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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

tested within the required test interval, they shall be tested for leakage before use or transfer and the shutter tested before use.

          (-b-) Devices kept in standby for future use are excluded from the 24-month time limit if the agency approves a plan for future use submitted by the licensee. Licensees shall submit plans at least 30 days prior to the end of the 24 months of nonuse.

          (-c-) The general licensee shall perform quarterly physical inventories of these devices while they are in standby. The licensee shall make, maintain, and retain for intervals of 5 years, records of the quarterly physical inventories for inspection by the agency;

        (XVI) not export the device containing radioactive material except in accordance with Title 10, CFR, Part 110;

        (XVII) comply with the provisions of §289.202(ww) and (xx) of this title for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of §289.202 and §289.203 of this title;

        (XVIII) respond to written requests from the agency to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency a written justification for the request; and

        (XIX) assure that the device is used in accordance with information contained in the device safety evaluation.

    (I) The general license in subparagraph (H) of this paragraph does not authorize the manufacture or import of devices containing radioactive material.

    (J) The written instructions specified in subparagraph (H)(iv)(III)(-a-) and (-b-) of this paragraph shall be followed while performing the testing and the written instructions in subparagraph (H)(iv)(III)(-b-) of this paragraph shall be maintained for inspection by the agency.

    (K) General license for certain items and self-luminous products containing radium-226.

      (i) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer radium-226 contained in the following products manufactured prior to November 30, 2007.

        (I) Antiquities originally intended for use by the general public. For purposes of this subclause, antiquities are products distributed for use by the general public in the late 19th and early 20th centuries; such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.

        (II) Intact timepieces containing greater than 1 µCi (0.037 MBq), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.

        (III) Luminous items installed in air, marine, or land vehicles.

        (IV) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.

        (V) Small radium sources containing no more than 1 µCi (0.037 MBq) of radium 226. For the purposes of this paragraph, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.

      (ii) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in clause (i) of this subparagraph are exempt from the provisions of §§289.201, 289.202, 289.203, and 289.252 of this title, to the extent that the receipt, possession, use, or transfer of byproduct material is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed under §289.252 of this title.

      (iii) Any person who acquires, receives, possesses, uses, or transfers radioactive material in accordance with this subparagraph shall do the following.

        (I) Provide to the agency within 30 days of any indication of possible damage to the product that could result in a loss of the radioactive material. The report should include a brief description of the event, and the remedial action taken.

        (II) Not abandon products containing radium-226.

          (-a-) The product, and any radioactive material from the product, may only be disposed of according to §289.202 of this title or as otherwise approved by the agency.

          (-b-) The product, and any radioactive material from the product, may be transferred to a person authorized by a specific license to receive the radium-226 or as otherwise approved by the agency.

        (III) The general license in this subparagraph does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired provided that paint containing radium-226 is not applied or removed.

        (IV) Not export products containing radium-226 except in accordance with or equivalent regulations of the NRC Title 10, CFR, §110.

        (V) Dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any federal or state solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under this section, or under equivalent regulations of the NRC, or any agreement state.

        (VI) Respond to written requests from the agency, the NRC, or any agreement state to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the agency, the NRC, or any agreement state a written justification for the request.

(g) General license acknowledgements for radioactive material other than source material. In addition to the requirements of this section, all general license acknowledgement holders, unless otherwise specified, are subject to the requirements of §§289.201, 289.202(ww) and (xx), 289.204, 289.205, and 289.257 of this title.

  (1) Persons possessing a general license for devices in accordance with subsection (f)(4)(H) of this section and being in the possession of radioactive material in devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, 37 MBq (1 mCi) of americium-241, or any transuranic (for example, element with atomic number greater than uranium (92)), based on the activity indicated on the label on the device, shall file an application for acknowledgement within 30 days of receipt, acquisition, or possession of such a device. The application shall be on a form prescribed by the agency to include the following information and any other information specifically requested by the agency:

    (A) name and mailing address of the general licensee;

    (B) information about each device to include the manufacturer (or initial transferor), model number, and serial number of the device, and the radioisotope and activity (as indicated on the label), and serial number of the source;

    (C) name, title, and telephone number of the responsible person designated as a representative of the general licensee in accordance with subsection (f)(4)(H)(iv)(XIII) of this section;

    (D) address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage;

    (E) certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information;

    (F) certification by the responsible representative of the general licensee that they are aware of the requirements of this section; and

    (G) a completed RC Form 252-1, Business Information Form and the applicable fee as required by §289.204 of this title.

  (2) Persons generally licensed by the agency, the NRC, or any agreement state with respect to devices meeting the criteria in paragraph (1) of this subsection, are not subject to the requirements of paragraph (1) of this subsection if the devices are used in areas subject to agency jurisdiction for a period less than 180 days in any calendar year.

Cont'd...

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