Header:
WISCONSIN ADMINISTRATIVE CODE
DEPARTMENT OF HEALTH SERVICES
CHAPTER DHS 157. RADIATION PROTECTION
SUBCHAPTER II -- LICENSING OF RADIOACTIVE MATERIAL
Date:
08/31/2009
Document:
DHS 157.13 Specific licenses.
(1) FILING APPLICATION FOR SPECIFIC LICENSES. (a) An application for a specific license shall be filed on a form prescribed by the department.
Note: A specific license application form may be obtained by writing the Department, including a description of the proposed activity to be licensed. The Department's address is: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659; or by downloading from the Department's website at: http://dhs.wisconsin.gov/dph_beh/RadioactiveMat/Index.htm.
(b) The department may at any time after the filing of the original application, and before the expiration of the license, require further statements to enable the department to determine whether the application should be granted or denied or whether a license should be modified, suspended or revoked.
(c) The applicant, licensee or a person authorized to act on behalf of the applicant or licensee shall sign the application.
(d) A license application may include a request for a license authorizing one or more activities.
(e) In the application, the applicant may incorporate by reference information contained in previous applications, statements or reports filed with the department provided such references are clear and specific.
(f) The department shall make applications and documents submitted to the department available for public inspection under ss. 19.32 to 19.39, Stats.
(g) Each application to possess radioactive material in unsealed form, on a foil or plated source, or sealed in glass in excess of the quantities in Appendix P, "Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release", shall contain one of the following:
1. An evaluation showing that the projected dose to a person offsite due to a release of radioactive material would not exceed 0.01 Sievert (1 rem) total effective dose equivalent or 0.05 Sievert (5 rem) to the thyroid.
2. An emergency plan, reviewed and commented on by offsite response organizations expected to respond in the event of an accident, that contains the information described in Appendix Q for responding to any event in which radioactive material could be released from the site.
(h) Each application to use radioactive material in the form of a sealed source or in a device that contains a sealed source shall contain either of the following:
1. Information that identifies the source or device by manufacturer and model number as registered with the NRC or an agreement state.
2. The information identified in 10 CFR 32.210(c).
(i) Each application for a specific license, other than a renewal, shall contain information describing how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning and minimize, to the extent practicable, the generation of radioactive waste.
(j) Each application to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in a consortium authorized for medical use under subch. VI or equivalent NRC or agreement state requirements shall include all the following:
1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued by the department, NRC or an agreement state under this chapter or equivalent regulations for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in sub. (4) (i).
3. Identification of any individual authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in s. DHS 157.68.
4. Information identified in sub. (4) (i) 3. on the PET drugs to be noncommercially transferred to members of a consortium.
(2) GENERAL REQUIREMENTS FOR THE ISSUANCE OF SPECIFIC LICENSES. The department shall approve a license application within 180 working days of filing of a complete application if the department determines that all the following apply:
(a) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested under the requirements of this chapter in a manner that minimizes danger to public health and safety or property.
(b) The applicant's proposed equipment, facilities and procedures are adequate to minimize danger to public health and safety or property.
(c) 1. In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, or for the conduct of any other activity which the department determines will significantly affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values.
2. Commencement of construction prior to the department's conclusion in subd. 1. shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other pre-construction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
(d) The applicant satisfies any applicable requirements in subs. (3), (4) and (6), s. DHS 157.15 and subchs. IV, V and VI.
(e) The applicant pays all applicable fees as specified in s. DHS 157.10.
(f) In the case of an application for a license to possess and use an x-ray fluorescence analyzer (XRF) for the detection of lead in paint or portable gauges using sealed sources, the applicant shall verify that the operator training requirements of Appendix S are met prior to the operator using the device.
(3) SPECIAL REQUIREMENTS FOR SPECIFIC LICENSES OF BROAD SCOPE. (a) This subsection prescribes requirements for the issuance of specific licenses of broad scope for radioactive material and certain regulations governing holders of the licenses.
(b) The different types of broad scope licenses are as follows:
1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range, but may be limited based on types of radioactive materials, proposed use and the training and experience of users.
2. A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Appendix C, for any authorized purpose. The possession limit for a Type B license of broad scope, if only one radionuclide is possessed under the license, is the quantity specified for that radionuclide in Appendix C, Column I. If 2 or more radionuclides are possessed under the license, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Appendix C, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license may not exceed unity.
3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Appendix C, for any authorized purpose. The possession limit for a Type C license of broad scope, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Appendix C, Column II. If 2 or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Appendix C, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license may not exceed unity.
(c) The department shall approve an application for a Type A specific license of broad scope if all the following occurs:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material.
3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, accounting and management review that are necessary to assure safe operations, including all of the following:
a. The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management and persons trained and experienced in the safe use of radioactive material.
b. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection and who is available for advice and assistance on radiation safety matters.
c. The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user and the operating or handling procedures; and review, approval and recording by the radiation safety committee of safety evaluations of proposed uses prior to use of the radioactive material.
