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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.252Licensing of Radioactive Material

(a) Purpose. The intent of this section is as follows.

  (1) This section provides for the specific licensing of radioactive material.

  (2) Unless otherwise exempted, no person shall manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material except as authorized by the following:

    (A) a specific license issued in accordance with this section and/or any of the following sections:

      (i) §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography);

      (ii) §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material);

      (iii) §289.258 of this title (relating to Licensing and Radiation Safety Requirements for Irradiators); and/or

      (iv) §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)); or

    (B) a general license or general license acknowledgment issued in accordance with §289.251 of this title (relating to Exemptions, General Licenses, and General License Acknowledgements).

  (3) A person who manufactures, produces, receives, possesses, uses, transfers, owns, or acquires radioactive materials prior to receiving a license is subject to the requirements of this chapter.

(b) Scope. In addition to the requirements of this section, the following additional requirements are applicable.

  (1) All licensees, unless otherwise specified, are subject to the requirements in the following sections:

    (A) §289.201 of this title (relating to General Provisions for Radioactive Material);

    (B) §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials);

    (C) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections);

    (D) §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);

    (E) §289.205 of this title (relating to Hearing and Enforcement Procedures); and

    (F) §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).

  (2) Licensees engaged in well logging service operations and tracer studies are subject to the requirements of §289.253 of this title (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies).

  (3) Licensees engaged in industrial radiographic operations are subject to the requirements of §289.255 of this title.

  (4) Licensees using radioactive material for medical or veterinary use are subject to the requirements of §289.256 of this title.

  (5) Licensees using sealed sources in irradiators are subject to the requirements of §289.258 of this title.

  (6) Licensees possessing or using naturally occurring radioactive material are subject to the requirements of §289.259 of this title.

(c) Types of licenses. Licenses for radioactive materials are of two types: general and specific.

  (1) General licenses provided in §289.251 and §289.259 of this title are effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons, although the filing of an application for acknowledgement with the agency may be required for a particular general license. The general licensee is subject to any other applicable portions of this chapter and any conditions or limitations of the general license.

  (2) Specific licenses require the submission of an application to the agency and the issuance of a licensing document by the agency. The licensee is subject to all applicable portions of this chapter as well as any conditions or limitations specified in the licensing document.

(d) Filing application for specific licenses. The agency may, at any time after the filing of the original application, require further statements in order to enable the agency to determine whether the application should be denied or the license should be issued.

  (1) Applications for specific licenses shall be filed in a manner prescribed by the agency.

  (2) Each application shall be signed by the chief executive officer or other individual delegated the authority to manage, direct, or administer the licensee's activities.

  (3) An application for a license may include a request for a license authorizing one or more activities. The agency may require the issuance of separate specific licenses for those activities.

  (4) Each application for a specific license, other than a license exempted from §289.204 of this title, shall be accompanied by the fee prescribed in §289.204 of this title.

  (5) Each application shall be accompanied by a completed RC Form 252-1 (Business Information Form).

  (6) Each applicant shall demonstrate to the agency that the applicant is financially qualified to conduct the activity requested for licensure, including any required decontamination, decommissioning, reclamation, and disposal before the agency issues a license. Each licensee shall demonstrate to the agency that it remains financially qualified to conduct the licensed activity before a license is renewed. Methods for demonstrating financial qualifications are specified in subsection (jj)(8) of this section. The requirement for demonstration of financial qualification is separate from the requirement specified in subsection (gg) of this section for certain applicants or licensees to provide financial assurance.

  (7) If facility drawings submitted in conjunction with the application for a license are prepared by a professional engineer or engineering firm, those drawings shall be final and shall be signed, sealed and dated in accordance with the requirements of the Texas Board of Professional Engineers, Title 22, Texas Administrative Code (TAC), Chapter 131.

  (8) Applications for licenses shall be processed in accordance with the following time periods.

    (A) The first period is the time from receipt of an application by the agency to the date of issuance or denial of the license or a written notice outlining why the application is incomplete or unacceptable. This time period is 60 days.

    (B) The second period is the time from receipt of the last item necessary to complete the application to the date of issuance or denial of the license. This time period is 30 days.

    (C) These time periods are exclusive of any time period incident to hearings and post-hearing activities required by the Government Code, Chapter 2001.

  (9) Except as provided in this paragraph, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source shall:

    (A) identify the source or device by manufacturer and model number as registered in accordance with subsection (v) of this section or with equivalent regulations of the United States Nuclear Regulatory Commission (NRC) or any agreement state, or for a source or a device containing radium-226 or accelerator-produced radioactive material registered in accordance with subsection (v) of this section; or

    (B) contain the information specified in subsection (v)(3) - (4) of this section.

  (10) For sources or devices manufactured before October 23, 2012, that are not registered in accordance with subsection (v) of this section or with equivalent regulations of the NRC or any agreement state, and for which the applicant is unable to provide all categories of information specified in subsection (v)(3) - (4) of this section, the application shall include:

    (A) all available information identified in subsection (v)(3) - (4) of this section concerning the source, and, if applicable, the device; and

    (B) sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information shall include:

      (i) a description of the source or device;

      (ii) a description of radiation safety features;

      (iii) the intended use and associated operating experience; and

      (iv) the results of a recent leak test.

  (11) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with subsection (v)(8)(A) of this section, the applicant shall supply only the manufacturer, model number, and radionuclide and quantity.

  (12) If it is not feasible to identify each sealed source and device individually, the applicant shall propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.

  (13) Notwithstanding the provisions of §289.204(d)(1) of this title, reimbursement of application fees may be granted in the following manner.

    (A) In the event the application is not processed in the time periods as stated in paragraph (8) of this subsection, the applicant has the right to request of the director of the Radiation Control Program full reimbursement of all application fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.

    (B) Good cause for exceeding the period established is considered to exist if:

      (i) the number of applications for licenses to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;

      (ii) another public or private entity utilized in the application process caused the delay; or

      (iii) other conditions existed giving good cause for exceeding the established periods.

    (C) If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed in accordance with Title 1, TAC, Chapter 155, and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title.

  (14) Applications for licenses may be denied for the following reasons:

    (A) any material false statement in the application or any statement of fact required under provisions of the Texas Radiation Control Act (Act);

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

    (C) failure to clearly demonstrate how the requirements in this chapter have been addressed.

  (15) Action on a specific license application will be considered abandoned if the applicant does not respond within 30 days from the date of a request for any information by the agency. Abandonment of such actions does not provide an opportunity for a hearing; however, the applicant retains the right to resubmit the application in accordance with paragraphs (1) - (7) of this subsection.

(e) General requirements for the issuance of specific licenses. A license application will be approved if the agency determines that:

  (1) the applicant and all personnel who will be handling the radioactive material are qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this chapter in such a manner as to minimize danger to occupational and public health and safety, life, property, and the environment;

  (2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to occupational and public health and safety, life, property, and the environment;

  (3) the issuance of the license will not be inimical to the health and safety of the public;

  (4) the applicant satisfied any applicable special requirement in this section and other sections as specified in subsection (a)(2)(A) of this section;

  (5) the radiation safety information submitted for requested sealed source(s) or device(s) containing radioactive material is in accordance with subsection (v) of this section;

  (6) qualifications of the designated radiation safety officer (RSO) as specified in subsection (f) of this section are adequate for the purpose requested in the application;

  (7) the applicant submitted adequate operating, safety, and emergency procedures;

  (8) the applicant's permanent facility is located in Texas (if the applicant's permanent facility is not located in Texas, reciprocal recognition shall be sought as required by subsection (ee) of this section);

Cont'd...

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