DHS 157.09(1)(a)12.12. Only persons authorized by a license issued under 10 CFR 40.52, may initially transfer for sale or distribution such products containing source material to a person exempt under this subsection. DHS 157.09(1)(a)13.13. Persons authorized by an agreement state to manufacture, process, or produce materials or products containing source material, and persons who import finished products or parts for sale or distribution, shall be licensed for distribution only under 10 CFR 40.52, and are exempt from s. DHS 157.13 (2) (a) and (b) and subchs. III and X. DHS 157.09(1)(b)(b) The exemptions in par. (a) do not authorize the manufacture of any of the products described. DHS 157.09(2)(2) Exemptions of radioactive material other than source material. DHS 157.09(2)(a)(a) Exempt concentrations. Except as provided in this paragraph, a person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations no greater than those listed in ch. DHS 157 Appendix A. A person may not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this paragraph or equivalent regulations of the NRC, any agreement state or licensing state, except under a specific license issued under 10 CFR 32.11 or s. DHS 157.13 (4) (a). DHS 157.09(2)(a)1.1. This paragraph does not authorize the import of radioactive material or products containing radioactive material. DHS 157.09(2)(a)2.2. A manufacturer, processor or producer of a product or material is exempt from the requirements of subch. II if they transfer radioactive material contained in a product or material in concentrations not in excess of those in ch. DHS 157 Appendix A and introduced into the product or material by a licensee holding a specific license issued by the department, the NRC or another agreement state expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being. DHS 157.09(2)(b)(b) Exempt quantities. Except as provided in this paragraph, a person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in ch. DHS 157 Appendix B. DHS 157.09(2)(b)1.1. This paragraph does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution or the incorporation of radioactive material into products intended for commercial distribution. DHS 157.09(2)(b)2.2. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in ch. DHS 157 Appendix B to any person exempt from this chapter or equivalent regulations of the NRC, an agreement state or a licensing state, except under a specific license issued by the NRC under 10 CFR 32.18, or by the department under s. DHS 157.13 (4) (b) which license states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph or the equivalent regulations of the NRC, an agreement state or a licensing state. DHS 157.09(2)(b)3.3. A person, who possesses byproduct material received or acquired before September 25, 1971, under the general license then provided in 10 CFR 31.4 or similar general license of a State, is exempt from the requirements of this subchapter to the extent that this person possesses, uses, transfers, or owns byproduct material. DHS 157.09 NoteNote: 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 NRC, Washington, D.C. 20555.
DHS 157.09(2)(c)(c) Certain items containing radioactive material. Except for persons who apply radioactive material to the following products, or incorporate radioactive material into the following products, or initially transfer for sale or distribution the following products, a person is exempt from this subchapter if the person receives, possesses, uses, transfers, owns or acquires any of the following products: DHS 157.09(2)(c)1.1. Timepieces, hands or dials containing not more than the following specified quantities of radioactive material: DHS 157.09 NoteNote: Bezels, when used, should be considered as part of the dial.
