DHS 157.13(4)(d)5.b.b. Furnish a copy of the general license contained in the NRC’s, agreement state’s or licensing state’s regulation equivalent to ss. DHS 157.02, 157.06 (1), 157.11 (2) (b), 157.13 (18) and 157.32 (1) and (2), notification of the registration requirement equivalent to s. DHS 157.12 (1), a list of the services that can only be performed by a specific licensee, information on disposal options including estimated costs of disposal, and the name or title, address, and phone number of the contact at the agreement state or NRC from which additional information may be obtained to each person to whom he or she directly or through an intermediate person transfers radioactive material in a device for use under the general license of the NRC, the agreement state or the licensing state prior to the transfer. If a copy of the general license in s. DHS 157.11 (2) (b) is furnished to the person, it shall be accompanied by a note explaining that the use of the device is regulated by the NRC, agreement state or licensing state under requirements substantially the same as those in s. DHS 157.11 (2) (b). Regulations from the NRC, agreement state or licensing state that are equivalent to s. DHS 157.11 (2) (b) 3. b. to 3. d., may be omitted from a copy of the general license if the requirements do not apply to a particular device. Notification of the registration requirement equivalent to s. DHS 157.12 (1) may also be omitted if it does not apply to a particular device. DHS 157.13(4)(d)5.c.c. Report to the department all transfers of such devices to persons for use under the general license in s. DHS 157.11 (2) (b). The report shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact and relationship to the intended user. If no transfers have been made to persons generally licensed under s. DHS 157.11 (2) (b) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter. DHS 157.13(4)(d)5.d.d. Report to the NRC all transfers of such devices to persons for use under the NRC general license in 10 CFR 31.5. If no transfers have been made to NRC licensees during the reporting period, the report shall so indicate and be reported to the NRC. DHS 157.13(4)(d)5.e.e. For devices shipped to another state, report to the responsible state agency all transfers of devices manufactured and distributed under this paragraph for use under a general license in that state’s regulations equivalent to s. DHS 157.11 (2) (b). If no transfers have been made to general licensees within a particular state during the reporting period, the report shall so indicate and be sent to the responsible state agency upon request of that agency. DHS 157.13(4)(d)5.f.f. The reports in subd. 5. d. and e. shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the agency and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact and relationship to the intended user. If any changes are made to a device, such that the label is changed to update required information, the report shall identify the general licensee, the device, and the changes in information on the device label. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person, cover each calendar quarter and clearly indicate the period covered by the report. DHS 157.13(4)(d)5.g.g. For devices received from a general licensee, the report shall include the identity of the general licensee by name and address, the type, model number and serial number of the device received and the date of receipt. In the case of devices not initially transferred by the reporting licensee, the report shall also include the name of the manufacturer or initial transferor. DHS 157.13(4)(d)5.h.h. Retain records showing the name, address, and the point of contact for each general licensee to whom he or she directly or through an intermediate person transfers radioactive material in devices for use under the general license provided in s. DHS 157.11 (2) (b) or equivalent regulations of the NRC, an agreement state or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, compliance with the report requirements of this subdivision and be retained for 5 years from the date of transfer. DHS 157.13(4)(d)5.i.i. If a notification of bankruptcy has been made under s. DHS 157.13 (10) or the license is to be terminated, a person licensed under this paragraph shall provide, upon request, to the department and to the appropriate regulatory agency, NRC or other agreement state having jurisdiction at the device’s location, records of final disposition required under subd. 5. h. DHS 157.13(4)(e)(e) Special requirements for the manufacture, assembly or repair of luminous safety devices for use in aircraft. The department shall approve an application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under s. DHS 157.11 (2) (c) if the applicant satisfies the general requirements specified in sub. (2) and the requirements of 10 CFR 32.53 to 32.56, or their equivalent. DHS 157.13(4)(f)(f) Special requirements for license to manufacture calibration or reference sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under s. DHS 157.11 (2) (e). The department shall approve an application for a specific license to manufacture calibration or reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under s. DHS 157.11 (2) (e) if the applicant satisfies the general requirement of sub. (2) and the requirements of 10 CFR 32.57 to 32.59 and 10 CFR 70.39 or their equivalent. DHS 157.13(4)(g)(g) Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. The department shall approve an application for a specific license to manufacture or distribute radioactive material for use under the general license of s. DHS 157.11 (2) (f) if all of the following conditions are satisfied: DHS 157.13(4)(g)2.2. The radioactive material is to be prepared for distribution in prepackaged units of one of the following: DHS 157.13(4)(g)2.e.e. Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 microcurie) of iodine-129 and 185 Bq (0.005 microcurie) of americium-241 each. DHS 157.13(4)(g)3.3. Each prepackaged unit bears a durable, clearly visible label that does all the following: DHS 157.13(4)(g)3.a.a. Identifies the radioactive contents as to chemical form and radionuclide, and indicates that the amount of radioactivity does not exceed 370 kBq (10 microcuries) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 microcuries) of hydrogen-3; 740 kBq (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 microcurie) of iodine-129 and 185 Bq (0.005 microcurie) of americium-241 each. DHS 157.13(4)(g)3.b.b. Displays the radiation caution symbol described in s. DHS 157.29 (1) (a) and the words “CAUTION, RADIOACTIVE MATERIAL” and “Not for Internal or External Use in Humans or Animals”. DHS 157.13(4)(g)4.4. One of the following statements, as appropriate, 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 157.13(4)(g)4.a.a. This radioactive material may 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 from the material, 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 NRC has entered into an agreement for the exercise of regulatory authority. __________________
Name of manufacturer
DHS 157.13(4)(g)4.b.b. This radioactive material may 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.