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| {{#Wiki_filter:NUREG-1556 Volume 9, Rev. 3 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses Final Report Office of Nuclear Material Safety and Safeguards | | {{#Wiki_filter:}} |
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| AVAILABILITY OF REFERENCE MATERIALS IN NRC PUBLICATIONS NRC Reference Material Non-NRC Reference Material As of November 1999, you may electronically access Documents available from public and special technical NUREG-series publications and other NRC records at libraries include all open literature items, such as books, NRCs Library at www.nrc.gov/reading-rm.html. Publicly journal articles, transactions, Federal Register notices, released records include, to name a few, NUREG-series Federal and State legislation, and congressional reports.
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| publications; Federal Register notices; applicant, Such documents as theses, dissertations, foreign reports licensee, and vendor documents and correspondence; and translations, and non-NRC conference proceedings NRC correspondence and internal memoranda; bulletins may be purchased from their sponsoring organization.
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| and information notices; inspection and investigative reports; licensee event reports; and Commission papers Copies of industry codes and standards used in a and their attachments. substantive manner in the NRC regulatory process are maintained at NRC publications in the NUREG series, NRC regulations, The NRC Technical Library and Title 10, Energy, in the Code of Federal Regulations Two White Flint North may also be purchased from one of these two sources. 11545 Rockville Pike Rockville, MD 20852-2738
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| : 1. The Superintendent of Documents U.S. Government Publishing Office These standards are available in the library for reference Washington, DC 20402-0001 use by the public. Codes and standards are usually Internet: bookstore.gpo.gov copyrighted and may be purchased from the originating Telephone: (202) 512-1800 organization or, if they are American National Standards, Fax: (202) 512-2104 from American National Standards Institute
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| : 2. The National Technical Information Service 11 West 42nd Street 5301 Shawnee Road New York, NY 10036-8002 Alexandria, VA 22312-0002 www.ansi.org www.ntis.gov (212) 642-4900 1-800-553-6847 or, locally, (703) 605-6000 Legally binding regulatory requirements are stated only in A single copy of each NRC draft report for comment is laws; NRC regulations; licenses, including technical available free, to the extent of supply, upon written specifications; or orders, not in NUREG-series publications.
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| The views expressed in contractor prepared publications in request as follows:
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| this series are not necessarily those of the NRC.
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| Address: U.S. Nuclear Regulatory Commission The NUREG series comprises (1) technical and Office of Administration administrative reports and books prepared by the staff (NUREG-XXXX) or agency contractors (NUREG/CR-XXXX),
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| Multimedia, Graphics, and Storage &
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| (2) proceedings of conferences (NUREG/CP-XXXX),
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| Distribution Branch (3) reports resulting from international agreements Washington, DC 20555-0001 (NUREG/IA-XXXX),(4) brochures (NUREG/BR-XXXX), and E-mail: distribution.resource@nrc.gov (5) compilations of legal decisions and orders of the Facsimile: (301) 415-2289 Commission and Atomic and Safety Licensing Boards and of Directors decisions under Section 2.206 of NRCs regulations (NUREG-0750).
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| Some publications in the NUREG series that are posted at NRCs Web site address www.nrc.gov/reading-rm/ DISCLAIMER: This report was prepared as an account doc-collections/nuregs are updated periodically and may of work sponsored by an agency of the U.S. Government.
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| differ from the last printed version. Although references to Neither the U.S. Government nor any agency thereof, nor any employee, makes any warranty, expressed or implied, material found on a Web site bear the date the material or assumes any legal liability or responsibility for any third was accessed, the material available on the date cited partys use, or the results of such use, of any information, may subsequently be removed from the site. apparatus, product, or process disclosed in this publication, or represents that its use by such third party would not infringe privately owned rights.
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| NUREG-1556 Volume 9, Rev. 3 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses Final Report Manuscript Completed: September 2019 Date Published: September 2019 Prepared by:
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| M. Burkhart A. Cockerham J. Cook S. Daibes S. Forster S. Gabriel D. B. Howe P. Lanzisera T. Simmons K. Tapp R. Zelac Office of Nuclear Material Safety and Safeguards
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| ABSTRACT This technical report contains information intended to provide program-specific guidance and assist applicants and licensees in preparing applications for materials licenses for the medical use of byproduct material. In particular, it describes the types of information needed to complete U.S. Nuclear Regulatory Commission (NRC) Form 313, Application for Materials License, and the NRC Form 313A series for authorized users (AU), authorized medical physicists (AMP) and Ophthalmic Physicist, authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO) and associate RSO. This document describes both the methods acceptable to the NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the application to determine if the proposed activities are acceptable for licensing purposes.
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| The document contains appendices that include (i) copies of necessary forms; (ii) a checklist for preparing an application; (iii) step-by-step instructions for adding authorized individuals; and (iv) examples of the types of supporting documents, such as procedures, that may need to be prepared by applicants. Guidance in this document represents one means acceptable to NRC staff of complying with NRC regulations and is not intended to be the only means of satisfying requirements for a license.
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| Paperwork Reduction Act Statement This NUREG provides guidance for implementing the mandatory information collections in 10 CFR Parts 19; 20; 21; 30; 31; 35; 70; 71; and NRC Forms 313 and 314 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq.). These information collections were approved by the Office of Management and Budget, approval numbers 3150-0044; 3150-0014; 3150-0035; 3150-0017; 3150-0016; 3150-0010; 3150-0009; 3150-0008; 3150-0120; and 3150-0028. Send comments regarding this information collection to the Information Services Branch (T6-A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0044; 3150-0014; 3150-0035; 3150-0017; 3150-0016; 3150-0010; 3150-0009; 3150-0008; 3150-0120; and 3150-0028), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street, NW Washington, DC 20503; e-mail:
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| oira_submission@omb.eop.gov.
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| Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
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| iii
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| FOREWORD The U.S. Nuclear Regulatory Commissions (NRCs) NUREG-1556 technical report series provides a comprehensive source of reference information about various aspects of materials licensing and materials program implementation. These reports, where applicable, describe a risk-informed, performance-based approach to licensing consistent with the current regulations.
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| The reports are intended for use by applicants, licensees, license reviewers, and NRC personnel. The NUREG-1556 series currently includes the following volumes:
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| Volume No. Volume Title 1 Program-Specific Guidance About Portable Gauge Licenses 2 Program-Specific Guidance About Industrial Radiography Licenses 3 Applications for Sealed Source and Device Evaluation and Registration 4 Program-Specific Guidance About Fixed Gauge Licenses 5 Program-Specific Guidance About Self-Shielded Irradiator Licenses 6 Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses Program-Specific Guidance About Academic, Research and Development, and 7 Other Licenses of Limited Scope Including Electron Capture Devices and X-Ray Fluorescence Analyzers 8 Program-Specific Guidance About Exempt Distribution Licenses 9 Program-Specific Guidance About Medical Use Licenses 10 Program-Specific Guidance About Master Materials Licenses 11 Program-Specific Guidance About Licenses of Broad Scope Program-Specific Guidance About Possession Licenses for Manufacturing 12 and Distribution 13 Program-Specific Guidance About Commercial Radiopharmacy Licenses Program-Specific Guidance About Well Logging, Tracer, and Field Flood 14 Study Licenses Guidance About Changes of Control and About Bankruptcy Involving 15 Byproduct, Source, or Special Nuclear Materials Licenses Program-Specific Guidance About Licenses Authorizing Distribution to 16 General Licensees Program-Specific Guidance About Special Nuclear Material of Less Than 17 Critical Mass Licenses 18 Program-Specific Guidance About Service Provider Licenses Guidance for Agreement State Licensees About NRC Form 241 Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal 19 Jurisdiction, or Offshore Waters and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity) 20 Guidance About Administrative Licensing Procedures Program-Specific Guidance About Possession Licenses for Production of 21 Radioactive Material Using an Accelerator v
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| The current document, NUREG-1556, Volume 9, Revision 3, Program-Specific Guidance About Medical Use Licenses, is intended for use by applicants, licensees, and other NRC staff.
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| This revision provides a general update to the previous information contained in NUREG-1556, Volume 9, Revision 2, January 2008.
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| This report takes a risk-informed, performance-based approach to licensing the use of byproduct material for medical uses. A team composed of staff from NRC Headquarters, NRC regional offices, and Agreement States prepared this document, drawing on their collective experience in radiation safety in general and as specifically applied to medical uses of byproduct material.
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| The Medical Uses Licensee Toolkit Web page, which contains the following items, serves as another source of guidance for the implementation of Title 10 of the Code of Federal Regulations (10 CFR) Part 35:
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| * questions and answers on the implementation of 10 CFR Part 35
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| * specialty board certifications recognized by NRC
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| * inspection Procedures for inspections of medical use licensees
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| * licensing guidance for emerging technology and 10 CFR 35.1000 other medical uses
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| [e.g., Yttrium-90 Microsphere Brachytherapy, Leksell Gamma Knife Perfexion]
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| * list server subscription for automatic e-mail notifications of medical-related generic communications, Federal Register Notices, and NRC newsletters
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| * forms (e.g., Training and Experience for authorized users, authorized medical physicists, authorized nuclear pharmacists, and radiation safety officers; License Applications; Disposition of Materials)
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| NUREG-1556, Volume 9, Revision 3, is not a substitute for NRC or Agreement State regulations. The approaches and methods described in this report are provided for information only. Methods and solutions different from those described in this report may be acceptable, if they include a basis for the staff to make the determinations needed to issue or renew a license.
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| The comments received during the public comment period for NUREG-1556, Volume 9, Revision 3, were summarized and addressed in a document that can be located on the NRCs Agencywide Documents and Management System (ADAMS) under ML18327A102. Access to ADAMS is available on the public Web site at https://www.nrc.gov/reading-rm/adams.html.
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| The comments NRC received included general corrections and comments on patient release, radiation safety officer functions, and security of nuclear materials.
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| Andrea L. Kock, Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards vi
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| TABLE OF CONTENTS ABSTRACT ...............................................................................................................................iii FOREWORD ..............................................................................................................................v FIGURES ...................................................................................................................................xi TABLES ....................................................................................................................................xi ACKNOWLEDGMENTS ..........................................................................................................xiii ABBREVIATIONS ....................................................................................................................xv 1 OVERVIEW ..................................................................................................................1-1 1.1 Purpose of Report .............................................................................................1-1 1.2 Types of Licenses .............................................................................................1-6 1.2.1 Specific License of Limited Scope .........................................................1-7 1.2.2 Specific License of Broad Scope ...........................................................1-8 1.2.3 Research Involving Human Subjects .....................................................1-8 1.2.4 General In Vitro License ........................................................................1-8 1.3 Other Requirements..........................................................................................1-9 1.3.1 The As Low As Is Reasonably Achievable (ALARA) Requirement ........1-9 1.3.2 Office of Management and Budget (OMB) Clearances ........................1-10 2 AGREEMENT STATES ...............................................................................................2-1 2.1 Jurisdiction Determination .................................................................................2-1 2.2 Reciprocal Recognition of Specific Licenses .....................................................2-3 3 MANAGEMENT RESPONSIBILITY .............................................................................3-1 3.1 Commitments and Responsibilities ...................................................................3-1 3.2 Safety Culture ...................................................................................................3-2 4 APPLICABLE REGULATIONS ....................................................................................4-1 5 HOW TO FILE ..............................................................................................................5-1 5.1 Application Preparation .....................................................................................5-1 5.2 Where to File ....................................................................................................5-1 5.3 Paper Applications ............................................................................................5-2 5.4 Electronic Applications ......................................................................................5-2 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION.................................6-1 7 APPLICATION AND LICENSE FEES ..........................................................................7-1 8 CONTENTS OF AN APPLICATION .............................................................................8-1 8.1 Item 1: License Action Type .............................................................................8-2 8.2 Item 2: Name and Mailing Address of Applicant ...............................................8-2 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed .......................................................................................8-3 8.4 Item 4: Person To Be Contacted About This Application ..................................8-4 8.5 Item 5: Radioactive Material .............................................................................8-5 8.5.1 Byproduct Material and Depleted Uranium ............................................8-5 8.5.2 Financial Assurance and Recordkeeping for Decommissioning .............8-9 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used ........................8-12 vii
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| 8.7 Item 7: Individual(s) Responsible for the Radiation Safety Program and Their Training and Experience ...........................................................8-14 8.7.1 Radiation Safety Officer (RSO) and Associate Radiation Safety Officers (ARSOs).................................................................................8-16 8.7.2 Authorized Users (AUs) .......................................................................8-26 8.7.3 Authorized Nuclear Pharmacist (ANP).................................................8-32 8.7.4 Authorized Medical Physicist (AMP) ....................................................8-35 8.7.5 Ophthalmic Physicist ...........................................................................8-39 8.7.6 Individuals Authorized for Nonmedical Use .........................................8-41 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas .................................................................................................8-42 8.9 Item 9: Facilities and Equipment ....................................................................8-44 8.9.1 Facility Diagram...................................................................................8-45 8.9.2 Radiation Monitoring Instruments ........................................................8-51 8.9.3 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct Material ............................................8-52 8.9.4 Manual Brachytherapy Sources and Sealed Sources in Therapy Unit - Calibration and Use ...................................................................8-55 8.9.5 Other Equipment and Facilities ............................................................8-57 8.10 Item 10: Radiation Safety Program ................................................................8-61 8.10.1 Audit and Review Program................................................................8-62 8.10.2 Occupational Dose ............................................................................8-63 8.10.3 Public Dose .......................................................................................8-68 8.10.4 Operating and Emergency Procedures .............................................8-70 8.10.5 Spill/Contamination Procedures ........................................................8-73 8.10.6 Emergency Procedures for Therapy Devices Containing Sealed Sources.............................................................................................8-74 8.10.7 Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy Devices Containing Sealed Sources ...............................8-76 8.10.8 Ordering and Receiving ....................................................................8-77 8.10.9 Opening Packages ............................................................................8-78 8.10.10 Material Receipt and Accountability ..................................................8-78 8.10.11 Leak Tests ........................................................................................8-81 8.10.12 Area Surveys ....................................................................................8-83 8.10.13 Procedures for Administrations When a Written Directive Is Required ...........................................................................................8-86 8.10.14 Safe Use of Unsealed Licensed Material...........................................8-87 8.10.15 Safety Procedures for Treatment When Patients are Hospitalized ......................................................................................8-88 8.10.16 Release of Patients or Human Research Subjects ............................8-89 8.10.17 Mobile Medical Service .....................................................................8-90 8.10.18 Minimization of Contamination ..........................................................8-91 8.10.19 Records of Dosages and Use of Brachytherapy Sources ..................8-92 8.10.20 Recordkeeping ..................................................................................8-93 8.10.21 Reporting ..........................................................................................8-94 8.10.22 Transportation ...................................................................................8-94 8.10.23 Security Program for Category 1 and Category 2 Radioactive Material .............................................................................................8-97 8.11 Item 11: Waste Management .........................................................................8-98 8.12 Item 12: License Fees ..................................................................................8-103 8.13 Item 13: Certification ....................................................................................8-103 viii
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| 9 LICENSE AMENDMENTS AND RENEWALS ..............................................................9-1 9.1 Timely Submittals of Amendments and Renewals.............................................9-1 9.2 Timely Notification of Transfer of Control ..........................................................9-2 9.2.1 Transfer of Control ................................................................................9-2 9.2.2 Notification of Bankruptcy Proceedings .................................................9-3 9.2.3 Other Required Notifications..................................................................9-3 10 APPLICATIONS FOR EXEMPTIONS ........................................................................10-1 11 TERMINATION OF ACTIVITIES ................................................................................11-1 APPENDICES APPENDIX A SAFETY CULTURE POLICY STATEMENT ............................................... A-1 APPENDIX B U.S. NUCLEAR REGULATORY COMMISSION FORM 313 ...................... B-1 APPENDIX C SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN ITEMS 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY COMMISSION FORM 313 ................................................ C-1 APPENDIX D DOCUMENTATION OF TRAINING AND EXPERIENCE TO IDENTIFY INDIVIDUALS ON A LICENSE .................................................................. D-1 APPENDIX E U.S. NUCLEAR REGULATORY COMMISSION FORM 313A SERIES...... E-1 APPENDIX F CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390) ...F-1 APPENDIX G MODEL PROCEDURES FOR DOSE CALIBRATOR CALIBRATION........ G-1 APPENDIX H MODEL PROCEDURES FOR REMOTE AFTERLOADER SPOT-CHECKS ......................................................................................... H-1 APPENDIX I RADIATION SAFETY OFFICER DUTIES, RESPONSIBILITES, AND DELEGATION ..............................................................................................I-1 APPENDIX J MODEL TRAINING PROGRAM .................................................................. J-1 APPENDIX K GENERAL RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND SURVEY INSTRUMENT CALIBRATION PROGRAM ....................................................................... K-1 APPENDIX L MODEL MEDICAL LICENSEE AUDIT ........................................................L-1 APPENDIX M MODEL PROCEDURES FOR OCCUPATIONAL DOSE MONITORING PROGRAM ................................................................................................. M-1 APPENDIX N GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES AND MODEL EMERGENCY PROCEDURES ............................................ N-1 APPENDIX O MODEL PROCEDURES FOR ORDERING AND RECEIVING PACKAGES ............................................................................................... O-1 APPENDIX P MODEL PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL ................................................ P-1 APPENDIX Q MODEL LEAK TEST PROGRAM .............................................................. Q-1 APPENDIX R MODEL PROCEDURES FOR AREA SURVEY.......................................... R-1 APPENDIX S MODEL PROCEDURES FOR DEVELOPING, MAINTAINING, AND IMPLEMENTING WRITTEN DIRECTIVES ................................................. S-1 APPENDIX T MODEL PROCEDURES FOR SAFE USE OF UNSEALED LICENSED MATERIAL ..................................................................................................T-1 APPENDIX U RELEASE OF PATIENTS OR HUMAN RESEARCH SUBJECTS ADMINISTERED RADIOACTIVE MATERIALS ........................................ U-1 APPENDIX V RADIOACTIVE MATERIALS GUIDANCE FOR MOBILE MEDICAL SERVICES ................................................................................................. V-1 ix
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| APPENDIX W MODEL PROCEDURES FOR WASTE DISPOSAL BY DECAY-IN-STORAGE, GENERATOR RETURN, LICENSED MATERIAL RETURN AND DISPOSAL OF LIQUIDS INTO SANITARY SEWERAGE .......................................................................... W-1 APPENDIX X RECORDKEEPING REQUIREMENTS ...................................................... X-1 APPENDIX Y REPORTING REQUIREMENTS ................................................................. Y-1 APPENDIX Z
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| ==SUMMARY==
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| OF DOT REQUIREMENTS FOR TRANSPORTATION OF TYPE A, TYPE B, OR LIMITED QUANTITIES OF LICENSED MATERIAL ..................................................................................................Z-1 x
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| FIGURES Figure Page 2-1 U.S. Map: Locations of NRC Offices and Agreement States........................................2-1 8-1 Location of Use ............................................................................................................8-3 8-2 Licensing Examples of Potential Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) Arrangements .........................................8-19 8-3 Facility Diagram for Nuclear Medicine Suite ...............................................................8-46 8-4 Facility Diagram for PET Suite ....................................................................................8-47 8-5 Facility Diagram for HDR Suite ...................................................................................8-49 8-6 Annual Occupational Dose Limits for Adults ...............................................................8-65 TABLES Table Page 1-1 Sections of NUREG-1556, Volume 9, Revision 3, That Applicants for a Particular Type of Use Should Review..........................................................................1-2 2-1 Who Regulates the Activity? .........................................................................................2-2 3-1 Traits of a Positive Safety Culture.................................................................................3-4 8-1 Worksheet for Determining Need for Financial Assurance for Sealed Sources ...........8-11 8-2 Guidance on Personnel Monitoring and Bioassay ......................................................8-67 C-1 Items 5 and 6 on NRC Form 313: Radioactive Material and Use ............................... C-2 C-2 Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal .......................... C-8 C-3 Applicable Appendices Describing Model Procedures .............................................. C-30 K-1 Typical Survey Instruments ........................................................................................ K-1 M-1 Investigational Levels ................................................................................................. M-4 N-1 Relative Hazards of Common Radionuclides .............................................................. N-2 R-1 Ambient Dose Rate Trigger Levels ............................................................................. R-2 R-2 Surface Contamination Levels in Restricted Areas (dpm/100 cm2) ............................. R-3 R-3 Acceptable Surface Contamination Levels in Unrestricted Areas (per 100 cm2) ......... R-4 X-1 Typical Records and Retention Times ........................................................................ X-1 Y-1 Typical NRC Notifications and/or Reports................................................................... Y-1 xi
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| ACKNOWLEDGMENTS The working group would like to thank the staff in the regional offices of the U.S. Nuclear Regulatory Commission, the Advisory Committee on the Medical Uses of Isotopes, and all of the States who provided comments and technical information that assisted in the development of this report.
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| The working group also thanks Lisa Dimmick, John ODonnell, Monica Ford, Tara Weidner, Tomas Herrera, Duane White, Said Daibes, and Toye Simmons for developing the formatting and language used in many parts of the report. Lastly, the working group thanks Dr. Vincent Holahan and Jeff Kowalczik for providing technical information and support.
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| The Participants for this Revision Burkhart, Mary Cook, Jackie Forster, Sara Howe, Donna-Beth Lanzisera, Penny Tapp, Katie xiii
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| ABBREVIATIONS AAPM American Association of Physicists in Medicine AEA Atomic Energy Act ACMUI Advisory Committee on the Medical Uses of Isotopes ALARA as low as is reasonably achievable ALI annual limit on intake AMP authorized medical physicist ANP authorized nuclear pharmacist ANSI American National Standards Institute ARSO Associate Radiation Safety Officer AU authorized user AUD Authorized User Diagnostic AUS Authorized User Sealed Source AUT Authorized User Therapy bkg background Bq becquerel CEDE committed effective dose equivalent CFR Code of Federal Regulations Ci curie cc cubic centimeter cm centimeter cm2 square centimeter Co-57 cobalt-57 cpm counts per minute Cs-137 cesium-137 DAC derived air concentration DDE deep-dose equivalent DFP decommissioning funding plan DOT U.S. Department of Transportation dpm disintegrations per minute EPAct Energy Policy Act of 2005 FA financial assurance FDA U.S. Food and Drug Administration Ga-68 gallium-68 GBq gigabecquerel Ge-68 Germanium-68 GM Geiger-Mueller GSR gamma stereotactic radiosurgery HDR high dose-rate h hour I-125 iodine-125 I-131 iodine-131 ICRP International Commission on Radiological Protection IN Information Notice Ir-192 iridium-192 kBq kilobecquerel L/C License Condition LDR low-dose rate LLEA local law enforcement agency LSC Liquid scintillation counter xv
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| MARSSIM Multi-Agency Radiation Survey and Site Investigation Manual MBq megabecquerel MDA minimum detectable activity MDR medium-dose rate mGy milliGray MML Master Materials License mCi millicurie mg milligram Mo-99 molybdenum-99 mR milliroentgen mrad millirad mrem millirem mSv millisievert NaI sodium iodide NARM Naturally-Occurring and Accelerator-Produced Radioactive Material nCi nanocuries NCRP National Council on Radiation Protection and Measurements NIST National Institute of Standards and Technology NMSS Office of Nuclear Material Safety and Safeguards NORM Naturally Occurring Radioactive Material NRC U.S. Nuclear Regulatory Commission NSTS National Source Tracking System NSTTR National Source Tracking Transaction Report NVLAP National Voluntary Laboratory Accreditation Program OSL optically stimulated luminescence dosimeter OMB Office of Management and Budget PET Positron Emission Tomography P-32 phosphorus-32 PDR pulsed dose-rate PII Personally Identifiable Information Q quality factor QA quality assurance R roentgen Ra-226 radium-226 Rb-82 rubidium-82 RG Regulatory Guide RIS Regulatory Issue Summary RSC Radiation Safety Committee RSO Radiation Safety Officer SDE shallow-dose equivalent Sm-153 samarium-153 Sr-82 strontium-82 Sr-85 strontium-85 Sr-90 strontium-90 SSD sealed source and device std standard Sv Sievert Tc-99m technetium-99m TEDE total effective dose equivalent TI Transport Index TLD thermoluminescent dosimeter xvi
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| U-235 uranium-235 UN United Nations U.S.C. United States Code WD written directive Y-90 yttrium-90 yr year
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| µCi microcurie
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| µGy microGray WBL Web Based Licensing System WD written directive xvii
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| 1 OVERVIEW Part 35 Applicability 1.1 Purpose of Report 100 This report provides guidance to an applicant applying for medical 200 use of byproduct material 300 400 and also provides the U.S. Nuclear Regulatory Commission (NRC) 500 staff with the criteria for evaluating such applications. This 600 NUREG uses the terms byproduct material, licensed material, and radioactive material interchangeably. 1000 Chapter 8, Contents of an Application, of this report identifies the information needed to complete the following application form: NRC Form 313, Application for Materials License (see Appendix B of this NUREG), for medical use of byproduct material. Additionally, this report identifies the information needed to demonstrate necessary training and experience for individuals the applicant or licensee wishes to have listed on the license.
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| This NUREG outlines NRC criteria for evaluating a medical use license application and provides guidance for the following types of medical uses of byproduct material:
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| * use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive (WD) is not required under Title 10 of the Code of Federal Regulations (10 CFR) 35.40, Written Directives (see Subpart D, 10 CFR 35.100-190)
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| * use of unsealed byproduct material for imaging and localization studies for which a WD is not required under 10 CFR 35.40 (see Subpart D, 10 CFR 35.200-290)
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| * use of unsealed byproduct material for which a WD is required under 10 CFR 35.40 (see Subpart E, 10 CFR 35.300-396)
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| * use of sources for manual brachytherapy (see Subpart F, 10 CFR 35.400-491)
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| * use of sealed sources for diagnosis (see Subpart G, 10 CFR 35.500-590)
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| * use of a sealed source in a photon emitting remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit (see Subpart H, 10 CFR 35.600-690)
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| * other medical uses of byproduct material or radiation from byproduct material not specifically covered by 10 CFR Part 35, Medical Use of Byproduct Material, Subparts 10 CFR 35.100 through 35.600 (see Subpart K, 10 CFR 35.1000)
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| To assist applicants, this NUREG includes gray text boxes at the beginning of each section to indicate the type of use to which the guidance pertains. These boxes are intended to guide the applicant through the sections of the guidance that are relevant to the applicants particular type of use of byproduct material. A bullet indicates that applicants for that type of use should review the guidance section. Table 1-1 summarizes the material in the text boxes.
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| 1-1
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| Table 1-1. Sections of NUREG-1556, Volume 9, Revision 3, That Applicants for a Particular Type of Use Should Review Type of Part 35 Use NUREG-1556-Volume 9, Rev. 3 Section: 100 200 300 400 500 600 1000 8.1 License Action Type 8.2 Name and Mailing Address of Applicant 8.3 Address(es) Where Licensed Material Will Be Used or Possessed 8.4 Person to Be Contacted about This Application 8.5.1 Byproduct Material and Depleted Uranium 8.5.2 Financial Assurance and Recordkeeping for Decommissioning 8.6 Purpose(s) for Which Licensed Material Will Be Used 8.7 Individual(s) Responsible for Radiation Safety Program and Their Training and Experience 8.7.1 Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) 8.7.2 Authorized Users (AUs) 8.7.3 Authorized Nuclear Pharmacist (ANP) 8.7.4 Authorized Medical Physicist (AMP) 8.7.5 Ophthalmic Physicist 8.8 Training for Individuals Working In or Frequenting Restricted Areas 8.9 Facilities and Equipment 8.9.1 Facility Diagram 8.9.2 Radiation Monitoring Instruments 8.9.3 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct Material 8.9.4 Manual Brachytherapy Sources and Sealed Sources in Therapy Unit - Calibration and Use 8.9.5 Other Equipment and Facilities 8.10 Radiation Protection Program 8.10.1 Audit and Review Program 8.10.2 Occupational Dose 8.10.3 Public Dose 8.10.4 Operating and Emergency Procedures 8.10.5 Spill/Contamination Procedures 8.10.6 Emergency Procedures for Therapy Devices Containing Sealed Sources 8.10.7 Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy Devices Containing Sealed Sources 1-2
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| Table 1-1. Sections of NUREG-1556, Volume 9, Revision 3, That Applicants for a Particular Type of Use Should Review Type of Part 35 Use NUREG-1556-Volume 9, Rev. 3 Section: 100 200 300 400 500 600 1000 8.10.8 Ordering and Receiving 8.10.9 Opening Packages 8.10.10 Material Receipt and Accountability 8.10.11 Leak Tests 8.10.12 Area Surveys 8.10.13 Procedures for Administrations When a Written Directive Is Required 8.10.14 Safe Use of Unsealed Licensed Material 8.10.15 Safety Procedures for Treatment When Patients Are Hospitalized 8.10.16 Release of Patients or Human Research Subjects 8.10.17 Mobile Medical Service 8.10.18 Minimization of Contamination 8.10.19 Records of Dosages and Use of Brachytherapy Source 8.10.20 Recordkeeping 8.10.21 Reporting 8.10.22 Transportation 8.10.23 Security Program for Category 1 and Category 2 Radioactive Materials 8.11 Waste Management 8.12 License Fees 8.13 Certification Applicants should also be aware that 10 CFR Part 35 contains general information, administrative requirements, and technical requirements that are pertinent to some or all of the types of use listed above. See 10 CFR 35.1 through 35.92.
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| This NUREG is intended to consolidate, into one document, guidance that relates to satisfying regulations other than 10 CFR Part 35 that apply to medical use licensees, including the following:
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| * Provisions of 10 CFR Part 20, Standards for Protection Against Radiation, that relate to radiation safety
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| * Provisions of 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, that relate to licensing (e.g., 10 CFR 30.33, General requirements for issuance of specific licenses)
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| This NUREG does not address certain aspects of licensing and radiation safety for the medical use of byproduct materials. In particular, applicants and licensees should consider the following:
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| * NUREG-1556, Volume 15, Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses 1-3
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| * 10 CFR Part 19, Notices, Instructions and Reports to Workers: Inspection and Investigations
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| * 10 CFR Part 21, Reporting of Defects and Noncompliance Other regulatory requirements potentially applicable to medical use licensees are listed in Chapter 4, Applicable Regulations. Section 1.2.2. Specific License of Broad Scope, provides a general discussion on specific licenses of broad scope. NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope, provides additional licensing guidance on medical use programs of broad scope.
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| This NUREG does not address the commercial aspects of manufacturing, distribution, and service of sources containing byproduct material in devices. Applicants should review NUREG-1556, Volume 12, Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution, and NUREG-1556, Volume 18, Program-Specific Guidance About Service Provider Licenses.
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| This NUREG does not address the accelerator production of radionuclides by the medical use applicant for either commercial or noncommercial distribution of radionuclides. Applicants should review NUREG-1556, Volume 13, Program-Specific Guidance About Commercial Radiopharmacy Licenses, and NUREG-1556, Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator, for additional guidance. Consortium, as used here and in 10 CFR Part 30, is defined as an association of medical use licensees and a Positron Emission Tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distribution among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution, a Federal facility, or a medical facility.
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| As a guidance document intended to assist a wide variety of applicants, this NUREG contains a considerable amount of information about how licensees may choose to implement programs to meet NRC regulatory requirements. The information in this NUREG is not intended to impose any conditions beyond those required by the regulations in 10 CFR. This NUREG provides specific guidance on what information should be submitted in an application to satisfy NRC requirements. Except for procedures required by Subpart H, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units, of 10 CFR Part 35, written procedures do not need to be submitted as part of the license application.
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| Guidance and model procedures provided in this NUREG that are not required to be submitted are for illustrative purposes to guide applicants in developing programs. Use of the word should implies may and is not intended to mean must or shall; the procedures provided in this NUREG are intended to serve only as examples.
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| Chapters 1 through 7 of this NUREG provide background information. Chapter 8 describes, item by item, the information that should be provided in Items 1 through 11 of NRC Form 313, in completing a license application.
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| 1-4
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| The format within this NUREG for each item of technical information is as follows:
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| * Regulationsreferences the regulations applicable to the item.
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| * Criteriaoutlines the criteria used to evaluate the applicants response.
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| * Discussionprovides additional information about the topic.
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| * Response from Applicantprovides suggested response or responses, offers the option of an alternative reply, or indicates that no response is required on that topic during the licensing process.
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| Notes and references are self-explanatory and may not be found for each item on NRC Form 313. Sentences in this NUREG containing must and will are usually associated with NRC regulations. If these sentences are not tied to a regulatory requirement, they likely refer to a license condition or other obligation associated with the license. See NUREG-1556, Volume 20, Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures, for further information on license conditions.
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| Some sections of this NUREG include references to other documents or resources that may be useful to the applicant. If references, resource documents, or other resources include information conflicting with current regulations, the regulations in 10 CFR apply. For example, some references or resources may include alternate limits for occupational and public dose; however, licensees should note that the limits in 10 CFR Part 20 are applicable. Many of the documents may be accessed online at the NRC Library. See the Notice of Availability on the inside front cover of this report for more information.
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| NRC Form 313 does not have sufficient space to provide full responses to Items 5 through 11, as indicated on the form. Applicants should address those items on separate sheets of paper and submit them along with the completed NRC Form 313. For the convenience and streamlined handling of medical use applications, Appendix C of this NUREG may be used to provide supporting information. Additionally, Appendix D of this NUREG describes how to document the training and experience for individuals the applicant or licensee wishes to have listed on the license. The NRC Form 313A series can be used to provide training and experience documentation (see Appendix E).
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| Other appendices to this report provide the following supplementary information:
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| * Appendix A provides a copy of the NRCs Safety Culture Policy Statement.
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| * Appendix B includes NRC Form 313.
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| * Appendix F provides a checklist for withholding proprietary information.
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| * Appendices G through W provide model procedures.
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| * Appendices X, Y, and Z provide recordkeeping, reporting, and transportation requirements, respectively.
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| In this NUREG, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective 1-5
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| dose equivalent, as defined in 10 CFR Part 20. To describe units of radiation exposure or dose, rem and its International System of Units equivalent, sievert (Sv) (1 rem = 0.01 Sv), are used.
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| This is because 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad (Gray).
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| When the radioactive material emits beta and gamma rays, 1 roentgen is assumed to equal 1 rad, which is assumed to equal 1 rem. For alpha and neutron emitting radioactive material, 1 rad is not equal to 1 rem. Determination of dose equivalent (rem) from absorbed dose (rad) from alpha particles and neutrons requires the use of an appropriate quality factor (Q) value.
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| These Q values are used to convert absorbed dose (rad) to dose equivalent (rem);
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| Tables 1004(b)(1) and (2) in 10 CFR 20.1004, Units of radiation dose, address the Q values for alpha and neutrons.
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| 1.2 Types of Licenses Specific Medical Use License The NRC defines medical use as the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user (10 CFR 35.2, Definitions). An authorized user is defined as a physician, dentist, or podiatrist who meets the training and experience requirements specified in the board certification pathway in the applicable sections of 10 CFR Part 35 or who is identified as an AU(i) on an NRC or Agreement State license, (ii) on a permit issued by an NRC master materials licensee or an NRC master materials broad scope permittee that is authorized to permit the medical use of byproduct material, or (iii) on a permit issued by an NRC or Agreement State broad scope licensee authorized to permit the medical use of byproduct material (10 CFR 35.2).
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| The NRC issues two types of specific licenses for the medical use of byproduct material in medical practices and facilities:
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| * The specific license of limited scope (see Section 1.2.1)
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| * The specific license of broad scope (see Section 1.2.2)
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| Medical use includes research involving human subjects that may occur under either limited scope or broad scope specific licenses (see Section 1.2.3).
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| Although the NRC usually issues a single byproduct materials license to cover an entire radionuclide program, the NRC may issue separate licenses to individual licensees for different medical uses. The NRC does not usually issue separate licenses to different departments in a medical facility or to individuals employed by a medical facility or with whom the medical facility has contracted. Only the facilitys management may sign the license application.
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| General Laboratory License The NRC also issues a general license, pursuant to 10 CFR 31.11, under which a physician, clinical laboratory, or hospital may use byproduct material for certain in vitro clinical or laboratory testing. Such testing does not involve internal or external administration of byproduct material, or the radiation therefrom, to human beings (see Section 1.2.4).
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| 1-6
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| Overview Applicants should study this report, related guidance, and all applicable regulations carefully before completing NRC Form 313 and the NRC Form 313A series of forms. The NRC expects applicants to provide information on specific aspects of the proposed radiation protection program in attachments to NRC Form 313. When necessary, the NRC may ask the applicant for additional information to gain reasonable assurance that an adequate radiation protection program has been established.
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| After a license is issued, the licensee must conduct its program in accordance with the following:
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| * Statements, representations, and procedures contained in the application and in correspondence with the NRC, when incorporated into a license by reference
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| * Terms and conditions of the license
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| * NRC regulations In 10 CFR 30.9, Completeness and Accuracy of Information, the NRC requires that the information in the application be complete and accurate in all material aspects. This includes preceptor attestations for training and experience for authorized individuals, as described in IN 2007-38, Ensuring Complete and Accurate Information in the Documentation of Training and Experience for Individuals Seeking Approval as Medical Authorized Users, December 14, 2007.
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| Information is considered material if it has the ability to change or affect an agency decision on issuing the license.
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| 1.2.1 Specific License of Limited Scope The NRC issues specific medical licenses of limited scope to private or group medical practices and to medical institutions. A medical institution is an organization in which more than one medical discipline is practiced. In general, individual physicians or physician groups located within a licensed medical facility (e.g., hospital) may not apply for a separate license, because 10 CFR 30.33(a)(2) refers to the applicants facilities. Since a physicians group does not normally have control over the facilities, the hospital remains responsible for activities conducted on its premises and must apply for the license. On specific licenses of limited scope, the AUs are specifically listed in the license.
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| Byproduct material may be administered to patients on an inpatient (i.e., hospitalized) or outpatient basis. For patients to whom byproduct material is administered and who are not releasable under 10 CFR 35.75, Release of individuals containing unsealed byproduct material or implants containing byproduct material, inpatient facilities are required. In general, facilities for private and group practices do not include inpatient rooms; therefore, procedures requiring hospitalization of the patient under 10 CFR 35.75 cannot be performed.
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| A specific license of limited scope may also be issued to an entity requesting authorization to perform mobile medical services (10 CFR 35.80, Provision of Mobile Medical Service; 10 CFR 35.647 Additional Technical Requirements for Mobile Remote Afterloader Units).
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| A medical institution or a private or group practice may apply for authorization to use byproduct material in a mobile medical service.
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| 1-7
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| A specific license also may authorize certain nonmedical activities such as sources for self-shielded blood irradiators or calibration and certain in vitro use for materials listed under 10 CFR 31.11 when activity exceeds the quantity listed in 10 CFR 31.11.
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| 1.2.2 Specific License of Broad Scope Medical institutions that provide patient care and conduct research programs that use radionuclides for in vitro, animal, and medical procedures may request a specific license of broad scope in accordance with 10 CFR Part 33. No medical use of byproduct material, including research involving human subjects, may be conducted without an authorization in a license from the NRC or an Agreement State, as provided in 10 CFR Part 35. The criteria for the various types of broad scope licenses are found in 10 CFR 33.13 through 10 CFR 33.17.
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| Generally, the NRC issues specific licenses of broad scope for medical use (i.e., licenses authorizing multiple quantities and types of byproduct material for medical use under 10 CFR Part 35, as well as other uses) to institutions that (i) have experience successfully operating under a specific license of limited scope and (ii) are engaged in medical research and routine diagnostic and therapeutic uses of byproduct material. NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope, offers additional guidance to applicants for a specific license of broad scope.
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| 1.2.3 Research Involving Human Subjects In 10 CFR 35.2, the definition of medical use includes the administration of byproduct material or radiation therefrom to human research subjects. Furthermore, 10 CFR 35.6, Provisions for the protection of human research subjects, addresses the protection of the rights of human subjects involved in research by medical use licensees. For these licensees, prior NRC approval is not necessary if the research is conducted, funded, supported, or regulated by another Federal Agency that has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, the licensee must apply for a specific amendment and receive approval for the amendment before conducting such research. Whether or not a license amendment is required, licensees must obtain informed consent from human subjects and prior review and approval of the research activities by an Institutional Review Board in accordance with the meaning of those terms under the Federal Policy. In accordance with 10 CFR 35.6(a), research involving human subjects shall be conducted only with byproduct materials listed in the license for the uses authorized in the license. IN 2000-19, Implementation of Human Use Research Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials, December 5, 2000, reminds licensees that 10 CFR 35.6 is not a blanket authority to conduct research involving human subjects, and compliance with all regulatory requirements and license conditions is necessary.
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| 1.2.4 General In Vitro License In 10 CFR 31.11, General license for use of byproduct material for certain in vitro clinical or laboratory testing, NRC establishes a general license authorizing physicians, clinical laboratories, and hospitals to receive, acquire, possess, or use small quantities of certain byproduct material for in vitro clinical or laboratory tests not involving medical use (i.e., not involving administration to humans). The regulations in 10 CFR 31.11 explain the requirements for using the materials listed. If the general license alone meets the applicants needs, only NRC Form 483, Registration Certificate-in vitro Testing With Byproduct Material Under General License, needs to be filed with the NRC. Medical use licensees authorized under 10 CFR Part 35 do not need to file the form.
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| 1-8
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| The NRC limits possession to a total of 200 microcuries (µCi) [7.4 megabecquerels (MBq)] of byproduct materials listed in 10 CFR 31.11 at any one time, at any one location of storage or use. The use of materials listed in 10 CFR 31.11 within the inventory limits of that section is subject only to the requirements of that section and not the requirements of 10 CFR Parts 19, 20, and 21, except as set forth in 10 CFR 31.11.
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| An applicant needing more than 200 µCi [7.4 MBq] of these materials must apply for a specific license and may request the increased inventory limit as a separate line item on NRC Form 313.
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| This type of applicant generally requests an increased limit of 3 millicuries (mCi) [111 MBq]. If requesting an increased inventory limit, the applicant will be subject to the requirements of 10 CFR Parts 19, 20, and 21, including the requirements for waste disposal.
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| 1.3 Other Requirements 1.3.1 The As Low As Is Reasonably Achievable (ALARA) Requirement In 10 CFR 20.1101, Radiation protection programs, regulations state that each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and the licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that areALARA. This section also requires that licensees review the content of the radiation protection program and its implementation at least annually. The RSO is responsible for the day-to-day operation of the radiation protection program.
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| References and Resources: Applicants should consider the ALARA philosophy detailed in the following reports when developing plans to work with licensed radioactive materials. The following documents and resources contain information, methods, and references useful to those who are establishing radiation protection programs to maintain radiation exposures at ALARA levels in medical facilities:
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| * Regulatory Guide (RG) 8.10, Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable, August 2016.
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| * RG 8.29, Instruction Concerning Risks from Occupational Radiation Exposure, February 1996.
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| * RG 8.18, Information Relevant to Ensuring that Occupational Radiation Exposures at Medical Institutions Will Be As Low As Is Reasonably Achievable, April 2011.
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| * NUREG-1736, Consolidated Guidance: 10 CFR Part 20-Standards for Protection Against Radiation, contains information directly related to radiation protection standards in 10 CFR Part 20.
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| * National Council on Radiation Protection and Measurements (NCRP) Report No. 107, Implementation of the Principle of As Low As Reasonably Achievable (ALARA) for Medical and Dental Personnel, December 31, 1990.
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| * NCRP Report No. 127, Operational Radiation Safety Program, June 12, 1998.
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| 1-9
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| WRITTEN DIRECTIVE PROCEDURES In 10 CFR 35.41, Procedures for administrations requiring a written directive, certain medical use licensees are required to develop, implement, and maintain written procedures to provide high confidence that before each administration requiring a WD, the patients identity is verified, and the administration is in accordance with the WD. This regulation also specifies what an applicant must, at a minimum, address in these procedures. Appendix S of this NUREG provides further information on developing these procedures.
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| 1.3.2 Office of Management and Budget (OMB) Clearances The information collection requirements in 10 CFR Part 30 and 10 CFR Part 35, NRC Form 313, and the NRC Form 313A series of forms have been approved under the OMB Clearance Numbers 3150-0017, 3150-0010, and 3150-0120, respectively.
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| 1-10
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| 2 AGREEMENT STATES Part 35 Applicability 2.1 Jurisdiction Determination 100 Certain States, called Agreement States (see Figure 2-1), have 200 entered into agreements with the U.S. Nuclear Regulatory 300 Commission (NRC) that give them the authority to license and 400 inspect byproduct, source, and special nuclear materials, in 500 quantities not sufficient to form a critical mass, that are used or 600 possessed within their borders. Any applicant, other than a Federal entity, who wishes to possess or use licensed material in 1000 one of these Agreement States should contact the responsible officials in that State for guidance on preparing an application. These applications should be filed with State officials, not with the NRC. In areas under exclusive Federal jurisdiction within an Agreement State, the NRC continues to be the regulatory authority.
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| Figure 2-1. U.S. Map: Locations of NRC Offices and Agreement States 2-1
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| In the special situation of work at federally controlled sites in Agreement States, it is necessary to ascertain the jurisdictional status of the area to determine whether the NRC or the Agreement State has regulatory authority. These areas can also include Tribal lands of federally recognized Indian Tribes. 3 The NRC has regulatory authority over land determined to be exclusive Federal jurisdiction, while the Agreement State has jurisdiction over nonexclusive Federal jurisdiction land.
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| Applicants are responsible for determining, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. Additional guidance on determining jurisdictional status is found in the Office of Nuclear Material Safety and Safeguards (NMSS) procedures in the State Agreement series, SA-500, Jurisdiction Determination.
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| Table 2-1 provides a quick way to evaluate whether the NRC or an Agreement State has regulatory authority.
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| Table 2-1. Who Regulates the Activity?
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| Applicant and Proposed Location of Work Regulatory Agency Federal agency, regardless of location (except that the U.S. Department of Energy and, under most circumstances, its prime contractors are exempt from licensing, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 30.12, Persons NRC using byproduct material under certain U.S. Department of Energy and U.S. Nuclear Regulatory Commission contracts; also, see 10 FR 40.11, if applicable)
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| Non-Federal entity in non-Agreement State, District of Columbia, NRC U.S. territory or possession, or in offshore Federal waters Federally recognized Indian Tribe or Tribal member on Indian NRC Tribal land Non-Federal entity on federally recognized Indian Tribal land NRC 4 3For the purposes of this guidance, an Indian Tribe is defined as an Indian or Alaska Native tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994. A list of federally recognized Tribes is available at https://www.bia.gov.
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| 4The NRC can exercise jurisdiction as the regulatory authority on Tribal land of a federally recognized Indian Tribe.
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| Section 274b. agreements do not give States the authority to regulate nuclear material in these areas. However, there may be States that exercise regulatory authority over these areas based on treaties or agreements with specific tribes. Companies owned or operated by federally recognized Indian Tribe members or non-Indians who wish to possess or use licensed material on Tribal lands should contact the appropriate NRC regional office to determine the jurisdictional status of the Tribal lands and identify the appropriate regulatory agency for licensing and reciprocity.
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| 2-2
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| Table 2-1. Who Regulates the Activity?
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| Applicant and Proposed Location of Work Regulatory Agency Federally recognized Indian Tribe or Tribal member outside of Indian Agreement State Tribal land in Agreement State.
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| Non-Federal entity in Agreement State Agreement State 5 Non-Federal entity in Agreement State at federally controlled site not Agreement State5 subject to exclusive Federal jurisdiction Non-Federal entity in Agreement State at federally controlled site NRC subject to exclusive Federal jurisdiction Non-Federal entity in Agreement State using radioactive NRC materials (except industrial radiography) directly connected with 10 CFR Part 50 or 10 CFR Part 52 reactor operations or needed during the construction and preoperational phases of a reactor.
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| Non-Federal entity in Agreement State using radioactive materials Agreement State5 not directly connected with 10 CFR Part 50 or 10 CFR Part 52 reactor operations or needed during the construction and preoperational phases of a reactor.
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| ==Reference:==
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| A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) is available on the NMSS Directory of Agreement State and Non-Agreement State Directors and State Liaison Officers. A request for the list can also be made to an NRC regional office.
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| 2.2 Reciprocal Recognition of Specific Licenses Performing licensed activities in other jurisdictions is possible through reciprocal recognition of specific licenses (i.e., reciprocity). Agreement States have reciprocity provisions that permit NRC licensees to perform licensed activities under circumstances when an Agreement State is the regulatory authority (see Section 2.1). NRC licensees and Agreement State licensees are subject to the regulations of the regulatory authority, as indicated in Section 2.1. To ensure compliance with an Agreement States reciprocity requirements, licensees are advised to request authorization from the appropriate Agreement State radiation control program office well in advance of the scheduled use of licensed material.
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| Agreement State licensees that wish to conduct licensed activities in areas under NRC jurisdiction must either obtain a specific NRC license or file for reciprocity with the appropriate NRC regional office for the Agreement State that issued their license. Failure to file for reciprocity or obtain a specific NRC license before working in areas under NRC jurisdiction can result in NRC enforcement action, which may include civil penalties. The reciprocity filing must be renewed annually.
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| 5Section 274m. of the Atomic Energy Act (AEA) withholds to the NRC regulatory authority over radioactive materials covered under the Section 274b. agreements when the activity can affect the Commissions authority to protect the common defense and security, to protect restricted data, or guard against the loss or diversion of special nuclear material. (This is an uncommon situation that NRC usually evaluates on a case-by-case basis.) Individuals or companies wishing to possess or use licensed material should contact the licensee to determine the jurisdictional status for specific AEA radioactive materials they intend to possess or use.
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| 2-3
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| Specific guidance regarding NRC licensees filing for reciprocity in Agreements States and Agreement State licensees filing for reciprocity with the NRC or another Agreement State are provided in NUREG-1556, Volume 19, Consolidated Guidance About Materials Licenses: Guidance for Agreement State Licensees About NRC Form 241 Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity).
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| 2-4
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| 3 MANAGEMENT RESPONSIBILITY The U.S. Nuclear Regulatory Commission (NRC) recognizes that Part 35 Applicability effectiver radiation safety program management is vital for 100 achieving safe, secure, and compliant operations. Consistent 200 compliance with NRC regulations provides reasonable assurance 300 that licensed activities will be conducted safely and that effective management will result in increased safety, security, and 400 compliance. See Title 10 of the Code of Federal Regulations 500 (10 CFR) 35.24, Authority and responsibilities for the radiation 600 protection program. 1000 Management, as used in this volume, pursuant to the definition in 10 CFR 35.2, refers to the chief executive officer or other individual(s) having the authority to administer their licensees activities, or those individuals delegate(s). Any such individual or delegate must have authority and necessary resources to achieve regulatory compliance.
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| 3.1 Commitments and Responsibilities To ensure adequate management involvement in accordance with 10 CFR 35.12(a),
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| Application for license, amendment, or renewal, and 10 CFR 35.24(a), a management representative (i.e., chief executive officer or delegate) must sign the submitted application. If it is not clear whether the application was signed by someone duly authorized to act for and on behalf of the applicant or licensee, NRC license reviewers may ask for additional assurances that the individual who signed the application is duly authorized to act for and on behalf of the applicant or licensee. The signature on an application acknowledges the applicants or licensees commitments and responsibility for the following:
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| * Radiation safety, security, and control of radioactive materials and compliance with regulations.
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| * Completeness and accuracy of the radiation safety records and all information provided to the NRC (10 CFR 30.9).
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| * Knowledge about the contents of the license application.
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| * Compliance with current NRC and U.S. Department of Transportation regulations, the licensees operating, emergency, and security procedures, and NRC license commitments.
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| * Commitment to provide adequate financial and other resources (including space, equipment, personnel, time, and, if needed, contractors) to the radiation protection program to ensure that patients, the public, and workers are protected from radiation hazards and that compliance with regulations is maintained.
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| * Selection and assignment of a qualified individual to serve as the radiation safety officer (RSO), who agrees, in writing, to be responsible for implementing the radiation protection program. The RSO shall have independent authority to stop unsafe 3-1
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| operations and will be given sufficient time to fulfill radiation safety duties and responsibilities.
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| * Commitment to report defects, noncompliances, or reportable events, including medical events in accordance with regulations.
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| * Selection and assignment, if applicable, in writing, of one or more qualified associate radiation safety officers (ARSO) to support the RSO. The RSO, with written agreement of the licensees management, will assign to each ARSO specific duties and tasks restricted to the types of use for which each ARSO is listed on the license.
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| * Commitment to ensure that radiation workers have adequate training.
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| * Prevention of discrimination of employees engaged in protected activities and commitment to provide information to employees about employee protection provisions (10 CFR 30.7, Employee protection).
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| * Commitment to provide information to employees about deliberate misconduct provisions (10 CFR 30.10, Deliberate misconduct).
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| * Commitment to obtain NRCs prior written consent before transferring control of the license (see Section 9.2.1, Transfer of Control, of this NUREG.)
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| * Notification of the appropriate NRC regional administrator, in writing, immediately following the filing of petition for voluntary or involuntary bankruptcy (10 CFR 30.34(h),
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| as discussed further in Section 9.2.2, Notification of Bankruptcy Proceedings, of this NUREG.
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| * Approval of qualified individual(s) to serve as authorized medical physicists, ophthalmic physicists, authorized nuclear pharmacists, and authorized users for licensed activities.
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| For information on inspection, investigation, enforcement, and other compliance programs, see a description of the NRCs Enforcement process at NRC Enforcement Policy and the NRCs Inspection Procedures found on the Medical Uses Licensee Toolkit Web page. In addition, NUREG-1516, Management of Radioactive Material Safety Programs at Medical Facilities may contain useful information in setting up a radiation material safety program.
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| 3.2 Safety Culture Individuals and organizations performing regulated activities are expected to establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. This applies to all licensees; certificate holders; permit holders; authorization holders; holders of quality assurance program approvals; vendors and suppliers of safety-related components; and applicants for a license, certificate, permit, authorization, or quality assurance program approval, subject to NRC authority.
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| Nuclear safety culture is defined in the NRCs Safety Culture Policy Statement (76 FR 34773; June 14, 2011) as the core values and behaviors resulting from a collective commitment by leaders and individuals to emphasize safety over competing goals to ensure protection of people and the environment. Individuals and organizations performing regulated activities bear 3-2
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| the primary responsibility for safely handling and securing these materials. Experience has shown that certain personal and organizational traits are present in a positive safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal-conflict situations (e.g., production versus safety, schedule versus safety, and cost of the effort versus safety). Refer to Table 3-1 for the traits of a positive safety culture from NRCs Safety Culture Policy Statement.
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| Organizations should ensure that personnel in the safety and security sectors have an appreciation for the importance of each, emphasizing the need for integration and balance, to achieve both safety and security in their activities. Safety and security activities are closely intertwined. While many safety and security activities complement each other, there may be instances in which safety and security interests create competing goals. It is important that consideration of these activities be integrated so as not to diminish or adversely affect either; thus, mechanisms should be established to identify and resolve these differences. A safety culture that accomplishes this would include all nuclear safety and security issues associated with NRC-regulated activities.
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| The NRC, as the regulatory agency with an independent oversight role, reviews the performance of individuals and organizations to determine compliance with requirements and commitments through its existing inspection and assessment processes. However, the NRCs Safety Culture Policy Statement and traits are not incorporated into the regulations. Many of the safety culture traits may be inherent to an organizations existing radiation safety practices and programs. For instance, time-outs before a therapeutic procedure may provide an opportunity for the medical team to double-check treatment parameters and the written directive (WD) to reduce the likelihood of a medical event. The use of time-outs may correspond with the safety culture trait Work Processes (the process of planning and controlling work activities is implemented so that safety is maintained) (Table 3-1). However, licensees should be aware that this is just an example and should consider reviewing their radiation safety programs in order to develop and implement a safety culture commensurate with the nature and complexity of their organizations and functions.
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| Refer to Appendix A of this NUREG for the NRCs Safety Culture Policy Statement.
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| More information on NRC activities relating to safety culture can be found on the NRC Safety Culture Web site.
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| 3-3
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| Table 3-1. Traits of a Positive Safety Culture Leadership Safety Values Problem Identification and and Actions Resolution Personal Accountability Leaders demonstrate a Issues potentially impacting All individuals take personal commitment to safety in their safety are promptly responsibility for safety.
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| decisions and behaviors. identified, fully evaluated, and promptly addressed and corrected commensurate with their significance.
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| Environment for Raising Work Processes Continuous Learning Concerns The process of planning and Opportunities to learn about A safety-conscious work controlling work activities is ways to ensure safety are environment is maintained implemented so that safety sought out and implemented. where personnel feel free to is maintained. raise safety concerns without fear of retaliation, intimidation, harassment, or discrimination.
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| Effective Safety Respectful Work Communications Environment Questioning Attitude Communications maintain a Trust and respect permeate Individuals avoid focus on safety. the organization. complacency and continuously challenge existing conditions and activities in order to identify discrepancies that might result in error or inappropriate action.
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| 3-4
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| | |
| 4 APPLICABLE REGULATIONS It is the applicants or licensees responsibility to obtain and have Part 35 Applicability available up-to-date copies of applicable regulations, to read and 100 understand the requirements of each of these regulations, and to 200 comply with each applicable regulation. The following parts of Title 10 of the Code of Federal Regulations (10 CFR) contain 300 regulations applicable to licensing medical use of byproduct 400 material. Some of these parts are specific to one type of license, 500 while others are general and will apply to many, if not all, 600 licensees. 1000 The current versions of the following parts can be found online in the U.S. Nuclear Regulatory Commission (NRC) library using the links provided:
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| * 10 CFR Part 2 Agency Rules of Practice and Procedure
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| * 10 CFR Part 19 Notices, Instructions and Reports to Workers: Inspection and Investigations
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| * 10 CFR Part 20 Standards for Protection Against Radiation
| |
| * 10 CFR Part 21 Reporting of Defects and Noncompliance
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| * 10 CFR Part 30 Rules of General Applicability to Domestic Licensing of Byproduct Material
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| * 10 CFR Part 31 General Domestic Licenses for Byproduct Material
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| * 10 CFR Part 32 Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
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| * 10 CFR Part 33 Specific Domestic Licenses of Broad Scope for Byproduct Material
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| * 10 CFR Part 35 Medical Use of Byproduct Material
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| * 10 CFR Part 37 Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material
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| * 10 CFR Part 40 Domestic Licensing of Source Material
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| * 10 CFR Part 71 Packaging and Transportation of Radioactive Material
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| * 10 CFR Part 150 Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274
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| * 10 CFR Part 170 Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended 4-1
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| * 10 CFR Part 171 Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by the NRC Copies of these documents may be obtained by calling the Government Publishing Office Customer Contact Center toll-free at 866-512-1800, in Washington, DC; calling 202-512-1800; or ordering online at the U.S. Government Bookstore.
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| In addition, 10 CFR Parts 1 through 199 can be found on the NRCs Web site at https://www.nrc.gov/reading-rm/doc-collections/ under Regulations (10 CFR).
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| NRC regulations can also be accessed on the NRC Regulations Web site. Regulations are periodically amended, and the NRC (as well as all other Federal agencies) is required to publish notice of such amendments in the Federal Register.
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| 4-2
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| 5 HOW TO FILE 5.1 Application Preparation Part 35 Applicability 100 Applicants for a materials license should do the following: 200 300
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| * Use the most recent guidance in preparing an application.
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| 400
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| * Complete U.S. Nuclear Regulatory Commission (NRC) 500 Form 313 (Appendix B of this NUREG), Items 1 through 4, 600 12, and 13 on the form itself. 1000
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| * Complete NRC Form 313, Items 5 through 11, on supplementary pages, or use Appendix C of this NUREG.
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| * Complete the appropriate NRC Form 313A series (Appendix E of this NUREG) of forms to document training and experience.
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| * Provide sufficient detail for the NRC to determine that equipment, facilities, training, experience, and the radiation safety program are adequate to protect health and safety and minimize danger to life and property.
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| * For each separate sheet other than the NRC Forms 313 and 313A series (Appendix B and Appendix E of this NUREG) or Appendix C of this NUREG submitted with the application, identify and cross-reference submitted information to the item number on the application or the topic to which it refers.
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| * Avoid submitting proprietary information and personally identifiable information. If submitted, proprietary information and other sensitive information (e.g., personal privacy and security-related) should be clearly identified in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, Public inspections, exemptions, requests for withholding. (see Chapter 6, Identifying and Protecting Sensitive Information.)
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| 5.2 Where to File Applicants wishing to possess or use licensed material in any State, U.S. territory, or U.S. possession subject to NRC jurisdiction must file an application with the NRC regional office for the locale in which the material will be possessed or used. Figure 2-1 identifies the NRCs four regional offices and their respective areas for licensing purposes and the Agreement States. Section 8.10.17, Mobile Medical Service, and Appendix V of this NUREG provide further information on filing procedures for applicants who wish to perform mobile medical services. Note that all materials license applications are submitted to Regions I, III, or IV. All applicants for materials licenses located in the Region II geographical area should send their applications to Region I.
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| In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State and not with the NRC. However, if work will be conducted at federally controlled sites, or federally recognized Indian Tribal lands in Agreement States, applicants must first determine the jurisdictional status of the land in order to 5-1
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| | |
| determine whether the NRC or the Agreement State has regulatory authority. See Chapter 2, Agreement States, for additional information.
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| 5.3 Paper Applications Paper applications received by the NRC are scanned through an optical character reader and converted to an electronic format. To ensure a smooth transfer to an electronic format, applicants should do the following:
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| * Submit all documents, typed, on 81/2 x 11-inch or legal-sized paper that will feed easily into a document scanner.
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| * Choose typeface designs that are sans serif, such as Arial, Helvetica, or Futura (the text of this document is in the Arial font).
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| * Use 11-point or larger font.
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| * Avoid stylized characters, such as script or italics.
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| * Ensure that the print is clear and sharp.
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| * Ensure that there is high contrast between the ink and paper (black ink on white paper is best).
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| Applications must be signed by the applicants or licensees management, as required by 10 CFR 35.12(a). (see Section 8.13, Certification.)
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| 5.4 Electronic Applications Applications may be submitted in electronic form via the NRCs Electronic Information Exchange or CD-ROM. Detailed guidance on making electronic submissions can be obtained by visiting the NRCs e-submittal Web site (http://www.nrc.gov/site-help/e-submittals.html). The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of non-public information.
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| 5-2
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| 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION All licensing applications, except for portions containing sensitive Part 35 Applicability information, will be made available for review in the U.S. Nuclear 100 Regulatory Commissions (NRCs) Public Document Room and 200 electronically at the NRC Library.
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| 300 The applicant or licensee should identify, mark, and protect 400 sensitive information against unauthorized disclosure to the public. 500 License applications that contain sensitive information should be 600 marked, as indicated below, in accordance with Title 10 of the 1000 Code of Federal Regulations (10 CFR) 2.390, before the information is submitted to the NRC. Key examples are as follows:
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| * Proprietary Information and Trade Secrets: If it is necessary to submit proprietary information or trade secrets, follow the procedure in 10 CFR 2.390(b). Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Appendix F includes a checklist for requests for withholding information from public disclosure.
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| * Personally Identifiable Information: Personally identifiable information (PII) about employees or other individuals should not be submitted unless specifically requested by the NRC. Examples of PII are social security number, home address, home telephone number, date of birth, and radiation dose information. If PII is submitted, a cover letter should clearly state that the attached documents contain PII, and the top of every page of a document that contains PII should be clearly marked as follows: Privacy Act InformationWithhold Under 10 CFR 2.390. For further information, see Regulatory Issue Summary (RIS) 2007-04, Personally Identifiable Information Submitted to the U.S. Nuclear Regulatory Commission, dated March 9, 2007, and Information Notice 2013-22, Recent Licensing Submittals Containing Personally Identifiable Information, dated November 15, 2013, which can be found on the NRCs Generic Communications Web page.
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| * Security-Related Sensitive Information: Following the events of September 11, 2001, the NRC changed its procedures to avoid the release of information that terrorists could use to plan or execute an attack against facilities or citizens in the U.S. As a result, certain types of information are no longer routinely released and are treated as sensitive unclassified information. For example, certain information about the quantities and locations of radioactive material at licensed facilities, and associated security measures, are no longer released to the public. Therefore, a cover letter should clearly state that the attached documents contain security-related sensitive information and the top of every page of a document that contains such information should be clearly marked:
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| Security-Related InformationWithhold Under 10 CFR 2.390. For the pages having security-related sensitive information, an additional marking should be included (e.g., an editorial note box) adjacent to that material. For further information, see RIS 2005-31, Rev. 1, Control of Security-Related Sensitive Unclassified Non-Safeguards Information Handled by Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, Byproduct, and Special Nuclear Material, December 26, 2017. Additional information on procedures and any updates are available in the NRC Library on the Withholding of Sensitive Information page.
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| 6-1
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| The regulations list various forms of information that can be protected from public disclosure.
| |
| These include:
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| * trade secrets and commercial or financial information
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| * interagency or intra-agency memoranda or letters that would not be available by law to a party other than an agency in litigation with NRC
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| * certain records or information compiled for law enforcement purposes
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| * geological and geophysical information and data, including maps, or information concerning wells
| |
| * personnel files, medical files, and similar files, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy In 10 CFR 2.390, NRC specifies the procedures and requirements for persons to submit sensitive information to NRC so that it may be properly protected from disclosure.
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| Except for personal privacy information, which is not subject to the affidavit requirement, if NRC determines that the application or affidavit is deficient (i.e., does not contain the required information, as outlined in 10 CFR 2.390), the applicant will be notified that additional information is needed and that the review will continue when the required information is received.
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| If the request is denied, in whole or in part, NRC will give the applicant the option of withdrawing the information or application, as permitted in 10 CFR 2.390. If the applicant decides not to withdraw the information or application, NRC will notify the applicant, in writing, that the request for withholding has been denied and that NRC will disregard any references concerning the proprietary status of the information.
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| Any part of a license application or information provided by a licensee or applicant that the NRC determines should be withheld from public disclosure will be handled in accordance with Management Directive 12.6, NRC Sensitive Unclassified Information Security Program, and the licensee or applicant will be notified, in writing, that NRC plans to honor the request.
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| 6-2
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| Anyone submitting a request to withhold information from public disclosure should thoroughly review 10 CFR 2.390 and be familiar with its requirements and limitations.
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| Withholding from public inspection will not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, NRC may send copies of this information to NRC consultants working in that area. NRC will ensure that the consultants have signed the appropriate agreements for handling proprietary information.
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| If the basis for withholding this information from public inspection should change in the future, such that the information could then be made available for public inspection, the licensee or applicant should promptly notify the NRC. The licensee or applicant also should understand that NRC may have cause to review this determination in the future; for example, if the scope of a Freedom of Information Act request includes the information in question. In all review situations, if NRC makes a determination adverse to the above, the licensee or applicant will be notified in advance of any public disclosure. Anyone submitting commercial or financial information they believe to be privileged, confidential, or a trade secret must remember that the NRCs policy is to achieve an effective balance between legitimate concerns for the protection of competitive positions and the right of the public to be fully apprised of the basis for, and the effects of, licensing or rulemaking actions. It is within NRCs discretion to withhold such information from public disclosure.
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| 6-3
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| | |
| 7 APPLICATION AND LICENSE FEES Each application for which a fee is specified must be accompanied Part 35 Applicability by the appropriate fee. Refer to Title 10 of the Code of Federal 100 Regulations (10 CFR) 170.31, Schedule of fees for materials 200 licenses and other regulatory services, including inspections, and import and export licenses, to determine the amount of the fee. 300 The U.S. Nuclear Regulatory Commission (NRC) will not issue a 400 license until the fee is received. Consult 10 CFR 170.11, 500 Exemptions, for information on exemptions from these fees. 600 Once the technical review of an application has begun, no fees will 1000 be refunded. Application fees will be charged regardless of the NRCs disposition of an application or the withdrawal of an application.
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| Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16, Annual fees:
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| Materials licensees, holders of certificates of compliance, holders of sealed source and device registrations, holders of quality assurance program approvals, and government agencies licensed by the NRC. Consult 10 CFR 171.11 for information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as small entities.
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| Note that in order to pay reduced fees, a licensee that qualifies as a small entity must provide proper certification of this status to the NRC each year, along with its annual fee payment.
| |
| Direct all questions about the NRCs fees or completion of Item 12 of NRC Form 313 to the Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, 301-415-7554. Information about fees may also be obtained by calling NRCs toll-free number, 800-368-5642, extension 415-7554. The e-mail address is Fees.Resource@nrc.gov.
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| 7-1
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| | |
| 8 CONTENTS OF AN APPLICATION The following information applies to the indicated items on U.S. Nuclear Regulatory Commission (NRC) Form 313 (Appendix B of this NUREG).
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| All items in the application should be completed in enough detail for the NRC to determine whether the proposed equipment, facilities, training and experience, and the radiation safety program satisfy regulatory requirements and are adequate to protect public health and safety and minimize danger to life and property. Consideration should be given, when developing the application, to the concepts of keeping exposure as low as is reasonably achievable (ALARA),
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| minimizing contamination, and maintaining control of radioactive materials.
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| Title 10 of the Code of Federal Regulations (10 CFR) 20.1101(b) states: The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). Regulatory Guide (RG) 8.10, Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable, discusses the ALARA concept and philosophy. The application should document ALARA considerations, including establishing administrative action levels and monitoring programs.
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| 10 CFR 20.1406, Minimization of contamination, requires applicants for licenses to describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment; facilitate eventual decommissioning; and minimize, to the extent practicable, the generation of radioactive waste. As with ALARA considerations, applicants should address these concerns for all aspects of their programs.
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| The application should include information on how the licensee will implement the security requirements in 10 CFR 20.1801, Security of stored material, and 10 CFR 20.1802, Control of material not in storage.
| |
| All supplemental information should be provided as an attachment to the applicants signed and dated cover letter or on NRC Form 313. Tables C-1, C-2, and C-3 in Appendix C of this volume are provided to help applicants in submitting information required in Items 5 through 11 of NRC Form 313.
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| Several appendices in this report present sample procedures that applicants may use in developing their procedures. Suggested responses for each block on NRC Form 313 appear under Response from Applicant in this guide.
| |
| All information submitted to the NRC during the licensing process may be incorporated as part of the license and will be subject to review during inspection.
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| 8-1
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| | |
| 8.1 Item 1: License Action Type Item 1 of NRC Form 313 states the following:
| |
| This is an application for (check appropriate item):
| |
| Type of Action License No.
| |
| [ ] A. New License Not Applicable
| |
| [ ] B. Amendment XX-XXXXX-XX
| |
| [ ] C. Renewal XX-XXXXX-XX Check box A for a new license request. Note that a prelicensing visit may be required prior to issuance of the license. Also, note that an on-site security review may be conducted, in addition to the prelicensing visit and before issuance of the license, if the licensee plans to possess Category 1 or Category 2 material, as defined in 10 CFR 37.5.
| |
| Check box B for an amendment to an existing license, and provide the license number.
| |
| Check box C for a renewal of an existing license, and provide the license number.
| |
| See Chapter 9, License Amendments and Renewals, of this NUREG.
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| 8.2 Item 2: Name and Mailing Address of Applicant Regulations: 10 CFR 35.12 Part 35 Applicability 100 List the legal name of the applicants corporation or other legal entity with direct control over use of the radioactive material. A 200 division or department within a legal entity may not be a licensee. 300 An individual may be designated as the applicant only if the 400 individual is acting in a private capacity and the use of the 500 radioactive material is not connected with employment in a 600 corporation or other legal entity. Provide the mailing 1000 address where correspondence should be sent. A post office box number is an acceptable mailing address.
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| Notify the NRC of changes in mailing address. These changes do not require a fee.
| |
| See Section 8.13, Certification for proper signature of NRC forms.
| |
| Note: The NRC must be notified and the transfer approved before control of the license is transferred (see Section 9.2.1, Transfer of Control). The NRC must also be notified when bankruptcy proceedings have been initiated (see Section 9.2.2, Notification of Bankruptcy Proceedings). Guidance on information to be supplied to the NRC is available in NUREG-1556, Volume 15, Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses, and Regulatory Issue Summary (RIS) 2014-08, Rev. 1, Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials Licenses, May 5, 2016.
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| 8-2
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| 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed Regulations: 10 CFR 30.33(a)(2), 10 CFR 30.34(c), 10 CFR 35.12 Part 35 Applicability 100 Specify the street address, city, and State or other descriptive 200 address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each facility 300 at which licensed material will be used or stored. The descriptive 400 address should be sufficient to allow an NRC inspector to find the 500 facility location. A post office box address is not acceptable. 600 See Figure 8-1 below. In addition, applicants are encouraged to 1000 provide global positioning system coordinates, as appropriate, for each permanent storage or use facility.
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| An acceptable location of use or possession specifies street address, city, State, and zip code and does not include a post office box number.
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| Figure 8-1. Location of Use If byproduct material is to be used at more than one location under the license, the specific address (e.g., street and building) must be provided for each facility. If applying for a license for mobile medical services, as authorized pursuant to 10 CFR 35.18(b), the applicant should refer to Section 8.10.17 Mobile Medical Service, and Appendix V of this NUREG for specific licensing guidance. For additional addresses where licensed material will be used or possessed, an amendment must be approved.
| |
| A license amendment is required before receiving, using, or storing licensed material at an address or location not already listed on the license.
| |
| An NRC license does not relieve a licensee from complying with other applicable Federal, State, or local regulations (e.g., local zoning requirements).
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| 8-3
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| | |
| If an applicant submits documents that identify the exact location of use and storage for any amount of radioactive material, the applicant should mark these documents as Security-Related InformationWithhold Under 10 CFR 2.390. See Chapter 6, Identifying and Protecting Sensitive Information, for more details.
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| Response from Applicant:
| |
| * Provide the specific address of each location of use.
| |
| Note: As discussed in Section 8.5.2, Financial Assurance and Recordkeeping for Decommissioning, licensees must maintain permanent records describing where licensed material was used or stored while the license was in effect. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). For medical use licensees, acceptable records include sketches and written descriptions of the specific locations where material is (or was) used or stored and any records of leaking radioactive sources, spills (e.g., where contamination remains after cleanup procedures or when there is reasonable likelihood that contaminants may have spread),
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| damaged devices, or other unusual occurrences involving the possible spread of contamination in or around the licensees facilities.
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| 8.4 Item 4: Person To Be Contacted About This Application Identify the individual who can answer questions about the application, and include a telephone number where the individual may be contacted. Also include business cell phone numbers and e-mail addresses.
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| Note: Contact information provided should not contain Personally Identifiable Information (PII)
| |
| (e.g., home telephone number, personal cellular telephone number, or home email address).
| |
| For additional information on PII, see Chapter 6, Identifying and Protecting Sensitive Information.
| |
| This individual, usually the RSO, will serve as the point of contact during the review of the application. If this individual is not a full-time employee of the licensed entity, his or her position and relationship to the licensee should be specified. The NRC should be notified if the person assigned to this function changes or if his or her telephone number, cell phone number, or e-mail address changes. Notification of a contact change is only provided for informational purposes and would not be considered an application for license amendment, unless the notification involves a change in the contact person who is also the RSO.
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| The individual named in Item 4 might or might not be the same individual who signs the application as the certifying officer on behalf of the licensee with the authority to make commitments to the NRC. (See Item 13 on NRC Form 313.)
| |
| The NRC recognizes that licensees may contract with a consultant or consultant group to help prepare the license application and provide support to the radiation protection program.
| |
| However, the NRC reminds licensees that regardless of the role of the consultant in radiation protection program management, the licensee remains responsible for all aspects of the licensed program, including the services performed by the consultant.
| |
| 8-4
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| | |
| 8.5 Item 5: Radioactive Material 8.5.1 Byproduct Material and Depleted Uranium Regulations: 10 CFR 20.2207, 10 CFR 30.32, 10 CFR 31.11, Part 35 Applicability 10 CFR 32.210, 10 CFR 35.49, 10 CFR 35.65, 10 CFR 35.100, 100 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 200 10 CFR 35.600, 10 CFR 35.1000, 10 CFR Part 37, 10 CFR 40.4, 300 10 CFR 40.25 400 Criteria: Byproduct material for medical use in 10 CFR Part 35 is 500 divided into seven types of use: 10 CFR 35.100, 10 CFR 35.200, 600 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 1000 and 10 CFR 35.1000. Depleted uranium is used in shielding and collimation in medical devices. Licensees must also protect aggregated Category 1 and Category 2 quantities of radioactive material, as defined in 10 CFR 37.5, from theft, diversion, and sabotage.
| |
| Discussion: The applicant should indicate the byproduct material requested. Specifically, NRC Form 313 requests element and mass number, chemical and/or physical form, and the maximum amount that will be possessed at any one time. The applicant should refer to Table C-1 of Appendix C of this NUREG for an acceptable format for describing the radioactive material. The amount and type of information necessary will vary according to the type of use and material requested.
