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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

  (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);

      (iii) activity(ies);

      (iv) date inventory is performed;

      (v) location;

      (vi) unique identifying number or serial number; and

      (vii) signature of person performing the inventory;

    (M) to ensure that personnel are complying with this chapter, the conditions of the license, and the operating, safety, and emergency procedures of the licensee;

    (N) to serve as the primary contact with the department; and

    (O) to have knowledge of and ensure compliance with federal and state security measures for radioactive material.

  (4) The RSO shall ensure that the duties listed in paragraph (3)(A) - (O) of this subsection are performed.

  (5) The RSO shall be on site periodically, commensurate with the scope of licensed activities, to satisfy the requirements of paragraphs (3) and (4) of this subsection.

  (6) The RSO, or a Site RSO designated on the license, shall be capable of physically arriving at the licensee's authorized use site(s) within a reasonable time of being notified of an emergency situation or unsafe condition. A Site RSO shall meet the qualifications in paragraph (2) of this subsection.

  (7) Requirements for RSOs for specific licenses for broad scope authorization for research and development. In addition to the requirements in paragraphs (1) and (3) - (6) of this subsection, the RSO's qualifications for specific licenses for broad scope authorization for research and development shall include evidence of the following:

    (A) a bachelor's degree in health physics, radiological health, physical science or a biological science with a physical science minor and 4 years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed;

    (B) a master's degree in health physics or radiological health and 3 years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed;

    (C) 2 years of applied health physics experience in a program with radiation safety issues similar to those in the program to be managed and one of the following:

      (i) doctorate degree in health physics or radiological health;

      (ii) comprehensive certification by the American Board of Health Physics;

      (iii) certification by the American Board of Radiology in Nuclear Medical Physics;

      (iv) certification by the American Board of Science in Nuclear Medicine in Radiation Protection; or

      (v) certification by the American Board of Medical Physics in Medical Health Physics; or

    (D) equivalent qualifications as approved by the department.

  (8) The qualifications in paragraph (7)(A) - (D) do not apply to individuals who have been adequately trained and designated as RSOs on licenses issued before October 1, 2000.

(g) Duties and responsibilities of the Radiation Safety Committee (RSC). The duties and responsibilities of the RSC include the following:

  (1) meeting as often as necessary to conduct business but no less than three times a year;

  (2) reviewing summaries of the following information presented by the RSO:

    (A) over-exposures;

    (B) significant incidents, including spills, contamination, or medical events; and

    (C) items of non-compliance following an inspection;

  (3) reviewing the program for maintaining doses ALARA, and providing any necessary recommendations to ensure doses are ALARA;

  (4) reviewing the overall compliance status for authorized users;

  (5) sharing responsibility with the RSO to conduct periodic audits of the radiation safety program;

  (6) reviewing the audit of the radiation safety program and acting upon the findings;

  (7) developing criteria to evaluate training and experience of new authorized user applicants;

  (8) evaluating and approving authorized user applicants who request authorization to use radioactive material at the facility;

  (9) evaluating new uses of radioactive material;

  (10) reviewing and approving permitted program and procedural changes before implementation; and

  (11) having knowledge of and ensuring compliance with federal and state security measures for radioactive material.

(h) Specific licenses of broad scope.

  (1) Types of specific licenses of broad scope.

    (A) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license. The quantities specified are usually in the multicurie range.

    (B) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in subsection (jj)(10) of this section. The possession limit for a Type B specific license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in subsection (jj)(10) of this section. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in subsection (jj)(10) of this section, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

    (C) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in subsection (jj)(10) of this section. The possession limit for a Type C specific license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in subsection (jj)(10) of this section. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in subsection (jj)(10) of this section, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

  (2) An application for a Type A specific license of broad scope will be approved if:

    (A) the applicant satisfies the general requirements specified in subsection (e) of this section;

    (B) the applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

    (C) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:

      (i) the establishment of an RSC composed of such persons as an RSO, a representative of management, and persons trained and experienced in the safe use of radioactive materials management to fulfill the duties and responsibilities specified in subsection (g) of this section;

      (ii) the appointment of a full-time RSO meeting the requirements of subsection (f)(7) or (8) of this section who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

      (iii) the establishment of appropriate administrative procedures to ensure:

        (I) control of procurement and use of radioactive material;

        (II) completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

        (III) review, approval, and recording by the RSC of safety evaluations of proposed uses prepared in accordance with subclause (II) of this clause before use of the radioactive material.

  (3) An application for a Type B specific license of broad scope will be approved if:

    (A) the applicant satisfies the general requirements specified in subsection (e) of this section; and

    (B) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

Cont'd...

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