DHS 157.13(3)(e)3.3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control, accounting and management review necessary to assure safe operations. DHS 157.13(3)(f)(f) A specific license of broad scope is subject to all of the following conditions: DHS 157.13(3)(f)1.1. Unless specifically authorized, a person licensed under sub. (3) may not do any of the following: DHS 157.13(3)(f)1.a.a. Conduct tracer studies in the environment involving direct release of radioactive material. DHS 157.13(3)(f)1.b.b. Receive, acquire, own, possess, use or transfer devices containing 3.7 PBq (100,000 curies) or more of radioactive material in sealed sources used for irradiation of materials. DHS 157.13(3)(f)1.c.c. Conduct activities for which a specific license issued by the department under sub. (4) or subch. VI is required. DHS 157.13(3)(f)1.d.d. Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being. DHS 157.13(3)(f)2.2. A Type A specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals approved by the licensee’s radiation safety committee. DHS 157.13(3)(f)3.3. A Type B specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals approved by the licensee’s radiation safety officer. DHS 157.13(3)(f)4.4. A Type C specific license of broad scope issued under this section shall be subject to the condition that radioactive material possessed under the license may only be used by or under the direct supervision of individuals who satisfy the requirements of par. (e). DHS 157.13(4)(4) Special requirements for a specific license to manufacture, assemble, repair or distribute commodities, products or devices which contain radioactive material. DHS 157.13(4)(a)(a) Licensing the introduction of radioactive material into products in exempt concentrations. DHS 157.13(4)(a)1.1. In addition to the requirements set forth in sub. (2), a specific license authorizing the introduction of radioactive material, excluding byproduct material, into a product or material owned by or in the possession of the licensee or another to be transferred to a person exempt under s. DHS 157.09 (2) (a) shall be issued only under all the following conditions: DHS 157.13(4)(a)1.a.a. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material and estimated concentration of the radioactive material in the product or material at the time of transfer. DHS 157.13(4)(a)1.b.b. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in ch. DHS 157 Appendix A, that reconcentration of the radioactive material in concentrations exceeding those in ch. DHS 157 Appendix A is not likely, that use of lower concentrations is not feasible and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by or application to a human being. 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)(b) Licensing the commercial distribution of radioactive material in exempt quantities. 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)1.c.c. The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures. DHS 157.13(4)(b)1.d.d. Out of state manufacturers of the product hold a license issued by a licensing or agreement state. 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)(d) Licensing the manufacture and initial distribution of devices to persons generally licensed under s. DHS 157.11 (2) (b). 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: Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 150 mSv (15 rems)
Hands and forearms; feet and ankles; localized
areas of skin averaged over areas no larger than
one square centimeter 2000 mSv (200 rems)
Other organs 500 mSv (50 rems).
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). DHS 157.13(4)(d)2.2. Unless the model, serial number and name of the manufacturer or distributor is specified elsewhere in labelling affixed to the device, the label or labels identified in subd. 1. e. shall also contain one of the following statements, as appropriate, in the same or substantially similar form: DHS 157.13(4)(d)2.a.a. The receipt, possession, use, and transfer of this device, Model , Serial No. , are subject to a general license or the equivalent and the regulations of the NRC or a state with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION — RADIOACTIVE MATERIAL
_________________________________
Name of manufacturer or initial distributor
DHS 157.13(4)(d)2.b.b. The receipt, possession, use, and transfer of this device, Model , Serial No. , are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. CAUTION — RADIOACTIVE MATERIAL
_________________________________
Name of manufacturer or initial distributor
DHS 157.13(4)(d)3.3. If the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the “on-off” mechanism and indicator, if any or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the “on-off” mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the applicant shall submit all of the following information: DHS 157.13(4)(d)3.j.j. Operating experience with identical devices or similarly designed and constructed devices. DHS 157.13(4)(d)4.4. If the applicant desires that the general licensee under s. DHS 157.11 (2) (b) or equivalent regulations of the NRC, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the “on-off” mechanism and indicator or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities and bases for the estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10% of the limits specified in s. DHS 157.22 (1) (a). DHS 157.13(4)(d)5.5. A person licensed under this paragraph to distribute devices to generally licensed persons shall do all the following: DHS 157.13(4)(d)5.a.a. Furnish a copy of the general license contained in ss. DHS 157.11 (2) (b), 157.02, 157.06 (1), 157.13 (18) and 157.32 (1) and (2), notification of the registration requirement contained in 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 penalties for improper disposal under s. DHS 157.90 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 contained in s. DHS 157.11 (2) (b). Section DHS 157.11 (2) (b) 3. b. to 3. d. may be omitted from a copy of the general license, or notification of the registration requirements of s. DHS 157.12 (1) may be omitted if the requirements do not apply to a particular device. 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:
