DHS 157.11 Note
Note: 21 USC 301 also governs the availability and use of any specific diagnostic drugs in interstate commerce.
DHS 157.11(2)(f)2.
2. No person may receive, acquire, possess, use or transfer radioactive material under the general license established under this paragraph until the person has filed a “Certificate — In Vitro Testing with Radioactive Material Under General License" form with the department and received from the department a validated copy of the form with certification number assigned. A physician, veterinarian, clinical laboratory or hospital shall furnish on the “Certificate — In Vitro Testing with Radioactive Material Under General License" all the following information and such other information as may be required by that form:
DHS 157.11(2)(f)2.a.
a. Name and address of the physician, veterinarian, clinical laboratory or hospital.
DHS 157.11(2)(f)2.c.
c. A statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized by the general license under this paragraph and that the tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.
DHS 157.11 Note
Note: The “Certificate — In Vitro Testing with Radioactive Material 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.
DHS 157.11(2)(f)3.
3. A person who receives, acquires, possesses or uses radioactive material under the general license under this paragraph shall comply with all the following:
DHS 157.11(2)(f)3.a.
a. The general licensee may not possess at any one time, under the general license under this paragraph, at any one location for storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, or cobalt-57 in excess of 7.4 MBq (200 microcuries).
DHS 157.11(2)(f)3.b.
b. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.
DHS 157.11(2)(f)3.c.
c. The general licensee shall use the radioactive material only for the uses authorized by subd.
1. DHS 157.11(2)(f)3.d.
d. The general licensee may not transfer the radioactive material to a person who is not authorized to receive it under a license issued by the department, the NRC, any agreement state or a licensing state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
DHS 157.11(2)(f)4.
4. The general licensee may not receive, acquire, possess, or use radioactive material under subd.
1. except in prepackaged units which are labeled under the provisions of an applicable specific license issued under s.
DHS 157.13 (4) (g) or under the provisions of a specific license issued by the NRC, any agreement state or a licensing state which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3, iron-59, selenium-75, cobalt-57 or Mock Iodine-125 to persons generally licensed under subd.
1. or its equivalent and one of the following statements or a substantially similar statement that contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
DHS 157.11(2)(f)4.a.
a. This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the NRC or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.
__________________
Name of manufacturer
DHS 157.11(2)(f)4.b.
b. This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a licensing state.
__________________
Name of manufacturer
DHS 157.11(2)(f)5.
5. The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license under this paragraph shall report in writing to the department any changes in the information furnished by that person in the “Certificate — In Vitro Testing with Radioactive Material Under General License". The report shall be furnished to the department within 30 days after the effective date of such change.
DHS 157.11(2)(f)6.
6. Any person using radioactive material under the general license under this paragraph is exempt from the requirements of subchs.
III and
X with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in subd.
1. e. shall comply with the provisions of ss.
DHS 157.30 (1) and
157.32 (1) and
(2).
DHS 157.11(2)(g)
(g)
General license relating to ice detection devices. A general license is issued to own, receive, acquire, possess, use and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 1.85 MBq (50 microcuries) of strontium-90 and each device has been manufactured or imported under a specific license issued by the NRC or each device has been manufactured under the specifications contained in a specific license issued by the department or an agreement state to the manufacturer of the device under licensing requirements equivalent to those in
10 CFR 32.61.
DHS 157.11(2)(g)1.
1. A person who owns, receives, acquires, possesses, uses or transfers strontium-90 contained in ice detection devices under the general license under this paragraph shall do all the following:
DHS 157.11(2)(g)1.a.
a. Upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the NRC or an agreement state to manufacture or service the devices; or shall dispose of the device under the provisions of s.
DHS 157.30 (1).
DHS 157.11(2)(g)1.b.
b. Assure that all labels affixed to the device at the time of receipt and which bear a statement that prohibits removal of the labels, are maintained on the device.
DHS 157.11(2)(g)2.
2. A person who owns, receives, acquires, possesses, uses or transfers strontium-90 contained in ice detection devices under the general license under this paragraph are exempt from the requirements of subchs.
III and
X except that the person shall comply with the provisions of ss.
DHS 157.30 (1) and
157.32 (1) and
(2).
DHS 157.11(2)(g)3.
3. The general license in this paragraph does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.
DHS 157.11(2)(h)
(h) General license relating to certain items and self-luminous products containing radium-226. DHS 157.11(2)(h)1.1. A general license is issued to own, receive, acquire, possess, use or transfer radium-226 contained in the following products:
DHS 157.11(2)(h)1.a.
a. Antiquities originally intended for use by the general public that were manufactured in the 19
th and 20
th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts and healing pads.