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| As indicated on NRC Form 313 (see Appendix B of this NUREG), Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C of this NUREG for this purpose and should note that using the suggested wording of responses and committing to use the model procedures in this report will facilitate the NRCs review.
| |
| When determining both individual radionuclide and total quantities, all materials to be possessed at any one time under the license should be included [i.e., materials received awaiting use (e.g., new teletherapy or brachytherapy sources for exchange), materials in use or possessed, materials used for shielding, and materials classified as waste awaiting disposal or held for decay-in-storage].
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| 10 CFR 35.100 and 10 CFR 35.200 Use: The chemical/physical form may be Any unsealed byproduct material permitted by 10 CFR 35.100 or 35.200, as appropriate. The total amount requested may be As Needed.
| |
| 10 CFR 35.300 Use: The chemical/physical form may be Any unsealed byproduct material permitted by 10 CFR 35.300. The total amount requested must be specified. Table C-1 of Appendix C of this NUREG provides examples if only one radionuclide is used.
| |
| 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600 Use: The radionuclide; the chemical/physical form (e.g., sealed source or device identified by manufacturer and model number); the activity per source and the total activity in becquerels (Bq), microcuries (µCi), millicuries (mCi), or curies (Ci), including replacement sources; and the maximum number of sources or activity possessed at any one time must be specified. Applicants should include all possible alternate source models they might use to minimize the need for license amendments if they change model or vendor. For 10 CFR 35.500 use, the information described above does not need to be 8-5
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| | |
| provided for calibration, transmission, or reference sources used for medical use if the individual activity or a bundled activity (i.e., several sources bundled together for use) is not greater than the maximum activity of any single source authorized in 10 CFR 35.65. The information described above must be provided for all other sources and devices used under 10 CFR 35.500.
| |
| For therapy devices, the applicant must consider the shipped, installed, and medical use limitations on activity. Limitations are described in the Sealed Source and Device (SSD) registration certificates and U.S. Food and Drug Administration (FDA) 510k certificates.
| |
| Gamma stereotactic radiosurgery (GSR) and teletherapy sources are usually above Category 1 quantities, and co-located high dose-rate (HDR) brachytherapy sources may be at or above Category 2 quantities. The applicant should also review NUREG-2155, Rev. 1, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, and NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material, for additional guidance implementing 10 CFR Part 37 requirements for these therapy devices. Applicant information on manufacturers, model numbers, and possession limits is sensitive and should be marked accordingly. See Chapter 6, Identifying and Protecting Sensitive Information. Category 1 and Category 2 sources regulated by the NRC and Agreement States must be tracked in the National Source Tracking System (NSTS).
| |
| For 10 CFR 35.1000 Use: The radionuclide, the chemical/physical form, and the total amount must be specified. Applicants should refer to the Medical Uses Licensee Toolkit Web page and consult with the appropriate NRC Regional Office to discuss the contents of the application.
| |
| Calibration, Transmission, and Reference Sources: For all calibration, transmission, and reference sources covered under 10 CFR 35.65, the specific sources do not need to be listed on the license as long as the licensee is authorized pursuant to 10 CFR 35.11 for the medical use of byproduct material. However, if the quantity specified in 10 CFR 35.65 is exceeded, the specific sources need to be listed on the license. 10 CFR 35.65 permits use of the calibration, transmission, and reference sources for intentional internal or external administration of byproduct material, or the radiation from byproduct material, to patients or human research subjects (i.e., medical use) in accordance with the requirements in 10 CFR 35.500, in which case they may be used without listing them on the license for medical use. For instance, SPECT may have sources for assessing patient attenuation, and these sources may be possessed under 10 CFR 35.65, as long as the combined activity of the sources do not exceed the quantities specified therein.
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| Shielding Material/Depleted Uranium: Some high-activity radionuclide generators used to produce byproduct materials for 10 CFR 35.200 and 10 CFR 35.300 uses [e.g., technetium-99m (Tc-99m) generators] may include depleted uranium [i.e., uranium depleted in uranium-235 (U-235), as defined in 10 CFR 40.4] as shielding material. If a generator has depleted uranium shielding, an applicant should request authorization to possess depleted uranium as shielding material. Applicants receiving large therapy sources and devices also should determine if depleted uranium is used to shield or collimate the therapy sources and devices. This includes identifying depleted uranium used as shielding in linear accelerators because, even though the NRC does not regulate the accelerator, it does regulate the depleted uranium in the accelerator.
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| If applicable, the applicant should request authorization to possess depleted uranium (i.e., uranium depleted in U-235) in quantities sufficient to include shielding material in both the device(s) and source containers used for source exchange and shielding for other devices. The 8-6
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| applicant should review the manufacturers specifications for each device specified in the license request to determine (i) if depleted uranium is used to shield the source(s) within the device and (ii) the total quantity of depleted uranium present in the device in kilograms. The applicant should also consult the manufacturers specifications or the source supplier to determine if depleted uranium is contained in shielding source containers used during source exchange, as well as the total quantity of depleted uranium in such containers in kilograms.
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| Note: Most depleted uranium used for shielding or beam collimation in therapy devices is covered under a general license in accordance with 10 CFR 40.25. Applicants or licensees may either request to include the depleted uranium on the specific medical license or, as applicable, submit NRC Form 244, Registration Certificate-Use of Depleted Uranium Under General License, to register the material with the NRC.
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| Sealed Sources and Devices: For medical use, licensees may only use sealed sources meeting requirements specified in 10 CFR 35.49. In accordance with 10 CFR 30.32(g),
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| applicants must provide the manufacturers (or distributors) name and model number for each requested sealed source and device (except for calibration, transmission, and reference sources authorized by 10 CFR 35.65 for either medical uses under 10 CFR 35.500 or nonmedical uses under 10 CFR 35.65, and certain Naturally-Occurring and Accelerator-Produced Radioactive Material (NARM) sources for which this information is not available). Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by the NRC or an Agreement State or when information required in 10 CFR 30.32(g)(3) is provided.
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| Applicants will need to request authorization for possession of these sealed source(s) or device(s). The NRC or an Agreement State performs a safety evaluation of sealed sources and devices before authorizing a manufacturer to distribute the sources or devices to specific licensees. The safety evaluation is documented in an SSD registration certificate issued to the manufacturer (or distributor). Prior to 2005, some non-Agreement States may also have performed similar safety evaluations for sealed sources and devices containing NARM, and these safety evaluations may be documented in SSD registration certificates. If the sealed source or device contains NARM material and was produced before the effective date of the rule, November 30, 2007, it may not have an SSD registration certificate and the information required by 10 CFR 32.210 may not be available. If this is the case, the applicant must provide the information required in 10 CFR 30.32(g)(3). For example, if a discrete source of radium (Ra)-226 is requested, provide a complete description of the discrete source, including manufacturer, model number, activity, and intended use. If the sealed source is not registered, include construction and testing of the source, as described in 10 CFR 32.210(c). Requests to license Naturally Occurring Radioactive Material (NORM) should be made to the appropriate regulatory agency. As a result of the Energy Policy Act of 2005 (EPAct), the NRC, and the Agreement States through their agreements with the NRC, regulate discrete sources of Ra-226, accelerator-produced radioactive materials, and other discrete sources of NORM that pose a threat similar to that of a discrete source of Ra-226, as described in the definition of byproduct material in 10 CFR 30.4. Notwithstanding the EPAct, most NORM continues to be regulated by the States. The NRC will only license NORM if it is a discrete source and meets the criteria above. For additional resources and information on the EPAct, including NRCs regulatory authority over NARM, please refer to the NRCs NARM toolkit at https://scp.nrc.gov/narmtoolbox.html.
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| Sources that are authorized under 10 CFR 35.65, Authorization for calibration, transmission, and reference sources, should not be listed when used for either medical uses under 8-7
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| 10 CFR 35.500 or nonmedical uses under 10 CFR 35.65. However, calibration, transmission, and reference sources that do not meet the criteria or exceed the quantity in 10 CFR 35.65 should be listed and specifically described.
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| Applicants and licensees should consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible with each other and that they conform to the SSD registration certificates registered with the NRC or an Agreement State. Licensees may not make any changes to the sealed source, device, or source-device combination that would alter the description or specifications from those indicated in the respective SSD registration certificates without obtaining the NRCs prior permission in a license amendment. Licensees providing information in accordance with the provisions of 10 CFR 30.32(g) may not make changes to the sealed sources, device, or source-device combination that would alter the description or specifications provided to the NRC without obtaining the NRCs prior permission in a license amendment. To ensure that sealed sources and devices are used in ways that comply with the SSD registration certificates, applicants may want to review or discuss them with the manufacturer. The licensee or applicant should contact the manufacturer and distributor of the device for a copy of the SSD registration certificate. If the manufacturer and distributor is no longer in service, the licensee or applicant should contact the NRC or the issuing Agreement State for further guidance. In addition, the International Commission on Radiation Units and Measurements, Certification of Standardized Radioactive Sources, Report No. 12, 1968, contains useful information for standardizing activity measured in sources.
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| Other Material: The applicant should make a separate entry for other required items (e.g., unsealed Ra-226 not previously described, byproduct material for in vitro testing when activity exceeds the quantity listed in 10 CFR 31.11, radiation survey meter calibration source, dosimetry system constancy check source, material for animal or human research studies).
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| Sources that are authorized by 10 CFR 35.65 when used for either medical uses under 10 CFR 35.500 or nonmedical uses under 10 CFR 35.65 should not be listed.
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| Blood Irradiators: If the use of a device to irradiate blood is anticipated, the applicant should review NUREG-1556, Volume 5, Consolidated Guidance About Materials Licenses:
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| Program-Specific Guidance About Self-Shielded Irradiator Licenses, and submit information as applicable. The applicant should also review NUREG-2155, Rev.1, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, and NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material, for additional guidance implementing 10 CFR Part 37 requirements for blood irradiators. Applicant information on manufacturers, model numbers, and possession limits is sensitive and should be marked accordingly. See Chapter 6, Identifying and Protecting Sensitive Information. Category 1 and Category 2 sources regulated by the NRC and Agreement States must be tracked in the NSTS.
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| The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated Category 1 quantity of radioactive material or Category 2 quantity of radioactive material. These terms are defined in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions are listed in Appendix A to 10 CFR Part 37. See Section 8.10.23, Security Program for Category 1 and Category 2 Radioactive Material, of this NUREG for more information on the applicability and requirements of 10 CFR Part 37.
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| 8-8
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| Production of Radionuclides by Accelerators: If the applicant will use an accelerator to produce radionuclides, a separate license application will be needed for the production of the radionuclides. The applicant should review NUREG-1556, Volume 21, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator.
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| Production of PET Radioactive Drugs for Noncommercial Distribution to Medical Use Licensees Within a Consortium: If the applicant will produce Positron Emission Tomography (PET) radioactive drugs for its own medical use and noncommercial distribution to other members of its consortium, the applicant should review NUREG-1556, Volume 13, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses, for production guidance and NUREG-1556, Volume 21, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator.
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| When applying for this authorization, the applicant should also consider applying for authorization to take back potentially contaminated transport shields from other consortium members. Each consortium member should dispose of unused dosages and used syringes and vials at its own facility.
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| Response from Applicant: The applicant should submit the information as described above.
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| When responding to this section, follow the guidance in Chapter 6, Identifying and Protecting Sensitive Information, to determine if the response includes security-related sensitive information and needs to be marked accordingly.
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| 8.5.2 Financial Assurance and Recordkeeping for Decommissioning Regulations: 10 CFR 30.34(b), 10 CFR 30.35, 10 CFR 30.51, Part 35 Applicability 10 CFR 40.36, 10 CFR 40.61 100 Criteria: Licensees authorized to possess licensed material with 200 half-lives greater than 120 days and in excess of the limits 300 specified in 10 CFR 30.35 and 10 CFR 40.36, Financial 400 assurance and recordkeeping for decommissioning, must provide 500 evidence of financial assurance (FA) for decommissioning. 600 1000 Licensees are required to maintain, in an identified location, decommissioning records related to structures and equipment where devices are used or stored, as well as records related to leaking sources. Pursuant to 10 CFR 30.35(g) and 10 CFR 40.36(f), licensees must transfer records important to decommissioning to new proposed licensees before licensed activities are transferred or assigned, according to 10 CFR 30.34(b) and 10 CFR 40.46. Furthermore, pursuant to 10 CFR 30.51(f) and 10 CFR 40.61(f), prior to license termination, each licensee shall forward the records required by 10 CFR 30.35(g) and 10 CFR 40.36(f) to the appropriate NRC regional office.
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| Decommissioning records described above are not required for temporary jobsite locations.
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| Discussion: All licensees are required, under 10 CFR 30.35(g) and 10 CFR 40.36(f), to maintain records important to decommissioning in an identified location. These records must, in part, identify all areas where licensed material is (or was) used or stored and any information relevant to spills (e.g., where contamination remains after cleanup procedures or when there is 8-9
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| a reasonable likelihood that contaminants may have spread), leaking sealed sources, and contamination. All licensees need to maintain records of structures and equipment where radioactive material was used or stored. As-built drawings with modifications of structures and equipment shown as appropriate fulfill this requirement. If as-built drawings are not available, licensees must substitute appropriate records (e.g., a sketch of the room or building or a narrative description of the area) concerning the specific areas and locations. If no records exist regarding structures and equipment where radioactive materials were used or stored, licensees shall make all reasonable efforts to create such records based on historical information (e.g., employee recollections).
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| As an alternative to the potential need for site characterizations, some licensees prefer to maintain information on surveys and leak tests on an ongoing basis and as a low-cost means of providing evidence and assurance of an appropriate decommissioning status upon the termination of licensed activities and/or release of a site for nonlicensed use. Pursuant to 10 CFR 30.35(g) and 10 CFR 40.36(f), licensees must transfer the records important to decommissioning to the new proposed licensee before licensed activities are transferred or assigned, in accordance with 10 CFR 30.34(b), and must transfer records to the appropriate NRC Regional Office before the license is terminated, in accordance with 10 CFR 30.51 and 10 CFR 40.61.
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| Licensees using sealed sources authorized by 10 CFR Part 35 generally use licensed material in a manner that would preclude releases into the environment, would not cause the activation of adjacent materials, and would not contaminate work areas. The licensees most recent leak tests should demonstrate that there has been no leakage from the sealed sources while the sealed sources were in the licensees possession. However, any leakage from sealed sources in excess of the regulatory limits would warrant further NRC review of decommissioning procedures on a case-by-case basis.
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| Licensees authorized to possess byproduct material with half-lives greater than 120 days and in excess of the limits specified in 10 CFR 30.35 or source material meeting the criteria in 10 CFR 40.36 must also provide evidence of FA for decommissioning. The requirements for FA are specific to the types and quantities of radioactive material authorized on a license. Some medical use applicants and licensees may not need to take any action to comply with the FA requirements, because their total inventory of licensed material does not exceed the limits in 10 CFR 30.35 or meet the criteria in 10 CFR 40.36 or because the half-life of the unsealed byproduct material used does not exceed 120 days. Applicants requesting licensed material with a half-life in excess of 120 days should determine whether FA is necessary. In addition, applicants requesting more than one radionuclide must use the sum-of-the-ratios method to determine if FA is needed. If the sum of such ratios for all of the radionuclides possessed exceeds 1 (i.e., unity), applicants must submit evidence of FA for decommissioning.
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| Applications for authorization to possess and use unsealed byproduct material with a half-life exceeding 120 days must be accompanied by a decommissioning funding plan or certification of FA when the trigger quantities given in 10 CFR 30.35 are exceeded. Acceptable methods of providing FA may be found in NUREG-1757, Volume 3, Consolidated Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness. Note that FA is required for two types of licensed materials commonly used at medical licensees facilities: unsealed byproduct material and sealed byproduct material. The total amount of FA required to be provided is the sum of the FA required for each of these types of materials.
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| 8-10
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| The NRC will authorize sealed source possession exceeding the limits given in 10 CFR 30.35(d) without requiring decommissioning FA, for the purpose of a routine sealed source exchange, on a case-by-case basis. For example, the licensee may temporarily exceed the limits in 10 CFR 30.35(d) requiring decommissioning FA during source exchange for GSR.
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| Determining Need for Financial Assurance for Decommissioning The half-lives of most unsealed byproduct material used by medical licensees is less than 120 days. Therefore, most medical use applicants need only consider Germanium (Ge)-68, Ra-226, other long-lived unsealed radionuclides, and licensed material in sealed sources, to evaluate the need for FA.
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| Use Table 8-1 to determine if FA is required for the sealed sources listed. If requesting sealed sources other than those listed or any other unsealed byproduct material with a half-life greater than 120 days, refer to 10 CFR 30.35 and Appendix B to 10 CFR Part 30 for quantities for which FA is required. For source material, see the criteria in 10 CFR 40.36 for radioactive material requiring FA. The sum of the ratios method is also depicted in Table 8-1 and must be used to determine the need for FA for both sealed and unsealed byproduct material.
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| Table 8-1. Worksheet for Determining Need for Financial Assurance for Sealed Sources Step Number Description Cobalt-60 Cesium-137 Strontium-90 1 Activity possessed, in curies*
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| 2 Activity requiring FA, in curies 10,000 100,000 1,000 3 Divide data in Step 1 by data in Step 2 = RATIO 4 Add the ratios determined in Step 3
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| *This table uses only conventional units. The conversion to the International System of units is:
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| 1 curie = 37 gigabecquerels.
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| As 10 CFR 30.35 describes, if the sum of the ratios is greater than or equal to 1, the applicant must submit a decommissioning funding plan or FA, as applicable.
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| Decommissioning Funding Plan for Possession of Germanium-68 (Ge-68)/Gallium-68 (Ga-68) Generators In accordance with 10 CFR 30.35, Financial assurance and recordkeeping for decommissioning, applicants must have a decommissioning funding plan (DFP) to obtain a license to possess Ge-68/Ga-68 generators. The applicant may request an exemption to the DFP requirement pursuant to NRC Memorandum dated July 13, 2017, Revision of Technical Basis for Granting Specific Exemption from Decommissioning Funding Plan Requirement for Germanium-68/Gallium-68 Generators.
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| To request this exemption, provide:
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| * FA as appropriate to the Ge-68 activity
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| * legally binding agreement that is in place with the manufacturer or distributor of the generators that addresses the return of expired generators Licensees that are granted the exemption will have a specific license condition placed on their license addressing the exemption. Refer to the Medical Uses Licensee Toolkit Web page for 8-11
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| more detailed information. A licensees possession of doses of Ga-68, not a Ge-68/Ga-68 generator, would not trigger decommissioning funding requirements.
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| Response from Applicant: No response is required from most applicants. If FA is required, applicants must submit evidence of FA following the guidance of NUREG-1757, Volume 3 Consolidated Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness, February 2012.
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| Note: If applicants have questions about FA requirements, they should consult with the appropriate NRC Regional Office to discuss the contents of their application.
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| 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used Regulations: 10 CFR 30.33(a)(1), 10 CFR 35.100, Part 35 Applicability 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 100 10 CFR 35.600, 10 CFR 35.1000 200 Criteria: Byproduct material for medical use in 10 CFR Part 35 is 300 divided into seven types of use: 10 CFR 35.100, 10 CFR 35.200, 400 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 500 and 10 CFR 35.1000. The applicant should refer to Table C-1 of 600 Appendix C of this NUREG for an acceptable method for 1000 describing the purpose of use.
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| Discussion: The regulations in 10 CFR 30.33(a)(1) require that the application be for a purpose authorized by the Atomic Energy Act of 1954. Details for each purpose of use are listed below.
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| 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.300 Use: The applicant should define the purpose of use by stating the applicable section of 10 CFR Part 35 (e.g., 10 CFR 35.100) and the description of the applicable modality (e.g., any uptake, dilution, and excretion study permitted by 10 CFR 35.100).
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| For licensees conducting sentinel lymph node biopsy, the biopsied tissue may be transferred to a nonlicensed facility for pathology analysis as long as the tissue does not contain more than 100 µCi [3.7 megabecquerels (MBq)] of Tc-99m, which is based on the exemption criteria in 10 CFR 30.18, Exempt Quantities. See RIS 2008-31, Licensing Requirements for Sentinel Lymph Node Biopsy, December 1, 2008, for additional information.
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| If an applicants request is limited to one radionuclide under 10 CFR 35.300, the license will be limited to that radionuclide. In addition, the radionuclide and purpose may be limited, if the AUs training or experience is limited.
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| 10 CFR 35.400 Use: The applicant should define the purpose of use by stating that the applicable section is 10 CFR 35.400, and the use is manual brachytherapy.
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| 8-12
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| In manual brachytherapy, several types of treatments are available. These may include, for example:
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| * interstitial treatment of cancer
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| * eye plaque implants (considered interstitial, not topical, treatment)
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| * intracavitary treatment of cancer (for purposes of the NRCs sealed source and device evaluation on radiation safety issues, intraluminal use is considered analogous to intracavitary use)
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| * topical (surface) applications [e.g., strontium-90 (Sr-90) eye applicators]
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| 10 CFR 35.500 Use: The applicant should define the purpose of use by stating that the applicable use is 10 CFR 35.500 and, if applicable, confirm that the sources requested in Item 5 and the associated devices are compatible. In accordance with 10 CFR 35.65(c), calibration, reference, and transmission sources used under the provisions of 10 CFR 35.500 do not have to be listed on a specific medical use license and therefore will not be listed in item 5.
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| 10 CFR 35.600 Use: The applicant should define the purpose of use by stating the applicable section of 10 CFR 35.600 (e.g., teletherapy, remote afterloading, GSR) and include the manufacturers name(s) and model number(s) of the device(s) containing a sealed source(s)
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| [e.g., for use in a (Manufacturers Name and Unit Type, Model) radiation therapy unit for the treatment of humans]. An applicant may consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible and conform to the SSD registration certificates registered with the NRC or an Agreement State. If applicable, the applicant should specify that authorization is being requested for an additional source to be stored in its shipping container, for source replacement.
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| Shielding Material/Depleted Uranium Use: If applicable, the applicant should state that depleted uranium is used as shielding or collimation for a medical device.
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| 10 CFR 35.1000 Use: The applicant may apply for authorization to use byproduct material, or radiation therefrom, in medical applications under 10 CFR 35.1000 when the type of use is not covered under 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, and 10 CFR 35.600. If an applicant is applying for a medical use for which the NRC has already developed 10 CFR 35.1000 guidance, the applicant should review and follow the applicable licensing guidance posted on NRCs Medical Uses Licensee Toolkit Web site.
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| At the time of publication of this NUREG, known types of currently used medical applications that are licensed under 10 CFR 35.1000 include:
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| * Germanium-68/Gallium-68 Pharmacy Grade Generator
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| * Radioactive Seed Localization of Non-Palpable Lesions and Lymph Nodes
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| * Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon
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| * Yttrium-90 Microspheres
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| * ViewRay System for Radiation Therapy However, applicants should refer to the Medical Uses Licensee Toolkit Web page for current information or consult with the appropriate NRC Regional Office for these and any other medical applications that are not covered under 10 CFR Part 35.100-35.600. Contact your NRC 8-13
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| regional office to discuss a new medical use not currently described in 10 CFR Part 35 or the NRCs Medical Uses Licensee Toolkit Web page.
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| Nonmedical Uses: Applicants may also describe nonmedical uses [e.g., radiation survey meter calibrations with National Institute of Standards and Technology (NIST)-traceable brachytherapy sources] and reference the applicable radioactive material provided in response to Item 5.
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| Response from Applicant: The applicant must submit information regarding the purpose for which the licensed material will be used. The applicant should consider including the information described above, as applicable to the type of use(s) proposed.
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| When responding to this section, follow the guidance in Chapter 6, Identifying and Protecting Sensitive Information, to determine if the response includes security-related sensitive information and needs to be marked accordingly.
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| 8.7 Item 7: Individual(s) Responsible for the Radiation Safety Program and Their Training and Experience Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.24, Part 35 Applicability 10 CFR 35.50, 10 CFR 35.51, 10 CFR 35.55, 10 CFR 35.57, 100 10 CFR 35.59, 10 CFR 35.190, 10 CFR 35.290, 10 CFR 35.390, 200 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 300 10 CFR 35.491, 10 CFR 35.590, 10 CFR 35.690 400 Criteria: The RSO, ARSOs, AUs, AMPs, ophthalmic physicists, 500 and ANPs must have adequate training and experience. 600 1000 Discussion: The requirements in 10 CFR 35.24, Authority and responsibilities for the radiation protection program, describe the authority and responsibilities for the radiation protection program, including those of the licensees management and the RSO appointed by licensee management. Other personnel who have a role in the radiation protection program are ARSOs, AUs, AMPs, ANPs, ophthalmic physicists, and members of the Radiation Safety Committee (RSC), if the licensee is required to establish an RSC. The ARSO, AU, AMP, ophthalmic physicist, ANP, and RSO are defined in 10 CFR 35.2, Definitions. In 10 CFR 30.33(a)(3), the NRC requires that an applicant be qualified by training and experience to use licensed materials for the purposes requested in such a manner as to protect health and minimize danger to life or property. Subparts B, D, E, F, G, and H of 10 CFR Part 35 give specific criteria for acceptable training and experience for AUs for medical use, ANPs, the RSO, ARSO, ophthalmic physicist, and AMPs; individuals authorized for nonmedical uses must meet the criteria in 10 CFR 30.33(a)(3). Individuals authorized for nonmedical uses are sometimes called nonmedical AUs. A nonmedical AU is not AU as defined in 10 CFR 35.2, although an individual could serve as both a medical AU and a nonmedical AU.
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| 8-14
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| The information requested in this section may be submitted using an NRC Form 313A Series Form. Refer to Appendix D for details on how to document training and experience of individuals to be listed on an NRC license. Refer to the current Medical Uses Licensee Toolkit Web page for updates to NRC Form 313A Series Forms and for specific instructions on how to complete them. Also refer to the NRC Forms Web site at:
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| https://www.nrc.gov/reading-rm/doc-collections/forms/ for the NRC Form 313A series. Verify that the most current version of NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form.
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| Applicants should ensure that they submit the specific training information required by NRC regulations in 10 CFR Part 35, Subparts B, D, E, F, G, and H. The NRC Form 313A series of forms provides a suitable format for submitting this information. Submission of a résumé or a curriculum vitae should be avoided because such documents are likely to contain PII (see Chapter 6, Identifying and Protecting Sensitive Information), and the document usually does not supply all the information needed to evaluate an individuals training and experience for NRC purposes. If provided, the applicant should redact all PII from the documents. In addition, 10 CFR 35.57 describes grandfathering of RSOs, AMPs, AUs and ANPs.
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| [Note: Effective January 14, 2019, 10 CFR 35.57 requires that experienced RSOs and AMPs meet the requirements in 10 CFR 35.50(d) or 10 CFR 35.51(c), respectively, for new uses and authorizations. Further, board certified individuals meeting the provisions of 10 CFR 35.57(a)(2), 10 CFR 35.57(a)(3), or 10 CFR 35.57(b)(2), are not required to meet the requirements in Subparts B or D-H of 10 CFR Part 35 for those materials and uses the individual performed on or before October 24, 2005.] For all individuals, 10 CFR 35.59, Recentness of training, requires that individuals obtain the training and experience specified in 10 CFR 35, Subparts B, D, E, F, G, and H, within 7 years preceding the date of application, or the individual must have related continuing education and experience. For individuals authorized for nonmedical use, the information provided should focus on educational training and radiation safety training and experience specific to the radionuclides and uses requested.
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| Licensees may contract for medical use services, including those involving patient services.
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| However, the licensee should not assume that, by hiring a contractor (e.g., consultant) to provide certain services, it has satisfied all regulatory requirements or that it has transferred responsibility for the licensed program to the contractor. Licensee management should ensure that adequate mechanisms for oversight are in place to determine that the radiation protection program, including the training of contractor staff, is effectively implemented by the appropriate individuals.
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| Licensees are responsible for their radiation protection programs; it is essential that management oversight is in place to ensure that licensed activities are in accordance with the regulations and the licensees procedures. The licensees management must appoint an RSO, who agrees, in writing, to be responsible for implementing the radiation protection program and must provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to communicate with personnel and direct personnel regarding NRC regulations and license provisions, including: (i) identifying radiation safety problems; (ii) initiating, (iii) recommending, or providing corrective actions; (iv) stopping unsafe operations; and (v) verifying the implementation of corrective actions. Although not required, the licensees management may appoint one or more ARSOs to support the RSO. The ARSO is delegated radiation safety duties and tasks for the types of uses for which he or she is listed on the license. These duties and tasks are also commensurate with his or her training and 8-15
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| experience. Nevertheless, the licensee retains the ultimate responsibility for the conduct of licensed activities.
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| Licensees that are authorized for two or more different types of uses of byproduct material under 10 CFR Part 35 Subparts E, F, and H, or two or more types of units under Subpart H are required under 10 CFR 35.24(f) to establish an RSC to oversee all uses of byproduct material permitted by the license. Membership in the committee must include an AU for each type of use permitted by the license, the RSO, a representative of the nursing service, and a representative of management who is neither an AU nor the RSO. The committee may include other members the licensee considers appropriate.
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| Response from Applicant: Refer to Sections 8.7.1 - 8.7.5 for each type of individual responsible for the radiation protection program.
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| 8.7.1 Radiation Safety Officer (RSO) and Associate Radiation Safety Officers (ARSOs)
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| Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.13, 10 CFR 35.14, 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.57, Part 35 Applicability 10 CFR 35.59 100 200 Criteria: The licensee must also establish, in writing, the 300 authority, duties, and responsibilities of the RSO, as required by 400 10 CFR 35.24(e). The licensee may appoint one or more ARSOs 500 to support the RSO. The ARSO is delegated radiation safety 600 duties and tasks by the RSO for the types of uses for which he or she is listed on the license. These duties and tasks are also 1000 commensurate with his or her training and experience. The RSO and ARSOs must have adequate training and experience. The training and experience requirements for the RSO and ARSOs are described in 10 CFR 35.50, Training for Radiation Safety Officer and Associate Radiation Safety Officer, and allow for the following training pathways:
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| * Certification, as provided in 10 CFR 35.50(a), by a specialty board whose certification process has been recognized by the NRC or an Agreement State, and completion of training as specified in 10 CFR 35.50(d).
| |
| * Completion of classroom and laboratory training (200 hours) and 1 year of full-time radiation safety experience as described in 10 CFR 35.50(b)(1), plus a written attestation signed by a preceptor RSO or ARSO as provided in 10 CFR 35.50(b)(2), and completion of training as specified in 10 CFR 35.50(d).
| |
| * Certification, as provided in 10 CFR 35.50(c)(1), as a medical physicist under 10 CFR 35.51(a), demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO, and completion of training as specified in 10 CFR 35.50(d).
| |
| * Identification, as provided in 10 CFR 35.50(c)(2), on a Commission or Agreement State license, a permit issued by a Commission master material license, a permit issued by a Commission or Agreement State licensee of broad scope, or a permit issued by a 8-16
| |
| | |
| Commission master material license broad scope permittee as an AU, AMP, or ANP with experience in the radiation safety aspects of similar types of byproduct material use for which the applicant seeks the approval of the individual to serve as the RSO or ARSO, and completion of training as specified in 10 CFR 35.50(d).
| |
| * When simultaneously applying as an AU and RSO, as permitted by 10 CFR 35.50(c)(3),
| |
| completion of training and experience required to be named as an AU and meet the requirements in 10 CFR 35.50(d).
| |
| Discussion:
| |
| Radiation Safety Officer The person responsible for the radiation protection program is the RSO. The RSO is key to overseeing and ensuring safe operation of the licensees radiation protection program. The RSO must have adequate training to understand the hazards associated with radioactive material and be familiar with all applicable regulatory requirements. The RSO should have independent authority to stop operations that he or she considers unsafe. In accordance with 10 CFR 35.24, Authority and responsibilities of the radiation protection program, the licensee must provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to perform his or her duties. Additionally, the RSO must have a sufficient commitment from management to fulfill the duties and responsibilities specified in 10 CFR 35.24 to ensure that radioactive materials are used in a safe manner.
| |
| Typical RSO duties are described in the list below and in Appendix I of this NUREG. The NRC requires the name of the RSO to be listed on the license to ensure that licensee management always has a responsible, qualified person identified and that the named individual knows of his or her designation as RSO. Appendix I of this NUREG also provides a model Delegation of Authority, which should be used to further emphasize the agreement on duties and responsibilities of the RSO by management and the designated RSO. Instructions for documenting training and experience can be found in Appendix D of this NUREG.
| |
| NRC Form 313A (RSO), Radiation Safety Officer or Associate Radiation Safety Officer Training, Experience and Preceptor Attestation [10 CFR 35.57, 10 CFR 35.50], can be found on the Medical Uses Licensee Toolkit Web page. Also refer to the NRC Forms Web site at:
| |
| https://www.nrc.gov/reading-rm/doc-collections/forms/ for NRC Form 313A (RSO). Verify that the most current version of this form is being used by checking the Expires date in the right, top-hand corner of the form. Specific instructions for completing NRC Form 313A (RSO) can also be found at the Medical Uses Licensee Toolkit Web page.
| |
| The RSO is often directly employed by the licensed facility. However, the NRC has authorized individuals who are not directly employed by the licensee, such as consultants, to fill the role of RSO or to provide support to the facility RSO. To fulfill the duties and responsibilities, the RSO should be onsite periodically to conduct meaningful, person-to-person interactions with licensee staff, commensurate with the scope of licensed activities, to satisfy the requirements of 10 CFR 35.24.
| |
| RSO Responsibilities: Some of the typical duties and responsibilities of RSOs include the following:
| |
| * stopping unsafe activities involving licensed materials 8-17
| |
| * developing and maintaining an ALARA program
| |
| * conducting material accountability and disposal
| |
| * interacting with the NRC
| |
| * providing timely and accurate reporting and maintenance of appropriate records
| |
| * conducting annual program audits
| |
| * ensuring proper use and routine maintenance
| |
| * monitoring inventory and leak tests of sealed sources
| |
| * ensuring personnel are trained
| |
| * overseeing ordering, receipt, surveys, and delivery of byproduct material
| |
| * packaging, labeling, surveying, etc., of all shipments of byproduct material leaving the institution
| |
| * overseeing the waste disposal program
| |
| * controlling monitoring programs, including determining the need for and evaluating bioassays, monitoring personnel exposure records, and developing corrective actions for those exposures approaching maximum permissible limits
| |
| * conducting investigations of incidents involving byproduct material (e.g., medical events) and notifying appropriate agencies
| |
| * assigning specific duties and tasks to an ARSO, restricted to the types of use for which the ARSO is listed on the license
| |
| * for licensees possessing an aggregated Category 1 or Category 2 quantity of radioactive material, participating in the development and implementation of a security program for radioactive material in accordance with 10 CFR Part 37. A Category 1 quantity of radioactive material and a Category 2 quantity of radioactive material are defined terms in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions are listed in Appendix A to 10 CFR Part 37.
| |
| Associate Radiation Safety Officer A licensee may choose to identify one or more individuals as ARSOs to support the RSO in accordance with 10 CFR 35.24(b). The ARSOs may be assigned duties and tasks in the oversight of the radiation safety operations of designated sections of the licensed program, but the RSO retains responsibility for all sections of the program. Figure 8-2 provides illustrative examples of potential ARSO duties and tasks with the RSO retaining overall responsibilities for all uses listed on a license in different size programs.
| |
| The ARSOs are required, per 10 CFR 35.50, to complete the same training and experience requirements as the named RSO for their assigned sections of the radiation safety program.
| |
| 8-18
| |
| | |
| The RSO, with written agreement from licensee management, may assign duties and tasks to each ARSO that are limited to the types of use for which the ARSO is listed on the license. The ARSOs would perform duties and tasks in the oversight of the radiation safety operations of their assigned sections of the program, while reporting to the named RSO.
| |
| The regulations continue to allow a licensee to name only one RSO on a license. Licensees with multiple operating locations or multiple types of uses can appoint a qualified ARSO at each location or for each type of byproduct material used. These individuals will be listed on the license as ARSOs. Their assigned sections of the program will also be listed.
| |
| (a)
| |
| (b)
| |
| Figure 8-2. Licensing Examples of Potential Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) Arrangements 8-19
| |
| | |
| (c)
| |
| Figure 8-2. Licensing Examples of Potential Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) Arrangements (Continued)
| |
| (a) A moderate-sized program-the RSO is responsible for the entire program and has direct oversight over the 10 CFR 35.300 and 10 CFR 35.400 medical uses-a single ARSO has oversight duties and tasks for 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.500 medical uses and reports to the RSO.
| |
| (b) A larger, single-campus program-the RSO is responsible for the entire program-there are two ARSOs with oversight duties and tasks over different sections of the program and both report to the RSO.
| |
| (c) A large, multi-campus program-the RSO is responsible for the entire program-there are two ARSOs with oversight duties and tasks over the two smaller campuses. Both ARSOs report to the RSO.
| |
| Before the ARSO may be assigned duties and tasks in the oversight of the radiation safety operations of a different section of the program, the licensee must amend the license and provide documentation that the individual meets the training and experience requirements for the new duties and tasks. As the ARSOs have the same training and experience requirements as an RSO, the ARSOs will qualify to be named as the RSO on other licenses for the types of uses for which they are listed.
| |
| Requirements Applicable to Both RSO and ARSO An AU, AMP, or ANP listed on any license or permit may be identified as an RSO or ARSO, consistent with the individuals training and experience [10 CFR 35.50(c)]. Additionally, both RSOs and ARSOs could serve as preceptors for individuals seeking to be named as the RSO or ARSO on a license [10 CFR 35.50(b)(2)].
| |
| If the individual was board certified by any of the boards listed in 10 CFR 35.57(a)(2) on or before October 24, 2005, the applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to 8-20
| |
| | |
| be an RSO or ARSO for those materials and uses. This documentation will be reviewed on a case-by-case basis to see if the time period of use, the materials used, and the types of use meet the criteria in the regulation. This provision of the rule lets these board certified individuals that were not named as an RSO be grandfathered for those materials and uses that these individuals performed on or before October 24, 2005.
| |
| Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
| |
| Specifically, RSO and ARSO applicants must have successfully completed the applicable training and experience described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, RSO and ARSO applicants must submit documentation for related continuing education and experience since completing the required training and experience.
| |
| This time provision applies to board certification as well as to other pathways to meeting requirements for training and experience.
| |
| Response from Applicant: Provide the following:
| |
| * name of the proposed RSO (RSO is required for all licenses)
| |
| AND
| |
| * name(s) of each proposed ARSO, if desired (A licensee may choose to identify one or more individuals as ARSOs to support the RSO)
| |
| AND
| |
| * for each proposed ARSO, identify the types of use (e.g., 10 CFR 35.200, 10 CFR 35.300) of byproduct material for which the individual may be assigned duties and tasks under the licensees program in oversight of the radiation protection program AND For an individual who is currently or was previously identified as an RSO or ARSO on an NRC or Agreement State license or Master Materials License (MML) permit for the same materials and use
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee on which the individual was named as the RSO or ARSO 1 Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required, as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required 1Some Agreement States may have listed Assistant RSOs on licenses prior to implementing equivalent Agreement State requirements to 10 CFR 35.50, effective January 14, 2019. If an individual is listed on an Agreement State license as an Assistant RSO prior to the Agreement State implementing 10 CFR 35.50, the licensee will have to document that the proposed Associate RSO meets the NRC requirements for an ARSO.
| |
| 8-21
| |
| | |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience as required by 10 CFR 35.59 For an individual who is a current RSO or ARSO seeking authorization to be recognized as an RSO or ARSO for additional medical uses
| |
| * attach documentation of completion of the supervised training and experience specified in 10 CFR 35.50(d) for any new materials or new medical uses requested AND
| |
| * if not qualified under 10 CFR 35.57(a)(1) or board certified by an NRC-recognized board, attach a written attestation as prescribed in 10 CFR 35.50(b)(2), signed by a preceptor RSO or ARSO, that the individual has successfully completed the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and is able to independently fulfill the radiation safety-related duties as an RSO or as an ARSO for a medical use licensee.
| |
| Provide documentation of the board certification, if applicable.
| |
| For an individual qualifying under 10 CFR 35.57(a)(4) because the individual was an RSO for only accelerator-produced materials or discrete sources of Ra-226 or both
| |
| * attach documentation that this individual was the RSO for only medical uses of accelerator-produced radioactive materials, discrete sources of Ra-226, or both, at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC AND
| |
| * attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who is board certified by an NRC-recognized board qualifying under 10 CFR 35.50(a)
| |
| * attach a copy of the board certification issued by a specialty board whose certification process has been recognized 2 by the NRC or an Agreement State under 10 CFR 35.50(a)
| |
| AND
| |
| * attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training 2Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates, as described on the Web page.
| |
| 8-22
| |
| | |
| in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of the individual as the RSO or ARSO AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who is board certified as a medical physicist by an NRC-recognized board qualifying under 10 CFR 35.50(c)(1) [see 10 CFR 35.51(a)]
| |
| * attach a copy of the board certification issued by a specialty board whose certification process has been recognized by the NRC or an Agreement State under 10 CFR 35.51(a) and documentation of the experience specified in 10 CFR 35.50(c)(1) demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of the individual as the RSO or ARSO AND
| |
| * attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of the individual as the RSO or ARSO AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who is board certified by an NRC-recognized board qualifying under 10 CFR 35.57(a)(2):
| |
| * attach a copy of the board certification issued on or before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(a)(2)
| |
| AND
| |
| * attach documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005 AND
| |
| * attach documentation of recent related continuing education and experience, as required by 10 CFR 35.59 For an individual who is an AU, ANP, or AMP qualifying under 10 CFR 35.50(c)(2):
| |
| * attach a copy of the NRC or Agreement State license, permit issued by an NRC master material licensee, permit issued by an NRC or Agreement State licensee of broad scope, or permit issued by an NRC master material license permittee of broad scope indicating 8-23
| |
| | |
| that the individual is an AU, AMP, or ANP identified on the license or permit and has experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO AND
| |
| * attach documentation of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who is applying simultaneously to be the RSO and AU on a new license qualifying under 10 CFR 35.50(c)(3)
| |
| * attach the license application that includes documentation of the training and experience of the new AU AND
| |
| * attach documentation of supervised training and experience specified in 10 CFR 35.50(d), demonstrating that the proposed RSO is qualified by training in radiation safety, regulatory issues, and emergency procedures, as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO For an individual who is qualifying by classroom/laboratory training and supervised radiation safety experience under 10 CFR 35.50(b)
| |
| * attach documentation of the training and experience specified in 10 CFR 35.50(b)(1) in completed NRC Form 313A (RSO) or equivalent documentation demonstrating that the proposed RSO or ARSO is qualified by training and experience, as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO AND
| |
| * attach documentation of supervised training and experience specified in 10 CFR 35.50(d) in attached NRC Form 313A (RSO) or equivalent documentation demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures, as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO AND
| |
| * attach a written attestation, as prescribed in 10 CFR 35.50(b)(2), signed by a preceptor RSO or ARSO, that the individual has satisfactorily completed the requirements in 10 CFR 35.50(b)(1), as well as the required training in radiation safety, regulatory 8-24
| |
| | |
| issues, and emergency procedures for the types of use for which the licensee seeks approval, and is able to independently fulfill the radiation safety-related duties as an RSO or as an ARSO for the medical use licensee AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 If the proposed RSO is an outside consultant or contractor, address the following in the application or amendment:
| |
| * An outside consultant or contractor must qualify as an RSO in accordance with 10 CFR 35.50 or 10 CFR 35.57 and 10 CFR 35.59 criteria specified above.
| |
| * Identify other commitments of the consultant-RSO for other NRC or Agreement State licensed facilities, along with a description of how the consultant-RSO will allocate time to permit the performance of the duties of the RSO, as described in the regulations. State the consultant-RSOs minimum amount of onsite time (hours per week or days per quarter, as appropriate for the size of the program).
| |
| * Identify an in-house representative who will serve as the point of contact during the RSOs absence.
| |
| Note: This person may be allowed to assist the consultant RSO in his or her duties. Any such duties should be clearly defined.
| |
| * Describe the overall availability of the consultant-RSO to respond to questions or operational issues that arise during the conduct of the radiation safety program and related regulatory requirements.
| |
| * Specify the maximum amount of time it will take the consultant RSO to arrive at the facility, in the event of an emergency that requires his or her presence.
| |
| Notes:
| |
| * NRC Form 313A (RSO), Radiation Safety Officer and Associate Radiation Safety Officer Training, Experience, and Preceptor Attestation [10 CFR 35.57, 10 CFR 35.50],
| |
| may be used to document training and experience for those individuals qualifying under 10 CFR 35.50.
| |
| * The licensee must notify the NRC within 30 days if, under 10 CFR 35.14, Notifications, an RSO or ARSO permanently discontinues performance of duties under the license or has a name change; licensees must also request an amendment to change an RSO or ARSO under 10 CFR 35.13.
| |
| * An AU for medical uses, AMP, or ANP may be designated as the RSO or ARSO on the license if the individual has experience with the radiation safety aspects of similar types of byproduct material use for which he or she will have RSO responsibilities or ARSO duties and tasks [see 10 CFR 35.50(c)(2)] and, as required by 10 CFR 35.24(g), the 8-25
| |
| | |
| RSO has sufficient time, authority, organizational freedom, resources, and management prerogative to perform the duties.
| |
| * Descriptions of training and experience will be reviewed using the criteria listed above.
| |
| The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to meet the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in evaluating such training and experience.
| |
| * The training and experience for the RSO of a medical use broad scope license will be reviewed using the above criteria and NUREG-1556, Volume 11.
| |
| 8.7.2 Authorized Users (AUs)
| |
| Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14, Part 35 Applicability 10 CFR 35.27, 10 CFR 35.57, 10 CFR 35.59, 10 CFR 35.190, 100 10 CFR 35.290, 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 200 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, 10 CFR 35.690 300 400 Criteria: Training and experience requirements for AUs for 500 medical uses are described in 10 CFR 35.190, 10 CFR 35.290, 600 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 1000 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, or 10 CFR 35.690 Discussion: 10 CFR 35.2 defines AU for medical use. The responsibilities of AUs involved in medical use include the following:
| |
| * radiation safety commensurate with use of byproduct material
| |
| * administration of a radiation dose or dosage and how it is prescribed
| |
| * direction of individuals under the AUs supervision in the preparation of byproduct material for medical use and in the medical use of byproduct material
| |
| * preparation of written directive (WD), if required Applicants must meet recentness of training requirements described in 10 CFR 35.59. The AU applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, applicants must submit documentation of related continuing education and experience since completing the required training and experience. This time provision applies to the board certification as well as to other training pathways.
| |
| Regulations in 10 CFR 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist, provide that experienced AUs who are named on a license or permit are not required to comply with the training requirements in Subparts D through H to continue performing those medical uses for which they were authorized before the effective date 8-26
| |
| | |
| of changes to the regulations in 10 CFR 35.57 (check the regulations to determine this date).
| |
| For example, a physician who was authorized to use sodium iodide (I)-131 for imaging and localization, involving greater than 30 µCi [1.11 MBq] (a quantity for which a WD is required under 10 CFR 35.40), would continue to be authorized for imaging and localization involving greater than 30 µCi even though after 2002 it was authorized under 10 CFR 35.300.
| |
| Effective January 19, 2019, 10 CFR 35.57 provides that a physician, dentist, or podiatrist that has never been identified as an AU and was board certified by any of the boards listed in 10 CFR 35.57(b)(2) on or before October 24, 2005, satisfies the requirements to be an AU for the use of those materials. The applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to be an AU for those materials and uses. This documentation will be reviewed on a case-by-case basis to see if the time period of use, the materials used, and the types of medical use meet the criteria in the regulation. This provision of the rule grandfathers these board certified individuals that were never named as an AU but perform medical uses with the same materials prior to October 24, 2005.
| |
| Technologists, therapists, or other personnel may use byproduct material for medical use under an AUs supervision, in accordance with 10 CFR 35.27, Supervision. As stated in 10 CFR 35.7, nothing in 10 CFR Part 35 relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
| |
| There is no NRC requirement that an AU must render an interpretation of a diagnostic image or results of a therapeutic procedure. The NRC recognizes that the AU may or may not be the physician who interprets such studies. Additionally, NRC regulations do not restrict who can read and interpret diagnostic scans or the results of therapeutic procedures involving the administration of byproduct material to individuals.
| |
| An individual who is qualified to be an AU but has not been named as an AU on a medical use license or permit may apply for and be authorized simultaneously as the RSO and the AU on the same new medical use license. The individual must have experience with radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous authorization and training specified in 10 CFR 35.50(d).
| |
| A licensee may request an AU on any medical use license or permit to be named as the RSO or ARSO for the same byproduct material and uses for which the AU is authorized.
| |
| Instructions for documenting training and experience can be found in Appendix D of this NUREG. NRC Forms 313A [Authorized User Diagnostic (AUD), Authorized User Therapy (AUT), and Authorized User Sealed Source (AUS)] can be found on the Medical Uses Licensees Toolkit Web page. Also refer to the NRC Forms Web site at:
| |
| https://www.nrc.gov/reading-rm/doc-collections/forms/ for the NRC Forms 313A (AUD, AUT, and AUS). Verify that the most current version of the NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form. Specific instructions for completing the NRC Forms 313A (AUD, AUT, and AUS) may be found at the Medical Uses Licensees Toolkit Web page. Information in 10 CFR 35.1000, Other medical uses of byproduct material or radiation from byproduct material, regarding training and experience for emerging technologies (e.g., microspheres) can also be found at the Medical Uses Licensee Toolkit Web page.
| |
| 8-27
| |
| | |
| Response from Applicant:
| |
| Provide the following:
| |
| * name of each proposed AU and uses requested AND
| |
| * medical, podiatry, or dental license number and issuing entity (e.g., State or territory)
| |
| AND For an individual currently or previously listed as an AU on an NRC or Agreement State license or permit for the same type of use(s) requested
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML permittee of broad scope on which the physician, dentist, or podiatrist was specifically named as an AU for the uses requested Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required, as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required.
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59.
| |
| For an individual listed as an AU on an NRC or Agreement State license or permit but seeking an additional authorization under 10 CFR Part 35
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML permittee of broad scope on which the individual was specifically named as an AU AND
| |
| * attach additional documentation of training and experience necessary to demonstrate the AU is qualified for the new medical uses requested:
| |
| To add 10 CFR 35.100 authorization for an AU qualified under 10 CFR 35.200, no additional documentation is needed.
| |
| To add 10 CFR 35.200 authorization for an AU qualified under 10 CFR 35.390, attach documentation of the supervised work experience eluting generator systems as required in 10 CFR 35.290(c)(1)(ii)(G).
| |
| 8-28
| |
| | |
| To add an additional authorization under 10 CFR 35.300, for an AU qualified under 10 CFR 35.390, attach documentation of casework experience for uses listed under 10 CFR 35.390(b)(1)(ii)(G)(1), 10 CFR 35.390(b)(1)(ii)(G)(2), and/or 10 CFR 35.390(b)(1)(ii)(G)(3), as applicable.
| |
| To add an authorization under 10 CFR 35.300 (for uses listed in 10 CFR 35.396),
| |
| for an AU qualified under 10 CFR 35.490 or 10 CFR 35.690, attach documentation of the classroom and laboratory training and supervised work experience required in 10 CFR 35.396(b)(1) and10 CFR 35.396(b)(2),
| |
| OR To add an additional authorization under 10 CFR 35.600 (for use of remote afterloader units, teletherapy units, and/or gamma stereotactic radiosurgery units), attach documentation of training needed to meet the requirements in 10 CFR 35.690(c).
| |
| AND
| |
| * attach a preceptor attestation, if required (e.g., attestation is required for all individuals to meet the requirements in 10 CFR 35.396 and for individuals seeking authorization under the alternate training and experience pathway for 10 CFR 35.390 and 10 CFR 35.690)
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59.
| |
| For an individual qualifying under 10 CFR 35.57(b)(3) because only accelerator-produced byproduct material was used for medical use
| |
| * attach documentation that the physician, dentist, or podiatrist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical uses performed at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC AND
| |
| * attach documentation that the physician, dentist, or podiatrist used these materials for the same medical uses requested AND
| |
| * attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who was certified before October 24, 2005, by a board listed in 10 CFR 35.57(b)(2) 8-29
| |
| * attach a copy of the board certification issued before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(b)(2)
| |
| AND
| |
| * attach documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005 AND
| |
| * attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H because of a recognized board certification
| |
| * attach a copy of the board certification(s) issued by a specialty board whose certification process has been recognized 3 by the NRC or an Agreement State under 10 CFR Part 35, Subpart D, E, F, G, or H, as applicable to the use requested AND
| |
| * attach additional documentation of training and experience necessary to demonstrate the AU is qualified for the medical uses requested:
| |
| To add 10 CFR 35.200 authorization with a board certification recognized under 10 CFR 35.390, attach documentation of the supervised work experience eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G).
| |
| To add 10 CFR 35.390 authorization with a board certification recognized under 10 CFR 35.390, attach documentation of the supervised work experience administering dosages of radioactive drugs required in 10 CFR 35.390(b)(1)(ii)(G)(1), 35.390(b)(1)(ii)(G)(2), and/or 35.390(b)(1)(ii)(G)(3), as applicable.
| |
| To add 10 CFR 35.396 authorization with a board certification recognized under 10 CFR 35.490 or 10 CFR 35.690, attach documentation of the classroom and laboratory training and supervised work experience required in 10 CFR 35.396(b)(1) and 10 CFR 35.396(b)(2) and a copy of the attestation required in 10 CFR 35.396(b)(3).
| |
| Note: Physicians seeking medical uses described in 10 CFR 35.392 or 10 CFR 35.394 with a board certification recognized under 10 CFR 35.392 and 10 CFR 35.394 do not need to provide a description of supervised work experience administering dosages of radioactive drugs.
| |
| 3Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and show issuance within specified dates, as described on the Web page.
| |
| 8-30
| |
| | |
| To add 10 CFR 35.600 authorization with a board certification recognized under 10 CFR 35.690, attach documentation of the training specified in 10 CFR 35.690(c).
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H by classroom and laboratory training, supervised work experience, and supervised clinical experience
| |
| * attach documentation of the classroom and laboratory training, supervised work experience, and supervised clinical experience identified in 10 CFR Part 35, Subpart D, E, F, G, or H, demonstrating that the proposed AU is qualified by training and experience for the use(s) requested Note: NRC Form 313A series of forms may be helpful in documenting the above information.
| |
| AND
| |
| * for an individual seeking authorization under 10 CFR Part 35, Subpart G or H, attach documentation of the training specified in 10 CFR 35.590(d) or 10 CFR 35.690(c), as applicable, demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought AND
| |
| * attach a written attestation, signed by a preceptor physician AU or, if applicable, the residency program director, that the above training and experience have been satisfactorily completed and the individual is able to independently fulfill the radiation safety-related duties as an AU for the requested medical uses AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying for medical use of specific emerging technologies under Subpart K, 10 CFR 35.1000
| |
| * attach documentation of training and experience, as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page Notes:
| |
| * NRC Form 313A (AUD), Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.500) [10 CFR 35.57, 10 CFR 35.190, 10 CFR 35.290, and 10 CFR 35.590];
| |
| or NRC Form 313A (AUT), Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.300) [10 CFR 35.57, 10 CFR 35.390, 8-31
| |
| | |
| 10 CFR 35.392, 10 CFR 35.394, and 10 CFR 35.396]; or NRC Form 313A (AUS),
| |
| Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.400 and 10 CFR 35.600) [10 CFR 35.57, 10 CFR 35.490, 10 CFR 35.491, and 10 CFR 35.690] may be used, as appropriate, to document training and experience for those individuals qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H.
| |
| * Under 10 CFR 35, licensees must notify the NRC within 30 days if an AU permanently discontinues his or her duties under the license or has a name change.
| |
| * Descriptions of training and experience will be reviewed using the criteria listed above.
| |
| The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35 are met. If the training and experience do not appear to meet the 10 CFR Part 35 criteria, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
| |
| The documentation should include the terminal degree designation(s) (e.g., D.O., M.D.),
| |
| if those designations are relevant to the authorized use requested.
| |
| Note to reviewers: Licenses will reflect any limitations on use for listed AUs (e.g., whether administrations in excess of 33 mCi [1.22 GBq] of I-131 are allowed and specific uses under 10 CFR 35.600).
| |
| 8.7.3 Authorized Nuclear Pharmacist (ANP)
| |
| Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.11, Part 35 Applicability 10 CFR 35.14, 10 CFR 35.27, 10 CFR 35.55, 10 CFR 35.57, 100 10 CFR 35.59 200 Criteria: Training and experience requirements for ANPs are 300 described in 10 CFR 35.55. 400 500 Discussion: At some licensed medical facilities, an ANP is directly 600 involved with the preparation of radiopharmaceuticals under the 1000 provisions of 10 CFR 35.100(b), 10 CFR 35.200(b),
| |
| 10 CFR 35.300(b), or 10 CFR 35.1000 guidance found at the NRCs Medical Uses Licensees Toolkit Web page.
| |
| Technologists, or other personnel, may prepare byproduct material for medical use under an ANPs supervision, in accordance with 10 CFR 35.27, Supervision. Preparation of byproduct material for medical use may also be performed under the supervision of a physician who is an AU. As stated in 10 CFR 35.7, nothing in 10 CFR Part 35 relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
| |
| Applicants are reminded that the recentness of training requirements described in 10 CFR 35.59 also apply to training and experience requirements in 10 CFR Part 35, Subpart B. Specifically, nuclear pharmacist applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, nuclear pharmacist applicants must submit documentation of related continuing education and experience since initially completing the required training and 8-32
| |
| | |
| experience. This time provision applies to the board certification as well as to other training pathways for meeting requirements for training and experience.
| |
| Response from Applicant: Provide the following:
| |
| * name of the proposed ANP AND
| |
| * documentation demonstrating that the proposed ANP has an active license to practice pharmacy. Include information on the issuing entity (e.g., State or territory).
| |
| AND For an individual currently or previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs for the same type of use(s) requested
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML broad scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required. In addition, the information may be contained within the WBL used by the NRC and some Agreement States. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required.
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who used only accelerator-produced radioactive materials or discrete sources of Ra-226, or both, and is qualifying under 10 CFR 35.57(a)(4)
| |
| * attach documentation that the nuclear pharmacist used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, in the practice of nuclear pharmacy at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or at an earlier date, as noticed by the NRC AND
| |
| * attach documentation that the nuclear pharmacist used these materials for the same uses as requested 8-33
| |
| | |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual who is board certified by an NRC-recognized board qualifying under 10 CFR 35.55(a)
| |
| * attach a copy of the board certification of a specialty board whose certification process has been recognized 4 by the NRC or an Agreement State under 10 CFR 35.55(a)
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying by classroom/laboratory training and supervised practical experience in nuclear pharmacy under 10 CFR 35.55(b)
| |
| * Attach completed NRC Form 313A (ANP) or equivalent documentation of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience AND
| |
| * Attach a written attestation, signed by a preceptor ANP, that the above training and experience have been satisfactorily completed and that the individual is able to independently fulfill the radiation safety-related duties as an ANP AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying for medical use of specific emerging technologies under Subpart K, 10 CFR 35.1000
| |
| * attach documentation of training and experience, as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page Notes:
| |
| * NRC Form 313A (ANP), Authorized Nuclear Pharmacist Training and Experience, and Preceptor Attestation [10 CFR 35.55] may be used to document training and experience for those individuals qualifying under 10 CFR 35.55.
| |
| 4Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and show issuance within specified dates, as described on the Web page.
| |
| 8-34
| |
| * Under 10 CFR 35.14, licensees must notify the NRC within 30 days if an ANP permanently discontinues his or her duties under the license or has a name change.
| |
| * Descriptions of training and experience will be reviewed using the criteria listed above.
| |
| The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B are met. If the training and experience do not appear to meet the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience. The documentation should include the terminal degree designation(s)
| |
| (e.g., R.Ph., Pharm.D.), if those designations are relevant to the requested authorization.
| |
| 8.7.4 Authorized Medical Physicist (AMP)
| |
| Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14, Part 35 Applicability 10 CFR 35.51, 10 CFR 35.57, 10 CFR 35.59 100 200 Criteria: Training and experience requirements for AMPs are 300 described in 10 CFR 35.51. 400 Discussion: While the AMP may not administer the dose, at 500 licensed medical facilities conducting radiation therapy treatments, 600 an AMP is directly involved with the calculation and other tasks 1000 associated with the administration of the radiation dose. A licensee performing ophthalmic radiation therapy treatments under 10 CFR 35.400 must ensure that certain tasks described in 10 CFR 35.433(b) are performed by either an AMP or an ophthalmic physicist. The American Association of Physicists in Medicine (AAPM) suggests that a medical physicist limit his or her involvement in radiation therapy to areas for which he or she has established competency.
| |
| Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
| |
| Specifically, medical physicist applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, medical physicist applicants must submit documentation of related continuing education and experience since completing the required training and experience. This time provision applies to the board certification as well as to other training pathways for meeting requirements for training and experience.
| |
| The regulation in 10 CFR 35.57 provides that experienced AMPs who were named on a license or permit are not required to comply with the training requirements in 10 CFR 35.51 to continue performing those uses for which they were authorized on or before January 14, 2019.
| |
| Section 35.57 also provides that physicists holding certain board certifications on or before October 24, 2005, are not required to comply with the training requirements in 10 CFR 35.51 for those materials and uses that they performed on or before October 24, 2005. All AMPs are required to meet the requirements of 10 CFR 35.51(c) after January 14, 2019, if they are seeking authorizations for new materials and medical uses.
| |
| If the medical physicist has never been identified as an AMP and was board certified by any of the boards listed in 10 CFR 35.57(a)(3) on or before October 24, 2005, the applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to be an AMP for those materials and uses.
| |
| 8-35
| |
| | |
| This documentation will be reviewed on a case-by-case basis to see if the time period of use, the materials used, and the types of medical use meet the criteria in the regulation. This provision of the rule grandfathers these board certified individuals that were never named as an AMP but perform medical uses with the same materials prior to October 24, 2005.
| |
| The NRC will only list medical physicists on a license if they meet the definition in 10 CFR 35.2 and their authorization is requested in accordance with other requirements in 10 CFR Part 35 (e.g., 10 CFR 35.433, 10 CFR 35.605, 10 CFR 35.610, 10 CFR 35.615, 10 CFR 35.632, 10 CFR 35.633, 10 CFR 35.635, 10 CFR 35.642, 10 CFR 35.643, 10 CFR 35.645) or a 10 CFR 35.1000 guidance document.
| |
| Response from Applicant: Provide the following:
| |
| * name of the proposed AMP AND For an individual currently or previously identified as an AMP on an NRC or Agreement State license or permit for the same type of use(s) requested
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML permittee of broad scope on which the individual was specifically named an AMP for the uses requested Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required, as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required.
| |
| AND
| |
| * If applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual listed on a license or permit but seeking authorization for a new medical use under 10 CFR 35.51(c)
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML permittee of broad scope on which the individual was specifically named an AMP for the uses requested Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required, as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required.
| |
| 8-36
| |
| | |
| AND
| |
| * attach documentation of the additional training and experience specified in 10 CFR 35.51(c) demonstrating that the individual is also qualified by training in the new types of use for which the applicant seeks approval of the individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system AND
| |
| * if not board certified by a board recognized under 10 CFR 35.51(a) or listed in 10 CFR 35.57(a)(3), attach a written attestation, signed by a preceptor AMP, that the required training and experience in 10 CFR 35.51(c) has been satisfactorily completed and that the individual is able to independently fulfill the radiation safety-related duties as an AMP for the type of therapeutic medical unit for which the individual is requesting authorized medical physicist status For an individual qualifying under 10 CFR 35.57(a)(4), because the individual was an AMP for only accelerator-produced material or discrete sources of Ra-226 or both
| |
| * attach documentation that the AMP used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for medical uses at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC AND
| |
| * attach documentation that the medical physicist used these materials for the same medical uses as requested AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying under 10 CFR 35.51(a)
| |
| * attach a copy of the board certification issued by a specialty board whose certification process has been recognized 5 by the NRC or an Agreement State under 10 CFR 35.51(a)
| |
| AND
| |
| * attach documentation of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the applicant seeks approval of the individual as the AMP, including hands-on 5Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates as described on the Web page.
| |
| 8-37
| |
| | |
| device operation, safety procedures, clinical use, and operation of a treatment planning system AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying by board certification under 10 CFR 35.57(a)(3):
| |
| * attach a copy of the board certification issued by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, X-ray and radium physics, or radiological physics, or by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, for the same medical uses requested AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying because of a degree, medical physics training, and medical physics work experience under 10 CFR 35.51(b)
| |
| * attach documentation of the training and experience specified in 10 CFR 35.51(b)(1),
| |
| demonstrating that the proposed AMP is qualified by training and experience for the use(s) requested Note: NRC Form 313A (AMP) may be helpful in documenting the above information.
| |
| AND
| |
| * attach documentation of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the licensee seeks approval of an individual as AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system AND
| |
| * attach a written attestation, signed by a preceptor AMP, that the proposed AMP has satisfactorily completed the training and experience required in 10 CFR 35.50(b)(1), as well as the training in 10 CFR 35.51(c) for the types of use specified, and that the individual is able to independently fulfill the radiation safety-related duties as an AMP for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 8-38
| |
| | |
| For an individual qualifying for medical use of specific emerging technologies under Subpart K, 10 CFR 35.1000
| |
| * attach documentation of training and experience as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page Notes:
| |
| * NRC Form 313A (AMP), Authorized Medical Physicist or Ophthalmic Physicist Training and Experience and Preceptor Attestation [10 CFR 35.51, 10 CFR 35.57(a)(3),
| |
| and 10 CFR 35.433], may be used to document training and experience for those individuals qualifying under 10 CFR 35.51.
| |
| * Under 10 CFR 35.14, licensees must notify NRC within 30 days if an AMP permanently discontinues his or her duties under the license or has a name change.
| |
| * Descriptions of training and experience will be reviewed using the criteria listed above.
| |
| The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to meet the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience. The documentation should include the terminal degree designation(s)
| |
| (e.g., M.S., Ph.D.), if those designations are relevant to the requested authorization.
| |
| 8.7.5 Ophthalmic Physicist Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14, Part 35 Applicability 10 CFR 35.59, 10 CFR 35.433 100 200 Criteria: Training and experience requirements for ophthalmic 300 physicists are described in 10 CFR 35.433(a)(2).
| |
| 400 Discussion: A licensee performing ophthalmic radiation therapy 500 treatments under 10 CFR 35.400 must ensure that either an AMP 600 or an ophthalmic physicist performs certain tasks described in 1000 10 CFR 35.433(b). These individuals perform the same tasks but have different training and experience requirements.
| |
| While the ophthalmic physicist may not administer the dose at licensed medical facilities conducting ophthalmic radiation therapy treatments, this individual is responsible for calculating the activity of each strontium-90 source that is used to determine treatment times. This individual will further assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive.
| |
| Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
| |
| Specifically, ophthalmic physicist applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, ophthalmic physicist applicants must have had related continuing education and experience since completing the required training and experience.
| |
| 8-39
| |
| | |
| Response from Applicant: Provide the following:
| |
| * name of the proposed Ophthalmic Physicist For an individual currently or previously identified as an authorized Ophthalmic Physicist on an NRC or Agreement State license or permit
| |
| * provide an NRC license number or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML permittee of broad scope on which the individual was specifically named an authorized Ophthalmic Physicist Note: If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required, as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL, submission of the license is not required.
| |
| AND
| |
| * if applicable, attach documentation of recent, related continuing education and experience, as required by 10 CFR 35.59 For an individual qualifying as an Ophthalmic Physicist based on education and supervised work experience under 10 CFR 35.433
| |
| * attach documentation of the training and experience specified in 10 CFR 35.433, demonstrating that the proposed ophthalmic physicist is qualified by training and experience for ophthalmic treatments using Strontium-90 sources Note: NRC Form 313A (AMP) may be helpful in documenting the above information.
| |
| AND
| |
| * if applicable, attach a description of recent related continuing education and experience as required by 10 CFR 35.59 Notes:
| |
| * NRC Form 313A (AMP), Authorized Medical Physicist and Ophthalmic Physicist, Training and Experience, and Preceptor Attestation [10 CFR 35.51, 10 CFR 35.57(a)(3),
| |
| and 10 CFR 35.433], may be used to document training and experience ophthalmic physicist identified in 10 CFR 35.433.
| |
| * Under 10 CFR 35.14, licensees must notify NRC within 30 days if an ophthalmic physicist permanently discontinues his or her duties under the license or has a name change.
| |
| * Descriptions of training and experience will be reviewed using the criteria listed above.
| |
| The NRC will review the documentation to determine if the applicable criteria in 10 CFR 35.433(a)(2) are met. If the training and experience do not appear to meet the 8-40
| |
| | |
| criteria in 10 CFR 35.433(a)(2), the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
| |
| 8.7.6 Individuals Authorized for Nonmedical Use Regulations: 10 CFR 30.33(a)(3) Part 35 Applicability 100 Criteria: Individuals authorized for nonmedical use must have 200 adequate training and experience with the types and quantities of 300 licensed material they propose to use.
| |
| 400 Discussion: 500 600
| |
| * For in vitro studies, animal research, calibration of survey 1000 instruments, and other uses that do not involve human use, the list of proposed individuals authorized for non-medical use or uses should include the individuals who will actually be responsible for the safe use of the byproduct material for the requested use.
| |
| * An applicant should note which user will be involved with a particular use by referring to Items 5 and 6 of the application and providing information about the users training and experience. Authorized nonmedical use or uses that do not involve human use (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on a case-by-case basis.
| |
| Response from Applicant: Provide the following:
| |
| * name of the proposed nonmedical use AU AND
| |
| * description of types, quantities, and proposed nonmedical uses for each individual requested AND
| |
| * documentation of individuals education and radiation safety training and experience with the types of materials and uses requested. This may include the NRC license number or a copy of the Agreement State license, permit issued by an NRC master materials licensee, permit issued by an NRC or Agreement State broad scope licensee, or permit issued by an NRC Master Materials License broad scope permittee on which the individual was specifically named AND
| |
| * detailed radiation training and experience applicable to the use requested Note: Authorized nonmedical use or uses that do not involve the intentional exposure of humans (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on a case-by-case basis. Refer to the applicable NUREG volume for additional guidance 8-41
| |
| | |
| (e.g., NUREG-1556, Volume 7, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope Including Electron Capture Devices and X-Ray Fluorescence Analyzers).
| |
| 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas Regulations: 10 CFR 19.12, 10 CFR 35.27, 10 CFR 35.310, Part 35 Applicability 10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.2310, 10 CFR 37.43 100 200 Criteria: Individuals working with or in the vicinity of licensed material must have adequate safety instructions, as required by 300 10 CFR Part 19 and 10 CFR Part 35. For individuals who, in the 400 course of employment, are likely to receive in a year an 500 occupational dose of radiation over 1 millisievert (mSv) 600
| |
| [100 millirem (mrem)], the licensee must provide safety 1000 instructions, as required by 10 CFR 19.12, Instruction to workers.
| |
| Additional requirements for training in radiation safety for individuals involved with therapeutic treatment of patients are described in 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610. Under 10 CFR 35.27, the licensees AUs and ANPs are required to provide safety instruction to all personnel using byproduct material under their supervision.
| |
| Any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material (as defined in 10 CFR 37.5) must implement a training program for those individuals implementing the security program.
| |
| Discussion: Licensees must evaluate potential radiation doses received by any individual working in or frequenting restricted areas. All individuals working with or around licensed materials should receive safety instructions commensurate with their assigned duties, and if it is likely that they could receive doses over 1 mSv [100 mrem] in a year, they must receive instructions, as specified by 10 CFR 19.12. For example, a licensee might determine that housekeeping staff, while not likely to receive doses over 1 mSv [100 mrem], should be informed of the nature of the licensed material and the meaning of the radiation symbol and instructed not to touch the licensed material and to remain out of the room if the door to the licensed material storage location is open. Providing minimal instruction to ancillary staff (e.g., housekeeping, security) may assist in controlling abnormal events, such as loss of radioactive material. In addition, licensees should ensure that contractor staff receives safety instructions.
| |
| In addition to safety instructions required by 10 CFR 19.12, and in accordance with 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610, the licensee must provide radiation safety instructions to personnel (e.g., nurses) caring for patients undergoing radiopharmaceutical therapy and/or implant therapy who cannot be released in accordance with 10 CFR 35.75. This safety instruction should be commensurate with the duties of the personnel and include safe handling of byproduct material, patient control, visitor control, contamination control, waste control, and notification of the RSO and the AU, if the patient has a medical emergency or dies.
| |
| A licensee must retain a record of individuals receiving instruction in accordance with 10 CFR 35.2310.
| |
| 8-42
| |
| | |
| In accordance with 10 CFR 35.27(a), individuals working with licensed material under the supervision of an AU must receive instructions on the licensees written radiation protection procedures, WD procedures, NRC regulations, and NRC license conditions, with respect to the use of byproduct material.
| |
| In accordance with 10 CFR 35.27(b), a licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an ANP or an AU, as allowed by 10 CFR 35.11(b)(2), shall instruct the supervised individual in the preparation of byproduct material for medical use and require the individual to follow their instructions, the licensees written radiation protection procedures, the license conditions, and NRC regulations.
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| Under 10 CFR 35.27(c), a licensee that permits supervised activities, under paragraphs 10 CFR 35.27(a) and (b), is responsible for the acts and omissions of the supervised individuals.
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| Appendix J of this NUREG provides a model training program that provides one way to satisfy the requirements referenced above. In addition, the Medical Uses Licensee Toolkit Web page provides guidance for training suggested for emerging technologies [e.g., yttrium(Y) -90 microsphere brachytherapy], regulated under 10 CFR 35.1000.
| |
| In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material must implement a training program in accordance with 10 CFR 37.43, General security program requirements, and specifically, must comply with 10 CFR 37.43(c), Training, to ensure that those individuals who may have a responsibility to implement portions of the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively.
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| Additionally, in accordance with 10 CFR 37.43(c)(3), refresher training must be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
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| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may be subject to review and inspection.
| |
| Response from Applicant: Provide a statement that, We have developed and will implement and maintain written procedures for a program for training required under 10 CFR 19.12 for each group of workers, including (i) topics covered, (ii) qualifications of the instructors, (iii) method of training, (iv) method for assessing the success of the training, (v) initial training, and (vi) annual refresher training.
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| 8-43
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| 8.9 Item 9: Facilities and Equipment Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.12(b)(1), Part 35 Applicability 10 CFR 35.18(a), 10 CFR Part 37, 10 CFR 37.5, 10 CFR 37.49, 100 10 CFR 37.53 200 300 Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Facilities and 400 equipment must also provide enhanced physical protection of 500 aggregated Category 1 and Category 2 quantities of radioactive 600 materials, as defined in 10 CFR 37.5. They must minimize the 1000 possibility of contamination and keep exposures to workers and the public ALARA.
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| Discussion: Requirements to provide information about the design and construction of facilities and safety equipment are contained in 10 CFR 30.33(a)(2), 10 CFR 35.12(b)(1), and 10 CFR 35.18(a). Applications will be approved if, among other things, the applicants proposed equipment and facilities are adequate to protect health and minimize danger to life or property. Facility and equipment requirements depend on the scope of the applicants operations (e.g., planned use of the material, types of radioactive emissions, quantity and form of radioactive materials possessed). Applicants should focus particularly on operations using large quantities of radioactive materials; preparation steps involving liquids, gases, and volatile radioactive materials; and the use of alpha emitters, high-energy photon emitters, and high-energy beta emitters.
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| 8-44
| |
| | |
| In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material must, among other things
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| * implement the physical protection requirements in 10 CFR Part 37 for material in use and storage, at both permanent and temporary jobsites; and
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| * in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and respond to any unauthorized entries into security zones, including those surrounding mobile devices, and immediately detect any unauthorized removal of Category 1 quantities of radioactive material from the security zone. (Monitoring and detection systems may include, among other methods, monitored video surveillance systems and electronic devices for intrusion detection alarms.)
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| * for mobile devices containing Category 1 or Category 2 quantities of radioactive material, have two independent physical controls to secure the material from unauthorized removal when the device is not under direct control and constant surveillance in accordance with 10 CFR 37.53. Mobile device is defined in 10 CFR 37.5 For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may be subject to review and inspection.
