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: DHS 157.11(1)(a)2.a.a. Not administer source material under the general license issued under this paragraph, or radiation from the source material, either externally or internally, to human beings except as authorized by the department in a specific license. DHS 157.11(1)(a)2.c.c. Not abandon source material under the general license issued under this paragraph. DHS 157.11(1)(a)3.a.a. A cumulative total of 0.5 kg (1.1 lbs) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. A person is exempt from the requirement to obtain a license under this subchapter if source material is transferred to the person for permanent disposal under the provisions of this paragraph, and the person is not authorized to possess source material under a specific license issued under this chapter. DHS 157.11(1)(a)4.4. A person who receives, possesses, uses or transfers source material under the general license issued under this paragraph is subject to the provisions in ss. DHS 157.01 to 157.03, 157.05 (2), 157.06 (1) to (3), 157.13 (9), (10), (15), and (16), 157.31, 157.32, 157.89 (4) (b), and 157.90 to 157.91. DHS 157.11(1)(a)5.5. A person who receives, possesses, uses, or transfers source material under the general license issued under this paragraph shall conduct activities so as to minimize contamination of the facility and the environment. The general licensee shall notify the department immediately if evidence of contamination is identified when activities at any site involving source materials have permanently ceased. The department may offer consultation to the general licensee regarding the appropriateness of sampling and restoration activities to ensure that contamination or residual source material remaining at the site is not likely to result in exposures that exceed the limits in s. DHS 157.33 (2). DHS 157.11(1)(a)6.6. A person who receives, possesses, uses or transfers source material pursuant to the specific terms of a general license issued under this paragraph, and who does not possess source material under a specific license issued under this chapter, is exempt from subchs. III and X, except that such person shall comply with ss. DHS 157.30 (1) and 157.33 (2) DHS 157.11(1)(a)7.7. No person may initially transfer or distribute source material to persons in possession of a general license issued in subd. 1. a. or b., or equivalent regulations of the NRC or another agreement state, unless authorized by a specific license issued by the department, the NRC, or another agreement state. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. DHS 157.11(1)(b)(b) General license authorizing receipt of title to source material without regard to quantity. A general license is issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use or transfer source material. DHS 157.11 NoteNote: A person may take title to source material under a general license. In order to receive, possess, use or transfer source material, he or she must obtain a specific license under s. DHS 157.13. DHS 157.11(1)(c)(c) General license relating to depleted uranium in industrial products and devices. DHS 157.11(1)(c)1.1. A general license is issued to receive, acquire, possess, use or transfer, under the provisions of subds. 2., 3., 4., 5. and 6., depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device. DHS 157.11(1)(c)2.2. The general license issued under this paragraph applies only to industrial products or devices that have been manufactured or initially transferred either under a specific license issued to the manufacturer of the products or devices under s. DHS 157.13 (4) (k) or under a specific license issued to the manufacturer by the NRC or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the NRC or the agreement state. DHS 157.11(1)(c)3.3. A person who receives, acquires, possesses or uses depleted uranium under the general license under this paragraph shall file a “Certificate — Use of Depleted Uranium Under General License” form with the department. The form shall be filed within 30 days after the first receipt or acquisition of depleted uranium and is considered filed when it is received by the department. The general licensee shall furnish on the “Certificate — Use of Depleted Uranium Under General License” all of the following information and any other information required by that form: DHS 157.11(1)(c)3.b.b. A statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium described in this paragraph and designed to prevent transfer of the depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium. DHS 157.11(1)(c)3.c.c. Name and title, address and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in subd. 3. b. DHS 157.11(1)(c)4.4. The general licensee possessing or using depleted uranium under the general license established under this paragraph shall report in writing to the department any changes in information furnished by that person in the “Certificate — Use of Depleted Uranium Under General License”. The report shall be filed within 30 days after the effective date of the change. DHS 157.11(1)(c)5.5. A person who receives, acquires, possesses or uses depleted uranium under the general license established under this paragraph shall comply with all of the following: DHS 157.11(1)(c)5.a.a. Not introduce the depleted