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.a.a. Carbon-14, in units not exceeding 370 kBq (10 microcuries) each.
DHS 157.11(2)(f)1.b.b. Cobalt-57, in units not exceeding 370 kBq (10 microcuries) each.
DHS 157.11(2)(f)1.c.c. Hydrogen-3, in units not exceeding 1.85 MBq (50 microcuries) each.
DHS 157.11(2)(f)1.d.d. Iodine-125, in units not exceeding 370 kBq (10 microcuries) each.
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(2)(f)1.f.f. Iodine-131, in units not exceeding 370 kBq (10 microcuries) each.
DHS 157.11(2)(f)1.g.g. Iron-59, in units not exceeding 740 kBq (20 microcuries) each.
DHS 157.11(2)(f)1.h.h. Selenium-75, in units not exceeding 370 kBq (10 microcuries) each.
DHS 157.11 NoteNote: 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.b.b. The location of use.
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 NoteNote: 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)3.e.e. The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in subd. 1. e. as required by s. DHS 157.30 (1).