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| Response from Applicant: Refer to Sections 8.9.1 through 8.9.5 for guidance.
| |
| 8.9.1 Facility Diagram Regulations: 10 CFR 20.1003, 10 CFR 20.1101, Part 35 Applicability 10 CFR 20.1201, 10 CFR 20.1301, 10 CFR 20.1601, 100 10 CFR 20.1602, 10 CFR 30.33(a)(2), 10 CFR 35.12, 200 10 CFR 35.13, 10 CFR 35.14, 10 CFR 35.18(a)(3), 10 CFR 35.75, 300 10 CFR 35.315(a), 10 CFR 35.415, 10 CFR 35.615 400 Criteria: To issue a license, the NRC must find that facilities and 500 equipment are adequate to protect health and minimize danger to 600 life or property, as required under 10 CFR 30.33(a)(2) and 1000 10 CFR 35.18(a)(3). In accordance with 10 CFR 20.1101, the licensee must design facilities to ensure occupational doses and doses to members of the public are ALARA.
| |
| Discussion: Applicants must describe the proposed facilities and equipment, as required by 10 CFR 30.33(a)(2) and 10 CFR 35.12. The facility diagram should include the room or rooms where byproduct material is prepared, used, administered, and stored, at a level of detail that is sufficient to demonstrate that the facilities and equipment are adequate to protect health and minimize danger to life or property. Because of the low energy of radionuclides used in nuclear medicine departments for diagnostic studies, a description of adjacent areas is unnecessary.
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| 8-45
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| | |
| However, if PET radionuclides are used, a description of the specialized PET facilities should be provided. The description should include facility diagrams, the shielding installed, specialized handling equipment, and survey results to ensure that the regulatory limits in 10 CFR 20.1201, Occupational dose limits for adults, and 10 CFR 20.1301, Dose limits for individual members of the public, are not exceeded. The applicant should demonstrate that the limits specified in 10 CFR 20.1301(a) will not be exceeded and how access will be controlled in accordance with 10 CFR 20.1601 and 10 CFR 20.1602. If the facility descriptions or calculations demonstrate that these limits cannot be met, indicate any further steps that will be taken to limit exposure to individual members of the public. The applicant may consider adding shielding to the barrier in question, with corresponding modification of the facility description if necessary.
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| Drawings and diagrams that provide the exact location of materials or depict specific locations of safety or security equipment should be marked as Security-Related Information - Withhold Under 10 CFR 2.390. See Chapter 6, Identifying and Protecting Sensitive Information.
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| For types of use permitted by 10 CFR 35.100 and 35.200, applicants should provide room numbers for areas in which byproduct materials are used or prepared for use (i.e., hot labs).
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| (see Figure 8-3.)
| |
| SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390*
| |
| SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390*
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| *For the purpose of this NUREG, the facility diagram is marked appropriately for an application. This particular diagram does not contain real security-related sensitive information.
| |
| Figure 8-3. Facility Diagram for Nuclear Medicine Suite 8-46
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| | |
| SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390*
| |
| Suite 301 is on the top floor in the corner of the building.
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| Suite 302 is occupied by an oncology practice.
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| Suite 303 is occupied by an obstetrics and gynecology practice.
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| Directly below Suite 301 is a dental practice.
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| XX centimeters (cm) of lead or XX cm of poured concrete will be in doors, walls, ceiling, and floors of hot lab, quiet rooms, and imaging rooms.
| |
| SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390*
| |
| *For the purpose of this NUREG, the facility diagram is marked appropriately for an application. This particular diagram does not contain real security-related sensitive information.
| |
| AAPM task group report 108 provides guidance on determining appropriate thicknesses based on workload and distances to meet the regulatory requirements in 10 CFR 20.1301. Applicants should provide assumptions used in their calculations to determine this thickness.
| |
| Figure 8-4. Facility Diagram for PET Suite If the applicant uses PET radionuclides under 10 CFR 35.100 or 10 CFR 35.200, the applicant should provide a description of the imaging rooms, quiet rooms, hot cells (if applicable), and location of the PET delivery line (if applicable). A discussion of the shielding associated with the PET facility, including shielding calculations, should also be provided. (See Figure 8-4.) AAPM Task Group 108, PET and PET/CT Shielding Requirements, provides guidance on how to 8-47
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| | |
| design a PET facility and perform associated shielding calculations. The document also provides guidance on appropriate safety equipment to use.
| |
| For types of use permitted by 10 CFR 35.300 and 10 CFR 35.400, applicants should provide the locations where sources are stored (e.g., fume hood or shielded cave). The most widely used source of radiopharmaceutical therapy is I-131 sodium iodide. Since this radionuclide is volatile in either liquid or capsule form, applicants should consider establishing appropriate radiological controls. In general, though, the amount of I-131 sodium iodide that may become volatile is greatly reduced when encapsulated and is a fraction of a percent of the capsule activity; and therefore, fume hoods may not be necessary for storage. In addition, in accordance with 10 CFR 35.315(a) and 10 CFR 35.415, the applicant should describe the rooms where patients will be housed, if they cannot be released under 10 CFR 35.75. When patients are treated with I-131 sodium iodide, sources of contamination include airborne I-131, urine, perspiration, saliva, and other secretions.
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| The discussion should include a description of shielding to ensure that the dose rates in adjacent areas are in accordance with the regulations. Regulatory requirements, the principle of ALARA, and access control should be considered when determining the location of the therapy patients room.
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| If radiopharmaceutical therapy and brachytherapy patient rooms are added after the initial license is issued, additional room diagrams should be submitted if the room design (including shielding) and the occupancy of adjacent areas are significantly different from the original information provided. A written description should be submitted for simple changes.
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| Note: If applicants are proposing to use portable shielding to protect health and minimize danger to life or property, they should describe the alternative equipment and administrative procedures they propose to use for evaluation and approval by the NRC. If applicants elect to use portable shielding, they should commit to having administrative procedures to control configuration management to maintain dose within regulatory limits.
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| For types of use permitted by 10 CFR 35.500, the applicant should provide the room numbers of use.
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| For types of use permitted by 10 CFR 35.600 and as required by 10 CFR 35.615, the applicant should provide a diagram and the shielding calculations for the facility. See Figure 8-5 for an example of a basic diagram. The applicants diagram should be based on proposed room layout and shielding.
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| 8-48
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| | |
| SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390*
| |
| Iridium (Ir)-192 gamma constant from NCRP Report No. 49: 4.8 roentgen-cm2h-1mCi-1 Ir-192 Tenth Value Layer from NCRP Report No. 49: 2 cm lead, 14.7 cm poured concrete XX centimeters (cm) of lead or XX cm of poured concrete will be in doors, walls, ceiling, and floor.
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| SECURITY-RELATED INFORMATIONWITHHOLD UNDER 10 CFR 2.390*
| |
| *For the purpose of this NUREG, the facility diagram is marked appropriately for an application. This particular diagram does not contain real security-related sensitive information.
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| NCRP report Numbers 49 and 151 provide guidance on determining appropriate thicknesses based on the assumed beam on-time, distances, and maximum loading to meet the regulatory requirements in 10 CFR 20.1301.
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| Applicants should provide assumptions used in their calculations to determine these thicknesses.
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| Figure 8-5. Facility Diagram for HDR Suite When preparing applications for use under 10 CFR 35.1000, applicants should review the guidance on the Medical Uses Licensee Toolkit Web page to determine the type of information appropriate to evaluate the adequacy of the facilities.
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| All limited, specific medical use licensees are required by 10 CFR 35.13, License amendments, to obtain a license amendment before adding to or changing an area of use identified in the application or on the license. However, changes and additions to the 10 CFR 35.100 and 10 CFR 35.200 medical use areas located in the same address of use do not require a license amendment and can be made, provided the NRC is notified, as required by 8-49
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| | |
| 10 CFR 35.14, within 30 days following the changes. The broad scope medical use licensee does not have to notify NRC of changes that do not require a license amendment.
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| Response from Applicant: All medical use applicants, including broad scope medical use applicants, are required to provide facility diagrams.
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| Provide the following:
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| * Facility diagrams. Drawings should be to scale, and the scale used should be indicated.
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| The direction of north should be indicated.
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| * Location, room numbers, and principal use of each room, including patient treatment rooms or area where byproduct material is prepared, used, and stored.
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| * Principal use of adjacent rooms (e.g., office, file, toilet, closet, hallway), including areas above, beside, and below therapy treatment rooms and Positron Emission Tomography (PET).
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| * Doors should be indicated, and specify which doors are access controlled (i.e., locked).
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| * Shielding calculations for PET facilities, in-patient rooms for 10 CFR 35.300 and 10 CFR 35.400 use, High Dose-Rate/Pulsed Dose Rate and Low-Dose Rate Remote Afterloaders, Teletherapy, and Gamma stereotactic radiosurgery (GSR). Include information about the type, thickness, and density of any necessary shielding to enable independent verification of shielding calculations, and a description of any portable shields used (e.g., shielding of proposed patient rooms used for implant therapy, including the dimensions of any portable shield, if one is used; source storage safe).
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| The calculations should include the workload assumptions used.
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| * For PET, radiopharmaceutical, and sealed-source therapies, provide a description of surrounding areas, including the occupancy factors, and indicate whether the areas are restricted or unrestricted, as defined in 10 CFR 20.1003. For calculations of the maximum exposure in any given hour, an occupancy factor will not be used.
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| * For teletherapy facilities, applicants should provide the directions of primary beam use and, in the case of an isocentric unit, the plane of beam rotation is identified in the shielding calculations.
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| * For 10 CFR 35.1000 (e.g., Perfexion, View-Ray), applicants should provide information described in the guidance on the Medical Uses Licensee Toolkit Web page.
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| Note: The applicant should follow the guidance in Chapter 6, Identifying and Protecting Sensitive Information, to determine if the response includes security-related sensitive information and needs to be marked accordingly.
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| References and Resources:
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| * National Council on Radiation Protection and Measurements (NCRP) Report No. 40, Protection Against Radiation from Brachytherapy Sources, 1972.
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| 8-50
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| * NCRP Report No. 49, Structural Shielding Design and Evaluation for Medical Use of XRays and Gamma Rays of Energies up to 10 MeV, 1976.
| |
| * NCRP Report No. 102, Medical X-Ray, Electron Beam and Gamma-Ray Protection for Energies up to 50 MeV (Equipment Design, Performance and Use), 1989.
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| * NCRP Report No. 151 Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities, 2005.
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| * AAPM Task Group 108, PET and PET/CT Shielding Requirements, 2005.
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| 8.9.2 Radiation Monitoring Instruments Regulations: 10 CFR 20.1101, 10 CFR 20.1501, Part 35 Applicability 10 CFR 30.33(a)(2), 10 CFR 35.61 100 Criteria: All licensees shall possess calibrated radiation detection 200 and measuring instruments that will be used for radiation 300 protection, including survey and monitoring instruments and 400 quantitative measuring instruments needed to monitor the 500 adequacy of radioactive materials containment and 600 contamination control.
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| 1000 Discussion: The radiation protection program that licensees are required to develop, document, and implement, in accordance with 10 CFR 20.1101, must include provisions for survey instrument calibration (10 CFR 20.1501). Licensees shall possess instruments used to measure radiation levels, radioactive contamination, and radioactivity, as applicable.
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| Instruments used for quantitative radiation measurements must be calibrated for the radiation measured. The instruments should be available for use at all times when byproduct material is in use. The licensee should possess survey instruments sufficiently sensitive to measure the type and energy of radiation used, including survey instruments used to locate low-energy or low-activity seeds [e.g., iodine(i)-125, palladium-103] if they become dislodged in the operating room or patients room (e.g., NaI instruments).
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| For the purposes of this document, radiation monitoring instruments are defined as any device used to measure the radiological conditions at a licensed facility. Some of the instruments that may be used to perform the above functions include
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| * portable or stationary count-rate meters
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| * portable or stationary dose-rate or exposure-rate meters
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| * area monitors
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| * single or multichannel analyzers
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| * liquid scintillation counters
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| * gamma counters
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| * proportional counters
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| * solid-state detectors
| |
| * hand- and foot-contamination monitors It is not necessary for a licensee to possess a radiation survey meter solely for sealed source use under 10 CFR 35.500, but a radiation survey meter should be available on short notice in the event of an accident or emergency involving the sealed source.
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| 8-51
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| | |
| Radiation survey meter calibrations must be performed by persons, including licensed personnel, who are qualified to perform calibrations. One method a licensee may use to determine if the service vendor is qualified to perform these activities is to determine that it has an NRC (or an equivalent Agreement State) license. Alternatively, an applicant may choose to develop, implement, and maintain procedures to calibrate their own instruments. Appendix K of this NUREG provides guidance regarding appropriate instrumentation and model survey instrument calibration procedures, if the licensee requests to perform in-house calibration of their own radiation survey meters to meet the requirements detailed in 10 CFR 35.61, Calibration of survey instruments.
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| Regardless of whether an applicant is authorized to calibrate radiation survey meters or contracts an authorized vendor to perform calibrations, the licensee must retain records of the calibration of instruments and equipment used for quantitative radiation measurements for 3 years after the record is made in accordance with 10 CFR 20.2103(a).
| |
| Response from Applicant: Provide the following:
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| * A statement that: Radiation monitoring instruments will be calibrated by a vendor who is licensed by the NRC or an Agreement State to perform instrument calibrations.
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| AND/OR
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| * A statement that: We have developed and will implement and maintain written radiation survey meter calibration procedures in accordance with the requirements in 10 CFR 20.1501 and that meet the requirements in 10 CFR 35.61.
| |
| AND
| |
| * A description of the instrumentation (e.g., gamma counter, solid-state detector, portable or stationary count-rate meter, portable or stationary dose-rate or exposure-rate meter, single or multichannel analyzer, liquid scintillation counter (LSC), proportional counter) that will be used to perform required surveys.
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| Note: A licensee reserves the right to upgrade survey instruments as necessary, as long as they are adequate to measure the type and level of radiation for which they are used.
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| 8.9.3 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct Material Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.60, 10 CFR 35.63 Part 35 Applicability 100
| |
| * Criteria: In 10 CFR 35.60, Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct 200
| |
| * material, and 10 CFR 35.63, Determination of dosages of 300
| |
| * unsealed byproduct material for medical use, the NRC describes 400 500 600 1000 *
| |
| *If applicant will measure patient dosages or use other than unit dosages 8-52
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| | |
| requirements for the use, possession, calibration, and check of instruments (e.g., dose 6 calibrators) used to measure patient dosages.
| |
| Discussion: As described in 10 CFR 35.63, dosage measurement is required for licensees who prepare patient dosages.
| |
| If the licensee uses only unit dosages made by a manufacturer or preparer licensed under 10 CFR 32.72, Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35, or a PET radioactive drug producer authorized under 10 CFR 30.32(j) (and does not split, combine, or otherwise modify unit dosages), the licensee is not required to possess an instrument to measure the dosage.
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| Furthermore, licensees may rely on the providers dose label for the measurement of the dosage and decay-correct the dosage to the time of administration.
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| If the licensee performs direct measurements of dosages in accordance with 10 CFR 35.63 (e.g., prepares its own dosages, breaks up unit dosages for patient administration, or decides to measure unit dosages), the licensee is required to possess and calibrate all instruments used for measuring patient dosages. See Appendix G of this NUREG.
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| Equipment used to measure dosages must be calibrated in accordance with nationally recognized standards [e.g., American National Standards Institute (ANSI)] or the manufacturers instructions. The measurement equipment may be a well-type ionization chamber, an LSC, etc., as long as the instrument can be calibrated appropriately for the type and energy of radiation emitted and is both accurate and reliable.
| |
| For other than unit dosages, the activity must be determined by direct measurement, by a combination of radioactivity measurement and mathematical calculation, or by a combination of volumetric measurement and mathematical calculation. However, there are inherent technical difficulties to overcome. For beta emitting radionuclides, these difficulties include dependence on geometry, lack of an industry standard for materials used in the manufacture of vials and syringes, and lack of an NIST-traceable standard for some radionuclides used. For instance, when determining the dosage of phosphorus-32, assays with a dose calibrator may result in inaccuracies caused by inherent variations in geometry; therefore, a volumetric measurement and mathematical calculation may be more accurate. Licensees must assay patient dosages in the same type of vial and geometry as used to determine the correct dose calibrator settings.
| |
| Using different vials or syringes may result in measurement errors due to, for example, the variation of bremsstrahlung created by interaction between beta particles and the differing dosage containers. Licensees are reminded that beta emitters should be shielded using a low-atomic-numbered material to minimize the production of bremsstrahlung. When a high-activity source is involved, consideration should be given to adding an outer shield made from material with a high atomic number to attenuate bremsstrahlung.
| |
| The inherent technical difficulties in measuring alpha emitting radionuclides are even greater than those of measuring beta emissions. In the absence of an additional photon, gamma, or beta particle emission that can be measured with traditional instrumentation used in nuclear medicine (e.g., ion chambers) and quantified in relation to the alpha-particle emissions, most 6NRC used the term, dosage, in the 2002 revision of 10 CFR Part 35 with the new definition of prescribed dosage in an effort to replace the previous term, dose, which also refers to the amount of energy absorbed per unit mass.
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| However, NRC understands dose continues to be used by many medical professionals to refer to the activity of unsealed byproduct material, hence the name dose calibrator.
| |
| 8-53
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| | |
| alpha-measuring instruments (e.g., gas-proportional counters and LSC) will require preparation and measurement of an aliquot of the unsealed byproduct material. Measurement of aliquots introduces additional uncertainties associated with removing precise and reproducible volumes from homogeneous samples. For example, NRC issued Information Notice (IN) 2016-03, Revision to the National Institute of Standards and Technology Standard for Radium-223 and Impact on Dose Calibration for the Medical Use of Radium-223 Dichloride, January 12, 2016, to notify licensees of a correction in measuring radium-223, which is primarily an alpha emitter. To avoid these difficulties, the best method is to use unit dosages and the manufacturers or commercial nuclear pharmacys dose label for measurement of the dosage and decay-correct the dosage to the time of administration. These difficulties can also be avoided when not using unit dosages by relying on the providers dose label for measurement of the radioactivity and a combination of volumetric measurement and mathematical calculation.
| |
| Licensees who use rubidium (Rb)-82/strontium (Sr)-82 generators should refer to the following for further guidance on the measurement of dosages:
| |
| * RIS 2013-12, Notice of Issuance of Enforcement Guidance MemorandumInterim Guidance for Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of Instrumentation to Measure the Activity of Rubidium-82 and the Determination of Rubidium-82 Patient Dosages, August 23, 2013
| |
| * EGM-13-003, Interim Guidance for Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of Instrumentation to Measure the Activity of Rubidium-82 and the Determination of Rubidium-82 Patient Dosages, April 18, 2013 Response from Applicant, if Applicable:
| |
| For the administration of alpha, gamma, and beta emitting unsealed byproduct materials, provide the following:
| |
| * A statement that: Equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions.
| |
| AND
| |
| * A description of the equipment used to measure the dosages.
| |
| AND
| |
| * For measurement of alpha emitters where gamma or beta emissions are not measurable in a traditional dose calibrator, identify specialized measurement equipment and the nationally recognized standard used to calibrate the instrument or provide a copy of the manufacturers instructions to calibrate the instrument.
| |
| 8-54
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| | |
| 8.9.4 Manual Brachytherapy Sources and Sealed Sources in Therapy Unit -
| |
| Calibration and Use Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.12(c)(2),
| |
| 10 CFR 35.432, 10 CFR 35.433, 10 CFR 35.630, 10 CFR 35.632, Part 35 Applicability 10 CFR 35.633, 10 CFR 35.635, 10 CFR 35.642, 10 CFR 35.643, 100 10 CFR 35.645, 10 CFR 35.652 200 300 Criteria: The above regulations contain NRC requirements for 400
| |
| * verification and periodic spot-checks of source activity or output. 500 To perform these measurements, the applicant must possess 600
| |
| * appropriately calibrated dosimetry equipment. For manual 1000 brachytherapy sources and low-dose rate (LDR) remote *Special requirements re:
| |
| afterloader sources, licensees may use source activity or output brachytherapy and LDR determined by the manufacturer, provided that the manufacturers afterloader sources and measurements meet applicable requirements. Similar provisions Sr-90 sources.
| |
| are included in licensing guidance for certain therapy 10 CFR 35.1000 medical uses. See NRCs Medical Uses Licensee Toolkit Web page for specific information.
| |
| Discussion: Manual brachytherapy sources and LDR remote afterloader sources are often measured by the manufacturer for source output or activity. In accordance with 10 CFR 35.432, if the manual brachytherapy source output or activity is not determined by the manufacturer, the licensee must perform a calibration prior to medical use. Manual brachytherapy sources must be calibrated only initially, prior to use. For all other sealed sources used in a therapy unit, the licensee must possess a calibrated dosimetry system (e.g., Farmer chamber, electrometer, well-type ionization chamber) that will be used to perform calibration measurements of sealed sources to be used for patient therapy. Dosimetry systems and sealed sources used to calibrate the licensees dosimetry systems must be traceable to NIST or to a laboratory accredited by AAPM, pursuant to 10 CFR 35.630, Dosimetry equipment. For sealed sources used in therapy, and in particular, for new types of use, licensees should select dosimetry equipment that will accurately measure the output or the activity of the source. The licensee must maintain records of calibrations of dosimetry equipment for the duration of the license.
| |
| Licensees must perform full calibrations before first medical use and at intervals as defined in 10 CFR 35.632, 10 CFR 35.633, and 10 CFR 35.635. In addition, licensees must perform full calibrations whenever one of the following conditions are met:
| |
| * spot-check measurements (if required) indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for decay
| |
| * following replacement of the sources or reinstallation of the unit in a new location not previously described in the license
| |
| * following any repairs of the unit that include removal of sealed sources or major repair of the components associated with the source exposure assembly If the licensee seeks authorization for a medical use under 10 CFR 35.1000, the licensing guidance on NRCs Medical Uses Licensee Toolkit Web page should be reviewed to determine if calibration and use procedures need to be submitted for that 10 CFR 35.1000 medical use.
| |
| 8-55
| |
| | |
| The licensees AMP must perform full calibrations of sealed sources and devices used for therapy in accordance with published protocols currently accepted by nationally recognized bodies (e.g., AAPM, American College of Radiology, ANSI). Calibration by an AMP is not required for manual brachytherapy sources, except for calculating the activity of Sr-90 sources.
| |
| In accordance with 10 CFR 35.433, the licensees AMP or ophthalmic physicist must calculate the activity of each Sr-90 source that is used to determine the treatment times for ophthalmic therapy. The calibration procedures for therapy sources should address, in part, the method used to determine the exposure rate (or activity) under specific criteria (e.g., distances used for the measurement, whether the measurement is an in air measurement or done using a phantom configuration of the chamber with respect to the source(s) and device, scatter factors used to compute the exposure rate).
| |
| In addition, the licensee must perform spot-check measurements of sealed sources and devices used for therapy in accordance with written procedures established by the AMP (10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645). These procedures must be submitted in accordance with 10 CFR 35.12(b)(2). Calibration procedures described by the AAPM or any published protocol approved by a nationally recognized body, as applicable, may be used.
| |
| See Appendix H of this NUREG for model procedures for performing spot-checks of remote afterloader devices. In addition, AAPM Report No. 41, Remote Afterloading Technology (Remote Afterloading Technology Task Group No. 41), 1993, may also be helpful.
| |
| In accordance with 10 CFR 35.652, licensees must perform surveys around therapy devices to ensure that the maximum radiation levels and the average radiation levels from the surface of the main source safe with the sources in the shielded position do not exceed the levels stated in the SSD registry.
| |
| Response from Applicant: Provide the following:
| |
| * The applicant must provide the procedures required by 10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645, if applicable to the license application.
| |
| * The applicant for a medical use under 10 CFR 35.1000 should provide the procedures required by 10 CFR 35.12(b)(2) that are described in the licensing guidance posted for that 10 CFR 35.1000 medical use on NRCs Medical Uses Licensee Toolkit Web page, or explain why the procedure is not provided.
| |
| References and Resources:
| |
| * AAPM Task Group No. 21, A Protocol for the Determination of Absorbed Dose from High Energy Photon and Electron Beams, 1983.
| |
| * AAPM Report No. 46, Comprehensive QA for Radiation Oncology, (Radiation Therapy Committee Task Group No. 40), 1994.
| |
| * AAPM Report No. 54, Stereotactic Radiosurgery, 1995.
| |
| * AAPM Report No. 59, Code of Practice for Brachytherapy Physics, (Radiation Therapy Committee Task Group No. 56), 1997.
| |
| * AAPM Report No. 61, High Dose-Rate Brachytherapy Treatment Delivery, (Radiation Therapy Committee Task Group No. 59), 1998.
| |
| 8-56
| |
| * AAPM Report No. 67, Protocol for Clinical Reference Dosimetry of High-Energy Photon and Electron Beams, Medical Physics 26(9), pp. 1847-1870, (Radiation Therapy Committee Task Group No. 51), September 1999.
| |
| * AAPM Report No. 68, Permanent Prostate Seed Implant Brachytherapy, (Radiation Therapy Task Group No. 64), October 1999.
| |
| * AAPM Report No. 84, Update of AAPM Task Group No. 43 Report: A Revised AAPM Protocol for Brachytherapy Dose Calculations, February 2004.
| |
| * Erratum: Supplement to the 2004 update of the AAPM Task Group No.43 Report, December 2004.
| |
| * AAPM Report No. 84S, Supplement to the 2004 Update of the AAPM Task Group No. 43 Report, June 2007.
| |
| * NCRP Report No. 69, Dosimetry of X-Ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV, 1981.
| |
| 8.9.5 Other Equipment and Facilities Regulations: 10 CFR 20.1101, 10 CFR 20.1901, 10 CFR 20.1902, Part 35 Applicability 10 CFR 30.33(a)(2), 10 CFR 35.12, 10 CFR 35.415, 100 10 CFR 35.610, 10 CFR 35.615 200 Criteria: Facilities and equipment must be adequate to protect 300 health and minimize danger to life or property. 400 500 Discussion: Applicants must describe the proposed facilities and 600 equipment, as required by 10 CFR 30.33(a)(2) and 10 CFR 35.12.
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| 1000 The applicant should describe, in Item 9 of the application, any other proposed equipment and facilities available for safe use and storage of byproduct material listed in Item 5 of this application. In accordance with 10 CFR 20.1901 and 10 CFR 20.1902, the applicant should ensure that the facilities include the appropriate caution signs and postings.
| |
| For uses authorized by 10 CFR 35.400, 10 CFR 35.600, and 10 CFR 35.1000, as applicable, applicants are required to provide a description of emergency response equipment. In addition, the items below describe other necessary radiation safety equipment.
| |
| For PET radionuclide use: The applicant should focus on remote handling devices and storage containers that may be needed when handling and storing the higher energy emissions of these materials. AAPM Task Group 108, PET and PET/CT Shielding Requirements, provides additional information on this topic, such as the use of tungsten syringe shields or automatic dispensing systems to reduce exposure.
| |
| For radiopharmaceutical therapy: The applicant should focus on facilities to be used for radioactive drug therapy administration and patient accommodations described in Section 8.9.1 (e.g., patient rooms). The most widely used source of radiopharmaceutical therapy is I-131 sodium iodide. If the radionuclide is administered in volatile liquid form, it is important to place the patient dosage in a closed environment (e.g., a fume hood) and consider the hazards from airborne I-131. Additionally, for both liquid and capsule form of I-131, applicants should 8-57
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| | |
| recognize the source of potential contamination from I-131 found in the patients urine, perspiration, saliva, and other secretions.
| |
| For manual brachytherapy: The applicant should describe the emergency response equipment and its availability in accordance with 10 CFR 35.415.
| |
| For teletherapy, GSR, and remote afterloader (LDR, MDR, PDR, and HDR) facilities: The applicant should focus on facilities and equipment necessary to comply with 10 CFR 35.610 and 10 CFR 35.615:
| |
| * Appropriate radiation monitors to be used by any individual entering the treatment room to ensure that radiation levels have returned to ambient levels. One method of meeting this requirement is a beam-on radiation monitor permanently mounted in each therapy treatment room that is equipped with an emergency power supply separate from the power supply for the therapy unit. Such beam-on monitors can provide a visible indication (e.g., flashing light) of an exposed or partially exposed source.
| |
| * Equipment or methods to be used to prevent dual operation of more than one radiation-producing device (e.g., linear accelerator, X-ray machine) in a treatment room, if applicable.
| |
| * Methods used to ensure that console keys will be inaccessible to unauthorized persons when the device is not in use or is unattended.
| |
| * Except for LDR remote afterloaders, a system for continuous observation of the patient while the patient is in the treatment room. If a shielded viewing window will be used, the thickness, density, and type of material used should be specified. If a closed-circuit television system (or some other electronic system) will be used to view the patient, the backup system or procedure to be used in case the electronic system malfunctions should be specified, or the applicant must commit to suspending all treatments until the electronic system is repaired and functioning again.
| |
| * Except for LDR afterloaders, a system for communication with the patient in the event of medical difficulties. An open microphone system can be used to allow communication without requiring a patient to move to activate controls.
| |
| * An electrical interlock system to control the on-off mechanism of the therapy unit. The interlock system must cause the source(s) to be shielded if the door to the treatment room is opened. The interlock system must also prevent the operator from initiating a treatment cycle, unless the treatment room entrance door is closed. Further, the interlock must be wired so that the source(s) cannot be exposed after interlock interruption until the treatment room door is closed and the on-off control for the source(s) is reset at the console.
| |
| For pulsed dose-rate (PDR) remote afterloaders: The applicant should focus on the alarm system because of the unique characteristics and the lack of constant surveillance of their operation. A more sophisticated alarm system is essential to ensure the patient is protected during treatment. In addition to the above, consider the following:
| |
| * The PDR device control console is not accessible to unauthorized personnel during treatment.
| |
| 8-58
| |
| * An AU or someone working under the supervision of an AU checks the patient to ensure that the patients device has not been moved, kinked, dislodged, or disconnected.
| |
| * A more sophisticated interlock/warning system is normally installed for PDR devices.
| |
| This system should perform the following functions or possess the following characteristics:
| |
| The signal from the PDR device and the signal from the room radiation monitor should be connected in such a manner that an audible alarm sounds if the room monitor indicates the presence of radiation and the device indicates a safe or retracted position.
| |
| The alarm circuit should also be wired in such a manner that an audible alarm is generated for any device internal error condition that could indicate the unintended extension of the source. This would constitute a circuit that generates the audible alarm when either the source retracted and radiation present or the appropriate internal error condition(s) exists.
| |
| The source safe and radiation present signal should also be self-testing. If a source not safe input is received without a corresponding radiation present signal, the circuit should generate an interlock/warning circuit failure signal that will cause the source to retract. Reset this circuit manually before attempting to continue treatment.
| |
| The audible alarm should be sufficiently loud to be clearly heard by the facilitys responsible device/patient monitoring staff at all times.
| |
| No provisions for bypassing this alarm circuit or for permanently silencing the alarm should be made to the circuit, as long as the room radiation monitor is indicating the presence of radiation. If any circuitry is provided to mute the audible alarm, such circuitry should not mute the alarm for a period of more than 1 minute. No engineering controls that disable this alarm circuit or silence the alarm for periods in excess of 1 minute should be used.
| |
| If the alarm circuit is inoperative for any reason, licensees should prohibit further treatment of patients with the device until the circuit has been repaired and tested. If the alarm circuit fails during the course of a patient treatment, the treatment in progress may continue as long as continuous surveillance of the device is provided during each treatment cycle or fraction.
| |
| For LDR remote afterloaders: The applicant should describe how the patient and device will be monitored during treatment to ensure that the sources and catheter guide tube are not disturbed during treatment and to provide for prompt detection of any operational problems with the LDR device during treatment.
| |
| For LDR and PDR remote afterloaders: The applicant may submit information on alternatives to fixed shielding as part of their facility description. This information must demonstrate that the shielding will remain in place during the course of patient treatment.
| |
| For radiopharmaceutical therapy and therapy devices regulated under 10 CFR 35.1000, similar provisions regarding equipment and facilities are included in licensing guidance for the specific 10 CFR 35.1000 medical uses. See NRCs Medical Uses Licensee Toolkit Web page for specific information.
| |
| 8-59
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| | |
| Response from Applicant:
| |
| Provide the following, if applicable:
| |
| For PET radionuclide use and radiopharmaceutical therapy programs, describe the additional equipment for these uses, as applicable.
| |
| For manual brachytherapy facilities, provide a description of the emergency response equipment.
| |
| For teletherapy, GSR, and remote afterloader facilities, provide a description of the following:
| |
| * warning systems and restricted area controls (e.g., locks, signs, warning lights and alarms, interlock systems) for each therapy treatment room
| |
| * area radiation monitoring equipment
| |
| * viewing and intercom systems (except for LDR units)
| |
| * steps that will be taken to ensure that no two units can be operated simultaneously, if other radiation-producing equipment (e.g., linear accelerator, X-ray machine) is in the treatment room
| |
| * methods to ensure that whenever the device is not in use or is unattended, the console keys will be inaccessible to unauthorized persons
| |
| * emergency response equipment For 10 CFR 35.1000 medical uses, review the licensing guidance posted for that 10 CFR 35.1000 medical use on NRCs Medical Uses Licensee Toolkit Web page and provide the appropriate descriptions of other equipment and facilities.
| |
| Note: Follow the guidance in Chapter 6, Identifying and Protecting Sensitive Information, to determine if the response to this section includes security-related sensitive information and needs to be marked accordingly.
| |
| | |
| ==Reference:==
| |
| * NCRP Report No. 88 - Radiation Alarms and Access Control Systems, 1986 8-60
| |
| | |
| 8.10 Item 10: Radiation Safety Program Regulations: 10 CFR 20.1101, 10 CFR 30.32, 10 CFR 30.34(e), Part 35 Applicability 10 CFR 35.24, 10 CFR 35.26 100 200 Criteria: Applicants must develop, document, and implement a 300 radiation safety program commensurate with the scope of the licensed activity, in accordance with 10 CFR 20.1101, and submit 400 portions of that program, when required, to assist in NRCs 500 review of the application, in accordance with 10 CFR 30.32. The 600 program must be sufficient to ensure compliance with the 1000 provisions of 10 CFR Part 20 regulations. The licensee is responsible for the conduct of all licensed activities and the acts and omissions of individuals handling licensed material. Under 10 CFR 30.34(e), the NRC may incorporate into materials licenses, at the time of issuance or thereafter, additional requirements and conditions that it deems appropriate or necessary to protect health or to minimize danger to life and property. Licensee managements authorities and responsibilities for the radiation safety program are described in 10 CFR 35.24, while 10 CFR 35.26 sets forth four circumstances in which the licensee may revise its radiation protection program without NRC approval:
| |
| * The revision does not require a license amendment under 10 CFR 35.13.
| |
| * The revision is in compliance with the regulations and the license.
| |
| * The revision has been reviewed and approved by the RSO and licensee management.
| |
| * The affected individuals are instructed on the revised program before the changes are implemented.
| |
| Applicants for 10 CFR 35.1000 medical uses may apply for license conditions that will permit the licensee to revise its radiation safety program for that 10 CFR 35.1000 medical use to conform to revised licensing guidance posted on NRCs Medical Uses Licensee Toolkit Web page without additional NRC approvals. The circumstances for this approval are similar to those in 10 CFR 35.26.
| |
| Discussion: Applicants/licensees must abide by all applicable regulations; develop, implement, and maintain procedures when required; and provide requested information about the proposed radiation safety program during the licensing process. Appendix C of this NUREG may be helpful in determining what information should be provided when requesting a license.
| |
| Response from Applicant: Respond to subsequent sections of this document regarding Item 10 of the application.
| |
| | |
| ==Reference:==
| |
| * NCRP Report No. 127, Operational Radiation Safety Program, 1998
| |
| * International Commission on Radiological Protection (ICRP) Report No. 75, General Principles for the Radiation Protection of Workers, 1997 8-61
| |
| | |
| 8.10.1 Audit and Review Program Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 37.33, Part 35 Applicability 10 CFR 37.55 100 Criteria: Under 10 CFR 20.1101, all licensees must annually 200 review the content and implementation of the radiation protection 300 program. The review should ensure the following: 400 500
| |
| * The radiation protection program complies with NRC and 600 applicable U.S. Department of Transportation (DOT) 1000 regulations and the terms and conditions of the license.
| |
| * Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101).
| |
| * Records of audits and other reviews of program content and implementation are maintained for 3 years after the record is made.
| |
| Licensees that are subject to the requirements in 10 CFR Part 37 must annually review their access authorization program and security program.
| |
| Discussion: Appendix L of this NUREG contains a suggested annual audit program that is specific to medical licensees. Since all areas indicated in Appendix L may not be applicable to every licensee and all items may not need to be addressed during each audit, licensees may wish to develop a program-specific audit checklist. Reviews or audits of the content and implementation of the radiation protection program must be conducted at least annually.
| |
| The NRC encourages licensee management to conduct performance-based reviews by observing work in progress, interviewing staff, and spot-checking required records. As part of the review or audit programs, licensees should consider including unannounced audits of authorized and supervised users to observe whether radiation safety procedures are being followed.
| |
| It is essential that once problems are identified, comprehensive corrective actions are taken in a timely manner. Information Notice (IN) 96-28, Suggested Guidance Relating to Development and Implementation of Corrective Action, dated May 1, 1996, provides guidance on this subject. The NRC routinely reviews licensees records to verify whether appropriate corrective actions were implemented in a timely manner to address recurrence. It is in the best interest of the licensee to identify potential violations of regulatory requirements and take necessary steps to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee for these violations if prompt and effective corrective actions are implemented. The NRCs Enforcement Policy and Enforcement Manual provide additional information. For examples of the NRCs use of discretion in issuing a notice of violation, refer to the most recent version of NRCs enforcement documents.
| |
| With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records of audits and other reviews of program content and implementation for 3 years after the record is made. The NRC has found audit records that contain the following information to be acceptable: date of audit, name of person(s) who conducted audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow up.
| |
| 8-62
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| | |
| In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material must, among other things,
| |
| * In accordance with 10 CFR 37.33, review its access authorization programs at least annually to confirm compliance with the requirements of Subpart B of 10 CFR Part 37 and ensure that comprehensive actions are taken to correct any noncompliance that is identified; and
| |
| * In accordance with 10 CFR 37.55, review its security program at least annually to confirm compliance with the requirements of Subpart C of 10 CFR Part 37 and ensure that comprehensive actions are taken to correct any noncompliance that is identified.
| |
| For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but will be subject to review and inspection.
| |
| Response from Applicant: No response required. The licensees program for auditing its Radiation Safety Program may be reviewed during NRC inspections.
| |
| | |
| ==Reference:==
| |
| * NCRP Report No. 162, Self Assessment of Radiation-Safety Programs, 2009 8.10.2 Occupational Dose Regulations: 10 CFR 19.13, 10 CFR 20.1003, Part 35 Applicability 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203, 100 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 200 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR 20.1703, 10 CFR 20.2104, 10 CFR 20.2106, 10 CFR 20 Appendix B 300 400 Criteria: Licensees must evaluate the potential occupational 500 exposure of all workers and monitor occupational exposure. 600 1000 The use of individual monitoring devices for external dose is required, pursuant to 10 CFR 20.1502(a), for:
| |
| * adults who are likely to receive an annual dose from sources external to the body in excess of any of the following (each evaluated separately) 5 mSv [0.5 rem] deep-dose equivalent (DDE) 15 mSv [1.5 rems] lens (of the eye) dose equivalent 50 mSv [5 rems] shallow-dose equivalent to the skin of the whole body 50 mSv [5 rems] shallow-dose equivalent to the skin of any extremity 8-63
| |
| * minors who are likely to receive an annual dose from sources external to the body in excess of any of the following (each evaluated separately) 1 mSv [0.1 rem] DDEt 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent 5 mSv [0.5 rem] shallow-dose equivalent to the skin 5 mSv [0.5 rem] shallow-dose equivalent to any extremity
| |
| * declared pregnant women who are likely to receive a dose from radiation sources external to the body during the entire pregnancy in excess of 1 mSv [0.1 rem] DDE
| |
| * individuals entering a high or very high radiation area Internal exposure monitoring is required, pursuant to 10 CFR 20.1502(b), for the following:
| |
| * adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable annual limit on intake for ingestion and inhalation
| |
| * minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 1 mSv [0.1 rem] and declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 1 mSv [0.1 rem]
| |
| The licensee must reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person in accordance with 10 CFR 20.1201(f).
| |
| Discussion: Applicants should review the use of all NRC-regulated materials and State-regulated activities (e.g., X-ray and accelerator operation) when determining, for NRC requirements, who is an occupationally exposed individual. The definitions in 10 CFR 20.1003 define occupational dose, a minor, a declared pregnant woman, and the embryo/fetus of a declared pregnant woman.
| |
| The licensee must evaluate the exposure of all occupational workers (e.g., nurses, technologists) to determine if monitoring is required to demonstrate compliance with Subpart F of 10 CFR Part 20. If an adult radiation worker is likely to receive in 1 year a dose greater than 10 percent of any applicable limit (see Figure 8-6 for annual dose limits), monitoring for occupational exposure is required. Monitoring is required for minors and declared pregnant women, as shown in the criteria section. The licensee should perform an evaluation of the dose the individual is likely to receive prior to allowing the individual to receive the dose. This evaluation need not be made for every individual; evaluations can be made for employees with similar job functions or work areas.
| |
| If this prospective evaluation shows that an adult individuals dose is not likely to exceed 10 percent of an applicable regulatory limit, there are no recordkeeping or reporting requirements in regard to the individuals exposure. For individuals who have received doses at other facilities in the current year, the previous dose need not be considered in this prospective evaluation. Only dose that could be received at the facility performing the evaluation need be considered when determining the need for monitoring, and associated recordkeeping and reporting. If it was determined that monitoring was not required, and a subsequent evaluation shows that the 10 percent threshold has or will be exceeded, the dose received when monitoring was not provided should be estimated, recorded, and reported. These estimates can 8-64
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| | |
| Skin Eyes (Lens) 0.50 Sv 0.15 Sv
| |
| [50 rem] [15 rem]
| |
| Elbows to hands Dose Limits for Adult 0.50 Sv
| |
| [50 rem] Radiation Worker (10 CFR 20.1201)
| |
| Knees to feet 0.50 Sv
| |
| [50 rem]
| |
| Total effective dose equivalent TEDE (whole body) 0.05 Sv (5 rem) rad0003a.ppt 072298 Figure 8-6. Annual Occupational Dose Limits for Adults be based on any combination of work location radiation monitoring or survey results, monitoring results of individuals in similar work situations, or other estimates to produce a best estimate of the actual dose received. The licensees must also consider the internal and external dose and the occupational workers assigned duties when evaluating the need to monitor occupational radiation exposure and must have a program in place to sum those exposures in accordance with 10 CFR 20.1202.
| |
| Total effective dose equivalent (TEDE) equals the effective dose equivalent (for external exposures) plus the committed effective dose equivalent (for internal exposures).
| |
| Licensees should use NRC Form 4, Cumulative Occupational Dose History, and NRC Form 5, Occupational Dose Record for a Monitoring Period, to record individual dose. If monitoring is not required to demonstrate compliance with all limits but is required relative to one or more specific limits, the licensee should enter N/A for not applicable in the blocks on NRC Form 4, Cumulative Occupational Dose History, and NRC Form 5, Occupational Dose Record for a Monitoring Period, to indicate the areas for which monitoring was not required (e.g., extremity or skin doses). Where monitoring was provided but not measurable, the licensee should enter ND for not detectable.
| |
| If the prospective evaluation shows that the individual adult is likely to exceed 10 percent of an applicable limit, then monitoring is required, regardless of the actual dose received. Licensees must provide individual radiation exposure data to each worker as required by 10 CFR 19.13.
| |
| Licensees should also perform prospective evaluations of the doses that may be received by occupationally exposed minors and declared pregnant women. As with individual adult workers, licensees must supply and require the use of individual monitoring devices to monitor external exposures and monitor the occupational intake of radioactive material when the results of prospective dose evaluations exceed the doses specified in 10 CFR 20.1502.
| |
| When evaluating doses from xenon gas or aerosols, licensees may take credit for the reduction of dose resulting from the use of xenon or aerosol traps. Licensees may vent xenon 8-65
| |
| | |
| gas or aerosols directly to the atmosphere, as long as the effluent concentration is within 10 CFR Part 20 limits.
| |
| Appendix M of this NUREG provides model procedures for monitoring external occupational exposure. If external dose monitoring is necessary, the applicant should evaluate the type of personnel dosimetry, such as film badges, optically stimulated luminescence dosimeters (OSLs), and thermoluminescent dosimeters (TLD), that personnel will use. If occupational workers handle licensed material, the licensee should evaluate the need to provide extremity monitors, which are required if workers are likely to receive a dose in excess of 0.05 Sv [5 rems]
| |
| shallow-dose equivalent, in addition to whole body badges. Additionally, applicants should ensure that their personnel dosimetry program contains provisions that personnel monitoring devices be worn in such a way that the part of the body likely to receive the greatest dose will be monitored.
| |
| Some licensees use self-reading or electronic dosimeters in lieu of processed dosimetry. This is acceptable if the regulatory requirements are met. See ANSI N322-1997, Inspection, Test, Construction, and Performance Requirements For Direct Reading Electrostatic/Electroscope Type Dosimeters and Regulatory Guide 8.4, Personnel Monitoring DeviceDirect-Reading Pocket Dosimeters, for more information. If pocket dosimeters are used to monitor personnel exposures, applicants should state the useful range of the dosimeters, along with the procedures and frequency for their calibration [10 CFR 20.1501(c)].
| |
| When personnel dosimeters that require processing to determine the radiation dose are used to comply with the individual monitoring requirement for external doses in 10 CFR 20.1502(a),
| |
| dosimeters must be processed by a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited processor [10 CFR 20.1501(d)]. Most licensees use either OSLs, TLDs, or film badges. The exchange frequency for dosimeters is typically monthly or quarterly.
| |
| Applicants should consult with their NVLAP-accredited processor for its recommendations for exchange frequency and proper use of the dosimeter. The NIST maintains a directory of laboratories that are NVLAP-accredited.
| |
| RG 8.40, Methods for Measuring Effective Dose Equivalent from External Exposure, July 2010, provides guidance for evaluating occupational dose when some exposure is due to X-rays, and dosimeters are used to measure exposure behind lead aprons and elsewhere.
| |
| It may be necessary to assess the intake of radioactivity for occupationally exposed individuals in accordance with 10 CFR 20.1204 and 10 CFR 20.1502. If internal dose assessment is necessary, the applicant shall measure the following:
| |
| * concentrations of radioactive material in air in work areas
| |
| * quantities of radionuclides in the body
| |
| * quantities of radionuclides excreted from the body
| |
| * combinations of these measurements The applicant should describe in its procedures the criteria used to determine the type of bioassay and the frequencies at which bioassays (both in vivo and in vitro) will be performed to evaluate intakes. The criteria should also describe how tables of investigational levels are derived, including the methodology used by the evaluated internal dose assessments (i.e., the empirical models used to interpret the raw bioassay data). The bioassay procedures should provide for baseline, routine, emergency, and follow-up bioassays. If a commercial bioassay 8-66
| |
| | |
| service will be used, the applicant should ensure that the service is licensed by the NRC or an Agreement State for that service or provide an alternative for review.
| |
| Acceptable criteria that applicants may use in developing their bioassay programs are outlined in RG 8.9, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program, July 1993.
| |
| For guidance on occupational exposure monitoring and recent events, refer to Table 8-2.
| |
| Table 8-2. Guidance on Personnel Monitoring and Bioassay Regulatory Guide 8.7, Revision 4 Instructions for Recording and Reporting Occupational Radiation Dose Data Regulatory Guide 8.9, Revision 1 Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program Regulatory Guide 8.20, Revision 2 Applications of Bioassay for Radioiodine Regulatory Guide 8.25, Revision 1 Air Sampling in the Workplace Regulatory Guide 8.34 Monitoring Criteria and Methods to Calculate Occupational Radiation Doses Regulatory Guide 8.36 Radiation Dose to the Embryo/Fetus Information Notice 2000-10 Recent Events Resulting in Extremity Exposures Exceeding Regulatory Limits Response from Applicant: Provide one of the following statements:
| |
| We will maintain, for inspection by the NRC, documentation demonstrating that unmonitored individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502.
| |
| OR We will monitor individuals in accordance with the criteria in the section titled, Radiation Safety Program-Occupational Dose in NUREG-1556, Vol. 9, Rev. 3, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licensees.
| |
| OR, IN LIEU OF THESE STATEMENTS, Provide a description of an alternative method for demonstrating compliance with the referenced regulations.
| |
| References and Resources:
| |
| * F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, Federal Guidance Report No.
| |
| 11, Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion, Report No. EPA-520/1-88-020, 1988 8-67
| |
| * ANSI N13.30-2011, Performance Criteria for Radiobioassay.
| |
| * ANSI N322-1997, Inspection, Test, Construction, and Performance Requirements For Direct Reading Electrostatic/Electroscope Type Dosimeters.
| |
| * NUREG/CR-4884, Interpretation of Bioassay Measurements, July 1987.
| |
| * NCRP Report No. 87, Use of Bioassay Procedures for Assessment of Internal Radionuclide Deposition, February 1987.
| |
| * NCRP Report No. 124, Sources and Magnitude of Occupational and Public Exposures from Nuclear Medicine Procedures, March 1996.
| |
| * ICRP Report No. 26, Recommendations of the International Commission on Radiological Protection, 1977.
| |
| * ICRP Publication No. 54, Individual Monitoring for Intakes of Radionuclides by Workers:
| |
| Design and Interpretation, 1989.
| |
| * ICRP Publication No. 60, 1990 Recommendations of the International Commission on Radiological Protection, 1991.
| |
| * ICRP Publication No. 78, Individual Monitoring for Internal Exposure of Workers, 1997.
| |
| * RG 8.9, Revision 1, Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program, July 1993.
| |
| * RG 8.40, Methods for Measuring Effective Dose Equivalent from External Exposure, July 2010.
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| 8.10.3 Public Dose Regulations: 10 CFR 20.1101(d), 10 CFR 20.1301, Part 35 Applicability 10 CFR 20.1302, 10 CFR 20.1801, 10 CFR 20.1802 100 200 Criteria: Licensees must do the following:
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| 300
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| * Ensure that licensed material will be used, transported, 400 and stored in such a way that members of the public will 500 not receive more than 1 mSv [100 mrem] in a year, and 600 the dose in any unrestricted area will not exceed 0.02 1000 mSv [2 mrem] in any one hour from licensed operations
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| [10 CFR 20.1301(a)(1) and (2)].
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| * Ensure that air emissions of radioactive materials to the environment, excluding radon-222 and its daughters, will not result in exposures to individual members of the public in excess of 0.1 mSv [10 mrem] [total effective dose equivalent (TEDE)] in a year from these emissions [10 CFR 20.1101(d)].
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| 8-68
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| * Control and maintain constant surveillance of licensed material that is not in storage and secure stored licensed material to prevent unauthorized access, removal, or use (10 CFR 20.1801 and 10 CFR 20.1802).
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| Discussion: Public dose is defined in 10 CFR 20.1003 as the dose received by a member of the public from exposure to radiation or to radioactive material released by a licensee, or to any other source of radiation under the control of a licensee. Public dose excludes occupational dose, doses received from background radiation, medical procedures the individual has received, from exposure to individuals administered radioactive material and released under 10 CFR 35.75, or from voluntary participation in medical research programs. Whether the dose to an individual is an occupational dose or a public dose depends on the individuals assigned duties. It does not depend on the area (restricted, controlled, or unrestricted) where the individual is when he or she receives the dose.
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| 10 CFR 20.1302 describes how compliance may be achieved for public dose limits. Public dose is controlled, in part, by ensuring that licensed material is secure (e.g., located in a locked area) to prevent unauthorized access or use by individuals coming into the area. Some medical use devices containing licensed material are usually restricted by controlling access to the keys needed to operate the devices and/or to keys to the locked storage area. Only AUs and personnel using byproduct material under their supervision should have access to these keys.
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| Typical unrestricted areas may include offices, shops, laboratories, areas outside buildings, property, and nonradioactive equipment storage areas. The licensee does not control access to these areas for purposes of controlling exposure to radiation or radioactive materials; however, the licensee may control access to these areas for other reasons, such as security. For areas adjacent to facilities where licensed material is used or stored, calculations or a combination of calculations and measurements (e.g., using an environmental TLD), are often used to show compliance.
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| The definition of public dose in 10 CFR 20.1003 does not include doses received due to exposure to patients released in accordance with 10 CFR 35.75. Dose to members of the public in waiting rooms was addressed in Informational Notice (IN) 94-09, Release of Patients with Residual Radioactivity from Medical Treatment and Control of Areas Due to Presence of Patients Containing Radioactivity Following Implementation of Revised 10 CFR Part 20, February 1994. The provisions of 10 CFR 20.1301(a) should not be applied to radiation received by a member of the general public from patients released under 10 CFR 35.75. If a patient is released pursuant to 10 CFR 35.75, licensees are not required to limit the radiation dose to members of the public (e.g., visitors in a waiting room or individuals near a PET quiet room) from a patient to 0.02 mSv [2 mrem] in any one hour. Patient waiting rooms and quiet rooms need only be controlled for those patients who have not been released, per release criteria in 10 CFR 35.75.
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| The regulations in 10 CFR 20.1301(c) allow licensees to permit visitors to a patient who cannot be released under 10 CFR 35.75 to receive a dose greater than 0.1 rem [1 mSv], provided the dose does not exceed 0.5 rem [5 mSv], and the AU has determined before the visit that it is appropriate. RIS 2005-24, Control of Radiation Dose to Visitors of Hospital Patients, November 23, 2005, discusses some of the measures that may be used to maintain control and minimize doses to visitors. RIS 2006-18, Requesting Exemption from the Public Dose Limits for Certain Caregivers of Hospital Patients, August 31, 2006, describes dose limits for members of the public that are designated as caregivers. Caregiver dose limits may be established on a case-by-case basis by the licensee. The justification for incurring the exposure 8-69
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| is that it is beneficial, or possibly essential, to the wellbeing of the patient, and may, therefore, be considered an extension of the patients medical treatment.
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| In assessing the adequacy of facilities to control public dose, licensees should consider the design factors discussed under Facility Diagram in Section 8.9.1 and may find confirmatory surveys to be useful in assuring compliance with 10 CFR 20.1301.
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| The licensee must control emissions to air of all byproduct material such that the individual member of the public likely to receive the highest TEDE does not exceed the constraint level in 10 CFR 20.1101(d), Radiation Protection Programs, of 0.10 mSv/year (yr) [10 mrem/yr] from those emissions. If exceeded, the licensee must report this as described in Section 8.10.21 and Appendix Y of this NUREG and take prompt actions to ensure against recurrence.
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| Response from Applicant: No response required from the applicant, but compliance will be examined during NRC inspections.
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| 8.10.4 Operating and Emergency Procedures Regulations: 10 CFR 19.11(a)(3), Part 35 Applicability 10 CFR 20.1101,10 CFR 20.1601, 10 CFR 20.1602, 100 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906, 200 10 CFR 20.2201-2203, 10 CFR 21.21, 10 CFR 35.12, 300 10 CFR 35.41, 10 CFR 35.75, 10 CFR 35.310, 10 CFR 35.315, 10 CFR 35.404, 10 CFR 35.406, 10 CFR 35.410, 10 CFR 35.415, 400 10 CFR 35.610, 10 CFR 35.615, 10 CFR 35.3045, 500 10 CFR 35.3047, 10 CFR 35.3067, 10 CFR Part 37, 600 10 CFR 37.21(a), 10 CFR 37.45, 10 CFR 37.49 1000 Criteria: This section summarizes operating and emergency procedures. Many of these procedures are covered in greater detail in other sections of this document. The regulatory requirements are listed above for ease of reference by the applicant. In addition, these procedures must be posted in accordance with 10 CFR 19.11(a)(3).
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| The licensee must develop, implement, and maintain specific operating and emergency procedures sufficient to ensure compliance with 10 CFR 20.1101(a) and applicable sections in 10 CFR Part 35. Operating and emergency procedures must encompass the scope of the program, which may include the following elements:
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| * Instructions for opening packages containing licensed material (see Section 8.10.9, Opening Packages).
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| * Instructions for using licensed material, operating therapy treatment devices, and performing routine maintenance on devices containing sealed sources, according to the manufacturers written recommendations and instructions and in accordance with regulatory requirements (see Section 8.10.7, Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy Devices Containing Sealed Sources). There may be sources and devices containing NARM that do not have SSD registration certificates. If these legacy sources or devices have manufacturers recommendations or instructions, they should be followed. These devices and sources are, however, subject to the standard leak test provisions included in materials licenses.
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| 8-70
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| * Instructions for conducting area radiation level and contamination surveys (see Section 8.10.12, Area Surveys).
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| * Instructions for administering licensed material in accordance with the WD (see Section 8.10.13, Procedures for Administrations when a Written Directive Is Required).
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| * Steps to ensure that patient release is in accordance with 10 CFR 35.75 (see Section 8.10.16, Release of Patients or Human Research Subjects).
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| * Instructions for calibration of survey and dosage measuring instruments (see Sections 8.9.2, Radiation Monitoring Instruments, and Section 8.9.3, Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct Material).
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| * Periodic spot-checks of therapy device units, sources, and treatment facilities (see Section 8.9.4, Therapy Unit - Calibration and Use).
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| * Instructions for radioactive waste management (see Section 8.11, Waste Management).
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| * Steps to take, and whom to contact (e.g., RSO, local officials), when the following has occurred: (i) leaking or damaged source, (ii) device malfunction and/or damage, (iii) licensed material spills, (iv) theft or loss of licensed material, (v) medical event reporting, or (vi) any other incidents involving licensed material (see Sections 8.10.5, Spill/Contamination Procedures, and 8.10.21, Reporting).
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| * Steps for source retrieval and access control of damaged sealed source(s) and/or malfunctioning devices containing sealed source(s) (see Section 8.10.6, Emergency Procedures for Therapy Devices Containing Sealed Sources).
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| * Steps to take if a therapy patient undergoes emergency surgery or dies.
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| The licensee should:
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| * Make operating procedures, including emergency procedures, available to all users (e.g., post the procedures or the location of procedure storage).
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| * Maintain a current copy of the procedures at each location of use, or, if this is not practicable, post a notice describing the procedures and State where they may be examined.
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| * Use, to the extent practical, procedures and engineering controls based on sound radiation protection principles to achieve occupational doses and doses to members of the public that are ALARA in accordance with 10 CFR 20.1101(b).
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| * Secure or control byproduct material at all times.
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| Under certain 10 CFR 35.1000 medical uses, the applicant must develop, document, submit, and implement written safety procedures for emergency responses before using materials. The 8-71
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| licensing guidance on NRCs Medical Uses Licensee Toolkit Web page for 10 CFR 35.1000 medical uses provides specific information for each 10 CFR 35.1000 medical use.
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| Additionally, licensees that possess an aggregated Category 1 or Category 2 quantity of radioactive material, listed in Appendix A to 10 CFR Part 37, must also establish, implement, and maintain its access authorization program; coordinate, to the extent practicable, with local law enforcement authorities, for responding to threats to the licensees facility; and be able to monitor, detect without delay, assess, and respond to any unauthorized entries into security zones.
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| Discussion: Sealed sources and unsealed byproduct material used for therapy can deliver significant doses in a short time. The same may be true for high-activity PET radiopharmaceuticals, if not shielded. Access control to high- and very-high-radiation areas and the security of licensed material are described in 10 CFR 20.1601, Control of access to high radiation areas; 10 CFR 20.1602, Control of access to very high radiation areas; 10 CFR 20.1801, Security of stored material; and 10 CFR 20.1802, Control of Material Not in Storage. Unauthorized access to licensed material by untrained individuals could lead to a significant radiological hazard. Many licensees achieve access control by permitting only trained individuals to have access to licensed material (e.g., keys, lock combinations, security badges). Accountability of licensed material may be ensured by conducting physical inventories, controlling receipt and disposal, and maintaining use records.
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| If a therapy patient treated with unsealed radionuclides or permanent implant brachytherapy undergoes emergency surgery or dies, it is necessary to ensure the safety of others attending the patient. As long as the patients body remains unopened, the radiation received by anyone near it is due almost entirely to gamma rays. When an operation or autopsy is to be performed, there should be an increased awareness of the possible exposure of the hands and face to relatively intense beta radiation. Additional care for patients recently treated with medium- to high-energy gamma emitters, such as I-131, and high-energy beta emitters, such as Y-90, should be observed. Procedures for emergency surgery or autopsy can be found in NCRP Report No. 155, Management of Radionuclide Therapy Patients, December 2006.
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| Applicants should develop emergency procedures that address a spectrum of incidents (e.g., major spills, leaking sources, medical events, interlock failures, stuck sources). After its occurrence becomes known to the licensee, the NRC must be notified when an incident involving licensed material occurs. Refer to the regulations (10 CFR 20.2201-20.2203, 10 CFR 30.50, 10 CFR 21.21, 10 CFR 35.3045, 10 CFR 35.3047, 10 CFR 35.3067), and 10 CFR 35.3204) for a description of when notifications are required.
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| Appendix N of this NUREG provides model procedures that represent one acceptable method for responding to some types of emergencies. Applicants requesting authorization for licensed activities not addressed by the model procedures in Appendix N of this NUREG should develop operational and emergency procedures to address these other activities.
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| 8-72
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| In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material must, among other things,
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| * In accordance with 10 CFR 37.21(a), establish, implement, and maintain its access authorization program in accordance with the requirements of 10 CFR Part 37, Subpart B.
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| * In accordance with 10 CFR 37.45, coordinate with their local law enforcement agency (LLEA) for responding to threats to a licensees facility.
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| * In accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and respond to any unauthorized entries into security zones, including those surrounding mobile devices.
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| For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
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| Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, but will be subject to review and inspection.
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| Response from Applicant: No response required.
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| 8.10.5 Spill/Contamination Procedures Regulations: 10 CFR 20.1101 Part 35 Applicability Criteria: Before using licensed material, the licensee must 100 develop, document, and implement a radiation protection program 200 that includes proper response to spills of licensed material. 300 Discussion: The radiation protection program that licensees are 400 required to develop, document, and implement in accordance with 500 10 CFR 20.1101, must include provisions for responding to spills 600 or other contamination events to prevent the spread of radioactive 1000 material. Appendix N of this NUREG contains model emergency response procedures, including model spill procedures. Spill procedures should address all types and forms of licensed material used and should be posted in restricted areas where licensed materials are used or stored. The instructions should specifically state the names and telephone numbers of persons to be notified (e.g., RSO, staff, State and local authorities, and the NRC, when applicable). Additionally, the instructions should contain procedures for evacuation of the area, and containment of spills and other releases, as well as appropriate methods for reentering and decontaminating facilities (when necessary).
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| Response from Applicant: Provide the following statement:
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| We have developed and will implement and maintain written procedures for safe response to spills of licensed material in accordance with 10 CFR 20.1101.
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| 8-73
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| ==Reference:==
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| * NCRP Report No. 65, Management of Persons Accidentally Contaminated with Radionuclides, 1980 8.10.6 Emergency Procedures for Therapy Devices Containing Sealed Sources Regulations: 10 CFR 35.12(c)(2), 10 CFR 35.610, 10 CFR 35.615 Part 35 Applicability 100 Criteria: Before using materials under 10 CFR 35.600, Use of a 200 sealed source in a remote afterloader unit, teletherapy unit, or 300 gamma stereotactic radiosurgery unit, the applicant must 400 develop, document, implement, and submit written emergency 500 procedures in accordance with 10 CFR 35.12(b)(2). Regulations 600 in 10 CFR 35.610, Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic 1000 radiosurgery units, require, in part, that written procedures be developed, implemented, and maintained for responding to an abnormal situation involving a remote afterloader unit, a teletherapy unit, or a GSR unit. The procedures needed to meet 10 CFR 35.610 must include
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| * instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions
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| * the process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure
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| * the names and telephone numbers of AUs, AMPs, and the RSO to be contacted if the unit or console operates abnormally A copy of these procedures must be physically located at the therapy unit console. The instructions must inform the operator of procedures to be followed if the operator is unable to place the source(s) in the shielded position, or remove the patient from the radiation field with controls from outside the treatment room.
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| Regulations in 10 CFR 35.615, Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units, require the physical presence of certain individuals for therapy units to ensure that safety precautions are appropriately implemented.
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| The following documents provide useful information regarding physical presence requirements:
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| * IN 2012-08, High Dose-Rate Remote Afterloader (HDR) Physical Presence Requirements, April 10, 2012
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| * RIS 2005-23, Clarification of the Physical Presence Requirement During Gamma Stereotactic Radiosurgery Treatments, October 7, 2005 When sources are placed within the patients body, 10 CFR 35.615(e) requires that licensed activities be limited to treatments that allow for expeditious removal of a decoupled or jammed source.
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| 8-74
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| Before using materials under certain 10 CFR 35.1000 medical uses, the applicant must develop, document, submit, and implement written safety procedures for emergency responses. The licensing guidance on NRCs Medical Uses Licensee Toolkit Web page for 10 CFR 35.1000 medical uses provides specific information for each 10 CFR 35.1000 medical use.
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| Discussion: The applicant must establish and follow written procedures for emergencies that may occur (e.g., a therapy source fails to retract or return to the shielded position, or a GSR couch fails). A copy of the manufacturers recommendations and instructions should be given to each individual performing therapy treatments or operating the therapy device. The licensee must provide instructions, initially and annually, to include responding to an abnormal situation described in 10 CFR 35.610(a)(4). Practice drills, using nonradioactive (dummy) sources when possible, must be practiced at least annually and may be conducted more frequently, as needed. Team practice is important for adequate emergency coordination. The drills should include dry runs of emergency procedures that cover stuck or dislodged sources and applicators, if applicable, and emergency procedures for removing the patient from the radiation field. These procedures, designed to minimize radiation exposure to patients, workers, and the general public, should address the following points, as applicable to the type of medical use:
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| * When the procedures are to be implemented, such as any circumstance in which the source becomes dislodged, cannot be retracted to a fully shielded position, or the patient cannot be removed from the beam of radiation.
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| * The actions specified for emergency source recovery or shielding that primarily consider minimizing exposure to the patient and health care personnel while maximizing the safety of the patient.
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| * The step-by-step actions for single or multiple failures that specify the individual(s) responsible for implementing the actions. The procedures should clearly specify which steps are to be taken under different scenarios. The procedure should specify situations in which surgical intervention may be necessary and the steps that should be taken in that event.
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| * Location of emergency source recovery equipment, specifying what equipment may be necessary for various scenarios. Emergency equipment should include shielded storage containers, remote handling tools, and if appropriate, supplies necessary to surgically remove applicators or sources from the patient and tools necessary for removal of the patient from the device.
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| * Radiation safety priorities, such as giving first consideration to minimizing exposure to the patient, usually by removing the patient from the room (rather than using tools to attempt to return the source to the off position).
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| * Instructing the staff to act quickly and calmly, and to avoid the primary beam of radiation.
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| * Specifying who is to be notified.
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| * Requirements to restrict (lock, as necessary) and post the treatment area with appropriate warning signs as soon as the patient and staff are out of the treatment room.
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| 8-75
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| Response from Applicant: Provide procedures required by 10 CFR 35.610.
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| If appropriate, review 10 CFR 35.1000 medical use licensing guidance on NRCs Web site Medical Uses Licensee Toolkit Web page, and provide safety and emergency procedures requested for the particular 10 CFR 35.1000 medical use.
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| 8.10.7 Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy Devices Containing Sealed Sources Regulations: 10 CFR 20.1101, 10 CFR 30.32, 10 CFR 35.605, Part 35 Applicability 10 CFR 35.655 100 200 Criteria: Applicants requesting authorization to install, maintain, 300 adjust, repair, and inspect their own therapy devices containing 400 sealed sources must develop, document, submit, and implement 500 those procedures, in accordance with 10 CFR 20.1101 and 600 10 CFR 30.32. In accordance with 10 CFR 35.605, Installation, maintenance, adjustment, and repair, and 10 CFR 35.655, 1000 Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units, licensees must ensure that therapy devices containing sealed sources are installed, maintained, adjusted, repaired, and inspected by persons specifically licensed to conduct these activities. The above activities should be conducted according to the manufacturers written recommendations and instructions and according to the SSD registration certificate. In addition, 10 CFR 35.655 requires that teletherapy and GSR units be fully inspected and serviced during source replacement. The interval between each full-inspection servicing shall not exceed 5 years for teletherapy units and 7 years for gamma stereotactic radiosurgery units to ensure that the source exposure mechanism and other safety components function properly. Maintenance is necessary to ensure that source integrity and safety components are not compromised and that the device functions as designed. Similar provisions are included in licensing guidance for certain therapy 10 CFR 35.1000 medical uses. See the Medical Uses Licensee Toolkit Web page for specific information.
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| Discussion: Maintenance and repair includes installation, replacement, and relocation or removal of the sealed source(s) or therapy unit that contains a sealed source(s). Maintenance and repair also includes any adjustment involving any mechanism on the therapy device, treatment console, or interlocks that could expose the source(s), reduce the shielding around the source(s), affect the source drive controls, or compromise the radiation safety of the unit or the source(s).
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| The NRC requires that maintenance and repair (as defined above) be performed only by persons specifically licensed by the NRC or an Agreement State to perform such services.
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| Most licensee employees do not perform maintenance and repair because they do not have the specialized equipment and technical expertise to perform these activities. Applicants requesting authorization to possess and use LDR remote afterloaders should review 10 CFR 35.605 before responding to this item. Regulations in 10 CFR 35.605 allow for an AMP to perform certain service activities with regard to LDR remote afterloader units.
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| Response from Applicant: No response is required if the licensee contracts with personnel who are licensed by the NRC or an Agreement State to install, maintain, adjust, repair, and inspect the specific therapy device possessed by the licensee. However, if the applicant requests that one of its own employees, who is trained by the manufacturer, be authorized to 8-76
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| perform the aforementioned activities, the applicant must provide sufficient information to allow the NRC to evaluate and approve such authorization in accordance with 10 CFR 35.605 and 10 CFR 35.655. This should include the following:
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| * name of the proposed employee(s) and types of activities requested AND
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| * description of the training and experience demonstrating that the proposed employee is qualified by training and experience for the use requested AND
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| * copy of the manufacturers training certification and an outline of the training in procedures to be followed AND
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| * written commitment from the licensee that the trained employee will follow manufacturer procedures.
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| Note: The applicant should specify only those installation, maintenance, inspection, adjustment, and repair functions, as described in a certificate or letter from the manufacturer of the device, that document the employees training in the requested function(s).
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| 8.10.8 Ordering and Receiving Regulations: 10 CFR 20.1801, 10 CFR 20.1802, Part 35 Applicability 10 CFR 20.1906 100 Criteria: The requirements for receiving packages containing 200 licensed material are found in 10 CFR 20.1906, Procedures for 300 receiving and opening packages. Additionally, the security of 400 licensed material, required by 10 CFR 20.1801 and 500 10 CFR 20.1802, must be considered for all receiving areas. 600 1000 Discussion: Licensees must ensure that the type and quantity of licensed material possessed is in accordance with the license. Additionally, licensees must ensure that packages are secured and radiation exposure from packages is minimized.
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| Appendix O of this NUREG contains model procedures that represent one acceptable method for ordering and receiving licensed material.
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| Response from Applicant: No response required.
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| 8-77
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| 8.10.9 Opening Packages Regulations: 10 CFR 20.1906 Part 35 Applicability Criteria: Licensees must ensure that packages are opened 100 safely and that the requirements of 10 CFR 20.1906 are met. 200 300 Discussion: Licensees must establish, maintain, and retain 400 written procedures for safely opening packages, to ensure that 500 the monitoring requirements of 10 CFR 20.1906 are met and that 600 radiation exposure to personnel coming near or in contact with the packages containing radioactive material are ALARA. 1000 Appendix P of this NUREG contains model procedures that represent one acceptable method for safely opening packages containing radioactive materials. Applicants are reminded that 10 CFR 20.1906(b) requires, in part, that licensees monitor the external surfaces of a labeled package for radioactive contamination within 3 hours of receipt if it is received during normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.
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| Response from Applicant: No response required.
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| 8.10.10 Material Receipt and Accountability Regulations: 10 CFR 20.1801, 10 CFR 20.1802, Part 35 Applicability 10 CFR 20.2108, 10 CFR 20.2201, 10 CFR 20.2207, 100 10 CFR 30.41, 10 CFR 30.51, 10 CFR 35.67, 10 CFR 35.406, 10 CFR 35.2067, 10 CFR 35.2406, 200 10 CFR 37.49, 10 CFR 37.71, 10 CFR 37.75, 10 CFR 37.77 300 400 Criteria: To maintain accountability of licensed material, 500 licensees must do the following:
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| 600
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| * Secure licensed material. (10 CFR 20.1801 and 1000 10 CFR 20.1802)
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| * Maintain records of receipt, transfer, and disposal of licensed material.
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| (10 CFR 30.51, 10 CFR 30.41, and 10 CFR 20.2108)
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| * Conduct physical inventories at required frequencies to account for licensed material.
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| Ensure that material received does not exceed license possession limits.
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| * Update transactions in the NSTS, including an annual inventory reconciliation.
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| (10 CFR 20.2207)
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| * Conduct physical inventories at semi-annual intervals (not to exceed 6 months) to account for all sealed sources containing byproduct material and retain records for 3 years. (10 CFR 35.67 and 10 CFR 35.2067) Individual GSR sources are exempt from this physical inventory requirement, as stated in 10 CFR 35.67(g). However, in accordance with 10 CFR 30.51, the licensee must maintain records of GSR source 8-78
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| receipt, transfer, and disposal to indicate the current inventory of sources at the licensees facility.
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| * Maintain accountability for brachytherapy sources in storage or use and retain records for 3 years. (10 CFR 35.406 and 10 CFR 35.2406)
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| * Maintain access control and surveillance to Category 1 and Category 2 quantities of radioactive material in accordance with 10 CFR 37.49.
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| * Before transferring aggregated Category 1 or Category 2 quantities of radioactive material listed in Appendix A to 10 CFR Part 37, use NRCs license verification system to verify that the recipient licensee is authorized to possess the radioactive material.
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| * Preplan, coordinate, and provide advance notification of shipment of Category 1 quantities of radioactive material and coordinate shipment of Category 2 quantities of radioactive material listed in Appendix A to 10 CFR Part 37. (10 CFR 37.75 and 10 CFR 37.77).
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| Discussion: Licensed materials must be tracked from cradle to grave, from receipt (from another licensee or from its own radionuclide production facility) to its eventual transfer/disposal, to ensure accountability at all times; identify when licensed material may be lost, stolen, or misplaced; and ensure that the possession limits listed on the license are not exceeded.
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| For aggregated Category 1 and Category 2 quantities of radioactive material listed in Appendix A to 10 CFR Part 37, licensees must fully implement the requirements of 10 CFR Part 37 before receipt of the radioactive material. Additionally, according to 10 CFR 37.49(a)(1), licensees must continuously monitor and detect, without delay, all unauthorized entries into security zones. Additionally, for Category 1 quantities of radioactive material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. For Category 2 quantities of radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through physical checks, tamper-indicating devices, use, or other means to ensure that the radioactive material is present.
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| Licensees are required under 10 CFR 20.1801 and 10 CFR 20.1802 to secure radioactive materials from unauthorized removal or access while in storage and to control and maintain constant surveillance over licensed material that is not in storage.
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| Receipt, inventory, transfer, and disposal records must be maintained for the times specified in Table X-1 in Appendix X of this NUREG. Typically, these records contain the following types of information:
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| * radionuclide and the activity (in units of becquerels or curies) of byproduct material in each sealed source, and assay date
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| * manufacturers or distributors name, model number, and serial number (if appropriate) of each device containing byproduct material
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| * location of each sealed source and device 8-79
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| * for inventories, the date of the inventory, and name and signature of the individual conducting the inventory
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| * for materials transferred or disposed of, the date of the transfer or disposal, the name and license number of the recipient, a description of the affected radioactive material (e.g., radionuclide, activity, manufacturers or distributors name and model number, serial number), and method of disposal (e.g., decay-in-storage return to pharmacy, return to manufacturer)
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| Category 1 and Category 2 sources listed in Appendix E to 10 CFR Part 20 (i.e., nationally tracked sources) must be tracked in the National Source Tracking System (NSTS) in accordance with 10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that each licensee that manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report (NSTTR) to the NRC. The NSTTRs are maintained in the NSTS, a secure computer system that tracks Category 1 and Category 2 nationally tracked sources from the time they are manufactured or imported through the time of their disposal or export, or until the source activity decays to below Category 2.
