Free Application for Radioactive Material License Authorizing the Use of Self Shielded Irradiators, F-45014 - Wisconsin

DEPARTMENT OF HEALTH SERVICES Division of Public Health F-45014 (Rev. 07/08)

STATE OF WISCONSIN Bureau of Environmental Health Radiation Protection Section (608) 267-4797

APPLICATION FOR RADIOACTIVE MATERIAL LICENSE AUTHORIZING THE USE OF SELF SHIELDED IRRADIATORS
The Wisconsin Department of Health Services is requesting disclosure of information for the purpose of 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 if this is an initial application or an application for renewal of a license. Refer to WISREG "Guidance for Self Shielded Irradiators." Use supplementary sheets where necessary. Retain one copy and submit original of the entire application ot 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 Amendment 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):

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LOCATION OF RADIOACTIVE MATERIAL
Item 4 Addresses Where Licensed Material Will Be Used or Possessed (Do not use Post Office Box): Telephone Number (Include area code) Address

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Address

Telephone Number (Include area code)

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Address

Telephone Number (Include area code)

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Item 5. Radiation Safety Officer (RSO) (Check one box and attach evidence of training and experience)

RADIATION SAFETY OFFICER
Name: Telephone Number (Include area code): (

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Before obtaining radioactive material, the proposed RSO will have successfully completed training as described in Appendix G of WISREG `Guidance For Self Shielded Irradiators'. Before being named as the RSO, future RSOs will have successfully completed training as described in Appendix G of WISREG `Guidance For Self Shielded Irradiators.' OR Alternative information demonstrating that the proposed RSO is qualified by training and experience is attached. Before being named as the RSO, future RSOs will have successfully completed training as described in Appendix G of WISREG `Guidance For Self Shielded Irradiators.'

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AUTHORIZED USERS
Item 6 Authorized Users (Check one box) Before using radioactive material, authorized users will have received training as described in Appendix G in WISREG `Guidance for Self Shielded Irradiators.' OR A description of the training and experience for proposed authorized users is attached.

RADIOACTIVE MATERIAL
Item 7 Radioactive Material (Attach additional pages if necessary) CHEMICAL AND PHYSICAL FORM ELEMENT AND MASS NUMBER Cobalt-60 Cesium-137 Strontium-90 Other Isotope (please specify): SEALED SOURCE

SEALED SOURCE MANUFACTURER OR DISTRIBUTOR AND MODEL NUMBER:

DEVICE MANUFACTURER OR DISTRIBUTOR AND MODEL NUMBER:

MAXIMUM QUANTITY (Not to exceed either the maximum activity per source or device as specified in the Sealed Source and Device Registration Certificate) INTENDED USE:

SEALED SOURCE AND DEVICE REGISTRATION SHEET NUMBER:

FACILITIES AND EQUIPMENT
Item 8 Facilities And Equipment (Check all that apply) Diagrams of radioactive material area(s) of use are attached. AND EITHER We will ensure that each area where a self-shielded irradiator is located corresponds to the `Conditions of Normal Use' and `Limitations and/or Other Considerations of Use' on the applicable irradiator's Sealed Source and Device Registration Certificate; the floor beneath the self shielded irradiator is secured to prevent unauthorized access or removal; and each area where a self shielded irradiator is located is equipped with an automatically operated fire detection and control system (sprinkler, chemical, or gas) or the location of the area and other controls ensure a low-level radiation risk attributable to fires. OR We will submit alternative information; be sure to include justification for placing an irradiator in an area that does not correspond to the `Conditions of Normal Use' and the `Limitations and/or Other Considerations of Use.'

