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.
DHS 157.11(2)(c)1.
1. A person who owns, receives, acquires, possesses or uses luminous safety devices under the general license under this paragraph is exempt from the requirements of subchs.
III and
X except that they shall comply with the provisions of s.
DHS 157.32 (1) and
(2).
DHS 157.11(2)(c)2.
2. The general license under this paragraph does not authorize the manufacture, assembly or repair of luminous safety devices containing tritium or promethium-147.
DHS 157.11(2)(c)3.
3. The general license under this paragraph does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.
DHS 157.11(2)(d)
(d)
General license relating to ownership of radioactive material. A general license is issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this section, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
DHS 157.11 Note
Note: A person may own radioactive material without the material being in their immediate possession. This general license does not allow the person to manufacture, produce devices containing material, transfer, receive, possess or use the material. A specific license is required for these activities.
DHS 157.11(2)(e)
(e)
General license relating to calibration and reference sources. A general license is issued to own, receive, acquire, possess, use and transfer americium-241, plutonium or radium-226 in the form of calibration or reference sources, under the provisions of subds.
1. to
5., to any person who holds a specific license issued by the department or the NRC which authorizes the person to receive, possess, use and transfer radioactive material.
DHS 157.11 Note
Note: For Americium-241 and plutonium, a specific license issued by the NRC is also required for any person to receive, possess or use and transfer special nuclear material.
DHS 157.11(2)(e)1.
1. The general license under this paragraph applies only to calibration or reference sources that have been manufactured under the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC under
10 CFR 32.57 or
10 CFR 70.39 or that have been manufactured under the specifications contained in a specific license issued to the manufacturer by the department, an agreement state or licensing state under licensing requirements equivalent to those contained in
10 CFR 32.57 or
10 CFR 70.39.
DHS 157.11(2)(e)2.
2. The general license under this paragraph is subject to the requirements of subchs.
III and
X.
DHS 157.11(2)(e)3.
3. A person who owns, receives, acquires, possesses, uses or transfers one or more calibration or reference sources under the general licenses provided under this paragraph may not receive, possess, use or transfer the source unless the source or the storage container bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:
DHS 157.11(2)(e)3.a.
a. The receipt, possession, use and transfer of this source, Model ____, Serial No. _____, is subject to a general license and the regulations of the NRC or of a state with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION — RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS (AMERICIUM-241).
(PLUTONIUM) DO NOT TOUCH RADIOACTIVE
PORTION OF THIS SOURCE.
____________________________
Name of manufacturer or importer
DHS 157.11 Note
Note: The label is to show only the name of the appropriate material.
DHS 157.11(2)(e)3.b.
b. The receipt, possession, use and transfer of this source, Model ______, Serial No. ____, is subject to a general license and the regulations of a licensing state. Do not remove this label.
CAUTION — RADIOACTIVE MATERIAL
THIS SOURCE CONTAINS RADIUM-226.
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
___________________________
Name of manufacturer or importer
DHS 157.11(2)(e)4.
4. A person who owns, receives, acquires, possesses, uses or transfers one or more calibration sources under the general license under this paragraph shall do all the following:
DHS 157.11(2)(e)4.a.
a. Not transfer, abandon or dispose of the source except by transfer to a person authorized by a license from the department, the NRC, an agreement state or a licensing state to receive the source.
DHS 157.11(2)(e)4.b.
b. Store the source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium or radium-226 that might otherwise escape during storage.
DHS 157.11(2)(e)4.c.
c. Not use the source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
DHS 157.11(2)(e)4.d.
d. Not possess at any one time, at any one location of storage or use, more than 185 kBq (5 microcuries) of americium-241, plutonium or radium-226.
DHS 157.11(2)(e)5.
5. The general license under this paragraph does not authorize the manufacture of calibration or reference sources containing americium-241, plutonium or radium-226.
DHS 157.11(2)(f)
(f)
General license for use of radioactive material for certain in vitro clinical or laboratory testing. DHS 157.11(2)(f)1.
1. A general license is issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, under the provisions of subds.
2. to
6., the following radioactive materials in prepackaged units for use as in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
DHS 157.11(2)(f)1.e.
e. Mock Iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (0.05 microcurie) of iodine-129 and 185 Bq (0.005 microcurie) of americium-241 each.
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.
