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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

      (iv) the results of a recent leak test.

  (12) 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.

  (13) 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.

  (14) 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 (9) 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 percent 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.

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

    (A) any materially 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 department to refuse to grant a license on an application; or

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

  (16) 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 department. 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) - (8) of this subsection.

(e) General requirements for the issuance of specific licenses. A license application will be approved if the department 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);

  (9) the owner of the property is aware that radioactive material is stored or used on the property, if the proposed facility is not owned by the applicant. The applicant shall provide a written statement from the owner, or from the owner's agent, indicating such. This paragraph does not apply to property owned or held by a government entity or to property on which radioactive material is used under an authorization for temporary job site use;

  (10) there is no reason to deny the license as specified in subsections (d)(15) or (x)(9) of this section; and

  (11) the applicant shall have a current registration with the Secretary of State to conduct business in the state, unless the applicant is exempt. All applicants using an assumed name in their application shall file an assumed name certificate as required under the Texas Business and Commerce Code, Chapter 71.

(f) RSO.

  (1) An RSO shall be designated for every license issued by the department. A single individual may be designated as RSO for more than one license if authorized by the department.

  (2) The RSO's documented qualifications shall include as a minimum:

    (A) possession of a high school diploma or a certificate of high school equivalency based on the GED test;

    (B) completion of the training and testing requirements specified in this chapter for the activities for which the license application is submitted; and

    (C) training and experience necessary to supervise the radiation safety aspects of the licensed activity.

  (3) Every licensee shall establish in writing the authority, duties, and responsibilities of the RSO and ensure that the RSO is provided sufficient authority, organizational freedom, time, resources, and management prerogative to perform the specific duties of the RSO which include the following:

    (A) to establish and oversee operating, safety, emergency, and as low as reasonably achievable (ALARA) procedures, and to review them at least annually to ensure that the procedures are current and conform with this chapter;

    (B) to oversee and approve all phases of the training program for operations and personnel so that appropriate and effective radiation protection practices are taught;

    (C) to ensure that required radiation surveys and leak tests are performed and documented in accordance with this chapter, including any corrective measures when levels of radiation exceed established limits;

    (D) to ensure that individual monitoring devices are used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made in accordance with §289.203 of this title;

    (E) to investigate and cause a report to be submitted to the department for each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this chapter and each theft or loss of source(s) of radiation, to determine the cause(s), and to take steps to prevent a recurrence;

    (F) to investigate and cause a report to be submitted to the department for each known or suspected case of release of radioactive material to the environment in excess of limits established by this chapter;

    (G) to have a thorough knowledge of management policies and administrative procedures of the licensee;

    (H) to assume control and have the authority to institute corrective actions, including shutdown of operations when necessary in emergency situations or unsafe conditions;

    (I) to ensure that records are maintained as required by this chapter;

    (J) to ensure the proper storing, labeling, transport, use and disposal of sources of radiation, storage, and transport containers;

    (K) to ensure that inventories are performed in accordance with the activities for which the license application is submitted;

    (L) to perform a physical inventory of the radioactive sealed sources authorized for use on the license every 6 months and make, maintain, and retain records of the inventory of the radioactive sealed sources authorized for use on the license every six months, to include the following:

      (i) isotope(s);

      (ii) quantity(ies);

Cont'd...

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