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RADIATION SAFETY PROGRAM
Item 9 Radiation Safety Program Item 9.1 Audit Program The applicant is not required to, and should not, submit its audit program to DHFS for review. This matter will be examined during inspection. Item 9.2 Radiation Monitoring Instruments (Check one box) We will use instruments that meet the radiation monitoring instrument specifications published in Appendix K of WISREG "Guidance for Self Shielded Irradiators." Additionally, each survey meter will have been calibrated by the manufacturer or other person authorized by DHFS, the NRC or an Agreement State to perform survey meter calibrations no more than 12 months before the date the meter is used. OR We will use instruments that meet the radiation monitoring instrument specifications published in Appendix K of WISREG "Guidance for Self Shielded Irradiators." Additionally, we will implement the model survey meter calibration program published in Appendix K of WISREG "Guidance for Self Shielded Irradiators" and we ensure that each survey meter will have been calibrated no more than 12 months before the date the meter is used. OR We will have access to survey equipment and/or procedures for ensuring that interlocks function, as required, to return moving self shielded irradiator sources to the shielded position and/or determining source shielding integrity after an incident involving the self shielded irradiator. Item 9.3 Material Receipt And Accountability (Check box) Physical inventories will be conducted at intervals not to exceed 6 months, to account for all sealed sources and devices received and possessed under the license. Item 9.4 Occupational Dose (Check one box) We will maintain, for inspection by DHFS, 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. HFS 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. Item 9.5 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 9.6 Operating And Emergency Procedures (Check one box) We will develop, implement, maintain and distribute operating procedures that will meet the Criteria in the section titled `Operating and Emergency Procedures' in WISREG "Guidance for Self Shielded Irradiators." (Procedures are attached) OR We will submit alternative procedures. (Procedures are attached) Item 9.7 Leak Tests (Check one box) Leak tests will be performed by an organization authorized by DHFS, 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 DHFS, the NRC or an Agreement State to provide leak test kits to other licensees according to kit supplier's instructions. List Name and License number of organization authorized to perform or analyze leak test ( Specify whether DHFS, NRC, or other Agreement State) Organization Name: License Number:

Note: An alternate organization may be used to perform or analyze leak test, without amending the license, provided the organization is specifically authorized by DHFS, NRC, or an Agreement State. OR We will perform leak testing and sample analysis and will follow the model procedures in Appendix P of WISREG "Guidance for Self Shielded Irradiators." (Procedures are attached) OR We will submit alternative procedures. (Procedures are attached)

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Item 9.8 Maintenance (Check one box for Routine Cleaning and Lubrication and one for Non-Routine Maintenance) ROUTINE CLEANING AND LUBRICATION: We will implement and maintain procedures for routine maintenance of our self shielded irradiators according to each manufacturer's (or distributor's) written recommendations and instructions. OR Alternative procedures are attached. NON-ROUTINE MAINTENANCE: We will have the self shielded irradiator manufacturer (or distributor) or other person authorized by DHFS, the NRC or an Agreement State perform the non-routine maintenance. OR We will provide procedures that address the information listed in Appendix I of WISREG "Guidance for Self Shielded Irradiators" supporting a request for authorization to perform this work. (Procedures attached) Item 9.9 Transportation (Check one box) We choose to transfer possession of radioactive material to an irradiator manufacturer, distributor or service licensee with a DHFS, NRC or Agreement State license who then acts as the shipper. OR Before offering a Type B package for shipment we will be registered with the NRC as user of the package and obtain DHFS approval of our QA program. DISPOSAL, TRANSFER AND LICENSE TERMINATION Item 10 Disposal, Transfer and License Termination Item 10.1 Disposal And Transfer ( Check Box) We will return the source to the manufacturer for disposal or transfer the device to a specific licensee authorized to receive radioactive material. Item 10.2 Termination Of Activities (Check box) We will notify DHFS, in writing, within 30 days of the decision to permanently cease radioactive material use per s. HFS 157.13(10)(d)

SPECIFIC LICENSE FEE
Item 11 License Fees (Refer to Wisconsin Administrative Code HFS 157.10) Category: License fee enclosed: Yes No Amount Enclosed:

CERTIFICATION (To be signed by an individual authorized to make binding commitments on behalf of the applicant.)
Item 12 I hereby certify that this application was prepared in conformance with Wisconsin Administrative Code HFS 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 Print Name and Title of above signatory Date signed: