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NEW YORK STATEDEPARTMENT OF HEALTH

BUREAU OF ENVIRONMENTAL RADIATION PROTECTIONINDUSTRIAL UNIT

Radiation Guide 1.7

GUIDE FOR THE PREPARATION OF APPLICATIONS FOR ANALYSIS OF LEAK TEST SAMPLES

Attachment(s): LLRW Guide07/07

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1. INTRODUCTION

APPLICATIONS WHICH DO NOT FOLLOW THE FORMAT AND CONTENT OF THISGUIDE CANNOT BE REVIEWED AND WILL BE RETURNED FOR REVISION.

1.1 PURPOSE OF GUIDE

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

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

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

Three general principles that will be considered in evaluating proposed radiationsafety 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 makeits policies and direct its activities.

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1.2 PURPOSE OF APPENDICES TO GUIDE

The regulations require that the licensee develop and implement procedures that willensure compliance with the regulations. Appendices to this guide describe model radiationsafety procedures. Each applicant should carefully read the applicable regulations and modelprocedures and adopt them as written whenever possible. If you are unable to adopt aparticular procedure as written, submit a copy of the procedure in the guide with yourchanges indicated in red ink. You must keep copies of these procedures with the licensedocument 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 theNew 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 radiationinstallations shall make every effort to maintain radiation exposures and releases ofradioactive material as far below the limits of Part 38 as is reasonably achievable. Licenseapplicants should give consideration to the ALARA philosophy in the development of plansfor work with radioactive materials.

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2. FILING AN APPLICATION

You, as the applicant for a materials license, must complete DOSH Form 236 (7/06). Youshould complete Items 1 through 4 and 18 on the form itself. For Items 5 through 17, submit theinformation on supplementary pages. Each separate sheet or document submitted with theapplication 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 x 11 inch paper to facilitatehandling and review. If larger drawings are necessary, they should be folded to 8 x 11inches. You should complete all items in the application in sufficient detail for the Department to determinethat your equipment, facilities, training and experience, and radiation safety program are adequateto protect health and to minimize danger to life and property.

You must submit two copies of your application with attachments. Retain one copy foryourself, because the license will require that you possess and use licensed material in accordancewith 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 HealthBureau of Environmental Radiation ProtectionIndustrial UnitFlanigan Square, 547 River StreetTroy, New York 12180

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

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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 ofadministration.

Item 2 List all addresses and locations where radioactive material will be used or stored if other thanthat in Item 1, e.g., laboratory-owned farm or research station. A post office boxnumber should not be stated as the address for a place of use. These addresses andlocations will become part of the license conditions, if the license application isapproved, and the addresses or locations at which radioactive materials or radioactivewastes are located or stored may not be changed without obtaining a licenseamendment.

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 radioactivematerials.

Item 6 List the names of all persons who will take leak tests, or analyze leak test or other surveysamples.

Item 7 Radiation Safety Officer - Part 38 requires that a Radiation Safety Officer be appointed. TheRadiation Safety Officer is responsible for the day-to-day operation of the radiationsafety program within the facility. A description of his/her training and experiencein radiation protection and the use of radioactive material should be provided, alongwith a curriculum vitae.

State the name and title of the person designated by, and responsible to, thecompany's management for the coordination of the company's radiation safetyprogram. If the radiation safety officer is assisted by a consultant or part-timeemployee, 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 bachelorsdegree in science, formal training in radiological health (e.g., college level or itsequivalent) and should have specific experience in radiation protection with thetypes, quantities and uses of the radioactive material requested in the application.

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Submit an outline of the candidate's training and experience in radiological healthand the use of radioactive materials. Include on-the-job and formal training, whereit was obtained, dates and durations and the topics covered. Also include experiencewith the use of materials; radionuclides used, the quantities handled and the type ofprocess. Experience in the specific functions the Radiation Safety Officer willperform (e.g., calibration of counting equipment, leak testing and inventory ofcalibration 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. Theextent of the Radiation Safety Officer's responsibility and authority will depend onthe scope of the proposed program; however, the following should be considered forinclusion in your statement:

(1) General surveillance over all activities involving radioactive material,including routine monitoring and special surveys of all areas in whichradioactive material is used.

(2) Determining compliance with rules and regulations, and license conditions.

(3) Monitoring and maintaining absolute and other special filter systemsassociated with the use, storage or disposal of radioactive material.

(4) Furnishing consulting services on all aspects of radiation safety to personnelat all levels of responsibility.

(5) Receiving, delivering and opening all shipments of radioactive material andreceiving, packaging and shipping all radioactive material leaving theinstitution.

(6) Distributing and processing personnel monitoring equipment, determining theneed for bioassays, keeping personnel exposure and bioassay records, andnotifying individuals and their supervisors of exposures approachingmaximum permissible amounts and recommending appropriate remedialaction.

(7) Conducting training programs and otherwise instructing personnel in theproper procedures for the use of radioactive material prior to use, at periodicintervals (refresher training), and as required by changes in procedures,equipment, regulations, etc.

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(8) Supervising and coordinating the radioactive waste disposal program,including keeping waste storage and disposal records, and monitoringeffluents.

(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 ofradionuclides to the amounts authorized by the license.

(12) The authority to terminate immediately a project that is found to be a threatto health or property.