Radiation Guide 1.7 - Guide for the Preparation of Applications for Analysis of Leak Test Samples

I. Introduction


1.1 Purpose of Guide

This guide describes the type of information that should be submitted in applications for specific licenses for the possession and use of radioactive material for the purpose of analyzing samples for radioactivity. It includes the general principles that will be considered in evaluating an applicant's proposed radiation safety measures.

The New York State Department of Health will normally issue a single license to cover the laboratory's entire radioisotope program. Separate licenses are not normally issued to different departments of a laboratory, nor are they issued to individuals associated with the laboratory.

The applicant should carefully study the regulations and this guide, and should submit all information requested. The Department will request additional information when necessary to provide reasonable assurance that the applicant has established an adequate radiation safety program. Such requests will delay final action on the application.

Three general principles that will be considered in evaluating proposed radiation safety measures are recognition by the laboratory of:

  1. The management's1 responsibility for the safety of employees and the public;
  2. Its responsibility for maintaining off-site releases as low as is reasonably achievable (ALARA) and avoiding significant increases in environmental radioactivity; and
  3. Its responsibility for minimizing exposures to employees.

1Management is defined as those persons authorized by the charter of the institution to make its policies and direct its activities.

1.2 Purpose of Appendices to Guide

The regulations require that the licensee develop and implement procedures that will ensure compliance with the regulations. Appendices 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 keep copies of these procedures with the license document when it is issued since they will be made a part of the license at that time.

1.3 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.

1.4 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.

2. Filing an Application

You, as the applicant for a materials license, must complete DOSH Form 236 (7/06). You should complete Items 1 through 4 and 18 on the form itself. For Items 5 through 17, submit the information on supplementary pages. Each separate sheet or document submitted with the application should be identified and keyed to the item number on the application to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8 ½ x 11 inch paper to facilitate handling and review. If larger drawings are necessary, they should be folded to 8 ½ x 11inches. You should complete all items in the application in sufficient detail for the Department to determine that your equipment, facilities, training and experience, and radiation safety program are adequate to protect health and to minimize danger to life and property.

You must submit two copies of your application with attachments. Retain one copy for yourself, because the license will require that you possess and use licensed material in accordance with the statements and representations in your application and in any supplements to it.

Mail your completed application and the required fee to:

New York State Department of Health
Bureau of Occupational Health and Injury Prevention
Empire State Plaza-Corning Tower, Room 1325
Albany, New York 12237
(518) 402-7900

Applications received without fees will not be processed and the fee is non-refundable.

3. Contents of an Application

The following paragraphs explain the information requested in Form DOSH 236.

Item 1

Enter the name and corporate address of the laboratory and the telephone number of administration.

Item 2

List all addresses and locations where radioactive material will be used or stored if other than that in Item 1, e.g., laboratory-owned 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

State the nature of the business in which your organization is engaged.

Item 4

Indicate whether the application is for a new license, an amendment to an existing license, or a renewal of an existing license.

Item 5

If applicable, identify the department(s) of your organization which will be using radioactive materials.

Item 6

List the names of all persons who will take leak tests, or analyze leak test or other survey samples.

Item 7

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 within the facility. 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 company's 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, as minimum qualifications, a bachelors degree in science, formal training in radiological health (e.g., college level or its equivalent) and 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 with the use of materials; radionuclides used, the quantities handled and the type of process. Experience in the specific functions the Radiation Safety Officer will perform (e.g., calibration of counting equipment, leak testing and inventory of calibration sources, training of staff) 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:

  1. General surveillance over all activities involving radioactive material, including routine monitoring and special surveys of all areas in which radioactive material is used.
  2. Determining compliance with rules and regulations, and license conditions.
  3. Monitoring and maintaining absolute and other special filter systems associated with the use, storage or disposal of radioactive material.
  4. Furnishing consulting services on all aspects of radiation safety to personnel at all levels of responsibility.
  5. Receiving, delivering and opening all shipments of radioactive material and receiving, packaging and shipping all radioactive material leaving the institution.
  6. Distributing and processing personnel monitoring equipment, determining the need for bioassays, keeping personnel exposure and bioassay records, and notifying individuals and their supervisors of exposures approaching maximum permissible amounts and recommending appropriate remedial action.
  7. Conducting training programs and otherwise instructing personnel in the proper procedures for the use of radioactive material prior to use, at periodic intervals (refresher training), and as required by changes in procedures, equipment, regulations, etc.
  8. Supervising and coordinating the radioactive waste disposal program, including keeping waste storage and disposal records, and monitoring effluents.
  9. Storing all radioactive materials not in current use, including wastes.
  10. Performing leak tests on all sealed sources.
  11. Maintaining an inventory of all radioisotopes and limiting the quantity of radionuclides to the amounts authorized by the license.
  12. The authority to terminate immediately a project that is found to be a threat to health or property.
  13. Maintaining other records not specifically designated above (e.g., receipt, transfer and survey records.

