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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

    (D) Nothing in this subsection relieves a person from complying with applicable requirements of the United States Food and Drug Administration (FDA) and other federal and state requirements governing the receipt, administration, and use of drugs.

(f) General licenses. In addition to the requirements of this section, all general licenses, unless otherwise specified, are subject to the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material), §289.202(ww) and (xx) of this title, §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).

  (1) Compliance history. In making a determination whether to revoke, suspend, or restrict a general license, the agency may consider the technical competence and compliance history of a general licensee. After an opportunity for a hearing, the agency may revoke, suspend, or restrict a general license if the general licensee's compliance history reveals that at least 3 agency actions have been issued against the general licensee, within the previous 6 years, that assess administrative or civil penalties against the general licensee, or that revoke or suspend the general license.

  (2) Modification, suspension, and revocation of a general license.

    (A) The terms and conditions of all general licenses shall be subject to revision or modification.

    (B) A general license may be suspended or revoked by reason of amendments to the Texas Radiation Control Act (Act), Health and Safety Code, Chapter 401, by reason of rules in this chapter, or orders issued by the agency.

    (C) Any general license may be revoked, suspended, or modified, in whole or in part, for any of the following:

      (i) any material false statement in the application for a general license acknowledgement or any statement of fact required in accordance with provisions of the Act;

      (ii) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a general license on an original application;

      (iii) violation of, or failure to observe, any of the terms and conditions of the Act, this chapter, or of the general license, or order of the agency; or

      (iv) existing conditions that constitute a substantial threat to the public health or safety or the environment.

    (D) Except in cases in which the occupational and public health, or safety requires otherwise, no general license shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the holder of the general license in writing and the holder of the general license shall have been afforded an opportunity to demonstrate compliance with all lawful requirements.

    (E) Each general license revoked by the agency expires at the end of the day on the date of the agency's final determination to revoke the general license, or on the revocation date stated in the determination, or as otherwise provided by agency order.

  (3) General licenses for source material.

    (A) General license for small quantities of source material.

      (i) A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions, and federal, state and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes in the following forms and quantities:

        (I) no more than 1.5 kg (3.3 lb) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time.

          (-a-) Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form.

          (-b-) A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 7 kg (15.4 lb) of uranium and thorium in any 1 calendar year.

          (-c-) Persons possessing source material in excess of these limits as of August 27, 2013, may continue to possess up to 7 kg (15.4 lb) of uranium and thorium at any one time until the NRC takes final action on any pending application submitted on or before August 27, 2014, for a specific license for such material; and may receive up to 70 kg (154 lb) of uranium or thorium in any one calendar year until the NRC takes final action on a pending application submitted on or before August 27, 2014, for a specific license for such material; and

        (II) no more than a total of 7 kg (15.4 lb) of uranium and thorium at any one time.

          (-a-) A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 70 kg (154 lb) of uranium and thorium in any 1 calendar year.

          (-b-) A person may not alter the chemical or physical form of the source material possessed as specified in this clause unless it is accounted for in accordance with the limits of clause (i)(I) of this subparagraph; or

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

        (IV) no more than 7 kg (15.4 lb) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material as specified in this clause may not receive more than a total of 70 kg (154 lb) of source material in any 1 calendar year.

      (ii) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in clause (i) of this subparagraph:

        (I) is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the agency in a specific license;

        (II) shall not abandon such source material. Source material may be disposed of as follows:

          (-a-) a cumulative total of 0.5 kg (1.1 lb) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material in accordance with the general license to persons receiving the material for permanent disposal. The recipient of source material transferred in accordance with this item is exempt from the requirements to obtain a license as specified in subsection (f)(3) of this section to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under §289.252 of this title; or

          (-b-) in accordance with §289.202(ff) of this title;

        (III) is subject to the regulations in subsection (f)(2), (h)(2), and (i) of this section and §§289.201(a), (b), (d) - (f), (i), (k), and (l); 289.202 (vv), (xx)(6) - (8) and (vv); 289.203(g)(3); 289.252(a), (w)(2), (x)(1) - (4), and (cc); and 289.257(b)(1) of this title; and

        (IV) shall not export such source material except in accordance with Title 10, CFR, Part 110.

      (iii) Any person who receives, possesses, uses, or transfers source material in accordance with clause (i) of this subparagraph shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the agency about such contamination and may consult with the agency as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used in accordance with this general license is not likely to result in exposures that exceed the limits in §289.202(ddd)(2) of this title.

      (iv) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in clause (i) of this subparagraph is exempt from the regulations in §§289.201, 289.202, and 289.203 of this title to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the regulations of §289.202(ff) and (ddd)(2)(A) of this title to the extent necessary to meet the requirements of clauses (ii)(II) and (iii) of this subparagraph. However, this exemption does not apply to any person who also holds a specific license issued under §289.252 of this title.

      (v) No person may initially transfer or distribute source material to persons generally licensed as specified in clause (i)(I) or (II) of this subparagraph, or equivalent regulations of any agreement state, unless authorized by a specific license issued in accordance with §289.252(cc)(6)(A) of this title or equivalent regulations of the NRC or any agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by clause (i) of this subparagraph may be continued until the NRC takes final action on a pending application for license or license amendment to specifically authorize distribution submitted on or before August 27, 2014.

    (B) A general license is issued to own source material without regard to quantity. This general license does not authorize any person to receive, possess, use or transfer source material.

    (C) A general license is issued to mine, transport, and transfer ores containing source material without regard to quantity. In addition to the provisions of subsection (f) of this section, persons who mine, transport, and transfer ores containing source material in accordance with this section shall comply with the provisions of §289.202(n) and (ff) of this title.

    (D) A general license is issued to receive, acquire, possess, use, or transfer depleted uranium contained in products or devices for the purpose of providing shielding, including beam shaping and collimation, in accordance with clauses (i) - (iv) of this subparagraph.

      (i) The general license in this paragraph applies only to products or devices that have been manufactured either in accordance with a specific license issued by the agency to the manufacturer of the products or devices in accordance with §289.252(s) of this title or in accordance with a specific license issued to the manufacturer by another agreement state or the NRC that authorizes manufacture of the products or devices for distribution to persons generally licensed by another agreement state or the NRC.

      (ii) Persons who receive, acquire, possess, or use depleted uranium in accordance with the general license in this paragraph shall notify the agency within 30 days after the first receipt of acquisition of such depleted uranium. The general licensee shall furnish the following information and such other information as may be required by the agency:

        (I) name and address of the general licensee;

        (II) a statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium in accordance with this paragraph and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

        (III) name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in clause (ii) of this subparagraph.

      (iii) The general licensee possessing or using depleted uranium in accordance with the general license in this paragraph shall report in writing to the agency any changes in information furnished by the general licensee. The report shall be submitted within 30 days after the effective date of such change.

      (iv) A person who receives, acquires, possesses, or uses depleted uranium in accordance with the general license in this paragraph:

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

        (II) shall not abandon such depleted uranium;

        (III) shall transfer or dispose of such depleted uranium only in accordance with the provisions of §289.252(cc) of this title. In the case where the transferee receives the depleted uranium in accordance with the general license in this paragraph or equivalent rule of the NRC or an agreement state, the transferor shall furnish the transferee a copy of this paragraph;

Cont'd...

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