DHS 157.09(2)(c)1.d.d. 3.7 MBq (100 microcuries) of promethium-147 per watch or 7.4 MBq (200 microcuries) of promethium-147 per any timepiece. DHS 157.09(2)(c)1.e.e. 0.74 MBq (20 microcuries) of promethium-147 per watch hand or 1.48 MBq (40 microcuries) of promethium-147 per other timepiece hand. DHS 157.09(2)(c)1.f.f. 2.22 MBq (60 microcuries) of promethium-147 per watch dial or 4.44 MBq (120 microcuries) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial). DHS 157.09(2)(c)2.2. Timepieces, hands or dials containing promethium-147, when measured through 50 milligrams per square centimeter of absorber, not exceeding the following radiation dose rate: DHS 157.09(2)(c)2.a.a. For wrist watches, one microgray (0.1 millirad) per hour at 10 centimeters from any surface. DHS 157.09(2)(c)2.b.b. For pocket watches, one microgray (0.1 millirad) per hour at one centimeter from any surface. DHS 157.09(2)(c)2.c.c. For any other timepiece, 2 microgray (0.2 millirad) per hour at 10 centimeters from any surface. DHS 157.09(2)(c)3.3. Timepieces containing up to 37 kBq (1.0 microcurie) of radium-226 per timepiece acquired prior to November 30, 2007. DHS 157.09(2)(c)4.4. Ionization chamber smoke detectors containing not more than 37 kBq (1 microcurie) of americium-241 per detector in the form of a foil and designed to protect life and property from fires. DHS 157.09(2)(c)5.5. Precision balances containing not more than 37 MBq (1 millicurie) of tritium per balance or not more than 18.5 MBq (0.5 millicurie) of tritium per balance part. DHS 157.09(2)(c)6.6. Marine compasses containing not more than 27.8 GBq (750 millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 millicuries) of tritium gas. DHS 157.09(2)(c)7.7. Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents, provided that the radiation dose rate from each electron tube containing radioactive material does not exceed 10 microgray (1 millirad) per hour at one centimeter from any surface when measured through 7 milligrams per square centimeter of absorber and that each tube does not contain more than one of the following specified quantities of radioactive material: DHS 157.09(2)(c)7.a.a. 5.55 GBq (150 millicuries) of tritium per microwave receiver protector tube or 370 MBq (10 millicuries) of tritium per any other electron tube. DHS 157.09(2)(c)8.8. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided all the following conditions are met: DHS 157.09(2)(c)8.b.b. Each instrument contains no more than 10 exempt quantities. For the purposes of this subd. par., an instrument’s source or sources may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in ch. DHS 157 Appendix B, provided that the sum of the fractions does not exceed unity. DHS 157.09(2)(c)8.c.c. For purposes of this subdivision, 1.85 kBq (0.05 microcurie) of americium-241 is considered to be an exempt quantity. DHS 157.09(2)(c)9.9. Static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device. DHS 157.09(2)(c)10.10. Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device. DHS 157.09(2)(c)11.11. Devices authorized before October 23, 2012 for use under the general license then provided in DHS 157.11 (2) (a), equivalent regulations of the NRC, or other agreement states, and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the NRC. DHS 157.09(2)(d)(d) Self-luminous products containing tritium, krypton-85,or promethium-147. DHS 157.09(2)(d)1.1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution of self-luminous products containing tritium, krypton-85 or promethium-147, and except as provided in subd. 3., any person is exempt from this subchapter to the extent that such person receives, possesses, uses, transfers, owns or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced or initially transferred under a specific license issued by the NRC according to 10 CFR 32.22, which authorizes the initial transfer of the product for use under this subdivision. DHS 157.09(2)(d)2.2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85 or promethium-147, or to transfer such products for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.22, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state. DHS 157.09(2)(d)3.3. The exemption in subd. 1. does not apply to tritium, krypton-85 or promethium-147 used in products primarily for frivolous purposes or in toys or adornments. DHS 157.09(2)(e)1.1. Except for persons who manufacture, process, produce or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, a person is exempt from this subchapter if the person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that the detectors containing radioactive material have been manufactured, processed, produced or