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Application for a Radioactive Material License for Academic ...

By Lillian Ray,2014-06-01 07:51
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Application for a Radioactive Material License for Academic ...

DEPARTMENT OF HEALTH SERVICES STATE OF WISCONSIN Division of Public Health F-45016 (Rev. 05/11)

    APPLICATION FOR A RADIOACTIVE MATERIAL LICENSE

    FOR ACADEMIC, RESEARCH AND DEVELOPMENT AND OTHER LICENSES OF

    LIMITED SCOPE

    The Wisconsin Department of Health Services is requesting disclosure of information for obtaining a radioactive material license. Failure

    to provide any information may result in denial or delay of a radioactive material license.

    Instructions Complete all items. Refer to WISREG „Guidance for Academic, Research and Development and Other Licenses of Limited Scope‟. Use supplementary sheets where necessary. Retain one copy and submit original of the entire application to the State of Wisconsin, Department of Health Services (DHS), P.O. Box 2659, Madison WI 53701-2659.

    APPLICATION TYPE

    Item 1 Type Of Application (Check one box )

     New License Renewal License Number

    CONTACT INFORMATION

    Item 2 Name And Mailing Address Of Applicant: Item 3 Person To Contact Regarding Application:

     , -

    Applicant‟s Telephone Number (Include area code): Contact‟s Telephone Number (Include area code): ( ) - x ( ) - x

    LOCATION OF RADIOACTIVE MATERIAL

    Item 4 Address(es) Where Radioactive Material Will Be Used Or Possessed (Do not use Post Office Box) Address Telephone Number (Include area code)

     ( ) - x

     , -

    Address Telephone Number (Include area code)

     ( ) - x

     , -

    Address Telephone Number (Include area code)

     ( ) - x

     , -

    Is radioactive material used at locations for field studies or other off-site locations? Yes No If yes, please attach an additional sheet(s) with the locations (addresses) and a list of activities to be conducted at each location. RADIATION SAFETY OFFICER

    Item 5 Radiation Safety Officer (RSO) (Check boxes)

     The name of the proposed RSO and other potential designees who will be responsible for ensuring that the licensee‟s radiation

    safety program is implemented in accordance with approved procedures.

    TELEPHONE NUMBER ( ) - x NAME (Include area code)

    AND

     We will provide information demonstrating that the proposed RSO is qualified by training and experience.

    F-45016 (Rev. 05/11) Page 2 of 5 AUTHORIZED USERS AND TRAINING

    Item 6 Authorized Users (Check both boxes)

     We will attach a list of each proposed authorized user with the types and quantities of licensed material to be used. AND

     Information is attached demonstrating that each proposed authorized user is qualified by training and experience to use the

    requested licensed material.

    Item 7 Training For Individuals Working In Or Frequenting Restricted Areas (Check box)

     A description of the radiation safety training program, including topics covered, groups of workers, assessment of training,

    qualifications of instructors and the method and frequency of training is attached.

    RADIOACTIVE MATERIAL

    Item 8 Radioactive Material (Attach additional pages if necessary)

    UNSEALED SOURCES

    Radioisotope Chemical/Physical Form Maximum Possession Limit Proposed Use

SEALED SOURCES

    Radioisotope Chemical/Physical Form SEALED SOURCE SEALED SOURCE SEALED SOURCE SEALED SOURCE Sealed Source Manufacturer or Distributor and Model Number

    Device Manufacturer or Distributor and Model Number

    Sealed Source & Device Registration Sheet Number

    Maximum Possession Limit Proposed Use

F-45016 (Rev. 05/11) Page 3 of 5

    FACILITIES AND EQUIPMENT

    Item 9 Facilities And Equipment (Check all that apply)

     A description is provided of the facilities and equipment at each location where radioactive material will be used. Diagrams should

    be drawn to a specified scale, or dimensions should be indicated. For facilities where it is anticipated that more than one laboratory

    or room may be used, a generic laboratory or room diagram may be submitted. (Diagrams are attached)

    NOTE: See Appendix K of WISREG „Guidance for Academic, Research and Development and Other Licenses of Limited Scope‟. AND

     A description showing the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to

    radiation safety is provided.

    AND IF APPLICABLE

     For animal use, a description is provided of the facilities and equipment at each location where radioactive material will be used.