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| There are additional security requirements for shipment and transfer of a Category 1 and Category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. Prior to transferring Category 1 or Category 2 quantities of radioactive material, licensees must use NRCs license verification system (or contact the licensing authority) to verify that the recipient licensee is authorized to possess the radioactive material. Licensees that ship Category 1 or Category 2 quantities of radioactive material must preplan and coordinate such shipments in accordance with 10 CFR 37.75. Shipments of Category 1 quantities are also subject to the 10 CFR 37.77 advance notification requirements. For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may be subject to review and inspection.
| |
| Response from Applicant: Provide the following statements:
| |
| * We will develop, implement, and maintain written procedures for licensed material accountability and control to ensure that:
| |
| license possession limits are not exceeded licensed material in storage is secured from unauthorized access or removal licensed material not in storage is maintained under constant surveillance and control records of receipt (either from the licensees own production operations or from another licensee), transfer, and disposal of licensed material, are maintained.
| |
| 8-80
| |
| | |
| AND
| |
| * If applicable, We will comply with the NSTS reporting requirement, as described in 10 CFR 20.2207.
| |
| 8.10.11 Leak Tests Regulations: 10 CFR 20.1501, 10 CFR 35.67 Part 35 Applicability 100
| |
| * Criteria: The NRC requires testing to determine if there is any radioactive leakage from sealed sources. The NRC finds testing 200
| |
| * to be acceptable if it is conducted by an organization licensed by 300
| |
| * the NRC or an Agreement State or if it is conducted in accordance 400 with procedures submitted by the applicant and approved by the 500 NRC or an Agreement State. Leak test records shall be retained 600 for 3 years after they are made or until the source in storage 1000 is removed.
| |
| *If possess sealed sources under 10 CFR 35.65 Discussion: Licensees must perform leak testing of sealed sources possessed under 10 CFR Part 35 (e.g., calibration, transmission, reference, or brachytherapy sources), in accordance with 10 CFR 35.67, Requirements for possession of sealed sources and brachytherapy sources. In addition, licensees must perform leak testing of all other sealed sources possessed under 10 CFR Part 30 (e.g., survey instrument calibration sources) in accordance with 10 CFR 20.1501.
| |
| The NRC has regulatory authority over sealed sources and devices containing accelerator-produced radioactive material and discrete sources of Ra-226 in accordance with the Energy Policy Act of 2005. Sources and devices containing this NARM byproduct material might not have SSD registration certificates. These devices and sources are, however, subject to the standard leak test provisions included in materials licenses.
| |
| Appendix Q of this NUREG provides model procedures that represent one acceptable method to perform leak testing for sealed sources. Under 10 CFR 35.67, licensees are required to perform leak tests at 6-month intervals or at other intervals approved by the NRC or an Agreement State and specified in the SSD registration certificate and before first use, unless accompanied by a certificate indicating that the test was performed within the past 6 months.
| |
| The measurement of the leak test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 Bq [0.005 µCi] of radioactivity on the sample. Leak test samples should be collected at the most accessible area where contamination would accumulate if the sealed source were leaking. The leak test may be performed in-house or by a contractor who is authorized by the NRC or an Agreement State to perform leak tests as a service to other licensees.
| |
| The licensee or contractor does not need to leak test sources if:
| |
| * Sources contain only byproduct material with a half-life of less than 30 days.
| |
| * Sources contain only byproduct material as a gas.
| |
| * Sources contain 3.7 MBq [100 µCi] or less of beta emitting or gamma-emitting material, or 0.37 MBq [10 µCi] or less of alpha emitting material.
| |
| 8-81
| |
| * Sources contain iridium-192 seeds in nylon ribbon.
| |
| * Sources are stored and not being used. The licensee, shall, however, test each such source for leakage before any use or transfer, unless it has been leak-tested within 6 months before the date of use or transfer.
| |
| Response from Applicant: Provide the following:
| |
| For in-house leak testing of sealed sources used pursuant to 10 CFR Part 35
| |
| * a statement that: We have developed and will implement and maintain written procedures for sealed-source leak testing that meet the requirements of 10 CFR 35.67.
| |
| For in-house leak testing of sealed sources other than those authorized pursuant to 10 CFR Part 35 (e.g., self-shielded irradiators, calibration sources)
| |
| * a statement that: We will conduct leak tests in-house.
| |
| AND
| |
| * a statement that: The attached leak test procedures will be followed for leak tests conducted in-house.
| |
| AND
| |
| * Attach leak test procedures.
| |
| OR
| |
| * a statement that the applicant will implement the model leak test program of the appendix of the appropriate NUREG-1556 volume for the type of use. For instance, if an applicant possesses a self-shielded irradiator, the applicant may state, We will implement the model leak test program published in Appendix N of NUREG-1556, Volume 5, Rev. 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses.
| |
| OR
| |
| * if a contractor is used to perform leak testing, the applicant should state the following:
| |
| Leak test sample collection and analysis will be performed by an organization authorized by the NRC or an Agreement State to provide leak testing services to other licensees; or by using a leak test sample collection kit supplied by an organization licensed by the NRC or an Agreement State to provide leak test kits or sample analysis services to other licensees and according to the instructions provided in the leak test sample collection kit.
| |
| 8-82
| |
| | |
| 8.10.12 Area Surveys Regulations: 10 CFR 20.1003, 10 CFR 20.1101, Part 35 Applicability 10 CFR 20.1201, 10 CFR 20.1301, 10 CFR 20.1501, 100 10 CFR 35.70, 10 CFR 35.315, 10 CFR 35.404, 10 CFR 35.604 200 Criteria: Licensees are required to make surveys of potential 300 radiological hazards in their workplace. For example, licensees 400 must perform surveys to 500 600
| |
| * Ensure that licensed material will be used, transported, 1000 and stored in such a way that doses to members of the public do not exceed 1 mSv/yr [100 mrem/yr] and that the dose in any unrestricted area will not exceed 0.02 mSv [2 mrem] in any one hour from licensed operations in accordance with 10 CFR 20.1301.
| |
| * Ensure that licensed material will be used, transported, and stored in such a way that occupational doses to individuals will not exceed the limits specified in 10 CFR 20.1201.
| |
| * Control and maintain constant surveillance over licensed material that is not in storage and secure licensed material from unauthorized access or removal.
| |
| * Ensure that licensed material will be used, transported, and stored in such a way that the air emissions do not exceed the constraint value in 10 CFR 20.1101.
| |
| Discussion: The radiation protection program that licensees are required to develop, document, and implement, in accordance with 10 CFR 20.1101, must include provisions for area surveys. Survey, as defined in 10 CFR 20.1003, is an evaluation of radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. These evaluations, as required by 10 CFR 20.1501, may be measurements (e.g., radiation levels measured with survey instruments or results of wipe tests for contamination), calculations, or a combination of measurements and calculations. The selection and proper use of appropriate instruments is one of the most important factors in ensuring that surveys accurately assess radiological conditions. Licensees should also use surveys to plan work in areas where licensed material or radiation exists and to evaluate doses to workers and individual members of the public. In certain cases, environmental monitoring may be required to demonstrate compliance with 10 CFR Part 20. To meet regulatory requirements for surveying, measurements of radiological quantities should be understood in terms of their properties (i.e., alpha, beta, or gamma) and compared to the appropriate regulatory limits.
| |
| There are many different kinds of surveys performed by licensees:
| |
| * contamination fixed removable
| |
| * personnel (during use, transfer, or disposal of licensed material)
| |
| * air effluent
| |
| * water effluent
| |
| * leak test 8-83
| |
| * bioassays
| |
| * air sample
| |
| * external radiation exposure levels
| |
| * restricted areas
| |
| * unrestricted areas Surveys are required when it is reasonable under the circumstances to evaluate a radiological hazard and when necessary for the licensee to comply with the appropriate regulations. Typical surveys may include:
| |
| * surveys for radioactive contamination that could be present on surfaces of floors, walls, laboratory furniture, and equipment
| |
| * measurements of radioactive material concentrations in air for areas where radiopharmaceuticals are handled or processed in unsealed form and where operations could expose workers to the inhalation of radioactive material (e.g., radioiodine) or where licensed material is or could be released to unrestricted areas (Refer to RG 8.25, Air Sampling in the Workplace, June 1992, and NUREG-1400, Air Sampling in the Workplace, September 1993, for further guidance on air sampling.)
| |
| * bioassays to determine the kinds, quantities, or concentrations, and in some cases, the location of radioactive material in the human body. Radioiodine uptake in a workers thyroid gland is commonly measured by external counting using a specialized thyroid detection probe.
| |
| * surveys of external radiation exposure levels in both restricted and unrestricted areas
| |
| * surveys of radiopharmaceutical packages entering (e.g., from suppliers) and departing (e.g., returned radiopharmaceuticals to the supplier)
| |
| The frequency of routine surveys depends on the nature, quantity, and use of radioactive materials, as well as the specific facilities, equipment, and procedures that are designed to protect workers and the public from external and internal exposure. Also, the frequency of the survey depends on the type of survey. Appendix R of this NUREG contains model procedures that represent one acceptable method of establishing survey frequencies for medical use, ambient radiation levels, and contamination surveys.
| |
| For example, in accordance with 10 CFR 35.70, medical use licensees are required to perform daily surveys in all areas used for the preparation and administration of radiopharmaceuticals for which a WD is required {diagnostic activities exceeding 1.11 MBq [30 µCi] of I-131 and all therapy treatments}. When the licensee administers radiopharmaceuticals requiring a WD in a patients room, the licensee is not required to perform a survey within the patients room.
| |
| Licensees should be cognizant of the requirement to perform surveys to demonstrate that public dose limits are not exceeded in adjacent areas. In addition, licensees should perform surveys after the patients release, in accordance with 10 CFR 35.315, and must perform surveys prior to the release of the room for unrestricted use.
| |
| 8-84
| |
| | |
| As sealed sources (including within applicators and catheters) may become dislodged during implantation or after surgery, and inadvertently lost or removed, the licensee must perform surveys in accordance with 10 CFR 35.404:
| |
| * Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.
| |
| * Immediately after removing the last temporary implant source from a patient or human research subject, the licensee shall make a survey of the patient or human research subject with a radiation survey instrument to confirm that all sources have been removed.
| |
| In addition, the licensee should also consider surveying the following:
| |
| * the patients bed linens before removing them from the patients room
| |
| * the operating room and the patients room after source implantation (e.g., radiation level and/or visual check)
| |
| * all trash exiting the patients room or surgical recovery room
| |
| * areas of public access in and around the patients room In accordance with 10 CFR 35.604, the licensee must survey patients and the remote afterloader unit to confirm that the source has been removed from the patient and returned to the safe shielded position.
| |
| Response from Applicant: Provide the following statement:
| |
| We have developed and will implement and maintain written procedures for area surveys, in accordance with 10 CFR 20.1101, that meet the requirements of 10 CFR 20.1501 and 10 CFR 35.70.
| |
| References and Resources:
| |
| * NCRP Report No. 57, Instrumentation and Monitoring Methods for Radiation Protection, 1978.
| |
| * RG 8.25, Air Sampling in the Workplace, June 1992.
| |
| * NUREG-1400, Air Sampling in the Workplace, September 1993.
| |
| 8-85
| |
| | |
| 8.10.13 Procedures for Administrations When a Written Directive Is Required Regulations: 10 CFR 35.40, 10 CFR 35.41, 10 CFR 35.457, Part 35 Applicability 10 CFR 35.657 100 200 Criteria: The requirements for WDs are set forth in 300 10 CFR 35.40, Written directives. Under 10 CFR 35.41, Procedures for administrations requiring a written directive, 400 medical use licensees are required to develop, maintain, and 500 implement written procedures to provide high confidence that 600 licensed material is administered as directed by AUs. 1000 Discussion: A medical use licensee preparing WDs must develop, implement, and maintain written procedures to provide high confidence that, among other things, each administration is in accordance with the WD and the patients identity is verified. Therefore, licensees should have checks in place to ensure that the correct patient is treated and each component of the WD is met. Some licensees procedures were developed when the predecessor to 10 CFR 35.41, called Quality Management Program, was initiated in the 1990s, and licensees may not have updated these procedures, even though administration methods and assessments may have changed. For instance, prior to 1990, many licensees implanted sources for prostate treatments without pre-planning or post-planning dosimetry. Today, many licensees perform extensive imaging and dosimetry to prescribe and evaluate doses to not only intended tissue (e.g., prostate), but also to nearby tissue (e.g., rectum, bladder, or urethra). Therefore, licensees are reminded that procedures should correctly document the program currently in place. Licensees are required to determine if a medical event, as defined in 10 CFR 35.3045, has occurred. For purposes of determining whether medical event reporting is required, licensees should also provide definitive criteria for evaluating the adequacy of the dose delivered or activity implanted to the intended treatment site, compared to the prescribed dose, and the acceptability of the dose delivered to any other organ or tissue, compared to the dose expected from the administration defined in the written directive. Licensees are required for permanent implant brachytherapy, to determine, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.
| |
| Additionally, under 10 CFR 35.457 and 10 CFR 35.657, the licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies.
| |
| The procedures do not need to be submitted to the NRC. This gives licensees the flexibility to revise the procedures to enhance effectiveness without obtaining NRC approval. Appendix S of this NUREG provides guidance on developing the procedures.
| |
| Licensees may find the list of INs on the Medical Uses Licensee Toolkit Web page useful in developing written directive procedures.
| |
| Response from Applicant: No response required.
| |
| 8-86
| |
| | |
| 8.10.14 Safe Use of Unsealed Licensed Material Regulations: 10 CFR 20.1101, 10 CFR 20.1201, Part 35 Applicability 10 CFR 30.33(a)(2) 100 Criteria: Before using licensed material, the licensee must 200 develop and implement a radiation protection program that 300 includes safe use of unsealed licensed material. 400 500 Discussion: The radiation protection program that licensees are 600 required to develop, document, and implement, in accordance with 10 CFR 20.1101, must include provisions for safe use of 1000 licensed material. Licensees are responsible for developing, documenting, and implementing procedures to ensure the security and safe use of all licensed material, from the time it arrives at their facilities until it is used, transferred, and disposed of.
| |
| The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to themselves, other workers, or members of the public.
| |
| In addition, licensees must develop, implement, and maintain procedures for protective measures to be taken by occupational workers to maintain their doses ALARA. Protective measures may include:
| |
| * use of syringe shields and/or vial shields, specific to the energy emitted (e.g., PET shields should be used when handling high-energy fluorine-18)
| |
| * wearing laboratory coats and gloves when handling unsealed byproduct material
| |
| * monitoring hands after handling unsealed byproduct material
| |
| * designing equipment and facilities to protect health and minimize danger to life or property in accordance with 10 CFR 30.33(a)(2)
| |
| Appendix T of this NUREG contains model procedures that provide one acceptable method for the safe use of unsealed licensed material.
| |
| Response from Applicant: Provide the following statement:
| |
| We have developed and will implement and maintain procedures for safe use of unsealed byproduct material that meet the requirements of 10 CFR 20.1101 and 10 CFR 20.1201.
| |
| 8-87
| |
| | |
| 8.10.15 Safety Procedures for Treatment When Patients are Hospitalized Regulations: 10 CFR 20.1201, 10 CFR 20.1301, Part 35 Applicability 10 CFR 20.1501, 10 CFR 20.1801, 10 CFR 35.315, 10 CFR 35.404(b), 10 CFR 35.415, 10 CFR 35.604(a), 100 10 CFR 35.615, 10 CFR 35.1000 200 300 Criteria: Applicants must develop and implement procedures to 400 ensure that access to therapy treatment rooms, and exposure 500 rates from therapy treatments, are limited to maintain doses to 600 occupational workers and members of the public within regulatory limits. 1000 Discussion: Under 10 CFR 35.315, 10 CFR 35.415, 10 CFR 35.615, and 10 CFR 35.1000, licensees are required to take certain safety precautions for uses of byproduct material involving radiopharmaceutical therapy, manual brachytherapy, LDR remote afterloader brachytherapy, or emerging technologies involving patients who cannot be released in accordance with 10 CFR 35.75. The precautions described below are provided to help ensure compliance with the exposure limits in 10 CFR Part 20.
| |
| Under 10 CFR 35.404(b) and 10 CFR 35.604(a), licensees are required to perform a radiation survey of the patient (and the remote afterloader unit) immediately after removing the last temporary implant source from the patient and prior to releasing the patient from licensee control. This is performed to confirm that all sources have been removed and accounted for.
| |
| In addition, applicants must take the following steps for patients who cannot be released under 10 CFR 35.75:
| |
| * Provide a room with a private sanitary facility for patients treated with a radiopharmaceutical therapy dosage. (Note: 10 CFR 35.315(a) allows for a room shared with another radiopharmaceutical therapy patient.)
| |
| * Provide a private room for patients implanted with brachytherapy sources.
| |
| (Note: 10 CFR 35.415 allows for a room shared with another brachytherapy patient.)
| |
| * Visibly post a Radioactive Materials sign on the patients room and a note on the door or in the patients chart indicating where and how long visitors may stay in the patients room (10 CFR 35.315 and 10 CFR 35.415).
| |
| * Either monitor material and items removed from the patients room (e.g., patient linens, surgical dressings) with a radiation survey meter set on its most sensitive scale with no interposed shielding to determine that residual radioactivity cannot be distinguished from the natural background radiation level or handle the material and items as radioactive waste (10 CFR 35.315 and 10 CFR 20.1501).
| |
| * Notify the RSO, or his/her designee, and AU as soon as possible if the patient has a medical emergency or dies (10 CFR 35.315, 10 CFR 35.415, and 10 CFR 35.615).
| |
| Licensees are required to perform adequate surveys to evaluate the extent of radiation levels in accordance with 10 CFR 20.1501. Therefore, licensees must evaluate the exposure rates around patients who cannot be released under the requirements of 10 CFR 35.75 and are 8-88
| |
| | |
| hospitalized following the dosage administration or implant (e.g., measured exposure rates, combination of measured and calculated exposure rates).
| |
| Licensees are required to secure licensed material in storage from unauthorized access or removal in accordance with 10 CFR 20.1801. Access control and appropriate training of authorized personnel may prevent unauthorized removal of licensed material temporarily stored in the patients room and unnecessary personnel exposures.
| |
| To control exposures to individuals, in accordance with 10 CFR 20.1201 and 10 CFR 20.1301, the licensee should consider briefing patients on radiation safety procedures for confinement to bed, visitor control, identification of potential problems, notification of medical staff in the event of problems, and other items, as applicable, to be consistent with good medical care.
| |
| Response from Applicant: No response required.
| |
| 8.10.16 Release of Patients or Human Research Subjects Regulations: 10 CFR 35.75 Part 35 Applicability 100 Criteria: Licensees may release from its control patients or 200 human research subjects (patients) who have been administered 300 licensed material if the TEDE to any other individual from 400 exposure to the released patient is not likely to exceed 5 mSv
| |
| [0.5 rem]. Licensees must provide radiation safety instructions to 500 patients released (or to their parent or guardian) in accordance 600 with 10 CFR 35.75(b). 1000 Discussion: Under 10 CFR 35.75, the licensee is required to provide the released individual (patient) with instructions, including written instructions, on actions recommended to maintain doses to other individuals ALARA if the TEDE to any other individual is likely to exceed 1 mSv
| |
| [0.1 rem]. If the dose to a breastfeeding infant or a child could exceed 1 mSv [0.1 rem],
| |
| assuming there was no interruption of breastfeeding, the instructions also must include:
| |
| * guidance on the interruption or discontinuation of breastfeeding
| |
| * information on the potential consequences of failure to follow the guidance Appendix U of this NUREG refers the applicant to Regulatory Guide 8.39 for guidance when
| |
| * The licensee may authorize the release of a patient who has been administered radiopharmaceuticals or who has been treated with implants containing radioactive material.
| |
| * Instructions to the patient are required by 10 CFR 35.75(b).
| |
| Regulatory Guide 8.39 lists activities for commonly used radionuclides and the corresponding dose rates with which a patient may be released in compliance with the dose limits in 10 CFR 35.75.
| |
| The NRC has issued additional information on controlling exposures to members of the public.
| |
| Licensees should review RIS 2011-01, NRC Policy on Release of Iodine-131 Therapy Patients 8-89
| |
| | |
| Under 10 CFR 35.75 to Locations Other Than Private Residences, January 25, 2011, and RIS 2008-11, Precautions to Protect Children Who May Come In Contact with Patients Released After Therapeutic Administration of Iodine-131, May 12, 2008.
| |
| Response from Applicant: No response required.
| |
| 8.10.17 Mobile Medical Service Regulations: 10 CFR 35.2, 10 CFR 35.80, 10 CFR 35.647, Part 35 Applicability 10 CFR Part 71, 10 CFR 150.20, 49 CFR Parts 171-178 100 200 Criteria: In addition to the requirements in 10 CFR 35.80 and 300 10 CFR 35.647, as applicable, mobile medical service licensees must comply with all other applicable regulations. 400 500 Discussion: Applicants for licensure of mobile medical 600 services, as defined in 10 CFR 35.2, should review other 1000 sections of this NUREG for information to be submitted as part of their applications; many other requirements are relevant to the use of byproduct material by mobile medical service providers, with details being dependent upon the scope of such programs. Temporary jobsite means a location, other than the specific location(s) of use authorized on the license, where mobile medical services are conducted for limited periods of time. Mobile medical service licensees may transport licensed material and equipment into a clients building or may bring patients into the transport (e.g., van). In either case, the van should be located on the clients property that is under the clients control. Mobile PET medical service licensees must consider a quiet room as an area of use if the patients in the quiet room cannot be released under the provisions of 10 CFR 35.75.
| |
| A self-contained mobile medical service involves a mobile treatment or administration facility that provides ready-to-deliver mobile medical services on arrival at a clients site. Companies providing transportation only will not be licensed for medical use under 10 CFR Part 35. Before using a remote afterloader for this type of service, the device should be installed in an appropriately shielded treatment room.
| |
| The general types of services provided as mobile medical services are
| |
| * Mobile medical services (byproduct material, trained personnel, and facility) that provide the device/facility (e.g., in-van use) and treatment of (or administration to) patients at the client site. These mobile medical service providers are responsible for all aspects of byproduct material use and authorized patient treatments (or administrations).
| |
| * Mobile medical service providers (byproduct material and trained personnel) that provide transportation to and use the byproduct material within the clients facility. These mobile medical service providers are also responsible for all aspects of byproduct material use and authorized patient treatments (or administrations).
| |
| Mobile medical service licensees must ensure that the criteria in 10 CFR 35.75 are met before releasing patients treated in their facilities.
| |
| 8-90
| |
| | |
| Refer to Appendix V of this NUREG for additional guidance on information to provide in applications and Appendix Z of this NUREG for information on transportation requirements (10 CFR Part 71 and 49 CFR Parts 171-178).
| |
| Agreement State licensees that request reciprocity for activities conducted in NRC States are subject to the general license provisions described in 10 CFR 150.20. This general license authorizes persons holding a specific license from an Agreement State to conduct the same activity in NRC States, if the specific license issued by the Agreement State does not limit the authorized activity to specific locations or installations. Licensees should contact the appropriate NRC Regional Office for reciprocity information.
| |
| An NRC licensee who wishes to conduct operations at temporary jobsites in an Agreement State should contact that States Radiation Control Program Office for information about State regulations, including notification requirements, whether the AU meets the requirements to be an AU in that State, and if mobile medical services are allowed within the Agreement State through reciprocity. The licensee should contact the appropriate Agreement State using the NRCs Agreement State Directory. To ensure compliance with Agreement State reciprocity requirements, an NRC licensee shall request authorization well in advance of scheduled work.
| |
| In addition to the requirements specified in 10 CFR 150.20, Reciprocity, applicants requesting a mobile medical service license should contact all States where they plan to conduct mobile medical services, to clarify requirements, including training and experience requirements for AUs, as well as requirements associated with an authorization to practice medicine within the States jurisdiction. Refer to NUREG-1556, Volume 19 Guidance for Agreement State Licensees About NRC Form 241 Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity) for more information.
| |
| Response from Applicant: The applicant should review the guidance in Appendix V of this NUREG to determine the response required.
| |
| 8.10.18 Minimization of Contamination Regulations: 10 CFR 20.1406 and 10 CFR 35.67 Part 35 Applicability 100 Criteria: Applicants must describe in the application how facility design and procedures for operation will minimize, to the extent 200 practicable, contamination of the facility and the environment, 300 facilitate eventual decommissioning, and minimize, to the extent 400 practicable, the generation of radioactive waste in accordance 500 with 10 CFR 20.1406. 600 1000 Discussion: Applicants should consider the importance of designing and operating their facilities to minimize the amount of radioactive contamination generated at the site during its operating lifetime and to minimize the generation of radioactive waste during decontamination. This is especially important for licensed activities involving unsealed byproduct material. As described in Section 8.10.5, Spill/Contamination Procedures, cleanup procedures should be implemented for contamination events. Recommended limits for acceptable levels of surface contamination in restricted and unrestricted areas are provided in Appendix R, Tables R-2 and R-3 of this NUREG.
| |
| 8-91
| |
| | |
| Sealed sources and devices that are approved by the NRC or an Agreement State and located and used according to their SSD registration certificates usually pose little risk of contamination.
| |
| Leak tests performed, as specified in the SSD registration certificate, should identify defective sources. Leaking sources must be immediately withdrawn from use and stored, repaired, or disposed of according to NRC requirements in 10 CFR 35.67. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts.
| |
| Response from Applicant: A response from applicants is not required under the following condition: The NRC will consider that the above criteria have been met if the information provided in the applicants responses satisfy the criteria in Sections 8.9, 8.9.1, 8.10, 8.10.5, 8.10.12, and 8.11, on the following topics: facility and equipment, facility diagram, radiation safety program, and waste management.
| |
| 8.10.19 Records of Dosages and Use of Brachytherapy Sources Regulations: 10 CFR 30.51, 10 CFR 35.63, 10 CFR 35.204, 10 CFR 35.406, 10 CFR 35.2063, 10 CFR 35.2204, Part 35 Applicability 10 CFR 35.2406 100 200 Criteria: Licensees must record the use of licensed material to 300 reflect proper use and accountability. Records of use must be 400 maintained for 3 years in accordance with 10 CFR 30.51. 500 600 Discussion: Licensees are required to make and maintain 1000 records of each dosage and administration prior to medical use.
| |
| In accordance with 10 CFR 35.2063, the records must include the
| |
| * radiopharmaceutical
| |
| * patients or human research subjects name or identification number (if one has been assigned)
| |
| * prescribed dosage, determined dosage, or a notation that the total activity is less than 1.11 MBq [30 µCi]
| |
| * date and time of dosage determination
| |
| * name of the individual who determined the dosage In accordance with 10 CFR 35.63, dosage determination for unit dosages may be made either by direct measurement or by a decay correction, based on the determination (e.g., measurement) made by the manufacturer or preparer licensed under 10 CFR 32.72 or equivalent Agreement State requirements or an NRC or Agreement State medical use licensee authorized under 10 CFR 30.32(j) to produce PET radioactive drugs.
| |
| If eluting an Mo-99/Tc-99m generator, the Mo-99 concentration is measured for each elution under 10 CFR 35.204, records of Mo-99 concentration must be made under 10 CFR 35.2204 and must include, for each elution of Tc-99m
| |
| * ratio of the measurements expressed as kilobecquerel (kBq) (µCi) of Mo-99 per MBq (mCi) of Tc-99m 8-92
| |
| * date and time of the measurement
| |
| * name of the individual who made the measurement If eluting a Sr-82/Rb-82 generator, Sr-82 and strontium-85 (Sr-85) concentrations are measured under 10 CFR 35.204, Permissible molybdenum-99, strontium-82, and strontium-85 concentrations, records of Sr-82 and Sr-85 concentrations must be made under 10 CFR 35.2204, Records of molybdenum-99, strontium-82, and strontium-85 concentrations, and must include for each measured elution of Rb-82:
| |
| * ratio of the measurements expressed in kBq (µCi) of Sr-82 per MBq (mCi) of Rb-82 and kBq (µCi) of Sr-85 per MBq (mCi) of Rb-82
| |
| * date and time of the measurement
| |
| * name of the individual who made the measurement If the licensee uses manual brachytherapy sources, the following records of use required by 10 CFR 35.406 must be kept in accordance with 10 CFR 35.2406:
| |
| * When temporary implant brachytherapy sources are removed from storage, a record will include the number and activity of sources removed, the time and date they were removed from storage, the location of use, and the name of the individual who removed them from storage.
| |
| * When temporary implant brachytherapy sources are returned to storage, a record will include the number and activity of sources returned, the time and date they were returned to storage, and the name of the individual who returned them to storage.
| |
| * For permanent implants, a record will be made and will include the number and activity of sources removed from storage, the date they were removed from storage, the name of the individual who removed them from storage, the number and activity of sources not implanted, the date they were returned to storage, the name of the individual who returned them to storage, and the number and activity of sources permanently implanted in the patient or human research subject.
| |
| Response from Applicant: No response required.
| |
| 8.10.20 Recordkeeping Regulations: 10 CFR Part 20, Subpart L; 10 CFR 30.51; Part 35 Applicability 10 CFR Part 35, Subpart L; 10 CFR 37.23, 10 CFR 37.31, 100 10 CFR 37.43, 10 CFR 37.75, 10 CFR 37.103 200 300 Criteria: Licensees must maintain records as provided in 10 CFR Part 20, Subpart L; 10 CFR 30.51; 10 CFR Part 35, 400 Subpart L. In accordance with 10 CFR Part 37, licensees 500 authorized to possess Category 1 or Category 2 quantities of 600 radioactive material must maintain records as provided in 1000 10 CFR 37.23, 10 CFR 37.31, 10 CFR 37.43, 10 CFR 37.75, and 10 CFR 37.103.
| |
| 8-93
| |
| | |
| Discussion: The licensee must maintain certain records to comply with NRC regulations, the conditions of the license, and commitments made in the license application and correspondence with the NRC. Operating procedures should identify which individuals in the organization are responsible for maintaining which records. A table (Table X-1) of recordkeeping requirements appears in Appendix X of this NUREG.
| |
| Response from Applicant: No response required.
| |
| 8.10.21 Reporting Regulations: 10 CFR Part 20, Subpart M; 10 CFR 21.21; Part 35 Applicability 10 CFR 30.6; 10 CFR 30.50; 10 CFR 31.5; 10 CFR 35.14(b), 100 10 CFR Part 35, Subpart M 200 Criteria: Licensees are required to report to the NRC via 300 telephone, written report, or both, in the event that the safety or 400 security of byproduct material may be compromised. The specific 500 events that require reporting are explained in 10 CFR 35.14(b), 600 10 CFR Part 35, Subpart M; 10 CFR Part 20, Subpart M; and in 1000 10 CFR 21.21, 10 CFR 30.50, and 10 CFR 31.5. The timing and type of report are specified within these parts. Licensees are also required in 10 CFR 35.3045 and 10 CFR 35.3047 to report information to referring physicians and certain individuals.
| |
| They are also required under 10 CFR 35.3204 to report to generator distributors that an eluate exceeded the permissible concentration listed in 10 CFR 35.204(a) at the time of generator elution.
| |
| Discussion: The NRC requires licensees to report incidents that might compromise the health and safety of patients, health care providers, or the public. Therefore, 10 CFR Part 20, 10 CFR Part 21, 10 CFR Part 30, 10 CFR Part 31, 10 CFR Part 35, and 10 CFR Part 40 include provisions that describe reporting requirements associated with the medical use of byproduct material. NRC also requires a licensee to notify (report) certain changes in the licensees program under the provisions of 10 CFR 35.14(b)(2), as described in Section 9.2.3. A table (Table Y-1) of reporting requirements appears in Appendix Y of this NUREG. 10 CFR 30.6 describe acceptable methods of submitting written reports.
| |
| Response from Applicant: No response required.
| |
| 8.10.22 Transportation Regulations: 10 CFR 30.41; 10 CFR 37, Subpart D; Part 35 Applicability 10 CFR 71.5; 10 CFR 71.13; 10 CFR 71.17; 10 CFR 71.37; 100 10 CFR 71, Subpart H; 49 CFR Parts 171-178 200 Criteria: Applicants who will prepare for shipment, ship, or 300 transport radioactive materials, including radioactive waste, must 400 develop, implement, and maintain safety programs for the 500 transport of radioactive material, to ensure compliance with NRC 600 and DOT regulations. 1000 8-94
| |
| | |
| In accordance with 10 CFR Part 37 (Subpart D), licensees must also preplan, coordinate, and provide advance notification of the shipment of Category 1 quantities of radioactive material and coordinate the shipment of Category 2 quantities of radioactive material.
| |
| Discussion: Most packages of licensed material for medical use contain quantities of radioactive material that require the use of Type A packages. Many packages shipped by medical licensees (e.g., unused radiopharmaceutical dosages) frequently meet the Limited Quantity criteria described in 49 CFR 173.421, Excepted Packages for Limited Quantities of Class 7 (Radioactive) Materials, and are, therefore, excepted from certain DOT requirements, provided certain other less restrictive requirements are met {e.g., activity in the package is less than the limited quantity and the radiation level on the surface of the package does not exceed 0.005 mSv/h [0.5 mrem/h]}.
| |
| The general license in 10 CFR 71.17, General license: NRC-approved package, provides the authorization used by most licensees to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance, or other approval has been issued by the NRC. This general license is subject to certain conditions. The requirements for transportation of licensed material are set forth in 10 CFR 71.5, Transportation of Licensed Material. The regulations in 10 CFR 71.13 exempt from the requirements in 10 CFR 71.5 any physician licensed by a State to dispense drugs in the practice of medicine, who is also licensed under 10 CFR Part 35 or the equivalent Agreement State regulations. This exemption applies to transport by the physician of licensed material for use in the practice of medicine.
| |
| Some medical use licensees (e.g., teletherapy or GSR) may need to ship licensed material in Type B packages. The Type B package requirements for transporting or delivering the package to a carrier for transport are set forth in 10 CFR Part 71. These include registration as a user of the package and the requirement to have an NRC-approved quality assurance (QA) plan. See 10 CFR 71.17(c)(3) for registration information and 10 CFR 71.101 for QA plan information. For information about these QA programs, see RG 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material, June 2015. For further information about registering as a user of a package or submitting a QA program for review, contact NRCs Division of Spent Fuel Management by calling the NRC toll-free at 800-368-5642, extension 415-9956. For information about associated fees, visit the NRC License Fees Web site.
| |
| Some medical use licensees that ship radioactive material have chosen to transfer possession of radioactive materials to a manufacturer (or service licensee) with an NRC or Agreement State license, who then acts as the shipper. The manufacturer (or service licensee) then becomes responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations. Licensees who do this must ensure that the manufacturer (or service licensee):
| |
| * is authorized to possess the licensed material (see 10 CFR 30.41)
| |
| * actually takes possession of the licensed material under its license Licensees should also ensure that the manufacturer (or service licensee) is authorized to possess the material at temporary jobsites (e.g., the licensees facilities).
| |
| During an inspection, the NRC uses the provisions of 10 CFR 71.5 and a Memorandum of Understanding with DOT on the Transportation of Radioactive Material (signed June 6, 1979) to examine and enforce various DOT requirements applicable to medical use licensees.
| |
| 8-95
| |
| | |
| Appendix Z of this NUREG lists major DOT regulations that apply to medical use licensees.
| |
| Medical use licensees are reminded of the following:
| |
| * The licensee must properly block and brace the transportation case when transporting byproduct material to ensure that the material does not shift during transport.
| |
| * The licensee must have emergency response information, including current emergency response telephone numbers that meet the requirements of 49 CFR Part 172, Hazardous Materials Table, Special Provisions, Hazardous Materials Communications, Emergency Response Information, Training Requirements, and Security Plans, Subpart G, Emergency Response Information.
| |
| * Initial and recurrent training must be given to all employees who transport byproduct material per the requirements of Subpart H, Training, of 49 CFR Part 172.
| |
| * The licensee shall maintain transportation shipping records in accordance with the requirements of Subpart C, Shipping Papers, of 49 CFR Part 172, including the proper shipping name, hazard class (Class 7), United Nations identification number, the name of the shipper, and the name and activity of each radionuclide. While in transit on a public highway, transportation papers must be kept within the immediate reach of the driver, pursuant to 49 CFR 177.817(e)(2)(i)(A) and other applicable 49 CFR Part 177 requirements.
| |
| Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material are subject to the requirements in 10 CFR Part 37, Subpart D (Physical Protection in Transit).
| |
| For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but will be subject to review and inspection.
| |
| Response from Applicant: No response is required from applicants during the licensing phase. However, before making shipments of licensed materials on its own in a Type B package, a licensee must have registered with the NRC as a user of the package and obtained the NRCs approval of its QA program. Transportation issues will be reviewed during NRC inspections.
| |
| 8-96
| |
| | |
| 8.10.23 Security Program for Category 1 and Category 2 Radioactive Material Regulations: 10 CFR Part 37 Part 35 Applicability Criteria: Licensees must ensure the security of Category 1 and 100 Category 2 radioactive material. 200 300 Note: The regulations in 10 CFR Part 37 apply to licensees that 400 possess an aggregated Category 1 or Category 2 quantity of 500 radioactive material. The specific radionuclides subject to 600 10 CFR Part 37 requirements are listed in Table 1 of Appendix A 1000 to 10 CFR Part 37.
| |
| Discussion: In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or Category 2 quantities of radioactive material must establish, implement, and maintain an access authorization program (Subpart B) and a security program (Subpart C) to ensure physical protection of the radioactive material.
| |
| Table 1 of Appendix A, Category 1 and Category 2 Radioactive Materials, to 10 CFR Part 37 lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant should refer to this table to determine whether its proposed activities would be subject to the 10 CFR Part 37 requirements.
| |
| Before giving individuals unescorted access to Category 1 or Category 2 quantities of radioactive material (as defined in 10 CFR 37.5), licensees must conduct background investigations of these individuals, to determine that they are trustworthy and reliable in accordance with 10 CFR 37.25.
| |
| In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to monitor and, without delay, detect, assess, and respond to any actual or attempted unauthorized access to Category 1 or Category 2 quantities of radioactive material.
| |
| Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or Category 2 quantities of radioactive materials in transit. These requirements apply to licensees delivering such material to a carrier for transport, as well as cases in which licensees are transporting such material. Please note that the Subpart D requirements applicable to the transport of Category 1 quantities of radioactive material are more stringent than those applicable to Category 2 quantities.
| |
| Applicants and licensees are required to implement the 10 CFR Part 37 security requirements before they take possession of an aggregated Category 1 or Category 2 quantity of radioactive material.
| |
| Any licensee that has not previously been made subject to the provisions of 10 CFR 37.5, Subpart C, shall notify the NRC regional office specified in 10 CFR 30.6 in writing at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold. Pursuant to 10 CFR 37.43(b), as part of the security program, the licensee must develop and maintain written procedures that document how the requirements of Subpart C will be met. These written procedures will be subject to NRC review and inspection.
| |
| For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 8-97
| |
| | |
| Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| Response from Applicant: No response is required from an applicant or licensee.
| |
| Compliance with access authorization and security program requirements will be reviewed during NRC inspections.
| |
| 8.11 Item 11: Waste Management Regulations: 10 CFR 20.1101, 10 CFR 20.1301, Part 35 Applicability 10 CFR 20.1302, 10 CFR 20.1501, 10 CFR 20.1802, 100 10 CFR 20.1902, 10 CFR 20.1904, 10 CFR 20.2001-2008, 200 10 CFR 30.3, 10 CFR 30.41(b), 10 CFR 31.11; 10 CFR 35.92, 300 10 CFR 37.11(c), 10 CFR 61.3 400 500 Criteria: Licensed materials must be disposed of in accordance with NRC requirements by: 600 1000
| |
| * transfer to an authorized recipient (10 CFR 30.41(b),
| |
| 10 CFR 20.2006, 10 CFR 20.2008)
| |
| * decay-in-storage (10 CFR 35.92)
| |
| * release in effluents within the limits in 10 CFR 20.1301 or
| |
| * as authorized under 10 CFR 20.2002 through 20.2005 Discussion: The radiation protection program that licensees are required to develop, document, and implement in accordance with 10 CFR 20.1101 must include provisions for waste disposal of licensed material. Appendix W of this NUREG contains model procedures that represent one acceptable method to provide for decay-in-storage, generator or other licensed material return and disposal of liquids into sanitary sewerage.
| |
| All radioactive waste must be stored in appropriate containers until its disposal, and the integrity of the waste containers must be assured. Radioactive waste containers must be appropriately labeled. All radioactive waste must be secured against unauthorized access or removal. The NRC requires medical licensees to dispose of radioactive waste generated at their facilities in accordance with regulations in 10 CFR 20.2001-2008, and 10 CFR 35.92. Generally, medical licensees dispose of radioactive waste by one or both of the following methods:
| |
| * decay-in-storage (DIS)
| |
| * transfer to an authorized recipient Licensees may choose any one or both of these methods to dispose of their radioactive waste.
| |
| Decay-in-Storage: The NRC has concluded that materials with half-lives of less than or equal to 120 days are appropriate for DIS and interim storage. The holding time of the waste should be based on the radionuclide(s), half-life, and the activity present when the waste was placed into storage. Such waste may be disposed of as in-house trash if radiation surveys of the waste 8-98
| |
| | |
| indicate that radiation levels are indistinguishable from background. The surveys should be performed with an appropriate radiation detection meter set on its most sensitive scale in a low background area and without any interposed shielding. In accordance with 10 CFR 20.1904(b),
| |
| all radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released in accordance with 10 CFR 35.92. If the decayed waste is compacted, all labels that are visible in the compacted mass must also be defaced or removed. Applicants must maintain accurate records of such disposals.
| |
| Except for material suitable for decay-in-storage and some animal carcasses handled by the licensee, solids are transferred to an authorized recipient licensed to receive such waste in accordance with 10 CFR 20.2001(b), 10 CFR 20.2006, or in applicable regulations in 10 CFR 30.3 or 10 CFR 61.3. Follow the packaging instructions received from the transfer agent and the burial site operator. Keep the consignment sheet from the transfer agent as the record of disposal.
| |
| When setting up a program for decay-in-storage, consider short-term and long-term storage.
| |
| Consider designing long-term storage to allow for segregation of wastes with different half-lives (e.g., the use of multiple shielded containers) and use of containers with shielded covers to maintain occupational exposure at ALARA levels. Storage areas must be in a secure location and appropriately posted in accordance with 10 CFR 20.1902. In addition, all storage containers must be appropriately labeled in accordance with 10 CFR 20.1904.
| |
| Note: Some short half-life radionuclide products (e.g., samarium-153, Tc-99m/Mo-99 generator columns and Y-90 microspheres) may contain long half-life contaminants that may preclude disposal by decay-in-storage. Long-lived contaminants need not be listed on an NRC license; however, licensees need to perform surveys and dispose of the material in accordance with 10 CFR Parts 20 and 10 CFR 35 requirements. Licensees using Y-90 microspheres should review IN 2007-10, Yttrium-90 Theraspheres and Sirspheres Impurities, for guidance.
| |
| Transfer to an Authorized Recipient Licensees may transfer radioactive waste to an authorized recipient for disposal. Check and calibration sources with half-lives greater than 120 days (e.g., cobalt-57, germanium-68, gadolinium-153) may not be held for DIS and must be disposed of in accordance with 10 CFR Part 20. It has been NRCs experience that most medical licensees only dispose of radioactive waste with half-lives greater than 120 days by transfer to authorized recipients (e.g., low-level radioactive waste disposal facilities or manufacturers).
| |
| Other Waste Management Issues
| |
| * Consider the monitoring and control mechanisms in place to ensure compliance with the appropriate requirements regarding the release of material into air and water under 10 CFR 20.1302, Compliance with dose limits for individual members of the public, and 10 CFR 20.2003, Disposal by Release into Sanitary Sewerage, respectively.
| |
| Regulations for disposal in sanitary sewerage appear in 10 CFR 20.2003.
| |
| Material must be readily soluble or dispersible in water. There are also monthly and annual limits, based on the total sanitary sewerage release of the facility.
| |
| [Excreta from patients undergoing medical diagnosis or therapy are not subject to 8-99
| |
| | |
| these limitations. See 10 CFR 20.2003(b).] See Appendix W for more information.
| |
| Limits on permissible concentrations in effluents to unrestricted areas are enumerated in Table II of Appendix B to 10 CFR Part 20. These limits apply at the boundary of the restricted area.
| |
| Liquid scintillation-counting media containing 1.85 kBq [0.05 µCi] or less per gram of tritium (H-3) or carbon-14 may be disposed of without regard to its radioactivity [10 CFR 20.2005(a)(1)].
| |
| * Waste from in vitro kits (except mock I-125) that are generally licensed under 10 CFR 31.11 is exempt from waste disposal regulations in 10 CFR Part 20, as set forth in 10 CFR 31.11(f). Radioactive labels should be defaced or removed. There is no need to keep any record of release or make any measurement.
| |
| * If applicants/licensees propose to treat or dispose of licensed material by incineration, they must comply with 10 CFR 20.2004. Contact the appropriate NRC Regional Office for guidance on treatment or disposal of material by incineration.
| |
| * Applicants who wish to use waste volume reduction operations (e.g., compactors) should provide a detailed description (as outlined below), along with their response to Section 8.9.1, Facility Diagram:
| |
| Describe the compactor to demonstrate that it is adequately designed and manufactured to safely compact the type and quantity of waste generated during licensed operations.
| |
| Provide manufacturers specifications, annotated sketches or photographs, and other information about the compactor design.
| |
| Describe the type, quantities, and concentrations of waste to be compacted.
| |
| Provide an analysis of the potential for airborne release of radioactive material during compaction activities.
| |
| Provide the location of the compactor(s) within the waste processing area(s), as well as a description of the ventilation and filtration systems used in conjunction with the compactors. Include a description of the procedures for monitoring filter blockage and exchange.
| |
| Discuss the methods used to monitor worker breathing zones and/or exhaust systems.
| |
| Discuss the types and frequencies of surveys that will be performed for contamination control in the compactor area.
| |
| Discuss the instruction provided to compactor operators, including instructions for protective clothing, checks for proper functioning of equipment, method of handling uncompacted waste, and examining containers for defects.
| |
| 8-100
| |
| | |
| Note: Before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), if licensees are authorized to possess byproduct material with a half-life greater than 120 days in an unsealed form, the licensees must, in accordance with 10 CFR 30.51(e), transfer the following records to the new licensee:
| |
| * records of disposal of licensed material made under:
| |
| 10 CFR 20.2002, Method for obtaining approval of proposed disposal procedures 10 CFR 20.2003, Disposal by release into sanitary sewerage 10 CFR 20.2004, Treatment or disposal by incineration 10 CFR 20.2005, Disposal of specific wastes
| |
| * records required by 10 CFR 20.2103(b)(4) of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment Nuclear pacemakers: Medical facilities are often the first to come into contact with plutonium-powered pacemakers or the first to be contacted by nursing homes and funeral homes when a patient with an implanted pacemaker dies. In such cases, and when the medical facility is not responsible for control or disposal of the pacemaker, notify the NRC and attempt to contact the hospital (licensee) where the pacemaker was implanted to address any removal or disposal concerns. The licensee that implanted the device is responsible for the follow-up, removal, and return of the pacemaker to the manufacturer for proper disposal. IN 98-12, Licensees Responsibilities Regarding Reporting and Follow-up Requirements for Nuclear-Powered Pacemakers, April 3, 1998, provides additional information.
| |
| Waste Return from Landfills or Medical Incinerators: Medical licensees are periodically contacted by the waste broker after receipt of potentially contaminated medical waste. As described in IN 99-33, Management of Wastes Contaminated with Radioactive Materials, December 21, 1999, licensees must evaluate waste in accordance with 10 CFR Part 20, Subpart F, Surveys and Monitoring, and manage the storage and disposal of the waste in accordance with applicable regulations and license conditions.
| |
| 8-101
| |
| | |
| In accordance with 10 CFR 37.11(c), a licensee that possesses radioactive waste that contains Category 1 or Category 2 quantities of radioactive material as defined in 10 CFR 37.5 is exempt from the requirements of 10 CFR Part 37, Subparts B, C, and D. However, any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg [4,409 lbs] is not exempt from the requirements of 10 CFR Part 37. For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Additional information regarding best practices for protection of risk-significant radioactive material is available in NUREG-2166, Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.
| |
| A licensee possessing radioactive waste that is exempt under 10 CFR 37.11(c) from the requirements of 10 CFR Part 37, Subparts B, C, and D must implement the following requirements to secure the radioactive waste:
| |
| * use continuous physical barriers that allow access to the radioactive waste only through established access control points;
| |
| * use a locked door or gate with monitored alarm at the access control point;
| |
| * assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and
| |
| * immediately notify the LLEA and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains Category 1 or Category 2 quantities of radioactive material.
| |
| Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but will be subject to review and inspection.
| |
| Response from Applicant: Provide the following statement:
| |
| We have developed and will implement and maintain written waste disposal procedures for licensed material, in accordance with 10 CFR 20.1101, that also meet the requirements of the applicable section of Subpart K to 10 CFR Part 20 and of 10 CFR 35.92.
| |
| Contact the appropriate NRC Regional Office for guidance on treatment or disposal of waste by incineration or compaction.
| |
| References and Resources:
| |
| * Information Notice 94-23, Guidance to Hazardous, Radioactive and Mixed Waste Generators on the Elements of a Waste Minimization Program, dated March 1994
| |
| * Information Notice 94-07, Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20, dated January 1994 8-102
| |
| * Information Notice 84-94, Reconcentration of Radionuclides Involving Discharges into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003),
| |
| dated December 1984
| |
| * Information Notice 90-09, Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees, dated February 1990
| |
| * Regulatory Issue Summary 2008-12, Considerations For Extended Interim Storage Of Low-Level Radioactive Waste By Fuel Cycle And Materials Licensees, dated May 2008
| |
| * Regulatory Issue Summary 2011-09, Available Resources Associated With Extended Storage Of Low-Level Radioactive Waste, dated August 2011
| |
| * Policy and Guidance Directive PG 8-10, Disposal of Incinerator Ash as Ordinary Waste, January 1997, ADAMS Accession Nos. ML003744979 and ML003752866 and Addendum, ADAMS Accession Nos. ML003744984 and ML003744988.
| |
| * Regulatory Issue Summary 2004-17, Revision 1, Revised Decay-In-Storage Provisions For The Storage Of Radioactive Waste Containing Byproduct Material, September 2005
| |
| * State and Tribal Communication Letter FSME 12-025 dated March 13, 2012 Clarification of the Authorization for Alternate Disposal of Material Issued Under 10 CFR 20.2002 and Exemption Provisions in 10 CFR (ADAMS Accession No. ML12065A038) 8.12 Item 12: License Fees Regulation: 10 CFR 170.31 Part 35 Applicability On NRC Form 313, enter the appropriate fee category from 100 10 CFR 170.31 and the amount of the fee enclosed with 200 the application.
| |
| 300 Direct all questions about the NRCs fees or completion of 400 Item 12 of NRC Form 313 to the Office of the Chief Financial 500 Officer at NRC Headquarters in Rockville, MD, 600 301-415-7554. Information about fees may also be obtained by 1000 calling NRCs toll free number, 800-368-5642, extension 415-7554. The e-mail address for fees questions is Fees.Resource@nrc.gov.
| |
| 8.13 Item 13: Certification A representative of the corporation or legal entity filing the application must sign and date NRC Form 313. The representative signing the application must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in Chapter 3, Management Responsibility, signing the application acknowledges managements commitment to and responsibility for the radiation protection program. The NRC will return all unsigned applications for proper signature.
| |
| 8-103
| |
| | |
| Notes:
| |
| * It is a criminal offense to knowingly and willfully make a false statement or representation on applications or correspondence (18 U.S.C. 1001).
| |
| * When an application references commitments, those items will be incorporated into the license and, therefore, will become binding and conditions to the license.
| |
| 8-104
| |
| | |
| 9 LICENSE AMENDMENTS AND RENEWALS 9.1 Timely Submittals of Amendments and Renewals Regulations: 10 CFR 2.109(a), 10 CFR 30.36, 10 CFR 30.37, Part 35 Applicability 10 CFR 30.38, 10 CFR 35.12, 10 CFR 35.13, 10 CFR 35.14, 100 10 CFR 35.24(c) 200 Criteria: It is the licensees obligation to keep the license current. 300 If any of the information provided in the original application is to be 400 modified or changed, the licensee must submit an application for a 500 license amendment before the change takes place. The change is not in effect until the amendment has been issued. Also, to 600 continue the license after its expiration date, the licensee must 1000 submit an application for a license renewal at least 30 days before the expiration date [10 CFR 2.109(a), 10 CFR 30.36(a)].
| |
| Discussion: In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 35.13, License amendments, a licensee is required to apply for and receive a license amendment before several activities can occur, including:
| |
| * receiving or using byproduct material for a type of use permitted by 10 CFR Part 35, but not authorized on the licensees current Part 35 license
| |
| * permitting anyone to work as an authorized user (AU) for medical uses, authorized medical physicist (AMP), ophthalmic physicist, or authorized nuclear pharmacist (ANP),
| |
| unless the individual meets one of the exceptions listed in 10 CFR 35.13(b) [information required to document training and experience may be provided on the appropriate U.S. Nuclear Regulatory Commission (NRC) Form 313A series of forms for change or addition of AU for medical uses, AMP, ophthalmic physicist, ANP, Radiation Safety Officer (RSO) or Associate Radiation Safety Officer (ARSO)]
| |
| * changing the RSO
| |
| * permitting an individual to work as an ARSO or before the RSO assigns a current ARSO duties and tasks in the oversight for a new section of the radiation protection program
| |
| * receiving byproduct material in excess of the authorized quantity, or receiving radionuclides or forms different than currently authorized by the NRC license
| |
| * receiving a sealed source from a different manufacturer or of a different model number than authorized by the license unless the sealed source is used in manual brachytherapy, is listed in the SSD registry, for the quantity and for an isotope authorized by the license
| |
| * changing an area or address of use identified in the application or on the license; includes additions and relocations, unless exempt (e.g., for certain 10 CFR 35.100 and 10 CFR 35.200 areas of use at previously authorized addresses)
| |
| * revising procedures required by 10 CFR 35.610, 10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645, when the revision reduces the level of radiation safety 9-1
| |
| | |
| In case of a medical emergency requiring an expedited license amendment, contact the materials licensing staff at the appropriate NRC regional office.
| |
| Response from Applicant: No response is required from an applicant for a new license. A licensee requesting a license amendment or renewal should do the following:
| |
| * Use the most recent guidance in preparing an amendment or renewal request.
| |
| * Submit either an NRC Form 313 or a letter requesting an amendment or renewal.
| |
| (10 CFR 30.37, 10 CFR 30.38, 10 CFR 35.12)
| |
| * Provide the license number and docket number.
| |
| * For renewals, provide a complete and up-to-date application, including all required program elements outlined in Appendix C of this NUREG. The licensee may reference recent documents that have been previously accepted. Training documentation for personnel currently listed on the license does not need to be submitted as part of the renewal application as long as the material and uses for each individual are the same as currently authorized on the license.
| |
| 9.2 Timely Notification of Transfer of Control 9.2.1 Transfer of Control Regulation: 10 CFR 30.34(b)
| |
| Part 35 Applicability Criteria: Licensees must provide all supporting information and 100 obtain the NRCs prior, written consent before transferring control 200 of the license, also referred to as a change of ownership and/or 300 transferring the license. 400 Discussion: Transferring control may be the result of mergers, 500 buyouts, or majority stock transfers. Although it is not the NRCs 600 intent to interfere with the business decisions of licensees, under 1000 10 CFR 30.34(b), and the Atomic Energy Act, licensees must obtain prior NRC written consent before transferring control of the license to ensure the following:
| |
| * Radioactive materials are possessed, used, or controlled only by persons who have valid NRC licenses or Agreement State licenses.
| |
| * Materials are properly handled and secured.
| |
| * Persons using these materials are capable, competent, and committed to implementing appropriate radiological controls.
| |
| * A clear chain of custody is established to identify who is responsible for disposition of records and licensed material.
| |
| * The transferee has the financial resources to decommission the license, if necessary.
| |
| 9-2
| |
| * Adequate financial assurance is provided for compliance with the applicable NRC requirements, if required.
| |
| * Public health and safety are not compromised by the use of such materials.
| |
| Response from Applicant: No response is required from an applicant for a new license.
| |
| However, current licensees should refer to NUREG-1556, Volume 15, Consolidated Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses, for more information about transfer of control (e.g., ownership).
| |
| | |
| ==Reference:==
| |
| For further information, see Regulatory Issue Summary (RIS) 2014-08, Rev. 1 Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials Licenses, dated May 5, 2016.
| |
| 9.2.2 Notification of Bankruptcy Proceedings Regulations: 10 CFR 30.34(h)
| |
| Part 35 Applicability Criteria: Immediately following the filing of a voluntary or 100 involuntary petition for bankruptcy by or against a licensee, the 200 licensee must notify the appropriate NRC Regional Administrator, 300 in writing, identifying the bankruptcy court in which the petition 400 was filed and the date of the filing. 500 600 Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains subject to all applicable NRC 1000 regulatory requirements. The NRC must be notified when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled and whether there are any public health and safety concerns (e.g., contaminated facility). The NRC shares the results of its determinations with other involved entities (e.g., trustee), so that health and safety issues can be resolved before bankruptcy actions are completed, and the NRC may request that the U.S. Department of Justice represent the NRCs interests in the bankruptcy proceeding.
| |
| Response from Applicant: None is required at the time of application for a new license.
| |
| Licensees must immediately notify the NRC, in writing, following the filing of a voluntary or involuntary petition for bankruptcy by or against the licensee.
| |
| | |
| ==Reference:==
| |
| See NUREG-1556, Volume 15, Consolidated Guidance About Materials Licenses:
| |
| Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses.
| |
| 9.2.3 Other Required Notifications Licensees are required to notify the NRC of program changes as noted below:
| |
| * decommissioning activities in accordance with 10 CFR 30.36(d)
| |
| * new AUs, AMPs, ophthalmic physicists, and ANPs who meet the criteria in 10 CFR 35.14(a) 9-3
| |
| * current AUs, AMPs, ophthalmic physicists, ANPs, RSOs, and ARSOs permanently discontinuing duties in accordance with 10 CFR 35.14(b)(1)
| |
| * temporary RSOs in accordance with 10 CFR 35.14(b)(2) and 10 CFR 35.24(c)
| |
| * change in mailing address in accordance with 10 CFR 35.14(b)(3)
| |
| * name change that does not constitute a transfer of control in accordance with 10 CFR 35.14(b)(4)
| |
| * new areas of use or changes to the areas of use at a current address of use where 10 CFR 35.100 and 10 CFR 35.200 materials are used in accordance with 10 CFR 35.14(b)(5)
| |
| Note: An amendment is needed to remove an area or address of use from a license.
| |
| * obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in 10 CFR 35.13(i) in accordance with 10 CFR 35.14(b)(6) 9-4
| |
| | |
| 10 APPLICATIONS FOR EXEMPTIONS Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11, Part 35 Applicability 10 CFR 35.15, 10 CFR 35.19 100 200 Criteria: Licensees may request exemptions from the U.S. Nuclear Regulatory Commission (NRC) regulations. The 300 licensee must demonstrate that the exemption is authorized by 400 law; will not endanger life, property, or the common defense and 500 security; and is otherwise in the public interest. Licensees may 600 also use existing specific exemptions outlined in the Title 10 of 1000 the Code of Federal Regulations (10 CFR) regulations if they meet the established criteria.
| |
| Discussion: Various sections of the NRCs regulations address requests for exemptions (e.g., 10 CFR 19.31, Applications for exemptions; 10 CFR 20.2301, Applications for exemptions; 10 CFR 30.11, Specific Exemptions; and 10 CFR 35.19, Specific Exemptions.
| |
| These regulations state that the NRC may grant an exemption, acting on its own initiative or on an application from an interested person.
| |
| Exemptions are not intended to revise regulations or to apply to large classes of licensees and are generally limited to unique situations. Requests for exemptions submitted to the NRC must identify the regulation for which the exemption is being requested and include a justification for the requested exemption.
| |
| Unless the NRC has granted an exemption in writing, licensees must comply with all applicable regulations.
| |
| Type A broad scope licensees are granted certain exemptions as described in 10 CFR 35.15, Exemptions regarding Type A specific licenses of broad scope.
| |
| 10-1
| |
| | |
| 11 TERMINATION OF ACTIVITIES Regulations: 10 CFR 20 Subpart E, 10 CFR 30.34(b), Part 35 Applicability 10 CFR 30.35(g), 10 CFR 30.36, 10 CFR 30.51 100 200 Criteria: In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 30.36(d), the licensee must do 300 the following: 400 500
| |
| * Notify the U.S. Nuclear Regulatory Commission (NRC), 600 in writing, within 60 days of the occurrence of any of 1000 the following:
| |
| expiration of its license a decision to permanently cease principal activities 1 at the entire site for licensees subject to 10 CFR 30.36, a decision to permanently cease principal activities in any separate building or outdoor area that contains residual radioactivity such that the building or area is unsuitable for release according to NRC requirements no principal activities under the license have been conducted for a period of 24 months no principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or area is unsuitable for release according to NRC requirements
| |
| * Submit a decommissioning plan, if required by 10 CFR 30.36(g).
| |
| * Conduct decommissioning, as required by 10 CFR 30.36(h) and (j).
| |
| * Submit, to the appropriate NRC regional office, a completed NRC Form 314, Certificate of Disposition of Materials, (or equivalent information) and information demonstrating that the premises are suitable for release for unrestricted use (e.g., results of final surveys and results of leak tests of sealed sources).
| |
| * Before a license is terminated, send the records important to decommissioning that are required by 10 CFR 30.35(g) to the appropriate NRC regional office in accordance with 10 CFR 30.51(d) and (f).
| |
| * Before a license is terminated, send records of disposal of licensed material made under 10 CFR 20.2002, 20.2003, 20.2004, 20.2005, and the results of measurement and calculations used to evaluate the release of radioactive effluents to the environment to the appropriate NRC regional office in accordance with 10 CFR 30.51(d), if authorized to 1Principal activities are activities that are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal Weand activities incidental to decontamination or decommissioning are not principal activities.
| |
| 11-1
| |
| | |
| possess byproduct material with a half-life greater than 120 days in an unsealed form and/or source material in an unsealed form, respectively.
| |
| Discussion: To comply with the above criteria, before a licensee can decide whether it must notify the NRC under 10 CFR 30.36(d), the licensee must determine whether residual radioactivity is present and, if so, whether the levels make the building or outdoor area unsuitable for release, according to the NRC requirements. A licensees determination that a facility is not contaminated is subject to verification by NRC inspection. For information about requirements that apply to the timeliness of decommissioning, see Regulatory Issue Summary (RIS) 2015-19, Rev. 1, Decommissioning Timeliness Rule Implementation and Associated Regulatory Relief, dated September 27, 2016.
| |
| In general, most medical licensees use licensed material with short half-lives
| |
| [e.g., technetium-99m (Tc-99m) with a 6-hour half-life] and sealed sources (e.g., dose calibrator sources and manual brachytherapy sources). Therefore, in these instances, the licensees should submit the following:
| |
| * area radiation level surveys, including a description of instruments used, showing that all areas previously used are at background
| |
| * area contamination wipes, including a description of instruments used, showing that all areas previously used are at background
| |
| * leak tests for all sealed sources transferred or disposed
| |
| * transfer or disposal documentation for all sealed sources (and unsealed material, if applicable)
| |
| If the half-life of the licensed material used is sufficiently short compared to the time of last use, area surveys and contamination wipes may be unnecessary. For instance, if only Tc-99m has ever been used and the last use was a month ago, surveys would not be warranted.
| |
| For guidance on the disposition of licensed material, see Section 8.11, Waste Management.
| |
| For guidance on decommissioning records, see Section 8.5.2, Financial Assurance and Recordkeeping for Decommissioning.
| |
| For regulations governing radiological criteria for license termination, licensees should refer to 10 CFR Part 20 Subpart E.
| |
| NUREG-1757, Volume 1, Consolidated Decommissioning Guidance: Decommissioning Process for Materials Licensees, September 2006, contains the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Licensees that have large facilities to decommission should review NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM). NUREG-1757, Volume 2, Consolidated Decommissioning Guidance: Characterization, Survey, and Determination of Radiological Criteria, September 2006, may also be useful guidance in describing the disposition of licensed material and facilities.
| |
| 11-2
| |
| | |
| Response from Applicant: The applicant is not required to submit a response to the NRC during the initial application. The licensees obligations in this matter begin when the license expires or at the time the licensee ceases operations, whichever is earlier. These obligations are to undertake the necessary decommissioning activities, to submit NRC Form 314 or equivalent information, and to perform any other actions summarized in Criteria above.
| |
| | |
| ==Reference:==
| |
| NRC Form 314 is available at https://www.nrc.gov/reading-rm/doc-collections/forms.
| |
| 11-3
| |
| | |
| APPENDIX A SAFETY CULTURE POLICY STATEMENT
| |
| | |
| Safety Culture The safety culture policy statement was published in the Federal Register (76 FR 34773) on June 14, 2011, and can be found at: https://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission (NRC) Agencywide Documents Access and Management System Accession Number ML11146A047.
| |
| Safety Culture Policy Statement The purpose of this Statement of Policy is to set forth the Commissions expectation that individuals and organizations establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. This includes all licensees, certificate holders, permit holders, authorization holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants for a license, certificate, permit, authorization, or quality assurance program approval, subject to NRC authority. The Commission encourages the Agreement States, Agreement State licensees, and other organizations interested in nuclear safety to support the development and maintenance of a positive safety culture, as articulated in this Statement of Policy.
| |
| Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective commitment by leaders and individuals to emphasize safety over competing goals to ensure protection of people and the environment. Individuals and organizations performing regulated activities bear the primary responsibility for safety and security. The performance of individuals and organizations can be monitored and trended and, therefore, may be used to determine compliance with requirements and commitments and may serve as an indicator of possible problem areas in an organizations safety culture. The NRC will not monitor or trend values.
| |
| These will be the organizations responsibility as part of its safety culture program.
| |
| Organizations should ensure that personnel in the safety and security sectors have an appreciation for the importance of each, emphasizing the need for integration and balance to achieve both safety and security in their activities. Safety and security activities are closely intertwined. While many safety and security activities complement each other, there may be instances in which safety and security interests create competing goals. It is important that consideration of these activities be integrated so as not to diminish or adversely affect either; thus, mechanisms should be established to identify and resolve these differences. A safety culture that accomplishes this would include all nuclear safety and security issues associated with NRC-regulated activities.
| |
| Experience has shown that certain personal and organizational traits are present in a positive safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal conflict situations (e.g., production, schedule, and the cost of the effort versus safety). It should be noted that although the term security is not expressly included in the following traits, safety and security are the primary pillars of the NRCs regulatory mission. Consequently, consideration of both safety and security issues, commensurate with their significance, is an underlying principle of this Statement of Policy.
| |
| A-1
| |
| | |
| The following are traits of a positive safety culture:
| |
| (1) Leadership Safety Values and Actions - Leaders demonstrate a commitment to safety in their decisions and behaviors; (2) Problem Identification and Resolution - Issues potentially impacting safety are promptly identified, fully evaluated, and promptly addressed and corrected commensurate with their significance; (3) Personal Accountability - All individuals take personal responsibility for safety; (4) Work Processes - The process of planning and controlling work activities is implemented so that safety is maintained; (5) Continuous Learning - Opportunities to learn about ways to ensure safety are sought out and implemented; (6) Environment for Raising Concerns - A safety-conscious work environment is maintained where personnel feel free to raise safety concerns without fear of retaliation, intimidation, harassment, or discrimination; (7) Effective Safety Communication - Communication maintains a focus on safety; (8) Respectful Work Environment - Trust and respect permeate the organization; and (9) Questioning Attitude - Individuals avoid complacency and continuously challenge existing conditions and activities, to identify discrepancies that might result in error or inappropriate action.
| |
| There may be traits not included in this Statement of Policy that are also important in a positive safety culture. It should be noted that these traits were not developed to be used for inspection purposes.
| |
| It is the Commissions expectation that all individuals and organizations, performing or overseeing regulated activities involving nuclear materials, should take the necessary steps to promote a positive safety culture by fostering these traits as they apply to their organizational environments. The Commission recognizes the diversity of these organizations and acknowledges that some organizations have already spent significant time and resources in the development of a positive safety culture. The Commission will take this into consideration as the regulated community addresses the Statement of Policy.
| |
| A-2
| |
| | |
| APPENDIX B U.S. NUCLEAR REGULATORY COMMISSION FORM 313
| |
| | |
| U.S. Nuclear Regulatory Commission Form 313 Please use the most current version of this form, which may be found at:
| |
| https://www.nrc.gov/reading-rm/doc-collections/forms/
| |
| B-1
| |
| | |
| APPENDIX C SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN ITEMS 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY COMMISSION FORM 313
| |
| | |
| Suggested Format for Providing Information Requested in Items 5 Through 11 of U.S. Nuclear Regulatory Commission Form 313 This Appendix contains the suggested format that may be used to assist in organizing an application, including the U.S. Nuclear Regulatory Commission (NRC) Form 313, Application for Materials License, (Appendix B) and the NRC Form 313A series, Medical Use Training and Experience and Preceptor Attestation, which can be found on the Medical Uses Licensee Toolkit Web page. Also refer to the NRC Forms Web site at: https://www.nrc.gov/reading-rm/doc-collections/forms/ for the NRC Form 313A series. Verify that the most current version of the NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form. An applicant may copy the checklist and include it in the license application.
| |
| Items 1-4 and 12-13 may be completed on NRC Form 313. Table C-1 provides a suggested format for providing information requested in Item 5 (Radioactive Material) and Item 6 (Purpose of Use), and Table C-2 provides a suggested format for providing information requested in Items 7 and 8 (Training and Experience), Item 9 (Facilities and Equipment),
| |
| Item 10 (Radiation Safety Program), and Item 11 (Waste Management). Table C-3, Applicable Appendices Describing Model Procedures, may be helpful to applicants in developing procedures for inclusion in their radiation safety program. Please note that the procedures provided are not all-inclusive (e.g., full calibration and emergency procedures for therapy devices are not included and only references to American Association of Physicists in Medicine and American National Standards Institute standards are made in this NUREG document). In addition, uses conducted under Title 10 of the Code of Federal Regulations (10 CFR) 35.1000 may require procedures specific to the emerging technology; however, the procedures described in the document may be helpful in developing these procedures. Finally, Appendices X, Y, and Z of this NUREG are not model procedures; however, they are included in Table C-3 to remind licensees of recordkeeping, reporting, and transportation requirements.
| |
| The applicant should review the guidance in Chapter 6, Identifying and Protecting Sensitive Information, and mark security-related sensitive information appropriately.
| |
| C-1
| |
| | |
| Table C-1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use This response includes security-related sensitive information that is included in Attachment _____ and marked Security-Related InformationWithhold Under 10 CFR 2.390 Yes No Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use Any byproduct Any As needed Any uptake, dilution, and material permitted excretion study permitted by by 10 CFR 35.100 10 CFR 35.100.
| |
| Any byproduct Any As needed Any imaging and localization material permitted study permitted by by 10 CFR 35.200 10 CFR 35.200.
| |
| Any byproduct Any _____ Any radiopharmaceutical material permitted millicuries therapy procedure permitted by 10 CFR 35.300 (mCi) by 10 CFR 35.300.
| |
| (Note: Check this inpatient (facility diagram of box if using all patient room(s) attached) radionuclides outpatient covered by (Note: Check the inpatient 10 CFR 35.300; box if keeping patients otherwise, check in-house who have not been subsequent boxes released pursuant to if limiting use by 10 CFR 35.75. If releasable, radionuclide). check outpatient.)
| |
| Iodine-131 Any ___mCi Oral administration of sodium permitted by iodide iodine-131.
| |
| 10 CFR 35.300 inpatient (facility diagram of patient room(s) attached) outpatient Samarium-153 Any ___mCi Parenteral administration of permitted by samarium-153 10 CFR 35.300 inpatient (facility diagram of patient room(s) attached) outpatient Radium-223 Any ___mCi Parenteral administration of permitted by radium-223 10 CFR 35.300 inpatient (facility diagram of patient room(s) attached) outpatient Lutetium-177 Any ___mCi Parenteral administration of permitted by lutetium-177 10 CFR 35.300 inpatient (facility diagram of patient room(s) attached) outpatient C-2
| |
| | |
| Table C-1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued)
| |
| This response includes security-related sensitive information that is included in Attachment _____ and marked Security-Related InformationWithhold Under 10 CFR 2.390 Yes No Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use Other byproduct Any ___mCi inpatient (facility diagram of material permitted patient room(s) attached) by 10 CFR 35.300 outpatient (please specify)
| |
| Iodine-125 Sealed sources ___mCi Any manual brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No._____)
| |
| Palladium-103 Sealed sources ___mCi Any manual brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No. _____)
| |
| Iridium-192 Sealed sources ___mCi Any manual brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No. _____) inpatient (facility diagram of patient room(s) attached)
| |
| Cesium-131 Sealed sources ___mCi Any manual brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No. _____)
| |
| Cesium-137 Sealed sources ___mCi Any manual brachytherapy permitted by (Manufacturer procedure permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No. _____) inpatient (facility diagram of patient room(s) attached)
| |
| Strontium-90 Sealed source ___mCi Strontium-90 for ophthalmic permitted by (Manufacturer radiotherapy permitted by 10 CFR 35.400 ______________, 10 CFR 35.400.
| |
| Model No._____)
| |
| Other Sealed source ____mCi _____________(specify byproduct material (Manufacturer authorized use) permitted by ______________, inpatient (facility diagram of 10 CFR 35.400 Model No. ______) patient room(s) attached)
| |
| _________ outpatient (please specify)
| |
| C-3
| |
| | |
| Table C-1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued)
| |
| This response includes security-related sensitive information that is included in Attachment _____ and marked Security-Related InformationWithhold Under 10 CFR 2.390 Yes No Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use Iodine-125 Sealed sources ___mCi per Diagnostic medical use of permitted by (Manufacturer source and sealed sources permitted by 10 CFR 35.500 ______________, ___curies total 10 CFR 35.500 in compatible Model No. _____) devices registered pursuant to 10 CFR 30.32(g).
| |
| Device (Manufacturer Model No. _____)
| |
| Cesium-137 Sealed sources ___curies per Diagnostic medical use of permitted by (Manufacturer source and sealed sources permitted by 10 CFR 35.500 ___________, Model ___curies total 10 CFR 35.500 in compatible No. _____) devices registered pursuant to 10 CFR 30.32(g).
| |
| Device (Manufacturer Model No. _____)
| |
| Gadolinium-153 Sealed sources ___curies per Diagnostic medical use of permitted by (Manufacturer source and sealed sources permitted by 10 CFR 35.500 ______________, ___curies total 10 CFR 35.500 in compatible Model No. _____) devices registered pursuant to 10 CFR 30.32(g).
| |
| Device (Manufacturer Model No. _____)
| |
| Other Sealed sources ___curies per Diagnostic medical use of byproduct material (Manufacturer source and sealed sources permitted by permitted by ______________, ___curies total 10 CFR 35.500 in compatible 10 CFR 35.500 Model No. _____) devices registered pursuant to 10 CFR 30.32(g).
| |
| (please specify) Device (Manufacturer (include ______________,
| |
| transmission Model No. _____)
| |
| sources bundled and exceeding single source limits in 10 CFR 35.65)
| |
| C-4
| |
| | |
| Table C-1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued)
| |
| This response includes security-related sensitive information that is included in Attachment _____ and marked Security-Related InformationWithhold Under 10 CFR 2.390 Yes No Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use Iridium-192 Sealed sources ___curies per One source for medical use permitted by (Manufacturer source and permitted by 10 CFR 35.600, 10 CFR 35.600 ______________, ___curies total in a Manufacturer Model No. _____) __________________, Model No. _________ remote afterloader unit. One source in its shipping container as necessary for replacement of the source in the remote afterloader device.
| |
| Note: If requesting an individual source activity of greater than 10 curies, see the Medical Uses Licensee Toolkit Web page for the current models approved for a higher activity.
| |
| Cobalt-60 Sealed sources ___curies per One source for medical use permitted by (Manufacturer source and permitted by 10 CFR 35.600, 10 CFR 35.600 ______________, ___curies total in a Manufacturer (teletherapy) Model No._____) __________________, Model No. _________ teletherapy unit. One source in its shipping container as necessary for replacement of the source in the teletherapy unit.
| |
| Cobalt-60 Sealed sources ___curies per For medical use permitted by permitted by (Manufacturer source and 10 CFR 35.600, in a 10 CFR 35.600 ______________, ___curies total Manufacturer (gamma Model No. _____) __________________, Model stereotactic No. _________ gamma radiosurgery) stereotactic radiosurgery device. Sources in the shipping container as necessary for replacement of the sources in the gamma stereotactic radiosurgery device.
| |
| Any byproduct Prepackaged kits ___mCi In vitro studies.
| |
| material listed under 10 CFR 31.11 when activity exceeds the quantity listed in 10 CFR 31.11 C-5
| |
| | |
| Table C-1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued)
| |
| This response includes security-related sensitive information that is included in Attachment _____ and marked Security-Related InformationWithhold Under 10 CFR 2.390 Yes No Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use Depleted Metal ___kilograms Shielding in _____________.
| |
| uranium Any radionuclide Sealed source ___mCi For use in a Manufacturer in excess of (Manufacturer __________________, Model 30 mCi for use in ______________, No. _________ for calibration, Model No. ______) calibrations and checking of transmission, and licensees survey instruments.
| |
| reference sources.
| |
| List radionuclide:
| |
| Americium-241 Sealed source ___mCi For use as an anatomical (Manufacturer marker.
| |
| Model No. _____)
| |
| Byproduct _______________ ____mCi _______________ (please material permitted (please specify form or specify purpose of use. Refer by manufacturer/model to 10 CFR 35.1000 licensing 10 CFR 35.1000 no. if sealed source guidance documents on the
| |
| ________(please NRC Medical Uses Licensee specify) Toolkit Web page)
| |
| Other Form or Manufacturer/ ___mCi Purpose of use Model No. ___________________.
| |
| C-6
| |
| | |
| Table C-2 contains a checklist that may be used to identify the attached documents that the applicant is supplying for items for which a response is required. For example, an applicant may fill in the name of the radiation safety officer (RSO) in Table C-2 and then check the boxes indicating which documents pertaining to the RSO are included in the license application. An applicant may copy the checklist and include it in the license application. Personal information about employees or other individuals should not be submitted unless specifically requested by the NRC. Examples of private information are social security number, home address, home telephone number, date of birth, and radiation dose information. If private information is submitted, it should be separated from the public portion of the application and clearly marked:
| |
| Privacy Act InformationWithhold Under 10 CFR 2.390. See Chapter 6, Identifying and Protecting Sensitive Information, for more information.
| |
| C-7
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal Item 7: Radiation Safety Officer (RSO) or Associate Radiation Safety Officer (ARSO)
| |
| Name of the proposed RSO (RSO is required for all licenses)
| |
| Name(s) of proposed ARSO(s), if desired (A licensee may choose to identify one or more individuals as ARSOs to support the RSO):
| |
| * for each proposed ARSO, identify the types of use (e.g., 10 CFR 35.200, 10 CFR 35.300) of byproduct material for which the individual may be assigned duties and tasks under the licensees program in oversight of the radiation protection program:
| |
| 10 CFR 35.100 10 CFR 35.200 10 CFR 35.300 10 CFR 35.400 10 CFR 35.500 10 CFR 35.600 (teletherapy) 10 CFR 35.600 (HDR) 10 CFR 35.600 (gamma stereotactic radiosurgery) 10 CFR 35.1000- (__________)
| |
| Individual currently or was previously identified as an RSO or ARSO on an NRC or Agreement State license or Master Material License permit for the same materials and use Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee on which the individual was named as the RSO or ARSO 1.
| |
| AND If applicable, attach documentation of recent, related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is a current RSO or ARSO seeking authorization to be recognized as a RSO or ARSO for the additional medical uses Attach documentation of completion of the supervised training and experience specified in 10 CFR 35.50(d) for any new materials or new medical uses requested.
| |
| AND If not qualified under 10 CFR 35.57(a)(1) or board certified by an NRC-recognized board, attach a written attestation as prescribed in 10 CFR 35.50(b)(2), signed by a preceptor RSO or ARSO, that the individual has successfully completed the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and is able to independently fulfill the radiation safety-related duties as an RSO or as an ARSO for a medical use licensee.
| |
| Provide documentation of the board certification, if applicable.
| |
| 1Some Agreement States list ARSOs on licenses prior to implementing equivalent Agreement State requirements to 10 CFR 35.50 effective January 14, 2019. Until all the Agreement States implement the rule which went into effect on January 14, 2019, the licensee will have to document that a proposed ARSO listed on an Agreement State license meets the NRC requirements under a different pathway.
| |
| C-8
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| OR Individual is qualified under 10 CFR 35.57(a)(4) because the individual was an RSO for only accelerator-produced materials or discrete sources of radium 226 or both:
| |
| Attach documentation that this individual was the RSO for only medical uses of accelerator-produced radioactive materials, discrete sources of Ra-226, or both, at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC AND Attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is Board certified by an NRC-recognized board under 10 CFR 35.50(a)
| |
| Attach copy of board certification issued by a specialty board whose certification process has been recognized 2 by the NRC or an Agreement State under 10 CFR 35.50(a).
| |
| AND Attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of the individual as the RSO or ARSO.
| |
| AND If applicable, documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is board certified as a medical physicist by an NRC-recognized board qualifying under 10 CFR 35.50(c)(1) [see 10 CFR 35.51(a)]
| |
| Attach copy of board certification issued by a specialty board whose certification process has been recognized by the NRC or an Agreement State under 10 CFR 35.51(a) and documentation of the experience specified in 10 CFR 35.50(c)(1) demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of the individual as the RSO or ARSO.
| |
| 2Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates as described on the Web page.
| |
| C-9
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| AND Attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of the individual as the RSO or ARSO.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is Board certified by an NRC-recognized board qualifying under 10 CFR 35.57(a)(2)
| |
| Attach a copy of board certification issued on or before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(a)(2).
| |
| AND Attach documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005.
| |
| AND Attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is an AU, ANP, or AMP qualifying under 10 CFR 35.50(c)(2):
| |
| Attach a copy of the NRC or Agreement State license, permit issued by a NRC master material licensee, permit issued by a NRC or Agreement State licensee of broad scope, or permit issued by a NRC master material license permittee of broad scope indicating that the individual is an AU, AMP, or ANP identified on the license or permit and has experience with radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO.
| |
| AND Attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR C-10
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is applying simultaneously to be the RSO and AU on a new license under 10 CFR 35.50(c)(3)
| |
| Attach the license application that includes documentation of the training and experience of the new AU AND Attach documentation of supervised training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO OR Individual is qualifying by classroom/laboratory training and supervised radiation safety experience under 10 CFR 35.50(b):
| |
| Attach documentation of the training and experience specified in 10 CFR 35.50(b)(1) in completed NRC Form 313A (RSO) or equivalent documentation demonstrating that the proposed RSO or ARSO is qualified by training and experience applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO.
| |
| AND Attach documentation of supervised training and experience specified in 10 CFR 35.50(d) in attached NRC Form 313A (RSO) or equivalent documentation demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO.
| |
| AND Attach a written attestation, as prescribed in 10 CFR 35.50(b)(2), signed by a preceptor RSO or ARSO, that the individual has satisfactorily completed the required training and experience specified in 10 CFR 35.50(b)(1), as well as the required training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval, and is able to independently fulfill the radiation safety-related duties as an RSO or ARSO for a medical use license.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| AND For a proposed RSO who is an outside consultant or contractor, address the following:
| |
| An outside consultant or contractor must qualify as an RSO in accordance with 10 CFR 35.50 or 10 CFR 35.57 and 10 CFR 35.59 criteria specified above.
| |
| C-11
| |
| | |
| AND Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Identify other commitments of the consultant-RSO for other NRC or Agreement State licensed facilities, along with a description of how the consultant-RSO will allocate time to permit the performance of the duties of the RSO as described in the regulations. State the consultant-RSO's minimum amount of onsite time (hours per week or days per quarter, as appropriate for the program).
| |
| AND Identify an in-house representative who will serve as the point of contact during the RSOs absence.
| |
| AND Describe the overall availability of the consultant-RSO to respond to questions or operational issues that arise during the conduct of the radiation safety program and related regulatory requirements.
| |
| AND Specify the maximum amount of time it will take the consultant-RSO to arrive at the facility in the event of an emergency that requires his/her presence.
| |
| Item 7: Authorized Users (AUs)
| |
| Authorized User(s) Name(s):
| |
| Uses requested:
| |
| Provide medical, podiatry, or dental license number and issuing entity (e.g., state or territory)
| |
| Individual is currently or was previously listed as an AU on an NRC or Agreement State license or permit for the same type of use(s) requested
| |
| * Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License permittee of broad scope on which the physician, dentist, or podiatrist was specifically named as an AU for the uses requested AND If applicable, attach documentation of recent continuing education and experience as required by 10 CFR 35.59.
| |
| OR C-12
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is listed as an AU on an NRC or Agreement State license or permit but is seeking an additional authorization under 10 CFR Part 35
| |
| * Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License permittee of broad scope on which the individual was specifically named as an AU.
| |
| AND Attach additional documentation of training and experience necessary to demonstrate the AU is qualified for the new medical uses requested:
| |
| to add 10 CFR 35.100 authorization, for an AU qualified under 10 CFR 35.200, no additional documentation is needed.
| |
| to add 10 CFR 35.200 authorization, for an AU qualified under 10 CFR 35.390, attach documentation of the supervised work experience eluting generator systems as required in 10 CFR 35.290(c)(1)(ii)(G);
| |
| to add an additional authorization under 10 CFR 35.300, for an AU qualified under 10 CFR 35.390, attach documentation of casework experience for uses listed under 10 CFR 35.390(b)(1)(ii)(G)(1), 10 CFR 35.390(b)(1)(ii)(G)(2), and/or 10 CFR 35.390(b)(1)(ii)(G)(3), as applicable; to add an authorization under 10 CFR 35.300 (for uses listed in 10 CFR 35.396), for an AU qualified under 10 CFR 35.490 or 10 CFR 35.690, attach documentation of the classroom and laboratory training and supervised work experience required in 10 CFR 35.396(b)(1) and (b)(2); or to add an additional authorization under 10 CFR 35.600 (for use of remote afterloader units, teletherapy units, and/or gamma stereotactic radiosurgery units), attach documentation of training needed to meet the requirements in 10 CFR 35.690(c)
| |
| AND Attach a preceptor attestation, if required (e.g., attestation is required for all individuals to meet the requirements in 10 CFR 35.396 and for individuals seeking authorization under the alternate training and experience pathway for 10 CFR 35.390 and 10 CFR 35.690).
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR C-13
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is qualified under 10 CFR 35.57(b)(3) because only accelerator-produced byproduct material was used for medical use Attach documentation that the physician, podiatrist, or dentist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical uses performed at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or at an earlier date as noticed by the NRC.
| |
| AND Attach documentation that the physician, podiatrist, or dentist used these materials for the same medical uses requested.
| |
| AND Attach documentation of recent continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual who was certified before October 24, 2005, by a board listed in 10 CFR 35.57(b)(2)
| |
| Attach a copy of the board certification issued before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(b)(2).
| |
| AND Attach documentation demonstrating that the individual was using the requested materials for the uses requested on or before October 24, 2005 AND Attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified under 10 CFR Part 35, Subparts D, E, F, G, and/or H because of a recognized board certification.
| |
| Attach a copy of the board certification(s) issued by a specialty board whose certification process has been recognized 3 by the NRC or an Agreement State under 10 CFR Part 35 Subparts D, E, F, G, or H, as applicable to the use requested.
| |
| AND 3
| |
| Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates as described on the Web page.
| |
| C-14
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Attach additional documentation of training and experience necessary to demonstrate the AU is qualified for the medical uses requested:
| |
| to add 10 CFR 35.200 authorization with a board certification recognized under 10 CFR 35.390, attach documentation of the supervised work experience eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G) to add 10 CFR 35.390 authorization with a board certification recognized under 10 CFR 35.390, attach documentation of the supervised work experience administering dosages of radioactive drugs required in 10 CFR 35.390(b)(1)(ii)(G)(1),
| |
| 35.390(b)(1)(ii)(G)(2), and/or 35.390(b)(1)(ii)(G)(3) as applicable to add 10 CFR 35.396 authorization with a board certification recognized under 10 CFR 35.490 or 10 CFR 35.690, attach documentation of the classroom and laboratory training and supervised work experience required in 10 CFR 35.396(b)(1) and (2) and a copy of the attestation required in 10 CFR 35.396(b)(3) to add 10 CFR 35.600 authorization with a board certification recognized under 10 CFR 35.690, attach documentation of the training specified in 10 CFR 35.690(c)
| |
| AND If applicable, attach documentation of recent, related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified under 10 CFR Part 35, Subparts D, E, F, G, and/or H by classroom and laboratory training, supervised work experience, and supervised clinical experience Attach documentation of the classroom and laboratory training, supervised work experience, and supervised clinical experience identified in 10 CFR Part 35, Subparts D, E, F, G, or H, demonstrating that the proposed AU is qualified by training and experience for the use(s) requested.
| |
| AND for an individual seeking authorization under 10 CFR Part 35, Subpart G or H, attach documentation of the training specified in 10 CFR 35.590(d) or 10 CFR 35.690(c), as applicable, demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought.
| |
| AND Attach the written attestation, signed by a preceptor physician AU, or if applicable, the residency program director, that the above training and experience have been satisfactorily completed and the individual is able to independently fulfill the radiation safety-related duties as an AU for the requested medical uses.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| C-15
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is qualified for medical use of specific emerging technologies under Subpart K, 10 CFR 35.1000 Attach documentation of training and experience as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page.
| |
| Item 7: Authorized Nuclear Pharmacist (ANP)
| |
| Authorized Nuclear Pharmacist(s) Name(s):
| |
| Attach documentation demonstrating that the proposed ANP has an active license to practice pharmacy. Include information on the issuing entity (e.g. state or territory)
| |
| AND For an individual currently or previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs for the same type of use(s) requested
| |
| * Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License broad scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual only used accelerator-produced radioactive materials or discrete sources of Ra-226, or both and is qualified under 10 CFR 35.57(a)(4)
| |
| Attach documentation that the nuclear pharmacist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, in the practice of nuclear pharmacy at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or at an earlier date as noticed by the NRC.
| |
| AND Attach documentation that the nuclear pharmacist used these materials for the same uses requested.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR C-16
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is board certified by an NRC-recognized board under 10 CFR 35.55(a)
| |
| Attach a copy of the board certification issued by a specialty board whose certification process has been recognized 4 by the NRC or an Agreement State under 10 CFR 35.55(a).
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified by classroom/laboratory training and supervised practical experience in nuclear pharmacy under 10 CFR 35.55(b)
| |
| Attach completed NRC Form 313A (ANP) or equivalent documentation of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience.
| |
| AND Attach a written attestation, signed by a preceptor ANP, that the above training and experience have been satisfactorily completed and the individual is able to independently fulfill the radiation safety-related duties as an ANP.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified for medical use of specified emerging technologies under Subpart K, 10 CFR 35.1000 Attach documentation of training and experience as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page.
| |
| 4 Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates as described on the Web page.
| |
| C-17
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Item 7: Authorized Medical Physicist (AMP)
| |
| Authorized Medical Physicist(s) Name(s):
| |
| Individual is currently or was previously listed as an AMP on an NRC or Agreement State license or permit for the same type of use(s) requested
| |
| * Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License permittee of broad scope on which the individual was specifically named an AMP for the uses requested.
| |
| AND If applicable, attach documentation of recent, related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is an AMP listed on a license or permit but seeking authorization for a new medical use under 10 CFR 35.51(c)
| |
| * Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License permittee of broad scope on which the individual was specifically named an AMP for the uses requested.
| |
| AND Attach documentation of the additional training and experience specified in 10 CFR 35.51(c) demonstrating that the individual is qualified by training in the new types of use for which the applicant seeks approval of the individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
| |
| AND If not board certified by a board recognized under 10 CFR 35.51(a) or listed in 10 CFR 35.57(a)(3), attach a written attestation, signed by a preceptor AMP, that the required training and experience in 10 CFR 35.51(c) has been satisfactorily completed and that the individual is able to independently fulfill the radiation safety-related duties as an AMP for the type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
| |
| OR C-18
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Individual is qualified under 10 CFR 35.57(a)(4) because the individual was an AMP for only accelerator-produced materials or discrete sources of Ra-226 or both:
| |
| Attach documentation that the AMP used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for the medical uses at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or at an earlier date as noticed by the NRC.
| |
| AND Attach documentation that the medical physicist used these materials for the same medical uses as requested.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified by board certification under 10 CFR 35.51(a)
| |
| Attach a copy of the board certification issued by a specialty board whose certification process has been recognized 5 by the NRC or an Agreement State under 10 CFR 35.51(a).
| |
| AND Attach documentation of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the applicant seeks approval of the individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified by board certification under 10 CFR 35.57(a)(3)
| |
| Attach a copy of the board certification issued by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, X-ray and radium physics, or radiological physics, or by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005 for the same medical uses requested.
| |
| AND 5
| |
| Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit Web page.
| |
| Board certificates should contain prescribed language and shows issuance within specified dates as described on the Web page.
| |
| C-19
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified because of degree, medical physics training, and medical physics work experience under 10 CFR 35.51(b)
| |
| Attach documentation of the training and experience specified in 10 CFR 35.51(b)(1),
| |
| demonstrating that the proposed AMP is qualified by training and experience for the use(s) requested.
| |
| AND Attach documentation of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the licensee seeks approval of an individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
| |
| AND Attach a written attestation, signed by a preceptor AMP, that the proposed AMP has satisfactorily completed the training and experience required in 10 CFR 35.51(b)(1), as well as the training in 10 CFR 35.51(c) for the types of use specified, and that the individual is able to independently fulfill the radiation safety-related duties as an AMP for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified for medical use of specified emerging technologies under Subpart K, 10 CFR 35.1000 Attach documentation of training and experience as described for the technology in the applicable guidance found on the Medical Uses Licensee Toolkit Web page.
| |
| Item 7: Ophthalmic physicist Ophthalmic Physicist(s) Name(s):
| |
| Individual is currently or was previously listed as an authorized ophthalmic physicist on an NRC or Agreement State license or permit Provide an NRC License #______________ or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License permittee of broad scope on which the individual was specifically named an authorized ophthalmic physicist.
| |
| C-20
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| AND If applicable, attach documentation of recent, related continuing education and experience as required by 10 CFR 35.59.
| |
| OR Individual is qualified to be an ophthalmic physicist based on education and supervised work experience under 10 CFR 35.433 Attach documentation of the training and experience specified in 10 CFR 35.433, demonstrating that the proposed ophthalmic physicist is qualified by training and experience for ophthalmic treatments using Strontium-90 sources.
| |
| AND If applicable, attach documentation of recent related continuing education and experience as required by 10 CFR 35.59.
| |
| Item 7: Individuals Authorized for Non-Medical Use:
| |
| Name of the proposed nonmedical use AU:
| |
| Attach a description of types, quantities, and proposed nonmedical uses for each individual requested.
| |
| AND Attach documentation of individuals education and radiation safety training and experience with the types of materials and uses requested. This may include the NRC license number or a copy of the Agreement State license, permit issued by an NRC master materials licensee, permit issued by an NRC or Agreement State broad scope licensee, or permit issued by an NRC Master Materials License broad scope permittee on which the individual was specifically named.
| |
| AND Attach detailed radiation training and experience applicable to the use requested.
| |
| C-21
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Item 8: Training for Individuals Working In or Frequenting Restricted Areas Provide the following:
| |
| A statement that, We have developed and will implement and maintain written procedures for a program for training required under 10 CFR 19.12 for each group of workers, including (i) topics covered, (ii) qualifications of the instructors, (iii) method of training, (iv) method for assessing the success of the training, (v) initial training, and (vi) annual refresher training.
| |
| C-22
| |
| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Item 9: Facility Diagram Provide the following:
| |
| * Facility diagrams. Drawings should be to scale, and the scale used should be indicated.
| |
| The direction of north should be indicated.
| |
| * Location, room numbers, and principal use of each room, including patient treatment rooms or area where byproduct material is prepared, used, and stored.
| |
| * Principal use of adjacent rooms (e.g., office, file, toilet, closet, hallway), including areas above, beside, and below therapy treatment rooms and Positron Emission Tomography (PET).
| |
| * Doors should be indicated, and specify which doors are access controlled (i.e., locked).
| |
| * Shielding calculations for PET facilities, in-patient rooms for 10 CFR 35.300 and 10 CFR 35.400 use, High Dose-Rate/Pulsed Dose Rate & Low Dose Rate Remote Afterloaders, Teletherapy, and Gamma stereotactic radiosurgery (GSR). Include information about the type, thickness, and density of any necessary shielding to enable independent verification of shielding calculations, and a description of any portable shields used (e.g., shielding of proposed patient rooms used for implant therapy, including the dimensions of any portable shield, if one is used; source storage safe). The calculations should include the workload assumptions used.
| |
| * For PET, radiopharmaceutical, and sealed-source therapies, provide a description of surrounding areas, including the occupancy factors, and indicate whether the areas are restricted or unrestricted, as defined in 10 CFR 20.1003. For calculations of the maximum exposure in any given hour, an occupancy factor will not be used.
| |
| * For teletherapy facilities, applicants should provide the directions of primary beam use and, in the case of an isocentric unit, the plane of beam rotation is identified in the shielding calculations.
| |
| * For 10 CFR 35.1000 (e.g., Perfexion, View-Ray), applicants should provide information described in the guidance on the Medical Uses Licensee Toolkit Web page.
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| C-23
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| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
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| Item 9: Radiation Monitoring Instruments Provide the following:
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| A statement that: Radiation monitoring instruments will be calibrated by a vendor who is licensed by the NRC or an Agreement State to perform instrument calibrations.
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| AND/OR A statement that: We have developed and will implement and maintain written radiation survey meter calibration procedures in accordance with the requirements in 10 CFR 20.1501 and that meet the requirements of 10 CFR 35.61.
| |
| AND A description of the instrumentation (e.g., gamma counter, solid-state detector, portable or stationary count-rate meter, portable or stationary dose-rate or exposure-rate meter, single or multichannel analyzer, liquid scintillation counter, proportional counter) that will be used to perform required surveys is attached.
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| Item 9: Dose Calibrator and Other Dosage Measuring Equipment For the administration of alpha, gamma, and beta emitting unsealed byproduct materials, we are providing the following:
| |
| A statement that: Equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturers instructions.
| |
| AND A description of the equipment used to measure the dosages.
| |
| AND For measurement of alpha emitters where gamma or beta emissions are not measurable in a traditional dose calibrator, identify specialized measurement equipment and the nationally recognized standard used to calibrate the instrument or provide a copy of the manufacturers instructions to calibrate the instrument.
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| Item 9: Sealed Sources in Therapy Unit - Calibration and Use Provide the procedures required by 10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645, if applicable to the license application.
| |
| The applicant for a medical use under 35.1000 should provide the procedures required by 10 CFR 35.12(b)(2) that are described in the licensing guidance posted for that 10 CFR35.1000 medical use on NRCs Medical Uses Licensee Toolkit Web page, or explain why the procedure is not provided.
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| C-24
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| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
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| Item 9: Other Equipment and Facilities Provide the following, if applicable:
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| For PET radionuclide use and radiopharmaceutical therapy programs, describe the additional equipment for these uses, as applicable.
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| For manual brachytherapy facilities, provide a description of the emergency response equipment.
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| For teletherapy, GSR, and remote afterloader facilities, provide a description of the following:
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| Warning systems and restricted area controls (e.g., locks, signs, warning lights and alarms, interlock systems) for each therapy treatment room Area radiation monitoring equipment Viewing and intercom systems (except for low dose-rate units)
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| Steps that will be taken to ensure that no two units can be operated simultaneously, if other radiation-producing equipment (e.g., linear accelerator, X-ray machine) is in the treatment room Methods to ensure that whenever the device is not in use or is unattended, the console keys will be inaccessible to unauthorized persons Emergency response equipment For 10 CFR 35.1000 medical uses, review the licensing guidance posted for that 10 CFR 35.1000 medical use on NRCs Medical Uses Licensee Toolkit Web page and provide the appropriate descriptions of other equipment and facilities.
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| C-25
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| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
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| Item 10: Occupational Dose Provide the following:
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| A statement that: We will maintain, for inspection by the NRC, documentation demonstrating that unmonitored individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502.
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| OR A statement that: We will monitor individuals in accordance with the criteria in the section titled, Radiation Safety Program-Occupational Dose in NUREG-1556, Vol. 9, Rev. 3, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licensees.
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| OR A description of an alternative method for demonstrating compliance with the referenced regulations.
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| Item 10: Spill/Contamination Procedures Provide the following:
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| A statement that: We have developed and will implement and maintain written procedures for safe response to spills of licensed material in accordance with 10 CFR 20.1101.
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| Item 10: Emergency Procedures for Therapy Devices Containing Sealed Sources Provide the following:
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| Attach procedures required by 10 CFR 35.610.
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| AND If appropriate, review 10 CFR 35.1000 medical use licensing guidance on NRCs Medical Uses Licensee Toolkit Web page, and provide safety and emergency procedures requested for the particular 10 CFR 35.1000 medical use.
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| Item 10: Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy Devices Containing Sealed Sources If requesting that the applicants own employee(s), who are trained by the manufacturer, be authorized to perform the activities noted in section 8.10.7 of this NUREG, provide the following:
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| Name of the proposed employee(s) and types of activities requested:
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| AND C-26
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| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Description of the training and experience demonstrating that the proposed employee is qualified by training and experience for the use requested.
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| AND Copy of the manufacturers training certification and an outline of the training in procedures to be followed.
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| AND Written commitment from the licensee that the trained employee will follow manufacturer procedures.
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| Item 10: Material Receipt and Accountability Provide the following:
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| A statement that: We will develop, implement, and maintain written procedures for licensed material accountability and control to ensure that:
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| license possession limits are not exceeded licensed material in storage is secured from unauthorized access or removal licensed material not in storage is maintained under constant surveillance and control records of receipt (either from the licensees own production operations or from another licensee), transfer, and disposal of licensed material, are maintained.
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| AND If applicable, a statement that We will comply with the National Source Tracking System (NSTS) reporting requirement, as described in 10 CFR 20.2207.
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| Item 10: Leak Tests Provide the following:
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| For in-house leak testing of sealed sources used pursuant to 10 CFR Part 35:
| |
| A statement that: We have developed and will implement and maintain written procedures for sealed-source leak testing that meet the requirements of 10 CFR 35.67.
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| OR For in-house leak testing of sealed sources other than those authorized pursuant to 10 CFR Part 35 (e.g., self-shielded irradiators, calibration sources):
| |
| A statement that: We will conduct leak tests in-house.
| |
| AND A statement that: The attached leak test procedures will be followed for leak tests conducted in-house.
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| AND Attach leak test procedures.
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| C-27
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| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
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| OR A statement that the applicant will implement the model leak test program of the appendix of the appropriate NUREG-1556 volume for the type of use. For instance, if an applicant possesses a self-shielded irradiator, the applicant may state, We will implement the model leak test program published in Appendix N of NUREG-1556, Volume 5, Rev. 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses.
| |
| OR If a contractor is used to perform leak testing, a statement that: Leak test sample collection and analysis will be performed by an organization authorized by the NRC or an Agreement State to provide leak testing services to other licensees; or by using a leak test sample collection kit supplied by an organization licensed by the NRC or an Agreement State to provide leak test kits or sample analysis services to other licensees and according to the instructions provided in the leak test sample collection kit.
| |
| Item 10: Area Surveys Provide the following:
| |
| A statement that: We have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 20.1501 and 10 CFR 35.70.
| |
| Item 10: Safe Use of Unsealed Licensed Material Provide the following:
| |
| A statement that: We have developed and will implement and maintain written procedures for safe use of unsealed byproduct material that meet the requirements of 10 CFR 20.1101 and 10 CFR 20.1201.
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| Item 10: Mobile medical service Review the guidance in Appendix V of this NUREG to determine the response required.
| |
| Item 10: Minimization of Contamination A response is not required under the following condition: The NRC will consider that the criteria have been met if the information provided in the applicants responses satisfies the criteria for the following sections in this NUREG: Sections 8.9, 8.9.1, 8.10, 8.10.5, 8.10.12, and 8.11 on the following topics: facilities and equipment, facility diagram, radiation safety program, spill and contamination procedures, area surveys, and waste management.
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| C-28
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| | |
| Table C-2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities and Equipment, Radiation Protection Program, and Waste Disposal (Continued)
| |
| Item 11: Waste Management Provide the following:
| |
| A statement that: We have developed and will implement and maintain written waste disposal procedures for licensed material in accordance with 10 CFR 20.1101, that also meet the requirements of the applicable section of 10 CFR Part 20, Subpart K, and of 10 CFR 35.92.
| |
| AND Contact the appropriate NRC Regional Office for guidance on treatment or disposal of waste by incineration or compaction.
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| C-29
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| | |
| Table C-3 is provided to help applicants determine which procedures must be developed, implemented, and maintained for the type of medical use requested. Several appendices in this report present sample procedures that applicants may use in developing their procedures.
| |
| Table C-3. Applicable Appendices Describing Model Procedures 10 CFR 35.100 10 CFR 10 CFR 10 CFR 10 CFR 10 CFR Appendix Topic 35.200 35.300 35.400 35.500 35.600 G Dose Calibrator x x Calibration H Remote Afterloader x Spot-Checks I Radiation Safety Officer x x x x x Duties, Responsibilities, and Delegation J Training Program x x x x x K General Radiation x x x x x Monitoring Instrument Specifications and Calibration L Medical Licensee Audit x x x x x M Occupational Dose x x x x x Monitoring Program N General Topics for Safe x x x Use of Radionuclides and Model Emergency Procedures O Ordering and Receiving x x x x x Packages P Safely Opening Packages x x x x x Containing Radioactive Material Q Leak Tests x x x x x R Area Surveys x x x x x S Developing, Maintaining, x x x and Implementing Written Directives T Safe Use of Unsealed x x Licensed Material U Release of Patients x x x V Mobile Medical Service x x x x x W Waste Disposal x x x x x X Recordkeeping x x x x x Y Reporting Requirements x x x x x Z Transportation x x x x x C-30
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| | |
| APPENDIX D DOCUMENTATION OF TRAINING AND EXPERIENCE TO IDENTIFY INDIVIDUALS ON A LICENSE
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| | |
| Documentation of Training and Experience to Identify Individuals on a License Licensees should use the most current version of the applicable NRC Form 313A. Refer to the NRC Medical Uses Licensee Toolkit Web page for the most current version of the forms and their associated instructions. Also refer to the NRC Forms Web site at:
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| https://www.nrc.gov/reading-rm/doc-collections/forms/ for the NRC Form 313A series. Verify that the most current version of the NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form.
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| I. Experienced Authorized Users, Authorized Medical Physicists, Ophthalmic Physicists, Authorized Nuclear Pharmacists, Radiation Safety Officer, or Associate Radiation Safety Officers An applicant or licensee who is adding an experienced authorized user (AU) for medical uses, authorized medical physicist (AMP), ophthalmic physicist (OP), authorized nuclear pharmacist (ANP), radiation safety officer (RSO) or associate radiation safety officer (ARSO) to its medical use license or application only needs to provide evidence that the individual is listed on a medical use license issued by the NRC or Agreement State, a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC master material broad scope permittee, provided that the individual is authorized for the same types of use(s) requested in the application under review, and the individual meets the recentness of training criteria described in 10 CFR 35.59. When adding an experienced ANP to the license, the applicant also may provide evidence that the individual is listed on an NRC or Agreement State commercial nuclear pharmacy license or identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs. For individuals who have been previously authorized by, but not listed on, the commercial nuclear pharmacy license, medical broad scope license, or Master Materials License medical broad scope permit, the applicant should submit either verification of previous authorizations granted or evidence of acceptable training and experience. Applicants are reminded that in accordance with 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610 instruction on the licensees operating and emergency procedures are required for the above personnel.
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| II. Experienced Physicians, Podiatrists, Dentists, Nuclear Pharmacists, Medical Physicists, and Radiation Safety Officers Who Only Used Accelerator-Produced Nuclear Materials, or Discrete Sources of Ra-226, or Both, for Medical or Nuclear Pharmacy Uses Pursuant to 10 CFR 35.57(a)(4) and 10 CFR 35.57(b)(3), the NRC grandfathered RSOs, physicians, podiatrists, dentists, medical physicists, and nuclear pharmacists that used only accelerator-produced radioactive materials, discrete sources of radium (Ra)-226, or both for medical or nuclear pharmacy uses at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, when using these materials for the same uses. The applicant or licensee that is adding one of these experienced individuals to its medical use license should document that the individual used only accelerator-produced radionuclides, or discrete sources of Ra-226, or both, for medical or nuclear pharmacy uses before or during the dates specified and that the materials were used for the same uses requested. This documentation may be, but is not restricted to, evidence that the individual was listed on an Agreement State or non-Agreement State license or permit authorizing these materials for the requested uses.
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| D-1
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| | |
| III. Applications that Include New Authorized User, Authorized Medical Physicist, Ophthalmic Physicist, Authorized Nuclear Pharmacist, Radiation Safety Officer or Associate Radiation Safety Officer Recognition by NRC Applicants should submit the appropriate completed form in the NRC Form 313A series to show that the individuals meet the correct training and experience criteria in 10 CFR Part 35, Subparts B, D, E, F, G, and H. For the applicants convenience, a separate NRC Form 313A is available for each type of user (e.g., RSO, AMP, Diagnostic AU). When an applicant wants to identify one or more ARSOs, the applicant must identify the types of use (e.g., 10 CFR 35.200, 10 CFR 35.300) of byproduct material for which the individual may be assigned duties and tasks under the licensees program in the oversight of the radiation safety operations.
| |
| The regulations provide multiple pathways which applicants can use to demonstrate that individuals are qualified as an AU, AMP, RSO, and ARSO. Applicants should provide documentation that each individual is qualified under one pathway. There are two primary training and experience routes to qualify an individual as a new AU, AMP, ANP, RSO or ARSO.
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| The first is by means of certification by a board recognized by NRC and listed on the NRC Web site as provided in 10 CFR 35.50(a), 10 CFR 35.51(a), 10 CFR 35.55(a), 10 CFR 35.190(a),
| |
| 10 CFR 35.290(a), 10 CFR 35.390(a), 10 CFR 35.392(a), 10 CFR 35.394(a), 10 CFR 35.396(a),
| |
| 10 CFR 35.490(a), 10 CFR 35.590(a), or 10 CFR 35.690(a), or included in the regulations in 10 CFR 35.57(a)(2), 10 CFR 35.57(a)(3), 10 CFR 35.57(b)(2). Additional training may also need to be documented for RSOs, ARSOs, AMPs, and AUs under 10 CFR 35.50, 10 CFR 35.51, 10 CFR 35.390, 10 CFR 35.396, and 10 CFR 35.690.
| |
| The second route is by meeting the structured educational program, supervised work experience, and preceptor attestation requirements in 10 CFR Part 35, Subparts B, D, E, F, G, and H. Ophthalmic physicists can only qualify under this route as the NRC does not have a regulation under which it recognizes ophthalmic physicist boards. For RSOs, ARSOs, ANPs, and AUs, the NRC requires supervised work experience conducted under the supervision of an authorized individual in a licensed material use program. In this case, a supervisor is an individual who provides frequent direction, instruction, and direct oversight of the student as the student completes the required work experience in the use of byproduct material. Supervision may occur at various licensed facilities, from a large teaching university hospital to a small private practice.
| |
| In some cases, there may be additional training and experience routes and requirements for recognized AUs, ANPs, AMPs, RSOs or ARSOs to seek additional authorizations.
| |
| IV. Recentness of Training The required training and experience, including board certification and prior approval on a license, described in 10 CFR Part 35 must be obtained within the 7 years preceding the date of the application, or the individual must document having completed related continuing education, and experience since obtaining the required training and experience as described in 10 CFR 35.59. Acceptable continuing education and experience for physicians include the following, to be reviewed on a case-by-case basis:
| |
| * successful completion of classroom and laboratory review courses that include radiation safety practices relative to the proposed type of authorized medical use (this review may include various types of instruction, including online training, as long as the subject D-2
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| | |
| matter relates to radiation safety and safe handling of byproduct material for the uses requested)
| |
| * practical and laboratory experience with patient procedures using radioactive material for the same use(s) for which the applicant is requesting authorization
| |
| * practical and laboratory experience under the supervision of an AU at the same or another licensed facility that is authorized for the same use(s) for which the applicant is requesting authorization
| |
| * for therapy devices, experience with the therapy unit and/or comparable linear accelerator experience and completion of an in-service review of operating and emergency procedures relative to the therapy unit to be used by the applicant V. General Instructions and Guidance for Filling Out NRC Form 313A Series If the applicant is proposing an individual for more than one type of authorization, the applicant may need to either submit multiple forms in the NRC Form 313A series or fill out some sections more than once. For example, an applicant that requests a physician be authorized for 10 CFR 35.200 and 10 CFR 35.300 medical uses and as the RSO, should provide three completed NRC Form 313A series forms [i.e., NRC Form 313A (RSO), NRC Form 313A (AUD) and NRC Form 313A (AUT)]. If the applicant has multiple supervising individuals, more than one form may be used to document supervised work experience. To identify any individual (i.e., proposed individual or supervising individual or preceptor) currently or previously listed on a license, provide the license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee on which the individual was identified. If the Agreement State license authorizes possession of Category 1 or Category 2 sources, submission of the Agreement State license is not required as this license should be in WBL. If the applicant knows that the referenced Agreement State license is contained within WBL for other licenses, submission of the license is not required. To identify an individual who is authorized under a broad scope license or broad scope permit of a Master Materials License, provide a complete copy of the permit issued by the broad scope licensee/permittee. Alternatively, provide a statement signed by the RSO or chairperson of the RSC similar to the following: __________ (name of individual) was authorized under
| |
| _______________ (name of licensee/permittee) broad scope license number__________ to use_________ (materials) during ____________ (time frame).
| |
| INTRODUCTORY INFORMATION Name of Individual Provide the individuals complete name so that the NRC can distinguish the individual from others with a similar name. Include terminal degree designation(s) documentation as applicable to the review of the individual that the applicant is requesting to be listed on the license.
| |
| Note: Do not include personal or private information (e.g., date of birth, social security number, home address, personal telephone number) as part of the qualification documentation.
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| D-3
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| | |
| State or Territory Where Licensed The NRC requires physicians, dentists, podiatrists, and pharmacists to be licensed by a State or territory of the U.S., the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine, as well as licensed in the practice of dentistry, podiatry, or pharmacy, respectively (see definitions of physician, dentist, podiatrist, and pharmacist in 10 CFR 35.2, Definitions).
| |
| Requested Authorization(s)
| |
| Indicate authorizations requested and fill in the blanks as provided.
| |
| Training and Experience Documentation Indicate the applicable training and experience pathway, as documented on the form.
| |
| Board Certification Pathway The applicant or licensee may use this pathway if the proposed new authorized individual is certified by a board recognized by the NRC. Specialty board certifications recognized by the NRC are either posted on the Medical Uses Licensee Toolkit Web page or if certified prior to October 24, 2005, by a board listed in 10 CFR 35.57.
| |
| Note: An individual that is board-eligible will not be considered for this pathway until the individual is actually board certified. Further, individuals holding other board certifications, but not certified by a board recognized by the NRC, will not be considered for this pathway.
| |
| The applicant or licensee will need to provide a copy of the board certification and other documentation of training, experience, or clinical casework, as indicated on the specific form of the NRC Form 313A series. To ensure that the board certification is current, applicants are reminded to review the sample certificate on NRCs Medical Uses Licensee Toolkit to assure that the language in the proposed individuals certificate is up to date.
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| With the exception of an applicant requesting a proposed individual under the provisions of 10 CFR 35.396, board certified applicants do not need to provide a preceptor attestation.
| |
| Alternate Pathway for Training and Experience for Proposed New Authorized Individuals or Individuals Seeking Additional Authorizations The regulatory requirements refer to two categories of training: (i) classroom and laboratory training, and (ii) supervised work experience. All hours credited to classroom and laboratory training must relate directly to radiation safety and safe handling of byproduct material and be allocated to one of the topics in the regulations. Each hour of training involving performance of radiation safety tasks or hands-on use of byproduct material may be credited to either (i) classroom and laboratory training, or (ii) supervised work experience. Note that a single hour of training may only be counted once and may not be credited to both of these categories.
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| The proposed authorized individual may receive the required classroom and laboratory training, supervised work experience, and clinical casework at a single training facility or at multiple training facilities; therefore, space is provided to identify each location and date of training or experience. The date should be provided in the month/day/year (mm/dd/yyyy) format.
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| D-4
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| | |
| The specific number of hours needed for each training and experience element will depend upon the type of approval sought. On the form, provide the number of clock hours spent on the topics listed in the regulatory requirements, ensuring to document hours for each topic.
| |
| The proposed authorized individual may obtain the required classroom and laboratory training in any number of settings, locations, and educational situations. For example, at some medical teaching/university institutions, a course may be provided for that particular need and taught in consecutive days. In other training programs, the period may be a semester or quarter as part of the formal curriculum. Also, the classroom and laboratory training may be obtained using a variety of other instructional methods. Therefore, the NRC will broadly interpret classroom and laboratory training to include various types of instruction, including online training, as long as it meets the specific clock hour requirements and the subject matter relates to radiation safety and safe handling of byproduct material for the uses requested. For online or other training programs new to the NRC, the training entity may be contacted by the NRC to discuss the training program components (course outline, test, mechanism to ensure proposed individual completed the training and test) and to ensure that the program is robust.
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| The supervised work experience for physicians must include, but is not limited to, the subject areas listed in the applicable training and experience requirements. The NRC recognizes that physicians in training will not dedicate all of their supervised work experience time specifically to the subject areas listed in the regulatory requirements and will be attending to other clinical activities involving the medical use of byproduct material (e.g., reviewing case histories or interpreting scans). Hours spent on these other duties not directly related to radiation safety or hands-on use of byproduct material, even though not specifically required by the NRC, may be credited to the supervised work experience category but not to the classroom and laboratory training category.
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| For other authorized individuals (i.e. RSO, ARSO, ANP, AMP, OP), all the hours of supervised experience should be allocated to the topics specified in the regulations. Other than for individuals qualifying under 10 CFR Part 35, Subpart G, the applicant must submit a Preceptor Attestation for all non-board certified individuals.
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| Note: If the proposed new authorized individual had more than one supervisor, provide the information requested for each supervising individual.
| |
| Preceptor Attestation The NRC defines the term preceptor in 10 CFR 35.2, Definitions, as an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer. While the supervising individual for the work experience may also be the preceptor, the preceptor does not have to be the supervising individual as long as the preceptor directs or verifies the training and experience required. The preceptor must attest in writing regarding the training and experience of any individual to serve as an authorized individual and attest that the individual has satisfactorily completed the appropriate training and experience requirements and is able to independently fulfill the radiation safety-related duties of an authorized individual. For authorized users, this does not require an attestation of general clinical competency but requires sufficient attestation to demonstrate that the individual is able to independently fulfill the duties of the position for which the attestation is sought. The preceptor also has to meet specific requirements and must have authorization for the same categories that the proposed candidate is seeking. In addition, D-5
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| | |
| a residency program director may make the attestation by affirming in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user for the uses requested, and concurs with the attestation provided by the residency program director.
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| VI. Specific Instructions and Guidance for Filling out NRC Form 313A Series Forms Because there are a number of different pathways to obtain the required training and experience for different authorized individuals, specific instructions are available for each form in the NRC 313A series. Please refer to the NRCs Medical Uses Licensee Toolkit for links to the current NRC 313A Series forms and associated instructions. Also refer to the NRC Forms Web site at: https://www.nrc.gov/reading-rm/doc-collections/forms/ for the NRC Form 313A series.
| |
| Verify that the most current version of the NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form.
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| D-6
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| APPENDIX E U.S. NUCLEAR REGULATORY COMMISSION FORM 313A SERIES
| |
| | |
| U.S. Nuclear Regulatory Commission Form 313A Series In addition to completion of NRC Form 313, Application for Materials License (see Appendix B), applicants can also use the appropriate NRC 313A form to document training and experience. The following are the six NRC Form 313A forms which can be used to document training and experience to request authorization for different individuals:
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| * NRC Form 313A (AMP)Authorized Medical Physicist or Ophthalmic Medical Physicist
| |
| * NRC Form 313A (ANP)Authorized Nuclear Pharmacist
| |
| * NRC Form 313A (AUD)Authorized User requesting authorization for diagnostic uses defined under 10 CFR 35.100, 10 CFR 35.200, or 10 CFR 35.500.
| |
| * NRC Form 313A (AUS)Authorized User requesting authorization for use of sealed sources defined under 10 CFR 35.400 or 10 CFR 35.600.
| |
| * NRC Form 313A (AUT)Authorized User requesting authorization for use of unsealed radioactive material for therapy defined under 10 CFR 35.300.
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| * NRC Form 313A (RSO)Radiation Safety Officer or Associate Radiation Safety Officer Applicants should refer to the Medical Uses Licensees Toolkit Web page or NRC forms Web page to find the most recent version of NRC Form 313 and 313A forms. Verify that the most current version of the NRC Form 313A is being used by checking the Expires date in the right, top-hand corner of the form.
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| E-1
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| APPENDIX F CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)
| |
| | |
| Checklist for Requests to Withhold Proprietary Information from Public Disclosure (Under 10 CFR 2.390)
| |
| In order to request that the U.S. Nuclear Regulatory Commission (NRC) withhold information from public disclosure, the applicant or licensee must submit the information, including an affidavit, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) CFR 2.390, Public Inspections, Exemptions, Requests for Withholding. The applicant should submit all of the following:
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| A proprietary copy of the information. Brackets should be placed around the material considered to be proprietary. This copy should be marked as proprietary.
| |
| A non-proprietary copy of the information. Applicants should white out or black out the proprietary portions (i.e., those in the brackets), leaving the nonproprietary portions intact. This copy should not be marked as proprietary.
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| An affidavit that:
| |
| Is signed under oath and affirmation (notarization may suffice).
| |
| Clearly identifies (such as by name or title and date) the document to be withheld.
| |
| Clearly identifies the position of the person executing the affidavit. This person must be an officer or upper-level management official who has been delegated the function of reviewing the information the organization is seeking to withhold and is authorized to apply for withholding on behalf of the organization.
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| States that the organization submitting the information is the owner of the information or is required, by agreement with the owner of the information, to treat the information as proprietary.
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| Provides a rational basis for holding the information in confidence.
| |
| Fully addresses the following issues:
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| Is the information submitted to, and received by, the NRC in confidence? Provide details.
| |
| To the best of the applicants knowledge, is the information currently available in public sources?
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| Does the applicant customarily treat this information, or this type of information, as confidential? Explain why.
| |
| Would public disclosure of the information be likely to cause substantial harm to the competitive position of the applicant? If so, explain why in detail. The explanation should include the value of the information to your organization, the amount of effort or money expended in developing the information, and the ease or difficulty for others to acquire the information.
| |
| F-1
| |
| | |
| APPENDIX G MODEL PROCEDURES FOR DOSE CALIBRATOR CALIBRATION
| |
| | |
| Model Procedures for Dose Calibrator Calibration The model procedure provides acceptable methods for dose calibrator testing when measuring photon emitting radionuclides. Applicants may either adopt this model procedure or develop an alternative procedure in accordance with manufacturers instructions or a nationally recognized standard pursuant to 10 CFR 35.60. For instance, ANSI N42.13 2004Calibration and Usage of Dose Calibrator Ionization Chambers for the Assay of Radionuclides may be ordered at ansi.org.
| |
| The tests should be performed at the indicated frequency:
| |
| * constancy, at least once each day prior to assay of patient dosages (+/ 10%)
| |
| * linearity, at installation and at least annually thereafter (+/ 10%)
| |
| * geometry dependence, at installation (+/ 10%)
| |
| * accuracy, at installation and at least annually thereafter (+/ 10%)
| |
| The dose calibrator will be repaired, replaced, or corrected arithmetically if the dose calibrator falls outside the suggested tolerances. For example, a licensee shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent and shall mathematically correct dosage readings [for dosages greater than 1.11 megabecquerels (MBq) or 30 microcurie
| |
| (µCi)] if the geometry or linearity error exceeds 10 percent. In addition, after repair, adjustment, or relocation to another building, the dose calibrator tests will be repeated before use.
| |
| Constancy means reproducibility in measuring a constant source over a long period of time. At least one relatively long-lived source, such as cesium-137 (Cs-137), cobalt-60, cobalt-57 (Co-57), or radium-226 will be assayed using reproducible geometry each day before using the calibrator. The source activity will normally be in the low millicurie to hundreds of microcuries range. Two sources with different photon energies and activities may also be used to ensure the photon energy range for radionuclides used is covered.
| |
| : 1. Assay each reference source using the appropriate dose calibrator setting (e.g., use the Cs-137 setting to assay Cs-137).
| |
| : 2. Measure background at the same setting and subtract or confirm the proper operation of the automatic background subtract circuit if it is used.
| |
| : 3. For each source used, record (e.g., plot, log) the activity measured, the model and serial number of the instrument, the identity of the radionuclide contained in the check source, the date of the check, and the name of the individual who performed the test.
| |
| : 4. Using one of the sources, repeat the above procedure for all commonly used radionuclide settings. Record (e.g., plot, log) the results.
| |
| : 5. Notify the radiation safety officer (RSO) or the authorized user if the test results fall outside +/ 10% of the expected results. For instance, the Cs-137 value should be compared to the reference activity, corrected for decay. Other radionuclides (e.g., Tc-99m) should be compared to the value determined during the last accuracy test, corrected for the reference standards decay.
| |
| Linearity means that the calibrator is able to indicate the correct activity over the range of use of that calibrator. The linearity of a dose calibrator will be ascertained over the range of its use G-1
| |
| | |
| between the maximum activity administered and 1.11 MBq [30 µCi]. This test will be performed using a vial or syringe of technetium-99m (Tc-99m) or other readily available radionuclide whose activity is at least as large as the maximum activity normally assayed for administration.
| |
| Tc-99m is routinely used due to its ready availability and lower energy, and therefore lower exposure to licensee personnel, as compared to higher energy radionuclides like those used in Positron Emission Tomography and Iodine-131.
| |
| Time Decay Method
| |
| : 1. Assay the Tc-99m syringe or vial in the dose calibrator and subtract background to obtain the next activity in millicuries. Record the date, time to the nearest minute, and net activity on the dose calibrator linearity test form.
| |
| : 2. Repeat the assay at approximately 4-hour intervals during the workday. Continue on subsequent days until the assayed activity is less than 1.11 MBq [30 µCi]. For dose calibrators on which the range is selected with a switch, select the range that would normally be used for the measurement.
| |
| : 3. Convert the time and date information that was recorded to hours elapsed since the first assay.
| |
| : 4. Record the measured activities, the calculated activities, the time elapsed between measurements, the model number and serial number of the dose calibrator, the date(s) of the test, and the name of the individual who performed the test.
| |
| : 5. Notify the RSO, if the deviation is more than +/ 10%.
| |
| Shield Method Sleeves of various thicknesses are used to test for linearity. However, they must first be calibrated. The applicant should review the procedure for calibrating sleeves against the manufacturers instructions. Some sleeve manufacturers procedures indicate that various sleeves should be stacked to achieve a desired attenuation. The following procedure should be modified to allow for stacking of sleeves:
| |
| : 1. Begin the linearity test as described in the decay method described above. After making the first assay, the sleeves can be calibrated as follows. Steps 2 through 4 below must be completed within 6 minutes (i.e., approximately 1 percent of decay of Tc-99m).
| |
| : 2. Put the base and sleeve 1 in the dose calibrator with the vial. Record the sleeve number and indicated activity.
| |
| : 3. Remove sleeve 1 and put in sleeve 2. Record the sleeve number and indicated activity.
| |
| : 4. Continue for all sleeves.
| |
| : 5. Complete the decay method linearity test Steps 2 through 5 above.
| |
| : 6. From the data recorded in step 4 of the decay method, find the decay time associated with the activity indicated with sleeve 1 in place. This is the equivalent decay time for sleeve 1. Record that time with the data recorded in step 2.
| |
| G-2
| |
| : 7. Find the decay time associated with the activity indicated with sleeve 2 in place. This is the equivalent decay time for sleeve 2. Record that time with the data recorded in step 3.
| |
| : 8. Continue for all sleeves.
| |
| : 9. The table of sleeve numbers and equivalent decay times constitutes the calibration of the sleeve set.
| |
| The sleeve set may now be used to test dose calibrators for linearity.
| |
| : 1. Assay the Tc-99m syringe or vial in the dose calibrator and subtract background to obtain the net activity. Record the net activity.
| |
| : 2. Steps 3 through 5 below must be completed within 6 minutes.
| |
| : 3. Put the base and sleeve 1 in the dose calibrator with the vial. Record the sleeve number and indicated activity.
| |
| : 4. Remove sleeve 1 and put in sleeve 2. Record the sleeve number and indicated activity.
| |
| : 5. Continue for all sleeves.
| |
| : 6. Record the measured activities, the calculated activities, the time elapsed between measurements, the model number and serial number of the dose calibrator, the date(s) of the test, and the name of the individual who performed the test.
| |
| : 7. Notify the RSO if the greatest deviation is more than +/ 10%.
| |
| Geometry independence means that the indicated activity does not change with volume or configuration. The test for geometry independence will be conducted using syringes and vials that are representative of the entire range of size, shape, and constructions normally used for injections or administrations, and a vial similar in size, shape, and construction to the generator and radiopharmaceutical kit vials normally used. The following test assumes injections are done with 3 cubic centimeter (cc) plastic syringes and that radiopharmaceutical kits are made in 30 cc glass vials and the predetermined safety margin is +/10%. If 5 cc syringes, 10 cc glass vials, or any other geometric variations are used, the geometry testing will include these.
| |
| Note: If these volumes are not used, change the procedure so that the syringes and vials are tested throughout the range of volumes commonly used.
| |
| : 1. In a small beaker or vial, mix 2 cc of a solution of Tc-99m with an activity concentration between 1 and 10 millicuries (mCi)/milliliter. Set out a second small beaker or vial with water.
| |
| : 2. To test the geometry dependence for a 3 cc syringe, draw 0.5 cc of the Tc-99m solution into the syringe and assay it. Record the volume and activity (e.g., mCi) indicated.
| |
| : 3. Remove the syringe from the calibrator, draw an additional 0.5 cc of water and assay again. Record the volume and activity indicated.
| |
| : 4. Repeat the process until a 2.0 cc volume has been assayed.
| |
| G-3
| |
| : 5. Select as a standard the volume closest to that normally used for injections. For all the other volumes, divide the standard activity by the activity indicated for each volume. The quotient is a volume correction factor. Alternatively, graph the data and draw horizontal 10% error lines above and below the chosen standard volume.
| |
| : 6. Record the model number and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the name of the individual who performed the test.
| |
| : 7. Notify the RSO if any correction factors are greater than 1.1 or less than 0.9, or if any data points lie outside the +/ 10% error lines.
| |
| : 8. To test the geometry dependence for a 30 cc glass vial, draw 1.0 cc of the Tc-99m solution into a syringe and then inject it into the vial. Assay the vial. Record the volume and activity indicated.
| |
| : 9. Remove the vial from the calibrator and, using a clean syringe, inject 2.0 cc of water and assay again. Record the volume and activity indicated.
| |
| : 10. Repeat the process until a 19.0 cc volume has been assayed. The entire process must be completed within 10 minutes.
| |
| : 11. Select as a standard the volume closest to that normally used for mixing radiopharmaceutical kits. For all other volumes, divide the standard activity by the activity indicated for each volume. The quotient is a volume correction factor.
| |
| Alternatively, graph the data and draw horizontal 10% error lines above and below the chosen standard volume.
| |
| : 12. Record the model and serial number of the dose calibrator, the configuration of the source measured, the activity measured for each volume measured, the date of the test, and the name of the individual who performed the test.
| |
| : 13. Notify the RSO if any correction factors are greater than 1.1 or less than 0.9, or if any data points lie outside the +/- 10% error lines.
| |
| Accuracy means that, for a given calibrated reference source, the indicated activity (e.g., mCi) value is equal to the activity value determined by the National Institute of Standards and Technology (NIST) or by the supplier who has compared that source to a source that was calibrated by NIST. Certified sources are available from the NIST and from many radionuclide suppliers. At least one source with a principal photon energy between 100 kiloelectron-volts (keV) and 500 keV (e.g., Co-57 or barium-133) will be used. At least one reference source whose activity is within the range of activities normally assayed will be used.
| |
| : 1. Assay a calibrated reference source at the appropriate settings (i.e., use the Co-57 setting to assay Co-57), and then remove the source and measure background.
| |
| Subtract background from the indicated activity to obtain the net activity. Record the net activity.
| |
| : 2. The measurement should be within +/ 10% of the certified activity of the reference source, mathematically corrected for decay.
| |
| G-4
| |
| : 3. Repeat the procedure for any other calibrated reference sources possessed.
| |
| : 4. Record the model and serial number of the dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the name of the individual who performed the test.
| |
| : 5. Notify the RSO if the test results do not agree, within +/ 10%, with the certified value of the reference source(s).
| |
| : 6. At the same time the accuracy test is done, assay the source that will be used for the daily constancy test (it need not be a certified reference source) on all commonly used radionuclide settings.
| |
| G-5
| |
| | |
| APPENDIX H MODEL PROCEDURES FOR REMOTE AFTERLOADER SPOT-CHECKS
| |
| | |
| Model Procedures for Remote Afterloader Spot-Checks This model provides acceptable procedures for performing spot-checks of Remote Afterloader units, equipment, and facilities as required in 10 CFR 35.643. This procedure applies to high dose-rate, medium dose-rate, pulsed dose-rate, or low dose-rate (LDR) remote afterloader units. Applicants may either adopt these model procedures or develop alternative procedures.
| |
| Periodic Spot-Checks for Remote Afterloader Units Before the first use on a given day (or before each patient treatment for LDR remote afterloaders) and after each source installation, the following spot-checks will be performed:
| |
| * Electrical Interlocks at Each Room Entrance Proper functioning of the treatment room door interlock will be performed using the remote afterloader source.
| |
| Expose the remote afterloader source inside the treatment room, open the treatment room door, and verify that the source retracts. The source should retract immediately, the area radiation monitor should alarm, and the control console should indicate that the door is open. A physical survey of the unit will be performed to ensure that the source has fully retracted to the shielded safe prior to closing the door and clearing all alarms.
| |
| * Source Exposure Indicator Lights Treatment Console Indicators and Status Lamps Turn on the remote afterloader unit and verify that the indicator lights flash to show proper function. In addition, when the source is exposed for the electrical interlock test above, verify that the source status indicator lights on the treatment console are lit to indicate an exposed source.
| |
| Remote Afterloader Indicators and Status Lamps Turn on the remote afterloader unit and verify that the indicator lights flash on the remote afterloader to show proper function. In addition, when the source is exposed for the electrical interlock test above, verify that the source status indicator lights on the remote afterloader are lit to indicate an exposed source.
| |
| * Viewing and Intercom Systems Viewing System Turn on the camera(s). Check that the camera(s) is (are) operable and that the treatment area can be viewed from the treatment console. Adjust, if necessary.
| |
| Intercom System Turn on the intercom system. The intercom system will be tested using a two-person method. One person will be at the treatment console while another H-1
| |
| | |
| person is in the treatment room. Both individuals will speak and confirm that the other is heard.
| |
| * Emergency Response Equipment Verify the presence of the emergency equipment within the treatment room. This equipment includes but is not limited to a mobile lead container large enough to hold the largest applicator, long-handled forceps, wire cutter, flashlight, suture removal kit, and timer (timer located at unit console). If a portable radiation survey meter is included, verify the presence, current calibration of the meter and check the operability using a radioactive check source.
| |
| * Radiation Monitors Used to Indicate the Source Position Verify that the area radiation monitor located inside the treatment room is on with the indicator light flashing green. Expose the remote afterloader source inside the treatment room with the door closed and verify that the indicator light flashes red; indicating the presence of radiation. This test will be performed with the area radiation monitor on A/C power and on battery backup power.
| |
| * Timer Accuracy Expose the remote afterloader source inside the treatment room with the door closed.
| |
| Immediately start a stopwatch when the control console indicates that the source is exposed. Stop the stopwatch when the control console indicates that the source is retracted. Compare the stopwatch measured time to the irradiation time indicated on the control console. Verify that the comparison is within 1 percent.
| |
| * Clock Date and Time in the Computer for the Remote Afterloader Verify clock date and time printed on the control console documentation of the pretreatment checks against the actual date and time. The date must be exact, and the time may be within 1 hour.
| |
| * Decayed Source Activity in the Computer for the Remote Afterloader Verify the source activity (or decay factor) displayed on the remote afterloader control console matches to within 0.5 percent of the manufacturers provided decay table for todays date.
| |
| If the results of the above checks indicate the malfunction of any system, the control console shall be locked in the off position, as required by Title 10 of the Code of Federal Regulations (10 CFR) 35.643(e), and not used except as may be necessary to repair, replace, or check the malfunctioning system.
| |
| H-2
| |
| | |
| In addition, consideration will be given to testing the following before the first use of the remote afterloader unit on a given day:
| |
| * Treatment Interrupt Button Press the Interrupt button on the control console while source is exposed. Verify that the source retracts immediately, and the control console indicates an alarm. A physical survey of the unit will be performed to ensure that the source has fully retracted to the shielded safe prior to closing the door and clearing all alarms.
| |
| * Emergency Off Button Press the Stop button on the control console while the source is exposed. Verify that the source retracts immediately, and the control console indicates an alarm. Repeat the test for all wall-mounted Stop buttons. A physical survey of the unit will be performed to ensure that the source has fully retracted to the shielded safe prior to closing the door and clearing all alarms.
| |
| * Dual Use Switch An X-ray unit is also used in the remote afterloader treatment room, and a selector switch to limit operation to only one unit at a time is installed.
| |
| With the key switch on the wall set to X-ray, attempt to expose the remote afterloader source. Verify that the area radiation monitor and the control console source indicator lights do not illuminate; indicating that the source did not expose. Switch the key to remote afterloader. Expose the remote afterloader source and confirm that the area radiation monitor illuminates. With the remote afterloader source still exposed, switch the key back to X-ray, and confirm that the remote afterloader source retracts and the area radiation monitor flashes green. A physical survey of the unit will be performed to ensure that the source has fully retracted to the shielded safe prior to closing the door and clearing all alarms.
| |
| * Misconnected or Missing Transfer Tube and/or Applicator Misconnect a transfer tube to the remote afterloader. This may either be performed by connecting the transfer tube to the wrong channel or by not fully inserting the transfer tube into the correct channel. Attempt to expose the remote afterloader source and verify that the source does not expose as indicated by the area radiation monitor.
| |
| Additionally, verify that an error is indicated on the control console for the misconnection.
| |
| Repeat the test with an applicator intentionally misconnected to a transfer tube that is correctly inserted into the remote afterloader.
| |
| * Mechanical Integrity of Applicators, Transfer Tubes, Connectors Perform a visual inspection of all applicators, transfer tubes, and connectors to be used for patient treatments that day. Check for any potential mechanical defects. Replace if a defect is noted.
| |
| H-3
| |
| * Position of Remote Afterloader Within the Treatment Room For some remote afterloader units located within minimally shielded rooms, the location of use within the room may have been specified in the application to ensure that the regulatory limits in 10 CFR 20.1301 will not be exceeded. If this is the case, verify that the positioning of the remote afterloader unit within the treatment room is in accordance with the commitments made in the application.
| |
| References and Resources:
| |
| AAPM Report No. 41, Remote Afterloading Technology (Remote Afterloading Technology Task Group No. 41), 1993 H-4
| |
| | |
| APPENDIX I RADIATION SAFETY OFFICER DUTIES, RESPONSIBILITES, AND DELEGATION
| |
| | |
| Radiation Safety Officer Duties, Responsibilities, and Delegation Typical Duties and Responsibilities of the Radiation Safety Officer The radiation safety officers (RSOs) duties and responsibilities include ensuring radiological safety, security, and compliance with both U.S. Nuclear Regulatory Commission (NRC) and U.S. Department of Transportation (DOT) regulations and the conditions of the license.
| |
| Typically, these duties and responsibilities include ensuring the following:
| |
| * Stop activities involving licensed material that the radiation safety officer (RSO) considers unsafe.
| |
| * Ensure that radiation exposures are kept as low as is reasonably achievable (ALARA).
| |
| * Oversee all activities involving radioactive material, including monitoring and surveying all areas in which radioactive material is used or stored.
| |
| * Ensure that up-to-date operating, emergency, and security procedures are developed, implemented, maintained, and distributed, as appropriate.
| |
| * An inventory of all radioactive material is maintained, as required. Ensure that possession, use, and storage of licensed material are consistent with the limitations in the license, the regulations, the Sealed Source and Device (SSD) registration certificate(s), and the manufacturers recommendations and instructions.
| |
| * The receipt, opening, and delivery of all packages of radioactive material arriving at the facility are overseen and coordinated. Also, radiation surveys of all shipments arriving or leaving the facility, as well as packaging and labeling of radioactive material leaving the facility are overseen.
| |
| * Ensure individuals installing, relocating, maintaining, adjusting, or repairing devices containing sealed sources are trained and authorized by an NRC or Agreement State license.
| |
| * Ensure personnel training is conducted and is commensurate with the individuals duties regarding licensed material.
| |
| * Ensure documentation is maintained to demonstrate that individuals are not likely to receive, in one year, a radiation dose in excess of 10 percent of the allowable limits or that personnel monitoring devices are provided.
| |
| * When necessary, ensure personnel monitoring devices are used and exchanged at the proper intervals, and personnel radiation exposure and bioassay records are monitored, reviewed, and maintained. Individuals are notified when radiation exposures are approaching established limits and appropriate corrective actions are taken.
| |
| * Properly secure radioactive material from unauthorized use or access.
| |
| I-1
| |
| * If the licensee possesses an aggregated Category 1 or Category 2 quantity of radioactive material, support development and implementation of a security program for radioactive material in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.
| |
| * Ensure documentation is maintained to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual member of the public likely to receive the highest dose from the licensed operation does not exceed the annual limit in 10 CFR 20.1301, Dose limits for individual members of the public.
| |
| * Notify proper authorities of incidents, such as damage to or malfunction of sources/devices, excess breakthrough values for Mo-99/Tc-99m or Sr-82/ Rb-82 generators, loss of licensed material, fire, theft.
| |
| * Serve as a point of contact for the NRCs and licensees management during routine operations, emergencies, or incidents.
| |
| * Medical events and precursor events are investigated and reported to the NRC, cause(s) and appropriate corrective action(s) are identified, and timely corrective action(s) are taken.
| |
| * Perform and document periodic audits, at least annually, of the radiation safety program to ensure that the licensee is complying with all applicable NRC regulations and the terms and conditions of the license.
| |
| * Ensure that the results of audits, identification of deficiencies, and recommendations for change are documented (and maintained for 3 years after the record is made) and provided to management for review; ensure that prompt action is taken to correct deficiencies.
| |
| * Ensure that the audit results and corrective actions are communicated to all personnel who use licensed material.
| |
| * When the licensee identifies violation(s) of regulations or license conditions or program weaknesses, ensure corrective action(s) are developed, implemented, and documented.
| |
| * Ensure that all incidents, accidents, and personnel exposure to radiation in excess of 10 CFR Part 20 and 10 CFR Part 30 limits are investigated, their cause(s) are identified, appropriate corrective action(s) are implemented, and reports are submitted to NRC and other appropriate authorities, if required, within the required time limits.
| |
| * Ensure that licensed material is transported, or offered for transport, in accordance with all applicable NRC and DOT requirements.
| |
| * Ensure that radioactive waste is disposed of in accordance with NRC regulations and license conditions. Supervise and coordinate the radioactive waste disposal program, including effluent monitoring and recordkeeping on waste storage and disposal records.
| |
| Oversee the storage of radioactive material not in current use, including waste.
| |
| * Perform/oversee the inventory and leak testing on all sealed sources.
| |
| I-2
| |
| * Oversee the calibration of radiation survey instruments.
| |
| * Supervise decontamination operations.
| |
| * Maintain up-to-date copies of NRC regulations, the license, revised licensee procedures, and ensure that the license is amended whenever there are changes in licensed activities, responsible individuals, or information or commitments provided to the NRC during the licensing process.
| |
| * Submit amendment and renewal requests in a timely manner.
| |
| * Assign tasks and duties to an ARSO, if applicable.
| |
| I-3
| |
| | |
| Model Delegation of Authority Memo To: (Name of Radiation Safety Officer)
| |
| From: (Name of Chief Executive Officer or other ranking official)
| |
| | |
| ==Subject:==
| |
| Delegation of Authority You, _______________________________, have been appointed Radiation Safety Officer and are responsible for ensuring the safe and secure use of radiation and radioactive material. You are responsible for managing the radiation protection program; identifying radiation protection problems; initiating, recommending, or providing corrective actions; verifying implementation of corrective actions; stopping unsafe activities; and ensuring compliance with regulations. You are hereby delegated the authority necessary to meet those responsibilities, including prohibiting the use of byproduct material by employees who do not meet the necessary requirements and shutting down operations when justified to maintain radiation safety. You are required to notify management if staff does not cooperate and does not address radiation safety issues. In addition, you are free to raise issues with the U.S. Nuclear Regulatory Commission at any time. It is estimated that you will spend _____ hours per week conducting radiation protection activities.
| |
| Signature of Management Representative Date I accept the above responsibilities, Signature of Radiation Safety Officer Date cc: Names of affected department heads I-4
| |
| | |
| Model Appointment of ARSO Memo To: Associate Radiation Safety Officer From: Chief Executive Officer Radiation Safety Officer
| |
| | |
| ==Subject:==
| |
| Appointment of ARSO You, _______________________________, have been appointed an Associate Radiation Safety Officer. The Radiation Safety Officer, with written agreement from management, will assign specific oversight duties and tasks to you. These duties and tasks are restricted to the types of use for which you are listed on our license.
| |
| You are free to raise issues with the Nuclear Regulatory Commission at any time. It is estimated that you will spend _____ hours per week conducting Associate Radiation Safety Officer duties and tasks.
| |
| You will report to the Radiation Safety Officer, who retains responsibility for oversight of the entire radiation safety program.
| |
| Signature of Management Representative Date Signature of Radiation Safety Officer Date cc: Names of affected department heads I-5
| |
| | |
| APPENDIX J MODEL TRAINING PROGRAM
| |
| | |
| Model Training Program Model procedures for describing training programs appear below. These models provide examples of topics to be chosen for training, based on the experience, duties, and previous training of trainees. The topics chosen will depend on the purpose of the training, the audience, and background knowledge of the audience. These models also may be useful to identify topics for annual refresher training. Refresher training should include topics with which the individual is not involved frequently and topics that require reaffirmation. Topics for refresher training need not include review of procedures or basic knowledge that the trainee routinely uses.
| |
| Applicants may either adopt these model procedures or develop an alternative program to meet U.S. Nuclear Regulatory Commission (NRC) requirements. Guidance on requirements for training and experience for authorized medical physicists (AMP), ophthalmic physicists (OP), and authorized users (AU) for medical use who engage in certain specialized practices is also included.
| |
| Model Training Program for Medical and Nonmedical Uses of Radionuclides, Sealed Sources, and Medical Devices Containing Sealed Sources Personnel will receive instruction before assuming duties with, or in the vicinity of, radioactive materials, during annual refresher training, and whenever there is a significant change in duties, regulations, terms of the license, or type of radioactive material or therapy device used.
| |
| Records of worker training will be maintained for 3 years. The training records will include the date of the instruction or training, a brief outline of subjects covered, and the name(s) of the attendee(s) and instructor(s).
| |
| Training for Individuals Involved in the Medical Use of Byproduct Material Training for professional staff [e.g., AU, AMP, ophthalmic physicist, authorized nuclear pharmacist, radiation safety officer (RSO), associate radiation safety officer (ARSO), nurse, dosimetrist, technologist, therapist] will contain the following elements for those who provide or are involved in the care of patients during diagnostic or therapeutic procedures, as commensurate with their duties:
| |
| * Basic radiation biology (e.g., interaction of ionizing radiation with cells and tissues).
| |
| * Basic radiation protection to include concepts of time, distance, and shielding.
| |
| * Concept of maintaining exposure as low as is reasonably achievable (ALARA).
| |
| (10 CFR 20.1101)
| |
| * Risk estimates, including comparison with other health risks.
| |
| * Posting requirements. (10 CFR 20.1902)
| |
| * Proper use of personnel dosimetry (when applicable).
| |
| * Access control procedures. (10 CFR 20.1601, 10 CFR 20.1802)
| |
| * Proper use of radiation shielding, if used.
| |
| J-1
| |
| * Patient release procedures (10 CFR 35.75)
| |
| * Instruction in procedures for notification of the RSO and AU, when responding to patient emergencies or death, to ensure that radiation protection issues are identified and addressed in a timely manner. The intent of these procedures should in no way interfere with or be in lieu of appropriate patient care. (10 CFR 19.12, 10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610)
| |
| * Occupational dose limits and their significance. (10 CFR 20.1201)
| |
| * Dose limits to the embryo/fetus, including instruction on declaration of pregnancy.
| |
| (10 CFR 20.1208)
| |
| * Workers right to be informed of occupational radiation exposure. (10 CFR 19.13)
| |
| * Each individuals obligation to report unsafe conditions to the RSO. (10 CFR 19.12)
| |
| * Workers right to contact the regulatory agency with concerns. (10 CFR Part 19)
| |
| * Applicable regulations, license conditions, information notices, bulletins, etc.
| |
| (10 CFR 19.12)
| |
| * Where copies of the applicable regulations, the NRC license, and its application are posted or made available for examination. (10 CFR 19.11)
| |
| * Proper recordkeeping required by NRC regulations. (10 CFR 19.12)
| |
| * Appropriate surveys to be conducted. (10 CFR 20.1501)
| |
| * Proper calibration of required survey instruments. (10 CFR 20.1501)
| |
| * Emergency procedures.
| |
| * Decontamination and release of facilities and equipment. (10 CFR 20, Subpart E, 10 CFR 30.36)
| |
| * Dose to individual members of the public. (10 CFR 20.1301)
| |
| * Licensees operating procedures (e.g., survey requirements, instrument calibration, waste management, sealed-source leak testing). (10 CFR 35.27)
| |
| * Hazardous Materials (HAZMAT) training for preparing shipments of radioactive material.
| |
| (49 CFR Part 172)
| |
| * Security (10 CFR 37) for Category 1 or Category 2 sources or aggregated quantities of material J-2
| |
| | |
| Training for Individuals Involved in Nonmedical Use of Byproduct Material Training for staff working with byproduct material for nonmedical uses or animals containing byproduct material will include, as appropriate, the elements that are listed above for medical uses. All training should be commensurate with the individuals duties.
| |
| Training for Staff Directly Involved in Administration to or Care of Patients Administered Byproduct Material for which a Written Directive Is Required (Including Greater-than-30 microcuries of I-131); Training for Staff Involved in Therapeutic Treatment Planning In addition to the topics identified above, the following topics will be included in instruction for staff involved in the therapy treatment of patients (e.g., nursing, RSO, AMP, AU, and dosimetrist), commensurate with their duties:
| |
| * leak testing of sealed sources (10 CFR 35.67 and 10 CFR 35.1000, as applicable)
| |
| * emergency procedures (including emergency response drills) (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| * operating instructions (10 CFR 35.27, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| * computerized treatment planning system (10 CFR 35.657, 10 CFR 35.1000, as applicable)
| |
| * dosimetry protocol (10 CFR 35.630, 10 CFR 35.1000 as applicable)
| |
| * detailed pretreatment quality assurance checks (10 CFR 35.27, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| * safe handling (when applicable) of the patients dishes, linens, excretions (saliva, urine, feces), and surgical dressings that are potentially contaminated or that may contain radioactive sources (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.1000, as applicable)
| |
| * patient control procedures (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| * visitor control procedures, such as visitors stay times and safe lines in radiation control areas (patients room) (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| * licensees written directive (WD) Procedures, to ensure that each administration is in accordance with the WD, patient identity is verified, and where applicable, attention is paid to correct positioning of sources, applicators, and collimators to ensure that treatment is to the correct site (10 CFR 35.40, 10 CFR 35.41, 10 CFR 35.1000 as applicable)
| |
| * proper use of safety devices and shielding to include safe handling and shielding of dislodged sources (or, in the case of remote afterloaders, disconnected sources)
| |
| (10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000, as applicable)
| |
| J-3
| |
| * size and appearance of different types of sources and applicators (10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000 as applicable)
| |
| * previous incidents, events, and/or accidents for remote afterloaders, teletherapy units, and GSR units
| |
| * licensee operational safety training (to new staff and annually to all individuals operating the unit) that is device model-specific and includes (10 CFR 35.610, 10 CFR 35.1000, as applicable) vendor training (prior to first use of a new unit or after manufacturer upgrades that affect operation and safety of the unit) design, use, and function of the device, including safety systems and interpretation of various error codes and conditions, displays, indicators, and alarms hands-on training in actual operation of the device under the direct supervision of an experienced user, including dry runs (using dummy sources) of routine patient set-up and treatment and implementation of the licensees emergency procedures a method, such as practical examinations, to determine each trainees competency to use the device for each type of proposed use Additional Training for Authorized Medical Physicists and Ophthalmic Physicists Applicants for licenses to include AMPs and OPs who plan to engage in certain tasks requiring special training should ensure that the AMP is trained in the activities specific to the different types of uses listed in Title 10 of the Code of Federal Regulations (10 CFR) 35.51(b)(1) and 10 CFR 35.433 and that the OP is trained in the activities specific to 10 CFR 35.433. Note, for example, that additional training is necessary for AMP planning tasks such as remote afterloader therapy, teletherapy, GSR therapy, the use of the treatment planning system that applicants contemplate using, as well as the calculation of activity of strontium-90 sources used for ophthalmic treatments and assisting the licensee in developing, implementing and maintaining written procedures to provide high confidence that the administration is in accordance with the WD (10 CFR 35.433). Medical physicists must also have training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system, as required in 10 CFR 35.51(c).
| |
| Additional Training for Authorized Users for Medical Uses of Byproduct Materials for Which a Written Directive Is Required Applicants for licenses should carefully consider the type of radiation therapy that is contemplated. In addition to the training and experience requirements of 10 CFR 35.390, 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.690 and 10 CFR 35.1000, as applicable, attention should be focused on the additional training and experience necessary for treatment planning, quality control systems, and clinical procedures.
| |
| J-4
| |
| | |
| Refer to the training and experience requirements associated with specialized uses discussed in 10 CFR 35.390, 35.490, 35.491, 35.690, and 10 CFR 35.1000, as applicable.
| |
| Training for Ancillary Staff For the purposes of this section, ancillary staff includes personnel engaged in janitorial and/or housekeeping, dietary, laboratory, security, and life-safety services. The training program for ancillary staff performing duties that are likely to result in a dose in excess of 1 millisievert
| |
| [100 millirem] will include instruction commensurate with potential radiological health protection problems present in the work place. Alternatively, prohibitions on entry into controlled or restricted areas may be applied to ancillary personnel unless escorted by trained personnel.
| |
| Topics of instruction will include the following, as commensurate with the individuals duties:
| |
| * storage, transfer, or use of radiation and/or radioactive material (10 CFR 19.12)
| |
| * potential biological effects associated with exposure to radiation and/or radioactive material, precautions or procedures to minimize exposure, and the purposes and functions of protective devices (e.g., basic radiation protection concepts of time, distance, and shielding) (10 CFR 19.12)
| |
| * the applicable provisions of NRC regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material (e.g., posting and labeling of radioactive material) (10 CFR 19.12)
| |
| * responsibility to report promptly to the licensee any condition that may lead to or cause a violation of NRC regulations and licenses or unnecessary exposure to radiation and/or radioactive material (e.g., notification of the RSO regarding radiation protection issues)
| |
| (10 CFR 19.12)
| |
| * appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material (10 CFR 19.12)
| |
| * radiation exposure reports that workers may request, as per 10 CFR 19.13, Notifications and reports to individuals (10 CFR 19.12)
| |
| References and Resources:
| |
| * National Council on Radiation Protection and Measurements (NCRP) Report No. 105, Radiation Protection for Medical and Allied Health Personnel, 1989.
| |
| * NCRP Report No. 134, Operational Radiation Safety Training, October 2000.
| |
| * International Commission on Radiological Protection (ICRP) Report No. 75, General Principles for the Radiation Protection of Workers, 1997.
| |
| J-5
| |
| | |
| APPENDIX K GENERAL RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND SURVEY INSTRUMENT CALIBRATION PROGRAM
| |
| | |
| General Radiation Monitoring Instrument Specifications and Survey Instrument Calibration Program The following provides acceptable guidelines for radiation survey instrument calibrations.
| |
| Licensees may either adopt these guidelines or develop their own to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 20 and 10 CFR 35.61.
| |
| Radiation Monitoring Instrument Specifications The specifications in Table K-1 may help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility(ies). Except where indicated by an asterisk below, the information in Table K-1 was extracted from The Health Physics and Radiological Health Handbook, Revised Edition, 1992. Additional information about instruments and their uses also can be found in NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM), Chapter 6 and Appendix H.
| |
| Table K-1. Typical Survey Instruments Portable Instruments Used for Contamination and Ambient Radiation Surveys Detectors Radiation Energy Range Efficiency Exposure Rate Meters Gamma, X-ray microroentgen N/A
| |
| (µR)-roentgen (R)
| |
| Count Rate Meters Geiger-Mueller (GM) Alpha All energies (dependent Moderate on window thickness)
| |
| Beta All energies (dependent Moderate on window thickness)
| |
| Gamma All energies < 1%
| |
| NaI Scintillator Gamma All energies (dependent Moderate on crystal thickness)
| |
| Plastic Scintillator Beta C-14 or higher (dependent Moderate on window thickness)
| |
| Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples Detectors Radiation Energy Range Efficiency Liquid Scintillation Counter* Alpha All energies High Beta All energies High Gamma Moderate Gamma Counter [sodium Gamma All energies High iodide (NaI)]*
| |
| Gas Proportional Alpha All energies High Beta All energies Moderate Gamma All energies < 1%
| |
| Equipment Selection Licensees should possess and use calibrated and operable radiation detection and measurement instruments that are sufficiently sensitive to detect and measure the type and energy of the radiation used. Applicants should determine the number and type of instruments necessary to support licensed activities by considering the scope of activities that will be performed at their facilities. Licensees typically possess one or more portable or handheld K-1
| |
| | |
| instruments to monitor radiological conditions, detect contamination, and perform package-preparation and receipt surveys. Portable instrumentation includes ionization chambers as well as other instrumentation, such as count-rate meters that are supported by a variety of handheld probes or detectors that can be used to detect various types of radiation. These include Geiger-Mueller (GM) detectors, sodium iodide [NaI(Tl)] scintillation detectors, and plastic scintillation detectors. Additionally, licensees may possess stationary or fixed instrumentation, such as well-type scintillation counters (LSCs), area monitors, stack monitors, or continuous air monitors.
| |
| When deciding which types of instruments are appropriate for the intended use, licensees may wish to consult with the instrumentation or equipment manufacturer or vendor to obtain specifications. The instrument should be capable of detecting the type of radiation (e.g., beta or gamma) and be sensitive to the energy or energy range of the radiation to be measured (e.g., keV, MeV). The characteristics of the instrument, including principles of operation and expected efficiency for the type and energy of the radiation being measured, should be understood by the licensee before use.
| |
| Low-energy beta emitters, such as carbon-14 and sulfur-35, are difficult to detect with GM probes. The detection efficiency generally is about 2 percent for low-energy beta emitters. The proper surveying method (e.g., speed and height above surface) is important to perform adequate surveys.
| |
| Medium- to high-energy beta emitters, such as phosphorus-32 and calcium-45, can be detected with a pancake GM. The efficiency ranges from 15 percent to 40 percent, depending on the beta energy.
| |
| Low-energy gamma emitters, such as iodine-125, can be detected with a sodium iodide (NaI) probe or a thin window GM probe (pancake or thin end-window). If the NaI probe possesses a thin window and thin crystal, the detection efficiency is approximately 20 percent. If a pancake or thin end-window GM probe is used, the detection efficiency is significantly lower, and care should be taken to ensure that the GM probe is capable of detecting the trigger levels.
| |
| Medium- to high-energy gamma emitters, such as iodine-131 (I-131), can be detected with either GM or NaI probes, depending on the required sensitivity. In general, the sensitivity of GM probes is much lower than for NaI probes.
| |
| Model Radiation Survey Instrument Calibration Program Training Before independently calibrating radiation survey instruments, an individual shall have sufficient training and experience to perform independent radiation survey instrument calibrations in accordance with 10 CFR 35.61.
| |
| * Classroom training may be in the form of lecture, video, computer-based, or self-study and will cover the following subject areas:
| |
| principles and practices of radiation protection radioactivity measurements, monitoring techniques, and the use of radiation detection instruments K-2
| |
| | |
| mathematics related to the use and measurement of radioactivity biological effects of radiation
| |
| * On-the-job training will be considered complete if the individual has completed both of the following:
| |
| observing authorized personnel performing radiation survey instrument calibration conducting radiation survey meter calibrations under the supervision and in the physical presence of an individual authorized to perform calibrations Facilities and Equipment for Calibration of Dose and Dose Rate Measuring Instruments To reduce doses received by individuals not calibrating radiation survey instruments, calibrations will be conducted in an isolated area of the facility or at times when no one else is present.
| |
| The calibration source should be well-collimated, and the calibration area should be designed to minimize scatter of radiation, which could affect the calibration process.
| |
| The calibration area should be appropriately controlled so that persons entering the area will be aware if a radiation source is in use.
| |
| Evaluate posting of the calibration area with appropriate radiation warning signs, as required by Subpart J of 10 CFR 20, Precautionary Procedures.
| |
| Individuals conducting radiation survey instrument calibrations will wear assigned dosimetry.
| |
| Individuals conducting calibrations will use a calibrated and operable radiation survey instrument to ensure that unexpected changes in exposure rates are identified and corrected.
| |
| Frequency of Calibration of Radiation Measurement Instruments and Equipment A licensee committed to a routine or emergency radiation survey program should perform an acceptable calibration of all radiation measurement instruments and equipment at the frequency specified in U.S. Nuclear Regulatory Commission (NRC) regulations, annually, or at the frequency recommended by the manufacturer, whichever period is shorter.
| |
| Special calibrations should be performed at any time there is reason to believe that the operating characteristics of a radiation measurement instrument have changed, by repair or alteration, or whenever system performance is observed to change significantly.
| |
| (Battery changes are not considered as a repair or alteration.)
| |
| Routine maintenance of radiation measurement instruments should be performed as recommended by the manufacturer.
| |
| Primary or secondary standard instruments used to calibrate radiation measurement instruments should be inspected frequently for consistency of performance.
| |
| K-3
| |
| | |
| Calibration Sources for Dose and Dose Rate Measuring Instruments Radiation survey instruments will be calibrated with a radioactive source in accordance with 10 CFR 35.61. Electronic calibrations alone are not acceptable. Radioactive sealed sources will be used for calibrating dose and dose rate measuring radiation survey instruments; these sources will have the following characteristics:
| |
| * The sources should approximate a point source.
| |
| * Calibration fields from gamma sources should be known with an accuracy when compared to secondary or primary national standards of 5 percent for dose rates greater than or equal to 1.0 microGray/h (µGy)/h [0.1 millirad (mrad)/h] and 10 percent for dose rates less than 1.0 µGy/h [0.1 mrad/h].
| |
| * The sources should contain a radionuclide that emits radiation of identical or similar type and energy [e.g., cesium-137 (Cs-137), cobalt-60] as the environment in which the calibrated device will be used.
| |
| * The sources should be strong enough to give an exposure rate of at least 7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters
| |
| [e.g., 3.1 gigabecquerels (85 millicuries) of Cs-137 or 780 megabecquerels (21 millicuries) of cobalt-60].
| |
| Note: Inverse square and radioactive decay laws should be used to correct for changes in exposure rate due to changes in distance or source decay.
| |
| Calibration of Dose or Dose Rate Measuring Instruments There are three kinds of scales frequently used on dose or dose-rate survey meters. These are calibrated as follows:
| |
| * Linear readout instruments with a single calibration control for all scales should be adjusted at the point recommended by the manufacturer or at a point within the normal range of use. Instruments with calibration controls for each scale should be adjusted on each scale. After adjustment, check the response of the instrument at approximately 20 percent and 80 percent of full scale. Instrument readings shall be within +/- x (noted below) of the conventionally true value for the following ranges:
| |
| Background to 10 µGy/h [1.0 mrad/h]; +/-x = +/-30%
| |
| 10 µGy/h [1.0 mrad/h] to 1.0 milliGray (mGy)/h [100 mrad/h]; +/-x = +/-20%
| |
| 1.0 mGy/h [100 mrad/h] to 10 Gray/h [1,000 Rad/h]; +/-x = +/-10%
| |
| * Logarithmic readout instruments, which commonly have a single readout scale spanning several decades, normally have two or more adjustments. Adjust the instrument for each scale according to site specifications or the manufacturers specifications. After adjustment, check the calibration at a minimum of one point on each decade. Instrument readings should have a maximum deviation from the conventionally true value as described for linear readout instruments.
| |
| K-4
| |
| * Digital readout instruments should be calibrated the same as linear readout instruments. Digital readout instruments without scale switching for indicating exposure rates shall be checked at two points on each decade.
| |
| * Integrating instruments shall be checked at two dose rates at approximately 20 percent and 80 percent of the stated dose rate range. Instrument readings shall be within the same +/- x of the conventionally true value as described for linear readout instruments.
| |
| Note: Readings above 2.58 x 104 coulomb/kilogram/hour [1R/h] need not be calibrated, unless the licensee expects to make measurements at higher dose rates; regardless, such scales may be checked for operation and response to radiation.
| |
| Note: Instruments used to monitor higher energies are most easily calibrated in known radiation fields produced by sources of gamma rays of approximately the same energies as those to be measured.
| |
| Calibration of Surface Contamination Measurement Instruments Instruments used to detect surface contamination usually consist of a count-rate meter and a detector that is appropriate for the type of radiation(s) being measured.
| |
| The efficiency of radiation survey meters must be determined by using radiation sources with similar energies and types of radiation that users of the radiation survey instrument intend to measure.
| |
| If each scale has a calibration potentiometer, the reading should be adjusted to respond to the calibration source at approximately 80 percent of full scale, and the response at approximately 20 percent of full scale should be observed. If only one calibration potentiometer is available, the response should be adjusted at mid-scale on one of the scales, and response on the other scales should be observed. The instrument efficiency factor [e.g., counts per minute (cpm)/disintegrations per minute (dpm)] thus obtained should have a signal-to-noise ratio, including the compilation of source and instrument uncertainties, of +/-x for the following ranges:
| |
| * alpha measurement 0.01 becquerel (Bq)/square centimeter (cm2) to 2.0 Bq/cm2 [60 to 12,000 dpm/100 cm2];
| |
| +/-x = +/-20%
| |
| 2.0 Bq/cm2 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2]; +/-x = +/-10%
| |
| * beta measurement 0.05 Bq/cm2 to 2.0 Bq/cm2 [300 to 12,000 dpm/100 cm2]; +/-x = +/-20%
| |
| 2.0 Bq/cm2 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2]; +/-x = +/-10%
| |
| Calibration of Analytical Instruments Such As Liquid Scintillation Counters, Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers Analytical instruments used to determine radioactivity in a sample may be specialized equipment according to the type of samples to be analyzed and the types and quantities of radioactivity to be measured. Typically, the sample sizes and activities are very small, and can be difficult to measure. Sample collection and preparation may differ for the various analytical K-5
| |
| | |
| instruments, so manufacturer procedures and industry standard practices should be followed.
| |
| Such analytical instruments should be calibrated in accordance with the manufacturers instructions. Analytical instruments typically require routine maintenance and verification procedures to ensure that they are operating properly when used.
| |
| As with calibration of other radiation measurement instruments, calibration of analytical instruments use a radioactive sealed source(s). These should be suitable for the geometry of the sample(s) to be analyzed. The calibration source(s) should have a known activity(ies) and be of similar type and energy as the radioactive materials to be analyzed. The analysis should be sensitive enough to detect the lowest levels of radioactivity desired. Correction of results for quenching, self-absorption, and other factors may be required, depending on the analytical instrument, the samples type, and other environmental conditions.
| |
| Model procedures for the calibration of LSC, well-type LSC, gas-flow proportional counters, and single or multi-channel analyzers are not provided in this document. For compliance with 10 CFR 20.1501(c), users should refer to manufacturers instructions and/or nationally recognized standards for instrument calibration information. In general, manufacturers instructions typically specify that for these types of instruments, calibration is expected to produce readings within plus or minus 20 percent of the actual values over the range of the instrument. The minimum detectable activity (MDA) for instruments used should be a fraction (10 to 50 percent) of the criteria that is to be met.
| |
| Calibration Records A record must be made of each radiation survey instrument calibration and retained for 3 years after each record is made (10 CFR 20.2103(a) and 10 CFR 35.2061).
| |
| Calibration records for all radiation survey instruments should indicate the procedure used and the results of the calibration. The records should include the following:
| |
| * the owner or user of the radiation survey instrument
| |
| * a description of the radiation survey instrument that includes the manufacturers name, model number, serial number, and type of detector
| |
| * a description of the calibration source, including the exposure rate at a specified distance or activity on a specified date
| |
| * for each calibration point, the calculated exposure rate or count rate, the indicated exposure rate or count rate, the deduced correction factor (the calculated exposure rate or count rate divided by the indicated exposure rate or count rate), and the scale selected on the radiation survey instrument
| |
| * the efficiency of the radiation survey instrument, for each radionuclide the instrument will be used to measure (if efficiency is not calculated before each use) the exposure reading indicated with the radiation survey instrument in the battery check mode (if available on the instrument)
| |
| * for radiation survey instruments with external detectors, the angle between the radiation flux field and the detector (i.e., parallel or perpendicular)
| |
| K-6
| |
| * for radiation survey instruments with internal detectors, the angle between the radiation flux field and a specified surface of the instrument
| |
| * for radiation detectors with removable shielding, an indication of whether the shielding was in place or removed during the calibration procedure
| |
| * the exposure rate or count rate from a check source, if used
| |
| * the name and signature of the individual who performed the calibration and the date on which the calibration was performed The following information will be attached to the radiation survey instrument as a calibration sticker or tag:
| |
| * for dose and dose rate measuring instruments, the source radionuclide that was used to calibrate the instrument (with correction factors) for each scale
| |
| * for surface contamination measurement instruments, the efficiency of the radiation survey instrument, for each radionuclide the instrument will be used to measure (if efficiency is not calculated before each use)
| |
| * the proper deflection in the battery check mode, unless this is clearly indicated on the instrument
| |
| * special use conditions (e.g., an indication that a scale or decade was checked only for function but not calibrated)
| |
| * for each scale or decade not calibrated, an indication that the scale or decade was checked only for function but not calibrated
| |
| * the date of calibration and the next calibration due date
| |
| * the apparent exposure rate or count rate from the check source, if used
| |
| * sensitivity of counting system Follow the procedures in Appendix Q of this NUREG to determine MDA, if there is a question concerning the ability to measure small quantities of radioactivity.
| |
| Calculating the Efficiency of Sodium Iodide (Thallium Doped) Uptake Probes Sodium iodide (thallium doped) uptake probes are commonly used for bioassays of personnel administering I-131 radionuclides in the form of liquid NaI. Refer to 10 CFR Part 20, Appendix B, Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage for the ALIs and DACs for occupational exposure to radionuclides. Convert count rates (e.g., in cpm) to units of activity (dpm, Ci) when performing bioassays to determine thyroid burdens of radioiodine.
| |
| K-7
| |
| | |
| Use the following procedure to calibrate the probe for uptake measurements:
| |
| * Check the instruments counting efficiency using either a standard source of the same radionuclide as the source being tested or one with similar energy characteristics.
| |
| Accuracy of standards will be within +/- 5% of the stated value and traceable to a primary radiation standard such as those maintained by the National Institute of Standards and Technology (NIST).
| |
| * Calculate the efficiency of the instrument.
| |
| For example:
| |
| [( ) ( )]
| |
| =
| |
| ( )
| |
| where: Effa = efficiency 1, cpm = counts per minute, std = standard, and bkg = background.
| |
| Operational and calibration checks, using a dedicated check source, should be conducted each day the instrument is used.
| |
| The date of the efficiency test should be attached to the instrument as a calibration sticker or tag, and the following information should be included:
| |
| * the due date of the next efficiency test
| |
| * results of efficiency calculation(s)
| |
| Calculating the Gamma Well Efficiency of Counting Equipment Gamma well counting equipment is often used for assaying the wipe testing of packages, sealed sources, and areas where unsealed byproduct material is prepared, administered, or stored. Converting cpm to dpm using smear wipes is required when dealing with radiation surveys of sealed and unsealed radioactive materials. Calculate the efficiency of all instruments used for assaying wipe tests on an annual basis, before first use, and/or after repair, using the following procedure:
| |
| * Check the instruments counting efficiency, using either a standard source of the same radionuclide as the source being tested or one with similar energy characteristics.
| |
| Accuracy of standards will be within +/- 5% of the stated value and traceable to a primary radiation standard such as those maintained by NIST.
| |
| * Calculate the efficiency of the instrument.
| |
| 1 The absolute efficiency is dependent on the counting geometry. Applicants may elect to use the intrinsic efficiency, which does not include the solid angle subtended by the detector and is much less dependent on the counting geometry. Intrinsic efficiency is defined as the ratio of the number of pulses recorded by the detector to the number of gamma rays hitting the detector, while absolute efficiency is defined as the number of counts recorded by the detector to the number of gamma rays emitted by the source in all directions.
| |
| K-8
| |
| | |
| For example:
| |
| [( ) ( )]
| |
| =
| |
| ( )
| |
| where Eff = efficiency, in cpm/microcurie, cpm = counts per minute, std = standard, and bkg = background.
| |
| Operational and calibration checks, using a dedicated check source, should be conducted each day the instrument is used.
| |
| The date of the efficiency test should be attached to the instrument as a calibration sticker or tag and the following information should be included:
| |
| * the due date of the next efficiency test
| |
| * results of efficiency calculation(s)
| |
| | |
| ==References:==
| |
| * Detailed information about portable radiation survey instrument calibration may be obtained by referring to American National Standards Institute (ANSI) N323AB-2013, American National Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments, 2013. Copies may be obtained from the ANSI eStandards Store.
| |
| * National Council on Radiation Protection and Measurements (NCRP) Report No. 112, Calibration of Survey Instruments Used in Radiation Protection for the Assessment of Ionizing Radiation Fields and Radioactive Surface Contamination, 1991.
| |
| K-9
| |
| | |
| APPENDIX L MODEL MEDICAL LICENSEE AUDIT
| |
| | |
| Model Medical Licensee Audit Annual Medical Licensee Audit Note: All areas indicated in audit notes may not be applicable to every license and may not need to be addressed during each audit. For example, licensees do not need to address areas that do not apply to the licensees activities, and activities that have not occurred since the last audit need not be reviewed at the next audit. Also, the audit notes may not be complete for nonmedical uses authorized on the license. Licensees should review audit lists in other volumes of the NUREG-1556 series, as appropriate, when completing the audit list that is specific to nonmedical uses.
| |
| Date of this audit: _________________
| |
| Date of last audit: _________________
| |
| Date of next audit: _________________
| |
| Auditor:
| |
| Signature Date Management review:
| |
| Signature Date All references are to Title 10 of the Code of Federal Regulations (10 CFR) Parts unless noted otherwise.
| |
| License (License Condition)
| |
| : 1. License Number.
| |
| : 2. Current Amendment Number.
| |
| : 3. Are all of the tie-down documents on file?
| |
| : 4. Has the Legal Entity having control over licensed activities changed since the last audit?
| |
| Are materials, uses, and locations of use confined to those specifically described in the license?
| |
| Audit History
| |
| : 1. Were previous audits conducted annually [10 CFR 20.1101(c)]?
| |
| : 2. Were records of previous audits maintained [10 CFR 20.2102(b)]?
| |
| : 3. Were any deficiencies identified during previous audit?
| |
| : 4. Were corrective actions taken? (Look for repeated deficiencies.)
| |
| : 5. Any previous problem/deficiency not corrected or repeated?
| |
| : 6. What corrective actions from previous audits, if any, are still in progress?
| |
| L-1
| |
| | |
| Organization and Scope of Program
| |
| : 1. Radiation Safety Officer (RSO)
| |
| : a. If the RSO was changed, was the license amended [10 CFR 35.13(c)]?
| |
| : b. Does the new RSO meet U.S. Nuclear Regulatory Commission (NRC) training requirements [10 CFR 35.50, 10 CFR 35.57, 10 CFR 35.59]?
| |
| : c. If the scope of the program expanded, does the RSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses
| |
| [10 CFR 35.50(e)]?
| |
| : d. Is the RSO fulfilling all duties and responsibilities [10 CFR 35.24(e)]?
| |
| : e. If the scope of the program expanded, have the RSO duties been updated to reflect the scope of the program [10 CFR 35.24(e)]?
| |
| : f. Is the written agreement in place for the new RSO [10 CFR 35.24(b)]?
| |
| : g. Has NRC been notified about a temporary RSO [10 CFR 35.14(b)(2)]?
| |
| : h. Are the written agreements and duties and responsibilities in place for the temporary RSO [10 CFR 35.24 (b), (c), (e), (g), and (h)]?
| |
| : 2. Associate Radiation Safety Officer (ARSO):
| |
| : a. If the ARSO was changed, was the license amended [10 CFR 35.13]?
| |
| : b. Does the new ARSO meet NRC training requirements [10 CFR 35.50, 10 CFR 35.57, 10 CFR 35.59]?
| |
| : c. If the scope of the program expands, did the RSO assign duties for the expanded program and does the ARSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses [10 CFR 35.50(d)]?
| |
| : d. Is the ARSO fulfilling all duties and tasks [10 CFR 35.24]?
| |
| : e. Is the written appointment in place for a new ARSO [10 CFR 35.24(b)]?
| |
| : 3. Multiple places of use? If yes, list locations. [License Condition (L/C)]
| |
| : 4. Are all locations listed on license? (L/C)
| |
| : 5. Were annual audits performed at each location? If no, explain.
| |
| : 6. Describe the scope of the program (e.g., staff size, number of procedures performed)
| |
| : 7. Licensed Material: (L/C)
| |
| : a. Isotope, chemical form, physical form, quantity, and use as authorized?
| |
| L-2
| |
| : b. Does the total amount of radioactive material possessed require financial assurance [10 CFR 30.35(a)]? If so, is financial assurance current based on NUREG-1757, Volume 3?
| |
| : c. Calibration, transmission, and reference sources [10 CFR 35.65]?
| |
| : i. Sealed sources manufactured and distributed by a person licensed pursuant to 10 CFR 32.74, equivalent Agreement State regulations, or redistributed by a licensee authorized to redistribute sealed sources, and sources do not exceed 1.11 gigabecquerel (GBq) [30 millicuries (mCi)] each [10 CFR 35.63(a)(1) and (2)]?
| |
| ii. Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq [15 mCi]
| |
| [10 CFR 35.65(a)(3)]?
| |
| iii. Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq [200 microcuries (µCi)] or 1,000 times the quantities in Appendix B of Part 30 [10 CFR 35.65(a)(4)]?
| |
| iv. Technetium-99m (Tc-99m) in individual amounts as needed
| |
| [10 CFR 35.65(a)(5)]?
| |
| : v. The sources are not used for medical use except in accordance with the requirements in 10 CFR 35.500 [10 CFR 35.65(b)(1) and (2)]?
| |
| vi. The sealed sources are not combined (bundled or aggregated) to create an activity greater than the maximum activity listed above
| |
| [10 CFR 35.65(b)(2)]?
| |
| : d. Unsealed materials used under 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.300 are:
| |
| : i. Obtained from a manufacturer or preparer licensed under 10 CFR 32.72?
| |
| OR ii. Obtained from a producer of Positron Emission Tomography radioactive drugs under 10 CFR 30.32(j)?
| |
| OR iii. Prepared by a physician authorized user (AU), an authorized nuclear pharmacist (ANP), or an individual under the supervision of an ANP or physician AU?
| |
| OR iv. Obtained and prepared for research in accordance with 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.300, as applicable?
| |
| L-3
| |
| : 8. Are the sealed sources possessed and used under 10 CFR 35.400, 10 CFR 35.500, and 10 CFR 35.600 approved in the Sealed Source and Device Registry? Are the sealed sources used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry? Are manufacturers manuals for operation and maintenance of medical devices possessed?
| |
| : 9. Are the actual uses of medical devices consistent with the authorized uses listed on the license? (L/C)
| |
| : 10. If places of use/storage changed, was the license amended [10 CFR 35.13(e)]?
| |
| : 11. If control of the license was transferred, was NRCs prior consent obtained or notification made [10 CFR 30.34(b)]?
| |
| : 12. If bankruptcy was filed, was NRC immediately notified [10 CFR 30.34(h)]?
| |
| : 13. Is radioactive material regulated under 10 CFR 35.1000 used in accordance with the license conditions and tie-down commitments? (L/C)
| |
| Radiation Safety Program
| |
| : 1. Minor changes to program [10 CFR 35.26 or, if license condition permits, changes conforming to revised licensing guidance for 10 CFR 35.1000 medical uses]?
| |
| : 2. Records of changes maintained for 5 years [10 CFR 35.2026(a)]?
| |
| : 3. Content and implementation reviewed annually by the licensee [10 CFR 20.1101(c)]?
| |
| : 4. Records of reviews maintained [10 CFR 20.2102(a)(2)]?
| |
| Nationally Tracked Sources
| |
| : 1. Reports of transactions involving nationally tracked sources submitted to National Source Tracking System (10 CFR 20.2207)?
| |
| Use by Authorized Individuals (L/C)
| |
| : 1. Authorized Nuclear Pharmacist [10 CFR 35.55, 10 CFR 35.57, 10 CFR 35.59]
| |
| : a. Listed on facility license?
| |
| : 2. Authorized User [10 CFR 35.57, 10 CFR 35.59, and 10 CFR 35.190, 10 CFR 35.290, 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, 10 CFR 35.690]:
| |
| : a. Listed on facility license?
| |
| : b. Each AU only uses material for which they are authorized?
| |
| L-4
| |
| : 3. Authorized Medical Physicist [10 CFR 35.51, 10 CFR 35.57, 10 CFR 35.59]:
| |
| : a. Listed on a facility license?
| |
| : b. Each AMP only uses material for which they are authorized?
| |
| : c. If applicable, performs tasks described in 10 CFR 35.433(b), 10 CFR 35.632, 10 CFR 35.633, 10 CFR 35.635, as appropriate?
| |
| : 4. Ophthalmic Physicist [10 CFR 35.433]
| |
| : a. Listed on facility license?
| |
| : b. Only uses material for which they are authorized?
| |
| : c. Performs tasks described in 10 CFR 35.433(b)?
| |
| : 5. Nonmedical use authorized users [10 CFR 30.33(a)(3), 10 CFR 40.32(b)]:
| |
| : a. Listed on facility license for same materials and uses?
| |
| Mobile Medical Service
| |
| : 1. Operates services per 10 CFR 35.80, 10 CFR 35.647?
| |
| : 2. Compliance with public dose limits evaluated and met [10 CFR 20.1301, 10 CFR 20.1302]?
| |
| : 3. Are all base locations listed on the license? (L/C)
| |
| : 4. Mobile Medical Agreement letter signed by management of each client
| |
| [10 CFR 35.80(a)]?
| |
| : 5. Licensed material not delivered to clients address, unless client was authorized
| |
| [10 CFR 35.80(b)]?
| |
| : 6. Dosage measuring instruments checked for proper function before use at each address of use or on each day of use, if more frequent [10 CFR 35.80(a)]?
| |
| : 7. Survey instruments checked for proper operation before use at each address of use
| |
| [10 CFR 35.80(a)]?
| |
| : 8. Survey all areas of use prior to leaving each client address [10 CFR 35.80(a)]?
| |
| : 9. Adequate security maintained for mobile trailer? Keypad codes changed, or keys retrieved when an employee terminates employment [10 CFR 20.1801, 10 CFR 20.1802]?
| |
| : 10. AUs briefed on responsibilities for supervising the use of licensed material 10 CFR 35.27]?
| |
| L-5
| |
| : 11. Compliance with additional technical requirements for mobile remote afterloaders evaluated and met, including record retention [10 CFR 35.647, 10 CFR 35.2647]?
| |
| Amendments Since Last Audit [10 CFR 35.13]
| |
| : 1. Any Amendments since last audit [10 CFR 35.13]?
| |
| : 2. Security-related sensitive information was properly marked [10 CFR 2.390]?
| |
| Notifications Since Last Audit [10 CFR 35.14]
| |
| : 1. Any Notifications since last audit [10 CFR 35.14]?
| |
| : 2. Appropriate documentation provided to NRC for ANP, AMP, ophthalmic physicist, or AU, no later than 30 days after the individual starts work [10 CFR 35.14(a),
| |
| 10 CFR 30.34(j)(4)]?
| |
| : 3. NRC notified within 30 days after: AU, ANP, AMP, ophthalmic physicist, or RSO/ARSO stops work or changes name; licensees mailing address changes; licensees name changes without a transfer of control of the license; or licensee has added to or changed an area of use for 10 CFR 35.100 or 10 CFR 35.200 use; the licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number [10 CFR 35.14].
| |
| Training, Retraining, and Instructions to Workers
| |
| : 1. Briefly describe the training program.
| |
| : 2. Is the training program implemented? Have workers been provided with required instructions [10 CFR 19.12, 10 CFR 35.27, 10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, 10 CFR 35.1000, as appropriate]?
| |
| : 3. Is the individuals understanding of current procedures and regulations adequate?
| |
| : 4. Do appropriate individuals have adequate understanding of appropriate:
| |
| : a. Operating procedures [10 CFR 35.27, 10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610]?
| |
| : b. Emergency procedures [10 CFR 35.27, 10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610]?
| |
| : 5. Do appropriate individuals have an up-to-date copy of the licensees operating use and emergency procedures?
| |
| : 6. Periodic training required and implemented [10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610]?
| |
| : 7. Vendor operational and safety training provided prior to first patient treatment of a new or upgraded remote afterloader, teletherapy, or gamma stereotactic radiosurgery unit
| |
| [10 CFR 35.610]?
| |
| L-6
| |
| : 8. Were all workers who are likely to exceed 1 millisievert (mSv) [100 millirem (mrem)] in a year instructed and was refresher training provided, as needed [10 CFR 19.12]?
| |
| : 9. Was each supervised user instructed in the licensees written radiation protection procedures and administration of written directives (WD), as appropriate
| |
| [10 CFR 35.27]?
| |
| : 10. Are initial and periodic training records maintained for each individual [10 CFR 35.2310]?
| |
| : 11. Hazardous Materials (HAZMAT) training [49 CFR Part 172]
| |
| : 12. Do additional therapy device instructions/training include:
| |
| : a. Unit operation, inspection, associated equipment, survey instruments?
| |
| : b. License conditions applicable to the use of the unit?
| |
| : c. Emergency drills [10 CFR 35.610]?
| |
| : 13. 10 CFR Part 20Are workers cognizant of requirements for:
| |
| : a. Radiation Safety Program [10 CFR 35.24, 10 CFR 35.26, 10 CFR 20.1101]?
| |
| : b. Annual dose limits [10 CFR 20.1201, 10 CFR 20.1301, 10 CFR 20.1302]?
| |
| : c. NRC Forms 4 and 5?
| |
| : d. 10 percent monitoring threshold [10 CFR 20.1502]?
| |
| : e. Dose limits to embryo/fetus and declared pregnant worker [10 CFR 20.1208]?
| |
| : f. Grave Danger Posting [10 CFR 20.1902(c)]?
| |
| : g. Procedures for opening packages [10 CFR 20.1906]?
| |
| : 14. Is supervision of individuals by AU and/or ANP in accordance with 10 CFR 35.27?
| |
| : 15. Was training provided for workers involved with emerging technologies in accordance with the NRC license and tie-downs?
| |
| Training for Manual Brachytherapy and Use of Unsealed Byproduct Material for Which a Written Directive Is Required
| |
| : 1. Does safety instruction to personnel include [10 CFR 35.310, 10 CFR 35.410]:
| |
| : a. Control of patient and visitors?
| |
| : b. Routine visitation to patients in accordance with 10 CFR 20.1301?
| |
| : c. Contamination control and size/appearance of sources?
| |
| : d. Safe handling and shielding instructions?
| |
| : e. Waste control?
| |
| : f. RSO and AU notification, if patient had a medical emergency or died?
| |
| : g. Records retained [10 CFR 35.2310]?
| |
| Facilities
| |
| : 1. Facilities, as described in license application? (L/C)
| |
| : 2. Therapy device facilities provided with electrical interlock system, viewing and intercom systems, radiation monitor, source retraction mechanism, and source indicator lights?
| |
| L-7
| |
| : 3. Emergency source recovery equipment available [10 CFR 35.415, 10 CFR 35.615]?
| |
| : 4. Storage areas:
| |
| : a. Materials secured from unauthorized removal or access [10 CFR 20.1801]?
| |
| : b. Licensee controls and maintains constant surveillance of licensed material not in storage [10 CFR 20.1802]?
| |
| : c. Locations appropriately shielded to control public and occupational exposures in accordance with 10 CFR Part 20?
| |
| : 5. Therapy unit operation:
| |
| : a. Unit, console, console keys, and treatment room controlled adequately
| |
| [10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 35.610(a)(1)]?
| |
| : b. Restricted to certain source orientations and/or gantry angles? (L/C)
| |
| : c. Ceases to operate in restricted orientation(s)? (L/C)
| |
| : d. Only one radiation device can be placed in operation at a time within the treatment room [10 CFR 35.610(a)(3)]?
| |
| Dose or Dosage Measuring Equipment
| |
| : 1. Possession, use, and calibration of instruments to measure activities of unsealed radionuclides [10 CFR 35.60]:
| |
| : a. Types of equipment listed?
| |
| : b. Approved procedures for use of instrumentation followed?
| |
| : c. Constancy, accuracy, linearity, and geometry dependence tests performed in accordance with nationally recognized standards or the manufacturers instructions?
| |
| : d. Instrument repaired or replaced or dosages mathematically corrected, as required, when tests do not meet the performance objectives provided in the nationally recognized standard or manufacturers instructions (e.g., +/-10 percent)?
| |
| : e. Records maintained and include required information [10 CFR 35.2060]?
| |
| : 2. Determination of dosages of unsealed byproduct material [10 CFR 35.63, 10 CFR 30.34(j)]?
| |
| : a. Each dosage determined and recorded prior to medical use [10 CFR 35.63(a)] 1?
| |
| Or transfer [10 CFR 30.34(j)]?
| |
| 1See Sections 8.9.3 and 8.10.19 for additional information regarding Rb-82 generators.
| |
| L-8
| |
| : b. Measurement of unit dosages of alpha, beta, or photon emitting radionuclides made either by direct measurement [10 CFR 35.63(b)], or by decay correction of the activity provided by the licensed producer [10 CFR 32.72, 10 CFR 30.34(j)(2)(ii)]?
| |
| : c. For other than unit dosages of alpha, beta, or photon emitting radionuclides, measurement made by direct measurement of radioactivity [10 CFR 35.63(c)] or by combination of radioactivity or volumetric measurement and calculation using the activity provided by the licensed producer [10 CFR 32.72, 10 CFR 30.34(j)(2)(ii)]?
| |
| : 3. Licensee uses generators?
| |
| : a. Each eluate tested for molybdenum-99 (Mo-99) breakthrough
| |
| [10 CFR 35.204(b)]?
| |
| : b. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 kilobecquerel (kBq) per MBq [0.15 µCi per mCi] of Tc-99m
| |
| [10 CFR 35.204(a)(1)]?
| |
| : c. Before first patient use of day eluate tested for strontium (Sr)-82 and strontium-85 (Sr-85) when eluting rubidium (Rb)-82 [10 CFR 35.204(c)]?
| |
| : d. No radiopharmaceuticals administered with Sr-82 concentrations over 0.02 kBq per MBq [0.02 µCi per mCi] of Rb-82 or Sr-85 concentrations over 0.2 kBq per MBq [0.2 µCi per mCi] of Rb-82 [10 CFR 35.204(a)(2)]?
| |
| : e. Each measurement that exceeds the limits in paragraph b or d above reported to NRC and distributor of the generator in accordance with 10 CFR 35.3204?
| |
| : f. Records maintained [10 CFR 35.2204]?
| |
| : 4. Confirmation of source output or activity for manual brachytherapy sources?
| |
| Alternatively, the manufacturers measurements may be accepted, if the criteria in 10 CFR 35.432(b) have been met.
| |
| : 5. Dosimetry Equipment [10 CFR 35.630]:
| |
| : a. Calibrated system available for use [10 CFR 35.630(a)]?
| |
| : b. Calibrated by National Institute of Standards and Technology or an American Association of Physicists in Medicine (AAPM)-accredited lab within previous 2 years and after servicing [10 CFR 35.630(a)(1)] or calibrated by intercomparison per 10 CFR 35.630(a)(2)?
| |
| : c. Calibrated within the previous 4 years [10 CFR 35.630(a)(2)]?
| |
| : d. Licensee has available for use a dosimetry system for spot-check measurements
| |
| [10 CFR 35.630(b)]?
| |
| L-9
| |
| : e. Record of each calibration, intercomparison, and comparison maintained
| |
| [10 CFR 35.2630]?
| |
| Radiation Protection and Control of Radioactive Material
| |
| : 1. Use of radiopharmaceuticals:
| |
| : a. Protective clothing worn?
| |
| : b. Personnel routinely monitor their hands?
| |
| : c. No eating/drinking in use/storage areas?
| |
| : d. No food, drink, or personal effects kept in use/storage areas?
| |
| : e. Proper dosimetry worn?
| |
| : f. Radioactive waste disposed of in proper receptacles?
| |
| : g. Syringe shields and vial shields used and are specific to the energy emitted?
| |
| : h. Proper use of remote-handling tools and radiation shields?
| |
| : 2. Leak tests and inventories:
| |
| : a. Leak test performed on sealed sources and brachytherapy sources at appropriate intervals [10 CFR 35.67(b)(1) or leak test license condition]?
| |
| : b. Inventory of sealed sources and brachytherapy sources performed semiannually
| |
| [10 CFR 35.67(g)]?
| |
| : c. If applicable, transactions associated with nationally tracked sources entered into the NSTS, including annual reconciliation [10 CFR 20.2207]?
| |
| : d. Records maintained [10 CFR 35.2067]?
| |
| Radiation Survey Instruments
| |
| : 1. Survey instruments used to show compliance with 10 CFR Part 20 and 10 CFR 30.33(a)(2):
| |
| : a. Appropriate operable survey instruments possessed or available
| |
| [10 CFR Part 20]?
| |
| : b. Calibrations [10 CFR 35.61(a) and 10 CFR 35.61(b)]:
| |
| : i. Before first use, annually, and after repairs?
| |
| ii. Within 20 percent on each scale or decade of interest, as applicable?
| |
| iii. Instrument sent to a licensed instrument service provider?
| |
| iv. Copy of instrument service provider license on file?
| |
| : c. Records maintained [10 CFR 35.2061]?
| |
| : 2. Radiation surveys performed in accordance with the licensees procedures and the regulatory requirements [10 CFR 20.1501, 10 CFR 35.70]?
| |
| : a. Daily in all areas where radiopharmaceuticals requiring a WD are prepared or administered (except patient rooms) [10 CFR 35.70]?
| |
| L-10
| |
| : b. Weekly in all areas where radiopharmaceuticals or wastes are stored?
| |
| : c. Weekly for wipes in all areas where radiopharmaceuticals are routinely prepared, administered, or stored?
| |
| : d. Trigger levels for surveys established?
| |
| : e. Corrective action taken and documented if trigger level exceeded?
| |
| : f. Techniques can detect 0.1 milliroentgen/hour, 2,000 disintegrations per minute?
| |
| : g. Surveys made to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the sources(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry [10 CFR 35.652(a)] and records maintained [10 CFR 35.2652]?
| |
| : i. After new source installation?
| |
| ii. Following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical mechanism that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s)?
| |
| Public Dose
| |
| : 1. Is licensed material used in a manner to keep doses below 1 mSv [100 mrem] in a year
| |
| [10 CFR 20.1301(a)(1)]?
| |
| : 2. Has a survey or evaluation been performed, per 10 CFR 20.1501(a)?
| |
| : 3. Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation?
| |
| : 4. Do unrestricted area radiation levels exceed 0.02 mSv [2 mrem] in any 1 hour
| |
| [10 CFR 20.1301(a)(2)]?
| |
| : 5. Is licensed material used or stored in a manner that would prevent unauthorized access or removal [10 CFR 20.1801 and 10 CFR 20.1802]?
| |
| : 6. Are records maintained [10 CFR 20.2103, 10 CFR 20.2107]?
| |
| Patient Release
| |
| : 1. Individuals released when total effective dose equivalent (TEDE) is less than 5 mSv
| |
| [0.5 rem] [10 CFR 35.75(a)]?
| |
| : 2. Instructions to the released individual, including breastfeeding women, include required information [10 CFR 35.75(b)]?
| |
| : 3. Release records maintained [10 CFR 35.2075(a)]?
| |
| L-11
| |
| : 4. Records of instructions given to breastfeeding women maintained, if required
| |
| [10 CFR 35.2075(b)]?
| |
| Unsealed Byproduct Material for Which a Written Directive Is Required
| |
| : 1. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance, release, and contamination controls [10 CFR 35.315(a)]?
| |
| : 2. RSO and AU promptly notified if patient had a medical emergency or died
| |
| [10 CFR 35.315(b)]?
| |
| Brachytherapy or Brachytherapy Source Use
| |
| : 1. Safety precautions implemented to include patient facilities, posting, stay times, and emergency response equipment [10 CFR 35.415]?
| |
| : 2. Survey immediately after implant [10 CFR 35.404(a)]?
| |
| : 3. Patients surveyed immediately after removing the last temporary implant source
| |
| [10 CFR 35.404(b)]?
| |
| : 4. RSO and AU promptly notified if patient had a medical emergency or died
| |
| [10 CFR 35.415(c)]?
| |
| : 5. Records maintained [10 CFR 35.2404]?
| |
| Radioactive Waste
| |
| : 1. Disposal:
| |
| : a. Decay-in-storage [10 CFR 35.92]?
| |
| : b. Procedures followed?
| |
| : c. Labels removed or defaced [10 CFR 20.1904, 10 CFR 35.92]?
| |
| : 2. Special procedures performed as required?
| |
| : 3. Authorized disposals [10 CFR 20.2001]?
| |
| : 4. Records maintained [10 CFR 20.2103(a), 10 CFR 20.2108, 10 CFR 35.2092]?
| |
| : 5. Effluents:
| |
| : a. Release to sanitary sewer [10 CFR 20.2003]?
| |
| : i. Material is readily soluble or readily dispersible [10 CFR 20.2003(a)(1)]?
| |
| ii. Monthly average release concentrations do not exceed 10 CFR Part 20, Appendix B, Table 2 values?
| |
| L-12
| |
| | |
| iii. No more than 5 curies (Ci) (185 GBq) of tritium (H-3), 1 Ci (37 GBq) of carbon-14, and 1 Ci (37 GBq) of all other radionuclides combined, released in a year [10 CFR 20.2003]?
| |
| iv. Procedures to ensure representative sampling and analysis implemented
| |
| [10 CFR 20.1501]?
| |
| : b. Release to septic tanks [10 CFR 20.2003]? Within unrestricted limits
| |
| [10 CFR Part 20, Appendix B, Table 2]?
| |
| : c. Waste incinerated?
| |
| : i. License authorizes [10 CFR 20.2004(a)(3)]?
| |
| ii. Exhaust directly monitored?
| |
| iii. Airborne releases evaluated and controlled [10 CFR 20.1302, 10 CFR 20.1501]?
| |
| : d. Air effluents and ashes controlled [10 CFR 20.1101, 10 CFR 20.1201, 10 CFR 20.1301, 10 CFR 20.1501, 10 CFR 20.2001]? (See also Inspection Procedure 87102, RG 8.37.)
| |
| : i. Air effluent less than 0.10 mSv [10 mrem] constraint limit
| |
| [10 CFR 20.1101]?
| |
| : 1. If no, reported appropriate information to the NRC?
| |
| : 2. If no, corrective actions implemented and on schedule?
| |
| ii. Description of effluent program:
| |
| : e. Monitoring system hardware adequate?
| |
| : f. Equipment calibrated, as appropriate?
| |
| : g. Air samples/sampling technique (e.g., charcoal, high-efficiency particulate air) analyzed with appropriate instrumentation?
| |
| : 6. Waste storage:
| |
| : a. Protection from elements and fire?
| |
| : b. Control of waste maintained including constant surveillance of waste not in storage and secure from unauthorized removal or access for waste in storage
| |
| [10 CFR 20.1801 and 10 CFR 20.1802]?
| |
| : c. Containers properly labeled and area properly posted [10 CFR 20.1902, 10 CFR 20.1904]?
| |
| : d. Package integrity adequately maintained?
| |
| L-13
| |
| : 7. Waste disposal:
| |
| : a. Sources transferred to authorized individuals [10 CFR 20.2006, 10 CFR 20.2001, 10 CFR 30.41, 10 CFR 40.51]?
| |
| : b. Name of organization: ______________________ .
| |
| : c. Copy of waste disposal recipients license on file?
| |
| : 8. Records of surveys and material accountability maintained [10 CFR 20.2103, 10 CFR 20.2108, 10 CFR 35.2092]?
| |
| Receipt and Transfer of Radioactive Material
| |
| : 1. Description of how packages are received and by whom?
| |
| : 2. Written package-opening procedures established and followed [10 CFR 20.1906(e)]?
| |
| : 3. All incoming packages with a U.S. Department of Transportation (DOT) label monitored for radioactive contamination, unless exempted (gases and special form)
| |
| [10 CFR 20.1906(b)(1)]?
| |
| : 4. Incoming packages surveyed [10 CFR 20.1906(b)(2)]?
| |
| : 5. Monitoring in (3) and (4) performed within time specified [10 CFR 20.1906(c)]?
| |
| : 6. Transfer(s) performed per [10 CFR 30.41, 10 CFR 40.51]?
| |
| : 7. All sources surveyed before shipment and transfer [10 CFR 20.1501(a)]?
| |
| : 8. Records of surveys and receipt/transfer maintained [10 CFR 20.2103(a), 10 CFR 30.51, 10 CFR 40.61]?
| |
| : 9. Package receipt/distribution activities evaluated for compliance with 10 CFR 20.1301?
| |
| Transportation (10 CFR 71.5(a) and 49 CFR 171-178)
| |
| : 1. Shipments are:
| |
| : a. Delivered to common carriers?
| |
| : b. Transported in own private vehicle?
| |
| : c. Both?
| |
| : d. No shipments since last audit?
| |
| : 2. Return radiopharmacy doses to drug manufacture or commercial nuclear pharmacy or sealed sources to source or device manufacturer?
| |
| : a. Licensee assumes shipping responsibility?
| |
| : b. If NO, describe arrangements made between licensee and radiopharmacy for shipping responsibilities.
| |
| L-14
| |
| : 3. Packages:
| |
| : a. Authorized packages used [49 CFR 173.415, 49 CFR 416]?
| |
| : b. Performance test records on file?
| |
| : i. DOT-7A packages ii. Special form sources
| |
| : c. Two labels (White-I, Yellow-II, Yellow-III), on opposite sides not to include the bottom, with Transport Index (TI), Nuclide, Activity, and Hazard Class?
| |
| [49 CFR 173.403, 49 CFR 415, 49 CFR 416]
| |
| : d. Properly marked [Shipping Name, United Nations (UN) Number, Weight, Package Type, Reportable Quantity, This End Up (liquids), Name and Address of consignee] [49 CFR 172.403, 49 CFR 172.441, 49 CFR 173.471]?
| |
| : e. Closed and sealed during transport [49 CFR 173.475(f)]?
| |
| : 4. Shipping Papers:
| |
| : a. Prepared and used [49 CFR 172.200(a)]?
| |
| : b. Contain proper entries (Shipping Name; Hazard Class; Identification Number (UN Number); Total Quantity; Package Type; Nuclide; Reportable Quantity; Physical and Chemical Form; Activity; Category of Label; TI; Shippers Name, Certification and Signature; Emergency Response Telephone Number; Limited Quantity {if applicable); Cargo Aircraft Only (if applicable)}
| |
| [49 CFR 172.200-204]?
| |
| : c. Readily accessible during transport [49 CFR 177.817(e)]?
| |
| : 5. Any incidents reported to DOT [49 CFR 171.15, 171.16]?
| |
| Teletherapy and Gamma Stereotactic Radiosurgery (as permitted under 10 CFR 35.600)
| |
| : 1. Full-inspection servicing performed following source replacement or at intervals not to exceed 5 years for each teletherapy unit and not to exceed 7 years for each gamma stereotactic radiosurgery unit [10 CFR 35.655(a)]?
| |
| : 2. Needed service arranged for as identified during the inspection?
| |
| : 3. Service performed by persons specifically authorized to do so [10 CFR 35.655(b)]?
| |
| : 4. Were security requirements implemented, if applicable? [10 CFR Part 37]
| |
| L-15
| |
| | |
| Full Calibration-Therapeutic Medical Devices
| |
| : 1. Proper protocol(s) used (e.g., AAPM Task Group (TG)-21 (TG-21), AAPM 54, AAPM TG-56, AAPM TG-40)?
| |
| : 2. Performed prior to first patient use [10 CFR 35.632(a)(1), 10 CFR 35.633(a)(1),
| |
| 10 CFR 35.635(a)(1)]?
| |
| : 3. At intervals not to exceed 1 year for teletherapy, gamma stereotactic radiosurgery (GSR), and low dose-rate (LDR) remote afterloader; at intervals not exceeding 1 quarter for high dose-rate, medium dose-rate (MDR), and pulsed dose-rate (PDR) remote afterloaders [10 CFR 35.632(a)(3), 10 CFR 35.633(a)(3) and 10 CFR 35.633(a)(4),
| |
| 10 CFR 35.635(a)(3)]?
| |
| : 4. Whenever spot-checks indicate output differs from expected by +/-5%
| |
| [10 CFR 35.632(a)(2)(i), 10 CFR 35.635(a)(2)(i)]?
| |
| : 5. After source exchange, relocation, and major repair or modification
| |
| [10 CFR 35.632(a)(2), 10 CFR 35.633(a)(2), 10 CFR 35.635(a)(2)]?
| |
| : 6. Performed with properly calibrated instrument [10 CFR 35.632(c), 10 CFR 35.633(c),
| |
| 10 CFR 35.635(c)]?
| |
| : 7. Includes:
| |
| : a. For teletherapy:
| |
| : i. Output measured within +/-3% of expected for the range of field sizes, range of distances [10 CFR 35.632(b)(1)]?
| |
| ii. Coincidence of radiation field and field light localizer
| |
| [10 CFR 35.632(b)(2)]?
| |
| iii. Uniformity of radiation field and beam angle dependence
| |
| [10 CFR 35.632(b)(3)]?
| |
| iv. Timer accuracy and linearity over the range of use
| |
| [10 CFR 35.632(b)(4)]?
| |
| : v. On-off error [10 CFR 35.632(b)(5)]?
| |
| vi. Accuracy of all measuring and localization devices
| |
| [10 CFR 35.632(b)(6)]?
| |
| : b. For remote afterloaders:
| |
| : i. Output measured within +/-5% of expected [10 CFR 35.633(b)(1)]?
| |
| ii. Source positioning accuracy within +/-1 millimeter [10 CFR 35.633(b)(2)]?
| |
| iii. Source retraction with backup battery upon power failure
| |
| [10 CFR 35.633(b)(3)]?
| |
| iv. Length of source transfer tubes [10 CFR 35.633(b)(4)]?
| |
| : v. Timer accuracy and linearity over the typical range of use
| |
| [10 CFR 35.633(b)(5)]?
| |
| vi. Length of the applicators [10 CFR 35.633(b)(6)]?
| |
| L-16
| |
| | |
| vii. Function of source transfer tubes, applicators, and transfer tube-applicator interfaces [10 CFR 35.633(b)(7)]?
| |
| viii. Autoradiograph quarterly of the LDR source(s) to verify source(s) arrangement and inventory [10 CFR 35.633(e)]?
| |
| : c. For gamma stereotactic radiosurgery:
| |
| : i. Output measured within +/-3% of expected [10 CFR 35.635(b)(1)]?
| |
| ii. Helmet factors [10 CFR 35.635(b)(2)]?
| |
| iii. Isocenter coincidence [10 CFR 35.635(b)(3)]?
| |
| iv. Timer accuracy and linearity over the range of use
| |
| [10 CFR 35.635(b)(4)]?
| |
| : v. On-off error [10 CFR 35.635(b)(5)]?
| |
| vi. Trunnion centricity [10 CFR 35.635(b)(6)]?
| |
| vii. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off [10 CFR 35.635(b)(7)]?
| |
| viii. Helmet microswitches [10 CFR 35.635(b)(8)]?
| |
| ix. Emergency timing circuit [10 CFR 35.635(b)(9)]?
| |
| : x. Stereotactic frames and localizing devices (trunnions)
| |
| [10 CFR 35.635(b)(10)]?
| |
| : 8. Output corrected mathematically for decay [10 CFR 35.632(e), 10 CFR 35.633(g),
| |
| 10 CFR 35.635(e)]?
| |
| : 9. Records maintained [10 CFR 35.2632]?
| |
| Periodic Spot-Checks for Therapeutic Devices
| |
| : 1. Performed at required frequency [10 CFR 35.642(a), 10 CFR 35.643(a),
| |
| 10 CFR 35.645(a)]?
| |
| : 2. Procedures established by AMP [10 CFR 35.642(b), 10 CFR 35.643(b),
| |
| 10 CFR 35.645(b)]?
| |
| : 3. Procedures followed?
| |
| : 4. Medical physicist reviews results within 15 days [10 CFR 35.642(c), 10 CFR 35.643(c),
| |
| 10 CFR 35.645(b)]?
| |
| : 5. Performed with properly calibrated instrument [10 CFR 35.642(a)(5),
| |
| 10 CFR 35.645(c)(2)(i)]?
| |
| : 6. Output and safety spot-checks include:
| |
| : a. For teletherapy:
| |
| : i. Timer accuracy and linearity over the range of use
| |
| [10 CFR 35.642(a)(1)]?
| |
| ii. On-off error [10 CFR 35.642(a)(2)]?
| |
| iii. Coincidence of radiation field and field light localizer
| |
| [10 CFR 35.642(a)(3)]?
| |
| L-17
| |
| | |
| iv. Accuracy of all measuring and localization devices
| |
| [10 CFR 35.642(a)(4)]?
| |
| : v. The output for one typical set of operating conditions
| |
| [10 CFR 35.642(a)(5)]?
| |
| vi. Difference between measured and expected output
| |
| [10 CFR 35.642(a)(6)]?
| |
| vii. Interlock systems [10 CFR 35.642(d)(1)]?
| |
| viii. Beam stops [10 CFR 35.642(d)(2)]?
| |
| ix. Source exposure indicator lights [10 CFR 35.642(d)(3)]?
| |
| : x. Viewing and intercom systems [10 CFR 35.642(d)(4)]?
| |
| xi. Treatment room doors, inside and out [10 CFR 35.642(d)(5)]?
| |
| xii. Electrical treatment doors with power shut off [10 CFR 35.642(d)(6)]?
| |
| : b. For remote afterloaders:
| |
| : i. Interlock systems [10 CFR 35.643(d)(1)]?
| |
| ii. Source exposure indicator lights [10 CFR 35.643(d)(2)]?
| |
| iii. Viewing and intercom systems, except for LDR [10 CFR 35.643(d)(3)]?
| |
| iv. Emergency response equipment [10 CFR 35.643(d)(4)]?
| |
| : v. Radiation monitors used to indicate source position
| |
| [10 CFR 35.643(d)(5)]?
| |
| vi. Timer accuracy [10 CFR 35.643(d)(6)]?
| |
| vii. Clock (date and time) in the units computer [10 CFR 35.643(d)(7)]?
| |
| viii. Decayed source(s) activity in the units computer [10 CFR 35.643(d)(8)]?
| |
| : c. For gamma stereotactic radiosurgery:
| |
| : i. Treatment table retraction mechanism [10 CFR 35.645(c)(1)(i)]?
| |
| ii. Helmet microswitches [10 CFR 35.645(c)(1)(ii)]?
| |
| iii. Emergency timing circuits [10 CFR 35.645(c)(1)(iii)]?
| |
| iv. Stereotactic frames and localizing devices [10 CFR 35.645(c)(1)(iv)]?
| |
| : v. The output for one typical set of operating conditions [10 CFR 35.645(c)(2)(i)]?
| |
| vi. Difference between measured and expected output
| |
| [10 CFR 35.645(c)(2)(ii)]?
| |
| vii. Source output compared against computer calculation of output
| |
| [10 CFR 35.645(c)(2)(iii)]?
| |
| viii. Timer accuracy and linearity over the range of use
| |
| [10 CFR 35.645(c)(2)(iv)]?
| |
| ix. On-off error [10 CFR 35.645(c)(2)(v)]?
| |
| : x. Trunnion centricity [10 CFR 35.645(c)(2)(vi)]?
| |
| xi. Automatic positioning system?
| |
| xii. Interlock systems [10 CFR 35.645(d)(1)]?
| |
| xiii. Source exposure indicator lights [10 CFR 35.645(d)(2)]?
| |
| xiv. Viewing and intercom systems [10 CFR 35.645(d)(3)]?
| |
| xv. Timer termination [10 CFR 35.645(d)(4)]?
| |
| xvi. Radiation monitors used to indicate room exposures
| |
| [10 CFR 35.645(d)(5)]?
| |
| xvii. Emergency off buttons [10 CFR 35.645(d)(6)]?
| |
| L-18
| |
| : 7. Licensee promptly repaired items found to be not operating properly and did not use unit until repaired, if required [10 CFR 35.642(e), 10 CFR 35.643(e), 10 CFR 35.645(f)]?
| |
| : 8. Records maintained [10 CFR 35.2642, 10 CFR 35.2643, 10 CFR 35.2645]?
| |
| Installation, Maintenance, and Repair of Therapy Devices
| |
| : 1. Only authorized individuals perform installation, maintenance, adjustment, repair, and inspection [10 CFR 35.605, 10 CFR 35.655]? Name of organization/individual.
| |
| : 2. License verification?
| |
| : 3. Records maintained [10 CFR 35.2605, 10 CFR 35.2655]?
| |
| Emergency Procedures for Therapy Devices
| |
| : 1. Instructions on location of emergency procedures and emergency response telephone numbers posted at the device console [10 CFR 35.610(c)]?
| |
| : 2. Copy of the entire procedures physically located at the device console
| |
| [10 CFR 35.610(b)]?
| |
| : 3. Procedures include:
| |
| : a. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions [10 CFR 35.610(a)(4)]?
| |
| : b. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure [10 CFR 35.610(a)(4)]?
| |
| : c. The names and telephone numbers of the AUs, the AMP, and the RSO to be contacted if the unit or console operates abnormally [10 CFR 35.610(a)(4)]?
| |
| : 4. AMP and AU:
| |
| : a. Physically present during initiation of patient treatment with remote afterloaders?
| |
| (Note: for MDR and PDR, an appropriately trained physician under the supervision of the AU may be physically present instead of the AU)
| |
| [10 CFR 35.615(f)(1) and 10 CFR 35.615(f)(2)].
| |
| : b. Physically present throughout all patient treatments with a gamma stereotactic radiosurgery device [10 CFR 35.615(f)(3)]?
| |
| Patient Surveys and Therapy Devices
| |
| : 1. Radiation survey of patient is performed to ensure source is returned to shielded position
| |
| [10 CFR 35.604(a)]?
| |
| L-19
| |
| : 2. RSO and AU promptly notified if patient had a medical emergency or died
| |
| [10 CFR 35.615(f)(4)]?
| |
| : 3. Records of radiation surveys maintained for 3 years [10 CFR 35.2404]?
| |
| Personnel Radiation Protection
| |
| : 1. Exposure evaluation performed [10 CFR 20.1501]?
| |
| : 2. As low as is reasonably achievable (ALARA) program implemented
| |
| [10 CFR 20.1101(b)]?
| |
| : 3. External Dosimetry:
| |
| : a. Monitors workers per [10 CFR 20.1502(a)]?
| |
| : b. External exposures account for contributions from airborne activity
| |
| [10 CFR 20.1203]?
| |
| : c. Supplier Frequency
| |
| : d. Supplier is National Voluntary Laboratory Accreditation Program-approved
| |
| [10 CFR 20.1501(c)]?
| |
| : e. Dosimeters exchanged at required frequency?
| |
| : 4. Internal Dosimetry:
| |
| : a. Monitors workers per 10 CFR 20.1502?
| |
| : b. Program for monitoring and controlling internal exposures [10 CFR 20.1701, 10 CFR 20.1702] briefly described?
| |
| : c. Monitoring/controlling program implemented (includes bioassays)?
| |
| : d. Respiratory protection equipment [10 CFR 20.1703]?
| |
| : 5. Review of Records and Reports:
| |
| : a. Reviewed by _________ Frequency_________
| |
| : b. Auditor reviewed personnel monitoring records for period _________ to
| |
| : c. Prior dose determined for individuals likely to receive doses [10 CFR 20.2104]?
| |
| : d. Maximum exposures TEDE _________ Other _________
| |
| : e. Maximum committed dose equivalents (CDEs) _________ Organs
| |
| : f. Maximum CEDE _________
| |
| L-20
| |
| : g. Internal and external summed [10 CFR 20.1202]?
| |
| : h. Occupational limits met for adults [10 CFR 20.1201]?
| |
| : i. If applicable, occupational limits met for minors [10 CFR 20.1202]?
| |
| : j. NRC forms or equivalent [10 CFR 20.2104(d), 10 CFR 20.2106(c)]?
| |
| : i. NRC-4 Complete:
| |
| ii. NRC-5 Complete:
| |
| : k. If a worker declared her pregnancy during the audit period, was the dose in compliance [10 CFR 20.1208] and were the records maintained
| |
| [10 CFR 20.2106(e)]?
| |
| : 6. Any planned special exposures (number of people involved and doses received)
| |
| [10 CFR 20.1206, 10 CFR 20.2104, 10 CFR 20.2105, 10 CFR 20.2204]?
| |
| : 7. Records of exposures, surveys, monitoring, and evaluations maintained
| |
| [10 CFR 20.2102, 10 CFR 20.2103, 10 CFR 20.2106]?
| |
| Other Medical Uses of Byproduct Material or Radiation from Byproduct Material
| |
| [10 CFR 35.1000]
| |
| Use specific 10 CFR 35.1000 licensing guidance and the above components, as applicable, to develop an audit of other medical uses licensed under 10 CFR 35.1000.
| |
| Security Program for Category 1 and Category 2 Materials [10 CFR Part 37]
| |
| : 1. Is access to the material controlled so that only authorized individuals can gain access to the material? Are personnel who have not been authorized escorted?
| |
| [10 CFR Part 37, Subpart B]
| |
| : 2. Have all personnel who have unescorted access to the material been deemed trustworthy and reliable, been fingerprinted, and been authorized in writing for access to the material? Is the list of authorized personnel up to date? [10 CFR Part 37, Subpart B]
| |
| : 3. Is a system in place so that any unauthorized access to the material will be detected immediately? Are weekly verification checks conducted for Category 2 quantities of radioactive material? [10 CFR 37.49(a)]
| |
| : 4. Are procedures in place to ensure that any unauthorized access will be assessed to determine whether further response is required? If there have been any such accesses, was the procedure followed? [10 CFR 37.49(b)]
| |
| : 5. Is the security plan current? Is contact information for the local law enforcement agency current? [10 CFR 37.43(a)]
| |
| : 6. Is the security system operable? [10 CFR 37.51]
| |
| L-21
| |
| : 7. Does the security system have a dependable means of communication to notify assessment personnel? Do personnel have a dependable means of communication to notify response staff or local law enforcement? [10 CFR 37.49(c)]
| |
| : 8. Are all documents being retained as required? [10 CFR 37.110]
| |
| : 9. Is all sensitive information secured and protected in accordance with the procedure?
| |
| Does the procedure address all required information? [10 CFR 37.31, 37.43(d)]
| |
| : 10. Have personnel with access to the material been trained on security procedures, including emergency response, notifications, and surveillance? [10 CFR 37.43(c)]
| |
| : 11. Are procedures in place to ensure the safe and secure transport of Category 1 and Category 2 radioactive sources or material? Were the procedures followed for preplanning, license verification, coordination, advance notification, physical protection, and reporting, as applicable? [10 CFR 37.71, 10 CFR 37.73, 10 CFR 37.75, 10 CFR 37.77, 10 CFR 37.79, and 10 CFR 37.81]
| |
| : 12. Is the security program content and implementation reviewed annually with records maintained for 3 years? [10 CFR 37.55]
| |
| Confirmatory Measurements
| |
| : 1. Detail location and results of confirmatory measurements.
| |
| Written Directive Review and Identification of Medical Events
| |
| : 1. Review a sampling of records for administrations requiring a WD. The number of patient cases to be sampled should be representative of each treatment modality performed in the institution.
| |
| : 2. Conduct a review of each applicable program area (e.g., radiopharmaceutical therapy, high dose-rate brachytherapy, implant brachytherapy, teletherapy, and emerging technologies). If feasible, the persons conducting the review should not review their own work. If this is not possible, two people should work together as a team to conduct the review of that work.
| |
| : 3. Review the procedures developed in accordance with 10 CFR 35.41 to ensure that the procedures for administrations requiring a WD are effective.
| |
| : 4. Determine whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the WD or treatment plan, as applicable. Determine if a medical event, as defined in 10 CFR 35.3045, has occurred, and for permanent implant brachytherapy, that within 60 calendar days from the date the implant was performed the total source strength administered outside of the treatment site was compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented in accordance with 10 CFR 35.41. When deviations from the WD are found, the cause of each deviation and the action required to prevent recurrence should be identified.
| |
| L-22
| |
| | |
| If medical events meeting the criteria in 10 CFR 35.3045 have occurred since the last audit, evaluate the incident(s) and procedures for implementing and administering WDs using the existing guidance.
| |
| : 1. Event date ___________ Information Source ________________________________
| |
| : 2. Notifications:
| |
| NRC Ops Center NRC Region Referring Physician Patient In writing By telephone If notification did not occur, why not?
| |
| : 3. Written Reports [10 CFR 35.3045]: Submitted to Region within 15 days?
| |
| : 4. Patient intervention that resulted in the total dose or dosage not being administered?
| |
| Describe each intervention.
| |
| Notification and Reports
| |
| : 1. In compliance with 10 CFR 19.13 (reports to individuals, public and occupational, monitored to show compliance with 10 CFR Part 20)?
| |
| : 2. In compliance with 10 CFR 20.2201 (theft or loss)?
| |
| : 3. In compliance with 10 CFR 20.2202 and 10 CFR 30.50 (incidents)?
| |
| : 4. In compliance with 10 CFR 20.2203 and 10 CFR 30.50 (overexposure and high radiation levels)?
| |
| : 5. Licensee in compliance with 10 CFR 21.21 (device defect)?
| |
| : 6. Aware of NRC Operations Center telephone number [301-816-5100]?
| |
| : 7. In compliance with 10 CFR 20.2203 (constraint on air emissions)?
| |
| Posting and Labeling
| |
| : 1. NRC Form 3, Notice to Workers is posted [10 CFR 19.11]?
| |
| : 2. 10 CFR Part 19, 10 CFR Part 20, 10 CFR Part 21, Section 206 of Energy Reorganization Act, procedures adopted pursuant to 10 CFR Part 21, and license documents are posted, or a notice indicating where documents can be examined is posted [10 CFR 19.11, 10 CFR 21.6]?
| |
| : 3. Other posting and labeling per 10 CFR 20.1902, 10 CFR 20.1904, and not exempted by 10 CFR 20.1903, 10 CFR 20.1905?
| |
| L-23
| |
| | |
| Recordkeeping for Decommissioning
| |
| : 1. Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination
| |
| [10 CFR 30.35(g)]?
| |
| : 2. Records include all information outlined in 10 CFR 30.35(g)?
| |
| NRC Correspondence
| |
| : 1. Bulletins, INs, Newsletters, etc., received and reviewed, as applicable? To receive these documents electronically, subscribe to the Medical List Server by sending an e-mail to Medical-GC.Resource@nrc.gov with the word subscribe in the subject line.
| |
| : 2. Appropriate action taken in response to Bulletins, Generic Letters, etc.?
| |
| Special License Conditions or Issues (L/C)
| |
| Special license condition or issues to be reviewed:
| |
| : 1. If authorized for 10 CFR 35.1000 medical uses, review the program for conformance with license application commitments, license conditions, and regulations.
| |
| : 2. Other special license conditions.
| |
| Performance-Based Review
| |
| : 1. Conduct performance-based reviews of radiation workers performing licensed activities:
| |
| : a. to assess the capability of the radiation workers to maintain exposures ALARA;
| |
| : b. to assess that radiation workers follow the operating procedures;
| |
| : c. to assess the effectiveness of the operating procedures and compliance with the regulations, license conditions and the licensee commitments submitted in support of a license (and incorporated by tie-down conditions);
| |
| : d. to ensure the safe and secure use of radioactive material;
| |
| : e. to verify that radiation workers are cognizant of the emergency procedures and, if necessary, would be able to implement them and maintain exposures ALARA; and
| |
| : f. to ensure that emergency procedures have been developed for all likely scenarios.
| |
| : 2. Take the necessary actions to address programmatic and performance deficiencies with radiation workers and facilitate immediate corrective actions.
| |
| L-24
| |
| | |
| Evaluation of Other Factors
| |
| : 1. Senior licensee management is appropriately involved with the radiation safety program and/or RSO oversight?
| |
| : 2. RSO has sufficient time to perform radiation safety duties and is not too busy with other assignments?
| |
| : 3. Licensee has sufficient staff?
| |
| Audits and Findings
| |
| : 1. Summary of findings.
| |
| : 2. Corrective and preventive actions.
| |
| : 3. Amendment required?
| |
| L-25
| |
| | |
| APPENDIX M MODEL PROCEDURES FOR OCCUPATIONAL DOSE MONITORING PROGRAM
| |
| | |
| Model Procedures for Occupational Dose Monitoring Program This model provides acceptable procedures for an external occupational dose monitoring program and references and resources for developing an internal occupational dose monitoring program. Applicants may either adopt these model procedures for an occupational dose monitoring program or develop alternative procedures to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1101 and Subparts C (Occupational Dose Limits) and F (Surveys and Monitoring) of 10 CFR Part 20. The model includes guidance as well as a discussion of regulatory requirements that are to be reflected in the elements of an occupational dose monitoring program.
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| Dosimetry is a broad term commonly applied to the use of monitoring devices, bioassay, and other methods to measure or otherwise quantify radiation doses to individuals. The licensee must control occupational doses and provide individuals with monitoring devices in accordance with the requirements of 10 CFR 20.1502(a). The occupational dose limits for adults are provided in 10 CFR 20.1201, while 10 CFR 20.1502, Conditions requiring individual monitoring of external and internal occupational dose, provides, in part, that adults likely to receive in a year a dose in excess of 10 percent of those dose limits must be provided with dosimetry.
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| Definitions of relevant terms, such as total effective dose equivalent (TEDE), deep-dose equivalent (DDE), and committed effective dose equivalent (CEDE) can be found in 10 CFR 20.1003, Definitions. In addition, if monitoring is required pursuant to 10 CFR 20.1502, each licensee shall maintain records of doses received (see 10 CFR 20.2106, Records of individual monitoring results). Also, if monitoring is required pursuant to 10 CFR 20.1502, the licensee must provide individuals with an annual report of their doses, if their occupational dose exceeds 1 mSv [100 mrem] TEDE or 1 mSv [100 mrem] to any individual organ or tissue or the individual requests their annual dose report (see 10 CFR 19.13(b), Notifications and reports to individuals).
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| The licensee must consider the dose that an individual may receive in the current year from all sources of employment where the individual's assigned duties involve exposure to sources of radiation. See RG 8.7, Instructions for Recording and Reporting Occupational Radiation Dose Data, May 2018.
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| If an individual may receive more than 10 percent of the annual dose limit, the NRC requires the licensee to monitor the dose, to maintain records of the dose, and, on at least an annual basis, to inform the worker of his or her dose.
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| The As Low As Reasonably Achievable ALARA Program Regulations in 10 CFR 20.1101 state that each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and the licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).
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| Additionally, 10 CFR 20.1101 requires that licensees periodically review the content of the radiation protection program and its implementation.
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| External Exposure It is necessary to assess doses to radiation workers to demonstrate compliance with regulatory limits for radiation dose and to help demonstrate that doses are maintained at ALARA levels.
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| M-1
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| Providing for the safe use of radioactive materials and radiation is a management responsibility.
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| It is important that management recognize the importance of radiation monitoring as part of the overall requirements for radiation protection.
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| There are three dose limits included in 10 CFR 20.1201 that apply to external exposure: deep dose to the whole body [5 rem or 0.05 Sievert (Sv)], shallow dose to the skin or extremities
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| [50 rem or 0.5 Sv], and dose to the lens of the eye [15 rem or 0.15 Sv]. According to the definitions in 10 CFR 20.1003, the DDE to the whole body is considered to be at a tissue depth of 1 centimeter (cm) [1,000 milligram (mg)/square centimeters (cm2)], shallow-dose equivalent (SDE) to the skin or extremities at 0.007 cm [7 mg/cm2], and lens of the eye dose equivalent at 0.3 cm [300 mg/cm2]. In evaluating the lens of the eye dose equivalent, it is acceptable to take credit for the shielding provided by protective lenses or other protection factors.
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| Under 10 CFR 20.1502(a), the use of individual monitoring devices is required for the following:
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| * Adults likely to receive, in a year, from sources external to the body, a dose in excess of 10 percent of the occupational dose limits in 10 CFR 20.1201(a). Monitoring devices are accordingly required for adults likely to receive an annual dose in excess of 0.5 rem [0.005 Sv] DDE 1.5 rem [0.015 Sv] lens (of the eye) dose equivalent 5 rem [0.05 Sv] SDE to the skin 5 rem [0.05 Sv] SDE to any extremity
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| * Minors who are likely to receive an annual dose in excess of:
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| 0.1 rem [1.0 millisievert (mSv)] DDE 0.15 rem [1.5 mSv] lens (of the eye) dose equivalent 0.5 rem [5 mSv] SDE to the skin, or 0.5 rem [5 mSv] SDE to any extremity
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| * Declared pregnant women likely to receive an annual dose in excess of 0.1 rem
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| [1.0 mSv] DDE during the entire pregnancy.
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| * Individuals entering a high- or a very-high-radiation area.
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| To demonstrate that monitoring of occupational exposure is not necessary for a group of radiation workers, it must be demonstrated that doses will not exceed 10 percent of the applicable limits. In these cases, the NRC does not require licensees to monitor radiation doses for this class of worker.
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| The following methods may be used to demonstrate that doses are expected to be within 10 percent of regulatory limits:
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| * Prior Experience: Reviews of radiation dose histories for workers in a specific work area show that they are not likely to receive a dose in excess of 10 percent of the limits.
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| * Area Surveys: Demonstrate through the conduct of appropriate radiation level surveys
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| [e.g., using a radiation survey meter or area thermoluminescent dosimeters (TLDs)] in the work area, combined with estimates of occupancy rates and calculations, that doses M-2
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| to workers are not likely to exceed 10 percent of the limits (exposures associated with reasonable accident scenarios should also be evaluated).
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| * The licensee performs a reasonable calculation, based upon source strength, distance, shielding, and time spent in the work area, that shows that workers are not likely to receive a dose in excess of 10 percent of the limits.
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| External dose is determined by using individual monitoring devices, such as film badges, optically stimulated luminescence dosimeters, or TLDs. These devices must be evaluated by a processor that is National Voluntary Laboratory Accreditation Program-approved, as required by 10 CFR 20.1501.
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| The device for monitoring the whole body dose, eye dose, skin dose, or extremity dose shall be placed near the location expected to receive the highest dose during the year
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| [10 CFR 20.1201(c)]. When the whole body is exposed fairly uniformly, the individual monitoring device is typically worn on the front of the upper torso.
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| If the radiation dose is highly nonuniform, causing a specific part of the whole body (head, trunk, arms above the elbow, or legs above the knees) to receive a substantially higher dose than the rest of the whole body, the individual monitoring device shall be placed near that part of the whole body expected to receive the highest dose. For example, if the dose rate to the head is expected to be higher than the dose rate to the trunk of the body, a monitoring device shall be located on or close to the head. For additional guidance, see RG 8.40, Methods for Measuring Effective Dose Equivalent from External Exposure, July 2010.
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| If, after the exposure is received, the licensee somehow learns that the maximum dose to a part of the whole body, eye, skin, or extremity was substantially higher than the dose measured by the individual monitoring device, an evaluation shall be conducted to estimate the actual maximum dose.
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| Under 10 CFR 20.2106, individual monitoring must be recorded on NRC Form 5, Occupational Dose Record for a Monitoring Period, or equivalent. Form 5 is used to record doses received for the calendar year. The monitoring year may be adjusted as necessary to permit a smooth transition from one monitoring year to another, as long as the year begins and ends in the month of January, the change is made at the beginning of the year, and no day is omitted or duplicated in consecutive years. For additional guidance, see RG 8.7, Instructions for Recording and Reporting Occupational Radiation Dose Data, May 2018.
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| Because evaluation of dose is an important part of the radiation protection program, it is important that users return dosimeters on time. Licensees should be thorough in their effort to recover any missing dosimeters. Delays in processing a dosimeter can result in the loss of the stored information.
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| If an individuals dosimeter is lost, the licensee needs to perform and document an evaluation of the dose the individual received and add it to the employees dose record, to demonstrate compliance with occupational dose limits in 10 CFR 20.1201. Sometimes the most reliable method for estimating an individuals dose is to use his or her recent dose history. In other cases, particularly if the individual does nonroutine types of work, it may be better to use doses of coworkers as the basis for the dose estimate. It also may be possible to estimate doses by modeling and calculation (i.e., reconstruction) of scenarios leading to dose.
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| M-3
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| Investigational Levels - External Dose Monitoring The NRC has emphasized that the Investigational Levels in this program are not new dose limits but, as noted in International Commission on Radiological Protection (ICRP) Report 26, Recommendations of the International Commission on Radiological Protection, Investigational Levels serve as check points above which the results are considered sufficiently important to justify investigation.
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| When the cumulative annual exposure to a radiation worker exceeds Investigational Level I in Table M-1 (i.e., 10 percent of the annual limit for occupational exposure), the radiation safety officer (RSO) or the RSOs designee should investigate the exposure and review the actions that might be taken to reduce the probability of recurrence. When the cumulative annual exposure exceeds the Investigational Level II in Table M-1 (i.e., 30 percent of the annual limit for occupational exposure), the RSO or the RSOs designee should investigate the exposure and review actions to be taken to reduce the probability of recurrence, and management should review the report of the actions to be taken to reduce the probability of occurrence.
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| Table M-1. Investigational Levels Investigational Level I Investigational Level II Part of Body (mrem/yr) (mrem/yr) whole body, head, trunk including 500 [5 mSv] 1,500 [15 mSv]
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| male gonads, arms above the elbow, or legs above the knee hands, elbows, arms below the 5,000 [50 mSv] 15,000 [150 mSv]
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| elbow, feet, knees, legs below the knee, or skin lens of the eye 1,500 [15 mSv] 4,500 [45 mSv]
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| Review and record on NRC Form 5, Occupational Dose Record for a Monitoring Period, or an equivalent form (e.g., dosimeter processors report), the results of personnel monitoring. Take the actions listed below when the investigation levels listed in Table M-1 are reached:
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| * Personnel dose less than Investigational Level I Except when deemed appropriate by the RSO or the RSOs designee, no further action will be taken, if an individuals dose is less than Table M-1 values for Investigational Level I.
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| * Personnel dose equal to or greater than Investigational Level I but less than Investigational Level II When the dose of an individual equals or exceeds Investigational Level I, the RSO or the RSOs designee should conduct a timely investigation and review the actions that might be taken to reduce the probability of recurrence, following the period when the dose was recorded. If the dose does not equal or exceed Investigational Level II, no action related specifically to the exposure is required, unless deemed appropriate by the RSO or the RSOs designee. Consider investigating the factors that led to the radiation exposure and the radiation doses and work habits of other individuals engaged in similar tasks to determine if improvements or additional safety measures are needed to reduce exposures. Evaluate, in the context of ALARA program quality, and record the results of investigations and evaluations.
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| M-4
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| * Personnel dose equal to or greater than Investigational Level II The RSO should investigate, in a timely manner, the causes of all personnel doses equaling or exceeding Investigational Level II. The RSO should consider actions to reduce the probability of occurrence, and a report of the actions should be reviewed by the licensees management at its first meeting following completion of the investigation.
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| * Reestablishment of Investigational Level II to a level above that listed in Table M-1 In cases where a workers dose or the dose for a group of workers needs to exceed an Investigational Level, a new, higher Investigational Level may be established for that individual or group on the basis that it is consistent with good ALARA practices. Justification for new Investigational Levels should be documented.
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| Declared Pregnancy and Dose to Embryo/Fetus Regulations in 10 CFR 20.1208, Dose equivalent to an embryo/fetus, state that the licensee shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem [5 mSv]. The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman. If the pregnancy is declared in writing and includes the workers estimated date of conception, the dose equivalent to an embryo or fetus shall be taken as the sum of
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| * the DDE to the declared pregnant woman, and
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| * the dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman Licensees should reference RG 8.13, Instructions Concerning Prenatal Radiation Exposure, June 1999, for information to help pregnant women and other personnel make decisions regarding radiation exposure during pregnancy and RG 8.36, Radiation Dose to the Embryo/Fetus, July 1992, for calculating the radiation dose to the embryo/fetus.
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| Internal Exposure With respect to internal exposure, licensees are required to monitor occupational intake of radioactive material and assess the resulting dose if it appears likely that personnel will receive greater than 10 percent of the annual limit on intake (ALI) from intakes in a year (10 CFR 20.1502). Values for radionuclide intakes by means of inhalation and ingestion (i.e., derived air concentration (DAC) and ALI) are provided in Table 1 of Appendix B of 10 CFR Part 20.
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| For each class of each radionuclide, there are two ALIs, one for ingestion and one for inhalation.
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| The ALI is the quantity of radioactive material that, if taken into the body of an adult worker by the corresponding route, would result in a committed effective dose equivalent of 5 rem
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| [0.05 Sv] or a committed dose equivalent of 50 rem [0.5 Sv] to any individual organ or tissue; again, with no consideration for the contribution of external dose.
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| M-5
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| The DAC for each class of radionuclide is the concentration of airborne radioactivity in microcurie (µCi)/milliliter that, if an occupational worker were to be continuously exposed to it for 2,000 hours [1 year], would result in one ALI.
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| The TEDE concept makes it possible to combine both the internal and external doses. The ALI and DAC numbers in 10 CFR Part 20 reflect the doses to all principal organs that are irradiated.
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| The ALI and DAC were derived by multiplying a unit intake by the appropriate organ weighting factors (WT), for the organs specifically targeted by the radionuclide compound, and then summing the organ-weighted doses to obtain a whole body risk-weighted effective dose. Per 10 CFR Part 20, Appendix B, when an ALI is defined by the stochastic dose limit, this value alone is given. When the ALI is determined by the nonstochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. Definitions for stochastic and nonstochastic effects can be found in 10 CFR 20.1003.
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| The types and quantities of radioactive material manipulated at most medical facilities do not provide a reasonable possibility for an internal intake by workers. However, uses such as preparing radioiodine capsules from liquid solutions, and opening and dispensing radioiodine from vials containing millicurie quantities, require particular caution. To monitor internal exposures from such operations, a routine bioassay program to periodically monitor workers should be established.
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| If a licensee determines that a program for performing thyroid uptake bioassay measurements is necessary, a program should be established. The program should include
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| * adequate equipment to perform bioassay measurements
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| * procedures for calibrating the equipment, including factors necessary to convert counts per minute into becquerel or µCi units
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| * the technical problems commonly associated with performing thyroid bioassays (e.g., statistical accuracy, attenuation by neck tissue)
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| * the interval between bioassays, differentiating between routine and special bioassays
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| * action levels
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| * the actions to be taken at those levels For additional guidance on developing occupational dose-monitoring programs, refer to the following:
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| * Regulatory Guide (RG) 8.2, Administrative Practices in Radiation Surveys and Monitoring, May 2011.
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| * RG 8.7, Instructions for Recording and Reporting Occupational Radiation Dose Data, May 2018.
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| * RG 8.9, Acceptable Concepts, Models, Equations and Assumptions for a Bioassay Program, July 1993.
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| M-6
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| * RG 8.20, Applications of Bioassay for Radioiodine, September 2014.
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| * RG 8.34, Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, July 1992.
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| * RG 8.40, Methods for Measuring Effective Dose Equivalent from External Exposure, July 2010.
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| * National Council on Radiation Protection and Measurements (NCRP) Report No. 87, Use of Bioassay Procedures for Assessment of Internal Radionuclide Deposition, February 1987.
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| * NUREG/CR-4884, Interpretation of Bioassay Measurements, July 1987.
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| * NUREG-1400, Air Sampling in the Workplace, September 1993.
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| Recordkeeping Records of measurement data, calculations of intakes, and methods for calculating dose must be maintained as required by 10 CFR 20.2106. For additional information on recordkeeping and reporting occupational exposure data, including intakes, refer to RG 8.7, Instructions for Recording and Reporting Occupational Radiation Dose Data, May 2018.
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| Summation of External and Internal Doses Pursuant to 10 CFR 20.1202, Compliance with requirements for summation of external and internal doses, the external and internal doses must be summed, if required to monitor both under 10 CFR 20.1502. RG 8.40, Methods for Measuring Effective Dose Equivalent from External Exposure, contains helpful information regarding occupational doses.
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| M-7
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| APPENDIX N GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES AND MODEL EMERGENCY PROCEDURES
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| General Topics for Safe Use of Radionuclides and Model Emergency Procedures Appropriate first aid and other immediate medical needs of injured individuals should not be neglected, delayed, or ignored due to suspected contamination.
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| This model provides acceptable procedures for responding to emergencies involving spills or patients administered therapeutic amounts of radionuclides. These model procedures also include instructions for autopsy or cremation of patients who have permanent implants or handling a deceased individual with a nuclear pacemaker. Applicants using unsealed licensed material may either adopt this model or develop alternative procedures to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1101. Applicants using therapeutic sealed sources should develop procedures specific to each use. Applicants using permanent implants can use the sample procedure in conjunction with facility-specific therapeutic sealed source emergency procedures.
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| General Safety Procedures to Handle Spills The name and telephone number of the radiation safety officer (RSO) should be posted conspicuously in areas of use, so that they are readily available to workers in case of emergencies. Licensee should have emergency equipment readily available for handling spills.
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| Spill/contamination kits should include the following items:
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| * disposable gloves
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| * disposable lab coats
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| * disposable head coverings
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| * disposable shoe covers
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| * roll of absorbent paper with plastic backing
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| * masking tape
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| * plastic trash bags with twist ties
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| * radioactive material labeling tape
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| * marking pen
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| * prestrung Radioactive Material labeling tags
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| * contamination wipes
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| * instructions for Emergency Procedures
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| * clipboard with a copy of Radioactive Spill Report Form
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| * pencil
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| * appropriate survey instruments, including batteries The decision to implement a major spill/contamination procedure instead of a minor spill/contamination procedure depends on many incident-specific variables, such as the number of individuals affected, other hazards present, likelihood of contamination spread, types of surfaces contaminated, and radiotoxicity of the spilled material.
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| For some spills of radionuclides with half-lives shorter than 24 hours and in amounts less than five times the lowest annual limit on intake (ALI), an alternative spill/contamination procedure may be to restrict access, pending complete decay. In most cases, determination of a major versus minor spill should be based on the lowest ALI for the radionuclide(s) involved in the spill or contamination.
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| N-1
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| The licensee should estimate the amount of radioactivity spilled and initiate a major or minor spill/contamination procedure. Use Table N-1 as general guidance to determine whether a major spill/contamination procedure or a minor spill/contamination procedure will be implemented. Spills above these millicurie (mCi) amounts should be considered major, and spills below these levels should be considered minor.
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| Table N-1. Relative Hazards of Common Radionuclides Radionuclide mCi MBq Radionuclide mCi MBq nitrogen-13 100 3700 technetium-99m 100 3700 carbon-14 10 370 indium-111 10 370 oxygen-15 100 3700 iodine-123 10 370 fluorine-18 100 3700 iodine-125 1 37 phosphorus-32 1 37 iodine-131 1 37 gallium-67 10 370 samarium-153 10 370 rubidium-82 10 370 ytterbium-169 10 370 strontium-82 1 37 mercury-197 10 370 strontium-85 10 370 gold-198 10 370 strontium-89 1 37 thallium-201 100 3700 yttrium-90 1 37 Alpha emitters * *
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| *For radiopharmaceuticals where the primary emission is alpha, consider implementing major spill precautions.
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| Note: A report to the U.S. Nuclear Regulatory Commission (NRC) may be required under 10 CFR 30.50.
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| Minor Spills of Liquids and Solids Instructions to Workers
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| * Notify persons in the area that a spill has occurred.
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| * Prevent the spread of contamination by covering the spill with absorbent paper.
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| * Wear gloves and protective clothing, such as a lab coat and booties, and clean up the spill using absorbent paper. Clean up the spill by wiping from the perimeter of the spill to the center of the spill.
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| * Carefully fold the absorbent paper with the clean side out and place in a bag labeled caution radioactive material for transfer to a radioactive waste container. Also, put contaminated gloves and any other contaminated disposable material in the bag.
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| * Survey the area with an appropriate low-range radiation detection instrument sufficiently sensitive to detect the radionuclide. Survey for removable contamination to ensure contamination levels are below trigger levels (see Appendix R for more information regarding trigger levels). Survey the area around the spill.
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| * Continue to clean up the spill and re-survey until radiation levels and removable contamination are below trigger levels.
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| * Survey hands, clothing, and shoes for contamination prior to leaving the area.
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| N-2
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| * Report the incident to the RSO promptly.
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| * Cooperate and follow the instructions of the RSO and the RSO staff (e.g., criteria for returning to the work area, investigation of root cause, provision of requested bioassay samples, decontamination techniques, surveys, requested documentation).
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| Reminders to RSO
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| * Follow up on the decontamination activities and document the results.
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| * As appropriate, determine cause and corrective actions needed; consider bioassays if licensed material may have been ingested, inhaled, or absorbed through the skin.
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| * If necessary, notify the NRC.
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| Major Spills of Liquids and Solids Instructions to Workers
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| * Clear the area. Notify all persons not involved in the spill to vacate the room.
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| * Prevent the spread of contamination by covering the spill with absorbent paper labeled caution radioactive material, but do not attempt to clean it up. Paper should be dampened, if solids are spilled. To prevent further spread of contamination, clearly indicate the boundaries of the spill and limit the movement of all personnel who may be contaminated.
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| * Shield the source only if it can be done without further contamination or a significant increase in radiation exposure.
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| * Close the room and lock or otherwise secure the area to prevent entry. Post the room with a sign to warn anyone trying to enter that a spill of radioactive material has occurred.
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| * Notify the RSO immediately.
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| * Survey all personnel who could possibly have been contaminated. Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water, then washing with mild soap. Document personnel decontamination efforts.
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| * Cooperate and follow the instructions of the RSO and the RSOs staff (e.g., criteria for returning to the work area, investigation of root cause, provision of requested bioassay samples, decontamination techniques, surveys, requested documentation).
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| Reminders to RSO
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| * Supervise and confirm decontamination of personnel. If decontamination of personnel was not fully successful, consider inducing perspiration by covering the area with plastic.
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| Then wash the affected area again to remove any contamination that was released by the perspiration.
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| N-3
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| * Document decontamination results, including all surveys, location of surveys, and decontamination results.
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| * Evaluate and determine personnel radiation exposure. Beta emitting radionuclides could have a potential for resulting in a shallow-dose exposure in excess of regulatory limits from µCi quantities of contamination.
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| * Determine cause and needed corrective actions; consider need for bioassays if licensed material may have been ingested, inhaled, or absorbed through the skin.
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| * If necessary, notify the NRC.
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| Emergency Surgery of Patients Who Have Received Therapeutic Amounts of Radionuclides For emergency surgery or autopsy of patients administered byproduct material, National Council on Radiation Protection and Measurements (NCRP) Report No. 111, Developing Radiation Emergency Plans for Academic, Medical, or Industrial Facilities, 1991, may contain helpful information.
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| If emergency surgery is performed within the first 24 hours following the administration of iodine-131 sodium iodide, fluids (e.g., blood, urine) will be carefully removed and contained in a closed system.
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| Protective eyewear will be worn by the surgeon and any personnel involved in the surgical procedure for protection of the eyes from possible splashing of radioactive material and exposure from beta radiation (if applicable).
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| The radiation safety staff will direct personnel in methods to keep doses as low as reasonably achievable (ALARA) during surgical procedures.
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| If an injury occurs during surgery that results in a cut or tear in the glove used, the individual involved will be monitored to determine if radioactive material was introduced into the wound.
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| The RSO will be informed of any possible radiation hazard.
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| Autopsy of Patients Who Have Received Therapeutic Amounts of Radionuclides
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| * Immediately notify the authorized user (AU) in charge of the patient and the RSO upon death of a therapy patient.
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| * An autopsy will be performed only after consultation and permission from the RSO.
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| Radiation safety staff should evaluate the radiation hazard(s), direct personnel in safety and protection, and suggest suitable procedures to keep doses ALARA during the autopsy.
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| * Protective eyewear should be worn by the pathologist and assisting staff for protection from possible splashing of radioactive material. Consider the need for protection against exposure from high-energy beta rays in cases involving therapy with phosphorus-32 and yttrium-90.
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| N-4
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| * Remove tissues containing large activities early to help reduce exposure of autopsy personnel. Shield and dispose of contaminated tissues in accordance with license conditions. In some cases, exposure reduction may be accomplished by removing tissues for dissection to a location where the exposure rate is lower.
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| * If an injury occurs during the autopsy that results in a cut or tear in the glove, monitor the wound and decontaminate as appropriate to the situation; inform radiation safety staff.
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| Autopsy or Cremation of Patients Who Have Permanent Implants Patients treated with seed implants will not usually represent a radiation hazard to persons dealing with the body unless there is to be an autopsy or cremation. For autopsy or cremation of patients with permanent implants, NCRP Report No. 155, Management of Radionuclide Therapy Patients, December 2006, may contain helpful information.
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| If an autopsy or cremation is to be performed
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| * Immediately notify the AU in charge of the patient and the RSO upon death of a therapy patient.
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| * Consult and get permission from the RSO.
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| * Instruct pathologist to excise tissue containing radioactive seeds.
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| Make pathologist aware seeds may have migrated and additional tissue may need to be removed.
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| Instruct pathologist to consult with RSO about the possibility of slicing through a seed and contaminating the facility.
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| * Seek municipal approval, if required, because the very high temperatures used in modern crematoria may cause seeds to burst, releasing radioactivity into the plume.
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| Nuclear Pacemakers Medical licensees are often the first to come into contact with plutonium-powered pacemakers or the first to be contacted by nursing homes and funeral homes when a patient with an implanted pacemaker dies. In such cases, and when the licensee is not responsible for control or disposal of the pacemaker, notify the NRC and attempt to contact the hospital where the pacemaker was implanted to arrange for explantation. The licensee that implanted the device is responsible for the follow-up, explantation, and return of the pacemaker to the manufacturer for proper disposal. Information Notice (IN) 98-12, Licensees Responsibilities Regarding Reporting and Follow-up Requirements for Nuclear-Powered Pacemakers, April 3, 1998, provides additional information.
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| N-5
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| APPENDIX O MODEL PROCEDURES FOR ORDERING AND RECEIVING PACKAGES
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| Model Procedures for Ordering and Receiving Packages This model provides acceptable procedures for ordering and receiving packages containing licensed material. Applicants may either adopt this model or develop alternative procedures.
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| Model Guidance
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| * Authorize, through a designee (e.g., radiation safety officer), each order of radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting authorized user (AU) and that possession limits are not exceeded.
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| * Establish and maintain a system for ordering and receiving radioactive material; include the following information:
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| records that identify the AU or department, radionuclide, physical and/or chemical form, activity, and supplier confirmation, through the above records, that material received was ordered through proper channels
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| * For deliveries during normal working hours, instruct carriers to deliver radioactive packages directly to a specified area and provide contact information to the carrier for any questions (e.g., delivery area not accessible, staff not present to receive package).
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| * For deliveries during off-duty hours, instruct security personnel or other designated persons to accept delivery of radioactive packages in accordance with procedures outlined in the sample memorandum for delivery of packages to the Nuclear Medicine Department, provided below. Develop a similar memorandum for delivery of packages to other divisions.
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| O-1
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| Sample Memorandum MEMO TO: Chief of Security FROM: Radiation Safety Officer
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| ==SUBJECT:==
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| Receipt of Packages Containing Radioactive Material The security guard on duty will accept delivery of radioactive material that arrives outside normal working hours. Packages will be taken immediately to the Nuclear Medicine Department, Room _____. Unlock the door, place the package _______________________,
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| and relock the door. If the package appears to be damaged, immediately contact one of the individuals identified below. Ask the carrier to remain at the hospital until it can be determined that neither the driver nor the delivery vehicle is contaminated.
| |
| If you have any questions concerning this memorandum, please call our hospital Radiation Safety Officer, at extension _________.
| |
| NAME HOME TELEPHONE Radiation Safety Officer _________________________________________
| |
| Director of Nuclear Medicine _________________________________________
| |
| Nuclear Medicine Technologist Supervisor _________________________________________
| |
| Nuclear Medicine Technologist on call _________________________________________
| |
| (call/page operator at extension ___)
| |
| Nuclear Medicine Physician on call _________________________________________
| |
| (call/page operator at extension ___)
| |
| O-2
| |
| | |
| APPENDIX P MODEL PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL
| |
| | |
| Model Procedures for Safely Opening Packages Containing Radioactive Material This model provides acceptable procedures for opening packages containing radioactive material. Applicants may either adopt this model procedure or develop an alternative procedure to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1906.
| |
| Special requirements must be followed for packages containing quantities of radioactive material in excess of the Type A quantity limits specified in Table A-1 in Appendix A of 10 CFR Part 71. Such packages must be received expeditiously when the carrier offers them for delivery or when the carrier notifies the licensee that the package has arrived at the carriers terminal. For these and other packages for which monitoring is required, check for external radiation levels and surface contamination within 3 hours of receipt, if received during working hours, or no later than 3 hours from the beginning of the next working day, if received after working hours, in accordance with the requirements of 10 CFR 20.1906(c). Notify the final delivery carrier and the U.S. Nuclear Regulatory Commission (NRC) Operations Center, 301- 816-5100, by telephone, when
| |
| * removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i)
| |
| * external radiation levels exceed the limits of 10 CFR 71.47, External radiation standards for all packages.
| |
| Model Procedure
| |
| : 1. Put on gloves to prevent hand contamination.
| |
| : 2. Visually inspect the package for any sign of damage (e.g., wet or crushed). If damage is noted, stop the procedure and immediately notify the radiation safety officer (RSO) or the designee of the RSO, if the RSO is not present.
| |
| : 3. Monitor the external surfaces of a labeled 1 package for radioactive contamination, unless the package contains only radioactive material in the form of a gas or in special form, as defined in 10 CFR 71.4, Definitions.
| |
| : 4. Monitor the external surfaces of a labeled package for radiation levels, unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 10 CFR 71.4 and Table A-1 in Appendix A of 10 CFR Part 71. Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels, if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
| |
| : 5. Check U.S. Department of Transportation (DOT) White I, Yellow II, or Yellow III label or packing slip for activity of contents, to ensure that the shipment meets the activity as requested by the order and does not exceed license possession limits.
| |
| : 6. Remove the packing slip.
| |
| 1Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations.
| |
| P-1
| |
| : 7. Open the outer package, following any instructions that may be provided by the supplier.
| |
| : 8. Open the inner package and verify that the contents agree with the packing slip.
| |
| : 9. Check the integrity of the final source container. Notify the RSO or the RSOs designee of any broken seals or vials, loss of liquid, condensation, or discoloration of the packing material or anything is found other than what was expected.
| |
| : 10. If there is any reason to suspect contamination, wipe the external surface of the final source container and remove the wipe sample to a low-background area. Assay the wipe sample to determine if there is any removable radioactivity. Use an appropriate instrument with sufficient sensitivity to assay the sample. For example, a sodium iodide crystal and rate meter, a liquid scintillation counter, or a proportional-flow counter may be used for these assays. Convert wipe sample from counts per minute to disintegrations per minute.
| |
| Note: A dose calibrator is not sufficiently sensitive for this measurement. Take precautions against the potential spread of contamination.
| |
| : 11. Check the user request to ensure that the material received is the material that was ordered.
| |
| : 12. Monitor the packing material and the empty packages for contamination with a radiation survey meter before discarding. If contaminated, treat this material as radioactive waste.
| |
| If not contaminated, remove or obliterate the radiation labels before discarding.
| |
| : 13. Make a record of the receipt, package survey, and wipe test results.
| |
| : 14. Notify the final delivery carrier and, the NRC Operations Center at 301-816-5100, by telephone, when removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i), or external radiation levels exceed the limits of 10 CFR 71.47, External radiation standards for all packages.
| |
| : 15. If applicable, comply with the National Source Tracking System reporting requirement, as described in 10 CFR 20.2207, Reports of Transactions Involving Nationally Tracked Sources.
| |
| For packages received under the general license in 10 CFR 31.11, implement the following procedure for opening each package:
| |
| : 1. Visually inspect the package for any sign of damage (e.g., wet or crushed). If damage is noted, stop the procedure and notify the RSO or the RSOs designee immediately.
| |
| : 2. Check to ensure that the material received is the material that was ordered.
| |
| P-2
| |
| | |
| APPENDIX Q MODEL LEAK TEST PROGRAM
| |
| | |
| Model Leak Test Program This model program provides acceptable procedures for sealed-source leak testing and analysis. Applicants may either adopt these model procedures or develop alternative procedures.
| |
| Training Before allowing an individual to perform leak testing, the licensee must ensure that he or she has sufficient classroom and on-the-job training to show competency in performing leak testing and sample analysis independently in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 30.33(a)(3). Records for training on the applicable leak test procedures should be maintained. See Appendix X of this NUREG for recordkeeping requirements.
| |
| Classroom training may be in the form of lecture, online, video, or self-study, and should cover the following subject areas:
| |
| * principles and practices of radiation protection
| |
| * radioactivity measurements, monitoring techniques, and using instruments
| |
| * mathematics and calculations used for measuring radioactivity
| |
| * biological effects of radiation Appropriate on-the-job training consists of the following:
| |
| * observing authorized personnel collecting and analyzing leak test samples
| |
| * collecting and analyzing leak test samples under the supervision and in the physical presence of an individual authorized to perform leak test and sample analysis Facilities and Equipment
| |
| * To ensure the required sensitivity of measurements is achieved, analyze leak tests in a low-background area.
| |
| * Use a calibrated and operable radiation survey instrument to check leak test samples for gross contamination before they are analyzed.
| |
| * Analyze the leak test sample using an instrument that is appropriate for the type of radiation to be measured (e.g., sodium iodide well-counter system for gamma emitters, liquid scintillation detector for beta emitters, or gas-flow proportional counters for alpha emitters).
| |
| * Instrumentation used to analyze leak test samples must be capable of detecting 185 becquerels (Bq) [0.005 microcuries (µCi)] of radioactivity.
| |
| If the sensitivity of the counting system is unknown, determine the minimum detectable activity (MDA). The MDA may be determined using the following formula:
| |
| 2.71 + 4.65 bkg xt MDA =
| |
| t xE Q-1
| |
| | |
| where MDA = minimum detectable activity in disintegrations per minute (dpm) bkg = background count rate in counts per minute (cpm) t = background counting time in minutes E = detector efficiency in counts per disintegration For example:
| |
| where bkg = 200 cpm E = 0.1 counts per disintegration (10 percent efficient) t = 2 minutes 2.71 + 4.65 200 cpm x 2 minutes 2.71 + 4.65 400 MDA = =
| |
| 2 x 0.1 0.2 2.71 + 4.65(20) 2.71 + 93 95.71
| |
| = = =
| |
| 0.2 0.2 0.2 478.55 disintegrations
| |
| =
| |
| minute 1 disintegration becquerels (Bq) =
| |
| second 478.55 disintegration minute MDA = x = 7.976 Bq minutes 60 seconds Note: The MDA equation shown assumes that counting times for the background measurement and for the sample will be equal. MDA equations for nonequal counting times, as well as derivations of equations and discussions of limitations, can be found in Decommissioning Health PhysicsA Handbook for MARSSIM Users, Eric W. Abelquist, published by Taylor & Francis Group, 2001.
| |
| Frequency for Conducting Leak Tests of Sealed Sources Leak tests will be conducted at the frequency specified in the respective Sealed Source and Device registration certificate. If a sealed source is not registered, leak tests should be conducted at 6 month intervals, unless a different interval is established during the licensing process. Leak testing of sealed sources may be required by license condition.
| |
| Procedure for Performing Leak Testing and Analysis [on all sealed sources except individual radium-226 (Ra-226) sealed sources]
| |
| * Follow the manufacturers instructions for performing the leak test.
| |
| * For each sealed source to be tested, list identifying information, such as sealed source serial number, manufacturer, model number, radionuclides, and activity of the sealed source.
| |
| * Use a radiation survey meter to monitor exposure.
| |
| Q-2
| |
| * Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source.
| |
| * Number each wipe to correlate identifying information for each source.
| |
| * Wear gloves.
| |
| * Wipe the most accessible area where contamination would accumulate if the sealed source were leaking, but do not wipe the surface of a plated or foil source (see manufacturers instructions).
| |
| Procedure for Performing Gaseous Emanation Test for Individual Ra-226 Sealed Sources (ANSI/HPS N43.6-1997, Sealed Radioactive Sources - Classification, Appendix A, Section A.2.1.5)
| |
| * For each source to be tested, list identifying information, such as sealed source serial number, manufacturer, model number, radionuclide, and activity.
| |
| * Number each container to correlate information for each source.
| |
| * Wear gloves.
| |
| * Put each Ra-226 sealed source into a separate small, gas-tight container with activated carbon or two cotton filters.
| |
| Leave source in an airtight container for 24 hours.
| |
| Remove source.
| |
| Close container.
| |
| * Measure immediately the activity of the Absorber. (See Model Procedure for Analysis of Gaseous Emanation and Leak Test below for (i) how to analyze the absorber, (ii) required records, (iii) leakage determination, and (iv) required response to a leaking source.)
| |
| * If the wipe test reveals 37 Bq [1 nanocurie (nCi)] or greater of radon or daughter products Notify the RSO.
| |
| Immediately withdraw the sealed source from use and store it, dispose of it, or cause it to be repaired in accordance with the requirements in 10 CFR Parts 20 and 10 CFR Parts 30 [10 CFR 35.67 or standard license condition].
| |
| File a report within 5 days of the leak test, in accordance with 10 CFR 35.3067, Report of a leaking source, or standard license condition.
| |
| Procedure for Analysis of Leak Test and Gaseous Emanation
| |
| * Select an instrument that is sensitive enough to detect 185 Bq [0.005 µCi] of the radionuclide and ensure that its calibration is current.
| |
| * Using the selected instrument, count and record background count rate.
| |
| Q-3
| |
| * Check the instruments counting efficiency using a standard source of the same radionuclide as the source being tested or one with similar energy characteristics. The calibration source should be in the same configuration as the sample. Accuracy of standards should be within +/- 5% of the stated value and traceable to a primary radiation standard, such as those maintained by the National Institute of Standards and Technology.
| |
| * Calculate the counting efficiency of the detector.
| |
| [(cpm from std) - (cpm from bkg)]
| |
| Efficiency in cpm/Bq =
| |
| activity of std in Bq where cpm = counts per minute std = standard bkg = background Bq = Becquerel
| |
| * Count each wipe (or absorber for a Ra-226 sealed source) sample; determine net count rate.
| |
| * For each sample, calculate and record activity in Bq (or µCi).
| |
| * The activity of the sample in becquerels may be calculated using the following formula:
| |
| [(cpm from wipe sample) - (cpm from bkg)]
| |
| Activity of sample [Bq] =
| |
| efficiency in cpm/Bq
| |
| * Leak test records (which include the gaseous emanation test) will be retained in accordance with 10 CFR 35.2067, Records of leak tests and inventory of sealed sources and brachytherapy sources, or standard license condition for 3 years.
| |
| Licensees should include the following in records:
| |
| the model number and serial number (if assigned) of each source tested the identity of each source radionuclide and its estimated activity the measured activity of each test sample expressed in Bq (or µCi) a description of the method used to measure each test sample the date of the test the name of the individual who performed the test
| |
| * If the wipe test reveals 185 Bq [0.005 µCi] [or 37 Bq [1 nCi] of radon or daughter products] or greater:
| |
| Notify the RSO.
| |
| Immediately withdraw the sealed source from use and store it, dispose of it, or cause it to be repaired in accordance with the requirements in 10 CFR Parts 20 and 10 CFR Parts 30 [10 CFR 35.67 or standard license condition].
| |
| File a report within 5 days of the leak test, in accordance with 10 CFR 35.3067, Report of a leaking source, or standard license condition.
| |
| Q-4
| |
| | |
| APPENDIX R MODEL PROCEDURES FOR AREA SURVEY
| |
| | |
| Model Procedures for Area Survey This model provides acceptable methods for area surveys. Applicants may either adopt these model procedures or develop alternative procedures to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1101, 10 CFR 20.1501, and 10 CFR 35.70, Surveys of ambient radiation exposure rate. Guidance for developing alternate trigger levels for contamination in restricted areas is included below. Before use of survey instrumentation, perform a daily check with a dedicated check source and battery checks.
| |
| Ambient Radiation Level Surveys Procedures for ambient radiation level surveys (reference 10 CFR 20.1101, 10 CFR 20.1501, and 10 CFR 35.70):
| |
| * Perform surveys of dose rates in locations where Workers are exposed to radiation levels that might result in radiation doses in excess of 10 percent of the occupational dose limits or An individual is working in an environment with a dose rate of 0.025 millisievert (mSv)/h [2.5 millirem/hour (h)] or more [5 rem/year (yr) divided by 2,000 h/yr].
| |
| * Regulations in 10 CFR 20.1301, Dose limits for individual members of the public, require that the total effective dose equivalent to an individual member of the public from the licensed operation does not exceed 1 millisievert (mSv) [0.1 rem] in a year and that the dose in any unrestricted area from external sources does not exceed 0.02 mSv
| |
| [0.002 rem] in any one hour. Appropriate surveys will be conducted to ensure that the requirements of 10 CFR 20.1301 are met.
| |
| * Perform radiation level surveys with a radiation survey meter sufficiently sensitive to detect 0.1 milliroentgen (mR)/h in the following areas, at the frequency specified:
| |
| Survey at the end of each day of use all radiopharmaceutical elution, preparation, assay and administration areas (except patient rooms, which will be surveyed at the end of the therapy instead of on the day of administration) when using radiopharmaceuticals requiring a written directive [e.g., all therapy dosages and any iodine (I)-131 dosage exceeding 30 microcuries (µCi)].
| |
| Survey monthly all laboratory areas where only small quantities of gamma-emitting radioactive material are used (less than 200 µCi at a time).
| |
| Survey weekly all radionuclide use, storage, and waste storage areas. If diagnostic administrations are occasionally made in patients rooms [e.g., bone scan injections, technetium (Tc)-99m heart agents] and special care is taken to remove all paraphernalia, those rooms need not be surveyed.
| |
| * If trigger levels are exceeded, follow internal procedures for responding and investigating what caused the trigger to be tripped. Examples of trigger levels for restricted and unrestricted areas are presented in Table R-1.
| |
| R-1
| |
| | |
| Table R-1. Ambient Dose Rate Trigger Levels Type of Survey Area Surveyed Trigger Level Ambient Dose Rate Unrestricted 0.1 mR/h Ambient Dose Rate Restricted 5.0 mR/h Contamination Surveys Facilities and equipment for contamination surveys:
| |
| To ensure achieving the required sensitivity of measurements, analyze survey samples in a low-background area. The section of Table K-1, entitled Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples, provides examples of appropriate instruments.
| |
| Perform contamination surveys using instruments suitable for removable and fixed contamination to identify areas of contamination that might result in doses to workers or to the public. Removable contamination can be detected and measured by conducting a wipe test of the surface, counted in an appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or germanium gamma counter, or a proportional alpha/beta counter.
| |
| Procedures for contamination surveys:
| |
| * Contamination surveys are performed in areas where unsealed forms of byproduct materials are used:
| |
| to evaluate radioactive contamination that could be present on surfaces of floors, walls, laboratory furniture, and equipment after any spill or contamination event when procedures or processes have changed to evaluate contamination of users and the immediate work area, at the end of the day or before leaving the area of use, when licensed material is used in unrestricted areas at frequencies consistent with the types and quantities of materials in use, but not less frequently than monthly in areas adjacent to restricted areas and in all areas through which licensed materials are transferred and temporarily stored before shipment
| |
| * Use methods for conducting surveys for removable contamination that are sufficiently sensitive to detect contamination for those radionuclides in use and for which the most restrictive limits apply, as listed in Tables R-2 for restricted areas and Table R-3 for unrestricted areas [e.g., 200 disintegrations per minute (dpm)/100 square centimeters (cm2) for isotopes of I-131 in unrestricted areas]. Table R-3 for unrestricted areas is based on Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source, or Special Nuclear Material (August 1987) (ADAMS Accession No. ML030590504). Removable contamination survey samples should be measured in a low-background area. The following areas and frequencies should be followed:
| |
| R-2
| |
| | |
| Removable contamination surveys weekly for radiopharmaceutical elution, preparation, assay, and administration areas. If diagnostic administrations are occasionally made in patients rooms (e.g., bone scan injections, Tc-99m heart agents), with special care taken to remove all paraphernalia, those rooms need not be surveyed.
| |
| Removable contamination surveys monthly of laboratory areas where only small quantities of photon emitting radioactive material are used (less than 200 µCi at a time).
| |
| Removable contamination surveys weekly for radionuclide storage and radionuclide waste storage areas.
| |
| * A radioactive source with a known amount of activity should be used to convert sample measurements (usually in counts per minute) to dpm.
| |
| * Contamination found in unrestricted areas should be immediately decontaminated to background levels using appropriately sensitive equipment. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table R-3.
| |
| * The area should be either decontaminated, shielded, or posted and restricted from use if it cannot be decontaminated.
| |
| * If trigger levels are exceeded, follow internal procedures for responding and investigating what caused the trigger to be tripped. Examples of trigger levels for restricted areas are presented in Table R-2. Contamination found in unrestricted areas and on personal clothing will be immediately decontaminated to background levels.
| |
| Note: For the purposes of release of facilities for unrestricted use or termination of the license, values located in Table R-2 have been superseded by 10 CFR 20, Subpart E, Radiological Criteria for License Termination, and cannot be used for that purpose. In particular, the acceptable contamination levels listed below for most alpha emitters exceed the levels that will meet the 10 CFR Part 20, Subpart E criteria. Table R-3 levels can continue to be used for release of equipment and material from licensed material facilities during operational activities prior to license termination. (63 FR 64132; November 18, 1998).
| |
| Table R-2. Surface Contamination Levels in Restricted Areas (dpm/100 cm2)
| |
| Area, clothing Restricted areas, protective clothing used only in restricted area alpha emitters 200 P-32, Co-58, Fe-59, Co-60, Se-75, 2000 Sr-85, Y-90, In-111, I-123, I-125, I-131, Sm-153, Yb-169, Lu-177, Au-198 Cr-51, Co-57, Ga-67, Tc-99m, Hg-197, 20000 Tl-201 R-3
| |
| | |
| Table R-3. Acceptable Surface Contamination Levels in Unrestricted Areas (per 100 cm2)
| |
| Nuclide1 Average2, 3, 4 Maximum2, 4, 5 Removable2, 4, 6 U-nat, U-235, U-238, and associated 83.3 Bq 250 Bq 16.7 Bq decay products 5,000 dpm 15,000 dpm 1,000 dpm Transuranics, I-125, I-129, Ra-226, 1.7 Bq 5.0 Bq 0.3 Bq Ra-228, Pa-231, Ac-227, Th-230 100 dpm 300 dpm 20 dpm I-126, I-131, I-133, Ra-223, Ra-224, 16.7 Bq 50.0 Bq 3.3 Bq Sr-90, U-232, Th-nat, Th-232 1,000 dpm 3,000 dpm 200 dpm Other alpha emitters 1 8.33 Bq 25 Bq 1.67 500 dpm 1,500 dpm 100 dpm Beta-gamma emitters (nuclides with 83.3 Bq 250 Bq 16.7 Bq decay modes other than alpha 5,000 dpm 15,000 dpm 1,000 dpm emission or spontaneous fission) except those noted above.
| |
| 1Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for alpha- and beta-gamma-emitting radionuclides should apply independently.
| |
| 2As used in this table, disintegrations per minute (dpm) means the rate of emission by radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation.
| |
| 3Measurements of average contaminants should not be averaged over more than 1 square meter. For objects of less surface area, the average should be derived for each such object.
| |
| 4The average and maximum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed 0.2 millirad/h at 1 cm and 1.0 millirad/h at 1 cm, respectively, measured through not more than 7 milligram/cm2 of total absorber.
| |
| 5The maximum contamination level applies to an area of not more than 100 cm2.
| |
| 6The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area with a filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of less surface area is determined, the pertinent levels should be reduced proportionally, and the entire surface should be wiped.
| |
| Establishing Alternate Trigger Levels for Restricted Areas The following guidance is provided for those applicants who plan to develop procedures for surveying and controlling contamination using action levels for controlling contamination that differ from those provided in Tables R-1 and R-2:
| |
| Alternate action levels for cleanup of contamination in restricted areas may be developed without prior NRC approval if
| |
| * acceptable unrestricted area trigger levels are implemented (e.g., Tables R-1 and R-3)
| |
| * the action levels maintain occupational doses as low as is reasonably achievable (ALARA)
| |
| * the action levels meet all other regulatory requirements (e.g., they should also be designed to minimize, to the extent practicable, contamination of the facility and the environment; facilitate eventual decommissioning; and minimize, to the extent practicable, the generation of radioactive waste) 1Surface contamination levels derived using one order of magnitude less than the values for beta-gamma emitters R-4
| |
| | |
| Contents of Survey Records Each survey record should include the following:
| |
| * a diagram of the area surveyed
| |
| * a list of items and equipment surveyed
| |
| * specific locations on the survey diagram where wipe tests were taken
| |
| * ambient radiation levels with appropriate units
| |
| * contamination levels with appropriate units
| |
| * make and model number of instruments used
| |
| * background levels
| |
| * name of the person making the evaluation and recording the results and date Licensees should record contamination levels observed and procedures followed for incidents involving contamination of individuals. The record should include names of individuals involved, description of work activities, calculated dose, probable causes (including root causes), steps taken to reduce future incidents of contamination, times and dates, and the surveyors signature.
| |
| Licensees must maintain records of surveys required by 10 CFR 20.1501 and 10 CFR 35.70.
| |
| Licensees must retain these records for 3 years after the record is made as required by 10 CFR 20.2103 and 10 CFR 35.2070.
| |
| R-5
| |
| | |
| APPENDIX S MODEL PROCEDURES FOR DEVELOPING, MAINTAINING, AND IMPLEMENTING WRITTEN DIRECTIVES
| |
| | |
| Model Procedures for Developing, Maintaining, and Implementing Written Directives This model provides acceptable procedures for administrations that require written directives (WD). Applicants may either adopt this model procedure or develop their own procedure to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 35.40.
| |
| Written Directive Procedures This model provides guidance to licensees and applicants for developing, maintaining, and implementing procedures for administrations that require WDs. This model does not restrict the use of other guidance in developing, implementing, and maintaining written procedures for administrations requiring a WD. Such procedures are to provide high confidence that the objectives specified in 10 CFR 35.41 will be met.
| |
| The WD must be prepared for any administration of iodine-131 sodium iodide greater than 1.11 megabecquerels [30 microcuries], any therapeutic dosage of a radiopharmaceutical, and any therapeutic dose of radiation from byproduct material. The WD must contain the information described in 10 CFR 35.40 and be retained in accordance with 10 CFR 35.2040, Records of written directives.
| |
| Discussion The administration of radioactive materials can be a complex process for many types of diagnostic and therapeutic procedures in nuclear medicine or radiation oncology departments.
| |
| A number of individuals may be involved in the delivery process. For example, in an oncology department, when the authorized user (AU) prescribes a high dose-rate treatment, the delivery process may involve a team of medical professionals, such as an authorized medical physicist (AMP), a dosimetrist, and a radiation therapist. Treatment planning may involve a number of measurements, calculations, computer-generated treatment plans, patient simulations, and film verifications to deliver the prescribed dose. Therefore, instructions must be clearly communicated to the professional team members with constant attention devoted to detail during the treatment process. Complicated processes of this nature require good planning and clear, understandable procedures. To help ensure that all personnel involved in the treatment fully understand instructions in the WD or treatment plan, the licensee should instruct all workers to seek guidance if they do not understand how to carry out the WD. Specifically, workers should ask if they have any questions about what to do or how it should be completed before administration, rather than continuing a procedure when there is any doubt. Licensees should also consider verification of WDs or treatment plans by at least one qualified person (e.g., an oncology physician, AMP, ophthalmic physicist, nuclear medicine technologist, or radiation therapist), preferably other than the individual who prepared the dose, the dosage, or the treatment plan.
| |
| The administration of radioactive materials can involve a number of treatment modalities (e.g., radiopharmaceutical therapy, teletherapy, brachytherapy, gamma stereotactic radiosurgery (GSR), and future emerging technologies). For each such modality for which 10 CFR 35.40 requires, or would require, a WD (as defined in 10 CFR 35.2, Definitions), the licensee should develop, implement, and maintain written procedures to meet the requirements and objectives of 10 CFR 35.40, 35.41, and 35.63, outlined below:
| |
| S-1
| |
| * Confirm that the WD is signed and dated by the AU prior to the administration, in accordance with 10 CFR 35.40, and includes the name of the patient or human research subject.
| |
| * Verify the identity of the patient or human research subject prior to each administration.
| |
| * Verify that the administration is in accordance with the treatment plan, if applicable, and the WD.
| |
| * Check both manual and computer-generated dose calculations.
| |
| * Verify that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical devices authorized by 10 CFR 35.600 or 10 CFR 35.1000.
| |
| * Determine if a medical event, as defined in 10 CFR 35.3045, has occurred.
| |
| * Determine, for permanent implant brachytherapy, within 60 calendar days from the date of implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implant portion of the written directive.
| |
| * Determine and record the activity of the radiopharmaceutical dosage or radiation dose before medical use.
| |
| The following procedures are provided as assistance in meeting the above objectives.
| |
| Procedures for Any Therapeutic Dose or Dosage of a Radionuclide or Any Dosage of Quantities Greater than 30 Microcuries of Iodine-131 Sodium Iodide Develop, implement, and maintain the following procedures to meet the objectives of 10 CFR 35.40 and 10 CFR 35.41:
| |
| * An AU must date and sign a WD prior to the administration of any dose or dosage. WDs may be maintained in patients charts and must be available for inspection and retained for 3 years in accordance with 10 CFR 35.2040.
| |
| * Prior to administering a dose or dosage, the identity of a patient or human research subject will be positively verified as the individual named in the WD. Examples of positive patient identity verification include examining the patients ID bracelet, hospital ID card, drivers license, or other forms of identification. Asking or calling the patients name does not constitute positive patient identity verification.
| |
| * The specific details of the administration will be verified, including the dose or dosage, in accordance with the WD or treatment plan. All components of the WD (e.g., radionuclide, total source strength, total dose, or dosage) will be confirmed by the person administering the dose or dosage to verify agreement with the WD. Appropriate verification methods include (i) measuring the activity in the dose calibrator, (ii) checking the serial number of the sealed sources behind an appropriate shield, (iii) using color-coded sealed sources, or (iv) using clearly marked storage locations.
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| S-2
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| Procedures for Sealed Therapeutic Sources and Devices Containing Sealed Therapeutic Sources Licensees are required under 10 CFR 35.40 and 10 CFR 35.41 to have WDs for certain administrations of doses and to have procedures for administrations for which a WD is required.
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| Model procedures for meeting these requirements appear below.
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| Complete the WD in accordance with 10 CFR 35.40. For temporary implants, before implantation, record the treatment site, radionuclide, and dose, as required by 10 CFR 35.40(b)(7)(i), and after implantation but before completion of the procedure, record the radionuclide, treatment site, number of sources, total source strength and exposure time (or the total dose), and date, as required by 10 CFR 35.40(b)(7)(ii). For permanent implants, before implantation, record the treatment site, radionuclide, and total source strength, as required by 10 CFR 35.40(b)(6)(i), and after implantation but before the patient leaves the post-treatment recovery area, record the treatment site, the number of sources implanted, the total source strength implanted, and the date, as required by 10 CFR 35.40(b)(6)(ii). The WD may be maintained in the patients chart.
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| To ensure that the dose is delivered in accordance with the WD, the AU (and the neurosurgeon for GSR therapy) must date and sign the treatment plan, indicating approval. The treatment plan should provide sufficient information and direction to meet the objectives of the WD.
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| For sealed sources inserted into the patients body, radiographs or other comparable images (e.g., computerized tomography) will be used as the basis for verifying the position of the nonradioactive dummy sources and calculating the administered dose before administration.
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| However, for some brachytherapy procedures, the use of various fixed geometry applicators (e.g., appliances or templates) may be required to establish the location of the temporary sources and to calculate the exposure time (or, equivalently, the total dose) required to administer the prescribed brachytherapy treatment. In these cases, radiographs or other comparable images may not be necessary, provided the position of the sources is known prior to insertion of the radioactive sources and calculation of the exposure time (or, equivalently, the total dose).
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| Dose calculations will be checked before administering the prescribed therapy dose. An AU or a qualified person under the supervision of an AU (e.g., an AMP, ophthalmic physicist, oncology physician, dosimetrist, or radiation therapist), preferably an individual who did not make the original calculations, will check the dose calculations. Methods for checking the calculations include the following:
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| : 1. for computer-generated dose calculations, examining the computer printout to verify that correct input data for the patient was used in the calculations (e.g., source strength and positions)
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| : 2. for computer-generated dose calculations entered into the therapy console, verifying correct transfer of data from the computer (e.g., channel numbers, source positions, and treatment times)
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| : 3. for manually-generated dose calculations, verifying
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| : a. no arithmetical errors
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| : b. appropriate transfer of data from the WD, treatment plan, tables, and graphs S-3
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| : c. appropriate use of nomograms (when applicable)
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| : d. appropriate use of all pertinent data in the calculations The therapy dose will be manually calculated to a single key point and the results compared to the computer-generated dose calculations. If the manual dose calculations are performed using computer-generated outputs (or vice versa), verify the correct output from one type of calculation (e.g., computer) to be used as an input in another type of calculation (e.g., manual).
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| Parameters such as the transmission factors for wedges and applicators and the source strength of the sealed source used in the dose calculations will be checked.
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| Acceptance testing will be performed by a qualified person (e.g., an AMP) on each treatment-planning or dose-calculating computer program that could be used for dose calculations.
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| Acceptance testing will be performed before the first use of a treatment-planning or dose-calculating computer program for therapy dose calculations. Each treatment-planning or dose-calculating computer program will be assessed, based on specific needs and applications. A check of the acceptance testing will also be performed after each source replacement or when spot-check measurements indicate that the source output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay.
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| Independent checks on full calibration measurements will be performed. The independent check will include an output measurement for a single specified set of exposure conditions and will be performed within 30 days following the full calibration measurements. The independent check will be performed by either
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| : 1. an individual who did not perform the full calibration (the individual will meet the requirements specified in 10 CFR 35.51) using a dosimetry system other than the one that was used during the full calibration (the dosimetry system will meet the requirements specified in 10 CFR 35.630), or
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| : 2. an AMP (or an oncology physician, dosimetrist, or radiation therapist who has been properly instructed) using a thermoluminescence dosimetry service available by mail that is designed for confirming therapy doses and that is accurate within 5 percent For GSR, particular emphasis will be directed on verifying that the stereoscopic frame coordinates on the patients skull match those of the treatment plan.
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| For emerging technologies (e.g., Yttrium-90 Microsphere Brachytherapy, Leksell Gamma Knife Perfexion), the licensee should review the applicable guidance on the Medical Uses Licensee Toolkit Web page to ensure the written directive contains all necessary components.
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| A physical measurement of the teletherapy output will be made under applicable conditions prior to administration of the first teletherapy fractional dose, if the patients treatment plan includes (i) field sizes or treatment distances that fall outside the range of those measured in the most recent full calibration; or (ii) transmission factors for beam-modifying devices (except nonrecastable and recastable blocks, bolus and compensator materials, and split-beam blocking devices) not measured in the most recent full calibration measurement.
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| A weekly chart check will be performed by a qualified person under the supervision of an AU (e.g., an AMP, ophthalmic physicist, dosimetrist, oncology physician, or radiation therapist) to detect mistakes (e.g., arithmetical errors, miscalculations, or incorrect transfer of data) that may S-4
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| have occurred in the daily and cumulative dose administrations from all treatment fields or in connection with any changes in the WD or treatment plan.
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| Treatment-planning computer systems using removable media to store each patients treatment parameters for direct transfer to the treatment system will have each card labeled with the corresponding patients name and identification number. Such media may be reused and must be relabeled in accordance with the manufacturers instructions.
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| Review of Administrations Requiring a Written Directive As required by 10 CFR 35.41, determine whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the WD or treatment plan, as applicable, and whether a medical event, as defined in 10 CFR 35.3045, has occurred. For permanent implant brachytherapy, determine, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implant portion of the WD, to evaluate whether a medical event, as defined in 10 CFR 35.3045, has occurred. When deviations from the WD are found, the cause of each deviation and the action required to prevent recurrence should be identified Conduct periodic reviews of each applicable program area (e.g., radiopharmaceutical therapy, high dose-rate brachytherapy, implant brachytherapy, teletherapy, and emerging technologies).
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| The number of patient cases to be sampled should be based on the number of treatments performed and be representative of each treatment modality performed in the institution.
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| If feasible, the persons conducting the review should not review their own work. If this is not possible, two people should work together as a team to conduct the review of that work.
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| Regularly review the findings of the periodic reviews to ensure that the procedures for administrations requiring a WD are effective.
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| Reports of Medical Events Notify by telephone the U.S. Nuclear Regulatory Commission (NRC) Operations Center at 301-816-5100 no later than the next calendar day after discovery of a medical event and submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6, Communications, within 15 days after the discovery of the medical event, as required by 10 CFR 35.3045, Report and notification of a medical event. Also, notify the referring physician and the patient as required by 10 CFR 35.3045.
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| S-5
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| APPENDIX T MODEL PROCEDURES FOR SAFE USE OF UNSEALED LICENSED MATERIAL
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| Model Procedures for Safe Use of Unsealed Licensed Material This model 1 provides acceptable procedures for safe use of unsealed licensed material.
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| Applicants may either adopt these model procedures or develop their own procedures. Some of the health physics practices listed below may also apply to sealed sources.
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| * Wear laboratory coats or other protective clothing at all times in areas where radioactive materials are used.
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| * Wear disposable gloves at all times while handling radioactive materials.
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| * Either after each procedure or before leaving the area, monitor hands for contamination in a low-background area using an appropriate survey instrument.
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| * Use syringe shields for reconstitution of radiopharmaceutical kits and administration of radiopharmaceuticals to patients, except when their use is contraindicated (e.g., recessed veins, infants). In these and other exceptional cases, use other protective methods, such as remote delivery of the dose (e.g., use a butterfly needle).
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| * Do not eat, store food, drink, smoke, or apply cosmetics in any area where licensed material is stored or used.
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| * Wear personnel monitoring devices, if required, at all times while in areas where radioactive materials are used or stored. These devices shall be worn as prescribed by the radiation safety officer. When not being worn to monitor occupational exposures, personnel monitoring devices shall be stored in the work place in a designated low-background area.
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| * Wear extremity dosimeters, if required, when handling radioactive material.
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| * Dispose of radioactive waste only in designated, labeled, and properly shielded receptacles.
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| * Never pipette by mouth.
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| * Wipe-test unsealed byproduct material storage, preparation, and administration areas weekly for contamination. If necessary, decontaminate the area.
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| * Survey all areas of licensed material use, including the generator storage, kit preparation, and injection areas, for contamination using a survey instrument each day of use. If necessary, decontaminate the area. Areas used to prepare and administer therapy quantities of radiopharmaceuticals must be surveyed daily in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 35.70 (except when administering therapy dosages in patients rooms when patients are confined).
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| * Store radioactive solutions in shielded containers that are clearly labeled.
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| 1NCRP Report No. 30, Safe Handling of Radioactive Materials, March 1964.
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| T-1
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| * Radiopharmaceutical multi-dose diagnostic and therapy vials, syringes, and unit dosages must be labeled in accordance with 10 CFR 35.69, Labeling of vials and syringes, and 10 CFR 20.1904, Labeling containers. Mark the label with the radionuclide, the activity, the date for which the activity is estimated, and the kind of materials (i.e., radiopharmaceutical). If the container is holding less than the quantities listed in Appendix C to 10 CFR Part 20, Quantities of Licensed Material Requiring Labeling, the syringe or vial need only be labeled to identify the radioactive drug (10 CFR 35.69). To avoid mistaking patient dosages, label the syringe with the type of study and the patients name.
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| * For prepared dosages, assay each patient dosage in the dose calibrator (or instrument) before administering it (10 CFR 35.63).
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| * Do not use a dosage if it does not fall within the prescribed dosage range or if it varies more than +/-20% from the prescribed dosage, except as approved by an authorized user.
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| * When measuring the dosage, licensees need not consider the radioactivity that adheres to the syringe wall or remains in the needle.
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| * Check the patients name and identification number and the prescribed radionuclide, chemical form, and dosage before administering. If the prescribed dosage requires a written directive (WD), the patients identity must be verified, and the administration must be in accordance with the WD (10 CFR 35.41).
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| * Always keep calibration, transmission, and reference sources, syringes, waste, and other radioactive material in shielded containers.
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| * Secure all licensed material when not under the constant surveillance and immediate control of an individual authorized under the U.S. Nuclear Regulatory Commission license or Agreement State license (or such individuals designee).
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| T-2
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| APPENDIX U RELEASE OF PATIENTS OR HUMAN RESEARCH SUBJECTS ADMINISTERED RADIOACTIVE MATERIALS
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| Release of Patients or Human Research Subjects Administered Radioactive Materials Regulations in Title 10 of the Code of Federal Regulations (10 CFR) 35.75 permit a licensee to authorize the release from its control any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv [0.5 rem]. However, a patient who meets the release criteria in 10 CFR 35.75 is not required to leave the hospital immediately following administration of radioactive materials and may be hospitalized for other medical reasons. The licensee can release the patient from its radiological controls while the patient remains hospitalized for other medical reasons if the licensee ensures 10 CFR 35.75 is met for that patients specific situation.
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| Regulatory Guide (RG) 8.39, Release of Patients Administered Radioactive Materials, provides guidance for releasing patients under 10 CFR 35.75. Licensees should use the most current version of RG 8.39 when developing procedures for the release of patients who are administered radioactive materials. The original RG was issued April 1997, and its errata issued May 1997, to provide guidance for the release of patients, under the 1997 revision of 10 CFR 35.75. Since that time, the NRC has looked in more detail at a number of specific issues associated with implementation of the 1997 revision and provided the following generic communications on these issues.
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| * Information Notice (IN) 2017-02, Best practice concepts for patient release, issued May 17, 2017.
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| * Regulatory Issue Summary (RIS) RIS 2011-01, NRC Policy on Release of Iodine-131 Therapy Patients Under 10 CFR 35.75 to Locations Other Than Private Residences, issued January 25, 2011.
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| * RIS 2008-11, Precautions to Protect Children Who May Come In Contact with Patients Released After Therapeutic Administrations of Iodine-131, issued in May 12, 2008.
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| * IN 2003-22, Heightened Awareness for Patients Containing Detectable Amounts of Radiation from Medical Administrations, issued on December 9. 2003 and its Supplement 1 issued July 29, 2009.
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| U-1
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| APPENDIX V RADIOACTIVE MATERIALS GUIDANCE FOR MOBILE MEDICAL SERVICES
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| Radioactive Materials Guidance for Mobile Medical Services Before submitting information to the U.S. Nuclear Regulatory Commission (NRC), review Chapter 6, Identifying and Protecting Sensitive Information, of this document for guidance on identifying and protecting sensitive information. All security-related sensitive information in the application should be identified and properly marked.
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| Mobile medical service providers must comply with all applicable sections of Title 10 of the Code of Federal Regulations (10 CFR) Part 30 and 10 CFR Part 35, as well as U.S. Department of Transportation (DOT) regulations regarding approved source holders, placement of sources in approved containers prior to their transport, and hazardous materials training. For example, providers offering remote afterloaders must comply with 10 CFR Part 35, Subpart H. The sections below describe the type of information that should be submitted when requesting to conduct mobile medical service provider activities.
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| Type and Location of Use In general, there are two types of mobile medical service. One type is transportation and use of byproduct material within a transport vehicle (e.g., in-van or trailer use). A second type is transportation of byproduct material to a clients facility for use within a clients facility by either the mobile medical services employees (i.e., transport and use) or the clients employees (i.e., transport only). Additionally, a licensee operating at a fixed location may contract for use of a mobile coach on a temporary (e.g., 3 months) or permanent basis under their own NRC license. This is traditionally done when a licensee is in the process of constructing new nuclear medicine facilities or when the licensee starts a Positron Emission Tomography (PET) program.
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| This is not a mobile medical service, since the mobile coach will be parked at the fixed location of use and operated by the non-mobile licensee. An amendment to add this additional area of use at their address of use should be requested as described in Chapter 9 of this NUREG.
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| For mobile medical service, which includes use by the service provider, the service provider should apply for full service authorization. Service providers who only transport and store a therapy device need only apply for authorization for possession and transport of the byproduct material. In this case, when the service provider is only transporting the therapy device for use, the client must possess a license for medical use of the byproduct material. Additionally, in this case, the client is authorized to provide the patient treatments and is responsible for all aspects of the byproduct material use and patient treatments upon transfer of the byproduct material to the clients possession.
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| A PET mobile medical service provider that uses a quiet room and/or a patient waiting area in the clients facility may either be authorized for in-van or trailer use only or transport and use, depending on whether the PET patients meet the criteria for release described in 10 CFR 35.75 while they are in the quiet room. If they do not, then the quiet room is an area of use for the mobile medical service licensee and should be under their control while onsite. In addition, for mobile nuclear medicine and PET imaging, the licensee should take into account the possibility of using the clients bathroom dedicated for their use for PET patients and finding the bathroom with low levels of radioactive contamination during the end-of-day surveys. In this event, the mobile licensee must provide direction to the client for restricting access to the bathroom until follow up surveys show the bathroom free of contamination (e.g., post and close off the patient bathroom for a designated period of time to allow for radioactive decay). The mobile medical service provider should also survey quiet rooms, provided for their use at the clients site, for V-1
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| contamination and radiation levels, to ensure that public dose limits are not exceeded and that these areas are left free of contamination following use.
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| The locations of use for mobile medical services are of two basic types. One type of location is the base location where licensed material is received, stored, and sometimes used. The other type of location is the temporary jobsite at client facilities. The following two sections describe the type of information necessary for base locations and temporary jobsites.
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| Mobile Medical Service Agreement Regulations in 10 CFR 35.80(a)(1) require, in part, that a licensee providing mobile medical service obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the clients address and clearly delineates the authority and responsibility of the licensee and the client. This agreement must be applicable for the entire period of time over which the service is to be provided. The letter will be retained for 3 years after the last provision of service, as required by 10 CFR 35.80(c) and 10 CFR 35.2080, Records of mobile medical services. Additionally, as required by 10 CFR 35.80(a)(4), the licensee must survey all areas of use, to ensure compliance with the requirements in 10 CFR Part 20 (e.g., ensure that all byproduct material, including radiopharmaceuticals, sealed sources, and all associated wastes, have been removed) before leaving a clients address.
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| The following is provided as an example of a PET mobile medical service agreement.
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| SAMPLE PET MOBILE MEDICAL SERVICE AGREEMENT In accordance with 10 CFR 35.80(a)(1), management designee, Sam Curie of ABC Hospital, Inc. acknowledges that mobile medical service provider, PET Mobile, Inc., will use byproduct material at client address 456 Rad Road, Somewhere, WV. Service will be provided every Monday beginning February 1, 2014. All radioactive material will be removed from the client facility prior to leaving the site. PET Mobile, Inc. will abide by all NRC and Agreement State regulations while on-site.
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| The following authority and responsibilities are delegated to the client:
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| * ordering of radioactive dosages The following authority and responsibilities are delegated to the mobile medical service provider:
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| * Package receipt and return surveys.
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| * Quality control testing on equipment used to measure radioactive dosages (e.g., dose calibrator).
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| * Quality control testing and calibration of survey instrumentation (e.g., radiation survey meter, well counter).
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| * Sealed-source inventories and leak testing.
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| * Shipping papers.
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| V-2
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| * Radiation safety and hazardous materials (HAZMAT) training for mobile medical service personnel.
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| * Radiation safety training for client staff involved in: (i) controlling patient waiting areas used by the mobile medical service provider in the hospital; (ii) performing surveys to support release of the patient bathroom located in the hospital; and (iii) providing patient escort.
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| * Surveys of all interior PET trailer areas.
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| * Surveys of areas exterior to the PET trailer to ensure compliance with 10 CFR 20.1301 and roping off of any area (if necessary) to ensure that the dose rate is less than 0.02 mSv [2 millirem (mrem)] in any one hour.
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| * Surveys of patient waiting area in the hospital to ensure compliance with 10 CFR 20.1301 {0.02 mSv [2 mrem] in any one hour and 1 mSv [0.1 rem] in a year}
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| since the patient has not yet been released under 10 CFR 35.75 and is awaiting scanning.
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| * Surveys of dedicated PET patient bathroom located within the hospital prior to leaving client site.
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| * Decay in storage and disposal of radioactive material/waste. Radioactive waste will be removed to the PET trailer for storage. Non-radioactive waste that has been surveyed and shown to be at background may be disposed into the normal waste stream at the clients site.
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| * Confirming that AUs designated on the application are cognizant that they will be responsible for supervising the use of licensed material, including at the clients facility.
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| * Providing dosimetry to staff that would require it in accordance with 10 CFR 20.1502.
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| * Maintaining security of mobile PET trailer (e.g., keys, keypad codes).
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| * Ensuring that all radioactive material is accounted for and removed from the client at the end of the day of service.
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| * Radiation safety program audits, including use at client sites in accordance with 10 CFR 20.1101.
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| Note: In the event that bathroom contamination is found in the dedicated PET bathroom on hospital property and cannot be cleaned to below trigger levels for an unrestricted area, the mobile medical service provider will block off the bathroom and post it as a restricted area. In addition, the mobile medical service provider will post it as a radiation area, if necessary, in accordance with 10 CFR 20.1902. The contamination will be reported to the client manager.
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| The bathroom will be surveyed with a calibrated radiation survey meter the next day and released for unrestricted use, if radiation levels are below trigger levels for an unrestricted area described in the mobile medical service provider license.
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| V-3
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| This agreement will be retained by the licensee for 3 years after the last provision of service in accordance with 10 CFR 35.2080.
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| Signed and Dated Signed and Dated Vice President of Operations President ABC Hospital, Inc. PET Mobile, Inc.
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| Base Location The base location (e.g., nuclear medicine hot lab or storage location for the remote afterloader) for the mobile medical service must be specified. A base location is one that is identified on the license, while a temporary jobsite (or client site) is a location that is other than a location of use identified on the license and where work is conducted for a limited period of time. The base location can be in a medical institution, noninstitutional medical practice, commercial facility, or mobile van or trailer. Applicants should specify in what type of facility the proposed base location is sited. A mobile licensee cannot provide a service to a private practice (nonlicensee) located within a licensed medical institution (e.g., hospital). The medical institutions management (i.e., hospital management) must be consulted in this event. As required by 10 CFR 30.33 and 10 CFR 35.12, applicants must submit a description and diagram(s) of the proposed base location and associated equipment in accordance with Chapter 9 of this NUREG. The description and diagram of the proposed base location should demonstrate that the building (or van or trailer) is of adequate construction and design to protect its contents from the elements (e.g., high winds, rain), ensures security of licensed material to prevent unauthorized access (e.g., control of keys), and ensures that radiation levels in unrestricted areas are in compliance with 10 CFR 20.1301 {e.g., shielding and roping off of areas greater than 0.02 mSv [2 mrem] in any one hour}. Include a diagram showing the location of the licensed material, receipt, and use areas, and identify all areas adjacent to restricted areas, including areas above and below the restricted areas. For storage locations within a van or trailer, the description of the van or trailer should address radiation levels in the van or trailer drivers compartment to demonstrate compliance with 10 CFR 20.1201, Occupational dose limits for adults.
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| * Applicants may request multiple base locations. Radioactive material must be delivered only to a facility licensed to receive the type of radioactive material ordered.
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| For diagnostic uses, the mobile medical service provider may list a portion of a clients site as a base location for which there is a clear, written agreement with the facility owner addressing security against unauthorized removal and establishing responsibility for the licensed material. This agreement should indicate the receipt and storage location and confirm that the mobile medical service provider will have sole access to the receipt/storage location and will be granted access to the facilities to remove any licensed material or decontaminate the facility, as necessary. In this case, the mobile medical service provider may arrange to have licensed material delivered to the base location without their personnel present.
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| * Base locations can include the use of a mobile van or trailer. When the base location is in the van or trailer, and there is no permanent structure for the byproduct material storage, provide for the following:
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| V-4
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| Secured off-street parking is under licensee control. Public rights-of-way are not considered part of the address of the client.
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| Secured storage facilities are available for storage of byproduct material and radioactive waste, if the van or trailer is disabled.
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| * Byproduct material is delivered directly to the van or trailer parked at a site owned by the mobile medical service provider occupied by licensee personnel. In addition, for diagnostic uses only, the mobile medical service provider may arrange to have licensed material delivered to the van or trailer parked at a client site only if the mobile medical service provider submits information clearly demonstrating that they will have their personnel at the van or trailer to accept delivery and ensure the security and control of the licensed material.
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| * The mobile medical service provider may list a portion of a clients site as a base location for which there is a clear written agreement with the facility owner addressing security against unauthorized removal and establishing responsibility for the licensed material. This agreement should indicate the receipt and storage location and confirm that the mobile medical service provider will have sole access to the receipt/storage location and will be granted access to the facilities to remove any licensed material or decontaminate the facility, as necessary. In this case, the mobile medical service provider may arrange to have licensed material delivered to the base location without their personnel present.
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| * If a base location is in a residential area, provide the following information:
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| Justification of the need for a private residence location rather than for a commercial location.
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| Documentation of the agreement between the residence owner and the licensee.
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| It is essential that the mobile medical service have access to the base location in the event of contamination. Provisions for decontamination of the mobile medical service van or trailer, etc., on the client property (if necessary) will be included.
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| Documentation from both parties will illustrate the agreement between the client and the mobile medical service.
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| A description of the program demonstrating compliance with 10 CFR 20.1301, Dose limits for individual members of the public.
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| Verification that restricted areas do not contain residential quarters.
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| * Perform surveys necessary to show that exposure rates do not exceed 0.02 mSv
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| [2 mrem] in any one hour nor 1 mSv/yr [100 mrem/yr].
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| V-5
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| Client Site for Diagnostic Uses In general, client facility information does not need to be submitted; however, the mobile medical service provider may arrange to have licensed material delivered to the client site, only if the licensee submits information clearly demonstrating that the mobile medical service provider licensee will have its own personnel at the client site to accept delivery and ensure the security and control of the licensed material.
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| Alternatively, the mobile medical service provider may list a portion of a clients site as a base location for which there is a clear written agreement with the facility owner addressing security against unauthorized removal and establishing responsibility for the licensed material. This agreement should indicate the receipt and storage location and confirm that the mobile medical service provider will have sole access to the receipt/storage location and will be granted access to the facilities to remove any licensed material or decontaminate the facility, as necessary. In this case, the mobile medical service provider may arrange to have licensed material delivered to the base location without their personnel present and must provide an example contract that will be used with clients to designate these areas.
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| In addition, as described above, the client may designate quiet rooms for use by PET mobile medical service providers. These areas must also be described in the contract with the client and the applicant must provide an example contract that will be used with clients to designate these areas.
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| Client Site for Therapeutic Uses This section applies only to therapeutic uses of byproduct material. For all types of therapy uses, the medical institutions, hospitals, or clinics and their addresses that comprise the client sites for mobile medical services must be listed.
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| For self-contained byproduct material services (e.g., in-van or trailer), the following additional facility information should be provided:
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| * For therapy treatments with byproduct material [e.g., high dose-rate (HDR) remote afterloader], provide a separate drawing for each client site showing the location of the treatment device and vehicle in relation to all nearby roads, sidewalks, structures, and any other locations accessible by members of the public.
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| * As delineated in the letter required by 10 CFR 35.80(a), a signed agreement that the location of the treatment device and vehicle will be on client-owned or controlled property.
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| * The protection from vehicular traffic that could adversely affect patient treatment(s),
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| which could be accomplished either by locating the facility away from all vehicular traffic or by using barriers. Any protective measures must be shown on the facility or site drawings provided.
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| * A description of the emergency lighting system that automatically activates on detection of the loss of primary power during patient remote afterloader treatments. The system must provide sufficient light to perform any possible emergency procedures, including the removal of a detached or stuck source that remains within the patient.
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| V-6
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| If transportable services will be provided to the clients site for use within the clients facility by the mobile medical services employees, the following client facility information and commitment should be provided:
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| * A detailed description and diagram(s) of the proposed use facility (e.g., client site) and associated equipment in accordance with Items 8.14 through 8.19 of this report. The description and diagram of the proposed use facility must demonstrate that the facility is of adequate construction and design to protect its contents from the elements (e.g., high winds, rain), ensure security of licensed material to prevent unauthorized access, and ensure that radiation levels in unrestricted areas are in compliance with 10 CFR 20.1301. Include a diagram showing the location of the equipment, receipt, and use areas, and identify all areas adjacent to restricted areas.
