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.
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:
