Chapter DHS 157

DHS 157.12(7)(a) (a) A general licensee shall complete an inspection by mail form, provided by the department with each annual registration renewal, and return it to the department by December 31 of that year. The form shall include information deemed necessary by the department.

DHS 157.12(7)(b) (b) No additional fee may be required for this form.

DHS 157.12(7)(c) (c) A general licensee who fails to complete this form may be subject to a site inspection.

DHS 157.12 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (3) (intro.), r. (5) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: renum. (1) to be (1) (a) and am., cr. (1) (b) Register April 2010 No. 652, eff. 5-1-10.

DHS 157.13 DHS 157.13 Specific licenses.

DHS 157.13(1) (1) Filing application for specific licenses.

DHS 157.13(1)(a) (a) An application for a specific license shall be filed on a form prescribed by the department.

DHS 157.13 Note 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.

DHS 157.13(1)(b) (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.

DHS 157.13(1)(c) (c) The applicant, licensee or a person authorized to act on behalf of the applicant or licensee shall sign the application.

DHS 157.13(1)(d) (d) A license application may include a request for a license authorizing one or more activities.

DHS 157.13(1)(e) (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.

DHS 157.13(1)(f) (f) The department shall make applications and documents submitted to the department available for public inspection under ss. 19.32 to 19.39, Stats.

DHS 157.13(1)(g) (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:

DHS 157.13(1)(g)1. 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.

DHS 157.13(1)(g)2. 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.

DHS 157.13(1)(h) (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:

DHS 157.13(1)(h)1. 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.

DHS 157.13(1)(h)2. 2. The information identified in 10 CFR 32.210(c).

DHS 157.13(1)(h)3. 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.

DHS 157.13(1)(h)4. 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.

DHS 157.13(1)(h)5. 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.

DHS 157.13(1)(i) (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.

DHS 157.13(1)(j) (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:

DHS 157.13(1)(j)1. 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.

DHS 157.13(1)(j)2. 2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in sub. (4) (i).

DHS 157.13(1)(j)3. 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.

DHS 157.13(1)(j)4. 4. Information identified in sub. (4) (i) 3. on the PET drugs to be noncommercially transferred to members of a consortium.

DHS 157.13(2) (2) General requirements for the issuance of specific licenses. The department shall approve a license application within 180 working days of filing of a complete application if the department determines that all the following apply:

DHS 157.13(2)(a) (a) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested under the requirements of this chapter in a manner that minimizes danger to public health and safety or property.

DHS 157.13(2)(b) (b) The applicant’s proposed equipment, facilities and procedures are adequate to minimize danger to public health and safety or property.

DHS 157.13(2)(c) (c)

DHS 157.13(2)(c)1. 1. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity which the department determines will significantly affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values.

DHS 157.13(2)(c)2. 2. Commencement of construction prior to the department’s conclusion in subd. 1. shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term “commencement of construction” means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other pre-construction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

DHS 157.13(2)(d) (d) The applicant satisfies any applicable requirements in subs. (3), (4) and (6), s. DHS 157.15 and subchs. IV, V and VI.

DHS 157.13(2)(e) (e) The applicant pays all applicable fees as specified in s. DHS 157.10.

DHS 157.13(2)(f) (f) In the case of an application for a license to possess and use an x-ray fluorescence analyzer (XRF) for the detection of lead in paint or portable gauges using sealed sources, the applicant shall verify that the operator training requirements of ch. DHS 157 Appendix S are met prior to the operator using the device.

DHS 157.13(3) (3) Special requirements for specific licenses of broad scope.

DHS 157.13(3)(a) (a) This subsection prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of the licenses.

DHS 157.13(3)(b) (b) The different types of broad scope licenses are as follows:

DHS 157.13(3)(b)1. 1. A “Type A specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range, but may be limited based on types of radioactive materials, proposed use and the training and experience of users.

DHS 157.13(3)(b)2. 2. A “Type B specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in ch. DHS 157 Appendix C, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed under the license, is the quantity specified for that radionuclide in ch. DHS 157 Appendix C, Column I. If 2 or more radionuclides are possessed under the license, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in ch. DHS 157 Appendix C, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license may not exceed unity.

DHS 157.13(3)(b)3. 3. A “Type C specific license of broad scope” is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in ch. DHS 157 Appendix C, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in ch. DHS 157 Appendix C, Column II. If 2 or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in ch. DHS 157 Appendix C, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license may not exceed unity.

DHS 157.13(3)(c) (c) The department shall approve an application for a Type A specific license of broad scope if all the following occurs:

DHS 157.13(3)(c)1. 1. The applicant satisfies the general requirements specified in sub. (2).

DHS 157.13(3)(c)2. 2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material.

DHS 157.13(3)(c)3. 3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, accounting and management review that are necessary to assure safe operations, including all of the following:

DHS 157.13(3)(c)3.a. a. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management and persons trained and experienced in the safe use of radioactive material.

DHS 157.13(3)(c)3.b. b. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection and who is available for advice and assistance on radiation safety matters.

DHS 157.13(3)(c)3.c. c. The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user and the operating or handling procedures; and review, approval and recording by the radiation safety committee of safety evaluations of proposed uses prior to use of the radioactive material.

DHS 157.13(3)(d) (d) The department shall approve an application for a Type B specific license of broad scope if all the following occurs:

DHS 157.13(3)(d)1. 1. The applicant satisfies the general requirements specified in sub. (2).

DHS 157.13(3)(d)2. 2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, accounting and management review that are necessary to assure safe operations, including all the following:

DHS 157.13(3)(d)2.a. a. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection and who is available for advice and assistance on radiation safety matters.

DHS 157.13(3)(d)2.b. b. The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user and the operating or handling procedures; and review, approval and recording by the radiation safety officer of safety evaluations of proposed uses prior to use of the radioactive material.

DHS 157.13(3)(e) (e) The department shall approve an application for a Type C specific license of broad scope if all the following occurs:

DHS 157.13(3)(e)1. 1. The applicant satisfies the general requirements specified in sub. (2).

DHS 157.13(3)(e)2. 2. The applicant submits a statement that radioactive material will be used only by or under the direct supervision of individuals who have received all the following:

DHS 157.13(3)(e)2.a. a. A college degree at the bachelor level in the physical or biological sciences or in engineering or equivalent training and experience.

DHS 157.13(3)(e)2.b. b. At least 40 hours of training and experience in the safe handling of radioactive material and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used.

DHS 157.13(3)(e)3. 3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control, accounting and management review necessary to assure safe operations.

DHS 157.13(3)(f) (f) A specific license of broad scope is subject to all of the following conditions:

DHS 157.13(3)(f)1. 1. Unless specifically authorized, a person licensed under sub. (3) may not do any of the following:

DHS 157.13(3)(f)1.a. a. Conduct tracer studies in the environment involving direct release of radioactive material.

DHS 157.13(3)(f)1.b. b. Receive, acquire, own, possess, use or transfer devices containing 3.7 PBq (100,000 curies) or more of radioactive material in sealed sources used for irradiation of materials.

DHS 157.13(3)(f)1.c. c. Conduct activities for which a specific license issued by the department under sub. (4) or subch. VI is required.

DHS 157.13(3)(f)1.d. d. Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being.

DHS 157.13(3)(f)2. 2. A Type A specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals approved by the licensee’s radiation safety committee.

DHS 157.13(3)(f)3. 3. A Type B specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals approved by the licensee’s radiation safety officer.

DHS 157.13(3)(f)4. 4. A Type C specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals who satisfy the requirements of par. (e).

DHS 157.13(4) (4) Special requirements for a specific license to manufacture, assemble, repair or distribute commodities, products or devices which contain radioactive material.

DHS 157.13(4)(a) (a) Licensing the introduction of radioactive material into products in exempt concentrations.

DHS 157.13(4)(a)1. 1. In addition to the requirements set forth in sub. (2), a specific license authorizing the introduction of radioactive material, excluding byproduct material, into a product or material owned by or in the possession of the licensee or another to be transferred to a person exempt under s. DHS 157.09 (2) (a) shall be issued only under all the following conditions:

DHS 157.13(4)(a)1.a. a. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material and estimated concentration of the radioactive material in the product or material at the time of transfer.

DHS 157.13(4)(a)1.b. b. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in ch. DHS 157 Appendix A, that reconcentration of the radioactive material in concentrations exceeding those in ch. DHS 157 Appendix A is not likely, that use of lower concentrations is not feasible and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by or application to a human being.

DHS 157.13(4)(a)2. 2. A person licensed under this paragraph shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made under par. (a) during the reporting period, the report shall so indicate. The report shall cover the previous 12-month period ending June 30 and shall be filed within 30 days thereafter.

DHS 157.13 Note Note: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the Nuclear Regulatory Commission, Washington, D.C. 20555.

DHS 157.13(4)(b) (b) Licensing the commercial distribution of radioactive material in exempt quantities.

DHS 157.13(4)(b)1. 1. The department shall approve an application for a specific license to distribute NARMs to persons exempted from this chapter under s. DHS 157.09 (2) (b) only under all the following conditions:

DHS 157.13(4)(b)1.a. a. The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion, inhalation by or application to a human being.

DHS 157.13(4)(b)1.b. b. The radioactive material is in the form of processed chemical elements, compounds or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution.

DHS 157.13(4)(b)1.c. c. The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

DHS 157.13(4)(b)1.d. d. Out of state manufacturers of the product hold a license issued by a licensing or agreement state.

DHS 157.13(4)(b)2. 2. The license issued under this paragraph is subject to all the following conditions:

DHS 157.13(4)(b)2.a. a. No more than 10 exempt quantities may be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions do not exceed unity.

DHS 157.13(4)(b)2.b. b. Each exempt quantity shall be separately and individually packaged. No more than 10 packaged exempt quantities may be contained in any outer package for transfer to persons exempt under s. DHS 157.09 (2) (b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 5 mSv (0.5 millirem) per hour.

DHS 157.13(4)(b)2.c. c. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that identifies the radionuclide and the quantity of radioactivity and bears the words “Radioactive Material”.

DHS 157.13(4)(b)2.d. d. In addition to the labeling information required by this subd. 2. c., the label affixed to the immediate container or an accompanying brochure shall state that the contents are exempt from licensing or agreement state requirements; the words “Radioactive Material — Not for Human Use — Introduction into Foods, Beverages, Cosmetics, Drugs or Medicinals or into Products Manufactured for Commercial Distribution is Prohibited — Exempt Quantities Should Not Be Combined”; and appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

DHS 157.13(4)(b)3. 3. A person licensed under this paragraph shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under s. DHS 157.09 (2) (b) or the equivalent regulations of a licensing or agreement state and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made under this paragraph during the reporting period, the report shall so indicate.