Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter II - Licensing of Radioactive Material › Section DHS 157.13 - Specific licenses

Current through June 24, 2024
(1) FILING APPLICATION FOR SPECIFIC LICENSES.
(a) An application for a specific license
				  shall be filed on a form prescribed by the department.
Note:
A specific license application form may
					 be obtained by writing the Department, including a description of the proposed
					 activity to be licensed. The Department's address is: Department of Health
					 Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659;
					 or by downloading from the Department's website at:
http://dhs.wisconsin.gov/radiation/radioactivematerials/index.htm
.
(b) The department may at any time
				  after the filing of the original application, and before the expiration of the
				  license, require further statements to enable the department to determine
				  whether the application should be granted or denied or whether a license should
				  be modified, suspended or revoked.
(c) The applicant, licensee or a person
				  authorized to act on behalf of the applicant or licensee shall sign the
				  application.
(d) A license
				  application may include a request for a license authorizing one or more
				  activities.
(e) 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.
(f) The department shall make applications
				  and documents submitted to the department available for public inspection under
				  ss. 19.32 to
				  19.39, Stats.
(g) Each application to possess radioactive
				  material in unsealed form, on a foil or plated source, or sealed in glass in
				  excess of the quantities in ch. DHS 157 Appendix P, "Quantities of Radioactive
				  Materials Requiring Consideration of the Need for an Emergency Plan for
				  Responding to a Release", shall contain one of the following:
1. An evaluation showing that the projected
				  dose to a person offsite due to a release of radioactive material would not
				  exceed 0.01 Sievert (1 rem) total effective dose equivalent or 0.05 Sievert (5
				  rem) to the thyroid.
2. An
				  emergency plan, reviewed and commented on by offsite response organizations
				  expected to respond in the event of an accident, that contains the information
				  described in ch. DHS 157 Appendix Q for responding to any event in which
				  radioactive material could be released from the site.
(h) Each application to use radioactive
				  material in the form of a sealed source or in a device that contains a sealed
				  source shall contain one of the following:
1.
				  Information that identifies the source or device by manufacturer and model
				  number as registered with the NRC under
				  10 CFR
				  32.210 or an agreement state, or for a source
				  or device containing radium-226 or accelerator-produced radioactive material,
				  information that identifies the source or device by manufacturer and model
				  number as registered with a state under provisions comparable to
				  10 CFR
				  32.210.
2. The information identified in
				  10 CFR
				  32.210(c).
3. For sources or devices containing
				  naturally occurring or accelerator-produced radioactive material manufactured
				  prior to November 30, 2007 that are not registered with the NRC under
				  10 CFR
				  32.210 or with an agreement state, and for
				  which the applicant is unable to provide all categories of information
				  specified in 10 CFR
				  32.210(c), the applicant
				  shall provide all available categories of information identified in
				  10 CFR
				  32.210(c) concerning the
				  source, and, if applicable, the device. For any unavailable categories of
				  information specified in 10
				  CFR 32.210(c), the applicant
				  shall provide 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 shall 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.
4. For sealed sources and devices allowed to
				  be distributed without registration of safety information in accordance with
				  10 CFR
				  32.210(g)(1), the applicant
				  may supply only the manufacturer, model number, and radionuclide and
				  quantity.
5. 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.
(i) Each application for a specific license,
				  other than a renewal, shall contain information describing how facility design
				  and procedures for operation will minimize, to the extent practicable,
				  contamination of the facility and the environment, facilitate eventual
				  decommissioning and minimize, to the extent practicable, the generation of
				  radioactive waste. Licensees shall, to the extent practical, conduct operations
				  to minimize the introduction of residual radioactivity into the site, including
				  the subsurface, in accordance with the existing radiation protection
				  requirements in s. DHS 157.21 and the radiological criteria for license
				  termination in s. DHS 157.33.
(j)
				  Each application to produce Positron Emission Tomography (PET) radioactive
				  drugs for noncommercial transfer to licensees in a consortium authorized for
				  medical use under subch. VI or equivalent NRC or agreement state requirements
				  shall include all the following:
1. A request
				  for authorization for the production of PET radionuclides or evidence of an
				  existing license issued by the department, NRC or an agreement state under this
				  chapter or equivalent regulations for a PET radionuclide production facility
				  within its consortium from which it receives PET radionuclides.
2. Evidence that the applicant is qualified
				  to produce radioactive drugs for medical use by meeting one of the criteria in
				  sub. (4) (i).
3. Identification of
				  any individual authorized to prepare the PET radioactive drugs if the applicant
				  is a pharmacy, and documentation that each individual meets the requirements of
				  an authorized nuclear pharmacist as specified in s. DHS 157.68.
4. Information identified in sub. (4) (i) 3.
				  on the PET drugs to be noncommercially transferred to members of a
				  consortium.