(d) The department shall approve an application for a Type B specific license of broad scope if all the following occurs:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, accounting and management review that are necessary to assure safe operations, including all the following:
a. The appointment of a radiation safety officer who is qualified by training and experience in radiation protection and who is available for advice and assistance on radiation safety matters.
b. The establishment of appropriate administrative procedures to assure control of procurement and use of radioactive material; completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user and the operating or handling procedures; and review, approval and recording by the radiation safety officer of safety evaluations of proposed uses prior to use of the radioactive material.
(e) The department shall approve an application for a Type C specific license of broad scope if all the following occurs:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant submits a statement that radioactive material will be used only by or under the direct supervision of individuals who have received all the following:
a. A college degree at the bachelor level in the physical or biological sciences or in engineering or equivalent training and experience.
b. At least 40 hours of training and experience in the safe handling of radioactive material and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used.
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.
(f) A specific license of broad scope is subject to all of the following conditions:
1. Unless specifically authorized, a person licensed under sub. (3) may not do any of the following:
a. Conduct tracer studies in the environment involving direct release of radioactive material.
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.
c. Conduct activities for which a specific license issued by the department under sub. (4) or subch. VI is required.
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.
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.
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.
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).
(4) SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR OR DISTRIBUTE COMMODITIES, PRODUCTS OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL. (a) Licensing the introduction of radioactive material into products in exempt concentrations. 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:
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.
b. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Appendix A of this chapter, that reconcentration of the radioactive material in concentrations exceeding those in 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.
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.
Note: 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.
(b) Licensing the commercial distribution of radioactive material in exempt quantities. 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:
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.
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.
c. The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.
d. Out of state manufacturers of the product hold a license issued by a licensing or agreement state.
2. The license issued under this paragraph is subject to all the following conditions:
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.
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 [mu] Sv (0.5 millirem) per hour.
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".
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.
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.
(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).
(d) Licensing the manufacture and initial distribution of devices to persons generally licensed under s. DHS 157.11 (2) (b). 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:
a. The applicant satisfies the general requirements of sub. (2).
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.
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).
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).
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.
Note: 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.
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.
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).
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:
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
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
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:
a. Primary containment of the source capsule.
b. Protection of primary containment.
c. Method of sealing containment.
d. Containment construction materials.
e. Form of contained radioactive material.
f. Maximum temperature withstood during prototype tests.
g. Maximum pressure withstood during prototype tests.
h. Maximum quantity of contained radioactive material.
i. Radiotoxicity of contained radioactive material.
j. Operating experience with identical devices or similarly designed and constructed devices.
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).
5. A person licensed under this paragraph to distribute devices to generally licensed persons shall do all the following:
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.
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.
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.
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.
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.
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.
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.
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.
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.
(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, 32.101 and 32.110 or their equivalent.
(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, 10 CFR 32.102 and 10 CFR 70.39 or their equivalent.
(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:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The radioactive material is to be prepared for distribution in prepackaged units of one of the following:
a. Carbon-14 in units not exceeding 370 kBq (10 microcuries) each.
b. Cobalt-57 in units not exceeding 370 kBq (10 microcuries) each.
c. Hydrogen-3 in units not exceeding 1.85 MBq (50 microcuries) each.
d. Iodine-125 in units not exceeding 370 kBq (10 microcuries) each.
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.
f. Iodine-131 in units not exceeding 370 kBq (10 microcuries) each.
g. Iron-59 in units not exceeding 740 kBq (20 microcuries) each.
h. Selenium-75 in units not exceeding 370 kBq (10 microcuries) each.
3. Each prepackaged unit bears a durable, clearly visible label that does all the following:
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.
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".
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:
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
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.
Name of manufacturer
5. The label affixed to the unit or the leaflet or brochure that accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source shall also contain directions to the licensee regarding the waste disposal requirements set out in s. DHS 157.30 (1).
(h) Licensing the manufacture and distribution of ice detection devices. The department shall approve an application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under s. DHS 157.11 (2) (g) if all the following applies:
1. The applicant satisfies the general requirements of sub. (2) and ch. 450, Stats.
2. The criteria of 10 CFR 32.61, 32.62, 32.103 and 32.110 are met.
(i) Manufacture, preparation, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium of radioactive drugs containing radioactive material for medical use under subchapter VI. The department shall approve an application for a specific license to manufacture, prepare, or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium drugs containing radioactive material for use by a person authorized under subch. VI if all of the following conditions are satisfied:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant submits evidence that the applicant is at least one of the following:
a. Registered or licensed with the FDA as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug under 21 CFR 207.20 (a).
b. Registered or licensed with a state agency as a drug manufacturer.
c. Licensed as a pharmacy by a state board of pharmacy.
d. Operating as a nuclear pharmacy within a Federal medical institution.
e. Registered with a state agency as a positron emission tomography (PET) drug production facility.
3. The applicant submits all of the following information on the radionuclide:
a. The chemical and physical form of the radiopharmaceutical.
b. The maximum activity per vial, syringe, generator, or other container of the radioactive drug and the shielding provided by the packaging to show medical use licensees that it is safe to handle and store.
4. The applicant satisfies all of the following labeling requirements:
a. A label is affixed to each transport radiation shield, whether the shield is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.
b. A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution or noncommercial transfer to medical use licensees in a consortium. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container may be correlated with the information on the transport radiation shield label.
5. The applicant submits information to demonstrate that individuals who will prepare the radioactive drugs for medical use meet the requirements of s. DHS 157.68.
6. The applicant shall submit information that he or she will do all of the following:
a. Possess and use instrumentation to measure the radioactivity of the drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting drugs prior to transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium.
b. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary.
c. Check each instrument for constancy and proper operation at the beginning of each day of use.
d. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m or strontium-82/rubidium-82 generator, test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to s. DHS 157.63 (3), and retain a record of each measurement under s. DHS 157.71 (14).
7. Nothing in this paragraph relieves a licensee or registrant from complying with applicable FDA, other federal and state requirements governing radioactive drugs.
(j) Manufacture and distribution of sources or devices containing radioactive material for medical use. The department shall approve an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under subch. VI for use as a calibration, transmission or reference source or for the uses listed in ss. DHS 157.65 (1), 157.66 (1), 157.67 (1) and 157.70 if all of the following conditions are satisfied:
1. The applicant satisfies the general requirements in sub. (2).
2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including all of the following:
a. The radioactive material contained, its chemical and physical form and amount.
b. Details of design and construction of the source or device.
c. Procedures for and results of prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents.
d. For devices containing radioactive material, the radiation profile of a prototype device.
e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests.
f. Procedures and standards for calibrating sources and devices.
g. Legend and methods for labeling the radioactive content of sources and devices.
h. Instructions for handling and storing the source or device from the radiation safety standpoint. The instructions shall be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions that are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.
3. The label affixed to the source or device or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the department for distribution to persons licensed under subch. VI and s. DHS 157.62 (4) or under equivalent licenses of the NRC, an agreement state or a licensing state.
4. If the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source. In determining the acceptable interval for the test for leakage of radioactive material, the applicant shall submit all of the following information:
a. Primary containment of the source capsule.
b. Protection of primary containment.
c. Method of sealing containment.
d. Containment construction materials.
e. Form of contained radioactive material.
f. Maximum temperature withstood during prototype tests.
g. Maximum pressure withstood during prototype tests.
h. Maximum quantity of contained radioactive material.
i. Radiotoxicity of contained radioactive material.
j. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.
(k) Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications. 1. The department shall approve an application for a specific license to manufacture industrial products and devices containing depleted uranium for use under s. DHS 157.11 (1) (c) or equivalent regulations of the NRC or an agreement state under the following conditions:
a. The applicant satisfies the general requirements specified in sub. (2).
b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one year a radiation dose in excess of 10% of the annual limits specified in s. DHS 157.22 (1).
c. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
2. In the case of an industrial product or device whose unique benefits are questionable, the department shall approve an application for a specific license under this paragraph only if the department determines that the product or device combines a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
3. The department may deny any application for a specific license under this paragraph if the end use or uses of the industrial product or device cannot be reasonably foreseen.
4. A person licensed under subd. 1. shall do all of the following:
a. Maintain the level of quality control required by the license in the manufacture of the industrial product or device and in the installation of the depleted uranium into the product or device.
b. Label or mark each unit to identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium and the quantity of depleted uranium in each product or device; and state that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the NRC or an agreement state.
c. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium".
d. Furnish a copy of the general license contained in s. DHS 157.11 (1) (c) and a copy of the "Certificate -- Use of Depleted Uranium Under General License" to each person to whom he or she transfers depleted uranium in a product or device; or furnish a copy of the general license contained in the NRC's or agreement state's regulation equivalent to s. DHS 157.11 (1) (c) and a copy of the NRC's or agreement state's certificate with a note explaining that use of the product or device is regulated by the NRC or an agreement state under requirements substantially the same as those in s. DHS 157.11 (1) (c).
e. Report to the department all transfers of industrial products or devices to persons for use under the general license in s. DHS 157.11 (1) (c). 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 of depleted uranium contained in the product or device. The report shall be filed with the department within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under s. DHS 157.11 (1) (c) during the reporting period, the report shall so indicate.
f. Report to the NRC all transfers of industrial products or devices to persons for use under the NRC general license in 10 CFR 40.25.
g. 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 (1) (c).
h. The report required in subd. 4. f. and g. shall identify each general licensee by name and address, an individual by name and position who may constitute a point of contact between the department and the general licensee, the type and model number of the device transferred and the quantity of depleted uranium contained in the product or device. The report shall be filed with the department within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.
i. If no transfers have been made to NRC licensees during the reporting period, the report shall so indicate.
j. If no transfers have been made to general licensees within this state or another particular agreement state during the reporting period, this information shall be reported to the department or the responsible agency in another agreement state, upon the request of that agency.
k. Keep records showing the name, address and point of contact for each general licensee to whom he or she transfers depleted uranium in industrial products or devices for use under the general license provided in s. DHS 157.11 (1) (c) or equivalent regulations of the NRC or an agreement state. The records shall be maintained for a period of 3 years from the date of each transfer respectively and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred and compliance with the report requirements of this section.
