Article 2. Specific Licensing Requirements
12VAC5-481-2670. Application for a specific license.
Article 2
Specific Licensing Requirements
A person, as defined in 12VAC5-481-10, may file an application for a specific license authorizing the use of sealed sources in an irradiator. Each application shall be sent to the agency along with the appropriate fee prescribed in 12VAC5-490.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2680. Specific licenses for irradiators.
A. The agency will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in subsection B of this section and includes the information, as appropriate, from subsections C through I of this section.
B. The applicant shall satisfy the general requirements specified in 12VAC5-481-450 and the requirements contained in this part.
C. The application shall describe the training provided to the irradiator operators including:
1. Classroom training;
2. On-the-job training or simulator training;
3. Safety reviews;
4. Means employed by the applicant to test each operator's understanding of the agency regulations and licensing requirements and the irradiator operating and emergency procedures; and
5. Minimum training and experience of personnel who may provide training.
D. The application shall include the outline of the written operating and emergency procedures listed in the 12VAC5-481-2840 that describes the radiation safety aspects of the procedures.
E. The application shall describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application shall specify who, within the management structure, has the authority to stop unsafe operations. The application shall also describe the training and experience required for the position of radiation safety officer.
F. The application shall include a description of the access control systems required by 12VAC5-481-2730, the radiation monitors required by 12VAC5-481-2760, the method of detecting leaking sources required by 12VAC5-481-2870 including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.
G. If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the agency. The description shall include:
1. Instruments to be used;
2. Methods of performing the analysis; and
3. Pertinent experience of the individual who analyzes the samples.
H. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall be done by an organization specifically licensed by the agency, NRC, or another agreement state to load or unload irradiator sources.
I. The applicant shall describe the inspection and maintenance checks, including the frequency of the checks required by 12VAC5-481-2880.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2690. Commencement of construction.
Commencement of construction of a new irradiator may occur prior to the submission to the agency of both an application for a license for the irradiator and the fee required by 12VAC5-490. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license. Commencement of construction, as defined in 12VAC5-481-10, may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2700. Applications for exemptions.
A. The agency may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
B. Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements in this part. The agency will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that it is likely to provide an adequate level of safety for workers and the public.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2710. Request for written statements.
A. After the filing of an application, the agency may request further information necessary to enable the agency to determine whether the application shall be granted or denied.
B. Each license is issued with the condition that the licensee will, at any time before expiration of the license, upon the agency's request, submit written statements to enable the agency to determine whether the license shall be modified, suspended, or revoked.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.