    Diagrams should be drawn to a specified scale, or dimensions should be indicated. For facilities where it is anticipated that more

    than one laboratory or room may be used, a generic laboratory or room diagram may be submitted. (Diagrams are attached) NOTE: See Appendices K and H of WISREG „Guidance For Academic, Research and Development and Other Licenses of

    Limited Scope‟. AND IF APPLICABLE

     For radioactive materials that may become airborne, diagrams contain schematic descriptions of the ventilation systems, with

    pertinent airflow rates, pressures, filtration equipment, and monitoring systems. (Diagrams are attached)

    RADIATION SAFETY PROGRAM

    Item 10.1 Audit Program The applicant is not required to submit its audit program to DHS for review during the licensing process. This matter will be

    examined during an inspection.

    Item 10.2 Radiation Monitoring Instruments (Check one box)

     We will use instruments that meet the radiation monitoring instruments specifications published in Appendix M of WISREG

    „Guidance for Academic, Research and Development and Other Licenses of Limited Scope‟. We reserve the right to upgrade our

    survey instruments as necessary. OR

     We will use instruments that meet the radiation monitoring instrument specifications published in Appendix M of WISREG „Guidance

    for Academic, Research and Development and Other License of Limited Scope‟. Additionally we will implement the survey meter

    calibration program published in Appendix M of WISREG „Guidance for Academic, Research and Development and Other License

    of Limited Scope‟. We reserve the right to upgrade our survey instruments as necessary. OR

     We will provide a description of alternative equipment and/or procedures for ensuring that appropriate radiation monitoring

    equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be

    performed. We reserve the right to upgrade our survey instruments as necessary. (Procedures are attached)

    Item 10.3 Material Receipt And Accountability (Check all that apply) UNSEALED SOURCES

     We will submit procedure(s) for ensuring radioactive material accountability.

SEALED SOURCES

     We will conduct physical inventories at intervals not to exceed 6 months, to account for all sealed sources and devices received and

    possessed under the license. OR

     We will submit a description of the frequency and procedures for ensuring that no sealed sources have been lost, stolen or

    misplaced. (Description is attached)

F-45016 (Rev. 05/11) Page 4 of 5

    Item 10.4 Occupational Dose (Check all that apply) For external dosimetry,

     We will maintain, for inspection by DHS, documentation demonstrating that unmonitored individuals are not likely to receive, in one

    year, a radiation dose in excess of 10 percent of the allowable limits in s. DHS 157.22. OR

     We will provide dosimetry processed and evaluated by a NVLAP-approved processor that is exchanged at a frequency

    recommended by the processor.

    IF UNSEALED SOURCES ARE USED

    For internal dosimetry,

     We will maintain, for inspection by DHS, documentation demonstrating that unmonitored individuals are not likely to receive, in one

    year, a radiation dose in excess of 10 percent of the allowable limits in s. DHS 157.22. OR

     We will submit procedures for performing bioassays of individuals who are likely to receive, in one year, a radiation dose in excess of

    10 percent of the allowable limits in s. DHS 157.22.

    Item 10.5 Public Dose No response is required in this license application, however the licensee‟s evaluation of public dose will be examined during an

    inspection.

    Item 10.6 Safe Use of Radionuclides and Emergency Procedures (Check all that apply)

     We will develop, implement and maintain safe use of radionuclides and emergency procedures that will meet the criteria in the

    section titled „Safe Use of Radionuclides and Emergency Procedures‟ in WISREG „Guidance for Academic, Research and

    Development and Other Licenses of Limited Scope‟. (Procedures are attached) AND IF APPLICABLE

     For Gas Chromatographs, we will submit the information requested in Appendix D of WISREG „Guidance for Academic, Research

    and Development and Other Licenses of Limited Scope‟. (Information is attached) AND IF APPLICABLE

     For use of radionuclides in animals, we will develop, implement and maintain safe use of radionuclides and emergency procedures

    that will meet the criteria in the section titled „Safe Use of Radionuclides and Emergency Procedures‟ in WISREG Guidance for

    Academic, Research and Development and Other Licenses of Limited Scope‟. (Procedures are attached)

    Note: See Appendix H „Considerations for Lab Animals and Veterinary Medical Use‟ of WISREG „Guidance for Academic,

    Research and Development and Other Licenses of Limited Scope‟ for additional information.