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| * A commitment, as delineated in the letter required by 10 CFR 35.80(a), that the mobile medical service licensee has full control of the treatment room during byproduct material use for each client.
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| * The initial installation records and function checks of a remote afterloader device for each site of use, as required by 10 CFR 35.633, Full calibration measurements on remote afterloader units; 10 CFR 35.643, Periodic spot-checks for remote afterloader units; and 10 CFR 35.647, Additional technical requirements for mobile remote afterloader units.
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| For a transport-only mobile medical service for therapy devices that are transported to the clients facility, used by the clients staff (under their own license), and removed by the service provider, ensure the following:
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| * Each client is properly licensed for medical use of byproduct material (which now also includes accelerator-produced radioactive materials and discrete sources of radium-226). If applicable, licensees should ensure that each client has received the necessary initial and, if appropriate, recurrent training for the specific make and model of the remote afterloader device being provided. If the above applicable conditions are not met, the mobile medical service licensee must not transfer the remote afterloader device to the client.
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| * No signed agreement with a client may state or imply any assumption of responsibility on the part of the mobile medical service for the use of byproduct material for patient treatments. This includes such activities as dosage measurements, source calibrations, and remote afterloader device operational checks. Although these and other services may be provided to the client by the mobile medical service, if the mobile medical service is specifically licensed to provide such services, the client (licensee) retains all of the responsibilities related to the use of the byproduct material for patient treatments.
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| The responsibilities for supervising individuals who use the byproduct material, set forth in 10 CFR 35.27, Supervision, transfer to the clients authorized users (AU) upon transfer of the device to the client by the mobile medical service provider.
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| * The initial installation of a remote afterloader device at the client site may be performed by either the mobile medical service provider or the client, but all device function checks are the responsibility of the client (i.e., the licensee authorized to provide patient treatments at the client site).
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| V-7
| |
| * As required by 10 CFR 30.51, Records, a formal record of the transfer of control of the byproduct material from the mobile medical service provider to the client, and from the client back to the mobile medical service provider, must be made for each transfer of byproduct material. A signed receipt of each transfer must be made and retained for inspection for 3 years.
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| Supervision In addition to the requirements in 10 CFR 19.12, 10 CFR 35.27 requires that instructions be given to supervised individuals in written radiation protection procedures, written directive procedures, regulations, and license conditions with respect to the use of byproduct material.
| |
| Additionally, 10 CFR 35.27 requires the supervised individual to:
| |
| * Follow the instructions of the supervising AU for medical uses of byproduct material.
| |
| * Follow the instructions of the supervising Authorized Nuclear Pharmacist or supervising AU for preparation of byproduct material for medical uses.
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| * Follow the written radiation protection procedures and written directive procedures established by the licensee.
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| * Comply with the provisions of 10 CFR Part 35 [e.g., 10 CFR 35.80 and 10 CFR 35.647 (if applicable)], and the license conditions with respect to the mobile medical use of byproduct material.
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| Training for Individuals Working in or Frequenting Restricted Areas Drivers and technologists (or therapists) will be properly trained in applicable transportation regulations and emergency procedures, in addition to the training requirements of 10 CFR 19.12, 10 CFR 35.27, 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610 (as applicable). The training for these individuals will include, at a minimum, DOT regulations, shielding, as low as is reasonably achievable (ALARA), basic radiation protection, and emergency response.
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| Survey Instrument and Dose Measurement Instrument Checks As required by 10 CFR 35.80, instruments should be checked for proper operation before use at each address of use. Dosage measurement instruments should be checked before medical use at each address of use or on each day of use, whichever is more frequent. Additionally, all other transported equipment (e.g., cameras) should be checked for proper function before medical use at each address of use.
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| Order and Receipt of Byproduct Material Byproduct material will be delivered by a supplier to the base location or to the clients address, if the client is licensed to receive the type of byproduct material ordered. Additionally, if the mobile medical service provider is specifically licensed for receipt and storage in the clients facility, byproduct material may be delivered to the clients address. Delivery of byproduct material to a van or trailer that is not occupied by the mobile medical service personnel will not be permitted.
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| V-8
| |
| | |
| Alternatively, licensees may pick up the byproduct material (e.g., radiopharmaceuticals) from the supplier (e.g., nuclear pharmacy) en route to client facilities.
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| Emergency Procedures The mobile medical service provider applicant should commit to develop, implement, and maintain emergency procedures in accordance with the radiation protection program required by 10 CFR 20.1101. Indicate typical response times of the radiation safety officer (RSO) and AU in the event of an incident, and develop and implement procedures that include emergency response regarding an accident scenario. An accident is defined as a vehicle collision or other event, such as wind, water, or fire that results in damage to exterior or interior portions of the vehicle or the byproduct material used in the mobile medical service. The transportation emergency response plan should cover both the actions to be taken by the mobile medical service providers headquarters emergency response personnel and the on-scene hazardous-material (HAZMAT)-trained personnel, and it will be readily available to both transport vehicle personnel and headquarters emergency-response contacts. The plan should include the following:
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| * A 24-hour emergency contact telephone number for the mobile medical service providers emergency response personnel.
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| * The emergency contact numbers for the NRCs Operation Center and all appropriate State radiological protection agencies.
| |
| * Procedures for restricting access to the transport vehicle until surveys have been made to determine if any radiological hazards exist.
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| * Procedures for retrieving and securing any byproduct material, including a sealed source that may become detached or dislodged to the extent that a radiological hazard is created, which may require one or more emergency shielded source containers.
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| * Predetermined (calculated) exposure rates for an unshielded therapy source (if applicable) as a function of distance for use in controlling the exposures of emergency response personnel to the maximum extent possible under various emergency response scenarios.
| |
| * Preplanned decontamination procedures, including ready access to all necessary materials.
| |
| * A calibrated, operational radiation survey meter maintained in the cab of the transporting vehicle, which may be used at an accident scene for conducting surveys.
| |
| * Security of the transport vehicle against unauthorized access, including the drivers compartment.
| |
| * Procedures to ensure that following any accident, no patient treatments with remote afterloaders will occur until all systems pertaining to radiation safety have been tested and confirmed to be operational by the RSO or authorized medical physicist. If any problem is found, including remote afterloader device interlocks and operation, the remote afterloader device or facility will be repaired and re-certified by the device vendor prior to return to service. In addition, a copy of the report, generated in accordance with V-9
| |
| | |
| 10 CFR 30.50, Reporting requirements, will be provided to clients following any accident in which there is actual or possible damage to the clients facility or the device.
| |
| Note: The type of response should be consistent with the level of the incident. The response may range from telephone contact for minor spills to prompt onsite response (less than 3 hours) to events such as a medical event or lost radioactive material.
| |
| Transportation The mobile medical service provider applicant should commit to develop, document, and implement procedures to assure that the following takes place:
| |
| * Radioactive material is transported in accordance with 49 CFR Parts 171-177, Transportation. Procedures will include use of approved packages use of approved labeling conduct of proper surveys complete and accurate shipping papers bracing of packages security provisions written emergency instructions
| |
| * Management (or managements designee) will perform audits, at least annually, of transportation documentation (e.g., shipping papers and survey reports) and activities at client facilities.
| |
| * Licensed material is secured during transport and use at the clients facilities.
| |
| * Radioactive waste is handled properly during transport. Describe the method of storage and final disposal.
| |
| * The transport vehicle, including the drivers compartment, if separate, will be secured at all times from any unauthorized access when the vehicle is unattended.
| |
| Note: The necessary DOT Type 7A package certification for remote afterloader devices is established by prior approval of the appropriate sealed source and device sheets; however, if the remote afterloader device is damaged in any way during use or transport, then the integrity of the DOT Type 7A packaging may be compromised, and the device must not be used or transported until checked by the vendor and certified as retaining its integrity as a Type 7A package.
| |
| Appendix Z of this NUREG summarizes DOT requirements for Transportation of Licensed Material.
| |
| Radioactive Waste Management If waste will be stored in vans or trailers, they must be properly secured and posted as byproduct material storage locations. Ensure that the van or trailer will be secured against unauthorized access and that the waste storage location will be posted as a byproduct material storage area.
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| V-10
| |
| | |
| Develop, document, and implement final waste disposal procedures in accordance with Section 8.11 of this NUREG.
| |
| Excreta from individuals undergoing medical diagnosis or therapy with radioactive material may be disposed of without regard to radioactivity, if it is discharged into the sanitary sewer system in accordance with 10 CFR 20.2003. However, collecting excreta from patients in a van or trailer restroom with a holding tank is not considered direct disposal into the sanitary sewer system. If restroom facilities are provided in the van or trailer for patient use, submit the following information for NRC review:
| |
| * A description of the structure of the tank holding facility and the location of the tank in relation to members of the public, workers in the van or trailer, and the driver of the van or trailer; a description of procedures to assess the tank for possible leakage; and a description of any restroom ventilation if any iodine-131 will be held in the tank.
| |
| * A description of procedures to ensure doses to occupational workers and members of the public will not exceed the exposure limits in 10 CFR 20.1201 and 10 CFR 20.1301; that the external surfaces of the van or trailer do not exceed 0.02 mSv/h [2 mrem/h] ;
| |
| and that doses to members of the public and workers are maintained ALARA, including considerations of external dose rates in the restroom caused by the proximity of the holding tank to the toilet.
| |
| * A description of procedures for emptying and disposing of the contents of the holding tank, including the frequency of disposal, who empties the tank into the sanitary sewer system, and the location of disposal into the sanitary sewer, including precautions taken to minimize contamination in this process.
| |
| Mobile Medical Services With Remote Afterloader Devices Because the movement of the remote afterloader device from one location to another increases the risk of electro-mechanical component failures or misalignments, it is important that the proper operation of the device be fully checked after each such relocation. Therefore, develop, document, and implement the following procedures to determine if a device is operating properly before the commencement of patient treatments:
| |
| * Conduct safety checks on a remote afterloader device and facility. The procedure will include the periodic spot-checks required by 10 CFR 35.643 and the additional spot-checks required by 10 CFR 35.647 before use at each address of use.
| |
| Additionally, the procedure should include provisions for prompt repair of any system not operating properly.
| |
| * The pretreatment operational function checks after each device move should include a review of any device alarm or error message and, if necessary, a resolution of problems indicated by such messages.
| |
| * Such tests should be performed in accordance with written procedures.
| |
| * As required by 10 CFR 35.2647 and 10 CFR 35.2643, records showing the results of the above safety checks must be maintained for NRC inspection and review for a period of 3 years.
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| V-11
| |
| * Perform surveys of the source housing and areas adjacent to the treatment room following relocation of an HDR unit. These surveys should include the source housing with the source in the shielded position and all areas adjacent to the treatment room with the source in the treatment position.
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| V-12
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| | |
| APPENDIX W MODEL PROCEDURES FOR WASTE DISPOSAL BY DECAY-IN-STORAGE, GENERATOR RETURN, LICENSED MATERIAL RETURN, AND DISPOSAL OF LIQUIDS INTO SANITARY SEWERAGE
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| | |
| Model Procedures for Waste Disposal by Decay-In-Storage, Generator Return, Licensed Material Return, and Disposal of Liquids into Sanitary Sewerage This model provides acceptable procedures for waste disposal. Most licensees will dispose of material that fall within these procedures. Note that some short half-life radionuclide products
| |
| [e.g., technetium (Tc)-99m/molybdenum (Mo)-99 generator columns and some yttrium (Y)-90 microspheres] may contain long half-life contaminants that may preclude disposal by decay-in-storage and may require disposal by alternate methods, such as return to the manufacturer. Applicants may either adopt these model procedures or develop alternative procedures to meet the requirements of Subpart K, Waste Disposal, to Title 10 of the Code of Federal Regulations (10 CFR) Part 20, 10 CFR 20.1101, and 10 CFR 35.92.
| |
| Model Procedure for Decay-In-Storage Regulations in 10 CFR 35.92, Decay-in-storage, describe the requirements for decay-in-storage. Applicants should ensure that adequate space and facilities are available for the storage of waste for decay-in-storage (DIS). Storage should be designed to allow for segregation of wastes with different half-lives (e.g., multiple shielded containers). Containers should have shielded covers to maintain occupational exposure at as low as is reasonably achievable (ALARA) levels. Storage areas must be in a secure location.
| |
| * Only short-lived waste (physical half-life of less than or equal to 120 days) may be disposed of by DIS.
| |
| * Waste should be stored in suitable well-marked containers, and the containers should provide adequate shielding.
| |
| * Liquid and solid wastes should be stored separately.
| |
| * If possible, use separate containers for different types of waste (e.g., needles and syringes in one container, other injection paraphernalia such as swabs and gauze in another, and unused dosages in a third container). Because the waste will be surveyed with all shielding removed, the containers in which the waste will be placed must not provide any radiation shielding for the material.
| |
| * When the container is full, seal it and attach an identification tag that includes the date sealed and the longest-lived radionuclide in the container.
| |
| * The container should be labeled in accordance with 10 CFR 20.1904 and 10 CFR 20.1905. The container may be transferred to the DIS area. When large quantities are held for DIS, measurable activities may be present even after many half-lives and persons performing surveys should be aware of the potential for measurable radiation.
| |
| * The contents of the container should be allowed to decay for a period of time after which it is expected that the radiation levels would not be distinguishable from background.
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| The period of time depends on both the half-life of the radionuclide(s) and the original amount present.
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| W-1
| |
| * Prior to disposal as ordinary or biomedical waste, monitor and record the results of monitoring of each container as follows:
| |
| Use a survey instrument on the lowest setting that is appropriate for the type and energy of the radiation being measured.
| |
| Check the radiation survey meter for proper operation and current calibration status.
| |
| Monitor in a low-level background radiation area away from all sources of radioactive material, if possible.
| |
| Remove any shielding from around the container or generator column.
| |
| Monitor, at contact, all surfaces of each individual container.
| |
| Remove or deface any radioactive material labels (unless the containers will be managed as biomedical waste after they have been released from the licensee, as described in 10 CFR 35.92).
| |
| Discard as in-house ordinary or biomedical waste only those containers that cannot be distinguished from background radiation. Containers may include trash bags full of waste, generator columns, and biohazard (needle) boxes.
| |
| Record the disposal date, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
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| Containers that can be distinguished from background radiation levels must be returned to the storage area for further decay or transferred to an authorized byproduct material recipient.
| |
| Short half-life radionuclide products, such as samarium-153 (Sm-153),
| |
| Tc-99m/Mo-99 generator columns, and Y-90 microspheres may contain long half-life contaminants that may preclude disposal by decay-in-storage.
| |
| Licensees need to perform surveys and dispose of long half-life contaminants in accordance with 10 CFR Part 20 and 10 CFR Part 35 requirements.
| |
| Note: Check for any calibration sources with half-lives greater than 120 days (e.g., cobalt-57, germanium-68, gadolinium-153), as these may not be held for decay-in-storage and must be disposed of in accordance with 10 CFR Part 20 and 10 CFR Part 30.
| |
| Model Procedure for Returning Generators to the Manufacturer Used Mo/Tc-99m, strontium-82/rubidium-82, or germanium-68/gallium-68 generators may be returned to the manufacturer. This permission does not relieve licensees from the requirement to comply with 10 CFR Part 71 and U.S. Department of Transportation (DOT) regulations.
| |
| Perform the following actions when returning generators:
| |
| * Retain the records needed to demonstrate that the package qualifies as a DOT Specification 7A container.
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| W-2
| |
| * Assemble the package in accordance with the manufacturers instructions.
| |
| * Perform the dose-rate and removable-contamination measurements.
| |
| * Label the package and complete the shipping papers in accordance with the manufacturers instructions.
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| * Retain records of receipts and transfers in accordance with 10 CFR 30.51, Records.
| |
| Model Procedure for Return of Licensed Material to Authorized Recipients Perform the following steps when returning licensed material to authorized recipients:
| |
| * In accordance with 10 CFR 30.41(a)(5), confirm that persons are authorized to receive byproduct material prior to transfer (e.g., obtain a copy of the transferees U.S. Nuclear Regulatory Commission license or Agreement State license that authorizes the byproduct material).
| |
| * Retain the records needed to demonstrate that the package qualifies as a DOT Specification 7A container.
| |
| * Assemble the package in accordance with the manufacturers instructions.
| |
| * Perform the dose-rate and removable-contamination measurements.
| |
| * Label the package and complete the shipping papers in accordance with the manufacturers instructions.
| |
| * Retain records of receipts and transfers in accordance with 10 CFR 30.51.
| |
| Model Procedure for Disposal of Liquids into Sanitary Sewerage
| |
| * Confirm that the sewer system is a public system, not a private sanitary sewer, septic system or leach field.
| |
| * Confirm that the liquid waste being discharged is soluble (or is biological material that is readily dispersible) in water.
| |
| * Calculate the amount of each radionuclide that can be discharged by using the information from prior, similar discharges and the information in 10 CFR Part 20, Appendix B.
| |
| * Make sure that the amount of each radionuclide does not exceed the monthly and annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR Part 20, Appendix B, Table 3.
| |
| * If more than one radionuclide is released, the sum of the ratios of the average monthly discharge of each radionuclide to the corresponding limit for each radionuclide in 10 CFR Part 20, Appendix B, Table 3 must not exceed unity.
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| W-3
| |
| * Confirm that the total quantity of licensed material and other radioactive material released into the sanitary sewerage system in a year does not exceed 185 gigabecquerel (GBq) [5 Curies (Ci)] of tritium (H-3), 37 GBq [1 Ci] of carbon (C)-14, and 37 GBq [1 Ci] of all other radioactive materials combined. Note:
| |
| 10 CFR 20.2003(a)(4) further limits the disposal of H-3, C-14, and other radioactive material to the limits noted above even when sewerage totals determined under 10 CFR 20.2003(a)(3), and as noted in the bullet above, may have allowed a higher sanitary sewerage disposal activity.
| |
| * Record the date, radionuclide(s), estimated activity of each radionuclide, location where the material is discharged, and the name of the individual discharging the waste.
| |
| * Liquid waste should be discharged only via designated sinks, toilets, or other release points.
| |
| * Discharge liquid waste slowly, to minimize splashing, with water running to be sure that the material moves out of the sink and into the sewer system.
| |
| * Survey the sink and surrounding work surfaces to confirm that no residual material or contamination remained in the sink or on work surfaces.
| |
| * Decontaminate all areas or surfaces if found to be contaminated.
| |
| * Maintain records of releases of licensed material to the sanitary sewer system. These records should include, for each release, the date, radionuclide(s), estimated activity of each radionuclide, location where the material is discharged, and the initials of the individual discharging the waste. For the licensed facility as a whole, records should be maintained of the quantity and concentration of radionuclides that are released into the sewer system that demonstrate compliance with the regulatory limits for total quantity released and concentrations released by the licensed facility.
| |
| W-4
| |
| | |
| APPENDIX X RECORDKEEPING REQUIREMENTS
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| | |
| Recordkeeping Requirements Table X-1. Typical Records and Retention Times Survey Recordkeeping Record Retention Period Requirement Requirement 20.1501; Results of surveys and calibrations 20.2103(a) 3 years 20.1906(b)
| |
| Results of surveys to determine dose 20.2103(b)(1) duration of license from external sources Results of measurements and calculations used to determine 20.2103(b)(2) duration of license individual intakes Results of air samplings, surveys, 20.1703(c)(1);
| |
| 20.2103(b)(3) duration of license and bioassays 20.1703(c)(2)
| |
| Results of measurements and calculations used to evaluate the 20.2103(b)(4) duration of license release of radioactive effluents to the environment Determination of prior occupational dose 20.2104 duration of license Planned special exposure 20.1206 20.2105 duration of license Individual monitoring results 20.1502 20.2106 duration of license Dose to a declared pregnant woman 20.1502 20.2106 duration of license Dose to individual members of the public 20.1301 20.2107 duration of license 20.2002; 20.2003; Waste disposal 20.2108 duration of license 20.2004; 20.2005 Records of information important to the 30.35(g); 40.36(f) duration of license decommissioning of a facility duration of Records of receipt of byproduct or source 30.51(a)(1); possession and material 40.61(a)(1) 3 years after transfer Records of transfer of byproduct or 30.51(a)(2); 3 years after source material 40.61(a)(2) transfer Records of disposal of byproduct material 30.51(a)(3) duration of license Authority and responsibilities of radiation 35.24(a) 35.2024 5 years protection program Radiation protection program changes 35.26(a) 35.2026 5 years Written directives 35.40 35.2040 3 years Procedures for administrations requiring 35.41(a) 35.2041 duration of license a written directive Calibrations of instruments used to measure activity of unsealed byproduct 35.60 35.2060 3 years material Radiation survey instrument calibrations 35.61 35.2061 3 years Dosages of unsealed byproduct material 35.63 35.2063 3 years for medical use X-1
| |
| | |
| Table X-1. Typical Records and Retention Times (Continued)
| |
| Survey Recordkeeping Record Retention Period Requirement Requirement Leak tests and inventory of sealed 35.67(b) 35.2067 3 years sources and brachytherapy sources Surveys for ambient radiation 35.70 35.2070 3 years exposure rate Release of individuals containing 3 years after date unsealed byproduct material or implants 35.75 35.2075 of release containing byproduct material 3 years after last Mobile medical services 35.80(a)(1) 35.2080(a) provision of service Surveys of client facilities 35.80(a)(4) 35.2080(b) 3 years Decay-in-storage 35.92 35.2092 3 years Molybdenum-99 or strontium-82 or 35.204(b) 35.2204 3 years strontium-85 concentrations 35.310; Safety instruction 35.410; 35.2310 3 years 35.610 Surveys after source implant 35.404; 35.2404 3 years and removal 35.604 Brachytherapy source accountability 35.406 35.2406 3 years Calibration measurements of 3 years after last 35.432 35.2432 brachytherapy sources use of source Decay of strontium-90 sources for 35.433 35.2433 life of source ophthalmic treatments Installation, maintenance, adjustment, and repair of remote afterloader units, 35.604 35.2605 3 years teletherapy units, and gamma stereotactic radiosurgery units duration of Emergency procedures for therapy 35.610(a)(4); possession of 35.2610 devices containing sealed sources 35.610(d)(2) specified equipment Calibration records for dosimetry equipment used with remote afterloader 35.630 35.2630 duration of license units, teletherapy units, and gamma stereotactic radiosurgery units Calibration records for teletherapy, 35.632; remote afterloader, and gamma 35.633; 35.2632 3 years stereotactic radiosurgery full calibrations 35.635 Periodic spot-checks of teletherapy units 35.642 35.2642 3 years Periodic spot-checks of remote 35.643 35.6243 3 years afterloader units Periodic spot-checks of gamma 35.645 35.6245 3 years stereotactic radiosurgery units Additional technical requirements for 35.647 35.6247 3 years mobile remote afterloader units X-2
| |
| | |
| Table X-1. Typical Records and Retention Times (Continued)
| |
| Survey Recordkeeping Record Retention Period Requirement Requirement duration of use of Surveys of therapeutic treatment units 35.652 35.2652 unit Full-inspection servicing for teletherapy duration of use of and gamma stereotactic radiosurgery 35.655 35.2655 unit units 3 years from the Documentation regarding the date the individual trustworthiness and reliability of 37.23(h)(1) no longer requires individual employees unescorted access 3 years after the Current access authorization procedure is 37.23(h)(2) program procedures superseded or no longer needed 3 years after the List of persons approved for unescorted 37.23(h)(3) list is superseded access authorization or replaced Documentation supporting fingerprinting, 3 years from the identification, and criminal history records date the individual 37.31(e) checks and other elements of no longer requires background investigations unescorted access 3 years after the plan is superseded Copy of current security plan 37.43(a)(4) or no longer required 3 years after the Copy of current security program procedure is 37.43(b)(3) implementing procedure superseded or no longer required Documentation of initial and refresher 3 years from the 37.43(c)(4) security program training date of the training Documentation for preplanning and coordination of shipment of Category 1 or 37.75(e) 3 years Category 2 quantities of radioactive material Record retention when a retention period 37.103 duration of license is not otherwise specified X-3
| |
| | |
| APPENDIX Y REPORTING REQUIREMENTS
| |
| | |
| Reporting Requirements Note: The following list of notification and reporting requirements is provided to inform licensees about typical notification and reporting requirements that apply to their licensed activities. Licensees should note that the list is incomplete in that not all potentially applicable requirements have been included. Also, notification and reporting requirements change; therefore, licensees should consult the regulations for definitive information about current requirements.
| |
| Table Y-1. Typical NRC Notifications and/or Reports Telephone Written Regulatory Event Notification Report Requirement Reports to individual workers None annually 10 CFR 19.13(b)
| |
| Reports to former individual workers None upon request 10 CFR 19.13(c)
| |
| Notification of special circumstances None 30 days 10 CFR 19.13(d) to individuals Reports to worker terminating None upon request 10 CFR 19.13(e) employment Package received with removable immediate none 20.1906(d) radioactive surface contamination [U.S. Nuclear exceeding the limits of Title 10 of the Regulatory Code of Federal Regulations (10 Commission (NRC)
| |
| CFR) 71.87(i) or external radiation and final delivery levels exceeding the limits of 10 CFR carrier must be 71.47 notified]
| |
| Theft or loss of material immediate 30 days 10 CFR 20.2201(a)(1)(i) 10 CFR 20.2201(b)(1)
| |
| Whole body dose greater than 0.25 immediate 30 days 10 CFR 20.2202(a)(1)(i),
| |
| Sieverts (Sv) [25 rem] 10 CFR 20.2203 (a)
| |
| Extremity dose greater than 2.5 Gray immediate 30 days 10 CFR 20.2202(a)(1)(iii),
| |
| [250 rads] 10 CFR 20.2203 (a)
| |
| Whole body dose greater than 0.05 24 hours 30 days 10 CFR 20.2202(b)(1)(i),
| |
| Sv [5 rem] in 24 hours 10 CFR 20.2203 (a)
| |
| Extremity dose greater than 0.5 Sv 24 hours 30 days 10 CFR 20.2202(b)(1)(iii),
| |
| [50 rem] in 24 hours 10 CFR 20.2203(a)
| |
| Doses in excess of specified criteria None 30 days 10 CFR 20.2203(a)(2)
| |
| Levels of radiation or concentrations None 30 days 10 CFR 20.2203(a)(3) of radioactive material in excess of 10 CFR 20.2203 (a) specified criteria Planned special exposures None 30 days 10 CFR 20.2204 Report to individuals of exceeding None 30 days 10 CFR 20.2205 dose limits Report of individual monitoring None annually 10 CFR 20.2206 Y-1
| |
| | |
| Table Y-1. Typical NRC Notifications and/or Reports (Continued)
| |
| Telephone Written Regulatory Event Notification Report Requirement Defect in equipment that could 2 days 30 days 10 CFR 21.21(d)(3)(i) create a substantial safety hazard 10 CFR 21.21(d)(3)(ii)
| |
| Event that prevents immediate Immediate (not more 30 days 10 CFR 30.50(a) protective actions necessary to avoid than 4 hours after 10 CFR 30.50(c)(2) exposures to radiation or radioactive discovery) materials that could exceed regulatory limits Equipment is disabled or fails to 24 hours 30 days 10 CFR 30.50(b)(2) function as designed when required 10 CFR 30.50(c)(2) to prevent radiation exposure in excess of regulatory limits Unplanned fire or explosion that 24 hours 30 days 10 CFR 30.50(b)(4) affects the integrity of any licensed material or device, container, or equipment with licensed material Generally licensed devices None 30 days 10 CFR 31.5(c)(14)
| |
| Licensee permits individual to work None 30 days 10 CFR 35.14(a) as authorized users (AU), authorized nuclear pharmacists (ANP),
| |
| authorized medical physicist (AMP) or ophthalmic physicist RSO, AU, ANP, ARSO, or AMP None 30 days 10 CFR 35.14(b)(1) discontinues performance of duties under license or has a name change Temporary Radiation Safety Officer None 30 days 10 CFR 35.14(b)(2)
| |
| Licensees mailing address changes None 30 days 10 CFR 35.14(b)(3)
| |
| Licensees name changes without None 30 days 10 CFR 35.14(b)(4) constituting a transfer of control Licensee adds or changes areas of None 30 days 10 CFR 35.14(b)(5) 10 CFR 35.100 or 35.200 use of byproduct material identified in application or license if the change or addition did not involve movement of a PET radionuclides production facility or transfer line from a PET radionuclide production facility The licensee obtains a sealed None 30 days 10 CFR 35.14(b)(6) source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment Medical event 1 day 15 days 10 CFR 35.3045(c) 10 CFR 35.3045(d)
| |
| Dose to an embryo/fetus that is 1 day 15 days 10 CFR 35.3047(c) greater than 50 millisieverts (mSv) [5 10 CFR 35.3047(d) rem] dose equivalent Dose to a nursing child that is 1 day 15 days 10 CFR 35.3047(c) greater than 50 mSv [5 rem] or 10 CFR 35.3047(d) resulted in unintended permanent functional damage Y-2
| |
| | |
| Table Y-1. Typical NRC Notifications and/or Reports (Continued)
| |
| Telephone Written Regulatory Event Notification Report Requirement Leaking source none 5 days 10 CFR 35.3067 Eluate exceeding permissible 7 days 30 days 10 CFR 35.3204 molybdenum-99, strontium-82, or strontium-85 concentrations Determination that any licensee that None 90 days before 10 CFR 37.41(a)(3) has not previously implemented the aggregating Security Orders (i.e., orders issued radioactive by the NRC to require licensees to material to a implement interim security quantity that measures) or been subject to the equals or provisions of 10 CFR Part 37, exceeds the Subpart C will aggregate radioactive Category 2 material to a quantity that equals or threshold exceeds the Category 2 threshold Coordination with local law 3 business days Submittal of a 10 CFR 37.45(b) enforcement agency (LLEA) has written report failed, either because the LLEA has concerning not responded or because the LLEA failures of does not plan to participate coordination with LLEA as described in 10 CFR 37.45(b) is not required; however, licensees must document their efforts to coordinate with the LLEA and keep this documentation for 3 years Determination that an unauthorized As soon as possible 30 days 10 CFR 37.57(a)&(c) entry resulted in an actual or (but not at the attempted theft, sabotage, or expense of causing diversion of Category 1 or Category delay or interfering 2 quantity of radioactive material with the LLEA response), but no later than 4 hours after discovery Assessment of any suspicious As soon as possible, none 10 CFR 37.57(b) activity related to possible theft, but no later than 4 sabotage, or diversion of Category 1 hours after notifying or Category 2 quantities of the LLEA radioactive material Determination that a shipment Within 1 hour of the 30 days and 10 CFR 37.81(a)(g)&(h) containing a Category 1 quantity of determination. Also, periodic updates material is lost or missing in notify LLEA within 1 (if subsequent transport hour of determination substantive information)
| |
| Y-3
| |
| | |
| Table Y-1. Typical NRC Notifications and/or Reports (Continued)
| |
| Telephone Written Regulatory Event Notification Report Requirement Determination that a shipment Within 4 hours of the 30 days and 10 CFR 37.81(b)(g)&(h) containing a Category 2 quantity of determination and periodic updates material is lost or missing in again within 24 hours (if subsequent transport if the material has not substantive yet been located and information) secured Discovery along the route of any As soon as possible 30 days (except 10 CFR 37.81(c)(g)&(h) actual or attempted theft or upon discovery. Also no report for diversion, or suspicious activity, notify LLEA as soon suspicious related to a Category 1 quantity of as possible upon activity) and material in transport discovery periodic updates after report (if subsequent substantive information)
| |
| Discovery of any actual or attempted As soon as possible 30 days (except 10 CFR 37.81(d)(g)&(h) theft or diversion, or suspicious no report for activity, related to a Category 2 suspicious quantity of material in transport activity) and periodic updates after report (if subsequent substantive information)
| |
| Upon recovery of any lost or missing As soon as possible. To be included 10 CFR 37.81(e)&(h)
| |
| Category 1 quantity of material Also notify the LLEA in the 30-day as soon as possible report of an event described in 10 CFR 37.81(g), if recovered during that time or in a subsequent update Upon recovery of any lost or missing As soon as possible To be included 10 CFR 37.81(f)&(h)
| |
| Category 2 quantity of material in the 30-day report of an event described in 10 CFR 37.81(g), if recovered during that time or in a subsequent update Note: Telephone notifications shall be made to the NRC Operations Center at 301-816-5100, except as noted. The Center is staffed 24 hours a day and accepts collect calls.
| |
| Y-4
| |
| | |
| APPENDIX Z
| |
| | |
| ==SUMMARY==
| |
| OF DOT REQUIREMENTS FOR TRANSPORTATION OF TYPE A, TYPE B, OR LIMITED QUANTITIES OF LICENSED MATERIAL
| |
| | |
| Summary of DOT Requirements for Transportation of Type A, Type B, or Limited Quantities of Licensed Material Note: The charts included at the end of this Appendix are for reference only and are not a substitute for U.S. Department of Transportation (DOT) and U.S. Nuclear Regulatory Commission (NRC) transportation regulations.
| |
| Licensed material must be transported in accordance with DOT regulations. Applicants and licensees should review the most recent regulations in Title 49 of the Code of Federal Regulations (49 CFR). Licensees should note that the list is incomplete, in that not all potentially applicable requirements have been included. Also, transportation requirements change; therefore, licensees should consult the regulations for definitive information about current requirements. The following are the major areas in DOT regulations most relevant for medical use licensees transporting licensed material:
| |
| * Table of Hazardous Materials and Special ProvisionsSubpart B 49 CFR 172.101Purpose and Use of Hazardous Materials Table
| |
| [proper shipping name, hazard class, identification number]
| |
| Table 2, Appendix A to 49 CFR 172.101List of Hazardous Substances and Reportable Quantities [for radionuclides]
| |
| * Shipping PapersSubpart C 49 CFR 172.201Preparation and retention of shipping papers 49 CFR 172.202Description of hazardous material on shipping papers 49 CFR 172.203Additional description requirements 49 CFR 172.204Shippers certification [if applicable]
| |
| * MarkingsSubpart D 49 CFR 172.301General marking requirements for non-bulk packagings 49 CFR 172.304Marking requirements 49 CFR 172.310Class 7 (radioactive) materials 49 CFR 172.324Hazardous substances in non-bulk packagings [designation of reportable quantities with the letters RQ]
| |
| * LabelingSubpart E 49 CFR 172.400General labeling requirements 49 CFR 172.400(a)Exceptions from labeling 49 CFR 172.403Class 7 (radioactive) material Z-1
| |
| | |
| 49 CFR 172.406Placement of labels 49 CFR 172.436, 172.438, 172.440, 172.450Labels [White-1, Yellow-2, Yellow-3, Empty]
| |
| * PlacardingSubpart F 49 CFR 172.504General placarding requirements 49 CFR 172.516Visibility and display of placards 49 CFR 172.556RADIOACTIVE placard
| |
| * Emergency Response InformationSubpart G 49 CFR 172.600Applicability and general requirements 49 CFR 172.602Emergency response information 49 CFR 172.604Emergency response telephone number
| |
| * TrainingSubpart H 49 CFR 172.702Applicability and responsibility for training and testing 49 CFR 172.704Training requirements [types of training, frequency, recordkeeping]
| |
| * Safety and Security Plans - Subpart I 49 CFR 172.800Purpose and applicability 49 CFR 172.802Components of a security plan
| |
| * ShippersGeneral Requirements for Shipments and Packaging49 CFR Part 173 Class 7 (Radioactive Materials) - Subpart I.
| |
| - 49 CFR 173.25Authorized packagings and overpacks
| |
| - 49 CFR 173.403Definitions
| |
| - 49 CFR 173.410General design requirements
| |
| - 49 CFR 173.412Additional design requirements for Type A packages
| |
| - 49 CFR 173.413Requirements for Type B packages
| |
| - 49 CFR 173.415Authorized Type A packages
| |
| - 49 CFR 173.416Authorized Type B packages [includes packaging certification requirements]
| |
| Z-2
| |
| | |
| - 49 CFR 173.421Excepted packages for limited quantities of Class 7 (radioactive) materials
| |
| - 49 CFR 173.422Additional requirements for excepted packages containing Class 7 (radioactive) materials
| |
| - 49 CFR 173.425Table of activity limitsexcepted quantities and articles [limited quantity]
| |
| - 49 CFR 173.431Activity limits for Type A and Type B packages
| |
| - 49 CFR 173.435Table of A1 and A2 values for radionuclides [for determination of package type]
| |
| - 49 CFR 173.441Radiation level limitations and exclusive use provisions
| |
| - 49 CFR 173.443Contamination control
| |
| - 49 CFR 173.471Requirements for U.S. Nuclear Regulatory Commission approved packages
| |
| - 49 CFR 173.476Approval of special form Class 7 (radioactive) materials [includes requirement for documentation of special form status]
| |
| * Carriage by Public Highway49 CFR Part 177 General Information and Regulations-Subpart A 49 CFR 177.817Shipping papers [location of shipping papers during transport]
| |
| * Loading and UnloadingSubpart B 49 CFR 177.842Class 7 (radioactive) material [includes requirement for blocking and bracing during transport]
| |
| Applicants should visit the DOT Web site for additional information on transportation requirements: https://www.dot.gov/.
| |
| Z-3
| |
| : 1. Minimum Required Packaging for Class 7 (Radioactive) Material:[1] (49 CFR 173 and 10 CFR 71)[2]
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| Minimum Packaging Required for Radioactive Materials other than Low Specific Activity (LSA) Material and Surface Contaminated Objects (SCO) based on Activity of Package Contents Limited Quantities and Radioactive Material Quantity[3] Type A[4] [9] Type B Articles the limits specified in A1 for special form > A1 for special form Activity Restrictions Table 4 of § 173.425 A2 for normal form > A2 for normal form Non-fissile and Contents of Excepted Package Type A Package Type B(U) or Type B(M) package Fissile Excepted Package Fissile N/A Type AF[10] package Type B(U)F or Type B(M)F package Minimum Packaging Required for LSA Material and SCO[5,6]
| |
| Type(s) of LSA LSA-I LSA-II LSA-III SCO-I SCO-II and/or SCO Unpackaged[8] - - Unpackaged[8] -
| |
| Category of IP-1: solids or liquids/exclusive use - - IP-1 -
| |
| Package for IP-2: liquids/non-exclusive use IP-2: exclusive use[9] IP-2: exclusive use - IP-2 Domestic or International Specification tank cars or cargo tank IP-3: liquids or IP-3: non-exclusive Transport[7,8] gases/non-exclusive - -
| |
| motor vehicles: liquids/exclusive use use use[9]
| |
| Alternative Packaging shall meet the requirements of §§ 173.24, 24a, and 173.410.
| |
| Provisions for Transportation shall be an exclusive use shipment.
| |
| Domestic only Transport[8] Activity per shipment must be less than an A2 quantity (see § 173.427(b)(4)).
| |
| [1] Additional provisions may apply for radioactive materials that are pyrophoric, oxidizing, fissile excepted, or uranium hexafluoride.
| |
| [2] Each NRC licensee shall comply with the applicable requirements of the DOT regulations in 49 CFR parts 107, 171 through 180, and 390 through 397 (see § 71.5).
| |
| [3] Materials that contain radionuclides, where both the activity concentration and the total activity in the consignment exceed either the values specified in the table in § 173.436 or the values derived according to the instructions in § 173.433, must be regulated in transport as Class 7 (radioactive) material.
| |
| [4] Except for LSA material and SCO, a Type A package may not contain a quantity of Class 7 (radioactive) material greater than A1 or A2 (see § 173.431(a)). See A1 and A2 definitions in § 173.403.
| |
| [5] The external dose rate from LSA material or SCO in a single package may not exceed 10 mSv/h (1 rem/h) at 3 meters from the unshielded material or objects (see §§ 173.427(a)(1) and (d)).
| |
| [6] LSA material and SCOs that are or contain fissile material in quantities that are not fissile excepted must be packaged in appropriate Type AF or Type BF packages, and not classified as LSA material or SCO. For alternate domestic transport provisions, see
| |
| § 173.427(b)(4). For comprehensive guidance on packaging and transportation of LSA material and SCO, see NUREG-1608.
| |
| [7] For the quantity of LSA material and SCO transported in a single conveyance, see the limits specified in § 173.427(a)(2).
| |
| [8] LSA material or SCO shall be appropriately packaged in accordance with § 173.427(b) or (d). Certain LSA-I material and SCO-I may be transported unpackaged under the conditions in § 173.427(c).
| |
| [9] See §§ 173.411(c) and 173.415(a) for requirements related to package record retention (2 years) and associated documentation of physical tests.
| |
| [10] See §§ 71.22(a), 71.23(a) and 173.417(a) for regulations regarding the use of non-AF packages for fissile materials.
| |
| Z-4
| |
| : 2. Radiation Level, TI and CSI Limits for Transportation by Mode:[1] (49 CFR 173 - 177, and 10 CFR 71)[10]
| |
| Type of Transport Non-exclusive use Exclusive use Air (cargo Mode of Transport Road, Rail, Vessel and Air[9] Road and Rail Vessel only)
| |
| Radiation Level Limits[2]
| |
| 2 mSv/h (200 mrem/h): other than closed vehicles 2 mSv/h[11] 2 mSv/h Package Surface 2 mSv/h (200 mrem/h) 10 mSv/h (1000 mrem/h): closed (200 mrem/h) (200 mrem/h)[3]
| |
| vehicles 2 mSv/h (200 mrem/h): outer surfaces (sides, top and underside) N/A N/A of vehicle[5]
| |
| Conveyance[4] N/A 0.1 mSv/h (10 mrem/h): at any point two (2) m (6.6 ft) from sides N/A N/A of the vehicle[5]
| |
| Requirements 0.02 mSv/h (2 mrem/h): in any Occupied position N/A of N/A normally occupied area[6]
| |
| § 176.708 apply Transport Index (TI) Limits[2]
| |
| 3: passenger aircraft Package[7] 10: road, rail, vessels and cargo No limit 10 aircraft 50: road, rail and passenger aircraft Conveyance[4] 50 to No limit: vessels[8] No limit 200 200: cargo aircraft N/A: for road, rail 50 to 200: vessel[8]
| |
| Overpack N/A No limit[8] N/A 3: passenger aircraft; 10: cargo aircraft Criticality Safety Index (CSI) Limit for fissile material[2]
| |
| Package[7] 50 100 100 100 50: road, rail and air 200 to No limit:
| |
| 50: for holds, compartments or Conveyance[4] 100 for a total 100 defined deck areas of vessels [8]
| |
| vessel[8]
| |
| 200 to No limit: for a total vessel [8]
| |
| Overpack 50: road, rail, vessels[8] and air N/A
| |
| [1] Radiation level, TI, and CSI are defined in § 173.403.
| |
| [2] In addition to any applicable radiation level, TI and CSI limits, separation distance requirements apply to packages, conveyances, freight containers and overpacks; to occupied positions; and to materials stored in transit. Separation distances are based on the sum of the TIs and, for fissile materials, the sum of the CSIs. [see applicable 49 CFR references for: Rail -
| |
| § 174.700; Air - §§ 175.700 through 175.703; Vessel - §§ 176.700 through 176.708; and Highway - § 177.842].
| |
| [3] Higher package surface radiation levels may be allowed through an approved special arrangement.
| |
| [4] Conveyance is, for transport by public highway or rail, any transport vehicle or large freight container; and for transport by air, any aircraft. See definitions in § 173.403.
| |
| [5] The outer surfaces (sides, top and underside) of vehicles are specified for road and rail vehicles in § 173.441.
| |
| [6] For rail, normally occupied areas include the transport vehicle and adjacent rail cars. The 0.02 mSv/h (2 mrem/h) limit does not apply to carriers operating under a State or federally regulated radiation protection program where personnel wear radiation dosimetry devices.
| |
| [7] Additional TI and CSI limits apply for individual packages when non-fissile radioactive material packages are mixed with fissile material packages (see § 173.459).
| |
| [8] For details on TI and CSI limits for transport by vessel, see § 176.708.
| |
| [9] Only excepted packages and packages intended for use in research, medical diagnosis, and treatment are permitted on passenger aircraft (see §§ 173.448(f) and 175.700).
| |
| [10] The limits in this table do not apply to excepted packages. See the following references for the radiation level limits for: limited quantities, § 173.421; instruments and articles, § 173.424; articles containing natural uranium or thorium, § 173.426; or empty packaging, § 173.428.
| |
| [11] 2 mSv/h (200 mrem/h) other than intermodal transport of closed transport vehicles or exclusive use vessel.
| |
| Z-5
| |
| : 3. Contamination Limits and Quality Control for Class 7 (Radioactive) Materials:
| |
| (49 CFR 173.443 and 173.475, and 10 CFR 71)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| Maximum Permissible Limits for Non-fixed Radioactive Contamination on Packages When Offered for Transport The level of non-fixed (removable) radioactive contamination on the external surface of each package, conveyance, freight container, and overpack offered for transport must be kept as low as reasonably achievable, and shall not exceed the values shown in the following table:
| |
| Maximum permissible limits (§ 173.443(a), Table 9)
| |
| Contaminant Bq/cm2 µCi/cm2 dpm/cm2 Beta and gamma emitters and low toxicity alpha emitters 4 10-4 240 All other alpha emitting radionuclides 0.4 10-5 24 The non-fixed contamination shall be determined by:
| |
| (a) wiping, with an absorbent material using moderate pressure, sufficient areas on the package to obtain a representative sampling of the non-fixed contamination; (b) ensuring each wipe area is 300 cm2 in size; (c) measuring the activity on each single wiping material and dividing that value by the surface area wiped and the efficiency of the wipe procedure, where an actual wipe efficiency may be used, or it may be assumed to be 0.10.
| |
| Alternatively, the contamination level may be determined using alternative methods of equal or greater efficiency.
| |
| A conveyance used for non-exclusive use shipments is not required to be surveyed unless there is reason to suspect that it exhibits contamination (see
| |
| § 173.443(a)(2)).
| |
| Provisions for Control of Contamination on Radioactive Material Packages Offered for Transport and at the Time of Receipt
| |
| * When offered for transport, the non-fixed contamination on each package of radioactive material must be kept as low as reasonably achievable and may not exceed the limits set forth in § 173.443(a), Table 9 (as shown above).
| |
| * During transport, non-fixed contamination levels on packages transported as exclusive use by rail or highway may not exceed 10 times the limits in
| |
| § 173.443(a), Table 9 (as shown above).
| |
| Provisions for Non-fixed (Removable) Contamination on Excepted and Empty Radioactive Material Packages
| |
| * The non-fixed radioactive surface contamination on the external surface of excepted and empty packages shall not exceed the limits specified in
| |
| § 173.443(a), Table 9 (as shown above).
| |
| * The internal contamination of an empty package must not exceed 100 times the limits in § 173.443(a), Table 9 (as shown above).
| |
| Provisions for Non-fixed (Removable) Contamination on Packages and in Rail and Road Vehicles used for Exclusive Use Shipments of Radioactive Material
| |
| * The levels of non-fixed radioactive contamination on the packages (a) at the beginning of transport, may not exceed the levels prescribed in the above table, and (b) at any time during transport, may not exceed ten times the levels prescribed in § 173.443(a), Table 9 (as shown above) [see § 173.443(b)].
| |
| * Each conveyance, overpack, freight container, or tank used for transporting Class 7 (radioactive) material as an exclusive use shipment that utilizes the provisions of § 173.443(b) must be surveyed with appropriate radiation detection instruments after each exclusive use transport. If contamination values exceed acceptable levels, the transport vehicle may not be returned to exclusive use transport service, and then only for subsequent exclusive use shipment, unless the radiation dose rate at each accessible surface is demonstrated to be 0.005 mSv/h (0.5 mrem/h) or less, and that there is no significant non-fixed radioactive surface contamination as specified in § 173.443(a), Table 9 (as shown above) [see § 173.443(c)].
| |
| Provisions for Non-fixed (Removable) Contamination in Closed Rail and Road Vehicles that are used Solely for the Transportation of Radioactive Material (§ 173.443(d))
| |
| * The contamination levels must not exceed 10 times the levels prescribed in § 173.443(a), Table 9 (as shown above).
| |
| * Each vehicle is marked with the words For Radioactive Materials Use Only in letters at least 76 mm (3 in) high in a conspicuous place on both sides of the exterior of the vehicle.
| |
| * The vehicle must meet the placard requirements of Subpart F of Part 172.
| |
| * A survey of the interior surfaces of the empty closed vehicle must show that the radiation dose rate at any point does not exceed 0.1 mSv/h (10 mrem/h) at the surface or 0.02 mSv/h (2 mrem/h) at 1 m (3.3 feet) from the surfaces.
| |
| * Each vehicle shall be kept closed except for loading or unloading.
| |
| Provisions for Quality Control Prior to Each Shipment of Radioactive Material (§ 173.475)
| |
| * Before each shipment of any radioactive materials package, the offeror must ensure, by examination or appropriate tests, that:
| |
| (a) the packaging is proper for the contents to be shipped; (b) the packaging is in unimpaired physical condition, except for superficial marks; (c) each closure device of the packaging, including any required gasket, is properly installed, secured, and free of defects; (d) for fissile material, each moderator and neutron absorber, if required, is present and in proper condition; (e) each special instruction for filling, closing, and preparation of the packaging for shipment has been followed; (f) each closure, valve, or other opening of the containment system is properly closed and sealed; (g) each packaging containing liquid in excess of an A2 quantity and intended for air shipment has been tested to show that it will not leak under an ambient atmospheric pressure of not more than 25 kPa, absolute (3.6 psia), where the test must be conducted on the entire containment system, or on any receptacle or vessel within the containment system, to determine compliance with this requirement; (h) the internal pressure of the containment system will not exceed the design pressure during transportation; and (i) the external radiation and contamination levels are within the allowable limits specified in §§ 173.441 and 173.443.
| |
| Z-6
| |
| : 4. Hazard Communications for Class 7 (Radioactive) Materials: Shipping Papers (49 CFR 172, Subpart C)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information. [1]
| |
| Shipping Paper Entries Always Required Sometimes Required Optional Entries Basic description (in sequence): Materials-based Requirements:
| |
| * The weight in grams or
| |
| * UN Identification number
| |
| * The criticality safety index (CSI) or Fissile Excepted for kilograms may be
| |
| * Proper Shipping Name fissile material inserted instead of activity
| |
| * Hazard Class (7)
| |
| * Highway route controlled quantity or HRCQ for highway units for fissile
| |
| * Maximum activity contained in each route controlled quantities radionuclides, except for package in SI units (e.g., Bq, TBq), or
| |
| * The letters RQ entered either before or after the basic Pu-239 and Pu-241 in both SI and customary units (e.g., description for each hazardous substance [see § 171.8]
| |
| * The weight in grams of Ci, mCi) with customary units in
| |
| * Enter applicable subsidiary hazard class(es) in parentheses Pu-239 and Pu-241 may parentheses following the SI units immediately following the primary hazard class when a be inserted in addition to
| |
| * Number and type of packages subsidiary hazard label is required the activity units Additional description:
| |
| * A hazardous waste manifest and the word Waste preceding the proper shipping name is required for radioactive material
| |
| * Other information is
| |
| * Name of each radionuclide[2] permitted provided it does that is hazardous waste
| |
| * Description of physical and not confuse or detract chemical form (unless special form) Package-based Requirements: from the proper shipping
| |
| * Special form when not in the
| |
| * The applicable DOE or NRC package approval identification name or other required proper shipping name marking for each Type B(U), Type B(M), or fissile material information
| |
| * Category of label used package
| |
| * Transport index (TI) of each package
| |
| * The International Atomic Energy Agency (IAEA) Certificate of bearing a Yellow-II or Yellow-III label Competent Authority identification marking for export shipment or shipment in a foreign made package Additional entry requirements:
| |
| * 24 hour emergency telephone Shipment- and Administrative-based Requirements:
| |
| number
| |
| * Specify exclusive use shipment as required
| |
| * Shippers Certification shall be
| |
| * Specify instructions for maintaining exclusive use controls for provided by each person offering shipments of LSA material or SCO under exclusive use radioactive material for transportation[3]
| |
| * Specify the notation DOT-SP followed by the special permit
| |
| * Proper page numbering (e.g., Page 1 number for a special permit shipment of 4)
| |
| Special Considerations/Exceptions for Shipping Papers
| |
| * For shipments of multiple cargo types, any HAZMAT entries must appear as the first entries on the shipping papers, or be entered in a color that readily contrasts with any description on the shipping papers or highlighted on the shipping papers in a contrasting color, or be designated by an X (or RQ if appropriate).
| |
| * Emergency response information consistent with §§ 172.600 - 172.606 shall be readily available on the transport vehicle.
| |
| * Shipments of excepted radioactive material in excepted packages, under UN2908, UN2909, UN2910, and UN2911, are excepted from shipping paper requirements if (a) the material is not a hazardous substance or hazardous waste and (b) the package does not contain fissile material or contain fissile material that is excepted by § 173.453.
| |
| * For road transport, the shipping papers shall be (a) readily available to authorities in the event of accident or inspection, (b) stored within the drivers immediate reach while he is restrained by the lap belt, (c) readily visible to a person entering the driver's compartment or in a holder which is mounted to the inside of the door on the driver's side of the vehicle, and (d) either in a holder mounted to the inside of the door on the driver's side of the vehicle or on the driver's seat [see § 177.817(e)].
| |
| [1] International Atomic Energy Agency (IAEA); International Air Transportation Association (IATA); International Civil Aviation Organization (ICAO); International Maritime Organization (IMO).
| |
| [2] For mixtures of radionuclides, the radionuclides to be shown must be determined in accordance with § 173.433(g), which is commonly known as the 95% rule; abbreviations (symbols) are authorized.
| |
| [3] The Shippers certification shall satisfy the requirements of § 172.204.
| |
| Z-7
| |
| : 5. Hazard Communication for Class 7 (Radioactive) Materials: Marking of Packages:
| |
| (49 CFR 172, Subpart D; and 49 CFR 173.471, 178.3 and 178.350)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.
| |
| Markings on Packages Markings Always Required Additional Markings Sometimes Required Optional Markings Unless Excepted[1]
| |
| For Non-bulk Packages: Package-based marking requirements:
| |
| * Both the name and
| |
| * Proper shipping name
| |
| * Gross mass, including the unit of measurement (which may be address of consignor
| |
| * Identification number abbreviated) for each package with gross mass greater than 50 kg and consignee is (110 lb) recommended.
| |
| (preceded by UN or NA, as appropriate)
| |
| * Package type as appropriate, i.e., TYPE IP-1, TYPE
| |
| * Name and address of IP-2, TYPE IP-3, TYPE A, TYPE B(U) or TYPE B(M)[1]
| |
| * Other markings on consignor or consignee, unless
| |
| * Marked with international vehicle registration code of country of origin packages such as advertising are the package is: for IP-1, IP-2, IP-3 or Type A package design (e.g., USA) permitted, but must be highway only and no motor located away from
| |
| * Radiation (trefoil) symbol[3] on outside of outermost carrier transfers; or required markings and receptacle of each Type B(U) or Type B(M) part of a rail carload or labeling.
| |
| packaging design truckload lot or freight container load, and entire For marking exceptions for contents of railcar, truck, or
| |
| * Each NRC-approved package (e.g., Type AF, Type B(U), Type B(M), LSA material and SCO, freight container are shipped Type B(U)F, and Type B(M)F) must be marked with the identification [see from one consignor to one marking indicated in the package approval § 173.427(a)(6)(vi)] (e.g.,
| |
| consignee
| |
| * For Specification 7A packaging, mark on the outside with USA DOT 7A RADIOACTIVE-LSA, For Bulk Packages: Type A, and the name and address or symbol of the manufacturer RADIOACTIVE-SCO, or
| |
| * Identification number on satisfying §§ 178.3 and 178.350 RQ, as appropriate).
| |
| orange panel or white Materials-based requirements: For an overpack, the square-on-point display [see
| |
| * For a non-bulk IP-1 package containing a liquid, use marking OVERPACK in
| |
| §§ 172.332 or 172.336]: underlined double arrow symbol indicating upright on each side and each end, lettering 12 mm orientation[4], where the symbol is placed on two (0.5 inches) high. This if the packaging has a opposite sides of the packaging [see § 172.312] marking is not required if capacity of 3,785 L the package type (1,000 gallons) or more[2], or
| |
| * For a non-bulk package containing a hazardous substance, mark the contained in the overpack on two opposing sides, if the outside of each package with the letters RQ in association with the is visible from the outside packaging has a capacity of proper shipping name [see § 173.25].
| |
| less than 3,785 L Administrative-based requirements:
| |
| (1,000 gallons)[2]
| |
| * For each Type B(U), Type B(M) or fissile material package destined for export shipment, mark USA in conjunction with specification marking, or certificate identification; and package identification indicated in the U.S. Competent Authority Certificate
| |
| * Mark DOT-SP followed by the special permit number assigned for each package authorized by special permit
| |
| * Competent authority identification marking and revalidation for foreign made Type B(U), Type B(M), Type H(U), Type H(M), or fissile material package for which a Competent Authority Certificate is required Special Considerations for Marking Requirements
| |
| * All markings are to be (a) on the outside of each package, (b) durable and legible, (c) in English, (d) printed on or affixed to the surface of a package or on a label, tag, or sign, (e) displayed on a background of sharply contrasting color, and (f) unobscured by labels or attachments.
| |
| * When an overpack is used, see §§ 173.25 and 173.448(g) for marking requirements.
| |
| [1] Some marking exceptions exist for excepted packages, as specified in §§ 173.421, 173.422, 173.424, 173.426 and 173.428.
| |
| [2] If the identification number marking on a bulk package is not visible, the transport vehicle or freight container must be marked on each side and each end [see § 172.331].
| |
| [3] The radiation symbol shall be resistant to the effects of fire and water, plainly marked by embossing, stamping or other means resistant to the effects of fire and water and conform to the size requirements of Appendix B to Part 172.
| |
| [4] The arrows must be either black or red on white or other suitable contrasting background and commensurate with the size of the package; depicting a rectangular border around the arrows is optional.
| |
| Z-8
| |
| : 6. Hazard Communications for Class 7 (Radioactive) Materials:
| |
| Labeling of Packages (49 CFR 172.400-450)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.
| |
| Requirements for Labels[1]
| |
| * Label each package, except for (a) excepted packages of radioactive material; and (b) Low Specific Activity (LSA) material and Surface Contaminated Objects (SCO), packaged or unpackaged, when transported under exclusive use controls domestically and when the material or object contains less than an A2 quantity.
| |
| * Labels are required to be (a) printed or affixed to a surface other than the bottom of the package, (b) placed near the proper shipping name marking, (c) printed or affixed to a background of contrasting color or have a dotted or solid line outer border, (d) clearly visible, (e) not obscured by markings or other attachments, (f) representative of the hazardous material content, and (g) in conformance with the label specifications of § 172.407.
| |
| * The appropriate radioactive label must be affixed to opposite sides or two ends (other than the bottom) of all non-bulk packages of radioactive material.
| |
| Category of Radioactive Labels [3] Other Radioactive Labels[2]
| |
| White-I Yellow-II Yellow-III Fissile Empty Maximum Radiation Surface Level (RSL) Empty labels required Fissile labels required for each package containing for empty Class 7 mSv/h RSL < 0.005 0.005 < RSL < 0.5 0.5 < RSL < 2[5]
| |
| fissile material, other than (radioactive) packages mrem/h RSL < 0.5 0.5 < RSL < 50 50 < RSL < 200[5] fissile-excepted material; satisfying § 173.428; and labels must be affixed and any previously-Transport Index (TI):[4] adjacent to radioactive used labels must not TI = 0 0 < TI < 1 1 < TI < 10[5] category labels. be visible.
| |
| Contents on Labels
| |
| * Each radioactive category label must contain: (a) Except for LSA-I material, the names of the radionuclides in the package where, for mixtures of radionuclides, the names listed must be in accordance with the 95% rule specified in
| |
| § 173.433(g); and, for LSA-I material, the term LSA-I; (b) maximum activity in appropriate SI units (e.g., Bq, TBq), or appropriate customary units (e.g., Ci, mCi) in parentheses following SI units; and (c) for Yellow-II or Yellow-III labels the Transport Index (TI).
| |
| Abbreviations and symbols may be used. Except for Pu-239 and Pu-241, the weight in g or kg of fissile radionuclides may be inserted instead of activity units; for Pu-239 and Pu-241, the weight in g of fissile radionuclides may be inserted in addition to the activity units [see
| |
| § 173.403 for fissile material definition].
| |
| * Each fissile label must contain the relevant Criticality Safety Index (CSI) [see § 172.403(e)].
| |
| [1] Additional labels may be required if the contents of a package contains material that also meets the definition of one or more other hazard class. See §§ 172.402 and 406(c) for details on additional labeling requirements. [See §§ 172.400a, 173.421 through 173.427 for details when labels are not required, and see § 172.407 for details on label durability, design, size, color, form identification, exceptions, and the trefoil symbol size].
| |
| [2] A Cargo Aircraft Only label is required for each package containing a hazardous material which is authorized for cargo aircraft only
| |
| [see § 172.402(c)].
| |
| [3] The category of the label must be the higher of the two values specified for RSL and TI [see § 172.403(b)].
| |
| [4] The TI is determined from the radiation level 1 meter from the package surface [see TI definition in § 173.403]. If the measured TI is not greater than 0.05, the value may be considered to be zero. When an overpack is used, it must be labeled in accordance with
| |
| § 72.403(h).
| |
| [5] Packages with a TI > 10 or an RSL > 2 mSv/h (200 mrem/h) must be transported under exclusive use provisions [see § 173.441(b)].
| |
| Any package containing a Highway Route Controlled Quantity (HRCQ) must be labelled as RADIOACTIVE YELLOW-III.
| |
| Z-9
| |
| : 7. Hazard Communications for Class 7 (Radioactive) Materials: Placarding (49 CFR 172, Subpart F)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.
| |
| Conditions when Display of Placards is Required [§§ 172.504, 172.507(a), 172.508, and 172.512]
| |
| * Each bulk package, freight container, unit load device[1], transport vehicle, or rail car containing any quantity of hazardous material must be placarded on each side and each end with the placards specified in § 172.504(e).
| |
| * Radioactive placards are required for: shipments that contain a package labeled as Radioactive Yellow-III; unpackaged LSA-I or SCO-I when transported under exclusive use provisions; shipments required by §§ 173.427, 173.441, and 173.457 to be operated under exclusive use; and closed vehicles marked For Radioactive Materials Use Only transported under § 173.443(d).
| |
| * The Radioactive placard is placed on a square background on any motor vehicle used to transport a package containing a Highway Route Controlled Quantity (HRCQ) Class 7 (radioactive) material[2].
| |
| Visibility and Display of Radioactive Placards [§ 172.516]
| |
| * Placards are required to:
| |
| * be clearly visible, on a motor vehicle and rail car, from the direction they face, except from the direction of another transport vehicle or rail car to which the motor vehicle or rail car is coupled[3]
| |
| * be securely attached or affixed thereto or placed in a holder thereon
| |
| * be located clear of appurtenances and devices such as ladders, pipes, doors, and tarpaulins
| |
| * be located, so far as practical, so dirt or water is not directed to it from the transport vehicle wheels
| |
| * be located at least 3 inches (76.0 mm) away from any marking (e.g. advertising) that could reduce its effectiveness
| |
| * have RADIOACTIVE printed on it displayed horizontally, reading from left to right
| |
| * be maintained by the carrier so format, legibility, color, and visibility of the placard will not be substantially reduced due to damage, deterioration, or obscurement by dirt or other matter
| |
| * be affixed to a background of contrasting color, or have a dotted or solid line outer border which contrasts with the background color.
| |
| Radioactive Placards PLACARD (FOR OTHER THAN HRCQ) PLACARD FOR HRCQ White triangular background color in the lower portion Square background must consist of a white square surrounded by with yellow triangle in the upper portion; trefoil symbol, one-inch black border. The placard inside the square is identical to text, class number and inner and outer borders in black. that for other than HRCQ.
| |
| [see § 172.556 and Appendix B of Part 172] [see § 172.527]
| |
| General Specifications for Placards and Subsidiary Hazard Placarding
| |
| * Placards must conform to the specifications in § 172.519.
| |
| * A CORROSIVE placard is also required for each transport vehicle that contains 454 kg (1001 pounds) or more gross weight of non-fissile, fissile-excepted, or fissile uranium hexafluoride [see § 172.505(b)].
| |
| * Placards are also required for subsidiary hazards of POISON INHALATION HAZARD, POISON GAS, or DANGEROUS WHEN WET [see
| |
| § 172.505].
| |
| [1] See § 172.512 for exceptions and variations to the placarding requirements for freight containers and aircraft unit load devices.
| |
| [2] See § 173.403 for the definition of Highway Route Controlled Quantity (HRCQ). A package containing an HRCQ must be labeled with RADIOACTIVE Yellow-III labels [see §§ 172.403(c) and 172.507(a)].
| |
| [3] Required placarding of the front of a motor vehicle may be on the front of a truck-tractor instead of or in addition to the placarding on the front of the cargo body to which a truck-tractor is attached § 172.516(b).
| |
| Z-10
| |
| : 8. Requirements/Guidance for Registration, Emergency Response and Action for Class 7 (Radioactive) Materials: (49 CFR 107, Subpart G; 49 CFR 171.15; 49 CFR 172, Subparts F and G)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| Provisions for Persons Who Offer or Transport Class 7 (Radioactive) Materials (49 CFR 107, Subpart G)
| |
| * Any person, other than those excepted by § 107.606, who offers for transportation, or transports, in foreign, interstate or intrastate commerce any of the following Class 7 (radioactive) materials must satisfy registration and fee requirements of Part 107, Subpart G:
| |
| o a highway route-controlled quantity of radioactive material; o a shipment in a bulk packaging with a capacity > 13,248 L (3,500 gallons) for liquids or gases, or > 13.24 cubic meters (468 cubic feet) for solids; or o any quantity of radioactive material that requires placarding, under provisions of Part 172, Subpart F.
| |
| * Any person required to register must submit a complete and accurate registration statement on DOT Form F 5800.2 by June 30th for each registration year, or in time to have on file a current Certificate of Registration in accordance with § 107.620.
| |
| * Each registrant or designee must maintain for a period of 3 years from the date of issuance a copy of the registration statement and Certificate of Registration issued by PHMSA and must furnish its Certificate of Registration (or a copy thereof) and related records to an authorized representative or special agent of DOT upon request.
| |
| * Each motor carrier subject to registration requirements of this subpart must carry a copy of its current Certificate of Registration or another document bearing the registration number on board each truck and truck tractor, and the Certificate of Registration or document must be made available, upon request, to enforcement personnel.
| |
| * The amount of fees to be paid and procedures to be followed are found at §§ 107.612 and 107.616.
| |
| Provisions for Providing and Maintaining Emergency Response Information (49 CFR 172, Subpart G)
| |
| * When shipping papers for the transportation of radioactive materials are required [see Part 172, Subpart C], emergency response information shall o be provided and maintained during transportation and at facilities where materials are loaded for transportation, stored incidental to transportation, or otherwise handled during any phase of transportation; o be provided by persons who offer for transportation, accept for transportation, transfer or otherwise handle hazardous materials during transportation; o be immediately available for use at all times the hazardous material is present; and o include and make available the emergency response telephone number [see § 172.604] to any person, representing a Federal, State or local government agency, who responds to an incident involving the material or is conducting an investigation which involves the material.
| |
| * Emergency response information is information that can be used in mitigating an incident involving radioactive materials. It must contain at least the information specified in §§ 172.602 and 172.604; and includes an emergency response telephone number that is monitored at all times the material is in transportation by (a) knowledgeable person, or (b) a person who has immediate access to a knowledgeable person, or (c) an organization capable of accepting responsibility for providing the necessary detailed information concerning the material.
| |
| * Each carrier who transports or accepts for transportation radioactive material for which a shipping paper is required shall instruct, according to the requirements of § 172.606, the operator of a conveyance to contact the carrier in the event of an incident involving the material.
| |
| Actions to be Taken in the Event of Spillage, Breakage, or Suspected Contamination by Radioactive Material
| |
| * If there is evidence of a leaking package or conveyance, access to the package or conveyance must be restricted, the area impacted and the extent of the contamination must be determined, and appropriate measures must be taken to minimize impact to persons and the environment [see § 173.443(e)].
| |
| * Except for a road vehicle used solely for transporting Class 7 (radioactive) material [see § 173.443(d)], each aircraft used routinely, and each motor vehicle used for transporting radioactive materials under exclusive use, must be (a) periodically checked for radioactive contamination, (b) taken out of service if contamination levels are above acceptable limits, and (c) remain out of service until the radiation dose rates at accessible surfaces are less than 0.005 mSv/h (0.5 mrem/h) and non-fixed radioactive surface contamination levels are below the limits in §§ 173.443(a), Table 9; and 173.443(c) for exclusive use vehicle provisions [see Chart 3].
| |
| * Following any breakage, spillage, release or suspected radioactive contamination incident, any rail or air carrier shall notify, as soon as possible, the offeror (i.e. the consignor); special provisions apply for buildings, areas, and equipment that might become contaminated during rail transport. Alternative provisions may apply for motor vehicles transporting radioactive materials under exclusive use [see §§ 174.750(a), 175.705(e), and 177.843(b)].
| |
| Provisions for Immediate Notification for Reportable Incidents Involving Radioactive Materials (§§ 171.15 and 171.16)
| |
| * Each person in physical possession of radioactive material must provide notice in the event of a reportable incident (see § 171.15(b)) as soon as practical, but no later than 12 hours after the occurrence of the reportable incident, to the National Response Center (NRC) by telephone at 800-424-8802 (toll free) or 202-267-2675 (toll call) or online at https://www.nrc.uscg.mil.
| |
| * Each notice must include the information specified in § 171.15(a)(1) - (a)(7).
| |
| * A detailed incident report must also submitted as required by § 171.16.
| |
| Guidance on Responding to Emergencies (Emergency Response Guidebook)
| |
| * The DOT issues guidance to aid first responders in quickly identifying the hazards of the dangerous goods involved in an accident or incident, and for protecting themselves and the general public during the initial response to the accident or incident. For each proper shipping name or UN ID Number, the user is led to a specific guide that provides insight into potential hazards and steps to be taken for public safety and emergency response.
| |
| * The current edition of the Emergency Response Guidebook is available at https://phmsa.dot.gov/hazmat/outreach-training/erg.
| |
| Z-11
| |
| : 9. Requirements for Training and Safety and Security Plans for Class 7 (Radioactive) Materials:
| |
| (49 CFR 172, Subparts H and I, 49 CFR 173, and 10 CFR 37)
| |
| These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.
| |
| Training (49 CFR 172, Subpart H)
| |
| * For any person who is employed by an employer or is self-employed, and who directly affects hazardous materials transportation safety, a systematic program shall be established to ensure that the person:
| |
| * has familiarity with the general provisions of Part 172, Subpart H;
| |
| * is able to recognize and identify radioactive materials;
| |
| * has knowledge of specific requirements of Part 172 that are applicable to functions performed by the employee;
| |
| * has knowledge of emergency response information, self-protection measures and accident prevention methods and procedures; and
| |
| * does not perform any function related to the requirements of Part 172 unless instructed in the requirements that apply to that function.
| |
| * The person shall be trained pursuant to the requirements of § 172.704(a) and (b), may be trained by the employer or by other public or private sources, and shall be tested by appropriate means. The training must include the following:
| |
| (a) general awareness training providing familiarity with applicable regulatory requirements; (b) function-specific training applicable to functions the employee performs; (c) safety training concerning emergency response information, measures to protect the employee from hazards, and methods and procedures for avoiding accidents; (d) security awareness training providing awareness of security risks and methods designed to enhance transportation security; and (e) in-depth security training if a security plan is required for the shipment(s) involved.
| |
| * Initial and recurrent training shall comply with the requirements of § 172.704(c).
| |
| * Records of training shall be created and retained in compliance with the requirements of § 172.704(d).
| |
| Security (49 CFR 172, Subpart I, 49 CFR 173, and 10 CFR 37)
| |
| * A security plan for hazardous materials that conforms to the requirements of Part 172, Subpart I must be developed and adhered to by each person who offers for transportation in commerce or transports in commerce in a motor vehicle, rail car, or freight container any of the following radioactive materials:
| |
| (a) IAEA Code of Conduct Category 1 and 2 materials (see §§ 172.800(b)(15) and 10 CFR 37);
| |
| (b) a highway route controlled quantity (HRCQ) of radioactive material as defined in § 173.403 [see § 172.800(b)(15)];
| |
| (c) known radionuclides in forms listed as radioactive material quantities of concern (RAM-QC) by the NRC [see §§ 172.800(b)(15) and 10 CFR 37]; or (d) a quantity of uranium hexafluoride requiring placarding under § 172.505(b) [see § 172.800(b)(14)].
| |
| * The security plan must include an assessment of possible transportation security risks and appropriate measures to address the assessed risks.
| |
| * Specific measures put into place by the plan may vary commensurate with the level of threat at a particular time.
| |
| * At a minimum, a security plan must address personnel security, unauthorized access, and enroute security.
| |
| * The security plan must be (a) in writing; (b) retained for as long as it remains in effect; (c) available as copies or portions thereof to the employees who are responsible for implementing it, consistent with personnel security clearance or background investigation restrictions and a demonstrated need to know; (d) revised and updated as necessary to reflect changing circumstances; and (e) maintained (all copies) as of the date of the most recent revision, when it is updated or revised.
| |
| * Security plans that conform to regulations, standards, protocols, or guidelines issued by other Federal agencies, international organizations, or industry organizations may be used to satisfy the requirements in Part 172, provided such security plans address the requirements specified in Part 172, Subpart I.
| |
| * Additional security planning requirements may apply for rail transport of a highway route controlled quantity of radioactive material
| |
| [see §§ 172.820 and 173.403].
| |
| Z-12
| |
| | |
| NRC FORM 335 U.S. NUCLEAR REGULATORY COMMISSION 1. REPORT NUMBER (12-2010) (Assigned by NRC, Add Vol., Supp., Rev.,
| |
| NRCMD 3.7 and Addendum Numbers, if any.)
| |
| BIBLIOGRAPHIC DATA SHEET NUREG-1556, Volume 9, (See instructions on the reverse) Revision 3: Final Report
| |
| : 2. TITLE AND SUBTITLE 3. DATE REPORT PUBLISHED Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical MONTH YEAR Use Licenses - Final Report September 2019
| |
| : 4. FIN OR GRANT NUMBER
| |
| : 5. AUTHOR(S) 6. TYPE OF REPORT M. Burkhart, A. Cockerham, J. Cook, S. Daibes, S. Forster, S. Gabriel, D.B. Howe, P. Lanzisera, T. Simmons, K. Tapp, R. Zelac Technical
| |
| : 7. PERIOD COVERED (Inclusive Dates)
| |
| January 2008 to September 2019
| |
| : 8. PERFORMING ORGANIZATION - NAME AND ADDRESS (If NRC, provide Division, Office or Region, U. S. Nuclear Regulatory Commission, and mailing address; if contractor, provide name and mailing address.)
| |
| Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
| |
| : 9. SPONSORING ORGANIZATION - NAME AND ADDRESS (If NRC, type "Same as above", if contractor, provide NRC Division, Office or Region, U. S. Nuclear Regulatory Commission, and mailing address.)
| |
| Same as above
| |
| : 10. SUPPLEMENTARY NOTES
| |
| : 11. ABSTRACT (200 words or less)
| |
| This technical report contains information intended to provide program-specific guidance and assist applicants and licensees in preparing applications for materials licenses for the medical use of byproduct material. In particular, it describes the types of information needed to complete U.S. Nuclear Regulatory Commission (NRC Form 313, "Application for Materials License," and the NRC Form 313A series for authorized users (AU), authorized medical physicists (AMP), authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO). This document describes both the methods acceptable to the NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating an application to determine if the proposed activities are acceptable for licensing purposes.
| |
| The document also contains appendices that include examples of the types of supporting documents, such as procedures, that may need to be prepared by applicants or licensees. Guidance is this document represents one means acceptable to NRC staff for complying with NRC regulations and is not intended to be the only means of satisfying requirements for a license.
| |
| : 12. KEY WORDS/DESCRIPTORS (List words or phrases that will assist researchers in locating the report.) 13. AVAILABILITY STATEMENT NUREG-1556 unlimited Volume 9 14. SECURITY CLASSIFICATION Medical Use of Byproduct Material (This Page) 10 CFR Part 35 unclassified License (This Report) unclassified
| |
| : 15. NUMBER OF PAGES
| |
| : 16. PRICE NRC FORM 335 (12-2010)
| |
| | |
| NUREG-1556, Vol. 9 Consolidated Guidance About Materials Licenses: Program-Specific September 2019 Revision 3, Final Guidance About Medical Use Licenses}}
| |