Item 8a

List the radionuclides expected to be found on samples, and in any sealed sources needed for calibration (except for exempt sources).

Item 8b

List the chemical and physical form and maximum quantity (in millicuries) of each radionuclide to be possessed at any one time. List the manufacturer, model number, and quantity for all sealed sources. The possession limit for each radionuclide should include material held as radioactive wastes.

Item 9

Describe the intended use for each radionuclide and form listed in items 8a and 8b.

Items 10 & 11 Training and Experience

Submit a resume of training and experience for the individual users listed above. This resume should cover formal academic training and on-the-job training in performing leak-tests on the specified equipment. It should also describe each individual's experience in counting and interpreting leaktest sample results. Guidelines on training and experience are:

  1. Formal training should encompass the following topics:
    1. The principles and practices of radiation protection.
    2. Radioactivity measurements, monitoring techniques, and the use of instruments.
    3. Mathematics and calculations basic to the use and measurement of radioactivity.
  2. A minimum of 40 hours of formal course work should be completed by each "individual user" listed.
  3. On-the-job training should encompass hands-on training in leak-testing the typical sources and devices specified, including performing independent analysis of leak-test samples. For individuals who have completed specific training presented by the manufacturers of the listed sources and devices, include copies of certificates or statements of training.
  4. Outline any additional training that will be provided periodically for your "individual users" to keep them up-to-date on new leak-testing techniques, new equipment to be leak-tested, and any factory modifications of existing equipment. You should indicate that such training will be augmented by using up-to-date manuals and instruction sheets provided by source and device manufacturers who provide new information on their recommended leak-test procedures and methods.
  5. Describe the training to be provided to ancillary personnel who may work in or frequency controlled areas. Consider secretarial and janitorial personnel and technicians.

    Appendix A to this guide contains a model procedure for training and instruction to employees. Please confirm that you will follow this procedure.

Item 12 Instruments

List the equipment available for radiation surveys and for analyzing wipes. Equipment must also be provided that is appropriate for surveying wipes before transfer from off-site locations to ensure that gross contamination is not present.

Your list should specify for each instrument (1) the type of instrument, (2) the number of instruments available, (3) the type of radiation detected, (4) the sensitivity range, and (5) the specific use. The instruments listed should have sufficient sensitivity to accurately measure any radioactive contamination on leak-test samples obtained from your customer's sources and devices. Table 1 is an example of such a listing.

Table 1 - Radiation Detection Instruments
Type Number Available Radiation Detected Sensitivity Range Use
1. Portable thin-window Gm survey meter 2 Beta, gamma 0-500 mr/hr Survey and monitoring (gross testing of samples)
2. Liquid scintillation counting system 1 low-energy beta 10-5 microcurie Analytical measurement
3. Well counter system with single channel analyzer 1 Gamma 10-6 microcurie Analytical measurement
4. Gas-Flow proportional counting system 1 Alpha, beta 10-6 - 10-8 microcurie Analytical measurement
5. Portable thin-window GM meter with constant geometry sample holder 1 Beta, gamma 10-3 microcurie Analytical measurement

Describe the lower limit of detection of equipment to be used for analyzing wupes, and provide an example calculation for converting counting results to activity.

Item 13

  1. Calibration of Instruments - If survey meter calibrations are performed at your facility. You must submit your procedures. 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.

    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.

  2. Quantitative Measuring Instruments - Instruments that will be used for quantitative analysis should be calibrated at six-month intervals. A description of the procedure for calibration of such instruments should be submitted and should include:
    1. the manufacturer and model number of the source(s);
    2. the nuclide and quantity of radioactive material in the source(s);
    3. the accuracy of the source(s);
    4. the step-by-step procedures for calibration, including associated radiation procedures; and
    5. the name(s) and pertinent experience of person(s) who will perform the calibrations.

Item 14 Personnel Monitoring Program

Describe your personnel monitoring polieies and procedures for staff who will collect leak test samples. This should include extremity and whole body monitoring, if a variety of sources are to be tested, and a monthly exchange interval should be used.

