DHS 157.13(4)(a)2.2. A person licensed under this paragraph shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made under par. (a) during the reporting period, the report shall so indicate. The report shall cover the previous 12-month period ending June 30 and shall be filed within 30 days thereafter.

DHS 157.13 NoteNote: 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 Nuclear Regulatory Commission, Washington, D.C. 20555.

DHS 157.13(4)(b)1.1. The department shall approve an application for a specific license to distribute NARMs to persons exempted from this chapter under s. DHS 157.09 (2) (b) only under all the following conditions:

DHS 157.13(4)(b)1.a.a. The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion, inhalation by or application to a human being.

DHS 157.13(4)(b)1.b.b. The radioactive material is in the form of processed chemical elements, compounds or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution.

DHS 157.13(4)(b)2.2. The license issued under this paragraph is subject to all the following conditions:

DHS 157.13(4)(b)2.a.a. No more than 10 exempt quantities may be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions do not exceed unity.

DHS 157.13(4)(b)2.b.b. Each exempt quantity shall be separately and individually packaged. No more than 10 packaged exempt quantities may be contained in any outer package for transfer to persons exempt under s. DHS 157.09 (2) (b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 5 mSv (0.5 millirem) per hour.

DHS 157.13(4)(b)2.c.c. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label that identifies the radionuclide and the quantity of radioactivity and bears the words “Radioactive Material”.

DHS 157.13(4)(b)2.d.d. In addition to the labeling information required by this subd. 2. c., the label affixed to the immediate container or an accompanying brochure shall state that the contents are exempt from licensing or agreement state requirements; the words “Radioactive Material — Not for Human Use — Introduction into Foods, Beverages, Cosmetics, Drugs or Medicinals or into Products Manufactured for Commercial Distribution is Prohibited — Exempt Quantities Should Not Be Combined”; and appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

DHS 157.13(4)(b)3.3. A person licensed under this paragraph shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under s. DHS 157.09 (2) (b) or the equivalent regulations of a licensing or agreement state and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 30 and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made under this paragraph during the reporting period, the report shall so indicate.

DHS 157.13(4)(c)(c) Licensing the incorporation of NARM into gas and aerosol detectors. The department shall approve an application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under s. DHS 157.09 (2) (e) if the application satisfies requirements equivalent to those contained in 10 CFR 32.26. The maximum quantity of radium-226 in each device may not exceed 3.7 kBq (0.1 microcurie).

DHS 157.13(4)(d)1.1. The department shall approve an application for a specific license to manufacture or initially distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under s. DHS 157.11 (2) (b) or equivalent regulations of the NRC, another agreement state or a licensing state only under all the following conditions:

DHS 157.13(4)(d)1.b.b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions and potential hazards of the device to provide reasonable assurance that the device may be safely operated by persons not having training in radiological protection.

DHS 157.13(4)(d)1.c.c. The applicant submits sufficient information, as specified in subd. 1. b., to provide reasonable assurance that under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one year a dose in excess of 10% of the annual limits specified in s. DHS 157.22 (1) (a).

DHS 157.13(4)(d)1.d.d. The applicant submits sufficient information, as specified in subd. 1. b., to provide reasonable assurance that under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

DHS 157.13(4)(d)1.e.e. Each device bears a durable, legible, clearly visible label or labels approved by the department, which contain in a clearly identified and separate statement, the following information: instructions and precautions necessary to assure safe installation, operation and servicing of the device; and the requirement or lack of requirement, for leak testing or for testing any “on-off” mechanism and indicator, including the maximum time interval for such testing and the identification of radioactive material by isotope, quantity of radioactivity and date of determination of the quantity.

DHS 157.13 NoteNote: Documents such as operating and service manuals may be identified in the label and used to provide instructions and precautions necessary to assure safe installation, operation and servicing of the device.

DHS 157.13(4)(d)1.f.f. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number; the isotope and quantity; the words, “Caution-Radioactive Material”; the radiation symbol described in DHS 157.29 (1); and the name of the manufacturer or initial distributor.

DHS 157.13(4)(d)1.g.g. Each device meeting the criteria of s. DHS 157.11 (2) (b), bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution-Radioactive Material “and if practicable, the radiation symbol described in s. DHS 157.29 (1).