(5) SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE FOR MEDICAL USE OF RADIOACTIVE MATERIAL. (a) License application. The department shall approve an application for a specific license for medical use of radioactive material if all of the following conditions are satisfied:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant submits procedures required by s. DHS 157.67, as applicable.
3. In addition to the requirements in this paragraph and par. (b), an application for a license or amendment for medical use of radioactive material as described in s. DHS 157.70 shall also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in ss. DHS 157.59 to 157.62, as well as any specific information on each of the following:
a. Radiation safety precautions and instructions.
b. Training and experience of proposed users.
c. Methodology for measurement of dosages or doses to be administered to patients or human research subjects.
d. Calibration, maintenance and repair of instruments and equipment necessary for radiation safety.
4. An applicant for a license for mobile services shall assure that release of individuals or human research subjects to whom radioactive drugs or implants containing radioactive material are administered will be released under s. DHS 157.62 (8).
5. The applicant or licensee shall provide any other information requested by the department in its review of the application.
(b) License amendment. An application for a license amendment shall meet all of the following requirements:
1. A licensee shall apply for and must receive a license amendment before the licensee does any of the following:
a. Receives or uses radioactive material for a type of use that is permitted under this subchapter, but that is not authorized on the licensee's current license issued under this subchapter.
b. Permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except an individual who is certified by a specialty board appropriate to the intended use of radioactive material and recognized by the NRC; or is named as an authorized user, authorized nuclear pharmacist or authorized medical physicist on a department, NRC or other agreement state license, or on a permit issued by a licensee who is authorized by a Type A license of broad scope to permit the medical use of radioactive material.
c. Changes radiation safety officers, except as provided in s. DHS 157.61 (1) (c).
d. Receives radioactive material in excess of the amount or in a different form or receives a different radionuclide than is authorized on the license
e. Adds to or changes the areas identified in the application or on the license, except for areas where radioactive material is used only under s. DHS 157.63 (1) and (2).
f. Changes the address or addresses of use identified in the application or on the license.
2. An application for a license amendment shall include procedures required by s. DHS 157.67, as applicable.
(c) Notifications. A licensee shall make all of the following notifications:
1. Provide to the department a copy of the board certification and the written attestation, signed by a preceptor, the NRC or agreement state license or the permit issued by a licensee of broad scope for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist or an authorized medical physicist under par. (b) 1. b. For individuals permitted to work under par. (b) 1. b., within the same 30 day time frame, the licensee shall also provide, as appropriate, verification of completion of all the following:
a. Any additional case experience required in s. DHS 157.64 (4) (b) 2. g. for an authorized user under s. DHS 157.64 (1).
b. Training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization as an authorized user under s. DHS 157.67 (1).
c. Training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization as an authorized medical physicist.
2. Notify the department in writing no later than 30 days after any of the following occurs:
a. An authorized user, an authorized nuclear pharmacist, a radiation safety officer or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change.
b. The licensee's mailing address changes.
c. The licensee's name changes but the name change does not constitute a transfer of control of the license.
d. The licensee has added to or changed the areas where radioactive material is used under s. DHS 157.63 (1) and (2).
(d) Exemptions for Type A broad scope licensees. 1. A licensee possessing a Type A specific license of broad scope for medical use is exempt from all of the following requirements:
a. The provisions of par. (a) 3. regarding the need to file an amendment to the license for medical uses of radioactive material as described in s. DHS 157.70.
b. The provisions of par. (b) 1. b.
c. The provisions of par. (b) 1. e. regarding additions to or changes in the areas of use only at the addresses specified in the license.
d. The provisions of par. (c) 1.
e. The provisions of par. (c) 2. a. for an authorized user, an authorized nuclear pharmacist or an authorized medical physicist.
f. The provisions of s. DHS 157.61 (6) (a).
(6) SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO CONDUCT INDUSTRIAL RADIOGRAPHY OPERATIONS. The department shall approve an application for a specific license to conduct radiography using radioactive materials if all the following conditions are satisfied:
(a) The applicant satisfies the general requirements specified in sub. (2).
(b) The applicant has an adequate program for training radiographers and radiographer's assistants that meets the requirements of s. DHS 157.44 (3).
(c) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
(d) The applicant submits written operating and emergency procedures that meet the requirements of s. DHS 157.44 (4).
