Radiation Guide 1.11 - Guide for the Preparation of Application to Possess Sealed Radioactive Sources for the Purpose of Distribution to Specific Licensees
- Radiation Guide 1.11 - Guide for the Preparation of Application to Possess Sealed Radioactive Sources for the Purpose of Distribution to Specific Licensees is also available in Portable Document Format (PDF, 81KB, 25pg.)
- Purpose of Guide
This guide describes the type of information that should be submitted in applications for specific licenses to possess radioactive sources for the purpose of distribution to specific licensees. It includes the general principles that will be considered in evaluating an applicant's proposed radiation safety program.
The applicant should carefully study Code Rule 38 and this guide, and should submit all required information in sufficient detail to allow a complete review. The Department will request additional information, when necessary to provide reasonable assurance that the applicant's proposed use, equipment, facilities, procedures and staffing are adequate to protect health and safety and minimize danger to life and property, from radiation hazards. Such requests will delay final action on the application.
Two general principles that will be considered in evaluating proposed radiation safety measures are recognition by the company of:
- The management's responsibility for the safety of employees and the public; and
- Its responsibility for maintaining all radiation exposures and releases as low as is reasonably achievable (ALARA).
- Purpose of Appendices to Guide
The regulations require that the licensee develop and implement procedures that will ensure compliance with the regulations. Appendices A through K to this guide describe model radiation safety procedures. Each applicant should carefully read the applicable regulations and model procedures and adopt them as written whenever possible. If you are unable to adopt a particular procedure as written, submit a copy of the procedure in the guide with your changes indicated in red ink. You must submit copies of these procedures with the application, and keep them with the license document when it is issued, since they will be made a part of the license at that time.
- Purpose of Guide
- Applicable Regulations
All regulations pertaining to this type of license are found in 12 NYCRR 38 of the New York Code of Rules and Regulations.
- As Low As is Reasonably Achievable (ALARA)
Part 38 requires that persons who operate or permit the operation of radiation installations shall make every effort to maintain radiation exposures and releases of radioactive material as far below the limits of Part 38 as is reasonably achievable. License applicants should give consideration to the ALARA philosophy in the development of plans for work with radioactive materials.
Filing an Application
A license application for a specific license for the use of unsealed radioactive material should be submitted in Form DOSH 236, "Application for Radioactive Materials License" and appropriate attachments. The applicant should complete all items on the application form in sufficient detail for the review staff to determine that the applicant's equipment, facilities, personnel training and qualifications, and radiation safety program are adequate to protect health and minimize danger to life and property.
For items 6 through 17, submit the required information on supplementary pages. You should identify and key each separate sheet or document submitted with the application to the item number on the application to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8 1/2 x 11 inch paper to facilitate handling and review. If larger drawings are necessary, fold them to 8 1/2 x 11 inches.
One copy of the application, with all attachments, should be retained by the applicant, since the license will require as a condition that the licensee follow the statements and representations set forth in the application and any supplement to it. The original and one copy should be mailed to the Bureau of Environmental Radiation Protection, Industrial Unit at the following address:New York State Department of Health
Bureau of Environmental Radiation Protection
547 River Street, Room 530
Troy, New York 12180
Telephone: (518) 402-7550
Fax: (518) 402-7554
Contents of an Application
The following paragraphs explain the information requested in Form DOSH 236.
Item 1. - Applicants' Name and Mailing Address
Enter the name and corporate address of the company and the telephone number of a contact person for licensing issues. The name of the company should be entered exactly as it appears on other legal documents.
The address specified here should be your mailing address to which correspondence should be sent. This may or may not be the same as the address at which the material will be used, as specified in Item 2.A.
Also enter your company's Federal Employers Identification Number (FEIN).
Item 2 - Locations of Use and Storage
List all addresses and locations where radioactive material will be used or stored if other than that in Item 1, e.g., a farm or research station. A post office box number should not be stated as the address for a place of use. These addresses and locations will become part of the license conditions, if the license application is approved, and the addresses or locations at which radioactive materials or radioactive wastes are located or stored may not be changed without obtaining a license amendment.
Item 3 - Nature of Business and Person to be Contacted about Application
State the type of business in which you are engaged.
Item 4 - License Information
Enter the license number of any previous or current licenses authorizing use of radioactive materials (including General Licenses) and the name of the issuing agency. If a license has ever been suspended or revoked, describe the circumstances on additional sheets.
