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 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 NRC, Washington, D.C. 20555.
DHS 157.09 History
History: 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.
-
See PDF for table 
DHS 157.10 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)
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 Note
Note: 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 Note
Note: 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 Note
Note: 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.
DHS 157.11(2)(b)3.d.
d. Maintain records showing compliance with the requirements of subd.
3. b. and
c. The records shall show the results of tests. The records shall also show the dates of performance of tests, and the names of persons performing, testing, installation, servicing and removal from installation of the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by subd.
3. b. shall be maintained for 3 years or until the sealed source is transferred or disposed of. Records of tests of the “on-off" mechanism and indicator required by subd.
3. b. shall be maintained for 3 years or until the sealed source is transferred or disposed of. Records that are required by subd.
3. c. shall be maintained for a period of 3 years from the date of the recorded event or until the device is transferred or disposed of.
DHS 157.11(2)(b)3.e.
e. Upon the occurrence of a failure of or damage to or any indication of a possible failure of or damage to, the shielding of the radioactive material or the “on-off" mechanism or indicator, or upon the detection of 185 Bq (0.005 microcurie) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the department, the NRC, an agreement state or a licensing state to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device. The licensee shall file a written report containing a brief description with the department within 30 days of the event.
DHS 157.11(2)(b)3.g.
g. Except as provided in subd.
3. h. and
j., transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the NRC, an agreement state or a licensing state whose specific license authorizes that person to receive the device and within 30 calendar days after transfer of a device to a specific licensee or export of the device shall furnish to the department a written report containing identification of the device by manufacturer's or initial transferor's name, model and serial number, the name, address and license number of the person receiving the device, and the date of the transfer.
DHS 157.11(2)(b)3.h.
h. Transfer the device to another general licensee only where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee, or where the device remains in use at a particular location. In the latter case, the transferor shall give the transferee a copy of sub.
(2) (b) and any safety documents identified in the label on the device and within 30 calendar days of the transfer. The licensee shall report to the department the manufacturer's name, model and serial number of device transferred, the name and address of the transferee, and the name, phone number and position of an individual who may constitute a point of contact between the department and the transferee.
DHS 157.11(2)(b)3.i.
i. Comply with the provisions of s.
DHS 157.32 (1) and
(2) for reporting radiation incidents, theft or loss of licensed material, but is exempt from the other requirements of subchs.
III and
X.
DHS 157.11(2)(b)3.k.
k. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.
DHS 157.11(2)(b)3.L.
L. Appoint an individual responsible for having knowledge of the appropriate requirements of this chapter and the authority for taking required actions to comply with these requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with the appropriate requirements of this chapter. This appointment does not relieve the general licensee of any of its responsibility under this chapter.
DHS 157.11(2)(b)3.m.
m. May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required under subd.
3. b. need not be performed during the period of storage only. When devices are put back into service or transferred to another person, and have not been tested within the required time interval, they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
DHS 157.11(2)(b)4.
4. The general license under this paragraph does not authorize the manufacture or import of devices containing radioactive material.
DHS 157.11(2)(c)
(c)
General license relating to luminous safety devices for aircraft. A general license is issued to own, receive, acquire, possess and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided that each device contains not more than 370 GBq (10 curies) of tritium or 11.1 GBq (300 millicuries) of promethium-147, and that each device has been manufactured, assembled or imported under a specific license issued by the NRC, or manufactured or assembled under the specifications contained in a specific license issued by the department or any agreement state to the manufacturer or assembler of such device under licensing requirements equivalent to those in
10 CFR 32.53.