DHS 157.11(2)(h)1.b.
b. Intact timepieces containing greater than 37 kBq (1 microcurie) of radium-226, nonintact timepieces, and timepiece dials and hands no longer installed in timepieces.
DHS 157.11(2)(h)1.d.
d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.
DHS 157.11(2)(h)1.e.
e. Small radium sources, such as discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations, electron tubes, lightning rods, ionization sources or static eliminators, containing no more than 37 kBq (1 microcurie) of radium-226.
DHS 157.11(2)(h)2.
2. The general license in this paragraph is exempt from the requirements of subchs.
III and
X with the exception of ss.
DHS 157.30 (1) and
157.32 (1) and
(2). This exemption does not apply to any person specifically licensed under this chapter.
DHS 157.11(2)(h)3.
3. A person who owns, receives, acquires, possesses, uses or transfers radium-226 under the general license in subd.
1. shall do all of the following:
DHS 157.11(2)(h)3.b.
b. Not abandon the product containing radium-226. The product, and any radioactive material from the product, shall be disposed of according to the requirements of s.
DHS 157.30 (8), by transfer to a person authorized under a specific license to receive the radium-226, or as approved by the department.
DHS 157.11(2)(h)3.d.
d. 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)(h)4.
4. The general license in subd.
1. does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.
DHS 157.11 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. — see Note at the start of the chapter; corrections in (1) (c) 3. c. and (2) (g) 1. a. made under s. 13.93 (2m) (b) 7., Stats.,
Register July 2002 No. 559;
CR 06-021: am. (2) (b) 5., (c) 4., (e) 2., (f) 3. e. and 6., (g) 1. a., 2. and 4.
Register October 2006 No. 610, eff. 11-1-06;
CR 09-062: am. (2) (b) 3. b., c., g., h. and 4., cr. (2) (b) 3. j. to m. and (h)
Register April 2010 No. 652, eff. 5-1-10;
CR 16-078: r. and recr. (1) (a), am. (2) (a)
Register January 2018 No. 745, eff. 2-1-18; correction in (1) (a) 4., 6., 7. made under s. 35.17, Stats.,
Register January 2018 No. 745, eff. 2-1-18;
CR 22-015: am. (1) (a) 1. b., c., (2) (b) 3. g., (h) 1. e., 3. d. Register June 2023 No. 810, eff. 7-1-23. DHS 157.12
DHS 157.12 Registration of generally licensed devices. DHS 157.12(1)(a)
(a) No person may possess, receive, use, own or transfer a device purchased under a general license that contains at least 370 MBq (10 millicuries) of cesium-137, 3.7 MBq (0.1 millicurie) of strontium-90, 37 MBq (1 millicurie) of cobalt-60, 3.7 MBq (0.1 millicurie) of radium-226 or 37 MBq (1 millicurie) of americium- 241 or any other transuranic unless that person registers annually with the department and pays a fee as prescribed in sub.
(6). Each address for a location of use as described in sub.
(3) (d) represents a separate general licensee and requires a separate registration.
DHS 157.12(2)
(2)
Exemptions. A person who possesses, receives, uses, owns or transfers a device purchased under a general license that is included under a new or existing specific license or that contains isotopes different from those listed in sub.
(1) is exempt from the requirements of this section.
DHS 157.12(3)
(3)
Information requirements. A general licensee shall furnish the following information and any other information specifically requested by the department:
DHS 157.12(3)(b)
(b) Information about each device: the manufacturer, model number, serial number, radioisotope and activity as indicated on the label.
DHS 157.12(3)(c)
(c) Name and telephone number of the individual designated by management as a representative of the general licensee.
DHS 157.12(3)(d)
(d) Address at which the device is used or stored. For a portable device, the address of the primary place of storage.
DHS 157.12(3)(e)
(e) Certification by signature from the individual representing the general licensee that the information concerning the device or devices has been verified through a physical inventory and check of label information.
DHS 157.12(3)(f)
(f) Certification by signature from the individual designated by management to represent the general licensee that the individual is aware of the requirements of the general license.
DHS 157.12(4)
(4)
Change of address. A general licensee shall report, in writing, an address change to the department within 30 calendar days after moving the devices. In the case of portable devices, a general licensee shall report the device's primary storage location.
DHS 157.12(6)(a)(a) A general licensee shall pay an annual registration fee of $100 per site and $50 per device specified in sub.
(1). The department may not assess an additional fee for recording changes in registration information.
DHS 157.12(6)(b)
(b) The annual registration fee for the next year shall be paid by December 31 of the prior year of registration. The department shall issue a notice of registration following receipt of the registration fee. If the annual registration fee for the next year is not received by the department by December 31 of the prior year of registration, a licensee shall pay a penalty fee of $25, in addition to the registration fee and regardless of the number of devices, before the department will issue a new notice of registration.
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)(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(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)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).
