorized by a license issued under Title 10, CFR, §40.52, to initially transfer such products for sale or distribution.

    (A) Persons initially distributing source material in products covered by the exemptions in subsection (d)(3) of this section before August 27, 2013, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the agency takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date.

    (B) Persons authorized by the agency, the NRC, or any agreement state to manufacture, process, or produce these materials or products containing source material, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued under Title 10, CFR, §40.52, for distribution only. These persons are exempt from the requirements of §289.202 (relating to Standards for Protection Against Radiation from Radioactive Materials), §289.203 (relating to Notices, Instructions, and Reports to Workers; Inspections), and §289.252(e)(1) and (2) of this title.

(e) Exemptions for radioactive material other than source material.

  (1) Exempt concentrations.

    (A) Except as provided in subparagraph (B) of this paragraph, any person is exempt from this section and §289.252 of this title if that person receives, possesses, uses, transfers, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in subsection (l)(1) of this section.

    (B) No person may introduce radioactive material into a product or material, including waste, knowing or having reason to believe that it will be transferred to persons exempt in accordance with subparagraph (A) of this paragraph or equivalent regulations of the NRC or any agreement state, except in accordance with a specific license issued under §289.252(i) of this title.

    (C) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license, as specified in §289.252 of this title, if the manufacturer, processor, or producer transfers radioactive material contained in a product or material that does not exceed the concentrations specified in subsection (l)(1) of this section, and that has been introduced into the product or material by a licensee holding a specific license issued by the NRC that expressly authorizes such introduction. The exemption specified in this subparagraph 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) Exempt quantities.

    (A) Except as provided in subparagraphs (C), (D), and (F) of this paragraph, any person is exempt from these rules if that 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 subsection (l)(2) of this section.

    (B) Any person who possesses radioactive material received or acquired, prior to September 25, 1971, in accordance with the general license provided in subsection (f)(4)(A) of this section is exempt from the requirements for a license set forth in §289.252 of this title if that person possesses, uses, transfers, or owns such radioactive material.

    (C) This paragraph does not authorize the production, packaging, or repackaging or transfer 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 quantities greater than the individual quantities set forth in subsection (l)(2) of this section, 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 NRC or any agreement state, except in accordance with a specific license issued by the NRC in accordance with Title 10, CFR, §32.18 or by the agency in accordance with §289.252(j) of this title, which states that the radioactive material may be transferred by the licensee to persons exempt in accordance with this paragraph or the equivalent regulations of the NRC or any agreement state.

    (E) The schedule of quantities set forth in subsection (l)(2) of this section applies only to radioactive materials distributed as exempt quantities under a specific license issued by the agency, the NRC, or any agreement state. Subsection (l)(2) of this section does not apply to radioactive materials that have decayed from quantities not originally exempt and does not make such material, or the sources or devices in which the material is contained exempt from the licensing requirements in this section or §289.252 of this title.

Cont'd...

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