PDFWAC 246-235-010
Filing application for specific licenses.
(1) An applicant applying for a specific license shall submit an application on a department approved form.
(2) The department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the department to determine whether the application should be granted or denied or whether a license should be modified or revoked.
(3) Each application must be signed by the applicant or licensee or a person duly authorized to act for and on the applicant's behalf.
(4) An applicant may apply on one application for multiple licenses authorizing other activities under chapters 246-220 through 246-254 WAC and under chapter 70A.388 RCW, provided that the application specifies the activities for which licenses are requested.
(5) In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the department provided such references are clear and specific.
(6)(a) Except as provided in (b), (c), and (d) of this subsection, an application for a specific license to use radioactive materials in the form of a sealed source or in a device that contains the sealed source must:
(i) Identify the source or device by manufacturer and model number as registered with the department under WAC 246-235-108, the NRC under 10 C.F.R. 32.210, an agreement state, or for a source or a device containing radium-226 or accelerator-produced radioactive material with a state under provisions comparable to 10 C.F.R. 32.210; or
(ii) Contain the information identified in WAC 246-235-108(3).
(b) For sources or devices manufactured before October 23, 2012, that are not registered with the NRC under 10 C.F.R. 32.210 or with an agreement state, and for which the applicant is unable to provide all categories of information specified in WAC 246-235-108(3), the application must include:
(i) All available information identified in WAC 246-235-108(3) concerning the source, and, if applicable, the device; and
(ii) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.
(c) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with WAC 246-235-108 (7)(a), the applicant may supply only the manufacturer, model number, and radionuclide and quantity.
(d) If it is not feasible to identify each sealed source and device individually, the applicant may 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.
(7) Applications and documents submitted to the department may be made available for public inspection except that the department may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.
(8) As provided by WAC 246-235-075, certain applications for specific licenses filed under chapters 246-220 through 246-254 WAC must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.
(9) An application from a medical facility, educational institution, or federal facility to produce positron emission tomography radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under chapter 246-240 WAC must include:
(a) A request for authorization for the production of positron emission tomography radionuclides or evidence of an existing license issued under chapters 246-220 through 246-254 WAC for a positron emission tomography radionuclide production facility within its consortium from which it receives positron emission tomography radionuclides.
(b) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in WAC 246-235-100 (1)(b).
(c) Identification of individuals authorized to prepare the positron emission tomography radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in WAC 246-235-100 (2)(b).
(d) Information identified in WAC 246-235-100 (1)(c) on the positron emission tomography drugs to be noncommercially transferred to members of its consortium.
(10) An application for a license to receive and possess radioactive material for the conduct of any activity which the department has determined will significantly affect the quality of the environment must be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and must be accompanied by any environmental report required under WAC 246-235-086, chapter 197-11, or 246-03 WAC.
[Statutory Authority: RCW 70A.388.040 and 70A.388.110. WSR 22-19-084, § 246-235-010, filed 9/20/22, effective 10/21/22. Statutory Authority: RCW 70.98.050 and 70.98.110. WSR 17-01-034, § 246-235-010, filed 12/12/16, effective 1/12/17; WSR 16-13-054, § 246-235-010, filed 6/10/16, effective 7/11/16. Statutory Authority: RCW 70.98.050. WSR 15-06-015, § 246-235-010, filed 2/23/15, effective 3/26/15; WSR 13-24-025, § 246-235-010, filed 11/22/13, effective 12/23/13. Statutory Authority: RCW 70.98.050 and 70.98.080. WSR 09-06-003, § 246-235-010, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 43.70.040. WSR 91-02-049 (Order 121), recodified as § 246-235-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. WSR 79-12-073 (Order 1459), § 402-22-020, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-050.]