    Item 10.7 Surveys (Check all that apply)

     We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels

    published in Appendix Q of WISREG „Guidance for Academic, Research and Development and Other Licenses of Limited Scope‟. IF SEALED SOURCES ARE USED

     Leak tests will be performed by an organization authorized by DHS, the NRC or an Agreement State to provide leak testing services

    to other licensees; or by using a leak test kit supplied by an organization licensed by DHS, the NRC or an Agreement State to

    provide leak test kits to other licensees according to kit supplier‟s instructions. List the name and license number of organization authorized to perform or analyze leak test (Specify whether DHS, NRC, or other

    Agreement State):

    Organization Name License Number Issuing Agency

     Note: An alternate organization may be used to perform or analyze leak tests, without amending the license, provided the

    organization is specifically authorized by DHS, NRC or an Agreement State. OR

     We will perform leak testing and sample analysis and will follow the procedures published in Appendix R of WISREG „Guidance for

    Academic, Research and Development and Other Licenses of Limited Scope‟. OR

     We will submit alternative procedures. (Procedures are attached)

    Item 10.8 Transportation

    No response is needed during the license process; this issue will be reviewed during inspection.

    F-45016 (Rev. 05/11) Page 5 of 5 Item 10.9 Minimization of Contamination No response is required if applicant meets the criteria in the following sections: „Unsealed and/or Sealed Sources‟, „Facilities and

    Equipment‟, Safe use of Radioisotopes and Emergency Procedures‟, „Surveys‟, and „Waste Management‟.

     Item 10.10 Termination Of Activities No response is required from the applicant during the application process. Refer to section titled „Termination of Activities‟ in

    WISREG „Guidance for Academic Research and Development and Other License of Limited Scope‟.

    WASTE MANAGEMENT

    Item 11 Waste Management (Check all that apply)

     We will follow the model waste procedures published in Appendix T of WISREG Guidance for Academic, Research and

    Development and Other Licenses of Limited Scope. OR

     We will follow: Decay-In-Storage or Disposal of Liquids Into Sanitary Sewerage waste procedures that

    are published in Appendix T of WISREG „Guidance for Academic, Research and Development and Other Licenses of Limited

    Scope‟. OR

     We will develop, implement and maintain procedures for waste collection, storage and disposal by any of the authorized methods

    described in Item 11 „Waste Management‟ of WISREG „Guidance for Academic, Research and Development and Other Licenses of

    Limited Scope‟. We will contact DHS for guidance to obtain approval of any method(s) of waste disposal other than those discussed

    in Item 11 „Waste Management‟ of WISREG „Guidance for Academic, Research and Development and Other Licenses of Limited

    Scope‟. (Procedures are attached) AND IF APPLICABLE

     If access to a radioactive waste burial site is unavailable, we will request authorization for extended interim storage of waste. We

    will refer to NRC Regulatory Issue Summary 2008-12 Considerations for Extended Interim Storage of Low-Level Radioactive Waste

    by Fuel Cycle and Materials Licensees‟ dated May 2008, for guidance and submit the required information with this application. NOTE: Applicants do not need to provide information to DHS if they plan to dispose of LLW via transfer to another authorized

    recipient or to dispose of liquid scintillation media or animals containing low levels of H-3 or C-14 as authorized by

     s. DHS 157.30(5).

    IF SEALED SOURCES ARE USED

     We will return sealed sources/devices to the manufacturer, distributor or an organization licensed by DHS, the NRC or another

    Agreement State.

    SPECIFIC LICENSE FEE

    Item 12 License Fees (Refer to Wisconsin Administration Code s. DHS 157.10)

    Category: Application fee enclosed (For new applications only):

     Yes No Amount Enclosed

    CERTIFICATION (To be signed by an individual authorized to make binding commitments on behalf of the applicant.) Item 13

    I hereby certify that this application was prepared in conformance with Wisconsin Administrative Code Chapter DHS 157 “Radiation Protection” and that all information contained herein, including any supplements attached hereto, is true and correct to the best of my knowledge and belief.

    SIGNATURE - Applicant Or Authorized Individual Date signed

    Print Name and Title of above signatory

OPTIONAL: CORRESPONDENCE AUTHORITY

    I have delegated correspondence authority for matters pertaining to our Radioactive Materials License to ________ ____________. The designee named here has approval to submit amendment requests concerning this Radioactive Materials License. I understand that license renewal applications must be signed by a member of upper management.

    SIGNATURE - Applicant Or Authorized Individual Date signed

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