(e) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed 6 months that meets the requirements of s. DHS 157.44 (3) (e).
(f) The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility.
(g) The applicant submits the qualifications of the individual designated as the radiation safety officer.
(h) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium shielding, the applicant shall describe the procedures for performing the test. The description shall include all of the following:
1. Methods of collecting the samples.
2. Qualifications of the individual who analyzes the samples.
3. Instruments to be used.
4. Methods of analyzing the samples.
(i) The applicant verifies that calibration of survey meters and alarming rate meters is performed according to the requirements of ss. DHS 157.38 and 157.44 (6) (g) 4., respectively.
(j) The applicant identifies and describes the location or locations of all field stations and permanent radiographic installations.
(k) The applicant identifies the location or locations where all records required by this and other subchapters will be maintained.
(L) If a license application includes underwater radiography, a description of all of the following:
1. Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography.
2. Radiographic equipment and radiation safety equipment unique to underwater radiography.
3. Methods for gas-tight encapsulation of equipment.
(m) If an application includes offshore platform or lay-barge radiography, a description of all of the following:
1. Transport procedures for radioactive material to be used in industrial radiographic operations.
2. Storage facilities for radioactive material.
3. Methods for restricting access to radiation areas.
(n) The applicant describes the program for inspection and maintenance of radiographic exposure devices and storage containers to ensure proper functioning of components important to safety.
(7) SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO CONDUCT IRRADIATOR OPERATIONS. (a) The department shall approve an application for a specific license for the use of radioactive material in an irradiator if all the following conditions are satisfied:
1. The applicant satisfies the general requirements in sub. (2).
2. The applicant submits an adequate program for training irradiator operators that includes all of the following:
a. Classroom training.
b. On-the-job or simulator training.
c. Safety reviews.
d. The method employed by the applicant to test each operator's understanding of the department's regulations and licensing requirements and the irradiator operating, safety and emergency procedures.
e. Minimum training and experience of personnel who may provide training.
3. The applicant submits an outline of the written operating and emergency procedures that describes the radiation safety aspects of the procedures.
4. The applicant submits a description of the overall organizational structure for managing the irradiator, including the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have radiation safety responsibilities or authorities, and who within the management structure has the authority to stop unsafe operations. The applicant shall also describe the training and experience required for the position of radiation safety officer.
5. The applicant includes a description of the access control systems required by s. DHS 157.73 (2), radiation monitors required by s. DHS 157.73 (5), the method of detecting leaking sources required by s. DHS 157.73 (16) including the sensitivity of the method and a diagram of the facility showing the locations of all required interlocks and radiation monitors.
6. If the applicant intends to perform leak testing, the applicant shall establish procedures for performing leak testing of dry-source-storage sealed sources and submit a description of these procedures to the department. The description shall include all the following:
a. Methods of collecting the leak test samples.
b. Qualifications of the individual who collects the samples.
c. Instruments to be used.
d. Methods of analyzing the samples.
7. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall only be done by a person specifically authorized by the department, the NRC or another agreement state to load or unload irradiator sources. The information in this subdivision shall also be indicated on the application.
8. The applicant describes the inspection and maintenance checks, including the frequency of the checks required by s. DHS 157.73 (17).
(b) A license issued under par. (a) is subject to all of the following conditions:
1. The applicant may not begin construction of a new irradiator prior to the submission to the department of both an application for a specific license for the irradiator and the fee required by s. DHS 157.10 (3). As used in this section, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site, but does not include engineering and other design work, purchase of a site, site surveys or soil testing, site preparation, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license by the department.
2. Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this subsection. The department shall approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates the likely provision of an adequate level of safety for workers and the public.
3. Each license will be issued with the condition that the licensee will, at any time before expiration of the license, upon the department's request, submit a written statement to enable the department to determine whether the license should be modified, suspended or revoked.
(8) SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO CONDUCT WELL LOGGING. The department shall approve an application for a specific license for the use of radioactive material in well logging if all the following conditions are satisfied:
(a) The applicant satisfies the general requirements specified in sub. (2).
(b) The applicant submits an adequate program for training well logging supervisors and well logging assistants that includes all the following:
1. Initial training.
2. On-the-job training.
3. Annual safety reviews provided by the licensee.
4. Means by which the applicant will demonstrate the well logging supervisor's knowledge and understanding of and ability to comply with the department's rules and licensing requirements and the applicant's operating and emergency procedures.
5. Means by which the applicant will demonstrate the well logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.
(c) The applicant submits to the department written operating and emergency procedures as described in s. DHS 157.53 (2) or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.
(d) The applicant establishes and submits to the department the applicant's program for annual inspections of the job performance of each well logging supervisor to ensure that the department's rules, license requirements, and the applicant's operating and emergency procedures are followed. The applicant's inspection records shall be retained for 3 years after each annual internal inspection.
(e) The applicant submits a description of its overall organizational structure as it applies to the radiation safety responsibilities in wire-line services or subsurface tracer studies, including specified delegations of authority and responsibility.
(f) If an applicant wants to perform leak testing of sealed sources, the applicant identifies the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant establishes procedures to be followed and submits a description of these procedures to the department. The description shall include all the following:
1. Instruments to be used.
2. Methods of performing the analysis.
3. Pertinent experience of the person who will analyze the wipe samples.
(9) ISSUANCE OF SPECIFIC LICENSES. (a) If the department determines that an application meets the applicable requirements, the department shall issue a specific license within 180 days of filing of a complete application authorizing the proposed activity in such form and containing such conditions and limitations as the department deems appropriate or necessary.
(b) The department may incorporate in any license at the time of issuance or thereafter, any additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material subject to this section as the department deems appropriate or necessary.
(10) SPECIFIC TERMS AND CONDITIONS OF LICENSES. (a) A license issued under this section shall be subject to all the provisions of ss. 254.31 to 254.45, Stats., this chapter and orders of the department.
(b) No license issued or granted under this section and no right to possess or utilize radioactive material granted by any license issued under this subsection may be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the department, after securing full information, finds that the transfer complies with the applicable provisions of the statutes, rules and orders of the department, and gives its consent in writing.
(c) A person licensed by the department under this section shall confine use and possession of the material licensed to the locations and purposes authorized in the license.
(e) A licensee shall notify the department in writing within 10 days following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 of the United States Code by or against any one of the following:
1. The licensee.
2. An entity defined in 11 USC 101(14) controlling the licensee or listing the license or licensee as property of the estate.
3. An affiliate defined in 11 USC 101(2) of the licensee.
Note: Title 11 of the U.S. Code deals with bankruptcy.
(f) The notification specified in par. (e) shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.
(11) EXPIRATION AND TERMINATION OF LICENSES AND DECOMMISSIONING OF SITES AND SEPARATE BUILDING OR OUTDOOR AREAS. (a) Except as provided in sub. (12) (b), a specific license shall expire at the end of the specified day in the month and year stated in the license. If an application for license renewal has been filed at least 30 days prior to the expiration date stated in the existing license and the department denies the renewal application, the license shall expire on the date as stated in the determination of denial. If an application for license renewal is filed less than 30 days from the expiration date stated in the existing license, the department may deny the renewal application and the license shall expire on the expiration date stated in the license.
(b) A specific license revoked by the department expires at the end of the day on the date of the department's final determination, or on the expiration date stated in the determination, or as otherwise provided by department order.
(c) A specific license remains valid, with respect to possession of radioactive material, until the department notifies the licensee in writing that the license is terminated. While the license is valid, the licensee shall do all of the following:
1. Limit actions involving radioactive material to those related to decommissioning and other activities related to preparation for release for unrestricted use.
2. Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the department notifies the licensee in writing that the license is terminated.
(d) A licensee shall do all of the following:
1. Notify the department within 60 days of any of the following:
a. Expiration of the license pursuant to par. (a) or (b).
b. The licensee's deciding to permanently cease principal activities at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with department requirements.
c. The absence of conduct of any principal activities under the license for a period of 24 months.
d. The absence of conduct of any principal activities for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with department requirements.
2. If any separate building or outdoor area contains stored radioactive material or residual radioactivity so that the building or outdoor area is unsuitable for release, do one of the following:
a. Begin decommissioning its site, separate building or outdoor area if a decommissioning plan has been previously approved by the department.
b. Submit a decommissioning plan within 12 months if required by par. (f) and begin decommissioning upon approval of that plan.
(e) Concurrent with the notification required by par. (d), the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to s. DHS 157.15 in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance shall be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to par. (f) 4. Following approval of the decommissioning plan and with the department's approval, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site.
(f) A licensee shall submit a decommissioning plan to the department if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site, separate building or outdoor area have not been previously approved by the department and the procedures and activities may adversely effect the health and safety of workers or the public. The procedures may not be carried out prior to the department's approval of the decommissioning plan. Examples of applicable procedures and activities include any of the following cases:
1. Procedures that would involve techniques not applied routinely during cleanup or maintenance operations.
2. Procedures by which workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation.
3. Procedures that could result in significantly greater airborne concentrations of radioactive materials than are present during operation.
4. Procedures that could result in significantly greater releases of radioactive material to the environment than those associated with operation.
(g) The department may approve an alternate schedule for submittal of a decommissioning plan required pursuant to par. (d) if the department determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.
(h) The proposed decommissioning plan for the site or separate building or outdoor area shall include all of the following elements:
1. A description of the conditions of the site, separate building or outdoor area sufficient to evaluate the acceptability of the plan.
2. A description of planned decommissioning activities.
3. A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning.
4. A description of the planned final radiation survey.
5. An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.
6. For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, a justification for the delay based on the criteria in par. (i).
(i) The department shall approve the proposed decommissioning plan if the information in the plan demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be ensured.
(j) Except as provided in par. (h), a licensee shall complete decommissioning of the site or separate building or outdoor area no later than 24 months following the initiation of decommissioning. When decommissioning involves the entire site, a licensee shall request license termination no later than 24 months following the initiation of decommissioning.
(k) The department may approve a request for an alternative schedule for completion of decommissioning of the site, separate building or outdoor area, and license termination if appropriate, if the department determines that the alternative is warranted after consideration of all the following:
1. Whether it is technically feasible to complete decommissioning within the allotted 24-month period.
2. Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period.
3. Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay.
4. Whether a significant reduction in radiation exposure to workers may be achieved by allowing short-lived radionuclides to decay.
5. Other site-specific factors which the department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, court decisions, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
(L) As the final step in decommissioning, a licensee shall do all the following:
1. Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed department form for disposition of radioactive materials or equivalent information.
Note: The form may be obtained by writing the Department at: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison WI 53701-2659; or by downloading from the Department website at: http://dhs.wisconsin.gov/dph_beh/RadiatioP/Index.htm.
2. Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in s. DHS 157.33.
3. Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels per 100 square centimeters, disintegrations per minute per 100 square centimeters or microcuries per 100 square centimeters -- removable and fixed -- for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete.
4. Specify the survey instruments used and certify that each instrument is properly calibrated and tested.
Note: Submit reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
(m) The department shall terminate a specific license, including an expired license, by written notice to the licensee when the department determines all of the following have occurred:
1. Radioactive material has been properly disposed of.
2. Reasonable effort has been made to eliminate residual radioactive contamination, if present.
3. The licensee has filed with the department sufficient information, including a radiation survey, to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in s. DHS 157.33.
4. The licensee has submitted records required under s. DHS 157.13 (18) (b) and (d) to the department.
(12) RENEWAL OF LICENSES. (a) An application for renewal of a specific license shall be filed under sub. (1).
(b) If a licensee, not less than 30 days prior to expiration of his or her existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, the license may not expire until final action by the department.
Note: A license renewal 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/dph_beh/RadiatioP/Index.htm.
(13) AMENDMENT OF LICENSES AT REQUEST OF LICENSEE. An application for amendment of a license shall be filed under sub. (1) and shall specify the respects in which the licensee desires the license to be amended and the grounds for the amendment. The licensee shall include the appropriate fee specified in s. DHS 157.10 (3) with the amendment application.
Note: A specific license application form is not required for an amendment request.
(14) DEPARTMENT ACTION ON APPLICATIONS TO RENEW OR AMEND. In considering an application by a licensee to renew or amend the license, the department shall apply the criteria set forth in subs. (2), (3) and (4) and in subchs. IV, V and VI, as applicable.
(15) TRANSFER OF MATERIAL. (a) No licensee may transfer radioactive material except as authorized under this subsection.
(b) Except as otherwise provided in its license and subject to the provisions of pars. (c) and (d), a licensee may transfer radioactive material to any of the following:
1. The department only after receiving prior approval from the department.
2. The U.S. department of energy.
3. Any person exempt from these regulations to the extent permitted under the exemption.
4. Any person authorized to receive radioactive material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the department, the NRC, any agreement state, any licensing state or to any person otherwise authorized to receive radioactive material by the federal government or any agency thereof, the department, an agreement state or a licensing state.
5. Any person as otherwise authorized by the department in writing.
6. The agency in another state that regulates radioactive material under 42 USC 5801.
(c) Before transferring radioactive material to a specific licensee of the department, the NRC, an agreement state or a licensing state, or to a general licensee who is required to register with the department, the NRC, an agreement state or a licensing state prior to receipt of the radioactive material, a licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form and quantity of radioactive material to be transferred.
(d) A licensee transferring radioactive materials as described in par. (c) may use any of the following methods for verification:
1. The transferor may possess and read a copy of the transferee's specific license or registration certificate that is currently in force.
2. The transferor may possess a written statement, from the transferee, certifying that the transferee is authorized by license or registration certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date.
3. For emergency shipments, the transferor may accept an oral statement by the transferee that the transferee is authorized by license or registration certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date; provided that the oral statement is confirmed in writing within 10 days.
4. The transferor may obtain other information compiled by a reporting service from official records of the department, the NRC, an agreement state or a licensing state regarding the identity of licensees and the scope and expiration dates of licenses and registration.
5. When none of the methods of verification described in subds. 1. to 4. are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the department, the NRC, an agreement state or a licensing state that the transferee is licensed to receive the radioactive material.
(e) Shipment and transport of radioactive material shall be under the provisions of subch. XIII.
(16) MODIFICATION, SUSPENSION AND REVOCATION OF LICENSES. (a) The terms and conditions of a license shall be subject to amendment, revision or modification by the department. The department may suspend, revoke or modify the license due to amendments to ss. 254.31 to 254.45, Stats., this chapter or orders issued by the department.
