459.198 - Terms and conditions of licenses

459.198. Terms and conditions of licenses

1. Each license issued pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive, :

(a) Is subject to all the provisions of chapter 459 of NRS, now or hereafter in effect, and to all regulations and orders of the Division ;

(b) Except as otherwise provided in the license, includes a right to receive, possess and utilize radioactive material; and

(c) Is governed by the provisions adopted pursuant to NAC 459.1997 with regard to the preparation for shipment and transportation of radioactive material.

2. No license issued or granted under NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive,, or right to possess or utilize radioactive material granted by any license issued pursuant to those provisions, may be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the Division, after securing full information, finds that the transfer is in accordance with the provisions of chapter 459 of NRS and gives its consent in writing.

3. A person licensed by the Division pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive may apply to the Division to transfer his or her license to another person. The application for such a transfer must include, without limitation:

(a) The identity and technical qualifications of the proposed transferee;

(b) The financial qualifications of the proposed transferee as determined by the Division based on the financial reports or certified financial statements of the proposed transferee; and

(c) The information concerning financial assurance for decommissioning required by NAC 459.1955.

4. Each person licensed by the Division pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive,, or each person seeking a license, shall:

(a) Confine his or her use and possession of the material licensed to the locations and purposes authorized in the license.

(b) Inform the Division in writing before the sale or lease of his or her business if the transaction involves the transfer of a source of radiation to another person.

(c) Inform the Division, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under Title 11 of the United States Code or the appropriate chapter of NRS by or against:

(1) The licensee;

(2) An entity, as that term is defined in 11 U.S.C. § 101(15), which controls the licensee or which lists the licensee as a property of the estate of the entity; or

(3) An affiliate, as that term is defined in 11 U.S.C. § 101(2), of the licensee.

The notice described in this paragraph must inform the Division of the bankruptcy court in which and the date on which the petition for bankruptcy was filed

(d) Keep records of information important to the safe and effective decommissioning of the facility where the radioactive material is located in a location identified to the Division until the license is terminated by the Division. If records of information relevant to decommissioning are kept for other purposes, references to those records and their locations may be used. Such information must include:

(1) Records of spills or other unusual occurrences involving the spread of contamination in or around the facility, the equipment of the facility or the site of the facility. The records may be limited to instances when contamination remains after any cleanup procedures or when there is a reasonable likelihood that contaminants may have spread to inaccessible areas, including possible seepage into porous materials such as concrete. The records must include any information known to the licensee on the identification of nuclides, quantities, forms and concentrations involved.

(2) Any available drawings of structures and equipment of the facility, as originally built and as modified, which are located in restricted areas where radioactive materials are used or stored, and of locations of inaccessible areas to which contaminants may spread, such as buried pipes which may be subject to contamination. If drawings are not available, the licensee shall provide to the Division other appropriate records of information concerning these areas.

(3) Records of any performance of an estimate of the costs of decommissioning for incorporation in a plan for financing the decommissioning and any records of the method used for assuring the availability of money for the costs of decommissioning the facility.

5. Each person licensed by the Division pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive who uses a portable gauge shall, when the gauge is not under the control and constant surveillance of the licensee, use :

(a) A minimum of two independent physical controls that form tangible barriers to secure the portable gauge from unauthorized removal; and

(b) A source-locking mechanism to prevent accidental exposure to radiation.

6. Each person licensed by the Division pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive shall conduct a physical inventory every 6 months to account for all sources of radiation received and possessed under his or her license. The licensee must retain records of the physical inventory for 3 years after the date of the inventory for inspection by the Division. The records of the physical inventory must indicate, without limitation, the quantity and kind of radioactive material, the location of each source of radiation, the model number and the name of the manufacturer of each source of radiation and the date of the inventory.

7. Each person licensed by the Division pursuant to NAC 459.180 to 459.950, inclusive, and sections 7 to 28, inclusive who prepares technetium-99m radiopharmaceuticals from molybdenum-99 and technetium-99m generators or who prepares rubidium-82 from strontium-82 and rubidium-82 generators shall:

(a) Test the generator eluates for molybdenum-99 breakthrough or contamination by strontium-82 and strontium-85, respectively, pursuant to 10 C.F.R. § 35.204;

(b) Record the results of each test and retain each record for at least 3 years after the record is made; and

(c) Report to the Division and to the manufacturer of the generator the levels of molybdenum-99, strontium-82 and strontium-85 that are above the permissible limits set forth in 10 C.F.R. § 35.204.

8. Each person licensed by the Division pursuant to NAC 459.300 who is required to appoint a radiation safety officer described in section 26 shall ensure that the radiation safety officer:

(a) Has the authority to terminate any activity relating to the license if such activity is deemed necessary to protect health and minimize danger to the public health and safety without consulting the management of the licensee; and

(b) Has sufficient time and commitment from the management of the licensee to fulfill his or her duties and responsibilities with regard to ensuring that radioactive materials are possessed and used in a safe manner.

9. Each licensee authorized pursuant to NAC 459.236 to produce positron emission tomography radioactive drugs for noncommercial distribution to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in paragraph (d) of subsection 1 of NAC 459.300 for each positron emission tomography radioactive drug, transport radiation shield and each syringe, vial or other container used to hold the positron emission tomography radioactive drug;

(b) Possess and use instrumentation to measure the radioactivity of the positron emission tomography radioactive drug and meet the procedures, radioactivity measurement, instrument test, instrument check and instrument adjustment requirements pursuant to subsection 3 of NAC 459.300;

(c) If the licensee is a pharmacy, ensure that any person who prepares positron emission tomography radioactive drugs:

(1) Is an authorized nuclear pharmacist who meets the requirements of paragraph (b) of subsection 2 of NAC 459.300; or

(2) Is under the supervision of an authorized nuclear pharmacist pursuant to 10 C.F.R. § 35.27; and

(d) If the licensee is a pharmacy that allows a person to work as an authorized nuclear pharmacist, it shall meet the requirements of paragraph (d) of subsection 2 of NAC 459.300.

Any authorization obtained pursuant to NAC 459.236 to produce positron emission tomography radioactive drugs for noncommercial distribution to medical use licensees in a consortium does not relieve the licensee from the requirement to comply with any applicable regulations of the United States Food and Drug Administration, or other federal and state laws or regulations governing radioactive drugs.

Bd. of Health, Radiation Control Reg. §§ 3.5.7-3.5.7.3, eff. 2-28-80-NAC A 9-6-88; 10-22-93; R085-06, 11-13-2006; R149-07, 1-30-2008; R185-08, 5-7-2010; A by R144-13A, eff. 10-13-2016

NRS 459.201

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