Indicate whether this is an application for a new license or a renewal of an existing license.
Item 5 - Department of Use
If applicable, identify the department(s) of your company which will be using radioactive materials.
Item 6 - Individual Users
List all individuals who will use or directly supervise the use of radioactive material. Give the title or position of each person.
Item 7 - Radiation Safety Officer
Radiation Safety Officer - Part 38 requires that a Radiation Safety Officer be appointed. The Radiation Safety Officer is responsible for the day-to-day operation of the radiation safety program. A description of his/her training and experience in radiation protection and the use of radioactive material should be provided, along with a curriculum vitae.
State the name and title of the person designated by, and responsible to, the company's management for the coordination of the radiation safety program. If the radiation safety officer is assisted by a consultant or part-time employee, state the consultant's name and describe his/her duties, responsibilities, and the amount of time to be devoted to the radiation safety program.
The Radiation Safety Officer should have specific experience in radiation protection with the types, quantities and uses of the radioactive material requested in the application. Submit an outline of the candidate's training and experience in radiological health and the use of radioactive materials. Include on-the-job and formal training, where it was obtained, dates and durations and the topics covered. Also include experience in radiation protection for the types and quantities of sources to be handled. Experience in the specific functions the Radiation Safety Officer will perform (e.g., leak-testing) should be individually listed.
A statement must be included delineating the Radiation Safety Officer's duties, responsibilities and authority for carrying out the radiation safety program. The extent of the Radiation Safety Officer's responsibility and authority will depend on the scope of the proposed program; however, the following should be considered for inclusion in your statement:
- General surveillance over all activities involving radioactive material, including routine monitoring of incoming and outgoing packages and of storage areas for radiation sources.
- Determining compliance with rules and regulations, license conditions, and the conditions of project approval specified by the radiation safety committee.
- Receiving, delivering and opening all shipments of radioactive material arriving at the company and receiving, packaging and shipping all radioactive material being shipped out.
- Distributing and processing personnel monitoring equipment, keeping personnel exposure and bioassay records, and notifying individuals of exposures approaching ALARA levels and recommending appropriate remedial action.
- Conducting training programs and otherwise instructing personnel in the proper procedures for the use of radioactive material prior to use, annually (refresher training), and as required by changes in procedures, equipment, regulations, etc.
- Supervising and coordinating the radioactive waste disposal program, including keeping waste storage and disposal records.
- Storing all radioactive materials not in current use, including wastes.
- Performing leak tests on all sealed sources.
- Maintaining an inventory of all radioisotopes and limiting the quantity of radionuclides to the amounts authorized by the license
- Maintaining other records not specifically designated above (e.g., receipt, transfer and survey records.
Item 8 - Radioactive Material to be Possessed
List each radionuclide to be used.
8.B & C
List the name of the manufacturer and model number of sealed sources, and the maximum activity for each.
Item 9. Purpose for Which Radioactive Materials will be Used
List the name of the manufacturer and model number of each device, and the purpose of use.
Describe the intended use for each source listed in items 8a and 8b (e.g. calibration of your own instruments, distribution to specific licensees, etc.).
Items 10 & 11 - Training and Experience of Individual Users
Provide the training and experience individual users in relationship to the radioactive material requesting.
Personnel Training Program - Appendix B to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink.
Items 12 & 13 - Instrumentation and Calibration
Submit a list of all radiation detection instrumentation available. Appendix C to this guide contains a form that may be used to describe the instruments. Complete this form and return with application.
- Calibration of Instruments - If survey meter calibrations are performed at your facility, you must submit your procedures. Appendix D to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink. If your survey meters are sent out for calibration, submit a statement that calibrations will be performed by persons licensed to perform this service by the U.S. Nuclear Regulatory Commission or an Agreement State and that a copy of this license will be kept on file with the calibration certificates for our inspection.
- Quantitative Measuring Instruments - Instruments that will be used for quantitative measurements to determine compliance with Department regulations (e.g., leak-test measurements, effluent monitoring) should be calibrated at annual intervals. A description of the procedure for calibration of such instruments should be submitted and should include:
- the manufacturer and model number of the source(s);
- the nuclide and quantity of radioactive material in the source(s);
- the accuracy of the source(s);
- the step-by-step procedures for calibration, including associated radiation protection procedures; and
- the name(s) and pertinent experience of person(s) who will perform the calibrations.
Item 14 - Personnel Monitoring
Personnel Monitoring Program - Describe your personnel monitoring program.
Item 15 - Facilities and Equipment
Facilities and Equipment - Describe the facilities and equipment available at each location where radioactive material will be used. Include a description of the area(s) assigned for the receipt and storage (including waste storage of radioactive sources. A diagram should be submitted showing the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety. Diagrams should be drawn to a specified scale, or dimensions should be indicated. The locations of the facilities and equipment should be specified with respect to the addresses and locations given in item 2.
Item 16 - Radiation Protection Program
Radiation Protection Program - Each licensee must develop, document and implement a radiation protection program commensurate with the size and complexity of their radioactive materials use.
This must include a management commitment to maintain radiation exposures and releases as low as reasonably achievable (ALARA). Please submit such a commitment over the signature of your chief executive officer, or a management representative authorized to sign such documents for him or her. Company management must also ensure that an annual review of the radiation protection program content and implementation, and of the performance of the RSO, is conducted.
- Procedures for Ordering and Receiving Radioactive Material - Appendix E to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink.
- Procedures for Package Opening - Appendix F to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink.
- Area Survey Procedures - Appendix I to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink.
- Leak-Testing of Sealed Sources - State whether leak tests of sealed sources will be performed prior to distribution. If so, Appendix K to this Guide contains a model procedure. State that you will follow the model procedure or submit a copy of the Appendix with your changes indicated in red ink. If an outside service analyzes leak-test samples submit a statement that the service will be performed by persons licensed to do so by the U.S. Nuclear Regulatory Commission or an Agreement State and that a copy of this license will be kept on file with the leak test reports for our review.
- Submit procedures for tracking the distribution of radioactive sources. No radioactive sources are to be distributed except to persons licensed to possess them. Your procedures must include provisions for obtaining a copy of each customer's license prior to shipment, and verifying that the license authorizes the radioactive sources requested. In addition you must ensure that shipments of radioactive sources are made only to the address of use indicated on a license.
- Confirm that sealed sources will be distributed in the original packaging and with the original documentation provided by the manufacturer.
- Emergency Procedures - Submit emergency procedures that you will provide to workers describing actions to be taken in case of an accident or emergency involving radioactive sources and listing the names and telephone numbers of persons to be contacted. You should also explain how these instructions will be communicated to non-employees who may respond to an accident or emergency.
- Security - Describe how security over radioactive sources will be maintained, ensuring that they are protected from damage, theft or loss.
Item 17 - Waste Management
Waste Disposal - Confirm that all sealed sources possessed under this license will be obtained from manufacturers who have agreed in writing to accept them back for eventual disposal.
You may wish to request authorization to accept back from your customers sealed sources which were distributed by your company, for purposes of disposal. If so, you must submit procedures for doing so, ensuring that the source manufacturer has agreed to accept them from you.
Item 18 - Certification
Certificate - The application should be signed by the President, or any Chief Executive Officer. Identify the title of the office held by the individual who signs the application.
Enter the name and telephone number (including area code) of the individual who knows your proposed radioactive materials program and can answer questions about the application. This should be a staff member and not a consultant.
Amendments to Liceses
Licensees are required to conduct their programs in accordance with statements, representations and procedures contained in the license application and supporting documents. The license must therefore be amended if the licensee plans to make any changes in the facilities, equipment (including type of monitoring and survey instruments), procedures, authorized users or radiation safety officer, or radioactive material to be used.
A request for amendment can be submitted in the form of a letter explaining the desired changes, and including any needed drawings, certificates, manufacturers specifications, etc. It is advisable to call this office first, so that the information to be submitted can be discussed in advance.
List of Appendices
The Appendices can be found on pages 11-25 of Radiation Guide 1.11 which is available in Portable Document Format (PDF, 81KB, 25pg.)
- Appendix B Model Personnel Training Program
- Appendix C Instrumentation
- Appendix D Model Procedure for Calibrating Survey Instruments
- Appendix E Model Procedure for Ordering and Receiving Radioactive Material
- Appendix F Model Procedure for Opening Packages Containing Radioactive Material
- Appendix I Model Procedures for Area Surveys
- Appendix J Waste Disposal (See attached Minimization and Management Guide)
- Appendix K Model Procedure for Leak-Testing Sealed Sources
- Appendix L Model Personnel External Exposure Monitoring Program