Item 15 Facilities and Equipment

Describe the facilities to be used for receiving, storing and counting wipes, including a diagram.

Describe the kinds of sealed sources or sources in devices to be leak-tested. For example, specify the isotope and amount of curies.

For sources in devices, specify the kinds of devices to be leak-tested, for example, gas chromatographs, portable moisture-density gauges, explosive detectors, fixed gauges (such as density gauges, level gauges, or gauges for measuring weight, bulk, moisture, thickness), and others appropriate to your proposed leak-testing program.

List the purpose of calibration sources separately.

NOTE: In describing the sealed sources and devices, you should provide enough additional information to show you are knowledgeable about the sealed sources and the devices containing sealed sources to perform the testing properly. Applications may contain statements such as "for leak-testing 10 mCi nickel-63 sources in chromatography detectors" or "for leak-testing 10 mCi cesium-137 sources and 40 mCi americium-241 sources in portable moisture-density gauges."

Item 16

  1. You should state that personnel will be provided with operating and emergency procedures. Submit an outline of the basic elements of these procedures to be provided to personnel. The following elements should be included in your operating and emergency procedures, if applicable:
    • Instructions for performing the wipe tests, including material to use and methods of handling samples to prevent or minimize exposure to personnel.
    • Surveys to be performed, such as those around the housing to be sure the device is in the "safe," "store" or "off" position before wipe samples are taken from designated areas of the device.
    • Surveys to be performed on wipe- or leak-test samples to check for gross contamination before removal from the site.
    • Any specific instructions provided by source and device manufacturers on recommended methods and areas to be wiped.
    • Instructions on what to do in case of emergencies, for example, if sources or devices are found to be leaking or excessive radiation levels are found around devices. These instructions should include procedures for proper notification to customer personnel, means of preventing and controlling the spread of contamination, and means of obtaining professional assistance, if needed.
    • Appendix C and Appendix D contain a set of model rules for laboratory work and procedures for area surveys. Please confirm that you will follow these protocols.
  2. If you plan to use a commercial leak test kit, you must specify the kit to be used, including the make and model and license number of the supplier.

    If you will use your own "kit," you must specify and describe the components.

  3. You should include copies or descriptions of the types of records you will maintain on leak-test samples as part of the documentation of your radiation protection program. These records should include:
    • Identification of each source or device (manufacturer, model number, serial number, isotope, quantity);
    • Identification of each site (name, address, person to contact);
    • Radiation survey measurements, as appropriate;
    • Date of test and date of next scheduled test;
    • Information on test methods used (i.e., type of wipe such as dry filter paper or wet cloth swipe and areas wiped);
    • Leak-test results expressed in microcuries of alpha, beta, or gamma radiation for each area wiped; and
    • Identification of the individual who performed the test.

      You should include a copy of the leak-test certificate you will supply to customers. A sample certificate is attached and may be adapted to your needs. (See Appendix E)

Item 17 Waste Disposal

See LLRW Guidance.

Item 18 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.

4. Amendments to Licenses

After you are issued a license, you must conduct your program in accordance with (1) the statements, representations, and procedures contained in your application; (2) the terms and conditions of the license; and (3) the Department's regulations.

It is your obligation to keep your license current. You should anticipate the need for a license amendment insofar as possible. If any of the information provided in your application is to be modified or changed, submit an application for a license amendment. In the meantime, you must comply with the terms and conditions of your license until it is actually amended; Department regulations do not allow you to implement changes on the basis of a submission requesting an amendment to your license.

An application for a license amendment may be prepared either on the application form or in letter form and should be submitted in duplicate to the address specified in Section 2 of this guide. Your application should identify your license by number and should clearly describe the exact nature of the changes, additions or deletions. References to previously submitted information and documents should be clear and specific and should identify the pertinent information by date, page and paragraph. For example, if you wish to change the RSO, your application for a license amendment should specify the new individual's name, training and experience. The qualifications of the new RSO should be equivalent to those specified in Item 6 of this guide.

List of Appendices

The Appendices can be found on pages 14-25 of Radiation Guide 1.7 which is available in Portable Document Format (PDF, 75KB, 25pg.)

  1. Appendix A - A Model Personnel Training Program
  2. Appendix B - Model Procedure for Calibrating Survey Instruments
  3. Appendix C - Model Rules for Safe Use of Radioactive Material
  4. Appendix D - Model Procedure for Area Surveys
  5. Appendix E - Sealed Source Leak Test Certificate