initially transferred for sale or distribution under a specific license issued by the NRC under 10 CFR 32.26, a licensing state, other agreement state or the department under s. DHS 157.13 (4) (c), which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by an agreement state under comparable provisions under 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements. DHS 157.09(2)(e)2.2. Gas and aerosol detectors previously manufactured and distributed to general licensees under the specific license issued by an agreement state shall be considered exempt under this subdivision provided that the device is labeled under the specific license authorizing distribution of the generally licensed device and provided further that they meet the requirements of s. DHS 157.13 (4) (c). DHS 157.09(2)(e)3.3. Gas and aerosol detectors containing NARM previously manufactured and distributed under a specific license issued by a licensing state shall be considered exempt under this subdivision provided the devices are labeled under the specific license authorizing distribution, and provided further that they meet the requirements of s. DHS 157.13 (4) (c). DHS 157.09(2)(e)4.4. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.26 and certificate of registration in accordance with 10 CFR 32.210, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state. DHS 157.09(2)(f)(f) Radioactive drug capsules containing no more than 37 kBq (1 microcurie) carbon-14 urea each for in vivo diagnostic use for humans. DHS 157.09(2)(f)1.1. Except as provided in subds. 2. and 3., a person is exempt from this subchapter provided that the person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for “in vivo” diagnostic use for humans. DHS 157.09(2)(f)2.2. Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license according to s. DHS 157.13. DHS 157.09(2)(f)3.3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license according to 10 CFR 32.21. DHS 157.09(2)(f)4.4. Nothing in this section relieves persons from complying with applicable FDA and other federal and state requirements governing receipt, administration and use of drugs. DHS 157.09(2)(g)(g) Industrial use devices containing exempt quantities or distributed under a general license. DHS 157.09(2)(g)1.1. Except for persons who manufacture, process, produce or initially transfer for sale or distribution of industrial devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere containing radioactive material, a person is exempt from this subchapter if the person receives, possesses, uses, transfers, owns, or acquires radioactive material in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere have been manufactured, processed, produced, or initially transferred for sale or distribution under a specific license issued by the NRC under 10 CFR 32.30, a licensing state, other agreement state or the department under s. DHS 157.13 (4) (c), which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources. DHS 157.09(2)(g)2.2. Industrial devices previously manufactured and distributed to general licensees under the specific license issued by an agreement state shall be considered exempt under this subdivision provided that the device is labeled under the specific license authorizing distribution of the generally licensed device and provided further that they meet the requirements of s. DHS 157.13 (4) (c). DHS 157.09(2)(g)3.3. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution of industrial devices containing byproduct material for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.30 and certificate of registration in accordance with 10 CFR 32.210, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state. DHS 157.09(3)(3) Exemptions of Category 1 or Category 2 quantities of radioactive waste. A licensee that possesses radioactive waste that contains category 1 or category 2 quantities of radioactive material, other than waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs), is exempt from the requirements of ss. DHS 157.9700 to 157.9722 and shall implement all the following requirements to secure the radioactive waste: DHS 157.09(3)(a)(a) Use continuous physical barriers that allow access to the radioactive waste only through established access control points. DHS 157.09(3)(b)(b) Use a locked door or gate with monitored alarm at the access control point. DHS 157.09(3)(c)(c) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred. DHS 157.09(3)(d)(d) Immediately notify the LLEA and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category 1 or category 2 quantities of radioactive material. DHS 157.09 NoteNote: 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 NRC, Washington, D.C. 20555.
