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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

      (i) the appointment of an RSO who is qualified by training and experience in radiation protection, and who is available for advice and assistance on safety matters; and

      (ii) 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 RSO of safety evaluations of proposed uses prepared in accordance with subclause (II) of this clause before use of the radioactive material.

  (4) An application for a Type C 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 submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

      (i) a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

      (ii) at least 40 hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

    (C) the applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

  (5) An application filed pursuant to subsection (e) of this section for a specific license other than one of broad scope will be considered by the department as an application for a specific license of broad scope under this subsection if the applicable requirements of this subsection are satisfied.

  (6) The following conditions apply to specific licenses of broad scope.

    (A) Unless specifically authorized in accordance with a separate license, persons licensed under this subsection shall not:

      (i) conduct tracer studies in the environment involving direct release of radioactive material;

      (ii) receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

      (iii) conduct activities for which a specific license issued by the department in accordance with subsections (i) - (u) of this section and §289.255, §289.256, and §289.259 of this title as required;

      (iv) add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being; or

      (v) commercially distribute radioactive materials.

    (B) Each Type A specific license of broad scope issued under this subsection shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSC.

    (C) Each Type B specific license of broad scope issued under this subsection shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's RSO.

    (D) Each Type C specific license of broad scope issued under this subsection shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of paragraph (4) of this subsection.

(i) Specific licenses for introduction of radioactive material into products in exempt concentrations. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt in accordance with §289.251 of this title except as specified with a license issued by the NRC.

(j) Specific licenses for commercial distribution of radioactive material in exempt quantities.

  (1) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source material, byproduct material, or naturally occurring and accelerator-produced radioactive material (NARM) whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission (NRC), Washington, DC 20555 in accordance with Title 10, Code of Federal Regulations (CFR), §32.18.

  (2) Licenses issued in accordance with this subsection do not authorize the following:

    (A) combining of exempt quantities of radioactive material in a single device;

    (B) any program advising persons to combine exempt quantity sources and providing devices for them to do so; and

    (C) the possession and use of combined exempt sources, in a single unregistered device, by persons exempt from licensing in accordance with §289.251(e)(2) of this title.

(k) Specific licenses for incorporation of byproduct material or NARM into gas and aerosol detectors. A specific license authorizing the incorporation of byproduct material or NARM into gas and aerosol detectors to be distributed to persons exempt from this chapter shall be issued only by the NRC in accordance with Title 10, CFR, §32.26.

(l) Specific licenses for the manufacture and commercial distribution of devices to persons generally licensed in accordance with §289.251(f)(4)(H) of this title.

  (1) In addition to the requirements in subsection (e) of this section, a specific license to manufacture or commercially distribute devices containing radioactive material to persons generally licensed in accordance with §289.251(f)(4)(H) of this title or equivalent requirements of the NRC or any agreement state will be issued if the department approves the following information submitted by the applicant:

    (A) the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

      (i) the device can be safely operated by persons not having training in radiological protection;

      (ii) under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one year a dose in excess of ten percent of the limits specified in §289.202(f) of this title; and

      (iii) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

        (I) 15 rems to the whole body; head and trunk; active blood-forming organs; gonads; or lens of eye;

        (II) 200 rems to the hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter (cm2 ); or

        (III) 50 rems to other organs;

    (B) procedures for disposition of unused or unwanted radioactive material;

    (C) each device bears a durable, legible, clearly visible label or labels approved by the department that contain the following in a clearly identified and separate statement:

      (i) instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

      (ii) the requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

      (iii) the information called for in one of the following statements, as appropriate, in the same or substantially similar form:

        (I) For radioactive materials other than NARM, the following statement is appropriate:

Attached Graphic

        (II) For NARM, the following statement is appropriate:

Attached Graphic

Cont'd...

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