uranium, in any form, into a chemical, physical or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium. DHS 157.11(1)(c)5.c.c. Transfer or dispose of the depleted uranium only under the provisions of s. DHS 157.13 (15). In the case where the transferee receives the depleted uranium under the general license established under this paragraph, the party making the transfer shall furnish the transferee a copy of this subsection and a copy of the “Certificate — Use of Depleted Uranium Under General License”. In the case where the transferee receives the depleted uranium under a general license contained in the NRC or agreement state regulations equivalent to this paragraph, the party making the transfer shall furnish the transferee a copy of this subsection and a copy of “Certificate — Use of Depleted Uranium Under General License” accompanied by a note explaining that use of the product or device is regulated by the NRC or an agreement state under requirements substantially the same as those in this subsection. DHS 157.11(1)(c)5.d.d. Within 30 days following a transfer, report in writing to the department the name and address of the person receiving the depleted uranium under the transfer. DHS 157.11(1)(c)6.6. A person receiving, acquiring, possessing, using or transferring depleted uranium under the general license established under this paragraph is exempt from the requirements of subchs. III and X with respect to the depleted uranium covered by that general license. DHS 157.11 NoteNote: The “Certificate — Use of Depleted Uranium Under General License” form may be obtained by writing the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659; or by downloading from the Department website at: http://dhs.wisconsin.gov/radiation/radioactivematerials/index.htm. Completed forms may be mailed to the Department at the same address. DHS 157.11(2)(2) General licenses — radioactive material other than source material. DHS 157.11(2)(a)(a) General license relating to certain devices and equipment. A general license is issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in all the following devices or equipment which have been manufactured, tested and labeled by the manufacturer under a specific license issued to the manufacturer by the NRC. This general license is exempt from the requirements of subch. III, with the exception of ss. DHS 157.30 (1), 157.32 (1) and (2), and subch. X. DHS 157.11(2)(a)1.1. ‘Static elimination device.’ Devices designed for use as static eliminators 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 157.11(2)(a)2.2. ‘Ion generating tube.’ Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of not more than 18.5 MBq (500 microcuries) of polonium-210 per device or a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 per device. DHS 157.11(2)(b)(b) General license relating to certain measuring, gauging or controlling devices. DHS 157.11(2)(b)1.1. A general license is issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business and state or local government agencies to own, receive, acquire, possess, use or transfer under the provisions of subds. 1. to 4., radioactive material, excluding special nuclear material, contained in 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 light or an ionized atmosphere. DHS 157.11(2)(b)2.2. The general license issued under this paragraph applies only to radioactive material contained in devices that have been manufactured and labeled under the specifications contained in a specific license issued by the department under s. DHS 157.13 (4) (d) or under the specifications contained in a specific license issued by the NRC, an agreement state or a licensing state, which authorizes distribution of devices to persons generally licensed by the NRC, an agreement state or a licensing state. DHS 157.11 NoteNote: Regulations under the Federal Food, Drug and Cosmetic Act authorizing the use of radioactive control devices in food production required certain additional labeling thereon which is found in 21 CFR 179.21. DHS 157.11(2)(b)3.3. A person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device under the general license under this paragraph shall do all the following: DHS 157.11(2)(b)3.a.a. Ensure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited, are maintained on the device and shall comply with all instructions and precautions provided by such labels. DHS 157.11(2)(b)3.b.b. Ensure that the device is tested for leakage of radioactive material and proper operation of the “on-off” mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, except for devices containing only tritium, not more than 3.7 MBq (100 microcuries) of other beta and gamma-emitting material, or 0.37 MBq (10 microcuries) of alpha-emitting material, and devices held in storage in the original shipping container prior to the initial installation. Devices containing only krypton need not be tested for leakage of radioactive material. DHS 157.11(2)(b)3.c.c. Ensure that the tests required by subd. 3. b. and other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed under the instructions provided by the labels, or by a person holding an applicable specific license from the department, the NRC, an agreement state or a licensing state to perform such activities.
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