(b) The department may revoke, suspend or modify any license or reciprocal recognition of an out-of-state license, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of ss. 254.31 to 254.45, Stats., or because of conditions revealed by such application or statement of fact or any report, record or inspection or other means which would warrant the department to refuse to grant a license on an original application or for violation of or failure to observe any of the terms and conditions of ss. 254.31 to 254.45, Stats., this chapter or orders issued by the department or voluntary application for amendment, revision or modification submitted by the licensee.
(c) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, the department may not modify, suspend or revoke a license unless, prior to such action, the department notifies the licensee, in writing, of the facts or conduct that warrant the action and the licensee has been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.
(d) A person who considers himself or herself affected by a department denial of license application or amendment, license revocation, or license suspension may submit to the department a written request for hearing about the license action. A written request for hearing on a license action shall be received by the department within 10 days after receipt of a notice of the department's decision to deny license application or renewal or revoke or suspend a license. The hearing request shall include the information required in s. DHS 157.90 (3).
Note: Hearing requests shall be sent to: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison, WI 53701-2659. Certified mail may be sent to: Department of Health Services, Radiation Protection Section, 1 West Wilson St, Room 150, Madison, WI 53702-0007.
(17) EVENT REPORTING. (a) Events that must be reported immediately. A licensee shall notify the department by telephone as soon as possible but not later than 4 hours after the discovery of an event, such as a fire, explosion or toxic gas release, which prevents immediate protective actions necessary to avoid exposures to radiation, radioactive materials or releases of licensed radioactive material that could exceed regulatory limits established in this chapter.
(b) Events that must be reported within 24 hours. A licensee shall notify the department within 24 hours by telephone, facsimile, or in person after the discovery of any of the following events involving licensed material:
1. An unplanned contamination event that meets all of the following criteria:
a. Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area.
b. Involves a quantity of material greater than 5 times the lowest annual limit on intake specified in Appendix E for the material.
c. Restricts access to the area for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
2. An event in which equipment is disabled or fails to function as designed under any of the following circumstances:
a. The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident.
b. The equipment is required to be available and operable when it is disabled or fails to function.
c. No redundant equipment is available and operable to perform the required safety function.
3. An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.
4. A fire or explosion damaging any licensed material or any device, container or equipment containing licensed material under any of the following circumstances:
a. The quantity of material involved is greater than 5 times the lowest annual limit on intake specified in Appendix E for the material limits.
b. The damage affects the integrity of the licensed material or its container.
Note: Submit report to the Department via telephone at (608) 267-4797 or via facsimile at (608) 267-3695.
(c) Content and submission of reports. 1. Reports required to be submitted to the department under pars. (a) and (b) shall, to the extent that the information is available, include all the following information:
a. The caller's name and call back telephone number.
b. A description of the event, including the date and time of its occurrence.
c. The exact location of the event.
d. The isotopes, quantities, and chemical and physical form of the licensed material involved in the event.
e. Any personnel radiation exposure data available.
2. A licensee who makes a report required by par. (a) or (b) shall submit a written report within 30 days of the initial telephone or facsimile report containing all of the following information:
a. A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned.
b. The exact location of the event.
c. The isotopes, quantities, and chemical and physical form of the licensed material involved.
d. The date and time of the event.
e. Corrective actions taken or planned and the results of any evaluations or assessments.
f. The extent to which individuals were exposed to radiation or to radioactive materials without identification of individuals by name.
Note: Submit written reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
(18) RECEIPT, TRANSFER AND DISPOSAL RECORDS. (a) Record retention. A licensee shall retain records required by s. DHS 157.06 (1) or by license condition. If a retention period is not otherwise specified by this chapter or license condition, the record shall be retained until the department terminates each license.
(b) Transfer of records to the department. Prior to license termination, a licensee authorized to possess radioactive material, in an unsealed form, with a half-life greater than 120 days, shall forward to the department all records of disposal of licensed material made under s. DHS 157.30 (2) to (5), including burials authorized before January 28, 1981, and the results of measurements and calculations required by s. DHS 157.31 (3).
(c) Transfer of records to new licensee. 1. If licensed activities are transferred or assigned in accordance with s. DHS 157.13 (10) (b), each licensee authorized to possess radioactive material in unsealed form, with a half-life greater than 120 days, shall transfer the following records to the new licensee:
a. Records of disposal of licensed material made under s. DHS 157.30 (2) to (5), including burials authorized before January 28, 1981.
b. Records of the results of measurements and calculations required by s. DHS 157.31 (3).
2. The new licensee shall be responsible for maintaining the records required in subd. 1. until the license is terminated.
(d) Transfer of records of decommissioning activities. A licensee shall forward the records required by s. DHS 157.15 (7) to the department prior to license termination.
(19) SERIALIZATION OF NATIONALLY TRACKED SOURCES. A licensee who manufactures a nationally tracked source shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.
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