DHS 157.09 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: r. and recr. (2) (a) 2., am. (2) (c) (intro.), 1. a. and 9. a., r. (2) (c) 12. and 15., cr. (2) (d) and (g), renum. (2) (c) 13. and 14. to be (2) (e) and (f) and am. (2) (e) 1. and (f) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: r. and recr. (2) Register April 2010 No. 652, eff. 5-1-10; CR 16-078: am. (1) (a) (intro.), 5. a., b., r. (1) (a) 8. a., renum. (1) (a) 8. b. to d. to (1) (a) 8. a. to c., am. (1) (a) 10. (intro.), r. and recr. (1) (a) 11., 12., cr. (1) (a) 13., am. (2) (c) 7. (intro.), cr. (2) (c) 9. to 11., am. (2) (d) 1., 2., (e) 1., cr. (2) (e) 4., (g), (3) Register January 2018 No. 745, eff. 2-1-18; correction in (1) (a) (intro.), 13., (2) (a) (intro.), (c) 8. a., (g) (intro.), 2. made under s. 35.17, Stats., and correction in (3) made under s. 13.92 (4) (b) 7., Stats., Register January 2018 No. 745; CR 22-015: am. (2) (c) 2. a. to c., 7. (intro.), (g) (title) Register June 2023 No. 810, eff. 7-1-23 DHS 157.10(1)(1) Types of licenses. A license for radioactive materials may be one of the following: DHS 157.10(1)(a)(a) General. A general license is effective without the filing of an application with the department or the issuance by the department of licensing documents to the particular person, although the filing of a certificate with the department may be required by the particular general license. The general licensee is subject to all other applicable parts of this chapter and any limitations of the general license. DHS 157.10(1)(b)(b) Specific. A specific license requires the submission of an application to the department and the issuance of a licensing document by the department. A licensee is subject to all applicable parts of this chapter as well as any limitations specified in the licensing document. A licensee shall pay the license fees as specified in sub. (3). DHS 157.10(2)(a)(a) Application fee. An application for a specific license shall be accompanied by payment in the full amount of the fee specified in sub. (3). The department may not process the application prior to receipt of the required fee. The application fee is not refundable except in those cases where the department determines that a license is not required. The department will consider any application abandoned if the department does not receive a reply within 90 days of its most recent request for additional information. In such cases, the applicant shall submit a new application with the application fee specified in sub. (3). DHS 157.10(2)(b)(b) Annual fee. A person holding a specific license in effect prior to the effective date of August 1, 2002, or a specific license issued after the effective date of August 1, 2002, shall pay the annual fee specified in sub. (3) at least 60 days prior to the anniversary date of the issuance of the license. The annual fee is not refundable except in those cases where the department determines that the fee is not required. DHS 157.10(2)(c)(c) Amendment fee. An application for amendment to a specific license shall be accompanied by payment in full of the fee specified in sub. (3). The department may not process the application prior to the department’s receipt of the required fee. The department may not charge an amendment fee to modify a license on its own initiative. DHS 157.10(2)(d)(d) Reciprocity fee. A person submitting an application for reciprocal recognition of a materials license issued by an agreement state or the nuclear regulatory commission shall include remittance for the full amount of the fee specified in sub. (3). The department may not process the application prior to the department’s receipt of the appropriate fee. Requests for reciprocal recognition approved by the department prior to November 1 shall remain in effect until December 31 of that year. Requests for reciprocal recognition approved on or after November 1 shall remain in effect until December 31 of the subsequent year. DHS 157.10(3)(3) Fee schedule. The following is the schedule of application, annual, amendment, and reciprocity fees for specific radioactive material licenses. DHS 157.10 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (3) Register October 2006 No. 610, eff. 11-1-06; CR 16-078: r. and recr. (3) Register January 2018 No. 745, eff. 2-1-18; CR 22-015: am. (3) (table) Register June 2023 No. 810, eff. 7-1-23. DHS 157.11(1)(a)(a) General license for certain organizations to use and transfer limited amounts of source material. A general license is issued authorizing commercial and industrial firms, research, educational and medical institutions and state and local government agencies to receive, possess, use, and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium, for research, development, educational, commercial, or operational purposes. DHS 157.11(1)(a)1.1. The general license issued under this paragraph shall be limited to the following forms and quantities: DHS 157.11(1)(a)1.a.a. No more than 1.5 kg (3.3 lbs) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material shall be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 7 kg (15.4 lbs) of uranium and thorium in any one calendar year. DHS 157.11(1)(a)1.b.b. No more than a total of 7 kg (15.4 lbs) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lbs) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subsection unless it is accounted for under the limits of subd. 1. a. DHS 157.11(1)(a)1.c.c. No more than 7 kg (15.4 lbs) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lbs) of uranium from drinking water during a calendar year under this paragraph. DHS 157.11(1)(a)1.d.d. No more than 7 kg (15.4 lbs) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lbs) of source material in any one calendar year. DHS 157.11(1)(a)2.2. A person who receives, possesses, uses or transfers source material under the general license issued under this paragraph shall comply with all the following:
