ML20237D235
| ML20237D235 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/1998 |
| From: | Gattone R, Andrea Jones, Penny Lanzisera, Reid R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V09-DR-FC, NUREG-1556-V9-DR-FC, NUREG-1556-V9-DRF-FC, NUDOCS 9808250203 | |
| Download: ML20237D235 (200) | |
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( 4 j f 1 NUREG-1556 4 L< Vol. 9. $ consolidated! Guidance About . Katerialslicenses . . Nogram-' Specific Guidance Abouti - MedicalLUse Licerises. 1 - ) raft R'eport ifdr Co,mmeri.t. 4 W.SFNuclear Regulatory Commission-r 1)ffice of Nuclear Material Safety 'and Safeguards : P.Ai Lanzisera, A.R. Jones, R.G. Gattone, R.D. Reid L 1 9
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; R*18!R!'"8 2 1556 R PDR
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.. AVAILABILITY NOTICE - .j l Availability of Reference' Materials Cited in NRC Put$ cations li q
- Most documents cited in NRC publications will be available from one of the following sources: y a
i 1. : The NRC Public Document Room, 2120 L Street, NW., Lower Level, Washington,' DC . El
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20555-0001: J2. : The Superintendent of Documents, U.S. Govemment Printing Offios. P. O. Bc t 37082,
- Washington, DC 20402-9328
- 3. ; The National Technical information Servios, Springfis,ld, VA 22161-0002 i Although the listing that follows represents the mejority of documents cited in 'NRC publica-:
' tions, it is not intended to be exhaustive. ..
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[3 . Referenced documents available for inspection and copying for a fee from the NRC Public l Document Room include NRC correspondence and intomal NRC memoranda; NRC bulletins,; -! circulars, information notices, inspection and investigation notices; licensee event reports * . . j ( vendor reports and correspondonos; Commission papers; and appiloant and lloonese docu- [- monts and correspondence. ' h : I The following documents in the NUREG series are available for purchase from the Govemment ;j
- Printing Office: formal NRC staff and contractor reports, NRC-eponsored conference pro-' J j
coedings', intomational agreement reports, grantee te ports,[and NRC booidets erwi bro . chures. Also available are regulatory puides,' NRC regulations in the Code of Federal Aspuis- !
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i ions t ~, and Nuclear Regulatory Commission issuanoes. j
- Documents avaliable from the National Technical information Service include NUIEG eerlos i reports and technical reports prepared by other Federal agencies and reports prepared by the 4 j L Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission. 'l Documents available from public and special technical librarios include au open literature j L' ' items, such as books.' journal articles, and transactions.- Federal Register notloos, Federal j p and State legislation, and cerr :':- ; reports can usuaNy be obtained from these libraries. . ;
p . Documents such as theses, dissertations, foreign reports and translations, and non-NRC con- ; forence" proceedings are available for purchase from the organization sponsoring the publicas j tion cited. Single copies of NRC draft reporta are available free, to the extent of supply, upon written request to the Office of Administration, Distribution and Mail Servioos Sectio'n, U.S. Nuclear.
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Copies rif industry codes and standards used in a substantive manner in the NRC regulatory j process are maintained at the NRC Library, Two White Flint North 11545 Rockville Pike, Rock-ville, MD 20852-2738, for use by the public. Codes and standards are usually copyrighted and may be purchased from the originating siv.r,; tion or, if they are American National
' Standards, from the American National Standards institute,1430 Broadway, New York, NY 10018-3308.
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i NUREG-1556 Vol. 9 Consolidated Guidance About Materials Licenses i 1
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Program-Specific Guidance About Medical Use Licenses l Draft Report for Comment I Manuscript Completed: August 1998 Date Published: August 1998 Prepared by P.A. Lanzisera, A.R. Jones, R.G. Gattone, R.D. Reid Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
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I ABSTRACT p This draft guide has been developed in parallel with the proposed revision of 10 CFR Part 35, j " Medical Use of Byproduct Material." Comments received in response to publication of this L draft NUREG will be considered in developing the final guide. Development of the f' mal l NUREG will continue to parallel the rulemaking, and result in a guidance document that is consistent with the final rule. As part ofits redesign of the materials licensing process, the United States Nuclear Regulatory
- Commission (NRC) is consolidating and updating numerous guidance documents into a single l comprehensive repository as described in NUREG-1539, " Methodology and Findings of the l NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541,
" Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG-1556, Vol. 9, " Consolidated Guidance about Materials Licenses:
Program-Specific Guidance About Medical Use Licenses," dated August 1998, is the ninth program-specific guidance document developed for the new process and is intended for use by applicants, licensees, and NRC staff and will also be available for use by Agreement States. This ! guidance document corresponds with the revision to the Code of Federal Regulations (CFR), Title 10, Part 35, concurrently published in draft in August 1998. This document combines and supersedes the guidance previously found in Regulatory Guide (RG) 10.8, Revision 2, " Guide for the Preparation of Applications for Medical Use Programs"; Appendix X to RG 10.8, Revision 2,
" Guidance on Complying With New Part 20 Requirements"; Draft RG DG-0009, " Supplement to Regulatory Guide 10.8, Revision 2, Guide for the Preparation of Applications for Medical Use Programs"; Draft RG FC 414-4, " Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs"; Policy and Guidance Directive (P&GD) FC 87-2, " Standard Review Plan for License Applications for the Medical Use of Byproduct Material"; P&GD FC l 86-4, Revision 1, "Information Required for Licensing Remote Afterloading Devices";
i Addendum to Revision 1 to P&GD FC 86-4,"Information Required for Licensing Remote Afterloading Devices-Increased Source Possession Limits"; P&GD 3-15," Standard Review Plan for Review of Quality Management Programs"; RG 8.39, " Release of Patients Administered Radioactive Materials"; RG 8.33," Quality Management Program"; P&GD 3-17," Review of l Training and Experience Documentation Submitted by Proposed Physician User Applicants"; and RG 8.23," Radiation Safety Surveys at Medical Institutions, Revision 1." This draft rcport, where applicable, provides a more risk-informed, performance-based approach to medical use licensing consistent with the proposed regulations. L l: 1 iii Draft NUREG - 1556, Vol. 9 I _ - _ _ _ - _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ - _ __. ._________--___-_-_-________--____- _ _ - _ - - _ a
l l CONTENTS A BSTRA CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 FOREWORD..............................................................................ix ACKNOWLE DG M ENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x1 A BBREVI ATION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x ill 1 P URPOS E O F DRAFT R E PO RT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -1 1.1 LI C EN S ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 1.1.1 G EN ERAL IN VITRO LICEN SE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 1-4 1.1.2 SPECIFIC LICENSE OF LIMITED SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 1.1.3 SPECIFIC LICENSE OF BROAD SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 1.2 THE "AS LOW AS IS REASONABLY ACHIEVABLE (ALARA)" CONCEPT .............15 1.3 WRITTEN DIRECTIVE (WD) PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 1.4 RESEARCH INVOLVING HUMAN SUBJECTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... 1-6 2 AG RE EM ENT STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2- 1 3 ' MANAG EM ENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 4 APPLICABLE REG ULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 5 H OW TO FI L E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5- 1 5.1 . PAPER A PPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5- 1 5.2 ELECTRONIC APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 6 WH E R E T O FI LE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6- 1 7 LIC E N S E F E ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7- 1 8 CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.1 ITEM 1: LICENSE ACTION TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 8.2 ITEM 2: APPLICANTS NAME AND MAILING ADDRESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED . 8-4 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION . . . . . . . . . . . . . . . . . . . 8-5 8.5 ITEM 5: RADIOACTIVE MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 8.6 ITEM 5: FINANCIAL ASSURANCE AND RECORDKEEPING FOR DECOMMISSIONING . . . 8-8 8.7 ITEM 5: SEALED SOURCES AND DEVICES . . . . . . . . . . . . . . . . . . . . . . . . . . ..........811 8.8 ITEM 6: PURI'OSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED . . . . . . . . . . . . 8-12 8.9 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 19 8.10 ITEM 7: RADIATION SAFETY OFFICER (RSO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 20
- 8.11 ITEM 7: AUTHORIZED USERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . 8-2 3 8.12 ITEM 7: AUTHORIZED NUCLEAR PHARMACIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26 8.13 ITEM 7: AUTHORIZED MEDICAL PHYSICIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
[ 8.14 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.......................................................................8-29 8.15 ITEM 9: FACILITIES AND EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30 t: 8.16 ITEM 9: FACILITY DIAGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3 0 i l' 8.17 ITEM 9: RADIATION MONITORING INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 8 )' 8.18 ITEM 9: DOSE CALIBRATOR AND OTHER DOSAGE MEASURING EQUIPMENT . . . . . . . 8-39 v DraftNUREG 1556,Vol.9
- _ _ _ - - - _ _ _ _ _ _ _ _ _ _ _ .i
CONTENTS 8.19 ITEM 9: DOSIMETRY EQUIPMENT - CALIBRATION AND USE . . . . . . . . . . . . . . . . . . . . . 8-41 8.20 ITEM 9: OTHER EQUIPMENT AND FACILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-42 8.21 ITEM 10: RADIATION PROTECTION PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-45 8.22 ITEM 10: AUDIT PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . 8-47 8.23 ITEM 10: OCCUPATIONAL DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 8 8.24 ITEM 10: PUBLIC DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 52 8.25 ITEM 10: MINIMIZATION OF CONTAMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-53 8.26 - ITEM 10: OPERATING AND EMERGENCY PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . 8-54 8.27 ITEM 10: MATERIAL RECEIPT AND ACCOUNTABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . 8-56 8.28 ITEM 10: ORDERING AND RECEIVING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-57 8.29 ITEM 10: OPENING PACKAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 8 8.30 ITEM 10: SEALED SOURCE INVENTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Q 8.31 ITEM 10: US E RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 9 8.32 ITEM 10: LEAK TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-60 8.33 ITEM 10: AREA SURVEYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-62 8.34 ITEM 10: PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIREC' LIVE 8-63 8.35 ITEM 10: SAFE USE OF UNSEALED LICENSED MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . 0-63 8.36 ITEM 10: MAINTENANCE OF THERAPY DEVICES CONTAINING SEALED SOURCES . . . 8-64 8.37 ITEM 10: SPILL PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-65 8.38 ITEM 10: EMERGENCY RESPONSE FOR SEALED S0URCES OR DEVICES CONTAINING SEA LED SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-66 8.39 ITEM 10: PATIENT OR HUMAN RESEARCH SUBJECT RELEASE . . . . . . . . . . . . . . . . . . . . . 8-68 8.40 ITEM 10: SAFETY PROCEDURES FOR TREATMENTS WHERE PATIENTS ARE HOSPITALIZED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . 8-69 8.41 ITEM 10: SAFETY AND DEVICE CALIBRATION PROCEDURES . . . . . . . . . . . . . . . . . . . . . . 8 71 8.42 ITEM 10: MOBILE MEDICAL SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-77 8.43 ITEM 10: TRAN SPORTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 79 8.44 ITEM 11 : WASTE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-81 8.45 ITEM 12 : FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 84 8.46 ITEM 13 : CERTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-84 9 AMENDMENTS AND RENEWALS TO A LICENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 10 TERMINATION OF ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 APPENDICES A. List of Documents Considered in Development of this Draft NUREG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 B . NRC Form 3 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B- 1 4 C. License Application Checklist and Sample Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 1 l D. Information Needed for Transfer of Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 E. Guidance on Financial Assurance Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 Draft NUREG - 1556, Vol 9 vi
CONTENTS F. Typical Duties and Responsibilities of the Radiation Safety Officer and Sample Delegation of Authority . . F 1 G. Documentation of Training and Experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .... .....G-1 H. ModelTraining Program . . ... ..... ....... .... ... .. . ...... ...... .. .. . . . . H- 1
- 1. Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program . . 1-1 J. Model Procedures for Dose Calibrator Calibration . . . . . . . . . . . . . . . ............... . .. ... J-l K. Suggested Medical Licensee Audit . . . . ........ ............... ......... ... .. .. . . . K- 1 L. Model Procedures for an Occupational Dose Program . . . . . . . . . . . . . . ..... .......... ........ L-1 M. Guidance for Demonstrating that Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits ... ........ ..... ........ .... . ... . . ... . . . . . M- 1 N. Emergency Procedures . . . ..... . ...... . . . .. . .. . ...... .. .. .. . N-1 O. Model Procedures for Ordering and keceiving Packages ... ..... . ......................O-1 P. Model Procedure for Safely Opening Packages Containing Radioactive Material . . ... . ..... . P-1 Q. Model Leak Test Program . . . . . ... .. . ........ .. . .. ....... ..... ......... . Q-1 R. Model Procedure for Area Surveys . . .. . ....... ......... . .............. ...... . .. R-1 S. Procedures for Developing, Maintaining, and Implementing Written Directives . . . . . . . . . . . . . ... S-1 T. Model Procedures for Safe Use of Licensed Material . . . ...... ............... .. ..... .. T-1 U. Release of Patients or Human Research Subjects Administered Radioactive Materials . . . . . . . . . . . . . . . U-l V. Guidance for Mobile Services ......... .............. ..............................V-1 W. Transportation . . . . ..... ...... . ..... ..... . .. .. ....... . . .. .... . W-1 X. Model Procedure for Waste Disposal by Decay-In-Storage, Generator Return, and Licensed Material Retum . ............ . . .... ........ ..... .. .. .. . . . . . X-1 Y. N RC Form 3 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. . . . Y- 1 FIGURES Figure 2.1 U.S. Map ..... ....... ...... ...... .. .. . ............ .. 2-2 Figure 8.1 Location of Use . . . . . ...... .... .... . .... ... . . .. . .. . 8-4 Figure 8.2 Decommissioning Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. 8-9 Figure 8.3 Financial Assurance Mechanisms . . . . , . . . . ... ........... .... ....... . 8-10 Figure 8.4 Gamma Stereotactic Radiosurgery Unit . . . . . . . .. . ......... .. . ..... ..... .. 8-15 Figure 8.5 Beta Radiation Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17 Figure 8.6 Stent Implantation. .................... ..... .. . . ... .... .. . .. 8-18 Figure 8.7 RSO Responsibilities . . . . . . . . . . . . . . . .. ....... .... .......... .. . . 8-22 Figure 8.8 Facility Diagram for Nuclear Medicine Suite. . . . ... . . .... ... ....... .. 8-31 Figure 8.9 lodine 131 Nal Administration for the Thyroid Carcinoma Patient . . . . . . . . . . . . . . . . . . . 8 -3 2 Figure 8.10 Overhead View of Manual Brachytherapy Patient Treatment Room . . . . . . . . . . . . . . . . . . 8-33 Figure 8.l l Teletherapy and HDR Treatment Room . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ... . 8-34 Figure 8.12 Annual Dose Limits for Radiation Workers . . . . . . . . . . . . . . ..... ........ . . 8-49 1
l Figure 8.13 Proper Security of Licensed Material . . . . . . . . . . . . . . . ... .. . ..... .. . .. . . 8-52 Figure 8.14 Material Receipt and Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . ..... 8-57 vii Draft NUREG - 1556, Vol. 9 L__________________________..._
CONTENTS Figure 8.15 Leak Test Sample . . . . . . . . . . . . . . . . . . . . . . . . . . .................. ..... ... . 8-61 Figure M.1 Diagram of 0ffice and HDR Facility . . . . . . . . . . . . . . . . . . . .. . . .. . M-3 ) 1 TABLES Table 1.1 When to Request NRC Approval for Human Research . . . . . . . . . . . . . . . . . ..... ....... 1-7 Table 2.1 Who Regulates the Activity? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... 2-1 Table 8.1 Sample Format for Byproduct Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Table 8.2 Minimum Scaled Source Inventory Quantity Requiring Financial Assurance . . . . . . . . . . . . . 8-9 Table 8.3 Radiopharmaceuticals Used in Therapy . . . . . . . . . . . . . . . . . . . . . .. . .... . 8-13 Table C.1 Applicability Table . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . ...... . ..... . . . C- 1 Table E.1 Worksheet for Determining Need for Financial Assurance for Sealed Sources .. . . . . . . . E- 1 Table L.1 Investigational Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... ... . ........ ... L-4 Table 1.,2 Bioassay Action Levels for 1-131 . . . . . .................... .... ....... .... L-9 Table L.3 Aerosol AMAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ... L-18 Table M.1 Information Known About the HDR Unit . . . . . . . ....... .......... ..... . . . . . . . . M -3 Table M.2 Calculational Method, Part 1: Hourly and Annual Dose Received From the HDR Unit . . ... M-4 Table M.3 Calculational Method, Part 2: Annual Dose Received From the HDR Unit . . . . . . . . . . . . . . . . . . M-5 Table M.4 Calculational Method, Part 3: Summary ofInformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M-5 Table M.5 Calculational Method, Part 3: Annual Dose Received from HDR . . ............ ..... M-6 Table M.6 Calculational Method, Part 4: Summary of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M-7 Table M.7 Calculational Method, Part 4: Annual Dose Received from HDR . . . . . . . . . . . . . . . . . . . . . . M-7 Table M.8 Combination Measurement-Calculational Method . . . . . . . . . . . . . . . . . . .. ........... M-9 Table N.1 Relative Hazards of Common Radionuclides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-2 Table R.1 Ambient Dose Rate Trigger Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R-2 Table R.2 Acceptable Surface Contamination Levels in Restricted Areas in dpm/100 cm2 . . . . . . . . . . R-4 Table R.3 Acceptable Surface Contamination Levels in Unrestricted Areas in dpm/100 cm2 . . . . . . . . . . R-4 Table U.I Activities and Dose Rates for Authorizing Patient Release . . .. . .. ......... . . . . U-5 Table U.2 Activities and Dose Rates Above Which Instmetions Should be Given When Authorizing Patient Rele ase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ .... ... .. . . .U-8 Table U.3 Activities of Radiopharmaceuticals that Require Instructions and Records When Administered to Patients Who are Breast-Feeding an Infant or Child . . . . .... . ... . .. . . ..U-10 Table U.4 Summary of Release Criteria, Required Instructions to Patients, and Records to Be Maintained . . U-16 Table U.S Half-Lives and Exposure Rate Constants of Radionuclides Used in Medicine ... . . . U-17 Table U.6 Uptake Fractions and Effective Half-Lives for Iodine-131 Treatments . .... .. ... ... U-25 l l l l Draft NUREG - 1556, Vol 9 viii
FOREWORD I l } This draft guide has been developed in parallel with the proposed revision of 10 CFR Part 35,
" Medical Use of Byproduct Material," which was published for comment in August 1998. It is j i distributed for comment to encourage public participation in its development. Comments l
l received in response to publication of this draft NUREG will be considered in finalizing this i
- NUREG. Finalization of the NUREG will continue to parallel the rulemaking, and result in a guidance document that is consistent v/ith the final rule.
l The NRC is using Business Process Redesign (BPR) techniques to redesign its materials i licensing process. This effort is described in NUREG-1539," Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new I process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series: Va! cme Volume Title Status Number 1 Program-Specific Guidance About Portable Gauge Final Report Licenses 2 Program-Specific Guidance About Industrial Draft for Use and Comment Radiography Licenses 3 Applications for Sealed Source and Device Evaluation Draft for Comment and Registration 4 Program-Specific Guidance About Fixed Gauge Draft for Comment Licenses 5 Program-Specific Guidance About Self- Shielded Draft for Comment , Irradiator Licenses 6 Program-Specific Guidance About 10 CFR Part 36 Draft for Comment Irradiator Licenses 7 Program-Specific Guidance About Academic, Draft for Comment Research and Development, and Other Licenses of Limited Scope 8 Program-Specific Guidance About Exempt Final Report Distribution Licenses The current document, draft NUREG-1556, Vol. 9," Consolidated Guidance about Materials I Licenses: Program-Specific Guidance About Medical Use Licenses," dated August 1998,is the ninth program-specific guidance document developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and ix Draft NUREG - 1556, Vol. 9 1
FOREWORD updates the guidance for applicants and licensees previously found in RG 10.8, Revision 2,
" Guide for the Preparation of Applications for Medical Use Programs," dated August 1987, and the guidance for licensing staff previously found in P& gds, draft RGs and Standard Review Plans. In addition, this draft report also contains pertinent information found in Information Notices (IN), as listed in Appendix A.
Since this draft report takes a risk-informed, performance-based approach to medical ase licensing, it reduces the amount ofinformation needed from an applicant seeking to possess and use relatively safe quantities of byproduct material. A team composed of NRC and State Department of Health staff drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to medical use of byproduct material. This draft report is strictly for public comment and is not for use in preparing or reviewing applications for medical use licenses until it is published in final form. It is being distributed for comment to encourage public participation in its development. NRC is requesting comments on the information provided about medical use of byproduct material, as well as comments on a risk-informed, performance-based approach to licensing. Please submit comments within 90 days of the draft report's publication. Comments received after that time will be considered if practicable. Address comments to: Secretary, U. S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Rulemakings and Adjudications Staff. Hand deliver comments to: One White Flint North,11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Copies ofcomments received may be examined at: NRC Public Document Room,2120 L Street, NW (Lower Level), Washington, DC. Draft NUREG-1556, Vol. 9, is not a substitute for NRC regulations. The approaches and methods described in this draft report are provided for information and comment only. fY i /k , Donald A. Cool, Acting Dekuty Ofsce Director l Office of Nuclear Material Safety and Safeguards l l I Draft NUREG - 1556, Vol 9 x
ACKNOWLEDGMENTS The guidance development team thanks the individuals listed below for assisting in the development and review of the draft report. All participants provided valuable insights, observations, and recommendations. 1 The Participants l Bolling, Lloyd A. Lieberman, James Cool, Donald A. Merchant, Sally L. DelMedico, Joseph R. Paperiello, Carl A. Flack, Diane S. Rothschild, Marjorie U. Haney, Catherine Roe, Mary Louise Hill, Thomas E. Siegel, M.D., Barry Howard, Marcia Trottier, Cheryl A. Jones, Samuel Z. Treby, Stuart A. Lohaus, Paul H. Walter, David The team also thanks Kay Avery, D. W. Benedict Llewellyn, Grace S. Lee, Steven W. l Schawaroch, and Gina G. Thompson, of Compute,r Sciences Corporation for their assistance in l the preparation of this document. We would also like to recognize the following individuals for their contribution to supporting documents that formed a basis for this draft: Ayers, Robert . Merchant, Sally L. l Bhalla, Nee!am Minnick, Sheri A. Brown, Keith D. Schlueter, Janet R. Frazier, Cassandra F. Smith, James A. Fuller, Mike L. Taylor, Torre M. Holahan, Patricia K. l l l l-1 xi Draft NUREG - 1556, Vol. 9 i h
t ABBREVIATIONS i ! i 1 AAPM. American Association of Physicists in Medicine ACMUI Advisory Committee on the Medical Use ofIsotopes ALARA as low as is reasonably achievable ALI annuallimit on intake AMP ~ Authorized Medical Physicist ANP Authorized Nuclear Pharmacist ANSI American National Standards Institute AU authorized user bkg background BPR Business Process Redesign Bq Becquerel CFR Code of Federal Regulations Ci curies cc centimeter cubed cm2 centimeter squared Co-57 cobalt-57 l Co-60 cobalt-60 cpm counts per minute j Cs-137 cesium-137 i -DAC - Derived Air Concentration DIS- decay-in-storage l DOT United States Department of Transportation 1
'dpm disintegrations per minute FDA United States Food and Dmg Administration ft foot l
G-M Geiger-Mueller ; GPO Government Printing Office GSR gamma stereotactic radiosurgery ; HDR high dose-rate l I-125 iodine-125 I-131 iodine-131 l IN Information Notice 1 Ir-192 - iridium-192 LDR low dose-rate l mci millicurie ; ml . milliliter mR milliroentgen mrem millirem , mSv millisievert Nal(TI) sodium iodide (thallium doped) NCRP National Council on Radiation Protection and Measurements NIST National Institute of Standards and Technology xiii Draft NUREG - 1556, Vol. 9 L_________________________________
ABBREVIATIONS NRC United States Nuclear Regulatory Commission NVLAP National Voluntary Laboratory Accreditation Program OCFO Office of the Chief Financial Officer OCR optical character reader OMB Office of Management and Budget P-32 phosphorus-32 Pd-103 palladium-103 PDR pulsed dose-rate P&GD Policy and Guidance Directive QA Quality Assurance Ra-226 Radium-226 RG Regulatory Guide
, RSC Radiation Safety Committee RSO Radiation Safety Officer SDE shallow-dose equivalent SI International System of Units (abbreviated SI from the French Le Systeme Intemationale d' Unites)
Sr-90 strontium-90 SSDR Sealed Source and Device Registration std standard Sv sievert Tc-99m technetium-99m TEDE total effective dose equivalent TLD thermoluminescent dosimeters U-235 uranium-235 Ci microcurie WD Written Directive
.DraR NUREG - 1556, Vol 9 xiv 4
1 PURPOSE OF DRAFT REPORT This document is strictly for public comment and is not for use in preparing or reviewing applications for medical use licenses until this document is published in final form. This draft report provides guidance to an applicant in preparing a medical use license application as well as NRC criteria for evaluating a medical use license application. It is not intended to address the research and development or the commercial aspects of manufacturing, distribution, and service of medical radionuclides or sources in devices. Radionuclides are used for a variety of purposes in medicine. Typical uses are:
- Diagnostic studies with unsealed radionuclides
. Therapeutic administrations with unsealed radionuclides
. Diagnostic studies with sealed radionuclides
. Manual brachytherapy
. Therapeutic administrations with sealed sources in devices [i.e., teletherapy, remote afterloaders, and gamma stereotactic radiosurgery (GSR) units).
This draft report identifies the information needed to complete NRC Form 313 (Appendix B),
" Application for Material License," for medical use of radionuclides. The information collection requirements in 10 CFR Parts 30 and 35, and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017,3150-0010, and 3150-0120, respectively.
Information in this draft report will also help medical users understand specific regulatory requirements and licensing policies as they apply to medical licenses. Applicants are expected to address all the iterns on NRC Form 313 and to either follow the specific guidance that will become available in the final version of this draft report or to respond to the items in a manner that assures safe operation and compliance with the regulations that apply. The format within this document for each item of technical information is as follows: l
. Regulations - references the regulations applicable to the item
. Criteria - outlines the criteria used tojudge the adequacy of the applicant's response l l . Discussion - provides additional information on the topic sufficient to meet the needs of l
most readers, and
. Response from Applicant - provides suggested response (s) or indicates that no response is needed on that topic during the licensing process.
11 Draft NUREG - 1556, Vol. 9 l L_________________
PURPOSE OF DRAFT REPORT The regulations require the applicant / licensee to develop and implement procedures that will ensure compliance with the regulations. The appendices describe model radiation protection ) procedures. Each applicant should carefully read the regulations and model procedures and then i decide if the model procedure appropriately addresses specific radiation protection program needs at the applicant's facility. Applicants may adopt a model procedure or they may develop their own procedures to comply with the applicable regulation. Written procedures developed by applicants do not need to be submitted as part of the license application. However, the applicar,t must state that applicable procedures have been developed and implemented in accordance with the regulations. NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. Appendix C includes sample medical licenses with conditions most often found on these licenses, although not all licenses will have all conditions. Appendix C also contains a checklist to assist the applicant in determining which sections of this document and required procedures apply to the type of medical license requested. Appendices D through Y contain additional information on various radiation protection topics. In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20. Rem, and Sievert (Sv), its SI equivalent (I rem = 0.01 Sv), are used to describe units of radiation exposure or dose. This is because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen, and the sources commonly used in therapy emit beta and gamma rays, which roughly means that I roentgen = 1 rad = 1 rem. This NUREG not only updates the information and guidance provided in Revision 2 of RG 10.8, " Guide for the Preparation of Applications for Medical Use Programs," but also revises the format in which it is presented to assist with the preparation of a medical use license. Revision 2 was issued in August 1987 to provide guidance for the revised 10 CFR Part 35, which became effective on April 1,1987. Since then,10 CFR Part 35 has been revised a number of times. Technology-specific information has been revised and expanded to include technologies that are now more commonly used, for example, computerized remote afterloading brachytherapy [particularly high dose-rate (HDR)] and GSR. Applicants and licensees should also be aware of two other domments that provide useful information for medical use licensees. The first is the October 1994 Draft RG DG-0005 (second proposed revision to RG 10.5), " Applications for Licenses of Broad Scope," which provides additional licensing guidance on medical use programs of broad scope. The second is the May 1997 NUREG-1516," Effective Management of Radioactive Materials Safety Programs at Medical Facilities." The guidance in NUREG-1516 emphasizes a team approach to program Draft NUREG - 1556, Vol. 9 l-2
PURPOSE OF DRAFT REPORT management as a means to effectively manage radiation protection programs, and provides tools to help licensees manage these programs. Radiation protection team members should include the management of the licensed facility, the Radiation Safety Committee (RSC), if applicable, and the Radiation Safety Officer (RSO). The document also includes discussions on the duties and responsibilities of the RSO and supervised individuals; conduct of required audits; advantages and disadvantages in using consultants or service companies to augment the radiation protection program; resources that may be needed to support the program; and NRC notification and reporting requirements. Specific tools for day-to-day operation of a radiation protection program are provided in several appendices. Additionally, an extensive annotated bibliography lists publications on radiation protection program management at medical facilities. 1.1 LICENSES NRC regulates the intentional internal or external administration of byproduct material, or the radiation therefrom, to patients or human research subjects for medical use. A specific license of either limited or broad scope is issued to authorize possession and use oflicensed material. These licenses are issued pursuant to 10 CFR Parts 30,33, and 35. NRC issues three types of licenses for the use of byproduct material in medical practices and facilities. These include; general in vitro license, specific license oflimited scope, and specific license of broad scope. NRC usually issues a single byproduct material license to cover an entire radionuclides program
- except for teletherapy, nuclear-powered pacemakers, and GSR. The teletherapy license will also contain the authorization for source material (i.e., depleted uranium) used as shielding in many teletherapy units. Although individual licensees may be issued separate licenses for different medical uses, separate licenses are not usually issued to different departments in a medical facility or to individuals employed by or contracted by the medical facility. Only the facility's management may apply for the license.
An applicant should carefully study this report, related guidance, and all applicable regulations before completing NRC Form 313. When necessary, NRC may ask the applicant for additional information in order to gain reasonable assurance that an adequate radiation protection program has been established. l After a license is issued, the bcensee must conduct its program in accordance with the following:
- statements, representations, and procedures contained in the application and in correspondence I
with NRC
- terms and conditions of the license i
- NRC's regulations.
l l3 Draft NUREG - 1556, Vol. 9 u___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . - - - - - _ . - - - - - - - - - - - - - _ _ _ _ _ - . _ _ _ - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
PURPOSE OF DRAFT REPORT In 10 CFR 30.9, NRC requires that the information in the application be complete and accurate in all material respects. Information is considered to be material ifit is likely to change or affect an agency decision on issuing the license. 1.1.1 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, veterinarians, clinical laboratories, and hospitals to receive, acquire, possess, or use certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving " medical use"(i.e., not involving administration to humans). Section 31.11 explains the requirements for using materials listed. If the general license alone meets the applicant's needs, only NRC Forrn 483,
" Registration Certificate - In Vitro Testing With Byproduct Material Under General License,
need be filed. Medical use licensees authorized pursuant to 10 CFR Part 35 do not need to file the form. In 10 CFR 31.11, NRC limits possession to a total of 200 microcuries, at any time, of photon-emitting materials listed in 10 CFR 31.11. The use of materials listed in 10 CFR 31.11 within the inventory limits of that section are subject only to the requirements of that section and not to the requirements of 10 CFR Parts 19,20,21, and 35, except as discussed in 10 CFR 31.11. An applicant needing more than 200 microcuries of these materials must apply for a specific license and may request the increased inventory limit as a separate line item on the NRC form 313 application. Such applicants generally request an increased limit of 3 millicuries. If requesting an increased inventory limit, the applicant will be subject to the requirements of , 10 CFR Parts 19,20,21, and 35, including the requirements for waste disposal. 1.1.2 SPECIFIC LICENSE OF LIMITED SCOPE Specific licenses oflimited scope are generally issued to physicians in private practice or in a l group practice with a limited number of medical disciplines, and not to physicians located within a licensed medical institution. These licensees are not authorized to perform procedures requiring hospitalization of the patient. Specific licenses oflimited scope are also issued to medical institutions. A medical institution is 1 an organization in which several medical disciplines are practiced. These licenses authorize the { medical use of byproduct material by physicians named on the institution's license or authorized by the licensee in accordance with 10 CFR Part 35. l .' l Draft NUREG - 1556, Vol. 9 14
t l PURPOSE OF DRAFT REPORT t A specific license oflimited scope may also be issued to a mobile service (10 CFR 35.80, 10 CFR 35.647): Physicians in private practice and medical institutions may apply for authorization to use byproduct material in a mobile service. 1.i.3 SPECTIC LICENSE OF BROAD SCOPE l Some medice.: mstitutions provide patient care and conduct research programs that use radionucties for in vitro, animal, and medical procedures. In these cases, the NRC may issue a specific ticense of broad scope as discussed in 10 CFR Part 33. Specific licenses of broad scope j for mecical use, i.e., licenses authorizing multiple quantities and types of byproduct material for unspecified uses, are issued to institutions that (1) have had previous experience successfully ! I operating under a specific institutional license oflimited scope and (2) are engaged in medical research, as well as in routine diagnostic and therapeutic uses of byproduct material. DG-0005 was issued for comment in October 1994 to offer additional guidance to applicants for specific medical use license of broad scope. Both DG-0005 and the final version of this draft NUREG report should be consulted for guidance on applying for a medical use license of broad scope. 1.2 THE "AS LOW AS IS REASONABLY ACHIEVABLE (ALARA)" CONCEPT 10 CFR 20.1101 states that "each licensee must develop, document, and implement a radiation protection program commensurate with the scope and extent oflicensed activities..." and "the licensee shall use, to the extent practicable, procedures and controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are ALARA." Additionally, this section requires that licensees periodically review the content of the radiation protection program and its implementation. The success of an ALARA program depends on the cooperation of each person working at the licensed facility. Each individual who is authorized to use byproduct material should appropriately instruct all other individuals who work with or in the vicinity of byproduct material and should ensure that the facility and equipment are adequate for safe use. Each worker should comply with procedures developed to ensure safety and should promptly report incidents and potential problems to the authorized user or RSO. Management should make a commitment to the ALARA philosophy and implement that commitment with adequate resources. The RSO and management must audit the byproduct material program to ensure the continued safe use of byproduct material. The RSO is responsible for the day-to-day operation of the radiation protection program. RGs 8.10," Operating Philosophy for Maintaining Occupational Radiation Exposures ALARA," and 8.18,"Information Relevant to Ensuring That Occupational Radiation Exposures at Medical 1-5 Draft NUREG - 1556, Vol. 9
PURPOSE OF DRAFT REPORT Institutions Will Be ALARA," provide the NRC staff position on this subject. Several other NRC publications contain background information on the ALARA philosophy and its application in the medical environment. For example, NUREG-0267, " Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions ALARA"; NUREG-1134, " Radiation Protection Training for Personnel Employed in Medical Facilities"; and NUREG-1516," Effective Management of Radioactive Material Safety Programs at Medical Facilities," all contain information, methods, and references useful in establishing radiation protection programs to maintain exposures ALARA in medical institutions. Applicants should consider the ALARA philosophy as detailed in these reports when developing plans for work with licensed radioactive materials. 1.3 WRITTEN DIRECTIVE (WD) PROCEDURES 10 CFR 35.41 requires medical use licensees to develop, maintain, and implement procedures to provide high confidence that for each administration requiring a WD, the patient's identity is verified prior to the administration and the administration is in accordance with the WD. Information on developing these procedures is found in Appendix S to this document. 1.4 RESEARCH INVOLVING HUMAN SUBJECTS Effective January 1,1995, the definition of" medical use" contained in 10 CFR 35.2 was revised to include the administration of byproduct material to human research subjects. Also, 10 CFR 35.6, " Provisions for research involving human subjects," was added to allow limited specific and broad scope medical use licensees to conduct "research involving human subjects," which meets specific criteria. Under 10 CFR 35.6, medical use licensees may conduct such research provided that the research is conducted, funded, supported, or regulated by another Federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, the licensee must apply for and receive approval of a specific amendment before conducting such research. Also, whether or not a license amendment is required, liceasees must obtain informed consent from human subjects and obtain 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. Draft NUREG - 1556, Vol. 9 l-6
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l i 2 AGREEMENT STATES Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant other than a Federal agency who wishes to possess or use licensed material in one of these Agreement States needs to contact the I responsible officials in that State for guidance on preparing an application. These applications are filed with State officials, not with the NRC. l i In the special situation of work at Federally-controlled sites in Agreement States, it is necessary l to know thejurisdictional status of the land in order to determine whether NRC or the Agreement l State has regulatory authority. NRC has regulatory authority over land determined to be l " exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive l Federaljarisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends i that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with l NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on ! l determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16,1996, which is available from NRC upon request. Table 2.1 provides a quick way to check on which agency has regulatory authority. Table 2.1 Who Regulates the Activity? Applicant and Proposed Location of Work Regulatory Agency Federal agency regardless oflocation (except that Department of Energy NRC [ DOE] and, under most circumstances, its prime contractors are exempt from licensing [10 CFR 30.12]) Non-Federal entity in non-Agreement State, U.S. territory, or possession NRC Non-Federal entity in Agreement State at non-Federally controlled site Agreement State Non-Federal entity in Agreement State at Federally-controlled site not - Agreement State subject to exclusive Federaljurisdiction Non-Federal entity in Agreement State at Federally-controlled site subject to NRC exclusive Federaljuricdiction l l l 21 Draft NUREG - 1556, Vol. 9 1
AGREEMENT STATES Locations of NRC Offices and Agreement States Region IV Region 111 y gg 1 3m MT VT,
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f .) COI l gg , ' WV DE MD CA
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" LA G Region 11 61 W,@ Sven SW, Suik 23T85 AK Atlanta,GA 30303 Hi OY v FL 404-562-4400, 1 800-577 8510
- Reglon H ,,,io, ,,,
801 Warrenville Road s 6 351 9 RegionalOfhee Q Headquarters _
$ Field Ofhce Region IV O 30 Agreernent States Headquarters 611 Ryan Plaza Dnve, Suite 400 (approx.15,800 hcnesees) Washington, D C. 20555-0001 Arhngton. TX 76011-8064 O 20 Non-Agreement States 301-415-7000, 1 800-368-5642 817 860-8100, 1-800-952-9677 (approx. 6.000 licensees)
Region l Walnut Creek Field Office Note. Alaska and Hawaii are included in 475 Allendale Road 1450 Mana Lane Region IV, Puerto Rco and Virgin Islands King of Prussia, PA 19406 1415 Walnut Creek. CA 94596-5368 in Region 11 610-337 5000,1-800-432-1156 510 975-0200, 1-800-882 4672 sa,4 4cas. 6 Figure 2.1 U.S. Map. Location ofNRC Offices and Agreement States. Note: As ofOctober 1, 1998, the ll'alnut Creek Field Ofice will close. All communications should beforwarded to Region ll'.
Reference:
A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional or Field Offices. Or visit NRC's Home Page <http://www.nre. gov >, choose " Nuclear Materials," then
" Review of State Radiation Control Program Query Form," and then " Directories."
The All Agreement States Letter, SP-96-022, dated February 16,1996,is available by contacting NRC's Office of State Programs; call NRC's toll free number (800) 368-5642, and then ask for extension 415-3340. Or visit NRC's Home Page <http://www.nrc. gov >, choose " Nuclear Materials," then choose " Review of State Radiation Control Program Query Form" and follow the directions for sul mitting a query for "SP-96-022." l l l Draft NUREG - 1556, Vol. 9 2-2 l _ ___o
3 MANAGEMENT RESPONSIBILITY The NRC recognizes that effective radiation protection program management is vital to i achieving safe and compliant operations (see 10 CFR 35.24). NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely.
" Management" refers to the chief executive officer or that person's delegate or delegates who have authority to provide necessary resources to achieve regulatory compllance.
To ensure adequate management involvement, a management representative (i.e., chief executive , officer or delegate) must sign the submitted application acknowledging management's commitments and responsibility for the following:
. Radiation protection, security and control of radioactive materials, and compliance with regulations . Completeness and accuracy of the radiation protection records and all information provided to NRC (10 CFR 30.9) . Knowledge about the contents of the license and application . Compliance with current NRC and United States Department of Transportation (DOT) regulations and the licensee's operating and emergency procedures . Commitment to provide adequate resources (including space, equipment, personnel, time, and, l
if needed, contractors) to the radiation protection program to ensure that patients, the public, and workers are protected from radiation hazards
. Appointment of a qualified individual to work as the RSO . Approval of qualified individual (s) to serve as Authorized Medical Physicists (AMPS),
Authorized Nuclear Pharmacists (ANPs), and authorized users (AUs) for licensed activities. For information on NRC inspection, investigation, enforcement, and other compliance programs, see " General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, dated June 1995," Compilation of NRC Enforcement Policy as of September 10,1997", and Manual Chapter 87100, Appendix B," Nuclear Medicine Inspection Field Notes"; see Notice of Availability (on inside front cover of this draft report). NUREG-1600 is also available on the Internet. Visit NRC's Home Page <http //www.nre. gov >, choose " Nuclear Materials," then
" Enforcement,"" Enforcement Guidance Documents," and then " Current Enforcement Policy."
l 31 Draft NUREG - 1556, Vol. 9 I
4 APPLICABLE REGULATIONS It is the applicant's or licensee's responsibility to have up-to-date copies ofapplicable regulations, read them, and abide by each applicable regulation. The following Parts of 10 CFR Chapter I contain regulations applicable to medical uses i licensees: , 1 10 CFR Part 2, " Rules of Practice for Domestic Licensing Proceedings and Issuance of ! Orders" 10 CFR Part 19," Notices, Instructions and Reports to Workers: Inspection and Investigations" 10 CFR Part 20," Standards for Protection Against Radiation" 10 CFR Part 21, " Reporting of Defects and Noncompliance" l 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct l Material" 1 10 CFR Part 32, " Specific Domestic Licenses to Manufacture or Transfer Certain Items I Containing Byproduct Material" 1 10 CFR Part 33," Specific Domestic Licenses of Broad Scope for Byproduct Material" ' 10 CFR Part 35, " Medical Use of Byproduct Material" 10 CFR Part 40," Domestic Licensing of Source Material"
- 10 CFR Part 71," Packaging and Transportation of Radioactive Material" Part 71 requires that licensees or applicants who transport licensed material or who may offer such material to a carrier for transport must comply with the applicable requirements of the DOT that are found in 49 CFR Parts 170 through I89. For ordering information on the regulations, see the Notice of Availability (on inside front cover of this draft report). I
= 10 CFR Part 150," Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274" '
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" 10 CFR Part 171," Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and l Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC" 41 Draft NUREG - 1556, Vol. 9
1 APPLICABLE REGULATIONS In addition to the information provided in the Notice of Availability (on inside front cover of this draft report), to request copies of the above documents, applicants may call the Government Printing Office's (GPO's) order desk in Washington, DC at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at <http://www.gpo. gov >. Request single copies of the above documents from NRC's Regional or Field Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes amendments to its regulations in the Federal Renister. Title 10 is also available at <http://www.nrc. gov >, choose " Reference Library", and then " Title 10 of The Code of Federal Regulations." I Draft NUREG - 1556, Vol. 9 42
l 5 HOW TO FILE l l 5.1 PAPER APPLICATION Applicants for a materials license should do the following:
. Be sure to use the most recent guidance in preparing an application
. Complete NRC Form 313 (Appendix B) Items I through 4,12, and 13 on the form itself
. Complete NRC Form 313 Items 5 through 11 on supplementary pages or use Appendix C
! . Provide sufficient detail for the NRC to determine that equipment, facilities, training and experience, and the radiation safety program are adequate to protect health and safety and l minimize danger to life and property
. For each separate sheet, other than Appendix C, that is submitted with the application, identify and key it to the item number on the application or the topic to which it refers
. Submit all documents, typed, on 8-1/2 x 11 inch paper
. Avoid submitting proprietary information unless it is absolutely necessary
. Submit an original, signed application and one copy
. Retain one copy of the license application for future reference.
As required by 10 CFR 30.32(c) and 10 CFR 35.12(a), applications must be signed by the l management of the facility; see section on " Certification."
]
Using the suggested wording of responses in this draft report will expedite NRC's review. ) i All license applications will be available for review by the general public in NRC's Public Document Rooms. Ifit is necessary to submit proprietary infonnation, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, and radiation dose information, should not be submitted unless specifically requested by NRC. NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper
- applications. However, these will be scanned and put through an optical character reader (OCR) i to convert them to electronic format. To ensure a smooth transition, applicants are requested to
. follow these suggestions:
5-1 Draft NUREG - 1556, Vol. 9
i HOW TO FILE
. Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed easily into the scanner . Choose typeface designs that are sans serif, such as Arial, Helveti::a, Futura, Univers; the text of this document is in a serif font called Times New Roman a Choose 12-point or larger font size
- Avoid stylized characters such as script, italic, etc.
- Be sure the print is clear and sharp
. Be sure there is high contrast between the ink and paper (black ink on white paper is best).
5.2 ELECTRONIC APPLICATION As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms fer filing applications via diskettes or CD-ROM, and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. The existing paper p'.ocess will be used until the electronic process is available. t Draft NUREG - 1556, Vol. 9 5-2
6 WHERE TO FILE i l Applicants wishing to possess or use licensed material in any State or U. S. territory or I possession subject to NRC jurisdiction must file an application with the NRC Regional Office ; for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four i Regional Offices and their respective areas for licensing purposes and identifies Agreement States. The Walnut Creek, California, Field Office, can respond to routine telephone inquiries until September 30,1998. Effective October 1,1998, the Walnut Creek, California, Field Office 3 will close and any communications previously involving that Field Office should be addressed to ! the Region IV Office. In general, applicants wishing to possess or use licensed material in an Agreement State must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine thejurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See Section 2," Agreement States," for additional information. } 6-1 Draft NUREG - 1556, Vol. 9 I i
1 i 7 LICENSE FEES Each application for which a fee is specified, including applications for new licenses and license ) amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical
- review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application.
l l Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult ! 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as "small entities." L Direct all questions about NRC's fees or completion ofItem 12 of NRC Form 313 (Appendix B) l to the Office of the Chief Financial Officer (OCFO) at NRC headquarters in Rockville, Maryland,(301) 415-7544. You may also call NRC's toll free number (800) 368-5642 and then ask for extension 415-7544. Enter the fee category and the amount of the fee enclosed with the application on NRC Form 313. t l l t I
)
71 Draft NUREG - 1556, Vol. 9
8 CONTENTS OF AN APPLICATION This section explains, item by item, the information requested on NRC Form 313. Items 5 through 11 on the form request specific information about the proposed radiation safety program. To assist the applicant in submitting complete information on these items, the applicable regulations are referenced in the discussion of each item. Applicants must provide detailed information about the following:
- Proposed facilities and equipment Training and experience of byproduct material users and the RSO
= Delegation of authority to RSO
= Financial assurance (if applicable) j = Mobile use of byproduct material (if applicable).
l l l Additionally, in response to items 9,10, and 11, the applicant must provide a commitment to develop and implement various procedures to meet the requirements of the applicable regulation. l Table 1 in Appendix C is provided to assist applicants determine which procedures must be ! developed and implemented for the type of medical use requested. Several appendices in this report present sample procedures that the applicant may use in developing their procedures. If a particular item requires the applicant to develop and implement a procedure, the applicant may l use the following wording in each response section on the application: I "We have developed and will implement written procedures for that meet the requirements of 10 CFR ." l If an applicant or licensee commits to a section of this report, that commitment will be incorporated as a part of the terms and conditions of the license. The licensee will be inspected against the commitments contained in the referenced section, appendix, or document,just as the applicant / licensee will be inspected against more detailed responses. If a particular part of a section does not apply simply note "NA" for "not applicable." If a particular section applies, but a procedure does not have to be developed, simply note "N" for "no response required." Short sentence responses,"NA" or "N" responses to items 5 through 10 should run consecutively on one or more sheets separate from responses provided on NRC Form 313. Lengthy responses should be appended as attachments. As indicated on NRC Form 313 (Appendix B), responses to Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C to assist with ; completion of the application. Applicants should note that using the suggested wording of responses will expedite NRC's review. i 8-1 Draft NUREG - 1556, Vol. 9 l 1
4 CONTENTS OF AN APPLICATION 1 8.1 ITEM 1: LICENSE ACTION TYPE THIS IS AN APPLICATION FOR (Check appropriate item) Type of Action License No. [ ] A. New License Not Applicable [ ] B. ' Amendment to License No. XX-XXXXX-XX [ ] C. Renewal of License No. XX-XXXXX-XX Check box A if the application is for a new license Check box B for an amendment' to an existing license, and provide license number. Check box C for a renewal' of an existing license, and provide license number. 8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A post office box number is an acceptable mailing address. Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC IN 97-30," Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3,1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. \ I
' See " Amendments and Renewals to a License" later in this document. Licensees may request an amendment to an existing license to add authorization for other uses of byproduct material. As described in 10 CFR 35.12(c), a separate application and license is required for the addition of 10 CFR 35.600 uses, with the exception of remote afterloaders.
Draft NUREG - 1556, Vol. 9 8-2
l CONTENTS OF AN APPLICATION
. Timely Notification of Transferring Control Regulations: 10 CFR 30.34(b),10 CFR 35.14(b).
Criteria: Licensees must provide full information and obtain NRC'sprior written consent before transferring control of the license, or, as some licensees call it, " transferring the license." l l . Discussion: Transferring control may be the result of mergers, buyouts, or majority stock i transfers. Although it is not NRC's intent to interfere with the business decisions oflicensees, it l is necessary for licensees to obtain prior NRC written consent before transferring control of the ! license. This is to ensure the following:
. Radioactive materials are possessed, used, or controlled only by persons who have valid NRC licenses
. Materials are properly handled and secured i
. Persons using these materials are competent and committed to implementing appropriate radiological controls l
- A clear chain of custody is established to identify who is responsible for final disposal of the j l material
. Public health and safety are not compromised by the use of such materials l l
! As provided in 10 CFR 35.14(b), if the licensee's name or mailing address changes, and the name change does not constitute a transfer of control of the license as described in 10 CFR 30.34(b), a ; l licensee must file a written 30 day notification with the NRC instead of obtaininc jaior NRC l written consent. Response from Applicant: No response is required from an applicant for a new license; Appendix D, excerpted from IN 89-25 (Rev.1), " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, identifies the information to be provided about transferring control. l
Reference:
See the Notice of Availability on the inside front cover of this draft report to obtain l copies ofIN 89-25 (Rev.1), " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, and IN 97-30," Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3,1997. I ! 8-3 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h). Criteria: Immediately following filing of a voluntary or involuntary petition for bankruptcy for
, or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in . I writing, identifying the bankruptcy court in which the petition was filed and the date the of filing.
Response from Applicant: None at time of application for a new license. Licensees must notify NRC immediately (i.e., within 24 hours) of filing a bankruptcy petition. 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED Specify the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A post office box address is not acceptable (see Figure 8.1). 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 a mobile service as authorized pursuant to 10 CFR 35.18(b), the applicant should refer to Section 8.42 and Appendix V of this report for specific licensing guidance. 32 Elm St. ity,ST 12345 , W w *ayg Figure 8.1 Location of Use. Draft NUREG - 1556, Vol. 9 84
CONTENTS OF AN APPLICATION Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or local regulations (e.g., local zoning requirements; a local ordinance requiring registration of a radiation-producing device). Note: As discussed later under " Financial Assurance and Record Keeping for Decommissioning " licensees do need to maintain permanent records on 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 l terminated). For medical use licensees, acceptable records are sketches or written descriptions of the specific locations where material is used or stored and any information relevant to spills (e.g., l where contamination remains after cleanup procedures or when there is reasonable likelihood l that contaminants may have spread), damaged devices, or leaking radioactive sources. ! 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION l Identify the individual who can answer questions about the application and include his or her l telephone number. This is typically the proposed RSO, unless the applicant has named a different person as the contact. The NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or his or her telephone number changes so that NRC can l contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment or a fee. l The individual named in Item 4 may or may not be the same individual who signs the application l as the " certifying official" on behalf of the licensee and has the authority to make commitments l to NRC (see Item 13 on Form 313). Any commitments made by the applicant should be signed by the individual named in Item 13 since only that individual is considered by NRC to have the authority to make commitments on behalf of the applicant. Therefore, NRC will not accept license amendments or renewals signed by the individual identified in Item 4, if this person differs from the one named in Item 13. NRC recognizes that licensees may use a consultant or consultant group to help prepare the license application and provide support to the radiation protection program. Licensees are reminded that regardless of the role of the consultant in radiation protection program management, the licensee remains ultimately responsible for all aspects of the licensed program, including the services performed by the consultant. 8-5 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION 1 As indicated on NRC Form 313 (Appendix B), Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C for guidance and should note that using the suggested wording of responses will expedite NRC's review. 8.5 ITEM 5: RADIOACTIVE MATERIAL Regulations: 10 CFR 30.32,10 CFR 30.33,10 CFR 30.34,10 CFR 30.35,10 CFR 35.100, 10 CFR 35.200,10 CFR 35.300,10 CFR 35.400,10 CFR 35.500,10 CFR 35.600, 10 CFR 35.1000. Criteria: 10 CFR Part 35 divides byproduct material for medical use into seven types of use (10 CFR 35.100,35.200,35.300,35.400,35.500,35.600, and 35.1000). Discussion: Using the table formats below (see Table 8.1), the applicant should indicate the byproduct material requested. For 35.100,35.200, and 35.300 material, the chemical / physical form may be "Any." For 35.100 and 35.200 material, the total amount requested may be "As Needed." For 35.300 material, the total amount requested must be specified. For 35.400, 35.500,35.600, and 35.1000 material, express the radionuclides, the chemical / physical form (e.g., sealed source and manufacturer's name and model number), the total amount in Becquerels (Bq), microcuries ( Ci), millicuries (mci), or curies (Ci), and maximum number of sources possessed at any one time. For sealed sources used in devices, an applicant may wish to request two sources, one to be used in the device and one to be stored in its shipping container, to accommodate the total quantity of material in the licensee's possession during replacement of the source in the device. The maximum activity for a single source or source loading may not exceed the activity specified by the manufacturer for the specific device and source combination as stated in the Sealed Source and Device Registration (SSDR) Certificate. However, it is permissible to request a maximum activity, for the source in the shipping container, that exceeds the maximum activity allowed in the device. To request such authorization, applicants should provide certification that the source transport container is approved for the requested activity. A source that is received with a higher activity than permitted in the device must be allowed to decay to, or below, the device source activity limit prior to installation in the device. If applicable, the applicant should request authorization for possession of depleted uranium [i.e., uranium depleted in uranium-235 (U-235)] in quantities sufficient to include shielding material in both the device (s) and source containers used for source exchange. The applicant should review the manufacturer's specifications for each device specified in the license request to determine (1) whether depleted uranium is used for shielding the source (s) within the device and (2) the total quantity of depleted uranium present in the device (in kilograms). The applicant should also consult the manufacturer's specifications or the source supplier to determine whether Draft NUREG - l$56. Vol. 9 8-6
l l CONTENTS OF AN APPLICATION I l depleted uranium is contained within shielding source containers used during source exchange j and determine the total quantity of depleted uranium in such containers (in kilograms). l A separate entry should be made for other items that need to be listed (e.g., more byproduct ! material for in vitro testing than is allowed under 10 CFR 31.11, depleted uranium for linear accelerator shielding, survey meter calibration source, dosimetry system cor.stancy check source, or material for in vitro, animal, or human research studies). Sources that are authorized by I j 10 CFR 35.65, " Authorization for calibration and references sources" should not be listed. Applicants should number each line entry consecutively following the 10 CFR Part 35 material. ) 1 1 Table 8.1 Sample Format for Byproduct Material 1 l ! Byproduct Material Chemical / Physical Form Maximum Amount l Any byproduct material Any As needed included in 10 CFR 35.100 Any byproduct material Any As needed included in 10 CFR 35.200 Any byproduct material Any 300 millicuries 1 t included in 10 CFR 35.300 Cesium 137 (i.e., specific sealed source (Manufacturer 2 curies total brachytherapy radionuclides) Name, Model #XYZ) Gadolinium 153 (i.e., specific sealed source (Manufacturer Not to exceed 500 millicuries diagnostic sealed source Name, Model #XYZ) per source and 1 curie total radionuclides) Cobalt 60 (i.e., specific sealed source (Manufacturer Not to exceed 9,000 curies per teletherapy sealed source Name, Model #XYZ) source and 18,000 curies total l radionuclides) Iridium 192 (i.e., specific sealed source (Manufacturer Not to exceed 10 curies per afterloader sealed source Name, Model #XYZ) source and 20 curies total radionuclides) i Cobalt 60 (i.e., specific sealed source (Manufacturer Not to exceed 36 curies per gamma stereotactic Name, Model #XYZ) source and 6,600 curies total radiosurgery sealed source radionuclides) Depleted Uranium Metal 99 kilograms Any byproduct material Prepackaged Kits 50 millicuries identified in 10 CFR 31.11 8-7 Draft NUREG - 1556, Vol. 9
l CONTENTS OF AN APPLICATION When determining both individual radionuclides and total quantities, all materials to be possessed at any one time under the license should be included, i.e., materials received awaiting use (new teletherapy or brachytherapy sources for exchange); materials in use or possessed; material used for shielding; and those materials classified as waste awaiting disposal or being held for " decay-in-storage (DIS)." Response from Applicant: The applicant shall submit the information as described above. 8.6 ITEM 5: FINANCIAL ASSURANCE AND RECORDKEEPING FOR DECOMMISSIONING Regulations: 10 CFR 30.34(b),10 CFR 30.35. Criteria: Licensees authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35 must provide evidence of financial assurance for decommissioning. Even if no financial assurance is required, licensees are required to maintain, pursuant to 10 CFR 30.35(g), in an identified location, decommissioning records related to structures and equipment where licensed material is used or stored, spills or spread of contamination, and leaking sealed sources (see Figure 8.2). Licensees must transfer these records important to decommissioning either to the new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to the appropriate NRC Regional Office before the license is terminated. Draft NUREG - 1556, Vol. 9 88
l CONTENTS OF AN APPLICATION s"y$N $I!?nl, i Surveys
**tnrissioninE Ercord, ,
ekg w v j y- at at
, n
/ '-
% )
J
'Qc th ,
- ' ' 6dNn 6 ht&
u_me.4ng Figure 8.2 Decommissioning Records. Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most medical use applicants and licensees do not need to take any action to comply with the financial assurance requirements because either their total inventory oflicensed material does not exceed the limits in 10 CFR 30.35 or the half-life of the unsealed byproduct material used does not exceed 120 days. The limits for some sealed sources are shown in Table 8.2. Applicants requesting more than one radionuclides need to use the sum of the ratios method to determine whether financial assurance is needed. See Appendix E for additionalinformation. Table 8.2 Minimum Sealed Source Inventory Quantity Requiring Financial Assurance Radionuclides Activity in GignBq . Activity in Ci cesium-137 (Cs-137) 3.7 x 106 100000
~ cobalt-60 (Co-60) 3.7 x 105 10000 strontium-90 (Sr-90) 3.7 x 104 1000 Applicants and licensees wanting to possess licensed materials exceeding the limits in 10 CFR 30.35 must submit evidence of financial assurance or a decommissioning funding plan (10 CFR 30.35 (b)). Figure 8.3 depicts acceptable methods of providing financial assurance.
Regulatory Guide (RG) 3.66," Standard Format and Content of Financial Assurance Mechanisms 8-9 Draft NUREG - 1556, Vol. 9 l
CONTENTS OF AN APPLICATION Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, contains approved wording for each mechanism authorized by the regulation to guarantee or secure funds, except for the Statement ofIntent for government licensees. See Appendix E for the recommended wording for a Statement ofIntent. Surety g Born _ M Tr Tu Statement of Intent Agreement nt
,' Cert e ny Guaranty 4
DW ,, a v.3m Figure 8.3 Financial Assurance Mechanisms. NRC will authorize possession exceeding the limits shown in Table 8.2 without requiring decommissioning financial assurance, for the purpose ofnormal sealed source exchange for no more than 30 days. Licensees using sealed sources as authorized by 10 CFR Part 35, in general, use licensed material in a manner that would preclude releases into the environment, would not cause the activation of adjacent materials, or would not contaminate work areas. Moreover, the licensee's most recent leak test should demonstrate that there has been no leakage from the sealed sources while in the licensee's possession. However, any significant leakage of the sealed source would warrant further review of decommissioning procedures on a case-by-case basis. Response from Applicants: No response is needed from most applicants. If financial assurance is required, applicants must submit evidence as described in RG 3.66. Pursuant to 10 CFR 30.35(g), licensees must transfer records important to decommissioning either to the new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to the appropriate NRC Regional Office before the license is terminated.
Reference:
See the Notice of Availability on the inside front cover of this draft report to obtain copies of Regulatory Guide 3.66, " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, and Policy and Guidance Directive FC 90-2 (Rev.1), " Standard Review Plan for Evaluating Compliance with Deconunissioning Requirements," dated April 30,1991. Draft NUREG - 1556, Vol. 9 8-10
1 CONTENTS OF AN APPLICATION l I l 8.7 ITEM 5: SEALED SOURCES AND DEVICES l l Regulation: 10 CFR 30.32(g),10 CFR 30.33(a)(2),10 CFR 32.210 l l Criteria: Applicants must provide the manufacturer's name and model number for each requested sealed source and device (except for calibration and reference sources authorized by 10 CFR 35.65). Licensees will be authorized to possess and use only those sealed sources and l devices specifically approved or registered by NRC or an Agreement State. Discussion: 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 i licensees. The safety evaluation is documented in a SSDR Certificate. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in an SSDR Certificate or specifically approved on a license. If such a review has not been conducted for the specific source / device model(s), licensees should request a copy of NUREG-1556, Vol. 3," Consolidated Guidance about Materials Licensees: Applications for Serled Source and Device Evaluation and Registration," dated September 1997, from the NRC Regional Office and submit the information requested therein to NRC for review. An applicant may consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible and conform to the SSDR designations registered with 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 SSDR Certificates, without obtaining NRC's prior permission in a license amendment. To ensure that sealed sources and devices are used according to the registration certificates, applicants may want to obtain a copy of the certificate and review it or discuss it with the manufacturer. Response from Applicant: No response is necessary.
Reference:
See the Notice of Availability on the inside front cover of this draft report to obtain a copy of NUREG-1556, Vol. 3, " Consolidated Guidance about Materials Licensees: Applications for Sealed Source and Device Evaluation and Registration," dated September 1997. Note: Information on SSD registration certificates is also available on the Intemet at
<http://www.hsrd.ornl. gov /nrc/ssdrform.htm> or contact the Registration Assistant by calling NRC's toll free number (800) 368-5642 and then <.sking for extension 415-7217.
8-11 Draft NUREG - 1556, Vol. 9 l
CONTENTS OF AN APPLICATION 8.8 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED Regulations: 10 CFR 30.33(a)(1),10 CFR 35.100,10 CFR 35.200,10 CFR 35.300, 10 CFR 35.400,10 CFR 35.500,10 CFR 35.600,10 CFR 35.1000. Criteria: 10 CFR Part 35 divides byproduct material for medical use into seven types of use as follows: 10 CFR Medical Use of Unsealed Byproduct Material for Uptake, Dilution and Excretion
.35.100 Studies for Which a Written Directive is not Required 10 CFR Medical Use of Unsealed Byproduct Material for Imaging and Localization Studies 35.200 for Which a Written Directive is not Required
'10 CFR Medical Use of Unsealed Byproduct Material for Which a Written Directive is 35.300 Required
'10 CFR Medical Use of Sources for Manual Brachytherapy 35.400
.10 CFR Medical Use of Sealed Sources for Diagnosis 35.500-10 CFR Medical Use of a Scaled Source (s) in a Device for Therapy-Teletherapy Unit 35.600 10 CFR - Medical Use of a Scaled Source (s) in a Device for Therapy-Remote' Afterloader Unit' 35.600 10 CFR Medical Use of a Sealed Source (s) in a Device for Therapy-Gamma Stereotactic 35.600 Radiosurgery Unit 10 CFR. Other Medical Uses of Byproduct Material or Radiation from Byproduct Material 35.1000 (Emerging Technology)
Discussion: For 35.100,35.200 and 35.300 material, the applicant must define the purpose of use by stating the applicable section of 10 CFR Part 35 (e.g.,10 CFR 35.100,10 CFR 35.200) and the description of the applicable modality (e.g., any uptake dilution and excretion procedure approved in 10 CFR 35.100). The use of unsealed byproduct material in therapy involves the administration of a radiopharmaceutical, either orally or by injection, to diagnose, treat or palliate a particular disease. The most common form of radiopharmaceutical therapy is the treatment of hyperthyroidism with iodine-131 (1-131) sodium iodide. Less common therapeutic procedures include ablation of thyroid cancer metastases, treatment of malignant effusions, treatment of Draft NUREG - 1556, Vol. 9 8-12
1 CONTENTS OF AN APPLICATION , l polycythemia vera and leukemias, palliation of bone pain in cancer patients, and radiation synovectomy for rheumatoid arthritis patients. Table 8.3 contains a summary of several therapeutic radiopham ?euticals and their use. Table 8.3 Radiopharmaceuticals Used in Therapy Form Route of Agent Therapeutic Use Administration I-131 sodium iodide solution / capsules oral hyperthyroidism thyroid carcinoma i total body scan for thyroid metastases (diagnostic) phosphorus-32 (P-32) colloidal intraperitoneal or peritoneal or pleural effusions chromic phosphate suspension intrapleural ! cavity injection P-32 sodium solution oral or IV polycythemia vera phosphate 1 leukemias strontium-89 chloride solution . IV skeletal metastases t i samaritun-153 solution IV skeletal metastases 1 EDTMP rhenium-186 HEDP solution - IV skeletal metastases fin-117m DTPA solution IV skeletal metastases I idysprosium-165' aggregate in IV rheumatoid arthritis FHMA solution l t yttrium-90 FHMA aggregate in IV rheumatoid arthritis solution _ v For 35.400 material, the applicant must define the purpose of use by stating the applicable ! I section of 10 CFR Part 35 (i.e.,10 CFR 35.400). For 35.400 material, applicants may need to define the purpose of use by describing the manufacturer's name(s's and model number (s) of i devices containing sealed sources (where applicable). The licensee should correlate the sealed ! sources listed in Item 5 with the devices described in this item. 8-13 Draft NUREG - 1556, Vol. 9
7...,,,..,.- CONTENTS OF AN APPLICATION In manual brachytherapy several types of treatments are available. These may include:
. Interstitial Treatment of Cancer. The following sources are routinely used:
- Cs-137 and Co-60 as a sealed source in needles and applicator cells
- iridium-192 (Ir-192) as seeds encased in nylon ribbon
- gold-198, iodine-125 (I-125), and palladium-103 (Pd-103) as a sealed source in seeds
. Eye Plaque Implants The eye plaque consists'of a curved soft plastic insert that has a series of grooves molded into the rear convex surface, which are designed to hold the radioactive seeds. After the plastic insert is loaded with the seeds, a solid gold cover, matched in size to the insert, is placed over the convex surface of the insert and cemented in place to seal the seeds into a fixed array within the plaque. The insert is completely surrounded by the gold cover except for the concave surface that is placed against the eye. When used with I-125 and Pd-103 seeds, the gold cover provides considerable shielding of the normal tissues surrounding the eye and limits the external dose rates surrounding the patient. Although not implanted into the tumor, because the plaque is placed in the orbit of the, eye over the tumor site and sutured to the sclera of the eye to stabilize its position on the tumor while in the orbit, this is considered interstitial, not topical, treatment.
. Intracavitary Treatment of Cancer. In addition, for purposes of NRC's sealed source and device evaluation on radiation safety issues, intraluminal use is considered analogous to intracavitary use. The following sources are routinely used for the intracavitary treatment of cancer:
- Cs-137 and Co-60 as a sealed source in needles and applicator cells
- -Ir-192 and Pd-103 seeds. <
. Topical (Surface) Applications. The following sources are routinely used for topical applications:
- Cs-137 and Co-60 as sealed sources in needles and applicator cells
- Sr-90 as a sealed source in an applicator for treatment of superficial eye conditions.
For 35.500 material, the applicant must define the purpose of use by stating the applicable section of 10 CFR Part 35 (i.e.,10 CFR 35.500) and describing the manufacturer's name(s) and model number (s) of devices containing sealed sources (where applicable). The licensee should correlate the sealed sources listed in Item 5 with the devices described in this item. Typically, a licensee should use the following sealed ~ sources according to manufacturer's radiation safety and
. handling instructions and must use the sources as approved in the SSDR:
Draft NUREG - 1556, Vol. 9 8-14
l i CONTENTS OF AN APPLICATION l 1-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral l analysis; and
- e I-125 as a sealed source in a portable imaging device.
For 35.600 material, the applicant must define the purpose of use by stating the applicable section of 10 CFR Part 35.600 (e.g., teletherapy, remote afterloading, GSR) and describing the manufacturer's name(s) and model number (s) of the device containing a sealed source (s) (e.g., for use in a Leksell Gamma System Model 23016 {a.k.a. Gamma Knife or Cerebral Stereotactic Radiosurgical Unit} radiation therapy unit for the treatment of humans). A schematic of a GSR unit is provided as Figure 8.4. The applicant should correlate the scaled source (s) listed in Item 5 with the device described in this item. If applicable, the applicant should state that depleted uranium is used as shielding for the device and specify that an additional source is requested to be stored in its shipping container incident to source replacement. Upper Shield Shieldsg Door Colhmator Helmet
\
D Helmet Support Base Sheld Sliding Cradle Hydraul Equipment
.wsyy, Figure 8.4 Gamma Stereotactic Radiosurgery Unit.
l For 35.1000 material, the applicant must define the purpose of use by stating the applicable section of 10 CFR Part 35 (e.g.,10 CFR 35.1000) and describing the manufacturer's name(s) and f model number (s) of devices containing sealed sources (where applicable). The licensee should ( correlate the sealed sources listed in Item 5 with the devices described in this item. I 8-15 Draft NUREG - 1556, Vo!. 9
CONTENTS OF AN APPLICATION One area of an emerging technology is the use of byproduct material to prevent restenosis. Post-operative radiation exposure has recently been shown to reduce the probability of restenosis following balloon angioplasty in patients. Balloon angioplasty can damage the smooth muscle lining the artery, stimulating cell growth that may result in restenosis. Vessel reclosure occurs in approximately 30% to 40% of angioplasty cases within 6 months because the artery wall collapses or scars and fills with tissue. There are two components to restenosis: the first, recoil, is the mechanical collapse of the dilated arteries; and the second, intimal hyperplasia, is the proliferation of smooth muscle cells in response to the vascular injury. Emerging technologies have been developed using radioactive catheters, pellets, and stents to l treat coronary and peripheral vascular problems. These therapy devices contain ionizing radiation ; in the form of a gas, liquid, or solid that retards recoil and proliferation of smooth muscle cells in the affected vessel wall. The radiation can be ion implanted, plated, or encapsulated in a sealed source device attached to a guide wire used in the angioplasty procedure. The radioactive device can be either permanently implanted or removed via the guide wire following treatment of the ! affected vessel wall. Intracoronary radiation therapy is emerging as the primary discipline of the new technology. Because of the trauma and expense of performing repeat coronary procedures, physicians and medical companies have developed devices that appear to inhibit restenosis rates in clinical trials. Three major innovative types ofintravascular radiation therapy devices are being clinically investigated following balloon angioplasty:
- 1. Intracoronary Beta Radiation Catheter (Figure 8.5)- The catheter is not an implant and the radiation is delivered post balloon angioplasty. The beta radiation catheter is i unsheathed in the affected coronary artery where the balloon angioplasty had occurred. The catheter delivers a high dose directly to the arterial wall while having a minimal effect on the whole body. Treatment times average around 5 minutes. The clinician controls the delivery and return of the source train. The catheter is retracted from the artery using the guide wire from the angioplasty procedure.
- 2. Intracoronary Beta Radiation Stent (Figure 8.6)- The stent is a permanent implant and i the radiation is delivered post balloon angioplasty. The stent is attached to the outside of the balloon catheter. The catheter is inflated and the stent is pressed against the arterial wall which becomes permanently implanted. The balloon is then deflated and retracted 4 from the coronary artery. The stent delivers a high dose directly to the arterial wall while I having a minimal effect on the whole body.
3. Intracoronary Beta Radiation Pellets - Radiation is delivered post balloon angioplasty. The pellets are temporarily implanted at the angioplasty site in the coronary artery for a short treatment time (approximately 30 minutes). The clinician controls the delivery and return of the source train from the coronary artery. The pellets deliver a high dose directly , to the arterial wall while having a minimal effect on the whole body. I Draft NUREG - 1556, Vol. 9 8 16
i CONTENTS OF AN APPLICATION Emerging Technology Beta Radiation Catheter / Post Balloon Angioplasty Coronary Artery Cross-section Beta source train Beta source train lurnen _a >- N^. k- -.2 - guxle w e Fluid lurnen l l Artenal wall i ow.<c2g;<; Figure 8.5 Beta Radiation Catheter. l l 8-17 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION Stent implantation Stents Using Beta Radiation Stent Mounted on a Balloon Catheter
,m & k
*l $ 4%
Coronary Artery Balloon Catheter The Stent is implanted in the Vessel emfR ., :.LLA'):WW jd m:n'hM? w:2
- $$[ kh,%9M,,m53'3@*'7%
- .. eu.m , NWmm W ?5[ abs!s:@AA?f " .pyyl Mfp,r%::n3(hysik Q LT '"AF=M?"'j g W Area of Restenosis
.v._ u, 0114H Figure 8.6 Stent Implantation.
A new clinical procedure uses beta radiation sutures to reduce restenosis in renal dialysis patients. Radiation is thought to produce an antiscarring effect by breaking the strands of DNA in the endothelial cells of the affected vessels. The United States Food and Drug Administration (FDA) considers the use of radiation in the coronary and/or peripheral vasculature for the prevention of restenosis investigational with the potential for risk to patients. Legal and ethical considerations require U.S. patients to be studied under an investigational device exemption application at the time of this writing. Benchtesting of the radiation device in an emerging technology includes the following criteria: Characterization of the radiation source l
. Biocompatibility of blood-containing materials used in the delivery system (if applicable)
Draft NUREG - 1556, Vol. 9 8-18
CONTENTS OF AN APPLICATION
. Mechanical integrity of components used in the delivery system (if applicable)
. Sterility of the source and delivery system.
Bench testing is conducted by the manufacturer and the clinical investigator (s). Radionuclides that are being used in the emerging technology include P-32, Sr-90, Ir-192, rhenium-186, rhenium-188, xenon-133, and hydrogen-3. The use of beta radiation and/or low energy photons localized to the affected site has the potential to subsequently reduce or eliminate ! restenosis. l Applicants must also describe non-medical uses and reference the applicable radioactive material provided in response to Item 5. Appendix C contains sample licenses that provide guidance on how to respond to Item 6. l Response from Applicant: The applicant shall submit the information as described above. l 8.9 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE Regulations: 10 CFR 30.33(a)(3),10 CFR Part 35. Criteria: The RSO, AUs, AMPS, and ANPs must have adequate training and experience. Discussion: Individuals responsible for the radiation protection program are licensee senior l management, the AUs, RSO, RSC (if applicable), AMPS, and ANPs. In 10 CFR 30.33(a)(3), NRC requires that an applicant be qualified by training and experience to use licensed nnterials for the purposes requested in such a manner as to protect health and minimize danger to life or I property. Subparts B, D, E, F, G, H, and J of 10 CFR Part 35 give specific criteria for acceptable training and experience for AUs for medical use, ANPs, the RSO, and AMPS. Applicants should note that a rdsum6 or a curriculum vitae does not usually supply all the information needed to evaluate an individual's training and experience. NRC holds the licensee responsible for the radiation protection program. Therefore, it is essential that strong management controls and oversight exist to ensure that licensed activities are conducted properly. Management responsibility and liability are sometimes underemphasized or not addressed in applications and are often poorly understood by licensee employees and managers. Senior management should delegate to the RSO and, if applicable, the RSC, in writing, sufficient authority, organizational freedom, and management prerogative, to communicate with and direct personnel regarding NRC regulations and license provisions and to l i 8-19 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION terminate unsafe activities involving byproduct material. The licensee maintains the ultimate responsibility, nevertheless, for the conduct oflicensed activities. In addition, licensees with multiple modalities or multiple users must develop, document, and implement administrative procedures for interdepartmental / interdisciplinary coordination of the radiation protection program (10 CFR 35.24). The licensee may use several mechanisms to ensure that all departments are kept informed of all activities regarding the radiation protection program, such as electronic mail or committee meetings, including an RSC. Licensees may contract for p. :ent services for which they have no in-house expertise. In those instances in which the contracted service is regulated by the NRC, the licensee should be aware that the licensee remains responsible for regulatory compliance and implementation of the radiation protection program. The licensee should not assume that by hiring a consultant to perform certain tasks it has fully satisfied all regulatory requirements or that it has transferred responsibility for the licensed program to a consultant. Licensee management should ensure that adequate mechanisms for oversight are in place to determine that the radiation protection program is effectively implemented by the appropriate individuals. Response from Applicant: Refer to the subsequent sections specific to the individuals described above. 8.10 ITEM 7: RADIATION SAFETY OFFICER (RSO) Regulations: 10 CFR 30.33(a)(3),10 CFR 35.24,10 CFR 35.50,10 CFR 35.57,10 CFR 35.59, 10 CFR 35.900,10 CFR 35.2024 Criteria: RSOs must have adequate training and experience. The training and experience requirements for the RSO are described in 10 CFR 35.50 and 10 CFR 35.900 and allow for the following three training pathways:
- 1. Certification by one of the professional boards approved by the NRC
- 2. Didactic and work experience as described in item b of each section and passing an examination 2
- 3. Identification as an AU, AMP, or ANP on the license and have experience in the types of use for which the individual has RSO responsibilities2 2
The requirement for an examination and the limitation that an AU can only be named the RSO for the types of use for which the individual has training and experience will become effective two years after the publication of the final rule (10 CFR Part 35). Draft NUREG - 1556, Vol. 9 8-20
CONTENTS OF AN APPLICATION In addition,10 CFR 35.24 requires that the licensee provide the RSO suffident authority, organizational freedom, and management prerogative to do the following:
. Identify radiation safety problems
. Initiate, recommend, or provide corrective actions
. Stop unsafe operations involving byproduct material
. Verify implementation of corrective actions.
The licensee must also establish in writing the authority, duties, and responsibilities of the RSO. Discussion: The RSO is responsible for day-to-day oversight of the radiation protection program. The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must be given sufficient time and resources and have sufficient commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe manner. NRC requires the name of the RSO on the license to ensure that licensee management has always identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Usually, the RSO is a full-time employee of the licensed facility; however, NRC has authorized individuals that are not employed by the ; licensee, such as a consultant, to fill the role of RSO or provide support to the facility RSO. l Typical RSO duties are illustrated in Figure 8.7 and described in Appendix F. Appendix F also contains a model RSO Delegation of Authority. Appendix G contains forms which can be used to document the RSO's training and experience. i l 8 21 Draft NUREO - 1556, Vol. 9
CONTENTS OF AN APPLICATION stop unsafe hcensed acovitam g, 4 ,e ; Proper use and rouane mantenance O Mat'l Accountability ' A [p O LeakTest ; secunty hA OOAudit {f Training j b Q Records h uaterw diws Interacton with NRC. other authorstes Records maintenance <'I [ Annualprogrammuda ua.ntenance . inspecoon eneck. Personnel training Q} invesugateanonnaievent. 6244402 Figure 8.7 RSO Responsibilities. 7)picalduties andresponsibilities ofRSOs. Response from Applicant: Provide the following:
. Name of the proposed RSO AND
= Delegation of Authority AND Previous license number (ifissued by the NRC) or a copy of the license (ifissued by an Agreement State) that authorized the uses requested and on which the individual was specifically named as the RSO.
OR
=
Copy of the certification (s) for the board (s) approved by the NRC and as applicable to the types of use for which he or she has RSO responsibilities. Draft NUREG - 1556, Vol. 9 8-22
i l CONTENTS OF AN APPLICATION f OR
- Description of the training and experience demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which he or she has RSO responsibilities. NRC Forms 313A and 313B may be used for this purpose (see Appendix G).
AND
. Documentation of successful completion of the radiation safety exam (e.g., certificate) [see Note above].
L AND
= Written certification, signed by a preceptor RSO, that the above training and experience has been satisfactorily completed.
Note: i . It is a requirement to notify NRC within 30 days if an RSO permanently discontinues his/her duties under the license or has a name change pursuant to 10 CFR 35.14 and to request an amendment to change an RSO pursuant to 10 CFR 35.13.
. An AU, AMP, or ANP may be designated as the RSO on the license if the individual has training and experience with the radiation safety aspects of similar types of use of byproduct material for which he or she has RSO responsibilities and has sufficient time to perform the i
duties.
. Descriptions of training and experience will be reviewed using the criteria listed above. This l
documentation will be reviewed on a case-by-case basis to determine whether the applicable
; criteria in Subparts B or J are met. If the training and experience do not appear to meet the Subparts B or J criteria, the NRC may request the assistance ofits Advisory Committee on the Medical Uses ofIsotopes (ACMUI).
8.11 ITEM 7: AUTHORIZED USERS Regulations: 10 CFR 30.33(a)(3),10 CFR 35.14,10 CFR 35.27,10 CFR 35.57,10 CFR 35.59, 10 CFR 35.290,10 CFR 35.292,10 CFR 35.390,10 CFR 35.490,10 CFR 35.590, 10 CFR 35.690,10 CFR 35.910,10 CFR 35.920,10 CFR 35.930,10 CFR 35.932, 10 CFR 35.934,10 CFR 35.940,10 CFR 35.941,10 CFR 35.950,10 CFR 35.960, 10 CFR 35.961. 8-23 Draft NUREG - 1556, Vol. 9 l't l
I CONTENTS OF AN APPLICATION Criteria: AUs must have adequate training and experience. Successful completion of training as described in 10 CFR 35.57,10 CFR 35.290,10 CFR 35.292,10 CFR 35.390,10 CFR 35.490, 10 CFR 35.590,10 CFR 35.690, or in Subpart J, as applicable, is evidence of adequate training and experience. Discussion: AUs involved in medical use have the following special responsibilities: Radiation safety commensurate with use of byproduct material Administration of a radiation dose or dosage and how it is prescribed Direction ofindividuals under the AU's supervision in the use of byproduct material e Preparation of WDs,if required. Technologists, therapists, or other personnel may use byproduct material under an AU's l supervision when permitted by Federal, State or local laws. Supervision is addressed in 10 CFR 35.27, " Supervision." J ! I For in vitro and animal research, calibration of survey instruments, and other uses that do not ! involve the intentional exposure of humans, the list of proposed AUs should include those 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 provide their training and experience. Those AUs may direct the use of byproduct material by users under their supervision for the requested use. Applicants are reminded of the recentness of training requirements described in 10 CFR 35.59. Specifically, physician-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 l application, or additional training may be necessary. This time restriction applies to board i certification as well as to other recognized training pathways. Response from Applicant: Provide the following: I- . Name of the proposed AU and uses requested. AND Previous license number (ifissued by the NRC) or a copy of the license (ifissued by an Agreement State) on which the physician was specifically named as an AU for the uses requested. Draft NUREG 1556, Vol. 9 8-24
CONTENTS OF AN APPLICATION f I OR l
. Description of the training and experience demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which he or she has RSO responsibilities. NRC Forms 313A and 313B may be used for this purpose (see Appendix G).
l AND i
. Documentation of successful completion of the radiation safety exam (e.g., certificate) [see Note above). ];
AND
. Written certification, signed by a preceptor RSO, that the above training and experience has l been satisfactorily completed.
Note:
. It is a requirement to notify NRC within 30 days if an RSO permanently discontinues his/her duties under the license or has a name change pursuant to 10 CFR 35.14 and to request an amendment to change an RSO pursuant to 10 CFR 35.13. . An AU, AMP, or ANP may be designated as the RSO on the license if the individual has training and experience with the radiation safety aspects of similar types of use of byproduct material for which he or she has RSO responsibilities and has sufficient time to perform the duties. . Descriptions of training and experience cill be reviewed using the criteria listed above. This '
documentation will be reviewed on a case-by-case basis to determine whether the applicable l criteria in Subparts B or J are met. If the training and experience do not appear to meet the~ Subparts B or J criteria, the NRC may request the assistance ofits Advisory Committee on the Medical Uses ofIsotopes (ACMUI). 8.11 ITEM 7: AUTHORIZED USERS l Regulations: 10 CFR 30.33(a)(3),10 CFR 35.14,10 CFR 35.27,10 CFR 35.57,10 CFR 35.59, ' 10 CFR 35.290,10 CFR 35.292,10 CFR 35.390,10 CFR 35.490,10 CFR 35.590, 10 CFR 35.690,10 CFR 35.910,10 CFR 35.920,10 CFR 35.930,10 CFR 35.932, 10 CFR 35.934,10 CFR 35.940,10 CFR 35.941,10 CFR 35.950,10 CFR 35.960, 10 CFR 35.961, i l 8-23 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION OR ,, , , a Copy of the certification (s) for the board (s) approved by the NRC and as applicable to th.: use . requested. 1 OR
. Description of the training and experience dernonstrating that the proposed AU is qualified by training and experience for the use requested. NRC Forms 313A and 313B may be used for this purpose (see Appendix G).
AND
. Documentation of successful completion of the radiation safety exam (e.g., certificate).
AND
- . Written certification, signed by a preceptor AU physician, that the above training and experience has been satisfactorily completed.
Note:
. It is a requirement to notify NRC within 30 days if an AU permanently discontinues his/her duties under the license or has a name change pursuant to 10 CFR 35.14.
- Subpart J will be deleted two years after the publication of the final 10 CFR Part 35. Until then, licensees do not have to comply with the training and experience requirements provided in other sections of 10 CFR Part 35 (e.g., radiation safety exam), with the exception of the section titled " Recentness of training".
. Descriptions of training and experience will be reviewed using the criteria listed above. This l documentation will be reviewed on a case-by-case basis to determine whether 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 the assistance ofits ACMUI. !
- Authorized use for nonmedical use or for 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.
l 8-25 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION l I 8.12 ITEM 7: AUTHORIZED NUCLEAR PHARMACIST Regulations: 10 CFR 30.33(a)(3),10 CFR 35.55,10 CFR 35.57,10 CFR 35.59, l 10 CFR 35.980. l l l Criteria: ANPs must have adequate training and experience. Successful completion of training I as described in 10 CFR 35.55,10 CFR 35.57, or 10 CFR 35.980, and 10 CFR 35.59 is evidence l of adequate training and experience. l Discussion: An ANP is defined in 10 CFR 35.2," Definitions." Training and experience criteria for an ANP is described in 10 CFR 35.55 and 10 CFR 35.980, both titled " Training for an authorized nuclear pharmacist," and 10 CFR 35.57," Training for experienced nuclec.r pharmacists." At many licensed medical facilities, an ANP is directly involved with the l preparatio . and administration of radiopharmaceuticals. Applicants are reminded of the recentness of training requirements described in 10 CFR 35.59. Specifically, nuclear pharmacist applicants must hev9 successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application, or additional training may be necessary. This time restriction applies to board , certification as well as to other recognized training pathways. ! Response from Applicant: i l Provide the following:
. Name of the proposed ANP.
l AND
. Previous license number (ifissued by the NRC) or a copy of the license (ifissued by an Agreement State) on which the individual was specifically named as an ANP.
OR
. Copy of the certification (s) for the radiopharmacy board (s) approved by the NRC.
OR
- Description of the training and experience demonstrating that the proposed ANP is qualified by training and experience. NRC Forms 313A and 313B may be used for this purpose (see Appendix G).
AND Draft NUREG - 1556, Vol. 9 8-26
CONTENTS OF AN APPLICATION
- Documentation of successful completion of the radiation safety exam (e.g., certificate).
AND 1
. Written certification, signed by a preceptor ANP, that the above training and experience has been satisfactorily completed and that the individual has achieved a level of competency ;
sufficient to independently operate a nuclear pharmacy. Note:
. It is a requirement to notify NRC within 30 days if an ANP permanently discontinues his/her duties under the license or has a name change, pursuant to 10 CFR 35.14.
. Subpart J will be deleted two years after the publication of the final 10 CFR Part 35. Until then, licensees do not have to comply with the training and experience requirements provided l
in Subpart B of 10 CFR Part 35 (e.g., radiation safety exam), with the exception of the section titled " Recentness of training".
. Descriptions of training and experience will be reviewed using the criteria listed above. This documentation will be reviewed on a case-by-case basis to determine whether the applicable criteria in Subparts B or J are met. If the traini' ng and experience do not appear to meet the Subparts B or J criteria, the NRC may request the assistance ofits ACMUI.
8.13 ITEM 7: AUTHORIZED MEDICAL PHYSICIST Regulations: 10 CFR 30.33(a)(3),10 CFR 35.51,10 CFR 35.57,10 CFR 35.59, 10 CFR 35.961. Criteria: AMPS must have adequate training and experience. Successful completion of training as described in 10 CFR 35.51,10 CFR 35.57 or 10 CFR 35.961, and 10 CFR 35.59 is evidence of adequate training and experience. Discussion: An AMP is defined in 10 CFR 35.2," Definitions." Training and experience criteria I for an AMP are described in 10 CFR 35.51, " Training for authorized medical physicist", or 10 CFR 35.961," Training for teletherapy physicist", and 10 CFR 35.57," Training for l experienced medical physicist." At many licensed medical facilities conducting radiation therapy treatments, an AMP is directly involved with the calculation and administration of the radiation dose. Additionally, the American Association of Physicists in Medicine (AAPM) I suggests that a medical physicist limit his or her involvement in radiation therapy to areas for which he or she has established competency. 8-27 Draft NUREG - 1556, Vol. 9 ! I.
CONTENTS OF AN APPLICATION Applicants are reminded of the 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, or additional training may be necessary. This time restriction applies to board certification as well as to other recognized training pathways. Response from Applicant: Provide the following:
. Name of the proposed AMP.
AND
. Previous license number (ifissued by the NRC) or a copy of the license (ifissued by an Agreement State) on which the individual was specifically named as an AMP.
OR
. Copy of the certification (s) for the board (s) approved by the NRC.
OR
= Description of the training and experience demonstrating that the proposed AMP is qualified by training and experience. NRC Forms 313A and 313B may be used for this purpose (see Appendix G).
AND e Documentation of successful completion of the radiation safety exam (e.g., certificate). AND
. Written certification, signed by a preceptor AMP, that the above training and experience has been satisfactorily completed.
Note:
- It is a requirement to notify NRC within 30 days if an AMP permanet.tly discontinues his/her duties under the license or has a name change, pursuant to 10 CFR 35.14.
.- Subpan J will be deleted two years after the publication of the final 10 CFR Part 35. Until then, licensees do not have to comply with the training and experience requirements provided in Subpart B of 10 CFR Part 35 (e.g., radiation safety exam), with the exception of the section titled " Recentness of training".
. Descriptions of training and experience will be reviewed using the criteria listed above. This documentation will be reviewed on a case-by-case basis to determine whether the applicable-Draft NUREG - 1556, Vol. 9 8-28
CONTENTS OF AN APPLICATION criteria in Subparts B or J are met. If the training and experience do not appear to meet the Subparts B or J criteria, the NRC may request the assistance ofits ACMUI. , 1 I 8.14 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS 1 1 Regulations: 10 CFR 19.12,10 CFR 35.27,10 CFR 35.310,10 CFR 35.410,10 CFR 35.610, 10 CFR 35.2310. I Criteria: Individuals working with, as well as in the vicinity of, licensed material must have l adequate training and experience as required by 10 CFR Parts 19 and 35. For those individuals I who work in the vicinity oflicensed material and. in the course of employment, are likely to receive in a year an occupational dose of radiation over 1 millisievert (mSv) [100 millirem (mrem)], the licensee must provide training as required by 10 CFR 19.12. Also,10 CFR 35.310, 10 CFR 35.410 and 10 CFR 35.610 describe additional training requirements for individuals involved with therapeutic treatment of patients.10 CFR 35.27 requires the licensee's AUs and ANPs to provide training to all personnel using byproduct material under their supervision on the licensee's wTitten procedures. Discussion: AUs, ANPs, AMPS, and RSOs would be most likely to receive doses in excess of 1 mSv (100 mrem) in a year. However, potential radiation doses received by any individual working in or frequenting restricted areas must also be evaluated. All individuals working with or around licensed materials should receive training commensurate with their assigned duties, and ifit is likely they could receive doses over 1 mSv (100 mrem) in a year, they must receive instrucuon as specified by 10 CFR 19.12. For example, a licensee could determine that housekeeping staff, while not likely to receive doses over 1 mSv (100 mrem), need to be informed of the nature of the licensed material and the meaning of the radiation symbol, and need to be 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. Additionally, since nursing staff often have direct involvement with patients undergoing therapy treatments with byproduct material, the licensee should ensure that nursing staff receive adequate training on the level of risks involved with the particular therapy treatment and emergency response procedures. In accordance with 10 CFR 35.27(a), individuals working with licensed material under the supervision of an AU must be trained regarding the instructions of the supervising AU for l medical uses oflicensed material, the written radiation protection procedures established by the i licensee, and compliance with NRC regulations and license conditions. In accordance with ; 10 CFR 35.27(b), an ANP or an AU, as allowed by 10 CFR 35.11(c), shall instruct supervised l individuals in the preparation of byproduct material for medical use and require the individuals to I 1 8 29 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION i follow their instructions and the written radiation protection program, the license conditions, and ! the NRC regulations. A model training program is provided in Appendix H. Responce from Applicant: No response is necessary. 8.15 ITEM 9: FACILITIES AND EQUIPMENT Regulations: 10 CFR 20.1302,10 CFR 30.33(a)(2),10 CFR 35.75. Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Discussion: In 10 CFR 30.33(a)(2), NRC states that an application will be approved if, among other things, the applicant's proposed equipment and Scilities are adequate to protect health and minimize danger to life or property. Facility and equipment requirements depend on the scope of the applicant's operations (e.g., planned use of the material, the types of radioactive emissions, the quantity and form of radioactive materials possessed, etc.). Particular attention should be focused 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. Response from Applicant: Refer to the subsequent sections for guidance. 8.16 ITEM 9: FACILITY DIAGRAM Regulations: 10 CFR 20.1003,10 CFR 20.1101,10 CFR 20.1201,10 CFR 20.1301, 10 CFR 20.1302,10 CFR 20.2102,10 CFR 30.33(a)(2),10 CFR 35.14,10 CFR 35.75. Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Discussion: Applicants must submit an annotated drawing of the room or rooms and adjacent areas in which byproduct material will be received, used, administered, and stored. Identify it as ATT. 9.1. This includes rooms used to confine patients awaiting nuclear medicine treatments and patients undergoing in-patient therapy procedures, rooms used for administering radiopharmaceuticals or radiation doses, radioactive waste storage areas, and all byproduct material use areas including those used for receipt and storage of the byproduct material. Pursuant to 10 CFR 20.1302," Compliance with Dose Limits for Individual Members of the Draft NUREG - 1556, Vol. 9 8-30
CONTENTS OF AN APPLICATION l Public," licensees must demonstrate compliance with 10 CFR 20.1301, " Dose Limits for Individual Members of the Public," for unrestricted or controlled areas that are adjacent to rooms I in which byproduct material will be received, used, administered, and stored. Figure 8.8 depicts a standard nuclear medicine suite. Facility Diagram for Nuclear Medicine Suite ! Halhway l
-3 v v ;
Trap Rest Rest Gamma Room Room ri _ck . ( Treadmill m Storage 4---- Lead p Shielding
- Generator Hot Sink 9 4 "L" Shield Camera Dressing
[w- m:,ato, A Waste j Room Room A8 g
/ -
Halhway Fume Hood u.w.mg ( Figure 8.8 Facility Diagram for Nuclear Medicine Suite.
)
i Regulatory requirements, the principle of ALARA, good medical care, and access control should be considered when determining the location of a therapy patient's room or a therapy treatment room. Use of byproduct material in a room that is not described in the license application requires prior NRC approval through a license amendment, except for areas of use where byproduct material is used in accordance with 10 CFR 35.100 and 10 CFR 35.200. Licensees must notify the NRC, pursuant to 10 CFR 35.14, within 30 days following changes in areas of use for 10 CFR 35.100 and 10 CFR 35.200 byproduct material. Figure 8.9 represents an l overhead view of a radiciodine patient isolation room that contains some of the required elements discussed in the response from applicant section. Figure 8.10 represents an overhead l view of a manual brachytherapy patient isolation room. Based on an evaluation of shielding and l planned use of each area, the applicant must have determined whether each area adjacent to the treatment room will be maintained as a restricted or an unrestricted area, and must demonstrate compliance with NRC regulations. For portable shields, the licensee should assure proper placement of the shield prior to each treatment. Applicants must also submit cross-sectional 8-31 Draft NUREG - 1556, Vol. 9 i
CONTENTS OF AN APPLICATION diagrams to illustrate areas above and below the facilities used for patient therapy treatments (e.g., other patient rooms, stairwells, nursing stations and waiting areas). The radiation dose levels associated with these areas must be in compliance with 10 CFR 20.1302," Compliance with dose limits for individual members of the public." Radiolodine Treatment - Thyroid Carcinoma (
. ;:,v ca xlrk.
- ne n; .~ : q g ef I ..
I i , ,& <
,3 i
sv<.<mg a Figure 8.9 Ioune-131 NaI Administration for the Thyroid Carcinoma Patient. Thepatient is required to be isolated in aprivate room with aprivate bath. Note: Applicants must also submit cross-sectional diagrams to illustrate areas above and below the patient's room. Draft NUREG - 1556, Vol. 9 8-32
l l l CONTENTSOF AN APPLICATION Exterior Wall Portable Shneld CEED Forceps pg v 1 ((' Nurse's Station 3 eatnroom
-D '
Posted Room E Vacant Room a2_p4 402ns Figure 8.10 Overhead View of Manual Brachytherapy Patient Treatment Room. Note: Applicants must also submit cross-sectional diagrams to illustrate areas above and below the patient's room. Figure 8.11 represents a combined HDR and teletherapy suite. Based on an evaluation of shielding and the planned use of each area, the applicant must have determined whether each area adjacent to the treatment room used for all therapies involving sealed sources will be maintained as a restricted or an unrestricted area, and must demonstrate compliance with NRC regulations. l l 8-33 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION Diagram of the HDR and Teletherapy Suite Erna Forceps HDR [
\
N- -
) Unit
[ Teletherapy Unit - - Treatment Roorn interlock Equg*f Door HDR and Teletherapy Urut core can.ow wseo ena Aumo uonnore 82.p4.@g Figure 8.11 Teletherapy and HDR Treatment Room. Note: Applicants must also submit cross-sectional diagrams to illustrate areas above and below the patient's room. It may be necessary to restrict use of the teletherapy unit's primary beam if the treatment room's walls, ceiling, or floor will not adequately shield adjacent areas from direct or scattered radiation. Electrical, mechanical, or other physical means (rather than administrative controls) must be used to limit movement or rotation of the unit. The teletherapy unit should be equipped with electrical or mechanical stops that limit use of the primary beam of radiation so as to ensure compliance with Subpart D of 10 CFR Part 20. Some applicants have found it helpful to have a sample response for guidance. The following is an example of an acceptable response on the use of a rotational unit with an integral beam absorber; the angle orientation convention described above applies.
- For the primary beam directed toward the integral beam absorber, electrical or mechanical stops are set so that the primary beam must be centered (within plus or minus 2 degrees) on Draft NUREG - 1556, Vol. 9 8-34 l
CONTENTS OF AN APPLICATION the integral beam absorber and, in that configuration, the attenuated primary beam may be rotated 360 degrees pointing toward the floor, east wall, ceiling, and west wall.
- For theprimary beam directed awayfrom the integral beam absorber, electrical or mechanical stops permit the unattenuated primary beam to be directed in a 95 degrees are from 5 degrees toward the west wall to vertically down toward the floor to 90 degrees toward the east wall.
Experience has shown that, given this type of example, many applicants can make changes to accommodate their own situations (e.g., use of a vertical unit, use of a rotational unit without an g integral beam absorber). Response from Applicant: Provide the following on the facility diagrams: Scale; use the same scale (preferably 1/4 inch = 1 foot) for all drawings Direction of north Location, room numbers and principal use of each room or area where byproduct material is used or stored (e.g., patient therapy rooms, radioactive waste storage, nuclear medicine hot lab, manual brachytherapy sour e storage room)
. Location, room numbers and principal use of each adjacent room (e.g., office, file, toilet, closet, hallway) including areas above and below therapy treatment rooms. Note that areas should be described as restricted or unrestricted as defined in 10 CFR 20.1003
. Type, thickness, and density of any necessary shielding applicable to the quantities, form, and emissions of the radionuclides that will be used (note: beta emitters should be shielded using a material with a low atomic number to minimize the production of bremsstrahlung). Include 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, etc.).
- Nature of and distances to all areas adjacent to therapy patient treatment rooms (including above and below). Note that plans are particularly helpful in showing the relationship of the patient treatment room with the rest of the building
. Location of additional radiation safety equipment (e.g., fume hood, L-block, dose calibrator, fixed area monitors, remote handling tools, t-bars, Allen key) within the facility.
In addition to the above, for remote afterloader, teletherapy, and GSR facilities, provide:
- Type, thickness, and density of the shielding materials used on all sides of the treatment room, including the walls, floor, and ceiling
. Location of doors, windows, conduits, and other penetrations and voids in the shielding materials 8-35 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION . Nature of and distances to all areas adjacent to the treatment room (including above and below), with an indication of whether the areas are restricted or unrestricted, as defined in 10 CFR 20.1003. Note that plans and elevation drawings are particularly helpful in showing the relationship among the treatment room, the roof, and the rest of the building in addition to the above, for teletherapy and GSR facilities, provide: . Location of the treatment unit and source within the treatment room . Directions of primary beam usage for teletherapy units and, in the case of an isocentric unit, the plane of beam rotation -
- Height of earth against outside walls, as applicable.
~
In addition to the facility description for remote afterloader units, provide detailed calculations of maximum radiation levels (and dose rates) that will exist in each area, restricted and unrestricted, adjacent to the room (s) where treatment is performed using a remote afterloader device, to demonstrate compliance with 10 CFR 20.1201 and 10 CFR 20.1301, respectively. (This includes areas above and below the treatment room.) The calculations should include the following:
. Expected radiation levels for each area adjacent to the room housing the device considering the most adverse source orientations and maximum source activity to be used in the device.
These calculations must be sufficient to demonstrate that the expected dose rates in restricted and unrestricted areas adjacent to the treatment room (s), meet the requirements of 10 CFR 20.1201 and 10 CFR 20.1301.
. Parameters (equations, constants, assumptions, etc.) used to perform the calculations described above. These parameters must include such factors as distance to each area of concem, the type and thickness of material (s) used in barriers and shields, the transmission factor of the barriers or shields, and the maximum source strength. For HDR and pulsed dose-rate (PDR) remote afterloader devices, the use of portable shielding to meeuhe dose rate requirements of 10 CFR 20.1201 and 10 CFR 20.1301 is not permitted.
a The maximum anticipated workload data, such as device maximum "on time" per hour and per week and occupancy factors used for all adjacent areas.
. Calculations to determine ihe dose received by individuals present in unrestricted areas should reflect continuous occupancy (i.e., occupancy factor of 1), unless the applicant can justify using a lower value.
. Demonstrate that the limits specified in 10 CFR 20.1301(a) will not buxceeded. If the calculations demonstrate that these limits cannot be met, provide further steps that will be taken to limit exposure to individual members of the public. The applicant may consider the following options:
Draft NUREG - 1556, Vol. 9 8-36
i CONTENTS OF AN APPLICATION adding shielding to the barrier in question, with corresponding modification of the facility description ifnecessary -
]
. requesting prior NRC authorization to operate up to an annual dose limit for an individual
{ member of the public of 5 mSv (0.5 rem) and demonstrating that the requirements of i 10 CFR 20.1301(c) will be met. The applicant must demonstrate the need for and the expected duration o'f operations which will result in an individual dose in~ excess of the limits specified in 10 CFR 20.1301(a). - A program to assess and control dose within the 5 mSv (0.5 rem) annual limit and procedures to be followed to maintain the dose ALARA (10 CFR 20.1101) must be developed.
- decreasing exposure times and/or limiting the number of patient treatments or increasing {
the size of the restricted area surrounding the treatment room In addition to the facility description for teletherapy and GSR units, provide:
- A copy of the. manufacturer's calculation of source (s) intensity l .
Calculations of the maximum radiation levels expected in each adjacent area. The calculations should include the following: l - maximum anticipated workload data (e.g., maximum number of patients treated per hour l and per week; maximum dose and treatment time per patient; maximum on-time per hour and per week)
- the value of each parameter used in your calculations. These parameters include such factors as beam orientation, maximum field size, scatter angle, scatter ratio, distance to scatterer, distance to area of concem, type and thickness of materials used in barrier, and transmission factor of barrier contributions from primary, leakage (with the source in the on position), and scattered radiation (including low-angle scatter thatjust misses the integral beam absorber for teletherapy)
- calculations for each area adjacent to the treatment room, including above and below the room, and a statement as to whether the area will be maintained as a restricted or L unrestricted area. Calculations need not be provided for areas that have not been excavated.
worst case situations (e.g., use of maximum beam size; all patients treated in I hour using the critical orientation that produces high radiation levels in an adjacent area; if the teletherapy integral beam absorber is not used for all patient treatmems, calculations based on use of the unattenuated primary beam where appropriate; situations within the capabilities of the teletherapy unit that are not prohibited by electrical or mechanical stops, regardless of the clinical usefulness of these orientations)
- the dose received by individuals present in unrestricted areas. Consider continuous occupancy (i.e., occupancy factor of 1), unless the licensee can make a compelling I
l argument for using a lower value. 8-37 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION
. For each unrestricted area, a statement of how the requirements of 10 CFR 20.1301 (a)(1) and
! (2) will be met
- Description of the teletherapy unit's mechanical or electrical beam stops that are operational and restrict beam orientation, specify the direction in which the teletherapy head can be moved, and describe the maximum angle (from vertical) of the beam orientation in each direction. Identify the angle orientation convention (e.g.,0 degrees is vertical toward the floor, 90 degrees is horizontal toward the east wall,180 degrees is vertical toward the ceiling, and 270 degrees is horizontal toward the west wall). If the teletherapy unit has an integral beam absorber (also called a beam catcher), provide similar information for those orientations in which (1) the primary beam is directed toward the integral beam absorber and (2) the primary beam is directed away from the integral beam absorber. Sketches may be used to describe how beam stops limit the use of the primary beam.
National Council on Radiation Protection and Measurements (NCRP) Report 49, " Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to 10 MeV" and Report 102," Medical X-Ray, Electron Beam and Gamma Ray Protection for Energies up to 50 MeV (Equipment Design, Performance and Use)", may be helpful in responding to the items above. 8.17 ITEM 9: RADIATION MONITORING INSTRUMENTS Regulations: 10 CFR 20.1101,10 CFR 20.1501,10 CFR 20.2102,10 CFR 20.2103(a), 10 CFR 30.33(a)(2),10 CFR 35.61,10 CFR 35.2061. Criteria: All licensees shall possess calibrated radiation detection and measuring instruments that will be used for radiation protection, including survey and monitoring instruments and quantitative measuring instruments needed to monitor the adequacy of radioactive materials containment and contamination control. Discussion: Licensees shall possess instruments used to measure radiation levels, radioactive contamination, and radioactivity, as applicable. Instruments used for quantitative radiation measurements must be calibrated for the radiation measured. The instruments must be available for use at all times when byproduct material is in use. The licensee must 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., I-125, Pd-103) if they become dislodged in the operating room or patient's room. Usually it is not necessary for a licensee to possess a survey meter solely for use during sealed source diagnostic procedures since it is not expected that a survey be performed each time a procedure is performed. In these cases it is acceptable for the meter to be available on short Draft NUREG - 1556, Vol. 9 8-38
( CONTENTS OF AN APPLICATION notice in the event of an accident or malfunction that could reduce the snielding of the sealed source (s). Surveys may be required to verify source integrity of the diagnostic sealed source and to ensure that dose rates in unrestricted areas and public and occupational doses are within regulatory limits. Survey meter calibrations must be performed by persons, including licensee personnel, who are specifically authorized by the NRC or an Agreement State to perform calibrations. If a calibration service will be used, the applicant should ensure that the service is licensed to perform these activities by an NRC (or an equivalent Agreement State) license. Applicants seeking authorization to perform survey meter calibrations must submit calibration facility diagrams in accordance with Section 8.16. Appendix I provides guidance regarding appropriate instrumentation and model survey instrument calibration procedures. Response from Applicant; Provide the following: Identify the instrument type, sensitivity, and range for each type of radiation detected. Additionally, if applicants possess only one survey instrument to meet the criteria established in 10 CFR Part 35, they should describe what is done when the survey instrument is being calibrated or repaired and either routine or emerge'ncy radiation surveys need to be performed. AND Provide one of the following:
. A statement that: " Radiation monitoring instruments will be calibrated by a person authorized by the NRC or an Agreemen State to perform survey meter calibrations."
AND/OR
= A statement that: "We have developed and will implement written survey meter calibration procedures in accordance with the requirements in 10 CFR 20.1101 and that meet the requirements of 10 CFR 35.61."
8.18 ITEM 9: DOSE CALIBRATOR AND OTHER DOSAGE MEASURING EQUIPMENT Regulations: 10 CFR 30.33,10 CFR 35.60,10 CFR 35.62,10 CFR 35.63,10 CFR 35.2060, 10 CFR 35.2063. 8-39 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION l Criteria: In 10 CFR 35.60,10 CFR 35.62, and 10 CFR 35.63, NRC describes requirements for the use, possession, calibration, and check of dose calibrators and other equipment 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 pursuant to 10 CFR 32.72, the licensee is not required to possess an instrument to measure the dosage. However, pursuant to 10 CFR 35.60, if the licensee prepares their 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. Appendix J provides model dose calibrator calibration procedures. Currently no alpha emitting nuclides are used in unsealed form in medicine. Therefore guidance is not provided in this document on the measurement of these radionuclides. Also, licensees receiving unit dosages of byproduct material and not splitting the dosages may rely on the provider's dose label for the measurement of the dosage. Equipment used to measure dosages that emit gamma, alpha, or beta radiation must be calibrated for the applicable radionuclides being measured. For othwr than unit dosages, the activity must be determined by direct measurement or by a combination of measurement and 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 both vials and syringes, and lack of a National Institute of Standards and Technology (NIST) traceable standard for all radionuclides used. Licensees must assay patient dosages in the same type of vial and geometry as used to determine the correct dose calibrator settings. The use of different vials or syringes may result in measurement errors, for example, due to 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, followed by a high-atomic-numbered material thick enough to attenuate the bremsstrahlung intensity. Calibrations of dosage measuring equipment may be performed by persons authorized by the NRC or an Agreement State to perform such services. If a calibration service will be used, the applicant must ensure that the service is licensed to perform these activities by an NRC (or an equivalent Agreement State) license. Response from Applicant: If applicable, provide the following:
- A statement that: " Dosage measuring equipment will be calibrated by a person authorized by the NRC or an Agreement State to perform dosage measuring equipment calibrations."
\
l Draft NUREG - 1556, Vol. 9 8-40
CONTENTS OF AN APPLICATION AND/OR
= A statement that: "We have developed and will implement written dosage measuring equipment calibration procedures that meet the requirements in 10 CFR 35.60 and 10 CFR 35.62 as applicable."
AND l I
. Identify the instrument type, manufacturer, and model number. Additionally, if only one dose calibrator is possessed, applicants shall describe what is done at their facility when the dose calibrator is being calibrated or repaired and patient dosages need to be measured.
8.19 ITEM 9: DOSIMETRY EQUIPMENT - CALIBRATION AND USE Regulations: 10 CFR 35.432,10 CFR 35.630,10 CFR 35.632,10 CFR 35.633,10 CFR 35.635, 10 CFR 35. 642,10 CFR 35.643,10 CFR 35.644,10 CFR 35.645,10 CFR 35.2432, 10 CFR 35.2630,10 CFR 35.2632,10 CFR 35.2633,10 CFR 35.2635,10 CFR 35.2642, 10 CFR 35.2643,10 CFR 35.2645. l Criteria: In the above regulations, NRC describes requirements for verification of source l activity or output. To perform this measurement, the applicant must possess appropriately calibrated dosimetry equipment. Discussion: The applicant must possess a calibrated dosimetry system (e.g., Farmer chamber, electrometer, well-type ionization chamber) which will be used to perform calibration measurements of sealed sources. Dosimetry systems and/or sealed sources used to calibrate , dosimetry systems must be calibrated by a laboratory accredited by NIST or AAPM. The licensee must maintain records of such calibrations for the duration of the license. The licensee must develop and implement procedures governing calibration of sealed sources used for therapy. The procedures must be approved by the licensee's AMP. The calibration procedures described in AAPM Task Group Nos. 21,40 or 56, and Report 54, or any published protocol approved by a nationally recognized body, as applicable, may be used. At a minimum, l the calibration procedures must address the following:
. Full calibration measurements of the sealed source (s) shall be conducted by the AMP (s). . The method used to determine the exposure rate (or activity) under specific criteria (i.e.,
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, etc.), i 8-41 Draft NUREG - 1$56, Vol. 9
1 CONTENTS OF AN APPLICATION . A commitment to maintain a record of calibration measurements and associated calculations. . The frequency for calibration measurements must be specified. Full calibrations must be performed: before first medical use; whenever spot-check measurements indicate that the output differs by more than 5% from the output obtained at the last full calibration; following installation of new sources or reinstallation of the unit in a new location not previously described in the license and before patient treatment is resumed; following device repairs involving sealed sources; and at intervals not to exceed 1 year. Manual brachytherapy sources must only be calibrated initially, prior to use. Response from Applicant: Provide the following: . A statement that: "We will calibrate dosimetry equipment in accordance with the requirements in 10 CFR 35.630." AND A statement that: "We have developed and will implement a written therapy sealed source calibration procedure that meets the requirements in 10 CFR 35.432,10 CFR 35.632, 10 CFR 35.633,10 CFR 35.635,10 CFR 35. 642,10 CFR 35.643,10 CFR 35.644, and 10 CFR 35.645 (as applicable to the type of medical use requested)." AND Identify the instrument type, manufacturer, and model number.
References:
Copies of AAPM Task Group No. 21,"A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams," AAPM Task Group No. 40, " Comprehensive QA for Radiation Oncology," AAPM Report No. 54," Stereotactic Radiosurgery," AAPM Task Group No. 56, " Code of Practice for Brachytherapy Physics," may be obtained from the American Association of Physicists in Medicine, One Physics Ellipse, College Park, MD 20740-3843 or ordered electronically at the following address: <http://www.aapm.org>. 8.20 ITEM 9: OTHER EQUIPMENT AND FACILITIES Regulations: 10 CFR 30.33(a)(2),10 CFR Part 35. Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Draft NUREG - 1556, Vol. 9 8-42
CONTENTS OF AN APPLICATION I Discussion: The applicant must describe other equipment and facilities available for safe use and storage of byproduct material listed in Item 5 of this application (e.g. fume hoods, xenon traps; emergency response equipment, area monitors, remote handling tools, source transport , containers, patient viewing and intercom systems, interlock systems, etc.). Identify it as ATT. 9.4. Describe additional facilities and equipment for the radiopharmaceutical therapy program to safely receive, use, store, and dispose of radioactive material. Particular attention should be focused on facilities you will use for radioactive drug therapy administration and patient accommodations (i.e., private room / private bath). I-131 sodium iodide is the most widely used source of radiopharmaceutical therapy. If the radionuclides is administered in liquid form, it is ) important to place the patient dosage in a closed environment (i.e., a fume hood) because of the i volatility of the radiopharmaceutical. If the patient has exceeded the release limits of 10 CFR 35.75 the patient must be accommodated in a private room with a private bath as , described in Item 8.16 of this report. Sources of patient contamination include airbome I-131 and radioactivity in the patient's urine perspiration, and saliva. To facilitate decontamination of tl ; patient room, floors, toilet areas, sink areas, countertops, and other permeable surfaces, the lice isee should consider covering areas with disposable materials l having plastic on one side and at :,orbent material on the other. In addition, items handled by the l patient may be covered with plastic. These articles would include the telephone, faucet and toilet handles, television remote, door handles, and nurse call buttons. P-32 is effectively shielded by n plastic syringe and once the radionuclides has been administered to the patient, there is no extemal radiation hazard and P-32 does not require that the patient be placed in isolation. l However, P-32 administered in colloidal form can result in contaminated bandages and dressings and designated waste containers should be maintained in the patient room. For teletherapy, GSR and HDR facilities, the licensee shall require any individual entering the treatment room to ensure, through the use of appropriate radiation monitors, that radiation levels [ have returned to ambient levels. A beam-on radiation monitor permanently mounted in each l therapy treatment room that is equipped with an emergency power supply separate from the ( power supply for the therapy unit meets the requirements of 10 CFR 35.615(c). In addition, the beam-on monitors traditionally installed in therapy treatment rooms are capable of providing a visible indication (e.g., flashing light) of an exposed or partially exposed source. l The applicant shall describe the system, required by 10 CFR 35.615(d), used to view and communicate with the patient continuously while the patient is in the treatment room. If a l shielded viewing window will be used, the thickness, density, and type of material used shall be specified. If a closed-circuit television system (or some other electronic system) will be used for viewing the patient, the backup system or procedure used in case the electronic system malfunctions shall be specified or a commitment must be made to suspend all treatments until the electronic system is repaired and functioning again. The communication system must allow the patient to communicate with the unit operator in the event of any medical difficulties. An open 8-43 Draft NUREG - 1556, Vol. 9 i
CONTENTS OF AN APPLICATION microphone system is recommended to allow communication without requiring the patient to move to activate buttons. The applicant must also provide adequate equipment and controls to maintain exposures of I radiation to workers ALARA and within regulatory limits.10 CFR 35.615(b), in part, requires that each door leading into the treatment room be provided with an interlock to control the on-off a mechanism of the therapy unit. The interlock must cause the source to move to the off condition or shield the source (s) if the door to the treatment room is opened when the source is exposed. The interlock system must prevent the operator from initiating a treatment cycle unless the treatment room entrance door is closed. Additionally, the interlock must be wired so that the source (s) cannot be retumed to the on condition after interlock interruption until the treatment ' l room door is closed and the system is reset at the control panel. Due to the unique characteristics of PDR remote afterloaders and lack of constant surveillance of their operation, a more sophisticated alarm system is essential to ensure protection of the patient during treatment. In addition to the above, it is necessary to ensure the following: The PDR device's control console is not accessible to unauthorized personnel during treatment i A primary care provider check the patient to ensure that the patient's device has not been f moved, kinked, dislodged, disconnected, etc. '
- 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 must indicate that the source is in the " safe" or retracted position connected with the signal indicating the presence of radiation from the room radiation monitor in such a manner that an audible alarm is generated whenever the room monitor indicates the presence of radiation and the device indicates a safe condition.
l - The alarm circuit must also be wired in such a manner that the audible alarm is also ) I 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 appropriate internal error j condition (s) exist.
- The " source safe and radiation present" signal must also be self-testing. This requires that if a " source not safe" input is received without a corre Jonding " radiation present" signal, the circuit will generate an interlock / warning circuit failure signal that will cause the source to retract. This circuit will require manual resetting before attempting to continue treatment.
- The audible alarm must be sufficiently loud to be clearly heard by the facility's responsible device / patient monitoring staff at all times.
- No provisions for bypassing this alarm circuit or for permanently silencing the alarm may be made to the circuit as long as the room radiation monitor is indicating the presence of Draft NUREG - 1556, Vol. 9 8-44
- CONTENTS OF AN APPLICATION l
radiation. If any circuitry is provided to mute the audible alarm, such circuitry may not mute the alarm for a period of more than 1 minute. Controls that disable this alarm circuit or provide for silencing the alarm for periods in excess of 1 minute are prohibited. I If the alarm circuit is inoperative for any reason, a commitment must be made to prohibit initiating any patient treatments with the device until the circuit has been repaired and te:ted. 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 patient rooms where low dose-rate (LDR) remote afterloader use is planned, neither a viewing nor an intercom system is required. However, the applicant must 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. Response from Applicant: Provide a description of additional facilities and equipment required by 10 CFR Parts 30 and 35. For teletherapy, GSR, and remote afterloader facilities, include a description of the:
. Waming systems and restricted area controls (e.g., locks, signs, waming lights and alarms, interlock systems) for each therapy treatment room . Methods for controlling occupancy for each restricted area . 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) are located 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.
8.21 ITEM 10: RADIATION PROTECTION PROGRAM Regulations: 10 CFR 20.1101,10 CFR 20.2102,10 CFR 30.34(e),10 CFR 35.24, 10 CFR 35.26,10 CFR 35.2024,10 CFR 35.2026. Criteria: 10 CFR 20.1101 states that each licensee must develop, document, and implement a i radiation protection program commensurate with the scope of the licensed activity. The program l must assure compliance with established standards, procedures, and provisions of NRC 8-45 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION regulations. Additionally, any calculations or measurements used to demonstrate compliance with NRC regulations must be representative of typical quantities in use or maximum patient doses (dosages). The licensee is responsible for the conduct of all licensed activities and the acts and omissions ofindividuals handling licensed material. 10 CFR 30.34(e) permits NRC to incorporate into licenses additional requirements and conditions that it deems appropriate or necessary to protect health and safety or to minimize danger to life and property. 10 CFR 35.24 describes the licensees management's authorities and responsibilities for the radiation protection program. 10 CFR 35.26 describes when the licensee may revise the radiation protection program - without NRC approval. One of the allowances to change the program without approval is when the revision does not reduce radiation safety. Examples of when this might apply include replacement of survey instruments with comparable survey instruments or reassignment of tasks among employees. Discussion: Applicants / licensees must abide by all applicable regulations, develop and implement procedures, and/or provide requested information about the proposed radiation protection program during the licensing process. The table in Appendix C may be helpful in determining the information that must be provided when requesting a license. The applicant / licensee must consider the following functional areas (as applicable to the type of medical program):
- Audit Program
. Occupational Dose
. Public Dose -
. Minimization of Contamination
. Operating and Emergency Procedures
. Material Receipt and Accountability Ordering and Receiving
- Opening Packages
- Sealed Source Inventory Use Records
- Leak Tests
- Area Surveys
- Administrations Requiring a Written Directive
- Safe Use of Unsealed Licensed Material Maintenance of Therapy Devices Containing Scaled Sources
- Spill Procedures
- Emergency Response for Sealed Sources or Devices Containing Sealed Sources Draft NUREG - 1$56, Vol. 9 8-46 i
CONTENTS OF AN APPLICATION I !
- Patient or Human Research Subject Release ,
- Safety Pmcedures for Therapy Treatments Where Patients are Hospitalized l
- Safety and Device Calibration Procedures ,
l
\ = Mobile Medical Service i . Transportation Waste Management i
{ 1 Response From Applicant: Respond to subsequent sections of this document regarding Item 10 of the application. 8.22 ITEM 10: AUDIT PROGRAM Regulations: 10 CFR 20.1101,10 CFR 20.2102. Criteria: Licensees must annually review the content and implementation of the radiation protection program to ensure the following: ( Compliance with NRC and DOT regulations (as applicable), and the terms and conditions of l the license
. Occupational doses and doses to members of the public ALARA (10 CFR 20.1101)
- Records of audits and other reviews of program content are maintained for 3 years.
Discussion: The licensee must develop and implement procedures for the audit program. Appendix K contains model procedures. All areas indicated in Appendix K may not be applicable to every licensee and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit need not be reviewed at the next audit. Generally, audits are conducted at least once every 12 months. Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of users to determine if, for example, Operating and Emergency Procedures are available and are being followed. It is essential that once identified, problems are corrected comprehensively and in a timely manner. IN 96-28," Suggested Guidance Relating to Development and Implementation of l 8-47 Draft NUIEG - 1556, Vol. 9
CONTENTS OF AN APPLICATION l Corrective Action," dated May 1,1996, provides guidance on this subject, and specifically ! describes the corrective action process to include three steps:
- 1. Conduct a complete and thorough review of the circumstances that led to the violation
- 2. Identify the root cause of the violation
- 3. Take prompt and comprehensive corrective actions that will address the immediate
- concerns and prevent recurrence of the violation.
! l The NRC will review the licensee's audit results and determine if corrective actions are thorough, timely, and sufficient to prevent recurrence. Depending on the significance of a violation, if a violation is identified by the licensee and these steps are taken, the NRC may exercise discretion and may elect not to cite a violation. The NRC's goal is to encourage prompt identification and prompt, comprehensive correction of violations and deficiencies. For additional information on NRC's use of discretion on issuing a notice of violation, refer to
" General Statement of Policy and Procedures for NRC Enforcement Actions," (NUREG 1600, dated June 1995).
Pursuant to 10 CFR 20.2102, licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. Audit records should contain the following information: audit findings, noted deficiencies, and corrective actions. Response from Applicant: The applicant is not required to, and should not, submit its audit program to the NRC for review.
References:
See the Notice of Availability on the inside front cover of this draft report to obtain copies of: NUREG-1600, " General Statement of Policy and Procedures on NRC Enforcement Actions," dated June 1995, and IN 96-28," Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1,1996. NUREG-1600 is also available on the Intemet. Visit NRC's Home Page <http://www.nrc. gov >, choose " Nuclear Materials," then
" Enforcement,"" Enforcement Guidance Documents," and then " Current Enforcement Policy."
8.23 ITEM 10: OCCUPATIONAL DOSE Regulations: 10 CFR 20.1101,10 CFR 20.1201,10 CFR 20.'1202,10 CFR 20.1204, 10 CFR 20.1207,10 CFR 20.1208,10 CFR 20.1501,10 CFR 20.1502,10 CFR 20.2102, 10 CFR 20.2106. Draft NUREG - 1556, Vol. 9 8-48
CONTENTS OF AN APPLICATION . l Criteria: Applicants must do either of the following: l
- Maintain, for inspection by NRC, documentation demonstrating that unmonitored individuals are not likely to receive, in 1 year, a radiation dose in excess of 10% of the allowable limits as shown in Figure 8.12.
OR
- Monitor external and/or intemal occupational radiation exposure, if required by 10 CFR Part 20.
skin
~
Eyes heMbW 1 I 0 50 sv Odre5s) Radiation Worker (* **)I T (10 CFR 20.1201) Elbows to hands 0.50 Sv Total effective dose equivalent TEDE (50 rems) (whole body) 0.05 Sv (5 rems) Knees to feet , 0.50 Sv l 50 rems) I o$ l Figure 8.12 Annual Dose Limits for Radiation Workers. Discussion: The licensee must evaluate the exposure of all occupational workers (e.g., nurses, technologists, etc.) to determine whether monitoring is required to demonstrate compliance with Subpart F of 10 CFR Part 20. Licensees must consider the internal and extemal dose and the occupational workers assigned duties when evaluating the need to monitor occupational radiation exposure. When evaluating extemal dose from xenon gas, the licensee may take credit for the reduction of dose resulting from the use of xenon traps. Additionally, periodic checks of the trap efiluent may be used to ensure proper operation of the xenon trap. Licensees may vent xenon gas directly to the atmosphere as long as the effluent concentration is within 10 CFR Part 20 limits. When evaluating dose from aerosols, licensees may take credit for the reduction of dose resulting from the use of aerosol traps. Licensees may vent aeroseis directly to the atmosphere as long as i the effluent concentration is within 10 CFR Part 20 lim'ts. A model procedure for monitoring occupational exposure is provided in Appendix L. 8-49 Draft NUREG - 1556, Vol. 9 E---_--____________-_
CONTENTS OF AN APPLICATION If external dose monitoring is necessary, the applicant should describe the type of personnel , dosimetry, i.e., film badges or thermoluminescent dosimeters (TLDs), that will be used by personnel. If occupational workers handle licensed material, the licensee should evaluate the l need to provide extremity monitors [i.e., required iflikely to receive a' dose in excess of 0.05 Sv (5 rem) shallow-dose equivalent (SDE)] in addition to whole body badges. Additionally, applicants should ensure that their personnel dosimetry program contains provisions that personnel monitoring devices should be worn so that the part of the body likely to receive the greatest proportion ofits permissible dose equivalent will be monitored. Some licensees use self-reading dosimeters in lieu of processed dosimetry. This is acceptable if the criteria above are met. See American National Standards Institute (ANSI) N322," Inspection and Test Specifications for Direct and Indirect Reading Quartz Fiber Pocket Dosimeters" for more information. If pocket dosimeters are used to monitor personnel exposures, applicants should state the useful range of the dosimeters; and procedures and frequency for calibration and maintenance of pocket dosimeters as required by 10 CFR 20.1501(b). When personnel monitoring is needed, most licensees use either film badges or TLDs that are supplied by a National Voluntary Laboratory Accreditation Program (NVLAP) approved processor. Film badges are usually exchanged monthly due to technical concerns about film fading. TLDs are usually exchanged quarterly. Applicants must verify that the processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use. It may be necessary to assess the intake of radioactivity for occupationally exposed individuals in accordance with 10 CFR 20.1204 and 20.1502. Ifinternal dose monitoring is necessary, the applicant must 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; or
- Combinations of these measurements.
For example, for individuals preparing or administering therapeutic dosages ofI-131, licensees may need to assess thyroid burden measurements. For those individuals who are occupationally exposed to lesser quantities ofI-131, RG 8.20, " Applications of Bioassay for I-125 and I-131, Revision 1", has suggested frequencies of bioassays for individuals, based on quantities handled, type of compounds (volatildnon-volatile), and facilities used. The applicant should describe in their procedures the criteria used to determine the type of bioassay and the frequencies at which bioassay (both in vivo and in vitro) will be performed to ;
. evaluate intakes. The criteria also should describe how tables ofinvestigational levels are Draft NUREG - 1556, Vol. 9 8 50 l
l
l CONTENTS OF AN APPLICATION f derived, including the methodology used by the evaluated intemal dose assessments, i.e., the ! empirical models used to interpret the raw bioassay data. The bioassay procedures should l provide for baseline, routine, emergency, and follow-up bioassays. The applicant must describe the equipment and facilities dedicated to the bioassay program. If a commercial bioassay service l l will be used, ensure that the service is licensed to perform these activities by an NRC (or an equivalent Agreement State) license. l RG 8.9, Revision 1, " Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program," and NUREG/CR-4884, " Interpretation of Bioassay Measurements," outline acceptable criteria that may be used by applicants in developing their bioassay programs. , 10 CFR 20.1202 desen .s the requirements for summing extemal and internal doses. Applicanl ts must ensure that their occupational monitoring procedures include criteria for summing extemal and intemal doses. I Response from Applicant: Provide the following: l i I . A description of facilities and equipment used for monitoring occupational exposure. 1 AND (
. A statement that:"We have developed and will implement written procedures for monitoring occupational dose in accordance with 10 CFR 20.1101 and that meet the requirements in Subparts C and F of 10 CFR Part 20."
References:
National Institute of Standards and Technology (NIST) Publication 810, " National Voluntary Laboratory Accreditation Program Directory," is published annually and is available for purchase from GPO and on the Internet at the following address:
<http://ts.nist. gov /ts/htdocs/210/214/dosim.htm>. Copies of ANSI N322 may be obtained from the American National Standards Institute,1430 Broadway, New York, NY 10018, or ordered electronically at the following address: <http://www. ansi.org>. See the Notice of Availability '
on the inside front cover of this draft report to obtain copies of RG 8.20, " Applications of Bioassay for I-125 and I-131, Revision 1," RG 8.9, Revision 1," Acceptable Concepts, Models, , Equations, and Assumptions for a Bioassay Program," and NUREG/CR-4884, " Interpretation of Bioassay Measurements." i l ( 8-51 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION 8.24 ITEM 10: PUBLIC DOSE Regulations: 10 CFR 20.1301,10 CFR'20.l'302,10 CFR 20.1801,'10 CFR 20.1802, 10 CFR 20.2107. Criteria: Licensees must do the following:
. Ensure that licensed material will be used, transported, and stored in such a way that members of the public will not receive more than I'mSv (100 mrem) in 1 year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour, from licensed operations.
- Control and maintain constant surveillance oflicensed material that is not in storage and secure stored licensed material from unauthorized access, removal, or use.
Discussion: Members of the public include persons who work or may be near locations where licensed material is used or stored and employees whose assigned duties do not include the use of licensed materials and who work in the vicinity where it is used or stored (see Figure 8.13). 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. 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. Licensed Material Location
\1
> l
, $. 4 ;
I
-hyhh Proper location: a sufficient distance from personneland secured against unauthorized access or removal epw402S 1
Figure 8.13 Proper Security of Licensed Material. LicensedMaterialshould be locatedaway I from occupied areas and secured to prevent unauthori:ed use or removal. Draft NUREG - 1556, Vol. 9 8-52 l
CONTENTS OF AN APPLICATION Public dose is also affected by the choice of storage and use locations and conditions. Licensed material may present a radiation field, and must be located so that the public dose in an unrestricted area (e.g., an ofnee or the exterior surface of an outside wall) does not exceed 1 mSv (100 mrem) in a year or 0.02 mSv (2 mrem) in any one hour. Use the concepts of time, distance, and shielding when choosing storage and use locations. Decreasing the time, increasing the distance, and using shielding (i.e., brick, concrete, lead, or other solid walls) will reduce the radiation exposure. Licensees can determine the radiation levels adjacent to licensed material either by calculations or a combination of direct measurements and calculations using some or all of the following: typical known radiation levels provided by the manufacturer, the " inverse square" law to evaluate the effect of distance on radiation levels, occupancy factor to account for the actual presence of the member of the public, and limits on the use oflicensed material. See Appendix M for an example demonstrating that individual members of the public will not receive doses exceeding the allowable public dose limits. If, after making an initial evaluation, a licensee changes the conditions used for the evaluation (e.g., changes the location oflicensed material within a designated room, changes the type or frequency oflicensed material use, or changes the occupancy of adjacent areas) then the licensee must perform a new evaluation to ensure that the public dose limits are not exceeded and take corrective action, as needed. l Response from Applicant: No response is required from the applicant in a license application, but this matter will be examined during inspection. During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public. See Appendix M for examples of methods to demonstrate compliance with public dose limits. 1 8.25 ITEM 10: MINIMIZATION OF CONTAMINATION Regulations: 10 CFR 20.1406 ) Criteria: Applicants for new licenses must ensure that facility design and procedures for l 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 ofradioactive waste. Discussion: All applicants for new licenses need to 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 8-53 Draft NUREG - 1556, Vol. 9 i
CONTENTS OF AN APPLICATION , decontamination. This is especially important for licensed activities involving unsealed i l byproduct material. As described in Item 8.37," Spill Procedures", cleanup procedures should be implemented for any contamination event. Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSDR Certificates usually pose little risk of contamination. Leak tests performed as specified in the SSDR Certificate should identify defective sources. Leaking sources must be immediately withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. Response from Applicant: Provioe a description of how facility design and procedures for operation will minimize contamination of the facility and the environment, facilitate eventual decommissioning, and minimize the generation of radioactive waste. 8.26 ITEM 10: OPERATING AND EMERGENCY PROCEDURES l Regulations: 10 CFR 19.11(a)(3),10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802, 10 CFR 20.2102,10 CFR 20.2201-2203,10 CFR 21.21,10 CFR 30.34(e),10 CFR 30.50, 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 35.415,10 CFR 35.610,10 CFR 35.615. Criteria: Before using licensed material, licensees must do the following: Develop, implement, and maintain specific operating and emergency procedures containing the following elements:
- Instructions for opening packages containing licensed material, using licensed material, operating therapy treatment devices, and performing routine maintenance on devices containing sealed sources, according to the manufacturer's written recommendations and instructions and in accordance with regulatory requirements Instructions for conducting area radiation level and contamination surveys
- Instructions for administering licensed material in accordance with the WD
- Steps to take, and whom to contact (e.g., RSO, local officials), when the following has occurred: (a) leaking or damaged source, (b) device malfunction and/or damage, (c) licensed material spills, (d) theft or loss oflicensed material, or (e) any other incidents involving licensed material Steps for source retrieval and access control of damaged sealed source (s) and/or malfunctioning devices containing sealed source (s)
- Steps to ensure that patient release is in accordance with 10 CFR 35.75 Draft NUREG - 1556, Vol. 9 8-54
CONTENTS OF AN APPLICATION
- Steps to take in case a therapy patient undergoes emergency surgery or dies
- Instructions for calibration of survey end dosage measuring instruments
- - Periodic spot checks of therapy device units, sources', and treatment facilities l -
Instructions for radioactive waste management. , AND l
= Make operating and emergency procedures available to all users
. . 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 stating where they may be examined).
- _ The licensee should also consider the following when developing their radiation protection program
. Steps to take to keep radiation exposures ALARA
~ . Steps to maintain licensed material accountability l Discussion: Applicants shall develop operating and emergency procedures that minimize radiation safety risks, while keeping radiation exposures ALARA. These procedures must be l ' specific to the type and form of the licensed material used.
l Sealed sources and radiopharmaceuticals used for therapy can deliver significant doses in a short period of time. Unauthorized access to licensed material by untrained individuals could lead to a significant radiological hazard. Therefore, operating procedures will also need to address access control. Many licensees achieve access control by permitting only trained individuals to have access to licensed material (e.g. keys, lock combinations, security badges, etc.). Accountability oflicensed material may be ensured by conducting physical inventories, controlling receipt and disposal, and maintaining use records. In the event that a therapy patient should undergo emergency surgery or die, it is necessary to ensure the safety of others attending the patient. As long as the body remains unopened, the radiation received by anyone near it is due almost entirely to gamma rays. The change in emphasis when an operation or autopsy is to be performed is due to the possible exposure of the hands and face to relatively intense beta radiation. Procedures for emergency surgery or autopsy can be found in section 5.3 of NCRP Report No. 37, " Precautions In The Management of Pdients Who Have Received Therapeutic Amounts of Radionuclides." Appendix N also provides model procedure; for responding to emergency surgery or death of the therapy patient. Applicants must develop emergency procedures that address a spectrum ofincidents (e.g., major spills, leaking source, medical events, interlock failure, stuck source, etc.). 8-55 Draft NUREG - 1556, Vol. 9
i CONTENTS OF AN APPLICATION The NRC must 5>e notified when licensed material in excess of 10 times the quantity specified in Appendix C to pac 20 is lost or stolen. The RSO must be proactive in evaluating whether NRC notification is requirad for any incident involving licensed material. Refer to the regulations (10 CFR 20.2201-20.2203,10 CFR 30.50, and 10 CFR 21.21) for a description of when notifications are required. Response from Applicant: No response is necessary. Refer to the subsequent sections for guidance.
Reference:
Copies of NCRP Report No. 37, " Precautions In The Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," may be obtained from the National Council on Radiation Protection and Measurements,7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095, or ordered electronically at the following address:
<http://www.ncrp.com>.
8.27 ITEM 10: MATERIAL RECEIPT AND ACCOUNTABILITY Regulations: 10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.1906,10 CFR 20.2201, 10 CFR 30.34(e),10 CFR 30.35(g)(2),10 CFR 30.41,10 CFR 30.51,10 CFR 35.67. Criteria: Accountability oflicensed material must be ensured at all times to prevent loss, theft, or misuse. Discussion: As illustrated in Figure 8.14, licensed materials must be tracked from " cradle to grave" in order to ensure accountability, identify when licensed material could be lost, stolen, or misplaced, and ensure that possession limits listed on the license are not exceeded. Licensees exercise control over licensed material accountability by including the following items (as applicable) in their radiation protection program:
. Physical inventories of sealed sources at intervals not to exceed 6 months
. Ordering and receiving licensed material
. Package opening
. Use records.
Draft NUREG - 1556, Vol. 9 8 56
f CONTENTS OF AN APPLICATION Cradle to Grave Accountability l
- v m -
l Receipt Disposal or transfer
-=
l Figure 8.14 Material Receipt and Accountability. Licensees must maintain records of j receipt, transfer, and disposal and conduct semiannualphysical inventories ofsealed sources. j l l l Response from Applicant: No response is necessdry. Refer to the subsequent sections for l guidance. 8.28 ITEM 10: ORDERING AND RECEIVING Regulations: 10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.1906,10 CFR 30.34(e), 10 CFR 30.51. Criteria: 10 CFR 20.1906 describes the requirements for receiving packages containing licensed material. Applicants are reminded that security oflicensed material, required by 10 CFR 20.1801 and 10 CFR 20.1802, must be considered for all receiving areas.10 CFR 30.51 requires licensees to maintain records showing the receipt of byproduct material. I Discussion: Licensees must ensure that the type and quantity oflicensed material possessed is in l accordance with the license. Additionally, licensees must ensure that packages are secured and radiation exposures from packages are minimized. Appendix 0 :ontains model procedures for ordering and receiving licensed material. Response from Applicant: No response is necessary. 8-57 Draft NUREG 1556, Vol. 9 l _
CONTENTS OF AN APPLICATION 8.29 ITEM 10: OPENING PACKAGES Regulations: 10 CFR 20.1906,10 CFR 20.2103. Criteria: Licensees must ensure that packages are opened safely and that the requirements of 10 CFR 20.1906 are met. Licensees must retain records of package surveys in accordance with 10 CFR 20.2103. Discussion: Licensees must develop and implement procedures for opening packages to ensure that the survey requirements of 10 CFR 20.1906 are met and that radiation exposures are minimized. Appendix P contains model procedures. 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 ifit arrives during normal working hours, or not later than 3 hours from the beginning of the next working day, ifit arrived after working hours. Response from Applicant: Provide the following: 'A statement that "We have developed and will implement written package opening procedures that meets the requirements of 10 CFR 20.1906." 8.30 ITEM 10: SEALED SOURCE INVENTORY Regulations: 10 CFR 20.1801,10 CFR 20.1802,10 CFR 30.51,10 CFR 35.67,10 CFR 35.406, 10 CFR 35.2067. Criteria: NRC requires the licensee in possession of a sealed source or brachytherapy source to conduct a semi-annual physical inventory of all such sources in its possessicn. Inventory records must be maintained for 3 years. Discussion: The licensee must conduct a semiannual physical inventory of all sealed sources and brachytherapy sources in your possession, pursuant to 10 CFR 35.67. Individual GSR sources are exempt from the semiannual physical inventory as stated in 10 CFR 35.67(g). However, the licensee must maintain records of GSR sources receipt and disposal, pursuant to 10 CFR 30.51, to indicate the current inventory of sources at the licensee's facility. The licensee shall retain each inventory in accordance with 10 CFR 35.2067. In addition,10 CFR 35.406 requires the licensee to make a record of brachytherapy source accountability when removing and returning brachytherapy sources from the storage location. Response from Applicant: No response is necessary. Draft NUREG - 1556, Vol. 9 8-58
l CONTENTS OF AN APPLICATION f l L 8.31 ITEM 10: USE RECORDS l Regulations: 10 CFR 30.51,10 CFR 35.2063,-10 CFR 35.2204,10 CFR 35.2406. l l Criteria: Licensees must record the use oflicensed material to reflect proper use and l accountability. Records of use must be maintained for 3 years. Discussion: Licensees are required to make and maintain records of dosage activity prior to medical use. Records of each dosage must be made and include: l . Radionuclides
. Generic name or its abbreviation or trade name
. Lot number
! = Patient's or human research subject's name and identification number if one has been assigned !
- Prescribed dosage and activity at the time of dosage determination, or a notation that the total l activity is less than 1.1 mega-Bq (30 Ci)
. Date and time of dosage determination
. Name of the individual who determined the dosage.
Dosage determination for unit dosages may be made either by direct measurement or by a decay l correction based on the determination (e.g., measurement) made by the manufacturer or preparer l licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements. t I ! If molybdenum concentration is measured pursuant to 10 CFR 35.204, records of molybdenum j concentration must be made and include: I
. Ratio of the measurements expressed as Ci of molybdenum per mci of technetium-99m l
. Date and time of the measurement
. Name of the individual who made the measurement.
1 If the licensee uses manual brachytherapy sources, the following records of use must be made: i j
- Each time temporary implant brachytherapy sources are removed from storage, a record will be made and include the number and activity of sources reinoved, the time and date they were removed from storage, the location of use, and the name of the individual who removed them from storage.
1 8-59 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION
. Each time temporary implant brachytherapy sources are retumed to storage, a record will be made and include the number and activity of sources retumed, the time and date they were remrned to storage, and the name of the individual who returned them to storage.
. For permanent implants, a record will be made and 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 returned to storage, 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 is necessary. 8.32 ITEM 10: LEAK TESTS Regulations: 10 CFR 20.1501,10 CFR 20.2103,10 CFR 30.53,10 CFR 35.67, 10 CFR 35.2067,10 CFR 35.3067. j Criteria: NRC requires testing to determine whether there is any radioactive leakage from sealed sources. Records of test results must be maintained for 3 years. Discussion: Licensees must perform leak testing of any sealed source or brachytherapy source in accordance with 10 CFR 35.67. Appendix Q provides model leak testing procedures. Pursuant to 10 CFR 35.67, licensees are required to perform leak tests at six month intervals or at other intervals approved by the NRC or an Agreement State and specified in the SSDR 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 Ci) of radioactivity. Leak tests samples should be collected at the most accessible area where contamination would accumulate if the sealed source were leaking (see Figure 8.15) Draft NUREG - 1556, Vol. 9 8-60
l CONTENTS OF AN APPLICATION l l Leak Testing y us.<ag
- Figure 8.15 Leak Test Sample.
The leak test may be performed in house or by a contractor who is authorized to perform leak tests as a service to other licensees. l The licensee or contractor does not need to leak test sources if: l
. Sources contain only byproduct material with a half-life less than 30 days a Sources contain only byproduct material as a gas a Sources contain 3.7 mega-Bq (100 Ci) or less of beta-emitting or gamma-emitting material {
or 0.37 mega-Bq (10 Ci) or less of alpha-emitting material
- Sources contain Ir-192 seeds in nylon ribbon
. Sources are stored for less than a 10-year period 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: No response is necessary.
References:
See the Notice of Availability on inside front cover of this draft report to obtain a l copy of Draft RG FC 412-4, " Guide for the Preparation of Applications for the Use of l Radioactive Materials in L:ak-Testing Services," dated June 1985. l l 8-61 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION 8.33 ITEM 10: AREA SURVEYS , l Regulations: 10 CFR 20.1003,10 CFR 20.1101,10 CFR 20.1301,10 CFR 20.1302, 10 CFR 20.1501,10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.2102,10 CFR 20.2103, 10 CFR 20.2107,10 CFR 35.70,10 CFR 35.2070. Criteria: Licensees must do the following: . Ensure that licensed material will be used, transported, and stored in such a way that members of the public will not receive more than 1 mSv (100 mrem) in 1 year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any I hour, from licensed operations. . 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, removal, or use. Discussion: Licensees must develop and implement area survey procedures. Appendix R contains model procedures with suggested survey frequencies. At a minimum, licensees must perform daily' surveys in all areas where radiopharmaceuticals requiring a WD were prepared for use or administered (i.e., diagnostic activities exceeding 30 Ci ofI-131 and all therapy treatments); however, for administrations, requiring a WD, in patients' rooms, the licensee is not required to perform a survey if the patient is not released, but should perform adequate surveys of patients' rooms gDfM patient release and pj:ipI to release of the room for unrestricted use. In addition, therapy sealed sources (including applicators and catheters) may become dislodged during implantation or after surgery, and inadvertently lost or removed. When developing area survey procedures, the licensee should consider: . a survey of the therapy patient's bed linens before removing them from the patient's room, and . a survey of the operating room and the patient's room after source implantation. Response from Applicant: Provide the following: A statement that: "We have developed and will implement written procedures for area surveys in accordance with 10 CFR 20.1101 and that meets the requirements of 10 CFR 20.1501 and 10 CFR 35.70." 1 Draft NUREG 1556, Vol. 9 8-62
l CONTENTS OF AN APPLICATION 8.34 ITEM 10: PROCEDURES FOR ADMINISTRATIONS REQUIRING l A WRITTEN DIRECTIVE 1 Regulations: 10 CFR 35.40,10 CFR 35.41,10 CFR 35.2040. l Criteria: 10 CFR 35.40 describes the requirements for WDs.10 CFR 35.41 requires medical l l use licensees to develop, maintain, and implement written procedures to provide high confidence that licensed material is administered as directed by authorized users. , 1 1 Discussion: The procedures do not need to be submitted to the NRC. This allows licensees the l flexibility to revise the procedures to enhance their effectiveness without obtaining NRC ! approval. Appendix S provides guidance for developing the procedures. Response from Applicant: Provide the following: A statement that: "We have developed and will implement written procedures for administrations requiring a written directive in accordance with 10 CFR 35.41." 8.35 ITEM 10: SAFE USE OF UNSEALED LICENSED MATERIAL Regulations: 10 CFR 20.1101,10 CFR 20.1301,10 CFR 20.1302,10 CFR 20.2102, 10 CFR 20.2103,10 CFR 30.34(e),10 CFR 35.69,10 CFR 35.70,10 CFR 35.310. Criteria: Before using licensed material, the licensee must develop and implement a radiation i protection program that includes safe use of unsealed licensed material. Discussion: Licensees must have adequate equipment and operating controls to ensure that radioactivity, surface contamination, and effluent releases are maintained within regulatory limits. l l Users oflicensed material must perform surveys required by 10 CFR 20.1302(a) (i.e., surveys of l radiation levels and release of effluents to unrestricted and controlled areas). In addition, applicants should establish a program to constrain doses from air emissions in accordance with , 10 CFR 20.1101(d). Records of the results of the measurements are required by 10 CFR 20.2103(b)(4). Applicants must show how releases to the environment will be ALARA. The general guideline is 10% of the limit specified in 10 CFR 20.1301(a)(1). Licensees that possess sufficient quantities of radioactive material to exceed 10 CFR Part 20 air emissions limits should demonstrate a basis for compliance with the applicable requirements. Such basis could include one or more of the following: 8-63 Draft NUREG - 1556, Vol. 9
l CONTENTS OF AN APPLICATION
. Measured concentrations of radionuclides in air effluents are below 10 CFR Part 20, Appendix B, Table 2 concentrations (and extemal dose < 50 mrem /yr). . Bounding calculations show that air effluents could not exceed 10 CFR Part 20, Appendix B, Table 2 concentrations (and extemal dose < 50 mrem /yr).
l
. Dose modeling shows that dose equivalent to the individual likely to receive the highest dose does not exceed 10 mrem /yr.
In addition, licensees must develop procedures for implementing protective measures occupational workers should take to maintain their doses ALARA. Protective measures may include:
. Use of syringe shields and/or vial shields . Wearing laboratory coats and gloves when handling unsealed byproduct material . Monitoring hands after handling unsealed byproduct material.
Appendix T contains model procedures for safe use of unsealed licensed material. Response from Applicant: Provide the following: A statement that: "We have developed and will implement procedures for safe use of unsealed licensed material that meet the requirements of 10 CFR 20.1101,10 CFR 20.1301 and 10 CFR 35.69." 8.36 ITEM 10: MAINTENANCE OF THERAPY DEVICES CONTAINING SEALED SOURCES Regulations: 10 CFR 20.1101,10 CFR 30.34(e),10 CFR 35.605,10 CFR 35.655, 10 CFR 35.2605,10 CFR 35.2655. Criteria: Licensees must ensure that therapy devices containing sealed sources are maintained according to manufacturer's written recommendations and instructions and according to the SSDR and the regulations. In addition,10 CFR 35.655 requires that teletherapy and GSR units be fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to ensure proper functioning of the source exposure mechanism. Maintenance is necessary to ensure that the device functions as designed and source integrity is not compromised. l Draft NUREG 1556, Vol. 9 8-64
CONTENTS OF AN APPLICATION 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 means 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), or affect the source drive controls. l Ee NRC requires that maintenance and repair (as defined above) be performed only by persons l specifically licensed by the Commission or an Agreement State to perfonn such services. Most licensee employees do not perform maintenance and repair because they do not have 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 prior to response to this item.10 CFR 35.605 allows for limited service activities with regard to LDR remote afterloader units. , Response from Applicant: No response is necessary if the licensee contracts with personnel who are licensed by the Commission or an Agreement State to perform maintenance and repair services on the specific therapy device possessed by the licensee. However, if the applicant l requests that an employee, who is trained by the manufacturer, be authorized to perform maintenance and repair, the applicant must submit,the following:
. Name of the proposed employee and types of maintenance and repair requested.
AND
= Description of the training and experience demonstrating that the proposed employee is qualified by training and experience for the use requested.
AND
. Copy of the manufacturer's training certification and an outline of the training.
I Note: The applicant should specify only those maintenance and repair functions described in a certificate or letter from the manufacturer of the device which documents the employee's training in the requested function (s). 8.37 ITEM 10: SPILL PROCEDURES ! Regulations: 10 CFR 19.11(a)(3),10 CFR 20.1101,10 CFR 201406,10 CFR 20.2102, l 10 CFR 20.2202,10 CFR 20.2203,10 CFR 30.34(e),10 CFR 30.35(g),10 CFR 30.50, 10 CFR 30.51. ; 8 65 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION Criteria: Before using licensed material, the licensee must develop and implement a radiation protection program that includes proper response to spills oflicensed material. Discussion: The applicant must develop and implement procedures to be used in the event of spills or other contamination events in order to prevent the spread of radioactive material. Appendix N contains model emergency response procedures, including model spill procedures. Spill procedures should address all types and forms oflicensed 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 on evacuation of the area, containment of spills and other releases,. appropriate methods for re,mtering, and decontaminating facilities that may have been accidentally contaminated. Response from Applicant: Provide the following: A statement that: "We have developed and will implement written procedures for safe response to spills oflicensed material in accordance with 10 CFR 20.1101." 8.38 ITEM 10: EMERGENCY RESPONSE FOR SEALED SOURCES OR DEVICES CONTAINING SEALED SOURCES Regulations: 10 CFR 19.11(a)(3),10 CFR 20.1101,10 CFR 20.2102,10 CFR 20.2201-2203, 10 CFR 21.21,10 CFR 21.51,10 CFR 30.34(e),10 CFR 30.50,10 CFR 30.51,10 CFR 35.410, 10 CFR 35.610. Criteria: Before handling sealed sources or using devices comaining sealed sources, the applicant must develop and implement procedures for emergency response.10 CFR 35.610 requires, in part, that instructions and telephone numbers of AUs, AMPS and RSO be posted at the therapy unit console. The instructions must inform the operator of procedures to be followed if the operator is unable to turn off the primary beam of radiation with the controls outside of the treatment room, remove the patient from the radiation field, or if any other abnormal operation occurs. Discussion: The applicant must develop and implement procedures to be used in response to emergencies involving sealed sources or devices containing sealed sources in order to prevent inadvertent release of, or exposure to, licensed material. Appendix N contains model emergency response procedures for teletherapy units. Emergency procedures must address all types of licensed material and devices used and should be posted in restricted areas where sealed sources are used or stored. The instructions must 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. Draft NUREG - 1556, Vol. 9 8-66
CONTENTS OF AN APPLICATION Additionally, the instructions must contain procedures on evacuation and security of the involved area (s), source recovery, area reentry, and decontamination of facilities (if applicable). All equipment necessary for complying with emergency procedures shall be immediately accessible in the treatment room or console area; for example, these may include remote handling tools, t-bars, Allen keys, and shielded containers. l The applicant must establish and agree to follow written procedures for emergencies that may occur, e.g., a manual brachytherapy source becomes dislodged, a therapy source fails to retract or return to the shielded position, a GSR couch fails to retract. A copy of the manufacturer's instructions should be given to each individual involved with therapy treatments. Practice drills, using nonradioactive (dummy) sources (when possible), including dry runs of emergency l procedures that cover stuck or dislodged sources and applicators (if applicable), and emergency j procedures for patient removal must be practiced annually. These procedures, designed to minimize radiation exposure to patients, workers, and the general public, must at a minimum address the following as applicable to the type of medical use: l
= When the procedures are to be implemented, such as, any circumstance under which the source becomes dislodged, cannot be retracted to a fully shielded position, or the patient l cannot be removed from the beam of radiation a
The actions specified for emergency source recovery or shielding which primarily consider minimizing exposure to the patient and healthcare personnel while maximizing safety of the patient. t The step-by-step actions for single or multiple failures that specify the individual (s) responsible for implementing the actions. The procedures must clearly specify which steps are to be taken under different scenarios. The procedure must specify situations in which surgical intervention may be necessary and the steps that should be taken in the event that surgicalintervention is required.
- Identification of the location of emergency source recovery equipment and specification of what equipment may be necessary for the various scenarios described in the procedure. At a minimum, emergency equipment must include shielded storage containers, remote handling tools, and, if appropriate, supplies necessary to surgically remove applicators or sources from the patient.
. Giving first consideration to minimizing the 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). Note: If a first step of the emergency procedures for teletherapy units specifies pressing the emergency bar on the teletherapy unit console, the applicant is advised that this action may cause the source to return to the off position but may also cut power to the entire teletherapy unit or to the gantry or the couch. = Instructing the staff to act quickly and calmly, and to avoid the primary beam of radiation.
- Specifying who is to be notified.
8-67 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION = 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. Response from Applicant: Provide the following: A statement that: "We have developed and will implement written procedures for safe response to emergencies involving sealed sources in accordance with 10 CFR 20.1101 and 10 CFR 35.610 (inapplicable)." 8.39 ITEM 10: PATIENT OR HUMAN RESEARCH SUBJECT RELEASE Regulations: 10 CFR 35.75,10 CFR 35.2075. Criteria: Licensees may release from confmement patients or human research subjects (patients) who have been administered licensed material if the TEDE to any other individual from exposure to the released patient is not likely'to exceed 5 mSv (0.5 rem). Licensees must provide radiation safety instructions to patients released in accordance with 10 CFR 35.75 (b). Discussion: 10 CFR 35.75 requius that the licensee provide the released individual 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 breast-feeding infant or a child could exceed 1 mSv (0.1 rem), assuming there was no interruption of bre'ast-feeding, the instructions shall also include:
= guidance on the interruption or discontinuation of breast-feeding; and
- information on the potential consequences of failure to follow the guidance. This implies that the licensee will confirm whether a patient is breast-feeding prior to release of the patient.
In addition,10 CFR 35.75 (c) requires that the licensee maintain a record of the basis for authorizing the release of an individual, for 3 years aller the date of release, if the TEDE is calculated by:
= using the retained activity rather than the activity administered; . using an occupancy factor less than 0.25 at I meter; = using the biological or effective half-life; or e considering the shielding by tissue.
Draf1 NUREG - 1556, Vol. 9 8-68
CONTENTS OF AN APPLICATION i l i In 10 CFR 35.75 (d), the licensee is required to maintain a record, for 3 years after the date of l release, that instructions were provided to a breast-feeding woman if the radiation dose to the l infant or child from continued breast-feeding could result in a TEDE exceeding 5 mSv (0.5 rem). l Appendix U provides guidance to the applicant for determining when: l
. The licensee may authorize the release of a patient who has been administered radiopharmaceuticals or treated with implants containing radioactive material (Section 1)
- Instructions to the patient are required by 10 CFR 35.75(b)(Section 2)
- Records are required by 10 CFR 35.75(c) and (d) to be generated and maintained (Section 3). !
I The appendix lists activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in 10 CFR 35.75. Response from Applicant: Provide the following: A statement that: "We have developed and will provide written instructions to patients or human research subjects, released pursuant to 10 CFR 35.75, that meet the requirements in 10 CFR 35.75." l i 8.40 ITEM 10: SAFETY PROCEDURES FOR TREATMENTS WHERE l PATIENTS ARE HOSPITALIZED i Regulations: 10 CFR 20.1501,10 CFR 20.1801,10 CFR 20.2103,10 CFR 35.315, l 10 CFR 35.404,10 CFR 35.415,10 CFR 35.615,10 CFR 35.2404. l j Criteria: Applicants must develop and implement procedures to ensure that access to therapy l treatment rooms and exposure rates from therapy treatments are limited to maintain doses to occupational workers and members of the public ALARA. Discussion: 10 CFR 35.315,10 CFR 35.415, and 10 CFR 35.615 (LDR and PDR) requires the licensee to take certain safety precautions regarding radiopharmaceutical therapy, manual brachytherapy, or remote afterloader brachytherapy involving patients hospitalized in accordance with 10 CFR 35.75. The precautions are to ensure compliance with the exposure limits in 10 CFR Part 20. 10 CFR 35.404(b) requires licensees to perform a radiation survey of the patient immediately after removing the last source from the patient. This is done to confirm that all sources have been removed and accounted for. A record of the patient survey must be maintained for 3 years. 10 CFR 35.615(e) requires that licensed activities where sources are placed within the patient's ( 8-69 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION body be limited to treatments which allow for expeditious removal of a decoupled orjammed source. Applicants must consider the following elements:
- Provide a private room with a private sanitary facility for patients treated with a .
radiopharmaceutical therapy dosage
- Post the patient's or the human research subject's door with a " Radioactive Materials" sign and note on the door or in the patient's or human research subject's chart where and how long .
visitors may stay in the patient's or the human research subject's room
. Either monitor material and items removed from the patient's or the human research subject's room (e.g., patient linens, surgical dressings, etc.) to determine that their radioactivity cannot -
be distinguished from the natural background radiation level or to confirm that they do not contain brachytherapy sources with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste
. Notify the RSO and AU as soon as possible, if the patient or human research subject has a medical emergency and, immediately, if the patient dies..
10 CFR 20.1501 requires licensees to perform adequate surveys to evaluate the extent of
- radiation levels. Therefore, licensees must evaluate the exposure rates around patients who are hospitalized in accordance with 10 CFR 35.75 following the dosage administration or implant (e.g., measured exposure rates, combination of measured and calculated exposure rates).
10 CFR 20.1801 requires licensees to secure licensed material in storage from unauthorized access or removal. Therefore, licensees must ensure that access to rooms where patients are hospitalized, in accordance with 10 CFR 35.75, is limited to authorized personnel. Access control and appropriate training of authorized personnel may prevent unauthorized removal of licensed material and unnecessary personnel exposures. In order to control exposures to individuals in accordance with 10 CFR Part 20, the licensee should consider briefing patients on radiation safety procedures for confinement to bed, visitor control, identification of potential problems, notification of medical staffin the event of problems, and other items as applicable and consistent with good medical care. Response from Applicant:. No response is necessary. Draft NUREG - 1556, Vol. 9 8-70 I
l CONTENTS OF AN APPLICATION l 8.41 ITEM 10: SAFETY AND DEVICE CALIBRATION PROCEDURES Regulations: 10 CFR 20.1101,10 CFR 20.1301,10 CFR 20.2102,10 CFR 20.2103, 10 CFR 20.2107,10 CFR 30.34(e),10 CFR 35.604,10 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 35.644,10 CFR 35.645,10 CFR 35.652,10 CFR 35.655,10 CFR 35.657, 10 CFR 35.2310,10 CFR 35.2404,10 CFR 35.2605,10 CFR 35.2632,10 CFR 35.2633, 10 CFR 35.2635,10 CFR 35.2642,10 CFR 35.2643,10 CFR 35.2645,10 CFR 35.2652, 10 CFR 35.2655. Criteria: Applicants must develop and implement procedures for providing radiation safety for the use of sealed sources in devices. Applicants must also develop and implement procedures to ensure that therapy sources and devices are calibrated and operating correctly. Procedures should be complete and self-contained. Pertinent information contained in equipment manuals and other publications may be extracted and included in your operating procedures. Applicable AAPM documents may be referenced. Discussion: Provided below is a separate discussion for each functional area where sealed sources in devices are used. The applicant should review the functional area (s) that apply to the type of medical use requested. Diagnostic Sealed Sources and Devices Good health physics practice dictates that the applicant will provide personnel with clear and specific instructions on usage of sealed sources or devices containing sealed sources. These procedures may include but are not limited to:
. Service and repair of the device . Routine proper use for sealed sources or devices containing sealed sources in accordance with the NRC license and 10 CFR Parts 19 and 20 . Reviews and discussions of the sealed sources " device specific" manufacturer literature and instructions . Description of checks performed on the device to verify its proper operation afler it has been moved and before it is used on patients. This should include manufacturer instruction for start-up, warm-up time and phantom analysis for bone mineral analyzers . Safety and security measures 8-71 Draft NUREG - 1556, Vol. 9
CONTENTS OF AN APPLICATION Teletherapy and GSR Sealed Sources and Devices Good healt h physics practice dictates that the applicant will provide personnel with operating procedures to give them clear and specific directions in their duties and responsibilities. These duties may include, safety device checks, instrument calibration, periodic spot checks, quality control checks, and leak tests. Operating procedures should not contain information that does not apply specifically to persons to whom they are directed. For example, housekeeping personnel would not follow the same procedures as therapy technologists. Applicants shall develop and implement procedures to ensure that access to therapy treatment rooms and exposure rates from therapy treatments are limited to maintain doses to occupational workers and members of the public ALARA. The applicant must establish and agree to adhere to written procedures governing the operation of the therapy unit. The applicant shall have written operating procedures specifically developed for and given to particular groups of staff members (e.g., therapists) outlining the responsibilities of each group to ensure your facility's compliance with NRC regulations, the terms and conditions of the license, and the commitments made in license applications and correspondence with NRC. The procedures must include:
- Use of the therapy unit, including security of the device, the console and the console keys Safety device checks
= Periodic spot check measurements
. Inspection and servicing
. Full calibration measurements
- Relocation of unit a Recordkeeping The functional areas listed above are described in more detail below.
Use of the Therapy Unit The operating procedures should specify who may operate the unit, how the unit may be used (i.e., in what orientations, for what purposes), typical treatment times and setups, how the unit is to be operated (i.e., the sequence of steps to be followed to begin treatment), and who must be present during the treatment. For example, the AU and AMP must be present for GSR treatments. The operating procedures shall contain instructions to ensure that the patient is alone in the room when the primary beam is on and may specify certain daily checks of the unit to , ensure its proper operation. i l Draft NUREG - 1556, Vol. 9 8 72 i
i CONTENTS OF AN APPLICATION Safety Device Checks Safety devices shall be checked periodically to ensure that they are operating properly. Such devices include timers, mechanical and electrical interlocks, waming lights and alarms, helmet position indicator microswitches, safety switches, door interlocks, beam collimators, and other ! devices that actively warn of, limit, or prevent radiation exposure to either patients or personnel. The frequencies required by the regulations for each safety device varies from daily to annually. The results shall be recorded. The operating procedures should contain instructions for making the checks, the frequency of such checks, prompt correction of any malfunctions or defects noted, and retention of appropriate records. A simple checklist may be used to complete the task l and recordkeeping quickly and efficiently. When checks of safety devices indicate defects or malfunctions, there may be some delay before the defects or malfunctions can be corrected. The operating procedures should describe the steps that personnel will follow should a delay occur. For example, use of the therapy unit might be prohibited until the problem is corrected. Documents such as ANSI N449.1-1978," Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment", NCRP Report 69," Dosimetry of X-Ray and Gamma , Ray Beams for Radiation Therapy in the Energy Range 10 kev to 50 MeV," NUREG/CR-6323,
" Relative Risk Analysis in Regulating the Use of Radiation-Emitting Medical Devices",
l NUREG/CR-6324," Quality Assurance for Gamma Knives" AAPM Report No. 54," Stereotactic Radiosurgery" provide standards and recommendations for the frequency and procedures for making certain tests. If the standards or recomn'endations in these documents conflict with NRC regulations or license conditions, the minimum acceptable frequency is that specified in the regulation or license condition. Relocation of Therapy Unit 10 CFR 35.13 requires that the NRC approve your plans and proposed location before a therapy unit is relocated. The operating procedures should ensure that the necessary amendment to the NRC license is obtained before the therapy unit is relocated. l Inspection and Servicing of the Therapy Unit 10 CFR 35.655 requires that teletherapy and GSR units be fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first. This work, to ensure proper functioning of the source exposure mechanism, must be done by a person or firm
- b. specifically licensed to do so by the NRC or an Agreement State. Preventis e maintenance should also be addressed to ensure that as systems deteriorate from use they are identified and repaired.
These items related to the GSR should be included in these sections, such as hydraulic system maintenance; collimator helmet supports, holes, plugs, bushings, and other helmet positioning equipment; and the systems related to the patient couch and the shielding door. Persons holding l 8 73 Draft NUREG - 1556, Vol. 9 f
CONTENTS OF AN APPLICATION an Agreement State license are granted a general license to perform the same activities in non-Agreement States, pursuant to the requirements of 10 CFR 150.20. Operating procedures shall be sufficient to ensure compliance with NRC regulations. Periodic Spot-Check Measurements of Teletherapy Units 10 CFR 35.642 specifies that output spot-check tests must be performed once in each calendar month and 10 CFR 35.630 describes the characteristics of a properly calibrated dosimetry system needed to make the output measurements. 10 CFR 35.642 also describes spot-checks that must be performed at each source installation. The operating procedures should specify when, how, and by whom the spot-check measurements will be made. The measurements required shall be performed in accordance with procedures established by an AMP. The AMP need not actually perform the spot-check measurements; however, the AMP must review the spot-check measurements within 15 days, as required by 10 CFR 35.642(c). Teletherapy Full Calibration Measurements 10 CFR 35.632 requires that a licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy source before the first medical use of the unit and under the conditions listed in 10 CFR 35.632(a)(2). Operating procedures shall be sufficient to ensure compliance with 10 CFR 35.632. Periodic Spot-Check Measurements of GSR Units 10 CFR 35.645 specifies that output spot-check tests must be performed once in each calendar month, and 10 CFR 35.630 describes the characteristics of a properly calibrated dosimetry system needed to make the output measurements. 10 CFR 35.645 also describes additional spot-checks that must be performed monthly, daily, and after each source exchange. The operating procedures should specify when, how, and by whom the spot-check measurements will be made. The measurements required shall be performed in accordance with procedures established by an AMP. The AMP need not actually perform the spot-check measurements; however the AMP must review the spot-check results within 15 days, as required by 10 CFR 35.645(b). GSR Full Calibration Measurements 10 CFR 35.635 requires that a licensee authorized to use a GSR unit for medical use shall perform full calibration measurements on each GSR sour:e before the first medical use of the unit and under the conditions listed in 10 CFR 35.635(a)(2). Operating procedures shall be sufficient to ensure compliance with 10 CFR 35.635. l l Draft NUREG - 1556, Vol. 9 8-74 i I~ _ _ _ _
CONTENTS OF AN APPL.lCATION Remote Afterloader Good health physics practice dictates that the applicant will provide personnel with operating procedures to give them clear and specific directions in their duties and respon sibilities. These
. duties may include, safety device checks, instrument calibration, periodic spot checks, quality control checks, and leak tests. Operating procedures should not contain information that does not apply specifically to persons to whom they are directed. For example, housekeeping personnel l would not follow the same procedures as therapy technologists. Applicants shall develop and l implement procedures to ensure that access to therapy treatment rooms and exposure rates from therapy treatments are limited to maintain doses to occupational workers and members of the !
l l public ALARA. The applicant must establish and agree to adhere to written procedures ! L governing the operation of the therapy unit. The applicant shall develop written operating ! procedures specifically for and given to particular groups of staff members (e.g., therapists) ! outlining the responsibilities of each group to ensure your facility's compliance with NRC regulations, the terms and conditions of the license, and the commitments made in license , applications and correspondence with NRC. The procedures must in'c lude: !
- Conduct of surveys following source replacement in remote afterloader devices and when the '
HDR/PDR device location changes significantly from that existing during previous surveys, At a minimum, the survey program must include surveys defined in the SSDR to ensure that ! the maximum and average radiation levels from the surface of the remote afterloader device j l safe do not exceed the levels stated in the SSDR with the source (s) in the shielded position. ; e Conduct of surveys incident to use including patient and device surveys performed l immediately after each use of the device, or upon responding to a device alarm, to ensure that the source has been returned to the fully shielded position. The patient must be surveyed, ! pursuant to 10 CFR 35.604, with a portable radiation detection survey instrument to confirm l that the source (s) has been removed and returned to the safe shielded position. The survey instrument should be capable of measuring dose rates of 1 - 1000 mrem per hour at I meter. ! a Steps to enssre that:
- The device, console, and treatment or storage room will be secured when unattended.
- The patient will be alone in the treatment room, unless contraindicated, during HDR/PDR therapy.
- Nursing personnel follow the AU's and RSO's. specific instructions regarding care to be provided to a patient during the treatment process. If the treatment is to be conducted over a period of several hours and direct patient care will be required, such instructions should be provided to the nursing staffin writing.
- Treatment planning computer systems using removable media to store each patient's treatment parameters for direct transfer to the treatment system should have each card labeled with the corresponding patient's name and identification number. Such media 8-75 Draft NUREG - 1556, Vol. 9
[ r
i CONTENTS OF AN APPLICATION may be reused (and should be relabeled) in accordance with the manufacturer's ( instructions.
- A treatment procedure will not be conducted if a decoupled orjammed source cannot be removed expeditiously from the patient and placed in a shielded container.
- During patient treatments, require the AU and the AMP to be present as defined in 10 CFR 35.615.-
- If the interlock system malfunctions, the device will be locked in the off position and not used, except as may be necessary for repair or replacement of the interlock system, until the interlock system is shown to be functioning properly.
If a radiation monitor used to indicate the source position is found to be either inoperable or intermittently inoperable, the device will be locked in the off position and not used, except as may be necessary for repair or replacement, until the radiation monitor is shown to be functioning properly. 10 CFR 35.643 and 10 CFR 35.644 require that a licensee authorized to use a remote afterloader unit for medical use shall' perform periodic spot-checks on each unit and facility. Operating procedures shall be sufficient to ensure compliance with the regulations. 10 CFR 35.633 requires that a licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit before the first medical use of the unit and under the conditions listed in 10 CFR 35.633(a)(2). Operating procedures shall be sufficient to ensure compliance with 10 CFR 35.633. Recordkeeping . - The licensee must maintain certain records to comply with NRC regulations, the_ conditions of your license, and commitments made in your license application and correspondence with NRC. Operating procedures should identify which individuals within your organization are responsible for maintaining which records. Examples of documents that must be maintained include:
= Copies of NRC licenses, your license applications, and correspondence with the NRC in support of a license request
- Personnel dosimetry records a Records of survey instrument calibrations Records of calibration of the dosimetry system used for full calibration measurements a
Records of calibration or intercomparison of the dosimetry system used for spet-check measurements Results of full calibration measurements Draft NUREG - 1556, Vol. 9 8-76
CONTENTS OF AN APPLICATION
* - Results of spot-check measurements
- Results ofleak tests
- Records of training of new personnel and annual refresher training of personnel e Records of training in emergency procedures
- Records of full inspection and servicing of the therapy unit a Records of receipt and disposal of radioactive material 1
i Response from Applicant: Provide the following: l A statement that: "We have developed and will implement written procedures for safe use of l i sealed sources and calibration of sources in accordance with 10 CFR 20.1101 and that meet the requirements of the applicable section(s) of Subpart H. j
References:
Copies of ANSI N449.1-1978," Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment," may be obtained from the American National Standards Institute,1430 Broadway, New York, NY 10018, or ordered electronically at the following address: <http://www. ansi.org>. Copies of NCRP Report 69," Dosimetry of X-Ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 kev to 50 MeV," may be obtained from the National Council on Radiation Protection and Measurements,7910 i Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095, or ordered electronically at the following address: <http:/hvww.ncrp.com>. See the Notice of Availability on the inside front cover of this draft report to obtain copies of NUREG/CR-6323, " Relative Risk Analysis in Regulating the Use of Radiation-Emitting Medical Devices," and NUREG/CR-6324, " Quality Assurance for Gamma Knives." Copies of AAPM Report No. 54," Stereotactic Radiosurgery," may be obtained from the American Association of Physicists in Medicine, One Physics Ellipse, College Park, MD 20740-3843 or ordered electronically at the following address:
<http://www.aapm.org>.
8.42 ITEM 10: MOBILE MEDICAL SERVICE Regulations: 10 CFR 20.1101,10 CFR 30.41,10 CFR 30.51,10 CFR 35.80,10 CFR 35.647, 10 CFR 35.2080,10 CFR 35.2647,10 CFR 71.5,10 CFR 71.12,10 CFR 71.13,10 CFR 71.14, 10 CFR 71.37,10 CFR 71.38, Subpart H of 10 CFR Part 71,10 CFR 150.20, 49 CFR Parts 171-178. Criteria: In addition to the requirements in 10 CFR 35.80, mobile medical service licensees must comply with all other applicable regulations. ! 8 77 Draft NUREG - 1556, Vol. 9
l l CONTENTS OF AN APPLICATION t, Discussion: Appendix V describes specific licensing items pertaining to mobile services. . The temporaryjob site at medical care facilities (client's address) is where mobile medical service l l licensees use byproduct material. Mobile medical service licensees may transport licensed l material and equipment from the van into a client's building, or may bring patients into the van. 1 In either case, the van should be located on the client's property that is under the client's control. l In-van imaging services may not be considered an NRC licensed activity if services are limited to patient imaging (i.e., byproduct material is not administered), and byproduct material is not possessed or used. 1 Self-contained mobile service involves a mobile treatment or administration facility that provides ready to deliver mobile services on arrival at a client's site. The facility is entirely self-contained ( with a shielded treatment or administration area, remote afterloader device (if applicable), and i
- safety equipment (e.g., dose calibrators, patient viewing systems, intercom, etc.).
l Transportable mobile service involves transport of the byproduct material for use in a pre-existing shielded treatment or administration facility at the client site. The mobile service , licensee may provide the byproduct material, associated equipment, and trained personnel, or the l client may choose to provide the trained personnel to use the byproduct material. Patient i treatments with remote afterloaders for this type of service require prior installation of the device l L -in an appropriately shielded and permanently located treatment room. Other support equipment, such as viewing systems, area monitors, and intercoms, must have been separately installed and available for use in the treatment room prior to commencing treatment of patients. Class 1 (byproduct material, trained personnel, and facility) mobile service providers are authorized to provide the device / facility (e.g., in-van use) and the treatment of(or administration to) patients at the client site. Class I mobile service providers are responsible for all aspects of byproduct material use and authorized patient trectments (or administrations).
- . Class 2 (byproduct material and traineu personnel) mobile service providers are authorized to provide the transportation to and use of the byproduct material within the client's facility. Class 2 mobile service providers are also responsible for all aspects of byproduct material use and authorized patient treatments (or administrations).
f f Class 3 (byproduct material only) mobile service providers are authorized to provide the byproduct material to a client site so that the client can perform treatments (or administrations). Under this class of service, the mobile service provider authorization is limited to the possession, limited servicing, and transport of the byproduct material and associated equipment. The client will need a separate authorization (license) to perform patient treatments (or administrations) with the byproduct material and the client will be responsible for all aspects of byproduct material use and patient treatment (s) (or administrations), as applicable, including, but not limited to, dose calibrator measurements, sealed source calibration, remote afterloader device function checks and all safety system checks. f Draft NUREG - 1556, Vol. 9 8 78 I I
l CONTENTS OF AN APPLICATION A mobile service provider may apply for one or multiple classes of service. However, a single client site may be authorized for only a single class of service. This restriction on client sites is intended to eliminate possible confusion that may arise over responsibilities for use and control of byproduct materials that could arise c' client sites authorized for multiple classes of service. For Class 1 and Class 2, mobile medical service licensees must ensure that patients treated meet the release criteria in 10 CFR 35.75. Note: NRC licensees requesting reciprocity for activities conducted in Agreement States are subject to the general license provisions of equivalent Agreement State regulations as described in 10 CFR 150.20. This general license authorizes persons holding a specific license from the NRC to conduct the same activity in Agreement States if the specific license issued by the NRC does not limit the authorized activity to specific locations or installations. NRC licensees who wish to conduct operations at temporary job sites in an Agreement State should contact that State's radiation control program office for information about State regulations. To ensure compliance with Agreement State reciprocity requirements, a licensee shall request authorization l well in advance of scheduled work. In addition to the requirements specified in 10 CFR 150.20, applicants performing procedures through a mobile service should contact the applicable State regulatory agency to determine if mobile services are allowed within the State through reciprocity and to clarify requirements associated with the authorization to practice medicine within the State jurisdiction. Response from Applicant: Refer to Appendix V for the type of additional information to provide. 8.43 ITEM 10: TRANSPORTATION Regulations: 10 CFR 20.1101,10 CFR 30.41,10 CFR 30.51,10 CFR 71.5,10 CFR 71.12, l 10 CFR 71.13,10 CFR 71.14,10 CFR 71.37,10 CFR 71.38, Subpart H of 10 CFR Part 71, 49 CFR Parts 171-178. i j Criteria: Applicarits should develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and DOT regulations. Discussion: The general license in 10 CFR 71.12 provides the authorization used by most licensees to transport, or offer for transport, packages of radioactive material and specifies certain conditions. Most packages oflicensed material for medical use contain quantities of radioactive material that require use of Type A packages. Some medical use licensees (e.g., teletherapy or gamma stereotactic radiosurgery) may need to ship licensed material in Type B packages. Before offering a Type B package for shipment, the 8-79 Drat 1 NUREG - 1556, Vol. 9 i
CONTENTS OF AN APPLICATION licensee needs to be registered as a user of the package and have an NRC-approved quality assurance (QA) plan, two of the requirements under the 10 CFR 71.12 general license. For information about QA plans, see Revision 1 ofRG 7.10," Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986. For further information about registering as a user of a package or submitting a QA program for review, contact NRC's Spent Fuel Pmject Office by calling NRC's toll-free number 800-368-5642 and asking for extension 415-8500. For information about associated fees, contact NRC's OCFO by calling NRC's foll-free number 800-368-5642 and asking for extension 415-7544. Some medical use licensees that ship radioactive material have chosen to transfer possession of radioactive materials to a manufacturer (or servic_e licensee) with an NRC or Agreement State license who then acts as the shipper. The manufacturer (or service licensee), who is subject to the provisions of 10 CFR 71.12 or 10 CFR 71.14, as appropriate, 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 at temporaryjob sites (e.g., at the licensee's facilities) Actually takes possession of the licensed material under its license ' Additionally, the licensee should verify and the manufacturer (or service licensee) must. Use an approved Type B package
. Register with the NRC as a user of the Type B package
. Possess an NRC-approved QA plan.
For each shipment, it must be clear who possesses the licensed material and is responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations. During an inspection, 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. Appendix W lists major DOT regulations that apply to medical licensees. { 1 Response from Applicant: No response is needed from applicants during the licensing phase. However, before offering a Type B package for shipment, a licensee needs to have registered with NRC as a user of the package and obtained NRC's approval ofits QA program. l Transportation issues will be reviewed during inspection. l Draft NUREG 1556, Vol. 9 8-80 t
CONTENTS OF AN APPLICATION
References:
"A Review of Department of Transportation Regulations for Transportation of Radioactive Materials (1983 revision)" can be obtained be calling DOT's Office of Hazardous Material Initiatives and Training at (202) 366-4425. See the Notice of Availability on inside front cover of this draft report to obtain a copy of the Memorandum of Understanding with DOT on the Transportation of Radioactive Material, signed June 6,1979, and Revision 1 of RG 7.10
" Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986.
8.44 ITEM 11: WASTE MANAGEMENT Regulations: 10 CFR 20.1101,10 CFR 20.2001-2007,10 CFR 20.2102,10 CFR 20.2108, j 10 CFR 30.41,10 CFR 30.51,10 CFR 35.92,10 CFR 35.2092,10 CFR 71.5. - Criteria: Licensed materials must be disposed ofin accordance with NRC requirements by: transfer to an authorized recipient; DIS; release to the environment; or treatment or disposal of the licensed material as described in 10 CFR 20.2004. Appropriate records must be maintained. Discussion: Licensees must develop and implement procedures for waste disposal oflicensed material in accordance with 10 CFR 20.1101. Appendix X contains model procedures for DIS and generator or other licensed material return. In 10 CFR 20.2001, NRC requires that licensees dispose oflicensed material by specific means. In 10 CFR 20.2006, NRC requires that for licensed material transferred to a land disposal facility, the licensee must comply with the specific requirements in Appendix F to 10 CFR Part 20, i.e., manifest, c; certification, and control and tracking. In 10 CFR 35.92, NRC specifies the requirements for handling of waste by DIS. In 10 CFR 71.5, NRC requires that licensees who transport licensed material or offer it for transport, comply with the regulations of DOT in 49 CFR Parts 170-189. Applicants shall address the following items (as applicable): Except fer material suitable for DIS and some animal carcasses, solids nIust be transferre an authorized recipient licensed to receive such waste in accordance with 10 CFR 20.2006 or ! in applicable regulations in 10 CFR Parts 30,40,60,61,70, or 72. Follow the packaging instructions you received from the transfer agent and the burial site operator. For your record of disposal, keep the consignment sheet that the transfer agent gave you. l . When setting up a prograni for DIS, applicants / licensees sh<;; id consider short-term and long-i term storage. Long-term storage should be designed to allow for segregation of wastes with ! different half-lives (e.g., the use of multiple shielded containers). Containers should have shielded covers to maintain occupational exposure at ALARA levels. Storage areas must be in a secure location. l l l 8-81 Draft NUREG - 1556, Vol. 9
l CONTENTS OF AN APPLICATION Waste from in vitro kits that are generally licensed pursuant to 31.11 is exempt from waste ! disposal regulations. Radioactive labels should be defaced or removed. There is no need to l- keep any record of release or make any measurement. l Applicants should describe the monitoring and control mechanisms in place to ensure compliance with the appropriate requirements regarding the release of material into air and water pursuant to 10 CFR 20.1302 and 20.2003, respectively.
- Regubtions for disposal in the sanitary sewer appear in paragraph 20.2003. Material must be readily sulaMa or dispersible in the water. There are monthly and annual limits based on the total sanitary sewerage release ofyour facility. (Excreta from patients undergoing medical diagnosis or therapy is exempt from all the above limitations; see paragraph 20,2003 (b)) Make a record of the date, radionuclides, estimated activity that was released, and of the sink or toilet at which the material was released.
l - 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. Make a record of the date, radionuclides, estimated activity that was l released and estimated concentration, and of the vent site at which the material was l
released.
- Liquid scintillation - counting media containing 1.85 kilo-Bq (0.05 Ci) per gram of H-3 or C-14 may be disposed of without regard to its radioactivity (Q 20.2005 (a) (1)). Make L a record of the date, radionuclides, estimated activity, calculated concentration, and how l the material was disposed.
i l . If applicants / licensees propose to treat or dispose oflicensed material by incineration, they must receive specific approval from the NRC. Contact your regional NRC office for guidance I on treatment or disposal ofmaterial by incineration in accordance with 10 CFR 20.2004. j
=
Applicants wishing to use waste volume reduction operations, e.g., compactors, must provide the below detailed description along with their response to Item 8.16 (Facility Diagram):
. A description of the compactor to demonstrate that it is designed to safely compact waste generated in your operations. (e.g., manufacturer's specifications, annotated sketches, I photographs) l -
The types, quantities, and concentrations of waste to be compacted - An analysis of the potential for airbome release of radioactive material during ! compaction activities
- The location of the compactors within the waste processing area (s), as well as a description of the ventilation and filtering systems used in conjunction with the compactors and procedures for monitoring filter blockage and exchange Methods used to monitor worker breathing zones and/or exhaust systems
- The types and frequencies of surveys that will be performed for contamination control in the compactor area !
Draft NUREG - 1556, Vol. 9 8-82
CONTENTS OF AN APPLICATION
- The instructions 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.
I General Guidance for Waste Disposal ;
- All radioactivity labels must be removed or obliterated from containers and packages prior to !
disposal in in house waste. If waste is compacted, all labels that are visible in the compacted mass must be defaced or removed. If waste is to be incinerated, labels may not need to be defaced. Contact your regional NRC office for guidance on this subject.
- Remind employees that nonradioactive waste such as leftover rergents, boxes, and packing material should not be mixed with radioactive waste.
. Occasionally monitor all procedures to ensure that radioactive waste is not created j unnecessarily. Review all new procedures to ensure that waste is handled in a manner ,
l consistent with established procedures.
. In all cases, cousider the impact of various available disposal routes. Consider occupational and public exposure to radiation, other hazards associated with the material and routes of disposal (e.g., toxicity, carcinogenicity, pathogenicity, flammability), and expense.
DlS For radionuclides of byproduct material with a half-life ofless than 120 days, licensees may dispose of waste in ordinary trash as long as they follow the below criteria:
. Hold byproduct material for decay until the waste cannot be distinguished from background level with a radiation detection survey meter set on its most sensitive scale and with no interposed shielding
- Remove or obliterate all radiation labels
. Maintain proper records.
Returning Sources Because of the nature of the material contained in brachytherapy, teletherapy, and GSR sources, j the only option for disposal is transfer to an authorized recipient as specified in 10 CFR 20.2001(a)(1). Authorized recipients are the original manufacturer of the sealed source, l a commercial firm licensed by the NRC or an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material (i.e., their license specifically authorizes the same radionuclides, form, and use). 8-83 Draft NUREG - 1556, Vol. 9 i
CONTENTS OF AN APPLICATION Before'transfe'rring radiedbtIve i$ateriskdli' censee must verify that the recipient is properly l authorized to receive the material using one of the methods described in 10 CFR 30.41. Additionally,10 CFR 71.5 requires that licensees who transport licensed material or offer it for transport, comply with the regulations of DOT in 49 CFR Parts 170-189. Records of the transfer must be maintained as required by 10 CFR 30.51.
,.,,)
x , , Licensees should promptly dispose of unused sealed sources to minimize potential problems of access by unauthorized individuals, use for inappropriate purposes, or improper disposal. Because of the difficulties and costs associated with disposal of scaled sources, applicants should preplan the disposal. Applicants may want to consider contractual arrangements with the source supplier as part of a purchase agreement. Response from Applicant: Provide the following: A statement that: "We have developed and will implement written waste disposal procedures for licensed material in accordance with' 10 CFR 20.1101, and that meet the requirements of the applicable section of Subpart K to 10 CFR Part 20 and 10 CFR 35.92." The next two items on NRC Form 313 are to be completed on the form itself. 8.45 ITEM 12: FEES On NRC Form 313, enter the appropriate fee categ'ory from 10 CFR 170.31 and the amount of the fee enclosed with the application. 8.46 ITEM 13: CERTIFICATION Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. These representatives must be authorized to make binding commitments and to sign official documents on behalfof the applicant. An application for licensing a private practice should be signed by a senior partner or the president. An application for licensing a medical institution (e.g., hospital, or medical center) must be signed by its chief executive officer (or delegate). The individual who signs the application should be identified by title of the office held. As discussed previously in " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection
~
program. NRC will retum all unsigned applications for proper signature. Note: Draft NUREG - l556, Vol.'9 8-8(
CONTENTS OF AN APPLICATION
- It is a criminal offense to make a willful false statement or representation on applications or l
correspondence (18 U.S.C.1001).
- When the application references commitments, those items become part of the licensing l conditions and regulatory requirements.
. It is a violation of 10 CFR 30.9 and 10 CFR 30.10 to make a false statement on an application.
Civil sanctions including revocation of the license and/or orders removing individuals from licensed activity may be taken. l l l i i q l l t I 8<85 Draft NUREG - 1556, Vol. 9
l 9 AMENDMENTS AND RENEWALS TO A LICENSE It is the licensee's obligation to keep the license current. If any of the information provided in the. original application is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its ~ expiration date, the licensee must submit an application for a license renewal at least 30~ days before the expiration date (10 CFR 2.109,10 CFR 30.36(a)). 10 CFR 35.13 describes activities that require a license amendment. These include the l following: !
- Receipt or use of byproduct material for a clinical procedure permitted by Part 35, but not l permitted by the license
. Permitting anyone to work as an AU, AMP, or ANP, unless the individual meets one of the l exceptions listed in 10 CFR 35.13(b) i Changing RSO
! . Ordering byproduct material in excess of the amount, or radionuclides or form different than currently authorized on the NRC license l
. Changing an area or address of use identified in the application or on the license.
l l
- Applications for license amendment, in addition to the following, must provide the appropriate l
fee. For renewal and amendment requests applicants must do the following:
. Be sure to use the most recent guidance in preparing an amendment or renewal request l . Submit in duplicate, either an NRC Form 313 or a letter requesting amendment or renewal l . Provide the license number l . For renewals, provide a complete and up-to-date application if many outdated documents are i referenced or there have been significant changes in regulatory requirements, NRC's guidance, the licensee's organization, or radiation protection program. Alternatively, describe clearly the exact nature of the changes, additions, and deletions.
l l Using the suggested wording of responses in this draft report will expedite NRC's review. t 9-1 Draft NUREG - 1556, Vol. 9
i l 10 TERMINATION OF ACTIVITIES l Regulations: 10 20.1401-1405,10 CFR 30.34(b),10 CFR 30.35(g),10 CFR 30.36(d) and (j), 10 CFR 30.51(f). Criteria: The licensee must do the following:
- Notify NRC, in writing, within 60 days, when its license has expired or a decision has been made to permanently cease licensed activities at the entire site regardless of contamination levels.
. Notify NRC, in writing, within 60 days, when principal activities have not been conducted for 24 months or a decision has been made to permanently cease licensed activities in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.
. Certify the disposition oflicensed materials by submission of NRC Form 314," Certificate of Disposition of Materials" or equivalent information.
. Before a license is terminated, send the records important to decommissioning (as required by 10 CFR 30.35(g)) to the appropriate NRC regional office. Iflicensed activities are transferred or assigned according to 10 CFR 30.34(b), transfer records important to decommissioning to the new licensee.
Discussion: Subpart E to 10 CFR Part 20 describes the radiological criteria for license l termination. A licensee's determination that a facility is not contaminated is subject to l verification by NRC inspection. l 1 For guidance on the disposition oflicensed material, see the section on " Waste Management." For guidance on decommissioning records, see the section on " Financial Assurance and Record Keeping for Decommissioning " Licensees should promptly dispose of unused licensed material to minimize potential problems l of access by unauthorized individuals, use for inappropriate purposes, or improper disposal. Response from Applic:.nt: The applicant is not required to submit a response to the NRC during the initial application. However, when the license expires or at the time the licensee ceases operations, then the applicant must perform decommissioning activities and submit NRC Form 314 or equivalent information.
Reference:
Copies of NRC Form 314, " Certificate of Disposition of Materials," are available , upon request from NRC's Regional or Field Offices; see Appendix Y. l l l l t 10-1 Draft NUREG - 1556, Vol. 9
Appendix A List of Documents Considered in Development of this Draft NUREG 9
APPENDIX A 1 1 List of Documents Considered in Development of this Draft NUREG This draft report incorporates and updates the guidance previously found in the Regulatory ) Guides (RG), Policy and Guidance Directives (P&GD), and Information Notices (IN) listed in Table A.I. When this draft report is issued in final form, the documents in Table A.1 will be l considered superseded and should not be used. Other references were also used in this draft report and are listed below. Document Title Date Identification RG 10.8, Revision 2 Guide for the Preparation of Applications for Medical Use 8/87 Programs l Appendix X to RG Guidance on Complying With New Part 20 Requirements 6/92 l 10.8, Revision 2 Draft RG DG-0009 Supplement to Regulatory Guide 10.8, Revision 2, Guide for the 3/97 Preparation of Applications for Medical Use Programs Draft RG FC 414-4 Guide for the Preparation of Applications for Licenses for 12/85 Medical Teletherapy Programs P&GD FC 87-2 Standard Review Plan (SRP) for License Applications for the 12/87 i Medical Use of Byproduct Material Supplement 1 TO Mobile Remote Afterloading Brachytherapy Licensing Module 5/97 l P&GD FC 86-4; Revision 1 - l P&GD FC 86-4, Information Required for Licensing Remote Afterloading 9/93 l Revision 1 Devices Addendum to Information Required for Licensing Remote Afterloading 7/95
-Revision 1 to P&GD Devices-Increased Source Possession Limits FC 86-4 l P&GD 3-15 Standard Review Plan for Review of Quality Management 6/95 l Programs RG 8.39 Release of Patients Administered Radioactive Materials 4/97 RG 8.33 Quality Management Program 10/91 P&GD 3-17 Review of Training and Experience Documentation Submitted by (previously 16) Proposed Physician User Applicants RG 8.23 Radiation Safety Surveys at Medical Institutions, Revision 1 1/81 A-1 Draft NUREG - 1556, Vol. 9
APPENDIX A Additionally, the below references were used. References Title 10, Code of Federal Regulations
- 1. Part 2 - Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders
- 2. Part 19 - Notices, Instructions, and Reports to Workers; Inspections
- 3. Part 20 - Standards for Protection Against Radiation
- 4. Part 21 - Reporting of Defects and Noncompliance
- 5. Part 30 - Rules of General Applicability to Domestic Licensing of Byproduct Material
- 6. Part 31 - General Domestic Licenses for Byproduct Material
- 7. Part 32 - Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
- 8. Part 33 - Specific Domestic Licenses of Broad Scope for Byproduct Material
- 9. Part 35 - Medical Use of Byproduct Material
- 10. Part 40 - Domestic Licensing of Source Material
- 11. Part 70 - Domestic Licensirg of Special Nuclear Material
- 12. Part 71 - Packaging and Transportation of Radioactive Material
- 13. Part 150 - Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274
- 14. Part 170 - Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of1954, As Amended
- 15. Part 171 - Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and l
Materials Licenses, including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Govemment Agencies Licensed by NRC l Draft NUREG - 1556, Vol. 9 A-2 l
l l l APPENDIX A l Title 49, Code of Federal Regulations )
- 1. Part 172 - Hazardous Materials Table, Special Provisions, Hazardous Materials Communications, Emergency Response Information, and Training Requirements
- 2. Part 173 - Shippers - General Requirements for Shipments and Packages
- 3. Part 177 - Carriage by Public Highway
- 4. Part 178 - Specifications for Packagings NRC Regulatory Guides (RG)
- 1. RG 1.86 - Termination of Operating Licenses for Nuclear Reactors, June 1974
- 2. RG 3.66 - Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72, June 1990
- 3. RG 7.10, Revision 1 - Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material, June 1986 ;
- 4. RG 8.4 - Direct-Reading and Indirect-Reading Pocket Dosimeters, February 1973
- 5. RG 8.7 -Instructions for Recording and Reporting Occupational Radiation Exposure Data, Revision 1, June 1992
- 6. RG 8.9 - Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program, Revision 1, June 1993
- 7. RG 8.10 - Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable, Revision 1-B, September 1975
- 8. RG 8.13 (Draft) - Instruction Concerning Prenatal Radiation Exposure, October 1994
- 9. RG 8.18 - Information Relevant to Ensuring that Occupational Radiation Exposures at Medical Institutions Will Be As Low As Reasonably Achievable, Revision 1, October 1982
- 10. RG 8.20 - Applications of Bioassay for I-125 and I-131, Revision 1, September 1979
- 11. RG 8.21 - Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants A-3 Draft NUREG - 1556, Vol. 9
APPENDIX A
- 12. RG 8.23 - Radiation Safety Surveys at Medical Institutions
- 13. RG 8.25 - Air Sampling in the Workplace, Revision 1, June 1992.
- 14. RG 8.29 - Instruction Concerning Risks from Occupational Radiation Exposure, Revision 1, February 1996
- 15. RG 8.34 - Monitoring Criteria and Methods to Calculate Occupational Radiation Doses, July 1992.
- 16. RG 8.36 - Radiation Dose to the Embryo / Fetus, July 1992
- 17. RG 10.2 - Guidance to Academic Institutions Applying for Specific Byproduct Material Licenses of Limited Scope, Revision 1, December 1976
- 18. RG 10.5 (Draft)- Applications for Type A Licenses of Broad Scope, October 1994
- 19. RG 10.8,1997 - Revision (Draft NUREG 1569 - never published), Program-Specific Guidance for Medical Use Licensees
- 20. RG FC 412-4 (Draft) - Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services, June 1985
- 21. RG FC 413-4 (Draft) - Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitering Instruments, June 1985 NRC Information Notices (IN) 1
- 1. IN 89-25, Revision 1 - Unauthorized Transfer of Ownership or Control of Licensed Activities
- 2. IN 94-70 -Issues Associated with Use of Strontium-89 and Other Beta Emitting Radiopharmacevticals
- 3. IN 96 Suggested Guidance Relating to Development and Implementation of Corrective Action l
- 4. IN 97 Control of Licensed Material during Reorganizations, Employee-Management i Disagreements, and Financial Crises l 4
Draft NUREG - 1556, Vol. 9 'A4
=
l APPENDIX A l NRC Policy and Guidance Directives (P&GD)
- 1. P&GD FC 90-2, Revision 1 - Standard Review Plan for Evaluating Compliance with Decommissioning Requirements, April 1991 I
NRC NUREGs
- 1. NUREG-0267, Revision 1 - Principles and Practices for Keeping Occupational Radiation J Exposures at Medical Institutions As Low As Reasonably Achievable, October 1982
- 2. NUREG-1134 - Radiation Protection Training for Personnel Employed in Medical J
Facilities, May 1985
- 3. NUREG-1492 - Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material, February 1997
- 4. NUREG-1516 - Effective Management of Radioactive Materials Safety Programs at Medical Facilities, May 1997
- 5. NUREG-1539 - Methodology and Findings of the NRC's Materials Licensing Process Redesign, April 1996 i
- 6. NUREG-1541 (Draft) - Process and Design for Consolidating and Updating Materials Licensing Guidance, April 1996 I
- 7. NUREG-1556, Volume 3 (Draft) - Consolidated Guidance about Materials Licensees:
Applications for Sealed Source and Device Evaluation and Registration, September 1997 l 8. NUREG-1600 - General Statement of Policy and Procedures for NRC Enforcement Actions, June 1995 and Compilation of NRC Enforcement Policy as of September 10,1997
- 9. NUREG/CR-4444 - Radiation Safety Issues Related to Radiolabeled Antibodies,1991 j l 10. NUREG/CR-4884 - Interpretation of Bioassay Measurement, July 1987
- 11. NUREG/CR-6323 - Relative Risk Analysis in Regulating the Use of Radiation-Emitting Medical Devices: A Preliminary Application, September 1995
_12. : NUREG/CR-6324 - Quality Assurance for Gamma Knives, September 1995 A-5 Draft NUREG - 1556, Vol. 9 { I
APPENDIX A National Council on Radiation Protection and Measurements (NCRP) Publications
- 1. NCRP Report No. 30 - Safe Handling of Radioactive Materials,1989
- 2. NCRP Report No. 37 - Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides,1970
- 3. NCRP Report No. 40 - Protection Against Radiation from Brachytherapy Sources,1972
- 4. NCRP Report No. 49 - Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies up to 10 MeV,1976
- 5. NCRP Report No. 57 - Instrumentation and Monitoring Methods for Radiation Protection, 1978
- 6. NCRP Report No. 58 - A Handbook of Radioactivity Measurement Procedures, Second Edition,1985
- 7. 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. NCRP Report No. 71 - Operational Radiation Safety - Training,1983
- 9. NCRP Report No. 87 - Use of Bioassay Procedures for Assessment ofInternal Radionuclides Deposition, February 1987
- 10. 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
- 11. NCRP Report No.105 - Radiation Protection for Medical and Allied Health Personnel, 1989
- 12. NCRP Report No.107 - Implementation of the Principle of As Low As Reasonably Achievable (ALARA) for Medical and Dental Personnel,1990
- 13. NCRP Commentary No.11 - Dose Limits for Individuals Who Receive Exposure from i Radionuclides Therapy Patients, February 1995 l l
I i l Draft NUREG - 1556, Vol. 9 A-6
APPENDIX A International Commission on Radiological Protection (ICRP) Publications
- 1. ICRP Report No. 26 - Recommendations of the International Commission on Radiological Protection,1977
- 2. ICRP Report No. 30 - Limits for Intakes of Radionuclides by Workers,1978
- 3. ICRP Report No. 35 - General Principles of Monitoring for Radiation Protection of Workers,1982
- 4. ICRP Publication No. 53 - Radiation Dose, to Patients from Radiopharmaceuticals,1987
- 5. ICRP Publication 54 - Individual Monitoring for Intake of Radionuclides by Workers:
Design and Interpretation,1987 ANSI Standards
- 1. ANSI N13.4-1971 (0.1983) - Specification of Portable X- or Gamma Radiation Survey Instruments ANSI N13.5-1972 (R1989)- Performance and Specifications for Direct Reading and 2.
Indirect Re ding Pocket Dosimeters for X- and Gamma Radiation
- 3. ANSI N13.6-1966 (R1989) - Practice for Occupational Radiation Exposure Records Systems
- 4. ANSI N14.5-1987 - Leakage Tests on Packages for Shipment of Radioactive Materials
- 5. ANSI N42.12-1994 - Calibration and Usage of Sodium Iodide Detector Systems
- 6. ANSI N42.13-1986 (R1993) - Calibration and Usage of Dose Calibrator Ionization Chambers for the Assay of Radionuclides
- 7. ANSI N42.15-1990 - Performance Verification of Liquid Scintillation Counting Systems
- 8. ANSI N42.17A-1989 - Performance Specifications for Health Physics Instrumentation-l Portable Instrumentation for Use in Normal Environmental Conditions I
- 9. ANSI N322 - Inspection and Test Specifications for Direct and Indirect Reading Quartz Fiber Pocket Dosimeters A-7 Draft NUREG - 1556, Vol. 9
APPENDIX A
- 10. ANSI N323A-1997 - Radiation Protection Instrumentation Test and Calibration, Portable l Survey Instruments
- 11. ANSI N449.1-1978 (R1984) - Procedures for Periodic Inspection of Cobalt-60 and Cesium-137 Teletherapy Equipment American Association of Physicists in Medicine (AAPM) Reports
- 1. AAPM Task Group No. 21 - A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams,1984
- 2. AAPM Radiation Therapy Committee Task Group No. 40 - Comprehensive QA for Radiation Oncology,1994
- 3. AAPM Radiation Therapy Committee Task Group No. 56 - Code of Practice for Brachytherapy Physics,1998
- 4. AAPM Radiation Therapy Committee Task Group No. 59 - HDR Treatment Delivery Safety,1997 Draft
- 5. AAPM Report No. 41 - Remote Afterloading Technology,1993
- 6. AAPM Report No. 54 - Stereotactic Radiosurgery,1995 Other Technical Publications
- 1. International Commission on Radiation Units and Measurements (ICRU)," Certification of ,
Standardized Radioactive Sources," Report No. 12,1968
- 2. U.S. Department of Health, Education, and Welfare, " Radiological Health Handbook,"
1970
- 3. R.C.T. Buchanan and J.M. Brindle,"Radioiodine Therapy to Out-patients - The Contamination Hazard," British Journal ofRadiology, Volume 43,1970
- 4. International Atomic Energy Agency (IAEA)," Monitoring of Radioactive Contamination on Surfaces," Technical Report Series No. 120,1970
- 5. IAEA, " Handbook on Calibration of Radiation Protection Monitoring Instruments,"
Technical Report Series No. 133,1971 Draft NUREG 1556, Vol. 9 A-8
APPENDIX A
- 6. A.P. Jacobson, P.A. Plato, and D. Toeroek, " Contamination of the Home Environment by Patients Treated with Iodine-131," American Journal of Public Health, Volume 68, Number 3,1978 -
' 7. A. Brodsky, "Resuspension Factors and Probabilities ofIntake of Material in Process (or 'Is 10-6 a Magic Number in Health Physics?)," Health Physics, Volume 39, Number 6,1980
- 8. Bureau of Radiological Health, " Radiation Safety in Nuclear Medicine: A Practical Guide," Department of Health and Human Services (HHS) Publication FDA 82-8180, November 1981
- 9. Center for Devices and Radiological Health, " Recommendations for Quality Assurance Programs in Nuclear Medicine Facilities," HHS Publication FDA 85-8227, October 1984
- 10. S. R. Jones, " Derivation and Validation of a Urinary Excretion Function for Plutonium Applicable over Ten Years Post Intake," Radiation Protection Dosimetry, Volume 11, No.
1,1985
- 11. " Guidelines for Patients Receiving Radioiodine Treatment," Society ofNuclear Medicine, 1987
- 12. J. R. Johnson and D. W. Dunford, "GENMOD--A Program for Intemal Dosimetry Calculations," AECL-9434, Chalk River Nuclear Laboratories, Chalk River, Ontario,1987 l
- 43. K.F. Eckerman, A.B. Wolbarst, and A.C.B. Richardson," Federal Guidance Report No. I1, j Limiting Values of Radionuclides Intake and Air Concentration and Dose Conversion l
~~.Lactgfor Inhalation, Submersion, and Ingestion," Report No. EPA-520/1-88-020,1988
~~- --
- 14. K. W. Skrable et al., " Intake RetentioM6iiohrand-Their_
d Applications to Bioassay and
- the Estimation ofInternal Radiation Doses," Health Physics JournTVoTGmr$5rNc/>~
1988 ~
- 15. A.S. Meigooni, S. Sabnis, R. Nath," Dosimetry of Palladium-103 Brachytherapy Sources for Permanent Implants," Endocurietherapy Hyperthermic Oncology, Volume 6, April 1990
- 16. R. Nath, A.S. Meigooni, and J.A. Meli," Dosimetry on Transverse Axes of 125I and 192Ir l Interstitial Brachytherapy Sources," Medical Physics, Volume 17, Number 6, l November / December 1990 j
- 17. M.G. Stabin et al., " Radiation Dosimetry for the Adult Female and Fetus from Iodine-131 Administration in Hyperthyroidism," Journal ofNuclear Medicine, Volume 32, Number 5, May 1991 A-9 Draft NUREG - 1556, Vol. 9
APPENDIX A
- 18. P. Early, D. B. Sodee," Principles and Practice of Nuclear Medicine," 2nd ed.,1995
- 19. M. Stabin, " Internal Dosimetry in Pediatric Nuclear Medicine," Pediatric Nuclear Medicine,1995
- 20. "Intravascular Brachytherapy - Guidance for Data to be Submitted to the Food and Drug Administration In Support ofInvestigational Device Exemption (IDE) Applications," Draft Version 1.3,1996
- 21. R.O. Dunkelberger, II, "Which Probe Should I Use," Baltimore-Washington Health Physics Society Newsletter N %,
'~~,%
' - ~ ~ -.. _ ,~ ~ ~ ~
~ ~ ~ ~ ,,,
1 l l Draft NUREG - 1556, Vol. 9 A-10
1 1 l l 1 1 I i 1 Appendix B NRC Form 313 1 N%
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I A-w sY OMS: NO,31e841.J .- ._ nittees NRC FORM 313 U. S. NUCLEAR REGULATORY COMMISSION (fr1997) Eelsneled Imlen por reaparme to compir weh tus tearmahan ~,e-em 10 CFA 30,32,33 request T ha as Simmniel of we = Prim ~i e nacasemy to elstermre viel 34,36,36,3e end 40 tie appimeni e qualined and fiel -w r aa procmAses samt to proled em pielm honah and selsly Forward comments regenleig tnaden estynets to to Hormelen and Reconis Management Brenet (T4 F33), U.S lAximar l APPLICATION FOR MATERIAL LICENSE $"*'a7c,q";'T, g ooc,27 ynd m y g ,, Weehenglon, DC 20603 NRC may not c slucl or eponsor, and a person h not reWred to respond 10, en WormacJri uis~*m unless A esplays a curently veed OM8 control number. INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING ; APPLICATION. SEND TWO COPlES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW. APPUCATION POR DISTRIBUTION OF EXEISPT PftODUCTS FILE APPUCATIONS WITH: IF YOU ARE LOCATED M: DMSiON OF INDUSTRML AND MEDICAL NUCLEAR SAFETY ILuleOIS, INDIAllA, IOWA, MOHIGAN, MIMllESOTA, MISSOUfu, OHIO, Oft WISCONSON, 1 OFFCE OF NUCEAR MATERMLS SAFETY AND SAFEGUARDS SEND APPUCATIODIS 70: U S NUCLEAR REGULATORY COMMISSON WASHWGT ON, DC 20555 4001 MATERMLS UCENSWG SECTON i ALL OTHER PERSONS FILE APPUCATIONS AS FOLLOWS: 801 WARRENVILLE RD IF YOU ARE LOCATED IN: USLE, IL 00532 4351 CONNECTOUT, DELAWARE, DISTRICT OF COLUMGM, MAINE, MARYLAND, ALASKA, AREZONA, ARKANSAS, CAUPORNIA COLORADO, HAWAN, IDAHO, KANSAS, j MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, NEW YORK, PENNSYLVANIA, LOUIStANA, ISONTANA, IIESRASKA, NEVADA, NEW ISEXICO, NORTH DAKOT A, RHODE ISLANO, OR VERIBONT, SEND MPUCATIONS TO: OKLAHOG8A. OftEGON, PACIFIC TRUST TERRITOf4ES, SOUTH DAKOTA, TEXAS, UTAH, WASHINGTON, OR WYOMING, SEND APPUCATIONS TO: LICENSING ASSISTANT SECTON fra; LEAR MATERIALS SAFEiY BRANCH NUCLEAR MATERMLS LEENSING SECTON h8 NUCLEAR REGULATORY COMMIS$0N, REGION i U 8. NUCLEAR REGULATORY COMMISSION, REGION N 611 RYAN PLAZA DRfVE, SulTE 400 05 ALLENDALE ROAD KMG OF PRUSSIA, PA 1940lL1415 ARLNGTON, TX 78011 4 064 a amm FLOfuOA, GEORGIA, KENTUCKY,IIISSISSIPPI, leORTH CAROUNA, PUERTO 141C0,9001M CAROUNA TENNESSEE, VIRGINIA, VlftGIN ISLANDS, OR WEST VIRGMIA, j SEND APPUCATIONS TO: i ATLANTA F EDERAL CENTER U S. NUCLEMt REGULATORY COMMISSION, REGION ll 81 FORSTFH STREET, S W., SUITE 23T85 ATLANTA, GEORGM 30303-3415 PERSONS LOCATED M AGREEMENT STATES SEND APPUCATIONS TO THE U,$. NUCLEAR REGULATORY COutBISSION ONLY IF THEY WlSH TO POSSESS ANO USE UCENSED MATEfilAL IN STATES SUSJECT TO U.S. NUCLEAR REOULATORY COtfutSSION JulWSDICTIONS, 1 THIS IS AN APPUCATION FOR (Check appropnose dem) 2. NAME AND MAluNG ADDRESS OF APPUCANT (incfutes 2)p code) A NEW UCENSE 8- AMENDMENT TO UCENSE NUMBER C. RENEWAL OF UCENSE NUMBER
- 3. ADORESSES)WHERE t CENSED MATERIAL WILL BE USED OR POSSESSED 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPUCATON TELEPHONE NUMBER SUBMIT ITEMS S THROUGH 11 ON 0-112 X 11" PAPER THE TYPE AND SCOPE OF HFORMATON TO BE PROVIDED 13 DESCRIBEQ IN THE UCENSE APPUCATON GUIDE.
- 5. RADIOACTNE MATERML.
e Element and mese number, b. crammel and/or physcal form, and c. monumum amount 6 PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED. whats we to possessed at any one tone. 7, INDMDUAL(S) RESPONSIBLE FOR RADMTION SAFETY DROGRAM AND THEIR
- 8. TRAINWG FOR INDMDUALS WORKMG IN OR FREQUENTING RESTRCTED AREAS.
TT,AINING EXPERIENCE. 9 FACOTIES AND EQUIPMENT. 10. RADMTON SAFETY PROGRAM 12 UCENSEE FEE 5 (See f 0 CFR 170 engt Seceon 170.31) "
- 11. WASTE MANAGEMENT. IAMOUNT " '
gpi-FEE CATEGOR( lENCtp* W S 13 CE%T FICATON (Muel be compefed Dr appecent) THE APPUCANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATO*'C '" W4st M THIS APPUCATON ARE SINDING UPON THE APPUCANT . THE APPUCANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF M JhuCANT, NAMED IN ITEM 2, CERTIFY THAT THIS APPLICATON 83 PREPARED IN CONFORMITY WITH TITLE 10. CODE OF FEDERAL REGULATIONS, " PARTS *::iE3i 34,35,36,39 AND 40, AND THAT ALL MFORMATON CONTAMED HEREIN IS TRUE AND COR*,f CT TO THE SEST OF THEIR KNOWLEDGEAID PFLf.7. WARNWG 18 U $ C. SECTION ?"Mi UFJUNE 25,1946 82 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO _ ANY DFpeCG Vet AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION SIGNATURE DATE CEFsTlFYING OFFICER - TYPED /PRWTED NAME AND TITLE I FOR NRC USE ONLY TYPE OF FEE FEE LOG FEE CATEGortY AMOUNT RECEIVED CHECit NUMSER COMMENTS APPROVED 9y DATE PRINTED ON RECYCLED PAPER NRC FORM 313 (51997)
. t i
l t j Appendix C l License Application Checklist and l Sample Licenses l l
APPEND!X C License Application Checklist and Sample Licenses The instructions on Table C.1, the Applicability Table, may be followed to determine whether the information must be provided or if"NA" may be the response to each item that follows. To determine those items to which you must respond, " highlight" the columns imder the categories of materials you requested in item 5. If any "Y" beside an item is highlighted, you must provide detailed information in response to the item. If the letters "NA" (not applicable) ' are highlighted, you may respond "NA" on your application. If any "N" beside an item is highlighted, no information in response is required; however the NRC regulations that apply to 1 the given category apply to your type oflicense. If any "P" beside an item is highlighted, you must provide a commitment to develop and implement a procedure in response to the item. Note that some modules have additional item numbers that may need to be addressed. 1 In addition, sample licenses are included that may provide guidance on the particular type of medical use you are requesting. Table C.1 Applicability Table i Item # - Tople - 35.100/200 35.300 35,400 35.500 35.600 35.1000 APP l N/A Unsealed Byproduct Material- Y Low Dose N/A: Unsealed Byproduct Matenal- Y. - _ , l High Dose N/A Manual Brachytherapy Y N/A Sealed Sources for Diagnosis : Y N/A Teletherapy Devices Y N'A - Remote AAerloader Devices - Y N/A Gamma Stereotactic Y Radiosurgery Devices l N/A Emerging Technologies Y l l 8.6 Financial Assurance Y Y Y Y Y Y E Determination
. 8.7 ' Sealed Source Registry Ni N N' N N N ;
8.10 Radiation Safety Officer Y Y Y Y Y Y F.G 8.11 Authorized User Training and Y Y Y' Y Y Y G Experience C-1 DraA NUREG - 1556, Vol. 9 m
v APPENDIX C Item # Topic 35.100/200 35.300 35.400 35.500 35.600 35.1000 APP 8.12 Authorized Nuclear Y Y N/A N/A N/A Y G Pharmacists Training and
~
Experience j l N/A N/A Y N/A Y Y G ' 8.13 Authorized Medical Physicist Training and Experience 8.14 Training Program N N N N N N H 8.16 Facility Diagram and Y Y Y Y Y Y Equipment i 8.17 Radiation Monitoring P P P N P P I instrument Calibration 8.18 Dose Calibrator Calibration P P N/A N/A N/A P J 8.19 Dosimetry Equipment and N/A N/A P N/A P P Therapy Scaled Source Calibration 8.20 Other Equipment and Facilities Y Y Y Y Y Y 8.22 Audit Program N N N N N N K 8.23 Occupational Dose P P P P P P L 8.24 Public Dose N N N N N N M 8.25 Minimization of Contamination Y Y Y Y Y Y 8.26 Operating and Emergency N N N N N N N Procedures 8.28 Ordering and Receiving N N N N N N O 8.29 Opening Packages P P P P P P P 8.30 Scaled Source Inventory N N N N N N 8.31 Use Records N N N N N N 8.32 Leak Tests N- N N N N N Q 8.33 Area Surveys P P P P P P R 8.34 Written Directive Procedures - N/A P P N/A P P S 8.35 Safe Use of Unsealed Licensed P P N/A N/A N/A P T Material 8.36 Maintenanceof Therapy N/A N/A N/A N/A Y Y Devices Containing Scaled Sources 8.37 Spill Procedures P P N/A N/A N/A P N Draft NUREG - 1556, Vol. 9 C-2
i APPENDIX C I i Item # Topie 35.100/200 35.300 35.400 35.500 35.600 35.1000 APP l l 8.38 Emergency Response for N/A N/A P P P P N Scaled Sources or Devices 8.39 Patient or Human Research P P P h/A N P U ! Subject Release l 8.40 Safety Precautions for Therapy N/A N N N/A N/A* N l Treatments where Patients are i llospitalized 8.41 Safety and Device Calibration N/A N/A N/A P P P l ! Procedures 8.42 Mobile Use of Radionuclides - Y Y Y Y Y Y V 8.43 Transportation N N N N N N W ( 1 8.44 Waste Management P P P P P P X !
- N for remote afterloaders l
l 1 l C-3 Draft NUREG - 1556, Vol. 9
NRC FOR2 374 U.s. NUCLEAR RE7uLAToRY Cot *CISSloN PAGE 1 OF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations h:ritofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and specla! nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all itpplicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified beloW. Licensee
- 1. Sample Gamma Knife 3. License Number 99-12345-01
- 2. 100 Main Street 4. Expiration D ay 31,2002 King of Prussia, Pennsylvania 5. Docket 0 21
, gQ { { @ eWenc
- 6. Byproduct, source, and/or y g\Chbmical and/or ph
~ form aximum amount that licensee special nuclear material "Y may possess at any one time p under this license A. Cobalt 60 A. Sealed C9
~'
TA. Not to exceed curies
!q (M o. J- per source and A g(sQ.sSeri 4 *) m curies total
- 9. Authorized Use T g
1> s
,t M; O A. One source to be used in
~
b
' A ..1 Stereotactic Radiosurgery device for therapeutic treatnMt of hu '
in its shipping container?as necessary for source replacement. n % ' , , . Tiih7 J[ @
,E s
"'t / CO sCONDITIONS.MW*V re
- 10. Licensed material may o -
e%@'s licensee ficilitisiilocated at 100 Main Street, King of Pr 5 hO' Pennsylvania. o 9?
& ")
11.A. Licensed material shall be'used by,or under t e supervision of a team of at least three individuals, to include the following: a Neurosurgeon, a. Radiation Therapist, and a Medical Physicist, each of whom is specifically named on the license. 4 " B. Radiation Therapists for this license are John Smith, M.D. and Jessica Water, M.D. C. Neurosurgeon for this license are Richard Adams, M.D. and Martin Rossi, M.D. D. The Medical Physicists for this license are Kimberly Therapy, Ph.D. and Ronato Stereo, M.S.
- 12. The Radiation Safety Officer for this license is Kimberly Therapy, Ph.D.
- 13. The licensee is authorized to transport licensed material only in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."
NUREG - 1556, Vol. 9 C-4
NRC FoR3 374A U.s. NUCLEAR RE7ULAToRY CoMMisslON PAGE 1 OF 1 PAGF.S License Number 99-12345-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-54321
- 14. Except as specifically provided otherwise, in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including ,
eny enclosures, listed below, except for minor changes in the medi radiation safety procedures as provided in 10 CFR 35.26. The U.S. Nuclear Regulatory Commi pulations shall govern unless tha statements, representations, and procedures in the, licensee o nd correspondence are j more restrictive than the regulations. g fx M M h G A. r& Application dated December-15,1996 si. I B. Letter dated March 4,1997 # ' C. Letter dated May 8,1997
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FOR THE U.S. NUCLEAR REGULATORY COMMISSION i Data: By: Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 C-5 NUREG - 1556, Vol. 9
NRC FORM 374 u.s. NUCLEAR REGULATORY Co% Mission PAGE 1 oF 5 PAGE@ MATERIALS LICENSE Pursuint to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Fedtral Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations h:rztofors made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, sourco, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to d liver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be dremed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicabli rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specificci b: low. Licensee
- 1. Sample Medical Institution Limited 3. License Number 99-02120-01
- 2. 1234 Main Street 4. Expiration D arch 31,2009 Anytown, Pennsylvania 02120 5. Docket t 20 g hR l l $F}efe[en
- 6. Byproduct, source, and/or aximum amount that licensee special nuclear material yghChemical and/or ph " I forrn 4 may possess at any one time As under this license A. Any byproduct materlai A. Any IA. As needed identified in 10 CFR 35.100 gg c- fM fy /--
B.
~~
Any byproduct mate' rial r.. f ;,3
'neratis
() (B.. BO ^*""d'd
!dentified in l- S i )<q 10 CFR 35.200 g) -
C. Any byproduct material ,t!t '- Cs. 300 millicuries
)J'f' .!'.
identified in ! i [ fi E / "/ N 10 CFR 35.300 4l!E"S D. Any byproduct materi - Seal 5cis$ .ources/Q \ D. 500 millicuries identified in 10 CFR 35.400 Y (MantW$rer No. xxx, N Model Bio, yyy) v,, o E. Any byproduct material E.T Saaled souro'es T E. Not to exceed 0.5 curies identified in (Manufacturer No. xxx, per source and 1 curie 10 CFR 35.500 Model No. yyy) total F. Any byproduct material F. Prepackaged Kits F. 50 millicuries identified in 10 CFR 31.11 G. Cesium-137 G. Sealed source G. 200 millicuries (Manufacturer No. aaa, Model No, bbb) H. Americium-241 H. Sealed sources H. Not to exceed (Manufacturer no. zzz, millicuries per Model No ccc) source and millicuries total
- 1. Depleted Uranium 1. Metal I. 99 kilograms i NUREG - 1556, Vol. 9 C-6
NRC FoR:3 374A u.s. NUCLEAR REoVLAToRY Commission PAGE.,l_OF 1 PAGES License Number 99-02120-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02120 Note: Insert total possession limit in items 8.C, D, F and G. Insert manufacturer and model number of sealed cources in parenthesis in item 7.E G and H. Insert activity per source and total activity for cccled cources in item 8.E and H. Depleted uranium should not ex- 999 kliograms in item 8.l. At 1,000 kilograms, a licensee is required to file a statement annuali ing foreign origin source m terirl; see 40.64(b). ,,,,, n, N:te: Insert manufacturer and model riiner of de'v ke M 9. lum-241 in item 6.H is not qg
~
by 10 CFR 35.67 (Calib tfon ia'n'd Reference Sou it would not need to be N U
- 9. Authorized Use A. Any uptake, dilution @and etion pr inJDCFR 35400.
B. Any imaging and looelizatio , CFRA 35.200, g g . C. Any radiopharmaceutical thera T10 CFR 35.300)- p ;i tr D. Any brachytheragproced
*g jj/
g E E. Medical use of sealed % 500i mpatibledevices registered pursuant to 10 CFR 30.32( i. # f#7 D N
\
JM g} d ' d'4ipfllH Q s F. In vitro studies. . G. Non-human use. For u k// N el for calibration and checking of licensee's survey instrum . W~ p H. Use as an anatomical marker. Yg ' 7 M
- l. Shielding in a linear accelerator.
CONDITIONS
- 10. Licensed material may be used only at the licensee's facilities located at 1234 Main Street, Anytown, Pennsylvania.
- 11. The Radiation Safety Officer for this license is Jane Diagnostic, M.D.
- N
- te: There must be at least one authorized user listed in Condition 12 who is authorized for each of the materials and uses listed in item 6. For example: If John Therapy, M.D. left the institution and no cuth:rized user qualified for his material and use authorizations was added to the license,35.400 materials and DU would need to be removed from the license. If Thomas Group, D.O. left, however, no ch:nges to the licensees' materials use authorization would be needed.
C-7 NUREG - 1556, Vol. 9
NRC FOR 3 374A u.s. NUCLEAR REGULATORY CoMMisslON PAGE.,J OF j_PAGES License Number 99-02120-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02120 12.' Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the following individuals for the materials and uses indicated: Authorized Users M.at rial and Jane Diagnostic, M.D. p 0- 00;
\,g ,8 b5700j35.200, Cesiu 7 e 41 Thomas Group, D.O. g 3 tium-89 for uses (O #
John Therapy, M.D.y DepleteIUranium (N . t~ ~.Rdies sfu), (y James Pathology,m Ph .D. [r 1 k
- 13. In cddition to the possession limit '
_s. a. Q material to quantities b#ow the see Ji110shall CFR further restni)ctand 30.35(d) 40.36(b), the possession 70.25(d) for of li establishing financial assurang 10ii gb. j 8 g N te: The Cesium-137 se ' item 8.6 and ericNm source in item 6.H, are not covired by Part 35 (35.65, MWrequEs that lif.ense conditions 14-17 regarding uses oisealed s on- s
~CSeiled source conditions need not be li:ted cn a medical license un lice'tise ' es EOsled 63rce not covered by Part 35.
14.A. Sealed sources shall be te fo(leakage and/or contarpination at intervals not to exceed the intervals specified in the certificate of registration issued by NRC under 10 CFR 32.210 or by an Agreement State. "% X " B. In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by NRC under 10 CFR 32.210 or by an Agreement State prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested. C. Sealed sources need not be tested if they are in storage and are not being used. However, when i they are removed from storage for use or transferred to another person, and have not been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or contamination. NUREG - 1556, Vol. 9 C-8
NRC FoR'.1374A u.s. NUCLEAR RE!uLAToRY CoMZissioN PAGE 1 oF,} PAGEs License Number 99-02120-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02120 D. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie or more of removable contamination, a' report shall be filed with the U.S. Nuclear R pry Commission in accordance with 1C CFR 30.50(b)(2), and the source shall be removed i y from service and decontaminated, repaired, or disposed9tjn accordance wit i regulations. The report shall be filed within 5 days of the dete%eleaKtest iss' ult s k U.S. Nuclear Regulatory Commission, Region I, ATT : Director, Division of N r' Mat ty,475 Allendale Road, King of Prussia, Pennsyl f i9406. The report sh iff urce involved, the test results, and corrective action ta n. , vc l E. Tests for leakage ar}d/or contamination shall ed he licsnsee or other persons specifically licensedf Ithe Commission entytateto perform such services. In addition, analysis by persons specifically licensed by the licensee is autjhori) the Commission or an Agreenten Jeak zed l'o'@t' sopices. C)
- 15. Serled sources contaihg licensed rn by the licensee.
' ohned MW or sources F $ moved from so (f) .*=
~4g,*, .-~=
- 16. Th3 licensee shall not _ ulre iff,a sealed,aource. r his been registered with Regulatory Co'mmission,o' device pursuant to 10 CFR 32.210lunless or the so equivalent regulations o tMe ; 4
- 17. The !icensee shall condu nventoy every,six hs to account for all sealed sources and j d; vices containing licensed I received a(psesse .
- 18. Tha licensee is authorized to trahsportlicensed material in accordaince with the provisions of 10 CFR Part 71, " Packaging and Transp'ortshon of Rad,ioactlye Material."
t n - C-9 NUREG - 1556, Vol. 9
NRC FORM 374A U.s. NUCLEAR REGULATORY CoMZissioN PAGE 1 OF 1 PAGES License Number 99-02120-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02120 l
- 19. Except as specifically provided othenvise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below, except for minor changes in the medi e radiation safety procedures as provided in 10 CFR.35.26. The U.S. Nuclear Regulatory Commi pulations shall govem unless the statements, representations, and procedures in the. licensee o nd correspondence are more restrictive than the regulations
%M MhG A Application dated June 10,g1998 "Y B Letter dated Novembeg18,'1998 C Letter dated March 16,1999 D A A
Qt / C T Q@% #6 o F- b. W5s o "y u) 5 %y b , <, I - / e
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ad! 3g f vt w Y }h- ~If' i FOR THE U.S. NUCLEAR REGULATORY COMMISSION Ditz March 20.1999 By: Oriainal sianed by Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 i NUREG - 1556, Vol. 9 C-10
NRC FoR'S 374 u.s. NUCLEAR REcULAToRY Commission PAGE 1 OF 3 PAGEs MATERIALS LICENSE Pursuint to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Fedsral Regulations, Chapter 1, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations : hir:toforo made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, stnd special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l driivtr or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license I shill be dremed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicabl3 rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee I
- 1. Sample Medical Institution Limited with differing 3. License Number 99-02120-04 is amended in its authorizations for two locations of use and 35.75 entirety to rea s follows:
limitation on 35.300 uses -
- 2. 3140 Highland Road 4.pExpiratio rc 31,2004
~
Hsrmitage, Pennsylvania 02120 5.~ Docket No. s(J R (1ce No.
- 6. Byproduct, source, and/or ,Y 7. Chemical and/ Maximum amount that licensee !
special nuclear material 4may possess at any one time y ,- < ~ , / -- (under this license I A. Any byproduct material N ANA I^ A., As needed identified in T
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tI O 10 CFR 35.100 tt . .( '3 ' A Any byproduct m"'arial d[h [ . B.$ As needed B. identified in f,! f / > 10 CFR 35.200 ,, 'b 4 ; [ [ } ' u >#j 7 ) ' O rm a :i millicuries C. Any byproduct mat identified in 10 CFR 35.300
*' Anyg[p?
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' 't/(J D' 7"dF s ; LAO,rg.y/ O(
Y 'A 4 N curies D. Any byproduct material D. Sealed s'ources , D. Not to exceed identified in 3h t y M' per source and 10 CFR 35.500 YNO curies total E. Any byproduct material E. Prepackaged Kits E. millicuries identified in 10 CFR 31.11
- 9. Authorized Use A. Any uptake, dilution and excretion procedure approved in 10 CFR 35.100.
B. Any imaging and localization procedure approved in 10 CFR 35.200. C. Any radiopharmaceutical therapy procedure approved in 10 CFR 35.300 for which the patient can be released under the provisions of 10 CFR 35.75. D. Medical use of sealed sources included in 10 CFR 35.500 in compatible devices registered pursuant to 10 CFR 30.32(g). E. In vitro studies. l l C-11 NUREG - 1556, Vol. 9
NRC FORM 374A u.s. NUCLEAR REluLAToRY Commission PAoE ,,2, oF ,J,,, PAGES Licenso Number 99-02120-04 MATERIALS LICENSE Docket or Reference Number SUPPL.EMENTARY SHEET 030-02120 Amendment No. 01 CONDITIONS 10.A. Licensed material may be used at the licensee's facilities located South Division,110 Mk.o Street, Greenville, Pennsylvania. B. Licensed material in items 6.A,6.B. exc{uding generators a ~ E may be used at the Pennsylvania. licensee's facilities located at NortgDivisl6n,2200.h(am 'al
- 11. The Radiation Safety Officer fo this ifcense is Frank N.
l .Qf
- 12. Licensed material listed in itek(6 above is only underaut the supervision of, the following individuals for the thaterials and uses in Authorized User M/
b Q.'
, yfn Frank N. Stein, M.D. * .500
;;36.2p0; 35.300;
[ i
>J 'f st0 dies
'9. E Kevin Leonard, M'.D. 100;- 3'5.300g36.500 I $tgit
- Q Tom B. Jones, M.D'. -
lDL
'35.1 0; 35.3g% 35.500
,, vitr les N 9g Gilbert Lawrence, M.D.
- 5.300 h John Miller, M.D. $ t M.
k $35.100; 35.200; 35.500 lodine-131 for treatment of hyperthyroidism and cardiac dysfunction In vitro studies
- 13. In addition to the possession limits in item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d),40.36(b), and 70.25(d) for establishing financial assurance for decommissioning.
- 14. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR 71,
" Packaging and Transportation of Radioactive Material."
NUREG - 1556, Vol. 9 C-12
NRC FORM 374A U.s. NUCLEAR REIULAToRY COMMisslON PAGE 1 OF 1 PAGES Licens3 Number 99-02120-04 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02120 Amendment No. 01
- 15. Except as specifically provided otherwise in this license, the licensee shall conduct its program in recordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below, except for minor changes in the medi e radiation safety procedures as provided in 10 CFR 35.26. The U.S. Nuclear Regulatory Commis
- pulations shall govern, unless the statements, representations, and procedures in the licensee o nd correspondence are more restrictive than the regulations. p gi8HdG r% k A Application dated January 1.0/1993 i B Letter received July 134993 C Letter dated March 7,1994 }-
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4 g. p 4 4 FOR THE U.S. NUCLEAR REGULATORY COMMISSION Datz By: Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 C-13 NUREG - 1556, Vol. 9
NRC FORM 374 u.s. NUCLEAR REGULATORY CO% Mission PAGE 1 oF 2 PAGES l MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, ucquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to dIliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license I shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all I applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee In accordance with the application dated September 30,1994 j 1. Sample Pacemaker License 3. License Num r SNM-22160 is amended in its entirety to r s follows: l
- 2. 100 Medical Center Drive . 4.
Expiratio to r 31,1999 l King of Prussia, Pennsylvania 19406 5.%'Do'cket >Q I No. l
.O" R ^ -hee Noi j
, 6. Byproduct, source, and/or [ 7. Chemical and/ .
- ] Maximum amount that licensee special nuclear material y ,.f may possess at any one time D
l ,- $nder
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this license Q) K_','AXSea / A. Plutonium g g r 'ncipal' A. . Not to exceed l b._ A -c O milligrams per N ( f u,?.38)3 O source and grams l l h\. %. A ff.. f p total
- 9. Authorized Use t y d f,! /
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A. As a component of M! . Y n>ulcNar-pow.h af en$d cardiac pacemakers for clinical evaluation in accor facturer's protisdoldat'dd -W , this authorization includes: follow-up, a f racoveryTseposaf^ahd'im pla ntation'. CONDiflONS i N l _y , y
- 10. Licensed material may be used only at the licensee's facilities located at 100 Medical Center Drive, King .
I of Prussia, Pennsylvania. T $ 6 ~y T /N
)
l 11, The Radiation Safety Officer for this license is Chief Radiologist, M.D. l l
- 12. The physicians responsible for implantation, follow-up, explantation, and return of nuclear-powered l pacemakers to the manufacturer for proper disposal are Chief Cardiosurgeon, M.D.
- 13. The specified possession limit for cardiac pacemakers includes all licensed material possessed by the licensee under this license whetner in storage, implanted in patients, or otherwise in use.
l
- 14. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient.
- 15. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.
- 16. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71," Packaging and Transportation of Radioactive Material."
NUREG - 1556, Vol. 9 C-14
NRC FORM 374A U.s. NUCLEAR RE!ULAToRY Commission PAGE 1 oF 1 PAGES License Number SNM-22160 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 070-22160 Amendment No. 01
- 17. Except as specifically provided otherwise in this license, the licensee shall conduct its program in recordance with the statements, representations, and procedures contained in the documents, including cny enclosures, listed below. The Nuclear Regulatory Commission' ufations shall govem unless the strtements, representations, and procedures in the licensee's ap nd correspondence are more restrictive than the regulations.
A c kB RE G Application dated September.30,,1994 f B Letter received October gh09'4 Y Y e 9
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FOR THE U.S. NUCLEAR REGULATORY COMMISSION Data: By: Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 C-15 NUREG - 1556, Vol. 9
NRC FoR3 374 u.S. NUCLEAR REGULATORY COMMISsloN PAGE 1 OF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations hsretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to diliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee
- 1. Sample Medical Private Practice permitting only 3. License Number 99-02200-01 out-patient therapy A
- 2. 123 Clinic Road 4. Expiration - ~ March 31,2004 King of Prussia, Pennsylvania 02200
_ s h.- pl 5[jDocket Nv. ~ s2p R(erencek
- 6. Byproduct, source, and/or y7.# Chemical and/or rrri ' Maximum amount that licensee special nuclear material y may possess at any one time
,qunder this license 69 ,
A. Technetium-99m g g Q'. An f~' .Ar 30 millicuries per unit dose g (% L'
. q f O, not to exceed 150 millicuries total M y )I V:
-Q n B. lodine-131 F S B,5 in V.: 2 B7 60 millicuries fD , ,'i h C. Strontium-90 D(.E 'lfiMin .l t O
CY 55 millicuries N 1'O'CFR 35.400 D. Palladium-103 C . 500 millicuries 10 C 35;400 p{. \ E. lodine-125 y E. As id
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in yO E. 500 millicuries
'g10,CFR 35.400 g
< vr s 4 s Ncte: Although many elements of 35.300 arid 35.400 are represented in 6 B-E, full 35.300 and 35.400 authorizations are not present. Separate line item listings must appear.
- 9. Authorized Use Hete: In adaition to " tie down" commitments from the licensee, items 9.D and E restrict authorized use to permit only out-patient procedures.
A. Any imaging and localization procedure approved in 10 CFR 35.200. B. Diagnosis and treatment of hyperthyroidism, and treatment of cardiac dysfunction. C. Treatment of superficial eye conditions using an applicator distributed pursuant to 10 CFR 32.74 and approved in 10 CFR 35.400. D. and E. Any manual brachytherapy procedure approved in 10 CFR 35.400 for which the patient can be released under the provisions of 10 CFR 35.75. t
]
NUREO - 1556, Vol. 9 C-16
NRc FORM 374A U.s. NUCLEAR RE utAToRY Commission PAGE ,,2., oF ,,J , PAGES License Number 99-02200-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02200 I CONDITIONS i
- 10. Licensed material may be used only at the licensee's facilities located 123 Clinic Road, King of Prussia, P4nnsylvania.
- 11. Tha Radiation Safety Officer for this license elba past, M.
- 12. Licensed material listed in item 6 abod.is only aut oriikf se tha supervision of, the following individuals for the ma(e(alir'and uses indicated:
V Authorized Users h Melba Toast, M.D. - lodi 131 fo trhatment of hyperthyroidism g - i _ dysfunction R- p () Patty Melt, M.D. T d 790,for treatmentof superficial eye F- nditio)isil%lladium-10lfor uses identified in (/) MSFR, _35 , lodine-1'26 for uses identified in 6CFRp6 ,, @ niw .
~ duct its program in
- 13. Except as specifically I e li e sh n accordance with the sta .
in the documents, including cny enclosures, listed be inore $r, hedical s cont _e radiation safety procedures as provided in 10 CFR 35.26. . NucYear ry Co'mmissio regulations shall govern unless tha statements, representation nd procedures the licensee's' application and correspondence are more restrictive than the regulations. g .)g A. Application dated April 22,1993 B. Letter dated July 8,1993 C. Letter dated February 10,1994 FOR THE U.S. NUCLEAR REGULATORY COMMISSION I Data: By: Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 I e C-17 NUREG - 1556, Vol. 9
NRC FORM 374 u.s. NUCLEAR REGULATORY Commission PAGE 1 oF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Ftderal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations bzrttofore made by the licensee, a license is hereby issued au"iorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to d!!iver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all a:pplicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. i Licensee
- 1. Sample High Dose Rate Remote Afterloader 3. License Number 99-02230-01
- 2. 111 Afterloader Road 4. Expiration Dgugust 31,2001 Brachytherapy, New Jersey 02230 5. Docket M 7p30
- h 9, [ { FReferenco g
- 6. Byproduct, source, and/or 77 .}Ch6mical and/or ph ' I form ..aximum amount that licensee special nuclear material ,Y N #may possess at any one time
[ ) under this license A. Iridium-192 Ca A. Sealed .- .Aod ' ) A. 10 curies per source and fj [ C x No.
- S. do. yyy)" A 20 curies total b
- 9. Authorized Use g {V V[7 ()
Nnte: Insert the sealed source manufac ' Mi numtidr in 7.A parenthesis above. Insert HDR afterloading unit mariufacture r in blank in 9.A below. A. a) One source to be used in a W g
*"y , , , ~
iHigh Dose, Rate Remote Afterloading Brachytherapy Devi~ce treatment. One~sodice'in its shipping container as necessary for replacement of o rAla remote afterlin&r de"vice. &) WCONDITIONSX ' <~' L 9 f,n & <W
- 10. Licensed material may be u at the licensee's~ facilities at 111)n 'Afterloader Street, Brachyth
~
New Jersey. ~/ C
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- 11. The Radiation Safety Officer for this li6ense is Cecil Source /M.D.
- 12. The Medical Physicist for this license is Albert Einstein, Ph.D.
- 13. Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the following individuals for the materials and uses indicated:
Authorized Users Material and Use Cecil Source, M.D. Iridium-192 for uses in a High Dose Rate Remote Afterloading Brachytherapy Device
- 14. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."
NUREG - 1556, Vol. 9 C-18
~
j NRC FoR3 374A u.s. NUCLEAR REGULATORY Commission PAGE 2,_ oF.2 PAGES l ! License Number ! 99-02230-01
- 1. MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02230 i
l 15. Except as specifically provided otherwise in this license, the licensee shall coriduct Ms program in recordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below, except for minor changes in the medi e radiation safety procedures as , provided in 10 CFR 35.26. The U.S. Nuclear Regulatory Commis putations shall govem unless ! th3 statements, representations, and procedures in the, licensee on nd correspondence are I more restrk;tive than the regulations ( % 8 H D G A. ^7 Application dated April 23,3996 ! B. Letter dated June 8,1996; C. Letter dated July 26,1996 D. Letter dated August 831996 h l! N U-/ kN v. f[
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1 FOR THE U.S. NUCLEAR REGULATORY COMMISSION )
- Data: By:
Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406 l C-19 NUREG - 1556, Vol. 9 '
NRC FORM 374 U.s. NUCLEAR REGULATORY Commission PAGE 1 oF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code l of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations ; h;ratofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, i source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to ' d; liver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license sh;ll be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all i cpplicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified l ' below. Licensee (
- 1. Sample Teletherapy 3. License Number 99-02300-01 200 Cobalt Street I
- 2. 4. Expiration Dpctober 31,2004 King of Prussia, Pennsylvania 02300 5. Docket N 7p00 Is R l { FRefe[ence- g
- 6. Byproduct, source, and/or 7.\CMmical and/or ph ' i form iaximum amount that licensee special nuclear material 9 *may possess at any one time Q under this license A. Cobalt-60 (/ A. Sealed odel IA. Not to exceed 5,500 curies
- o. yyy)'~' /- per source and 11,000 46* )c .,. No.
4 *
&: gj () curies total B. Depleted UraniumT T(B'h.
t . ,j . 4 Bq kilograms
- 9. Authorized Use ' '
, g N te: Insert teletherapy sealed so rer and model number in 7.A parenthesis above.
Depleted uranium possesil , e'may riotMceVd 99'9 kilo @itms. Insert teletherapy unit / device manufacturer berJn blank 9'.A belo@' @ A. One source for med ada w S W n,10 CFR 35300 in a g teletherapy unit. One s ' its shippInd$n'thiner or s neces'sary for replacement of the source in the teletherapy unit. / V $ B Shielding in a teletherapy unit 4 , y
' CONDITIONS
- 10. Licensed material may be used only at the licensee's facilities located at 200 Cobalt Street, King of Prussia, Pennsylvania.
- 11. The Radiation Safety Officer for this license is Sarah Smith, M.S.
- 12. The Medical Physicist for this license is Sarah Smith, M.S.
- 13. Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the following individuals for the materials and uses indicated:
Authorized Users Material and Use David Jones, M.D. 35.600; Depleted uranium NUREG - 1556, Vol. 9 C-24
NRC FoR'J 374A U.s. NUCLEAR REluLAToRY Commission PAGE 1 oF 1 PAGEs License Number 99-02300-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02300
- 14. The licensee is exempted from decommissioning financial assurance requirements for possession of licensed materia i in sealed sources in quantities greater than the limits in 10 CFR 30.35(d) for the purpose of source changes only. This exemption is granted for no than 30 days for any one source chinge.
- 15. The licensee is authorized to transport licensed minedal
- acco t provisions of 10 CFR Part 71, " Packaging and Tran'poh'atlo'n a o'f staidi a
,V
- 16. Except as specifically provided twise in this license, conduct its program in cccordance with the staten1erds representations, a ned in the documents, including eny enclosures, listed bel,ow?except for minor ch e radiation safety procedures as provided in 10 CFR 35.280The U.S. Nuclear ommissio#s regulations shall govern unless the statements, represdatatioQnd proced ncse'(application and correspondence are more restrictive than theregulations. . }3 g e Y. f [;f~-{
A. Application dat farch 4,1994T , y ,. 4 O B. Letter dated May ,1994 m., [2[ ,/ E C. Letter dated Oct 7,1 , 4 air p j Ifl MT l 7 Q s Co N*4tll ,. c
, h 4 0'o
% ,ga FOR THE U.S. NUCLEAR REGULATORY COMMISSION Data: By: Oriainal Sioned by Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 i
C-21 NUREG - 1556, Vol. 9
NRC FORM 374 U.s. NUCLEAR REGULATORY CoMM!ssioN PAGE 1 oF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations her tofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to delivar or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license thill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations. and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee in accordance with the application dated July 17, 1994
- 1. Sample In-Vitro Testing Laboratory 3. License Num r 99-02410-01 is amended in its l 1
entirety to r s,follows-J
- 2. 1234 Clinical Way n 3 4 7 Expiratio pt ber 30,2004 l
- i,s n~
DP
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Petri, Delaware 02410 + 5. Do'ke(No. c
,C" R ^ ^6ceNoi
- 6. Byproduct, source, and/or .{ v 7. Chemical and -
g Maximum amount that licensee special nuclear material ,. y /may possess at any one time O #Lnder this license d[j % .
/ J f-, ~
A. Hydrogen-3 l t AN% Any y A.,) 5 millicuries B. Carbon-14 <I' e
'T B, e fUI : L B.-
v 3 5 millicuries t , 4 C. Phosphorus-32 h i j= 2 C;> 5 millicuries D. Iron-59 q,
"[y,/ . ~( -
a Dj 2 millicuries k E. lodine-125 [ Lhtieled comkundsh f E' 10 millicuries
- 9. Authorized Use e CO ev x A. through E. In vitro labordt M C""v f@ Ss C)W les. " %[j CONDITIONS ,
- 10. Licensed material may be used only at the licensee's fNcilities located at 1234 Clinical Way, Petri, Delaware.
11.A. Licensed material shall be used by, or under the supervision of, Maria Kitt, Ray D. O' Tracer or Otto Radiograph. B. The Radiation Safety Officer for this license is Maria Kitt.
- 12. Licensed material shall not be used in or on human beings.
- 13. The licensee is authorized to hold radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash, provided:
A. Waste to be disposed of in this manner shall be held for decay a minimum of ten half-lives. NUREG - 1556, Vol. 9 C-22
. 'N NRC FORM 374A u.s. NUCLEAR RE;uLAToRY Commission PAGE10F1 PAGES License Number 99-02410-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02410 Amendment No. 01 B. Before disposal as ordinary trash, the waste shall be surveyed at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shie! ding to determine that its radioactivity cannot be distinguished from ba und. All radiation labels shall be removed or obliterated.
C. A record of each such disposal permitted undR this License n 11 be retained for three years. The record must include tfsiste'of disMsaf,-the date e byproduct material was placed in storage, the radiongchdes disposed, the s limtrum ed, the background dose rate, at the surface of each the name of the individual who the dosethe performed rate measurgls disposa A
- 14. The licensee is authorize'dh transport licens accordance with the provisions of 10 CFR Part 71, "PacFaisng afdTransportat
- ive f(aterial."^
k 1< n
- 15. Except as specifically provided ot _ licensee shall conduct its program in accordance with the statements, re ' uries containedin the documents, including eny enclosures, listed'below. Th Corsmission's regulakns shall govern unless the statements, representations, and
~
plication aNd correspondence are more restrictive than the regulations !"i e n 1lkpt . &.s :f e/f
'r1Iede'sa)% s A. Application dated J )Il b B. Letter dated Septe 8,'
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l l l Appendix D l Information Needed for Transfer of Control
APPENDIX D Information Needed for Transfer of Control Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license (10 CFR 30.34(b)). If NRC finds that the transfer is in ' accordance with the Act, NRC may, at the NRC's option, authorize the transfer by license amendment. Otherwise, a new license authorizing the transfer may be issued. The licensee must provide the following information concerning changes of control. If any items are not j applicable, so state.
- l. The new name of the licensed organization. If there is no change, the licensee should so l state.
- 2. The new licensee contact and telephone number (s) to facilitate communications.
- 3. Any changes in personnel having control over licensed activities (e.g., officers of a !
corporation) and any changes in personnel named in the license such as RSO, AUs, or any other persons identified in previous license applications as responsible for radiation safety or use oflicensed material. The licensee should include information conceming the qualifications, training, and responsibilities of new individuals. 4
- 4. An indication of whether the transferor will continue to exist without an NRC license.
- 5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control.
l
- 6. A complete description of any planned changes in organization, location. facility, equipment, or procedures (i.e., changes in operating or emergency procedures).
- 7. A detailed description of any changes in the use, possession, location, or storage of the licensed materials.
- 8. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, surveys, inventories, and accountability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records.
l 9. Confirmation that all records concerning the safe and effective decommissioning of the l facility, pursuant to 10 CFR 30.35(g); public dose; and waste disposal by release to sewers, ) incineration, radioactive material spills, and on-site burials, have been transferred to the new licensee, iflicensed activities will continue at the same location, or to the NRC for license terminations. D-1 Draft NUREG - 1556, Vol. 9
APPENDIX D
- 10. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site?
- 11. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35. Include both information about how the transferee and transferor propose to divide the transferor's assets and responsibility for any cleanup needed at the time of transfer.
12.t Confirmation that the transferee agrees to abide by all commitments and representations
- previously made to NRC by the transferor. These include, but are not limited to:
maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions. With regard to contamination of facilities and equipment, the transferee should. confirm, in writing, that it accepts full liability for the site and should provide evidence of adequate resources to fund decommissioning, or the transferor should provide a commitment to decontaminate the facility before transferring control. With regard to open inspection items, etc., the transferee should confirm, in writing, either that it accepts full responsibility for open _ inspection items and/or any resulting enforcement actions, or that the transferee proposes alternative measures for meeting the requirements, or that the transferor provides a commitment to close out all such actions with NRC before license transfer.
- 13. Documentation that the transferor and transferee agree to transferring control of the licensed material and activity, including the conditions of transfer, with the transferee made aware of all open inspection items and its responsibility for possible resulting
. enforcement actions.
- 14. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If the transferee does
.not make such a commitment, the transferee must provide a description ofits program, to ensure compliance with the license and regulations.
I
- Draft NUREG - 1556, Vol. 9 D-2
Appendix E Guidance on Financial Assurance Determination l
APPENDIX E Guidance on Financial Assurance Determination Determining Need for Financial Assurance for Decommissioning The halflives of unsealed byproduct material used by medical licensees have traditionally been less than 120 days. Therefore, most medical use applicants need only to consider licensed material in sealed sources to evaluate the need for financial assurance. Use Table E.1 to determine if financial assurance is required for the sealed sources listed. If requesting sealed sources other than those listed or any other unsealed byproduct material with halflives greater than 120 days, refer to 10 CFR 30.35 and Appendix B to Part 30 for possession limits requiring financial assurance. The sum of the fractions procedure is also depicted in Table E.1 and must be used in determining the need for financial assurance for both sealed and tmsealed byproduct material. Table E.1 Worksheet for Determining Need for Financial Assurance for Sealed Sources
; Step Description Cobalt-60 Cesium-137 Strontium-90 Number 1 Activity possessed, in Curies
- 2_ Activity requiring financial assurance, in 10,000 100,000 1,000 Curies -
3 Divide data in Step 1 by data in Step 2 = FRACTION 4 Add the fractions determined in Step 3
- This table uses only conventional units. The conversion to the International System of units (SI) is:
1 Curie = 37 gigabecquerels. If the sum of the fractions is greater than or equal to 1, the applicant will need to submit financial assurance. RG 3.66,' " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, l provides sample documents for financial mechanisms. The recommended wording for a Statement ofIntent for government licensees is shown below, since this mechanism is not
' described in RG 3.66.
' See the Notice of Availability (inside front cover of this draft report) to obtain copics of RG 3.66," Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72,"(dated June 1990).
E-1 Draft NUREG - 1556, Vol. 9
APPENDIX E Suggested Wording for a Statement of Intent for a Government Licensee l [DATE] TO: U. S. NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555 [or appropriate regional address] STATEMENT OF INTENT As [ Title] of[ Licensee Name], I exercise express authority and responsibility to approve funding for decommissioning activities associated with operations authorized by U. S. Nuclear Regulatory Commission Material License No. . This authority is established by [Name of Document (s) Governing Control of Funds]. Within this authority, I intend to have funds made available when necessary, in an amount up to [ Dollar Amount] to decommission [ Description of Facilities]. I intend to request and obtain these funds sufficiently in advance of decommissioning to prevent delay of required activities. A copy of[Name of Documents] is attached as evidence that I am authorized to represent [ Licensee Name] in this transaction. [ SIGNATURE] [NAME] [ TITLE]
Attachment:
As stated Draft NUREG - 1556, Vol. 9 E-2 l
[- l l l Appendix F l Typical Duties and Responsibilities of l the Radiation Safety Officer and Sample L Delegation of Authority i I
]
I i APPENDIX F Typical Duties and Responsibilities of the Radiation Safety Officer and ' Sample Delegation of Authority Model RSO Duties and Responsibilities i
~ The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license (see Figure 8.1). Typically, these duties and responsibilities include ensuring the following:
. Activities involving licensed material that the RSO considers unsafe are stopped
. Radiation exposures are ALARA
. Up-to-date radiation protection procedures in the daily operation of the licensee's byproduct material program are developed, distributed, and implemented
. Possession, use, and storage oflicensed material is consistent with the limitations in the license, the regulations, the SSDR Certificate (s), and the manufacturer's recommendations and instructions
. Individuals installing, relocating, maintaining, or repairing devices containing sealed sources are trained and authorized by an NRC or Agreement State license
. . Personnel training is conducted and is commensurate with the individual's duties regarding licensed material
. Documentation is maintained to demonstrate that individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits or that personnel monitoring devices are provided
. When necessary, personnel monitoring devices are used and exchanged at the proper intervals, and records of the results of such monitoring are maintained
. Licensed material is properly secured
- Documentation is maintained to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operetion does not exceed the annual limit for members of the public i
. Proper authorities are notified ofincidents such as loss or theft oflicensed material, damage to or malfunction of sealed sources, or fire
. Medical events are investigated and reported to the NRC. Cause(s) and appropriate corrective l action (s) are identified, and timely corrective action (s) are taken 1
. Audits of the radiation protection program are performed at least annually and documented
. If violations of regulations or license conditions or program weaknesses are identified, effective corrective actions are developed, implemented, and documented F-1 Draft NUREG - 1556, Vol. 9 i
APPENDIX F e Licensed material is transported in accordance with all applicable DOT requirements
= Licensed materialis disposed ofproperly
- Appropriate records are maintained
. Up-to-date license is maintained and amendment and renewal requests are submitted in a timely manner.
Model Delegation of Authority Memo To: Radiation Safety Officer From: Chief Executive Officer
Subject:
Delegation of Authority You, have been appointed Radiation Safety Officer and are responsible for ensuring the safe use of radiation. 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 where justified by radiation safety. You are required to notify management of situations where staff are not cooperating and not addressing radiation safety issues. In addition, you are free to raise issues with the Nuclear Regulatory Commission at anytime. It is estimated that you will spend hours per week conducting radiation protection activities. Signature of Management Representative I accept the above responsibilities, Signature of Radiation Safety Officer I cc: Affected department heads 1 l Draft NUREG - 1556, Vol. 9 F2
l I l Appendix G Documentation of Training and Experience l l l
l l APPENDIX G Documentation of Training and Experience ,< , General Guidance The required training and experience described in 10 CFR Part 35 must be obtained within the 7 years preceding the date of the application, or the individual must document as having had related continuing education, retraining, and experience since the required training and experience were obtained. Complete retraining is neither practical nor necessary in most cases. Examples of acceptable continuing education and experience are:
- 1. Successful completion of didactic review courses that include radiation safety practices relative to the proposed type of authorized medical use.
- 2. Practical and laboratory experience with patient procedures using radioactive material, for the same use(s) for which the applicant is requesting authorization.
- 3. 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.
- 4. For therapy devices, experience with the therapy unit and/or comparable linear accelerator experience and completion of an inservice to review the emergency procedures relative to the therapy unit to be used by the applicant.
The simplest and most straightforward method of demonstrating acceptable training and experience is through certification by one of the professional boards recognized by the NRC. Equally straightforward is evidence that the applicant is listed as an AU on an NRC or Agreement State license or permit issued by a medical broad scope licensee, provided that the applicant is authorized for the same types of use(s) being requested in the application under review, and that the applicant meets the requirements for recentness of training criteria described in 10 CFR 35.59. For AUs who have been previously authorized under a medical broad scope license, the applicant should submit either verification of previous authorization (s) granted by the broad scope licensee or evidence of acceptable training and experience. The NRC recognizes supervised work and practical experience, such as that described in 10 CFR 35.292(b), conducted under a preceptor in a licensed material use program. A preceptor is an AU who provides frequent direction, instruction and direct oversight of the student as the student completes the required work and practical experience in the use of byproduct material. Preceptorships may occur at various licensed facilities, from a large teaching university hospital to a small private practice. Upon completion of the supervised work and practical experience, the applicant should either submit the preceptor forms provided as NRC Forms 313A and 313B l G-1 Draft NUREG - 1556, Vol. 9
1 1 APPENDIX G to NRC Form 313, " Materials License Application" or a letter from the preceptor that indicates that the applicant has obtained all required experience elements. There is no NRC requirement that an AU must render an interpretation of a diagnostic image or resu!ts of a therapeutic procedure. 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. l I l Draft NUREG - 1556, Vol. 9 G-2
APPENDIX G NRC Form 313A U.S. Nuclear Regulatory Commission TRAINING AND EXPERIENCE Note: Descriptions of training and experience must contain sufficient detail to match the training and cxperience criteria in the applicable regulations. .
- 1. Name of Individual, Preposed Authorization (e.g., Radiation Safety Officer), and Applicable -
Training Requirements (e.g.,10 CFR 35.50)
- 2. For Physicians and Pharmacists, State or Territory Where Licensed
- 3. Certification
~
Specialty Board Category Month and Year Certified l
- 4. Didactic Training Description of Training Location Clock Hours Dates of Training Radiation Physics and instrumentation Radiation Protection Mathematics Pert <ining to the Use and Measurernent of Radioactivity Radiation Biology I
Chemistry of Byproduct Material for Medical Use Other l I f 1 l 9 G-3 Draft NUREG - 1556, Vol. 9 l f
l APPENDIX G j i
- 5. Practical Experience with Radiation. (Actual use of radionuclides or equivalent experience)
Description of Name of Location and Clock Hours and Related Radiation Experience Supervising Corresponding Dates Safety Exam l Individual (s) Materials License Score i Number
- 6. Formal Training Degree, Area of Study Name of Program and Dates Name of Organization Location with that Approved the Corresponding Program (e.g.,
Materials License Accreditation Council Number for Graduate Medical Education) and the Applicable Regulation (e.g.,10 CFR 35.294)
- 7. The individual named in item 1 of this form is competent to function independently as an authorized user.
[ ] Yes [ ] No Note: Response to item 7 is applicable to proposed authorized users, medical physicists. or radiation safety officer for the type of medical use requested.
- 8. The training and experience indicated 10. Preceptor's Signature above was obtained under the supervision of:
- a. Name of Supervisor
- b. Mailing Address
- c. City
- 9. Materials License Number 12. Date Draft NUREG - 1556, Vol,9 G-4
APPENDIX G NRC Form 3138 U.S. Nuclear Regulatory Commission PRECEPTOR STATEMENT l Note: Descriptions of training and experience must contain sufficient detail to match the training and experience criteria in the applicable regulations. Supplement B must be completed by the individual's preceptor. If more than one is necessary to document experience, obtain a separate preceptor statement from each. { 1. Name of Individual, Proposed Authorization (e.g., Authorized User), and Applicable Training Requirements (e.g.,10 CFR 36.490): Name, Proposed Authorization, and Applicable Training Requirements Street Address ! City State Zip Code l
- 2. Supervised Experience of Above Named Individual Radionuclides Type of Use Number of Cases Location and Corresponding involving Personal Materials License Number, Dates, i Participation and Clock Hours of Experience l
l l l l l , G-5 Draft NUREG - 1556, Vol. 9
APPENDIX G j
- 2. Supervised Experience of Above Named individual (Cont'd)
Radionuclides Type of Use Number of Cases Location and Corresponding involving Personal Materiale License Number, Dates, Participation and Clock Hours of Experience t
- 3. The individual named in item 1 of this form is competent to independently operate a nuclear pharmacy.
[ ] Yes [ ] No Note: Response to item 3 is only applicable to proposed authorizec' nuclear pharmacists. -
- 4. The training and experience indicated 6. Preceptor's Signature j above was obtained under the ;
supervision of: J
- a. Name of Supervisor
- 7. Preceptor's Name (Printed Clearly)
- b. Meiling Address
- c. City
- 5. Materials License Number 8. Date Draft NUREG - 1556, Vol. 9 G-6
l Appendix H Model Training Program l l i t I
1 APPENDIX H Model Training Program i Model Training Prograrn for Medical Uses of Radionuclides, Sealed Sources and Medical Devices Containing Sealed Sources l Personnel shall be instructed before assuming duties with, or in the vicinity of radioactive materials, during annual refresher training, and whenever there is a significant change in duties, l regulations, terms of the license, or type of radioactive material or therapy device used. Records of worker training will be maintained for at least three years. The training records will include ! the date of the instruction or training and the name(s) of the attendee (s) and instructor (s). Training for Individuals involved in the Usage of Byproduct Material ;
\
We will instruct the professional staff (e.g., AU, AMP, ANP, RSO, nurse, dosimetrist, technologist, therapist) providing or involved in the care of patients during diagnostic or therapeutic procedures in the following topics, commensurate with his/her duties: Basic radiation biology, e.g., interaction ofionizing radiation with cells and tissues (10 CFR 19.12) Basic radiation protection to include concepts of time, distance, and shielding (10 CFR 19.12)
. Concept of maintaining exposure ALARA (10 CFR 20.1101) . Risk estimates, including comparison with other health risks (10 CFR 19.12) . Posting requirements (10 CFR 20.1902) = Proper use of personnel dosimetry (when applicable) (10 CFR 20.1201) . Access control procedures (10 CFR 20.1601,10 CFR 20.1802) . Proper use of radiation shielding, if used (10 CFR 19.12) . 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) . Occupational dose limits and their significance (10 CFR 20.1201) l . Dose limits to the embryo / fetus, including instruction on declaration of pregnancy (10 CFR 20.1208)
Worker's right to be informed of occupational radiation exposure (10 CFR 19.13)
. Each individual's obligation to report unsafe conditions to the RSO (10 CFR 19.12)
H-1 Draft NUREG - 1556, Vol. 9
APPENDIX H . 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 19.12,10 CFR 35.27)
. Appropriate surveys to be conducted, including surveys of all material leaving radioactive material areas (10 CFR 20.1501) . Proper use of required survey instruments (10 CFR 20.1501) . Emergency procedures (10 CFR 19.12) . Decontamination and release of facilities and equipment (10 CFR 20.1406,10 CFR 30.36) . Dose to individual members of the public (10 CFR 20.1301) . Licensee's operating procedures (e.g., survey requirements, instrument calibration, waste management, sealed source leak testing)(10 CFR 35.27) Training for the Staff Directly involved in Administration to or Care of Patients Administered Therapeutic Quantities of Byproduct Material (including Greater than 30 microcuries of I-131), or Therapeutic Treatment Planning in addition to the topics identified above, we will instruct staffinvolved in the therapy treatment of patients (e.g., nursing, RSO, AMP, AU, and dosimetrist) in the following topics, commensurate with his/her duties: . Leak testing of sealed sources (10 CFR 35.67) . Emergency procedures (including emergency response drills) (10 CFR 35.310, 10 CFR 35.410,10 CFR 35.610) . Operating instructions (10 CFR 35.27,10 CFR 35.610) . Computerized treatment planning system (10 CFR 35.657) . Dosimetry protocol (10 CFR 35.610) . Detailed retreatment quality assurance checks (10 CFR 35.27) , . Safe handling (when applicable) of the patient's 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) ) . Patient control procedures (10 CFR 35.310,10 CFR 35.410,10 CFR 35.610) . Visitor control procedures, such as visitor's stay times and safe lines in radiation control areas (patient's room)(10 CFR 35.310,10 CFR 35.410,10 CFR 35.610) Draft NUREG 1556, Vol. 9 H-2
I l APPENDIX H
. Licensee's 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 and applicators to ensure that treatment is to the correct site (or, for GSR; correct positioning of the helmet) (10 CFR 35.41) = 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 35.310, 10 CFR 35.410,10 CFR 35.610)
- Size and appearance of different types of sources and applicators (10 CFR 35.410, 10 CFR 35.610)
- Previous incidents, events and/or accidents (10 CFR 35.310,10 CFR 35.410,10 CFR 35.610) l i
. For remote afterloaders, teletherapy units, and GSR units; initial training provided by the device manufacturer or by individuals certified by the device manufacturer that is device model-specific and includes: 1
- Design, use, and function of the device, including safety systems and interpretation of ;
various error codes / 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/ treatment and implementation of the licensee's emergency procedures; and
- A method of determining each trainee's competency to use the device for each type of proposed use, such as practical examinations.
Additional Training for Authorized Medical Physicists In addition to the training and experience requirements of 10 CFR 35.51 or 10 CFR 35.961, we will verify that the AMP has specific training and experience in performing the measurements and calculations associated with the specific type of therapy treatments that we are requesting (e.g, manual brachytherapy, remote afterloader therapy, teletherapy, GSR therapy) and that the training involved the use of the treatment planning system that will be used for therapy at our
- facility.
Additional Training for Therapy Authorized Users
- In addition to the training and experience requirements of 10 CFR 35.390,10 CFR 35.490, l
10 CFR 35.690 or Subpart J, we will verify that the therapy physician has specific training and experience in performing the specific therapy treatment that we are requesting, including training in the treatment planning system, quality control system, and clinical procedures that will be used at our facility. I H-3 Draft NUREG - 1556, Vol. 9 l
APPENDIX 11 Training for Contractors We will ensure that individuals who work under a contractual arrangement be instructed in the topics described above, equivalent to instruction given to facility employees and commensurate with their duties. Training for Ancillary Staff l l For the purposes of this'section, ancillary staffincludes personnel engaged in housekeeping, dietary services, laboratory services, security, custodial services, etc. For individuals whose assigned activities during norinal and abnormal situations are likely to ; result in a dose in excess of 1 mSv (100 mrem), we will provide instruction commensurate with I potential radiological health protection problems present in the work place. Alternatively, we may choose to prohibit ancillary personnel from entering restricted or controlled areas unless escorted by trained personnel. Topics ofinstruction will include the following:
- Storage, transfer, or use of radiation and/or radioactive material (10 CFR 19.12)
= Ilealth protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed (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 (10 CFR 19.12) l Draft NUREG - 1556, Vol. 9 11 4
_ _ -_____-___________a
i l Appendix I Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program 1 i
APPENDIX I Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program Facilities and Equipment
. To reduce doses received by individuals not calibrating instruments, calibrations should be conducted in an isolated area of the facility or at times when no one else is present.
. Individuals conducting calibrations will wear assigned dosimetry, if required.
Equipment Selection
. Low energy beta emitters, such as carbon-14 and sulfur-35, are difficult to detect with Geiger-Mueller (GM) probes. Generally the detection efficiency is on the order of 2% for low energy beta emitters. Particular attention to surveying method (e.g., speed and height above surface) is needed to perform adequate surveys. Additionally, wipes should be taken and counted on a liquid scintillation counter to verify potential contamination.
. Medium to high energy beta emitters, such as P-32 and Ca-45, can be detected with a pancake GM. The efficiency ranges 15 to 40%, depending on the beta energy.
. Low energy gamma emitters, such as I-125, can be detected with a sodium iodide probe. If the probe possesses a thin window and thin crystal, the detection efficiency is approximately 20%.
. Medium to high energy gamma emitters, such as Tc-99m, can be detected with either GM or sodium iodide probes, depending on the required sensitivity. The sensitivity of GM probes is much lower than for sodium iodide probes, therefore, sodium iodide probes are the preferred alternative.
Model Procedure for Calibrating Survey Instruments (Detailed information about survey instrument calibration may be obtained by referring to ANSI N323A-1997, " Radiation Protection Instrumentation Test and Calibration, Portable Survey f Instruments." Copies may be obtained from the American National Standards Institute,1430 ) Broadway, New York, NY 10018 or ordered electronically at the following address:
<http://www. ansi.org>.
l We will implement the following procedure when calibratmg survey mstruments: 6 I
. Radiation survey mstruments will be calibrated with a radioactive source m accordance with 10 CFR 35.61. Electronic calibrations alone are not acceptable. Survey meters must be calibrated at least annually, before first use, and after servicing. (Battery changes are not I-l Draft NUREG - 1556, Vol. 9
APPENDIX I considered " servicing.") 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. An ideal calibration source should emit the applicable radiation (e.g., alpha, beta, or gamma) with an energy spectrum similar to that to be measured and have a suitably long halflife.
. A radioactive sealed source (s) used for calibrating survey instruments will:
- Approximate a point source - Have its apparent source activity or the exposure rate at a given distance traceable by documented measurements to a standard certified to be within 5% accuracy by NIST - Emit the type of radiation measured - Approximate the same energy (e.g., Cs-137, Co-60) as the environment in which the calibrated device will be employed - Provide a radiation dose rate sufficient to reach the full scale (<1000 mR/hr) of the instrument calibrated.
- The inverse square and radioactive decay law must be used to correct changes in exposure rate due to changes in distance or source decay.
. A record must be made of each survey meter calibration and retained for 3 years after each record is made (10 CFR 20.2103(a) and 10 CFR 35.2061). . Instrument readings should be within 10% of known radiation values at calibrated points; however, readings within 20% shall be acceptable if a calibration chart or graph is prepared and made available with the instrument. . The kinds of scales frequently used on radiation survey meters are calibrated as follows:
- Linear Readout Instruments must be calibrated at no fewer than two points on each scale.
Calibration shall be checked near the ends of each scale (approximately 20% and 80% of each scale).
- Logarithmic Readout Instruments must be calibrated at one point (midpoir.t) on each decade. - Digital Readout Instruments with either manual or automatic scale switching for indicating exposure rates must be calibrated at no fewer than two points on each scale.
Calibration shall be checked near the ends of each scale (approximately 20% and 80% of I each scale). ;
- Digital Readout Instruments without scale switching for indicating exposure rates must l be calibrated at one point (midpoint) on each decade.
]
- Integrating Insmmnts must be calibrated at two dose rates (approximately 20% and l 80% or the dose rate range). !
4 Draft NUREG - 1556, Vol. 9 I-2
i I APPENDIX 1
- Readings above 1000 mR/hr (250 microcoulomb / kilogram per hour) need not be calibrated; ;
however, such scales may be checked for operation and approximately correct response.
- Survey meter calibration reports will indicate the procedure used and the data obtained. The j description of the calibration should include:
- A description of the instrument, including the manufacturer's name, model number, serial number, and type of detector L - A description of the calibration source, including the calibration procedure and the exposure rate at a specified distance on a specified date
- For each calibration point, the calculated exposure rate, the indicated exposure rate, the I deduced correction factor (the calculated exposure rate divided by the indicated exposure l rate), and the scale selected on the instrument )
( - The exposure reading indicated with the instrument in the " battery check" mode (if i available on the instrument) { ! - For instruments with extemal detectors, the angle between the radiation flux field and the detector (i.e., parallel or perpendicular)
- For instruments with intemal detectors, the angle between the radiation flux field and a specified surface of the instrument
- For detectors with removable shielding, an indication whether the shielding was in place or removed during the calibration procedure
- - The exposure rate from a check source, if used
- The name of the person who performed the calibration and the date it was performed
. The following information should be attached to the instrument as a calibration sticker or tag:
- The source that was used to calibrate the instrument
- 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)
- The date of calibration and the next calibration due date
- The apparent exposure rate from the check source, if used.
Calculating the Efficiency of the Nal(TI) Uptake Probe The sodium iodide (thallium doped) [Nal(TI)] uptake probe is commonly used for bioassays of , l ' personnel administering I-131 radionuclides in the form of sodium iodide. RG 8.20 gives the details of bioassay requirements for I-131 radionuclides. ' Appendix B to Part 20 considers the j Annual Limits on Intake (Alls) and Derived Air Concentrations (DACs) of radionuclides for occupational exposure. Converting counts per minute (cpm) to disintegrations per minute (dpm) 13 Draft NUREG - 1556, Vol. 9
I APPENDIX I in' determination of accurate bioassay values is ofimportance in determining thyroid burdens with radioiodine. We will calculate the efficiency of nuclear counting systems on an annual basis, before first use, and/or after repair, using the following procedure:
. Check the instrument's counting efficiency using either a standard source of the same radionuclides 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 efliciency of the instrument.
For example: f(com from std)-(com from bkell = efficiency in cpm / microcurie activity of std in microcuries where: cpm = counts per minute std = standard bkg = background The date of the efliciency test will be attached to the instrument as a calibration sticker or tag and the following information should be attached: . The date of the next efficiency due . 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. We will 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 instrument's counting efficiency, using either a standard source of the same radionuclides 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. ! l 4 Draft NUREG - 1556, Vol. 9 'I4
APPENDIX 1
- Calculate efficiency of the instrument.
For example: I(com from std)- (com from bkcll = efficiency in cpm / microcurie activity of std in microcuries where: cpm = counts per minute std = standard bkg = background The date of the efficiency test will be attached to the instrument as a calibration sticker or tag and the following information should be attached:
- The date of the next efficiency due e Results of efficiency calculation (s)
Reference:
Draft RG FC 413-4," Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments," dated June 1985. 4 i l 1 i 1-5 Draft NUREG - 1556, Vol. 9 l l
- 1
Appendix J Model Procedures for Dose Calibrator Calibration l l
i i i APPENDIX J Model Procedures for Dose Calibrator Calibration l Model Procedures for Testing Dose Calibrators Used to Measure Photon-Emitting Radionuclides We will test for the following at the indicated frequency. We will consider repair, replacement, or arithmetic correction if the dose calibrator falls outside the suggested tolerances. We will record, for all tests, the name of the individual who performed the test. Note: A licensee shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10% and shall mathematically correct dosage readings [for dosages greater than 1.11 MBq (30 Ci)] if the geometry or linearity error exceeds 10%.
. 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%). After repair, adjustment, or relocation to another building of the dose calibrator, we will repeat the above tests before use. 1 Constancy means reproducibility in measuring a constant source over a long period of time. We will assay at least one relatively long-lived source such as Cs-137, Co-60, cobalt-57 (Co-57)2, or radium-226 (Ra-226)2 using a reproducible geometry each day before using the calibrator. We will consider the use of two or more sources with different photon energies and activities. We will use the following procedure: 1
- 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 ifit is used.
- 3. For each source used, record (e.g., plot, log, etc.) the activity measured, the model and i
serial number of the instrument, the identity of the radionuclides contained in the check source, and the date of the check. 8 Co-57 and Ra-226 are not subject to NRC licensing; the appropriate State agency should be consulted to I determine its requirements for possessing this material. Jl Draft NUREG - 1556, Vol. 9 l
APPENDIX J
- 4. Using one of the sources, repeat the above procedure for all commonly used radionuclides l settings. Record (e.g., plot, log, etc.) the results.
- 5. Notify the RSO or the AU if the test results fall outside 10% of the expected results.
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 ofits use between the maximum activity administered and 1.1 MBq (30 Ci). This test will be done using a vial or syringe of technetium-99m (Tc-99m) whose activity is at least as large as the maximum activity normally assayed for administration. Time Decay Method We will use the following procedure:
- 1. Assay the Tc-99m syringe or vial in the dose calibrator, and subtract background to obtain the net 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 1.1 MBq (30 curies). For dose calibrators on which you select a range with a switch, select the range you would normally use for the measurement.
- 3. Convert the time and date information you 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, and the date(s) of the test.
- 5. Notify the RSO if the worst deviation is more than *10%.
Shield Method If we decide to use a set of" sleeves" of various thicknesses to test for linearity, it will first be necessary to calibrate the sleeves. We will use the following procedure: Note: The applicant should review the procedure for calibrating sleeves against the manufacturer's instructions. Some sleeve manufacturer's procedures indicate that various sleeves 1 i Draft NUREG - 1556, Vol. 9 J-2
APPENDIX J 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% of decay of Tc-99m).
L i 2. Put the base and sleeve 1 in the dose calibrator with the vial. Record the sleeve number and ! l indicated activity. l 3. Remove sleeve 1 and put in sleeve 2. Record the sleeve number and indicated activity. l l l 4. ' Continue for all sleeves.
- 5. Complete the decay method linearity test steps 2 through 5 above.
l 6. From the data recorded in step 4 of the decay method, find the decay time associated with i 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.
- 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. l 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.
J-3 Draft NUREG - 1556, Vol. 9
l APPENDIX J ,
- 6. Record the measured activities, the calculated activities, the time elapsed between -
measurements, the model number and serial number of the dose calibrator, and the date(s) of the test.
.7. ' Notify the RSO if the worst deviation is more than *10%.
Geometry independent means that the indicated activity does not change with volume or configuration. The test for geometry independence will be conducted using syringes and vials I that are representative of the entire range of size, shape, and constructions normally used for injections 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-centimeter cubed (cc) plastic syringes and that radiopharmaceutical kits are made in 30-cc glass vials and your predetermined safety margin is *10%.
' Note: If you do not use these volumes, change the procedure so that your syringes and vials are tested throughout the range of volumes commonly used. - We will use the following procedure:
- 1. In a small beaker or vial, mix 2 cc of a solution of Tc-99m with an activity concentration between 1 and 10 mci / milliliter (ml). Set out a second small beaker or vial with water.
- 2. - To test the geometry dependence for a 3-ce syringe, draw 0.5 cc of the Tc-99m solution l 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 you have assayed a 2.0-ce volume.
- 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. Alternately, you may graph the data and draw horizontal 10% error lines above and below the chosen " standard volume."
l
- 6. Record the model and serial number of the dose calibrator, the configuration of the source
, measured, the activity measured for each volume measured, and the date of the test. l
- 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.
Draft NUREG - 1556, Vol. 9 J-4 ; l
APPENDIX J
- 8. To test the geometry dependence for a 30-cc glass vial, draw 1.0 cc of the Tc-99m solution i into a syringe and then inject it into the vial. Assay the vial. Record the volume and 1 activity indicated. I
- 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 you have assayed a 19.0-ce volume. The entire process must be L completed within 10 minutes.
- 11. - Select as a standard the volume closest to that normally used for mixing )
radiopharmaceutical kits. For all the other volumes, divide the standard activity by the ! activity indicated for each volume. The quotient is a volume correction factor. Alternatively, you may graph the data and draw horizontal 10% error lines above and below the chosen " standard volume." l 12, Record the model and serial number of the dose calibrator, the configuration of the source j measured, the activity measured for each volume measured, and the date of the test.
]
! 13. Notify the RSO if any correction factors are greater than 1.1 or less than 0.9, or if any data pomts lie outside the 10% error lines. l i Accuracy means that, for a given calibrated reference source, the indicated activity (e.g., mci) value is equal to the activity value determined by 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 i and from many radionuclides suppliers. At least one source with a principal photon energy l- between 100 kev and 500 kev (e.g., Co-57 or Ba-133) will be used. We will consider using at least one reference source whose activity is within the range of activities normally assayed. l We will use the following procedure:
- 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 l ' 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.
l 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 radionuclides contained in the source and its activity,
< the date of the test, and the results of the test.
J-5 Draft NUREG - 1556, Vol. 9 I
. . _ --- .___.--__.---..-_-__.----____._______._____---.-----__n
APPENDIX J
- 5. Not:fy the RSO if the test results do not agree, within *10%, with the certified value of the 4
reference source (s). 1 l
- 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 radionuclides settings, We will, through the RSO,' ensure that the operation of the dose calibrator is in accordance with approved procedures and regulatory requirements.
l Draft NUREG - 1556, Vol. 9 J-6
l \ I i l Appendix K Suggested Medical Licensee Audit
APPENDIX K Suggested Medical Licensee Audit Annual Radiation Protection 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 which do { not apply to the licensee's activities, and activities that have not occurred since the last audit need j not be reviewed at the next audit. Date of This Audit: Date of Last Audit: 1 Next Audit Date: Auditor: Date: (Signature) Management Review: Date: i (Signature) I Audit History i A. Were previous audits conducted annually (20.1101]? B. Were records of previous audits maintained [20.2102]? C. Were any deficiencies identified during previous audit? 4 D. Were corrective actions taken? (Look for repeated deficiencies). Organization and Scope of Program A. Radiation Safety Officer
- 1. If the RSO was changed, was license amended [35.13]?
- 2. Does new RSO meet NRC training requirements [35.50 or 35.900,35.57,35.59]?
- 3. Is RSO fulfilling his/her duties [35.24]?
l B. Multiple places of use? If yes, list locations l C. Are all locations listed on license? [L/C] D. Were annual audits performed at each location [20.1101]? If no, explain. E. Describe scope of the program (staff size, number of procedures performed, etc.). K-1 Draft NUREG - 1556, Vol. 9 i
APPENDIX K F. Licensed Material ! 1. Isotope, chemical form, quantity and use as authorized [L/C)?
- 2. Does the total amount of radioactive material possessed require financial assurance
[30.35(a)]? If so, is financial assurance adequate? .
- 3. Calibration and reference sources [35.65]? !
i
- a. Scaled sources manufactured and distributed by a person licensed pursuant to l' 10 CFR 32.74 or equivalent Agreement State regulations and sources do not exceed 30 millicuries each [35.65(a)]?
- b. Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 15 millicuries [35.65(b)]?
- c. Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed 200 microcuries each and does not exceed 10E3 times the quantities in Appendix B of Part 30 [35.65(c)]?
- d. Technetium-99m in individual amounts as needed [35.65(d)]?
- 4. Unsealed material used under 35.100,200, and 300 are:
- a. Obtained from a manufacturer or properly licensed organization [32.72]? AND/OR
- b. Prepared by a physician user, an authorized nuclear pharmacist, or an individual under the supervision of an authorized nuclear pharmacist or physician user?
G. Are the sealed sources possessed as described in the Sealed Source and Device Registration (SSDR) Certificate? Are copies of(or access to) SSDR Certificates possessed? Are manufacturers' manuals for operation and maintenance of medical devices possessed? _[32.210]? H. Are the actual uses of medical devices consistent with the authorized uses listed on the
. license?
I. If places of use changed, was the license amended [35.13 (e)]? J. If control oflicense was transferred or bankruptcy filed, was NRC prior consent obtained or notification' made, respectively (30.34(b)]? Radiation Safety Program i
' A.' Minor changes pursuant to [35.26]?
B. Records ofchanges maintained [35.2026]? ' Draft NUREG - 1556, Vol. 9 K-2
I APPENDIX K l l C. Content and implementation reviewed annually by the licensee [20.1101(c)]? D. Records of reviews maintained [20.2102]? Use by Authorized Individuals [L/C] Compliance is established by meeting at least one criterion under each category. A. Authorized Nuclear Pharmacist [35.55 or 35.980,35.57,35.59] Does Not' Apply to Facilities That Are Registered / Licensed by FDA/ State Agency as a Drug Manufacturer with Distribution Regulated Under Part 32
- 1. Certified by specialty board ,
i
- 2. Identified on NRC or Agreement State hcense !
l i
- 3. Identified on permit issued by broad scope licensee
- 4. Listed on facility license B. Authorized User [35.57,35.59, .and 35.290,35.292,35.390,35.490,35.590,35.690, or Subpart J]
- 1. Certified by specialty board
- 2. Identified on NRC or Agreement State license
- 3. Identified on permit issued by broad scope licensee
- 4. Listed on facility license C. Authorized Medical Physicist [35.51 or 35.961,35.57,35.59]
- 1. Certified by specialty board j
- 2. Identified on NRC or Agreement State license
- 3. Identified on permit issued by broad scope licensee 4.- Listed on facility license ;
l Mobile Service A. Operates services per [35.80,35.647]? B. Compliance with 20.1301 evaluated and met? I C. Letter signed by management of each client [35.80(a)]? K-3 Draft NUREG - 1556, Vol. 9 t.
1 i APPENDIX K D. Licensed material was not delivered to client's address (unless client was authorized) [35.80(b)]? E. Dosage measuring instruments checked for proper function before used at each address of use or op each day of use, if more frequent [35.80(c)]? F. Survey instruments checked for proper operation before used at each address of use [35.80(d)]? G. Survey of all areas of use prior to leaving each client address [35.80(e)]? H. Additional technical requirements for mobile remote afterloaders per [35.647]? Amendments Since Last Inspection [35.13] A. Any Amendments since last inspection [35.13]? Notifications Since Last inspection [35.14] A. Appropriate documentation provided to the NRC for authorized nuclear pharmacists, authorized medical physicist, or authorized user no later than 30 days after the individual starts work [35.14(a)]? B. NRC notified within 30 days after authorized user, authorized nuclear pharmacist, authorized medical physicist, or RSO stops work or changes name, licensee's mailing address or name changes without a transfer of control of the license, or licensee has added to or changed an area of use for 35.100 or 35.200 use [35.14(b)]? C. Any Notifications since last inspection [35.14]? Training, Retraining, And instructions to Workers A. Have workers been provided with required instructions [19.12,35.27]? B. Is the individual's understanding of current procedures and regulations adequate? C. Training program implemented?
- l. Operating procedures [35.310,35.410,35.610]?
- 2. Emergency procedures [35.310,35.410,35.610]?
- 3. Periodic training required and implemented [35.310,35.410,35.610]?
- 4. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed and was refresher training provided, as needed [10 CFR 19.12]?
Draft NUREG - 1556, Vol. 9 K-4
APPENDIX K
- 5. Was each supervised user instructed in preparation of material, principles and procedures for radiation safety, device usage and administration of written directives, as appropriate
[35.27]?
- 6. Are initial and periodic training records maintained for each individual [35.2310]?
- 7. Briefly describe training program:
D. Additional therapy device instructions / training
- 1. Unit operation, inspection, associated equipment, survey instruments [35.610]?
- 2. I.icense conditions applicable to the use of the unit?
- 3. Emergency drills [35.610]?
E. Part 20 Workers cognizant of requirements for:
- 1. Radiation Safety Program [35.24,35.26,20.1101]?
- 2. Annual dose limits [20.1301,20.1302]?
- 3. New forms 4 and 57
- 4. 10% monitoring threshold [20.1502]?
- 5. Dose limits to embryo / fetus and declared pregnant worker (20.1208]?
- 6. Grave Danger Posting (20.1902]?
- 7. Procedures for opening packages [20.1906]?
F. Supervision ofindividuals by authorized user in accordance with 10 CFR 35.27? Manual Brachytherapy And Unsealed Therapy Training A. Safety instruction to personnel provided include [10 CFR 35.310,10 CFR 35.410]:
- 1. Control of patient and visitors?
- 2. Routine visitation to patients in accordance with 10 CFR 20.1301(a)(1) and (3)?
- 3. Contamination control and size / appearance of sources?
- 4. Safe handling and shielding instructions?
- 5. Waste control?
K-5 Draft NUREG - 1556, Vol. 9
- APPENDIX K-
- 6. RSO and AU notification in emergency or death?
- 7. Records retained [35.2310]? .
- Facilities A. Facilities as described in license application?
B. Therapy device facilities provided with electrical interlock system, viewing and intercom systems, radiation monitor, source retraction mechanism, and source indicator lights [35.615]? C. Emergency source recovery equipment available [35.415,35.615]?
' D. Storage areas:
- 1. Materials secured from unauthorized removal or access [20.1801]?
- 2. Licensee controls and maintains constant surveillance oflicensed material not in storage
[20.1802]? E. Therapy unit operation:
- 1. . Device, sources, and console keys controlled adequately [20.1801,35.610(a)(1)]?
- 2. Restricted to certain source orientations and/or gantry angles [L/C]?
- 3. Ceases to operate in restricted orientation (s) [L/C]?
- 4. Only one radiation device can be placed in operation at a time within the treatment room
[L/C)? Dose or Dosage Measuring Equipment A. Possession, use, calibration, and check ofinstruments to measure activities of photon emitting radionuclides {10 CFR 35.60]:
- 1. Instrumentation possessed and used?
- 2. Constancy and proper operation checked at the beginning of each day of use?
- 3. Accuracy, linearity, and geometry dependence tests performed before initial use and -
following repair for each instrument?
- 4. Accuracy and linearity tests performed annually?
l
- 5. Dosage readings mathematically corrected for geometry or linearity errors greater than )
*10%?
' Draft NUREG - 1556. Vol. 9 K-6 I l
APPENDIX K
- 6. Instrument repaired or replaced when accuracy or constancy error exceeded 10%?
- 7. Approved procedures followed?
- 8. Records maintained and include required information [10 CFR 35.2060]?
B. Instrumentation - Alpha- or beta-emitting radionuclides [35.62]?
- 1. List type of equipment used to assay alpha and beta particles:
- 2. Approved procedures for use ofinstrumentation followed?
- 3. Accuracy, linearity, and geometry dependence tests performed before initial use and following repair?
- 4. Constancy and proper operation checked at the beginning of each day of use?
- 5. Accuracy and linearity tests performed annually?
- 6. Dosage readings mathematically corrected for geometry or linearity errors greater than 10%?
- 7. Instrument repaired or replaced when accuracy or constancy error exceeded *10%?
- 8. Records maintained [10 CFR 35.2060]?
C. Determination of dosages of unsealed byproduct material [35.63]?
- 1. Each dosage determined and recorded prior to medical use [35.63(a)]?
- 2. Measurement made either by direct measurement or by decay correction [35.63(b)]?
- 3. Measurement for a dosage of photon-emitting radionuclides prepared by the licensee made by direct measurement or by combination of measurement and calculation [35.63(c)]?
- 4. Measurement of an alpha- or beta-emitting radionuclides prepared by the licensee made by direct measurement or by combination of measurements anu calculations [35.63(c)]?
D. Licensee uses generators?
- 1. First eluate after receipt used for radiopharmaceuticals tested for Mo-99 breakthrough
[35.204(b)]?
- 2. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 Ci per mci of Tc-99m (35.204(a)]?
- 3. Records maintained [35.2204]?
K-7 Draft NUREG - 1556, Vol. 9
APPENDIX K E. Dosimetry Equipment [35.630]
- 1. Calibrated system available for use [35.630(a)]?
- 2. Calibrated by NIST or an AAPM-accredited lab within previous two years and after servicing [35.630(a)(1)] OR calibrated by intercomparison per [35.630(a)(2)]?
- 3. Calibrated within the previous four years [35.630(a)(2)]?
- 4. Licensee has available for use a dosimety system for spot-check measurements
[35.630(b)]?
- 5. Record of each calibration, intercomparison, and comparison maintained [35.2630]?
Radiation Protection And Control of Radioactive Material A. Use ofradiopharmaceuticals:
- 1. Protective clothing worn?
- 2. Personnel routinely monitor their hands?
- 3. No eating / drinking in use/ storage areas?
- 4. No food, drink, or personal effects kept in use/ storage areas?
- 5. Proper dosimetry worn?
- 6. Radioactive waste disposed in proper receptacles?
- 7. Syringe shields and vial shields used [35.69]?
B. Leak tests and Inventories:
- 1. Leak test performed on sealed sources and brachytherapy sources [35.67(b)(1)]?
- 2. Inventory of sealed sources and brachytherapy sources performed at intervals not to exceed six months [35.67(g)]?
- 3. Records maintained [35.2067]?
Radiation Survey instruments ) i A. Survey instruments used to show compliance with Part 20 and 30.33(a)(2). l
- 1. Appropriate operable survey instruments possessed or available [10 CFR Part 20]? I I
DraA NUREG - 1556. Vol. 9 K-8
[ APPENDIX K
' 2. Calibrations [35.61(a) and (b)]:
- a. Before first use, annually & after repairs?
I b. Within 20% in each scale or decade ofinterest?
- 3. Records maintained [35.2061]?
B. Radiation surveys performed [20.1501,35.70]?
- 1. Daily in all areas where radiopharmaceuticals requiring a written directive are prepared or administered (except patient rooms) [35.70]? .
; 2. Weekly in all areas where radiopharmaceuticals or waste is stored?
L 3. Weekly wipes in all areas where radiopharmaceuticals are routinely prepared, administered or stored? I- 4. Triggerlevels established?
- 5. Corrective action taken and documented if trigger level exceeded?
- 6. Techniques can detect 0.1 mR/hr,2000dpm?
- 7. Quarterly in brachytherapy source storage area?
p
- 8. Surveys as defined in the Sealed Source and Device Registry 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 does not exceed the levels stated in the Registry [35.652(a)] and records maintained [35.2652]?
- a. - After new source installation?
- b. 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 device or the j E source (s)? l Public Dose A. ~ Is licensed material used in a manner to keep doses below ImSv (100 mrem) in a year [10 CFR 20.1301(a)(1)]? B. Has a survey or evaluation been performed per 10 CFR 20.1501(a)? ; C. Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation? ! D. Do unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in any one hour [10 CFR 20.1301(a)(2)]? l K9 Draft NUREG - 1556, Vol. 9 L_____ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . - - _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ - - - _ _ _ _ _ _ _ _ _ - - _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . - _ _ _ . - - - - - - - _ _ _
APPENDIX K E. Is licensed material used or stored in a manner that would prevent unauthorized access or removal [10 CFR 20.1801]? F. Records maintained [10 CFR 20.2103,10 CFR 20.2107]? Patient Release A. Individuals released when TEDE less than 0.5 rem [35.75(a)]? B. Instructions to breast-feeding women include required information [35.75(b)]? C. Release records maintained if 35.2075(b) criteria are met (35.2075(a)]? D. Records ofinstructions given to breast-feeding women maintained, if required [35.2075(c)]? Radiopharmaceutical Therapy A. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance, release and contamination controls [35.315(a)]? B. RSO and AU promptly notified if patient died or had a medical emergency [35.315(b)]? Brachytherapy A. Safety precautions implemented to include posting, stay times, and emergency response equipment [35.415]? B. Patients surveyed immediately after implant [35.404(a)]? C. Patients surveyed immediately after removing the last temnorary implant source [35.404(b)]? E. Records maintained [35.2404]? Radioactive Waste A. Disposal
- 1. Decay-in-storage [35.92]
- 2. Procedures followed [35.92]?
- 3. Labels removed or defaced [20.1904,35.92]?
B. Special procedures performed as required [L/C)? C. Improper / unauthorized disposals [20.2001]? Draft NUREG - 1556, Vol. 9 K-10
APPENDIX K Di Records maintained [20.2103(a),20.2108,35.2092]?
- E. Emuents
- 1. Release to sanitary sewer [20.2003]?
- a. Material is readily soluble or readily dispersible [20.2003(a)(1)]?
- b. Monthly average release concentrations do not exceed 10 CFR Part 20 App. B, Table 2 values? I
- c. No more than 5 Ci of H-3,1 Ci of C-14 and 1 Ci of all other rad:onuclides combined released in a year [20.2003]?
- d. Procedures to ensure representative sampling and analysis implemented [20.1501]?
- 2. Release to septic tanks (20.2003]?
- a. Within unrestricted limits [10 CFR Part 20 App. B, Table 2, Part 20]?
- 3. Wasteincinerated?
- a. License authorizes [20,2004(a)(3)]?
- b. Directly monitor exhaust?
E c. Airborne releases evaluated and controlled [20.1501,20.1701]?
- 4. Air emuents and ashes controlled [20.1101,1201,1301,1501,2001, L/C]? -
(See also IP 87102, RG 8.37}
- a. Air emuent less than 10 mrem constraint limit [20.1101]
- b. If no, reported appropriate information to NRC i.' Corrective actions implemented and on schedule?
l
- c. Description of emuent program
- i. Monitoring system hardware adequate?
ii. Equipment calibrated, as appropriate? 4 iii. Air samples / sampling technique (i.e. charcoal, HEPA, etc.) analyzed with appropriate instrumentation? r-
]
F. Waste storage 1
- 1. Protection from elements and fire?
K-11 Draft NUREG - 1S$6. Vol. 9
APPENDIX K
- 2. Control of waste maintained [20.1801]?
- 3. Containers properly labeled and area properly posted [20.1902,20.1904]?
- 4. Package integrity adequately maintained?
G. Waste disposal
- 1. Sources transferred to authorized individuals [20.301,20.2001,30.51]?
- 2. Name of organization:
H. Records of surveys and material accountability are maintained [20.2103,20.2108]? Receipt And Transfer of Radioactive Material A. Describe how packages are received and by whom: B. Written package opening procedures established and followed [20.1906(e)]? C. All incoming packages with a DOT label wiped, unless exempted (gases and special form) [20.1906(b)(1)]? D. Incoming packages surveyed [20.1906(b)(2)]? E. Monitoring in (C) and (D) performed within time specified [20.1906(c)]? F. Transfer (s) performed per [30.41]? G. All sources surveyed before shipment and transfer [20.1501(a),49 CFR 173.475(I)]? H. Records of surveys and receipt / transfer maintained [20.2103(a),30.51]? I. Package receipt / distribution activities evaluated for compliance with 20.1301? Transportation (10 CFR 71.5(a) and 49 CFR 171-189) A. Shipments are: [ ] delivered to common carriers [ ] transported in own private vehicle [ ] both [ ] no shipments since last audit i B. Retum radiopharmacy doses or sealed sources? 1
- 1. Licensee assumes shipping responsibility?
Draft NUREG - 1556, Vol. 9 K 12
l APPENDIX K
- 2. If NO, describe arrangements made between licensee and radiopharmacy for shipping responsibilities:
C. Packages
- 1. Authorized packages used [173.415,416]?
- 2. Performance test records on file?
- a. DOT-7A packages [173.415(a)]
- b. Special form sources [173.476(a))
- 3. Two labels (White-1, Yellow-II, Yellow-Ill) with TI, Nuclide, Activity, and Hazard Class
[l72.403,173.441]? l 4. Properly marked (Shipping Name, UN Number, Package Type, RQ, "This End Up" l (liquids), Name and Address of consignee) [172.301,304,310,312,324]?
- 5. Closed and sealed during transport [173.475(f)]? !
D. Shipping Papers
- 1. Prepared and used [172.200(a)]?
, 2. Proper (Shipping Name, Hazard Class, UN Number, Quantity, Package Type, Nuclide, l RQ, Radioactive Material, Physical and Chemical Form, Activity, Category of Label, TI, l Shipper's Name, Certification and Signature, Emergency Response Phone Number, l " Limited Quantity"(if applicable)," Cargo Aircraft Only"(if applicable)} [172.200-204]? l 3. Readily accessible during transport [177.817(e)]? Teletherapy And Gamma Stereotactic Radiosurgery Servicing A. Inspection and servicing performed following source replacement or at intervals not to exceed 5 years [35.655(a)]? B. Licensee arranged for needed service identified during the inspection? C. Service performed by persons specifically authorized to do so [35.655(b)]? Full Calibration-Therapeutic Medical Devices ' l l A. Licensee uses one of the proper protocols (TG-21, AAPM 54, TG-56, TG-40) [35.632,633, 635]? B. Performed prior to first patient use [35.632(a)(1),633(a)(1),635(a)(1)]? f K-13 Draft NUREG - 1556, Vol. 9
APPENDIX K C. At intervals not to exceed one year for teletherapy, gamma stereotactic, and LDR remote allerloader; at intervals not exceeding 120 days for HDR and PDR remote afterloaders [35.632(a)(3)], 633(a)(3) and (4),635(a)(3)]? D. Whenever spot-checks indicate output differs from expected by 5% [35.632(a)(2)(i), l 633(a)(2)(i),635(a)(2)(i)]? E. After source exchange, relocation, and major repair or modification [35.632(a)(2),633(a)(2), ! 635(a)(2)]? I F. Performed with properly calibrated instrument [35.632(c),35.633(d),35.635(c)]? G. Includes:
- 1. For teletherapy:
- a. Output measured within *3% of expected for the range of field sizes, range of distances [35.632(b)(1)]?
- b. Coincidence of radiation field and field light localizer [35.632(b)(2)]?
- c. Uniformity of radiation field and beam angle dependence [35.632(b)(3)]?
- d. Timer constancy and linearity over the range of use [35.632(b)(4)]?
- e. On-off error [35.632(b)(5)]?
- f. Accuracy of all measuring and localization devices [35.632(b)(6)]?
- 2. For HDR and PDR remote afterloaders:
- a. Output measured within 5% of expected [35.633(b)(1)]? l
- b. Source positioning accuracy within 1 millimeter [35.633(b)(2)]?
- c. Source retraction with backup battery upon power failure [35.633(b)(3)]?
- d. Electrically assisted treatment room doors with power turned off[35.633(b)(4)]?
- e. Source guide tubes [35.633(c)(1)]?
- f. Timer accuracy and linearity over the range of use [35.633(c)(1)]?
- g. Length of the connectors [35.633(c)(1)]?
- h. Annual check of source guide tube and connector function (35.633(c)(1)]?
- 3. For LDR remote afterloaders:
- a. Output measured within 5% of expected [35.633(b)(1)]?
- b. Source positioning accuracy within 1 millimeter [35.633(b)(2)]?
- c. Source retraction with backup battery upon power failure [35.633(b)(3)]?
Draf1 NUREG - 1556, Vol. 9 K-14
r APPENDIX K
- d. Autoradiograph of the source (s) to verify source (s) arrangement and inventory
[35.633(c)(2)]?
- e. Quarterly spot check of the absolute timer accuracy [35.633(c)(2)]?
l
- 4. For gamma stereotactic radiosurgery:
- a. Output measured within *3% of expected [35.635(b)(1)]?
- b. Helmet factors [35.635(b)(2)]?
- c. Isocenter coincidence [35.635(b)(3)]?
- d. Timer accuracy and linearity over the range of use [35.635(b)(4)]?
- e. On-off error [35.635(b)(5)]?
- f. Trunnion centricity [35.635(b)(6)]?
H. Output corrected mathematically [35.632(e),35.633(f),35.635(e)]? I. Records maintained [35.2632,35.2633,35.2635]? Periodic Spot Checks For Therapeutic Devices A. Performed at required frequency [35.642(a),643(a),644(a),645(a)]? D. Procedures established by medical physicist [35.642(b),35.643(b),35.644(c),35.645(b)]? C. Procedures followed? l D. Medical physicist reviews results within 15 days [35.642(c),35.643(b),35.644(c), 35.645(b)]? E. Performed with properly calibrated instrument (35.642(a)(5),35.643(c)(2),35.645(c)(2)(i)]? F. Output and safety spot checks include:
- 1. For teletherapy:
- a. Timer constancy and linearity over the range of use [35.642(a)(1)]?
l
- b. On-off error [35.642(a)(2)]?
- c. Coincidence of radiation field and field light localizer [35.642(a)(3)]?
- d. Accuracy of all measuring and localization devices [35.642(a)(4)]?
- e. The output for one typical set of operating conditions [35.642(a)(5)]? I l
- f. Difference between measured and expected output [35.642(a)(6)]?
l K 15 Draft NUREG - 1556, Vol. 9 l i
_ - = _ - - _ - _ _ - _ _ _ _ __ APPENDIX K :
- g. Interlock systems [35.642(d)(1)]?
l h. Beam stops and dead-man switches [35.642(d)(2)]? I. Source exposure indicator lights [35.642(d)(3)]?
- j. Viewing and intercom systems [35.642(d)(4)]?
- k. Treatment room doors, inside and out [35.642(d)(5)]?
- 1. Electrical treatment doors with power shut off[35.642(d)(6)]?
- 2. For HDR and PDR remote afterloaders:
- a. Source positioning accuracy [35.643(c)(1)]?
- b. The output [35.643(c)(2)]?
- c. Difference between measured and expected output [35.643(c)(3)]?
- d. Interlock systems [35.643 (d)(1)]?
- e. Source exposure indicator lights [35.643(d)(2)]?
- f. Viewing and intercom systems [35.643(d)(3)]?
- g. Emergency response equipment (35.643(d)(4)]?
- h. Radiation monitors used to indicate source position [35.643(d)(5)]?
- i. Timer constancy [35.643(d)(6)]?
- j. Clock (date and time) in the unit's computer [35.643(d)(7)]?
- k. Simulated cycle of treatment (35.643(e)]?
- 3. For LDR remote afterloaders:
- a. Interlock systems [35.644(a)(1)]?
- b. Source exposure indicator lights [35.644(a)(2)]?
- c. Viewing and intercom systems [35.644(a)(3)]?
- d. Emergency response equipment [35.644(a)(4)]?
- e. Radiation monitors used to indicate source position (35.644(a)(5)]? ,
- f. Timer constancy [35.644(a)(6)]?
- g. Clock'(date and time) in the unit's computer [35.644(a)(7)]?
- h. Simulated cycle of treatment [35.644(b)]?
Draft NUREG - 1556, Vol. 9 K 16
I APPENDIX K
- 4. For gamma stereotactic radiosurgery:
- a. Treatment table retraction mechanism [35.645(c)(1)(i)]?
- b. IIelmet microswitches [35.645(c)(1)(ii)]? :
1
- c. Emergency timing circuits [35.645(c)(1)(iii)]?
{
- d. Emergency off buttons [35.645(c)(1)(iv)]?
- e. Stereotactic frames and localizing devices [35.645(c)(1)(v)]?-
1
- f. The output for one typical set of operating conditions [35.645(c)(2)(i)]? -
1
- g. '
.ifference between measured and expected output [35.645(c)(2)(ii)]? i
- h. Source output compared against computer calculation of output [35.645(c)(2)(iii)]?
- i. Timer accuracy and linearity over the range of use [35.645(c)(2)(iv)]?
- j. On-off error [35.645(c)(2)(v)]?
- k. Trunnion centricity [35.645(c)(2)(vi)]?
- 1. Interlock systems [35.645(d)(1)]?
- m. Source exposure indicator lights (35.645(d)(2)]?
- n. Viewing and intercom systems [35.645(d)(3)]?
- o. Timer termination [35.645(d)(4)]?
- p. Radiation monitors used to indicate room exposures [35.645(d)(5)]?
- q. Ilydraulic cutoff mechanism (35.645(d)(6)]?
l i G. Licensee promptly repaired items found to be not operating properly and did not use unit l until repaired, if required [35.642(e), 35.643(g), 35.644(d), 35.645(f)]?
- 11. Records maintained [35.2642,35.2643,35.2645]?
i installation, Maintenance, and Repair of Therapy Devices ; A. Only authorized individuals perform maintenance, repair and inspection [35.605]? Name of , organization / individual: l B.- Records of maintenance, inspection and service maintained [35.2605]? ! l K-17 Draft NUREG - 1556, Vol. 9
APPENDIX K ' Operating Procedures For Therapy Devices A. Instructions on location of procedures and emergency response telephone numbers are posted at the device console [35.610(c)]? B. Copy of the entire procedures physically located at the device console [35.610(b)]? C. Proceduresinclude:
- 1. Securing the device, the console, and the console keys [35.610(a)(1)]?
- 2. Ensuring that only the patient is in the treatment room before starting a treatment (except for LDR)[35.610(a)(2)]?
- 3. Preventing dual operation of more than one radiation producing device in the treatment room [35.610(a)(3)]?
- 4. Responding to emergencies or abnormal situations [35.610(a)(4)]?
- 5. Radiation survey of patient is performed to ensure source is returned to shielded position
[35.604(a)]?
- 6. Records of radiation surveys maintained for three years [35.2404]?
D. Authorized medical physicist and authorized user:
- 1. Physically present during initiation of patient treatment with remote afterloaders
[35.615(f)(1), (2), and (3)]?
- 2. Physically present throughout all patient treatments with a gamma stereotactic radiosurgery device [35.615(f)(4)]?
Personnel Radiation Protection A. Exposure evaluation performed [20.1501]? B. ALARA program implemented [20.1101(b)]? C. Extemal Dosimetry
- 1. Monitors workers per [20.1502(a)]?
- 2. External exposures account for contributions from airborne activity [20.1203]? {
- 3. Supplier Frequency
- 4. Supplier is NVI.AP-approved [20.1501(c)]? )
- 5. Dosimeters exchanged at required frequency?
Draft NUREG - 1556, Vol. 9 K-18
, APPENDIX K D. Internal Dosimetry
- 1. Monitors workers per [20.1502]?
- 2. Briefly describe program for monitoring and controlling internal exposures (20.1701, 20.1702]?.
- 3. Monitoring / controlling program implemented (includes bioassays) [35.315(a)]?
- 4. Respiratory protection equipment [20.1703]?
E. Reports
- 1. Reviewed by Frequency
- 2. Auditor reviewed personnel monitoring records for period to
- 3. Prior dose determined for individuals likely to receive doses [20.2104]?
- 4. Maximum exposures TEDE Other
- 5. Maximum CDEs Organs ti. Maximum CEDE
- 7. Internal and external summed [20.1202]?
- 8. TEDEs and TODEs within limits [20.1201]?
- 9. NRC forms or equivalent [20.2104(d),2106(c)]?
- a. NRC-4 Complete:
- b. NRC-5 Complete:
- 10. Worker declared her pregnancy in writing during inspection period (review records)? If l yes, in compliance with [20.1208] and records maintained [20.2106(e)]?
l F. Who performed any PSEs at this facility (number of people involved and doses received) L [20.1206,2104,2105,2204]? G. Records of exposures, surveys, monitoring, and evaluations maintained [20.2102,2103, ; 2106]? l 1 i
- Confirmatory Measurements Detail location and results of confirmatory measurements K 19 Draft NUREG - 1556, Vol. 9 t.
APPENDIX K Medical Events A. If medical events [ criteria in 35.3045(a)] have occurred since the last audit, evaluate the . incident (s) and procedures for implementing & administering written directives using the ! existing guidance.
- 1. Event date Information Source
- 2. Notifications NRC Ops Center Region Referring Physician Patient In writing /By telephone If notification did not occur, why not?
- 3. Written Reports [35.3045]
- a. Submitted to Region within 15 days?
- b. Copy to patient within 15 days?
B. Records maintained (35.2045]? Notification and Reports A. In compliance with [19.13,30.50] (reports to individuals, public and occupational, monitored to show compliance with Part 20)? B. In compliance with [20.2201,30.50] (theft or loss)? { l C. In compliance with [20.2202,30.50] (incidents)? l D. In compliance with [20.2203,30.50] (overexposure and high radiation levels)? E. Aware of NRC Ops Center phone number? F. In compliance with [20.2203] (Constraint on air emissions)? l Posting and Labeling A. NRC Form 3," Notice to Workers"is posted [19.11]? B. Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures adopted pursuant to Part 21, and license documents are posted, or a notice indicating where documents can be examined is posted (19.11,21.6]? Draft NUREG - 1556, Vol. 9 K-20
l I l APPENDIX K l C. Other posting and labeling per (20.1902,1904] and not exempted by [20.1903,20.1905]? i Recordkeeping for Decommissioning A. Records ofinformation important to the safe and effective decommissioning of the facility ' maintained in an independent and identifiable location until license termination (30.35(g)]? B. Records include all information outlined in 10 CFR 30.35(g)? Bulletins and Information Noticos A. Bulletins, Information Notices, NMSS Newsletters, etc., received? l i B. Appropriate action in response to Bulletins, Generic Letters, etc.? l Special License Conditions or lasues ) l A. Special license conditions or issues to be revie>ved: B. Evaluation: Audits and Findings A. Summary of f'mdings: B. Corrective and preventive actions: I l l l i l t K 21 Draft NUREG - 1556, Vol. 9
I I l l l l f Appendix L i Model Procedures for an Occupational Dose Program l \ 1 1 I l 4 l i
1 l APPENDIX L l 1 Model Procedures for an Occupational Dose Program
)
Dosimetry is required for individuals likely to receive in 1 year a dose in excess of 10% of the ) applicable regulatory limits in 10 CFR 20.1201. The Total Effective Dose Equivalent (TEDE) is j l the sum of the deep-dose equivalent (external exposure) and the committed effective dose equivalent (internal exposure). To demonstrate that dosimetry is not required, the licensee needs i to have available, for inspection, an evaluation to demonstrate that the workers are not likely to ) exceed 10% of the applicable annual limits. If an individual is likely to receive more than 10% of the annual dose limits, the NRC requires ) the licensee to monitor the dose, to maintain records of the dose, and, at least on an annual basis, to inform the worker of his/her dose. The As Low As Reasonably Achievable "ALARA" Program 10 CFR 20.1101 states that "each licensee must develop, document, and implement a radiation protection program commensurate with the scope and extent oflicensed activities..." and "the licensee shall use, to the extent practicable, procedures and controls based upon sound standard protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA)." Additionally,10 CFR 20.1101 requires that licensees periodically review the content of the radiation protection program and its implementation. ; 1 External Dose Exposure The mechanism by which doses to individuals from exposure to radiamm is evaluated is called dosimetry. Dosimetry allows the licensee to ensure that doses are maintained ALARA. Dosimetry also allows the licensee to show compliance with the occupational dose limits required by the NRC. Providing for the safe use of radioactive materials and radiation is a management responsibility. It is important that management recognize the importance of radiation monitoring in the overall requirements for radiation protection. There are three dose limits included in 10 CFR 20.1201 that apply to external exposure: deep dose to the whole body (5 rems or 0.05 Sv), shallow dose to the skin or extremities (50 rems or 0.5 Sv), and dose to the lens of the eye (15 rems or 0.15 Sv). According to the definitions in i 10 CFR 20.1003, the deep-dose equivalent (DDE) to the whole body is considered to be at a l tissue depth of I cm (1000 mg/cm2), shallow-dose equivalent to the skin or extremities at 0.007 cm (7 mg/cm2), and eye dose equivalent at 0.3 cm (300 mg/cm2). In evaluating the eye dose equivalent, it is acceptable to take credit for the shielding provided by protective lenses. L-1 Draft NUREG - 1556, Vol. 9 l l
APPENDIX L Monitoring an individual's extemal radiation exposure is required by 10 CFR 20.1502(a) if the external occupational dose is likely to exceed 10% of the dose limit appropriate for the individual (i.e., adult, minor, or declared pregnant woman). External radiation monitoring is also required by 10 CFR 20.1502(a)(3) for any individual entering a high or very high radiation area. The use ofindividual monitoring devices for external dose is required for the following:
. For adults who are likely to receive an annual dose in excess of any of the following (each evaluated separately): '
0.5 rem (0.005 Sv) DDE 1.5 rems (0.015 Sv) eye dose equivalent
- 5 rems (0.05 Sv) shallow-dose equivalent to the skin
- 5 rems (0.05 Sv) shallow-dose equivalent to any extremity For minors who are likely to receive an annual dose in excess of any of the following (each evaluated separately):
- 0.05 rem (0.5 mSv) DDE
- 0.15 rem (1.5 mSv) eye dose equivalent
- 0.5 rem (0.005 Sv) shallow-dose equivalent to the skin
- 0.5 rem (0.005 Sv) shallow-dose equivalent to any extremity.
- For declared pregnant women who are likely to receive an annual dose from occupational exposure in excess of 0.05 rem (0.5 mSv) DDE, although the dose limit applies to the entire gestation period.
For individuals entering a high or a very high radiation area. If the licensee determines that monitoring the occupational exposure of some workers is not necessary, he/she must demonstrate to the NRC that these workers will not exceed 10% of these limits using acceptable criteria. In these cases, the licensee need not provide individual monitoring devices to these workers. i The following are examples of criteria NRC accepts: l < the licensee has previous dosimeter monitoring reports for workers in a specific work area that show that the workers are not likely to receive a dose in excess of 10% of the limits; e the licensee has performed appropriate radiation level surveys (using a survey meter or area ! thermoluminescent dosimeter (TLD)) of the work area, and has determined the number of l hours a worker will be present in that work area, and has calculated the dose to workers Draft NUREG - 1556, Vol. 9 L-2 !
APPENDIX L l
. (including " reasonable" accident scenarios) that shows that the workers are not likely to receive a dose in excess of 10% of the limits; a the lico,see 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% of the limits.
External dose is determined by using individual monitoring devices, such as film badges or l thermoluminescent dosimeters (DDE). These devices must be evaluated by a processor that is National Voluntary Laboratory Accreditation Program (NVLAP) approved, as required by j 10 CFR 20.1501. Acceptable exchange frequencies are every 3 months for TLDs and every l month for film badges. The device for monitoring the whole body dose shall be placed near the location expected to receive the highest dose during the year (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. 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 i I 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. l If, after the exposure is received, the licensee somehow learns that the maximum dose to a part of I the whole body was substantially higher than the dose measured by the individual monitoring device, an evaluation shall be conducted to estimate the actual maximum dose. An acceptable alternative approach for highly nonuniform radiation fields is to use more than one dosimeter to separately track doses to different parts of the whole body. At the end of the year, each of the doses for each location would be summed. The deep-dose equivalent to be recorded would be that of the dosimeter location receiving the highest dose. If the licensee determines that extremity monitoring is required, it may be appropriate to use an extremity dosimeter for some, but not all, radiation exposure. The licensee could supply an extremity dosimeter when exposure is nonuniform. When exposure is uniform, the shallow-dose equivalent measured by a torso dosimeter would be representative of the shallow-dose equivalent to the extremities, and separate extremity monitoring would not be needed. If protective gloves are used, it is acceptable to place the extremity' dosimeter under the gloves. 10 CFR 20.2106 requires that the recording for individual monitoring be done on NRC Form 5 or equivalent. NRC Form 5 is used to record for the calendar year doses received. The L-3 Draft NUREG - 1556, Vol. 9
APPENDIX L 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 within the month of January, the change is made at the beginning of the year, and no day is omitted or duplicated in consecutive years. l Because evaluation of dose is an important part of the radiation protection program, it is j important that users return dosimeters on time. Licensees shall be vigorous in their effort to { recover any missing dosimeters. Delays in processing a dosimeter can result in the loss of the stored information. If an individual's dosimeter is lost, the licensee needs to perform and document an evaluation of the dose the individual received and add it to the employee's dose record. Sometimes the most reliable method for estimating an individual's dose is to use his/her receni dose history. In other eases, particularly if the individual does non-routine types of work, it may be better to use doses of co-workers as the basis for the dose estimate. 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 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 investigations. When the exposure to a radiation worker exceeds Investigational Level I in Table L.1 of the occupational exposure in a quarter (Action Level I), an investigation should take place by the RSO, and a consideration of actions that might be taken to reduce the probability of recurrence will be reviewed by the RSO. When the exposure exceeds Investigational Level II in Table L.1 of the occupational exposure in a quarter (Action Level II), an investigation should take place by the RSO, with a consideration of actions to be taken to reduce the probability of occurrence, and a report of the actions should be reviewed by management. Table L.1 Investigational Levels Part of Body Investigational LevelI Investigational LevelII (mrems per calendar quarter) (mrems per calendar quarter) whole body; head and 125 375 trunk; active blood-forming organs; lens of eyes; or gonads hands and forearms; feet 1875 5625 and ankles I skin of whole body 750 2250 Draft NUREG - 1556, Vol. 9 L-4 l
APPENDIX L The RSO will review and record en Form NRC-5, " Current Occupational Extemal Radiation Exposures," or an equivalent form (e.g., dosimeter processor's report) results of personnel monitoring. The following actions shculd be taken at the investigational levels as stated in Table L.1: . Personnel dose less than Investigational Level I. Except when deemed appropriate by the RSO, no further action will be taken in those cases where an individual's dose is less than Table L.1 values for the Investigational Level I. . Personnel dose equal to or greater than Investigational Level I but less than Investigational Level II. When the dose of an individual whose quarterly dose equals or exceeds Investigational Level I, a timely investigation should take place by the RSO. A consideration of actions that might be taken to reduce the probability of recurrence should be reviewed by the RSO following the quarter 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. The RSO should, however, review each such dose in comparison with those of others performing similar tasks as an index of ALARA program quality and should make a record of the review.
- 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 11. A consideration of actions should be taken by the RSO to reduce the probability of occurrence, and a report of the actions should be reviewed by the licensee's management at its first meeting following completion of the investigation. . Re-establishment ofInvestigational Level Il to a level above that listed in Table L.l. In cases where a worker's or a group of workers' doses need 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. Declared Pregnancy and Dose to Embryo / Fetus 10 CFR 20.1208 states that the licensee shall ensure that the dose to an embryo / 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. The pregnancy is declared in writing to include the worker's estimated date of conception. If the fetal exposures have exceeded 0.5 rem (5 mSv), or are within 0.05 rem (0.5 mSv) of this dose, exposures to the fetus will not exceed 50 mrem (0.5 mSv) during the remainder of the pregnancy. The dose to an embryo / fetus shall be taken as the sum of: L-5 Draft NUREG - 1556, Vol. 9
APPENDIX L
. the deep-dose equivalent to the declared pregnant woman; and j~ .
the dose to the embryo / fetus from radionuclides in the embryo / fetus and radionuclides in the declared pregnant woman. I l Methods for calculating the radiation dose to the embryo / fetus can be found in Regulatory Guide 8.36, " Radiation Dose To The Embryo / Fetus." Internal Dose Exposure i With respect to internal exposure, you are required to monitor your occupational intake of f radioactive material and assess the resulting dose ifit appears likely that you will receive greater than 10% of the ALI from intakes in 1 year.10 CFR Part 20 provides terms for radionuclides intakes by means ofinhalation and ingestion, i.e., DAC and ALI.
)
Exposure to airborne radioactivity at a level of 1 DAC for 1 year (2,000 hours) would result in either a committed effective dose equivalent of 5 rems (50 mSv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue, with no consideration for the contribution of extemal dose. For each class of each radionuclides, there are two ALIs, one for ingestion and one for inhalation. 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 of 5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue, again, with no consideration for the contribution of external dose. The effective dose equivalent concept described above makes it possible to combine both the internal and external doses in assessing the overall risk to the health of an individual. The
~ 10 CFR Part 20 dose methodology evaluates the doses to all major body organs, multiplies these doses by the appropriate organ weightin~ g factors, and then sums the organ-weighted doses to obtain a whole body risk-weighted " effective dose." The ALIs and DACs in 10 CFR Part 20, Appendix B, therefore, reflect the doses to all principal organs that are irradiated. The ALI means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value ofintake of a given radionuclides in a year by the reference man that would result in a committed effective dose equivalent (CEDE) of 5 rems or a committed dose equivalent (CDE) of 50 rems to any individual organ or tissue.
Assessment ofintakes of radioactive materials by medical workers can best be determined by bioassay measurements. Bioassay services shall be available if the types and quantities of radioactive material licensed for use at your facility could, under normal operational occurrences, result in airborne levels in normally occupied areas exceeding DACs. Provisions shall be made Draft NUREG - 1556, Vol. 9 L-6
j APPENDIX L for the collection of appropriate samples, analysis of bioassay samples, and evaluation of the results of these analyses to determine intakes. If a worker receives a dose in excess of any of the annual dose limits, the regulations prohibit any l occupational exposure during the remainder of the year in which the limit is exceeded. The l licensee is also required to file an overexposure report with the NRC and provide a copy to the individual who received the dose as required by 10 CFR 20.2203 and 20.2205. l Internal Dose Monitoring (Bioassay Program) For each patient or human research subject receiving radiopharmaceutical therapy, the licensee should measure the thyroid burden of each individual who prepares or admhiisters a dosage of iodine-131 Nal within 24 to 72 hours after administering the dosage. Determining the appropriate frequency of routine bioassay measurements depends upon the exposure potential j and the physical and chemical characteristics of the radioactive material and the route of entry to the body. Elements that shall be considered include: 1) the potential exposure of the individual;
- 2) the retention and excretion characteristics of the radionuclides; 3) the sensitivity of the measurement technique; and 4) the acceptable uncertainty in the estimate ofintake and committed dose equivalent. Bioassay measurements used for demonstrating compliance with the occupational dose limits shall be conducted often enough to identify and quantify potential exposures and resultant intakes that, during any year, are likely to collectively exceed 0.1 times the ALI.
I Two separate categories of bioassay measurements further determine the frequency and scope of measurements: routine measurements and special measurements.
- 1. Routine Measurements include baseline measurements, periodic measurements, and l termination measurements. These measurements shall be conducted to confirm that appropriate control exits and to assess dose.
l Baseline measurements shall be conducted prior to initial work activities that involve i exposure to radiation or radioactive materials, for which monitoring is required. ! I Periodic measurements shall be performed on a frequency determined on an a priori basis, ! considering the likely exposure of the individual. Periodic measurements shall be made when the cumulative exposure to airbome radioactivity, since the most recent bioassay measurement, is > 0.02 ALI (40 DAC hours). Noble gases and airborne particulate with a l radioactive half-life ofless than 2 hours shall be excluded from the evaluation, since l external exposure is generally controlling for these radionuclides. As a minimum, periodic measurements shall be conducted annually. L-7 Draft NUREG - 1556, Vol. 9 l L
APPENDIX L I Termination measurements shall be made when an individual is no longer subject to the bioassay program because of termination of employment or change in employment status. These measurements ensure that any unknown intakes are quantified.
- 2. Special Monitoring considers abnormal and inadvertent intakes from situations such as a failed respiratory protective device, inadequate engineering controls, inadvertent ingestion, contamination of a wound, or skin absorption, which shall be evaluated on a case-by-case basis.
Methods are presented for evaluating bioassay data that will result in calculated intakes acceptable to the NRC for evaluating compliance with the occupational dose limits of 10 CFR 20.1202. Examples of specific exposure situations and the physical and biochemical processes considered in the assessment of the exposures are in Appendix A of Regulatory Guide 10.9," Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program." Estimating Intakes - Evaluation and Investigation Levels Licensees shall estimate the intake for any bioassay measurernent that indicates internally deposited radioactive material resulting from licensed activity. The scope of the evaluation shall be commensurate with the potential magnitude of the intake. For individual exposures with an estimate ofintake less than 0.02 ALI, minimum bioassay measurements are adequate to provide a reasonable approximation ofintake. Repeated follow-up measurements or additional exposure data reviews are not necessary, provided a reasonable estimate of the actual intake can be made based on available data. Evaluation Level The Evaluation Level is the level at which an intake shall be evaluated beyond the initial bioassay measurement. The Evaluation Level is 0.02 times the annual limit on intake (ALI), which is equivalent to 40 DAC hours. For very small intakes, a single bioassay measurement is adequate to estimate intake. For intakes that represent a significant contribution to dose, other available data shall be evaluated. Ifinitial bioassay measurements indicate that an intake is greater than an Evaluation Level of 0.02 ALI, additional available data, such as airbome measurements or additional bioassay measurements, shall be used to obtain the best estimate of actual intake. The primary radiopharmaceutical in medical bioassay programs is I-131 sodium iodide in either solution or capsule form. Greater volatility is associated with I-131 Nal in solution. The j Evaluation Level (0.02 ALI) for I-131(inhalation) is (1 Ci). The ALI for class D I-131 is SE+1 ] Ci (from Appendix B to 10 CFR 20.1001-20.2401); therefore, the Evaluation Level is: i 0.02 x ALI (50 Ci) = 1 Ci (3.7E+4 Bq) Draft NUREG - 1556, Vol. 9 L-8 !
APPENDIX L Investigational Level The Investigational Level is the level at which an intake shall be investigated. The Investigation Level is any intake greater than or equal to 0.1 times the annual limit on intake (ALI). For single intakes that are greater than 10% of the ALI, a thorough investigation of the exposure shall be made; therefore, if a potential intake exceeds an investigation level of 0.1 ALI, multiple bioassay measurements and an evaluation of available workplace monitoring data shall be conducted. If practical, daily measurements shall be made until a pattern of bodily retention and excretion can be established. Such a determination is feasible after as few as three measurements; however, physiologically related variations and uncertainties require that measurements be continued over a longer period of time in some cases. For potential intakes near or exceeding the ALIs, the bioassay data evaluations shall consider any additional data on the physical and chemical characteristics and the exposed individual's physical and biokinetic processes. The Investigational Level for I-131 is: 0.l(10%) x the ALI (50 Ci) = 5 Ci (1.9E+5 Bq) Table L.2 Bioassay Action Levels forI-131 I-131 Intake Level Activity Action Level for I-131 Evaluation Level 1 Ci(2.22 x 106 dpm) 0.02 ALI Investigation Level 5 Ci(1.11 x 10 7dpm) 0.1 ALI Actions taken by RSO if radionuclides Intake level is exceeded:
. Evaluation Level The RSO should collect additional available data, such as airborne measurements or additional bioassay measurements to obtain the best estimate of actual intake. A consideration of actions that might be taken to reduce the probability of recurrence should be reviewed by the RSO in a timely manner following the time when the intake was recorded. If the intake does not equal {
or exceed the Investigational Level, no action related specifically to the intake is required i unless deemed appropriate by the RSO. The RSO should, however, review each such intake in comparison with those of others performing similar tasks as an index of ALARA program l quality and should make a record of the review.
. Investigational Level The RSO should collect multiple bioassay measurements and should evaluate available workplace monitoring data. If practical, daily measurements shall be made until a pattern of bodily retention and excretion can be established. Such a determination is feasible after as L-9 Draft NUREG - 1556, Vol. 9
i 1 APPENDIX L l j few as three measurements. The RSO should investigate in a timely manner the causes of all i personnel intakes exceeding the Investigational Level. A consideration of actions should be taken by the RSO to reduce the probability of occurrence, and a report of the actions should be reviewed by the licensee's management at its first meeting following completion of the investigation. If a worker receives an intake in excess of ALI, the regulations prohibit any occupational exposure during the remainder of the year in which the limit is exceeded. For I-131, the ALI is 50 Ci to the thyroid gland. ALI is the smaller value of uptake of a given radionuclides in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) to the whole body or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table 1, Columns 1 and 2, of Appendix B to 10 CFR 20.1001-20.2401. Types of Measurements Characteristics such as mode ofintake, uptake, and excretion and mode of radioactive decay shall be considered in selecting the most effective and reliable types of measurements. For example, in vivo lung or total body measurements shortly following exposure generally provide reliable estimates ofintakes for most gamma-emitting radionuclides. In vitro measurements shall be used for radionuclides that emit little or no gamma radiation; however, in vitro urine or fecal measurements for the first voiding following exposure, while providing important information for assessing potential significance, do not generally represent equilibrium conditions and thereby shall not be relied upon in evaluating intakes. ICRP Publication 54 and NCRP Report No. 87 provide guidance acceptable to the NRC for determining the types of bioassay measurements that shall be made considering the physical and biological characteristics of the radioactive material. Recordkeeping Records of measurement data, calculations ofintakes, and methods for calculating dose must be maintained as required by 10 CFR 20.1204 (c),20.2103 (b), and 20.2106 (a). Interpretation of Bloassay Measurements The specific scope and depth of the evaluation of bioassay measurements, as discussed in the Estimating Intake - Evaluation and Investigational Levels section, depends on the potential significance of the intake. The methods presented below are acceptable to the NRC staff for correlating bioassay measurements to estimates ofintakes for the purpore of demonstrating compliance with the occupational dose limits of 10 CFR 20.1201. Draft NUREG - 1556, Vol. 9 L-10
APPENDIX L Time of Exposure Accurate estimation ofintake from bioassay measurencats is dependent upon knowledge of time ofintake. Generally, the time ofintake is known considering work activities and other monitoring data, such as air sample data; therefore, the time ofintake will be known for all but unusual situations. When the time ofintake cannot be determined from monitoring data, it can often be determined from information provided by the individual. When information is insufficient to determine the time ofintake, it is acceptable to assume that the intake occurred at the midpoint of the time period since the last bioassay measurement. This initial assumption should be refined by using any available information such as the individual's work schedule, facility operations data, historical air monitoring data, and effective half-life of the radionuclides detected.- Acceptable Biokinetic Models Determining a worker's intake from bioassay measurements involves comparing the measured bodily retention or excretion to a tabulated value. The models and methods used for evaluating bioassay measurements should provide a reasonable assessment of the worker's exposure. For intakes that are a small fraction of the limit, greater inaccuracy in the estimate ofintake can be accepted without significant impact on the overall assessment of a worker's dose; however, for annual exposures for which monitoring is required by 10 CFR 20.1502(b), these methods should i not lead to significant underestimation or overestimation of the actual intake. Variations from predicted retention and excretion for specific individuals can be expected. Excretion of radionuclides may be influenced by the worker's diet, health condition, age, level of physical and metabolic activity, or physiological characteristics. The lung deposition and
)
clearance of the inhaled radionuclides, the particle size distribution, and the time of the excretion also influence the excretion rate of radionuclides. Important considerations for evaluating bioassay measurements include:
*- Appropriate measurement technique (in vivo or in vitro) based on radionuclides decay characteristics (i.e., types of radiation emitted) and biokinetic characteristics (i.e., systemic i uptake and retention and urine and fecal excretion fractions)-
c
. The effects of diuretics or chelation to reduce systemic uptake and to increase excretion or excretion rates; e Representativeness of measurements such as 24-hour or accumulated urine or fecal l l
measurements; ;
- The appropriate lung clearance class (D, W, or Y), if known (see definition of class in ;
10 CFR 20.1003), or if no information on the biological behavior or chemical form is L-11 Draft NUREG - 1556, Vol. 9 i
APPENDIX L ! available, the most restrictive clearance class relevant for the particular element should be assumed (i.e., that class that gives the lowest value of ALI);
- Particle size distribution;
. Chemical toxicity, as in the case of uranium (see 10 CFR 20.1201(e)).
The metabolic models in ICRP-30 and accompanying addenda and ICRP-54 present acceptable bases for estimating intake from bioassay measurements. Other acceptable models are the tritium model developed by Johnson and Dunford and the plutonium urinary excretion model developed by Jones. The use of computer codes that apply these models is also acceptable for evaluating bioassay j measurements, provided it can be demonstrated through documented testing that the models and methods employed provide results consistent with the acceptable models. There are several commercially available computer codes for interpreting bioassay measurements; these codes may be used as long as the software application is based on acceptable models and provides resuhs that correctly implement the models. No specific computer codes are endorsed by the NRC staff. Licensees are responsible for ensuring that computer codes are appropriate for use in their particular circumstances. Intake Retention and Excretion Fractions for Calculating Intakes ICRP-54 presents urinary excretion and fecal excretion equations as a function of time following intake for a number of radionuclides. By differentiating these equations, intake retention functions can be derived. The solution of these equations over a range of times allows the 6 development of tabulated intake retention and excretion fractions. The intake retention fractions (IRFs) contained in NUREG/CR-4884 were developed in this manner and represent an acceptable basis for correlating bioassay measurements to estimates ofintake. To apply the use ofIRFs for calculating an individual's radionuclides intake from a single bioassay measurement, divide the total activity in 24-hour urine,24-hour feces, accumulated urine, or accumulated feces,7 or the radionuclides content in the total body, systemic organs, lungs, nasal passages, or GI tract, by the appropriate IRF value in NUREG/CR-4884. 6For purposes of this guide and the application of the data from NUREG/CR-4884, the parameter IRF denotes both intake retention fractions and intake excretion fractions. 7The term 24-hour urine" means the total urine output collected over a 24-hour period, and the term 24-hour feces" means the total feces output collected over a 24-hour period. Accumulated urine" and accumulated feces" mean the total output since time of exposure. Draft NUREG - 1556, Vol. 9 L-12
. APPENDIX L l
l l Equation I demonstrates this method: l Equation 1: M') I = /RF(t) - where: I = Estimate ofintake with units the same as A(t)
=
A(t) Numerical value of the bioassay measurement obtained at time t (decay corrected to tim 0 of sampling for in vitro measurements) with appropriate units ( Ci, Bq, or g)
= Intake retention fraction corresponding'to type of measurement for time t IRF(t) after' estimated time ofintake Evaluating Spot Samples if the' total urine or feces is not collected for the 24-hour period, the following equations may be used to estimate the total activity excreted or eliminated over the 24-hour period based on less frequent sampling (spot samples).
Equation 2: AA i = C, E(ti- it . i) ; I Equation 3: Ai = AAi + AA 2+ ...AAi ' where: 1 AA i = Activity or amount of radioactive material in sample i i = The sequence number of the sample
.C i = The radionuclides concemration in urine (activity / liter) or feces -
(activity / gram) of sample i, decay corrected to the time of sampling E = Daily excretion rate (use measured rates when available, or assume values l of 1.4 liters / day for urine and 135 grams / day for feces for standard man or i 1.0 liter / day for urine and 110 grams / day for feces for standard woman) t, = The time (days) after intake that sample i is collected l Ai = - Total activity excreted or eliminated up to time j L-13 Draft NUREG - 1556, Vol. 9
1 l l APPENDIX L i This method is applicable only if spot samples are collected with a frequency consistent with the significance of changes in the excretion rates. In general, spot samples should be collected frequently enough that there is no more than a 30% increase in the IRFs between bioassay measurements. For example, if the IRF for accumulated urine increases at a rate of 30% per day, spot samples should be collected daily. If the rate is 10% per day, collecting spot samples once every 3 days would be adequate. Also, the rapid clearance and excretion ofinhaled particles from the N-P region of the lu 3 makes it important that at least one spot sample be collected within the first 24 hours after exposure. Otherwise, the reliability of using accumulated samples and excretion fractions for calculating intakes should be examined; calculations based on spot samples correlated to 24-hour samples may provide better estimates. For spot samples used to estimate an equivalent 24-hour sample, correcting for abnormal conditions of high or low fluid intake or excessive loss of fluids by perspiration may be warranted. NCRP-87 presents the following method based on a relationship between the specific gravity (sp. gr.) of the sample to the average specific gravity of urine (1.024 g/ml).
. 1.024 - 1 (g/ml)
Equation 4: corr. conc. = meas. conc. meas. sp. gr. - 1 (g/ml) An alternative to this method is a correction based on the expected creatine excretion rate of 1.7 grams / day for men and 1.0 grams / day for women. Refer to NCRP-87 for additional information. Logarithmic interpolation should be used for interpolating retention and excretion fractions. For example, using the NUREG/CR-4884 data, an IRF value for 2.8 days post intake should be calculated by a logarithmic interpolation between the 2-day and the 3-day IRF values. Evaluating Multiple Bioassay Measurements When multiple bioassay measurements are made, a statistical evaluation of the data should be performed. Numerous statistical methods are available for evaluating multiple measurements, but the results will be no better than the reliability of the data set. Measurements that are suspect or known to be inaccurate should be excluded from the analysis. Additional measurements should be used for obtaining an appropriate data set. For the evaluation of multiple measurements, NUREG/CR-4884 recommends the use of unweighted, minimized chi-squared statistics, assuming all variances are the same (i e., a least squares fit). This method is acceptable to the NRC staff; it is simple and straightforward for evaluating multiple bioassay measurements. The equation is as follows: I l= /RF,(t)XA,(t) Equation 5: E/RF,(t)2 Draft NUREG - 1556, Vol. 9 L-14
APPENDIX L Other statistical analyses of the data may provide a better fit of the data, considering the particulars of the measurements. For example, a minimized chi-squared fit weighted by the inverse of the variance may be used. Several methods are available for estimating the variance of measurements. One approach, applicable to radioactivity measurements, is to assume that the variance is proportional to the value of the measurement itself. Another is the assumption that the variance is proportional to the expected value. In selecting the statistical method to be used for evaluating multiple measurements, consideration should be given to available information, particularly observed variability of the data and reliability ofindividual measurements. Other statistical methods are acceptable to the NRC staff, provided it can be demonstrated that the results provide reasonable estimates ofintake. Adjusting Intake Estimates for Multiple and Continuous intakes In practice, a worker may receive repeated exposures to the same radionuclides over a period of time. These intakes should be treated as separate acute intakes if measurements collected ' through the period allow for the individual quantification of each exposure. As a general rule, if intakes are separated in time so that the retained or eliminated fraction from an earlier intake is i less than 10% of the retention or excretion fraction for the next intake, each intake may be j evaluated separately without regard to any previous intakes. 1 Continual intakes that are distributed equally in size and time may be approximated using a relationship based on time integration of the IRF. The total intake is estimated by dividing the measured activity by the appropriate time integrated retention or excretion fraction. An example using the IRF values from NUREG/CR-4884 would be to perform a numerical integration over l the individual IRF values covering the time period ofinterest. Any one of a number of standard i integration techniques, including numerical and analytical solutions, can be used. For example, using the trapezoidal rule yields the following method: i For bioassay measurements taken during an exposure time interval, the equation is: l I= fort < T Equation 6: j IRF(u) du 0 Using the trapezoidal rule to solve Equation 6 yields the following approximation: I= A(t)xTxn Equation 7:
, , (IRF(t)+1RF(t=0.ldays) +IR IRFM
[ L-15 Draft NUREG - 1556, Vol. 9 1
I APPENDIX L l For bioassay measurements taken after an exposure interval, the equation is: . MtVT J- fortn T Equation 8: ff t-T 4 Likewise, Equation 8 may be approximated using the trapezoidal rule, which yields Equation 9: f, A(t)xn Equation 9: [IRF(I-7)+1RF(t) +/RF( ,)+...+1RF( , 3)] where: I = Total intake during period T A(t) = Amount of activity in com;iartment or whole body at time t following onset ofintake T = Duration ofintake (exposure time period) t = Time from onset ofintake to time of measurement IRF(u) = Intake retention fraction at time u in compartment or whole body for a - single intake of a radionuclides
= Variable time between integration limits n = number ofincrements The number ofincrements to be used for a numerical integration should be selected to minimize unnecessary errors associated with the particulars of the IRF values over which the integration is being performed. In general, errors associated with the integration technique used should be limited to less than 10%.
Correcting Intake Estimates far Particle Size Differences The models used for deriving intake retention and excretion fractions, such as those in NUREG/CR-4884, are typically based on 1-micrometer activity median aerodynamic diameter (AMAD) particles. It is acceptable to correct intake estimates for particles of different sizes. These corrections often help explain retention or excretion rates different from those expected, Draft NUREG - 1556, Vol. 9 - L.16
l APPENDIX L 1 such as would occur for larger panicles preferentially deposited in the upper region of the l respiratory tract (N-P region) with more rapid clearance times. Guidance for determining AMADs is provided in Regulatory Guide 8.25, Air Sampling in the Workplace." Equation 10, taken from Appendix B to NUREG/CR-4884, should be used for revising the total { body IRFs in NUREG/CR-4884 to particle size distributions between 0.1 to 20 m AMAD. H,o7W D,*,(AMAD) l IRF"" = IRF'""[7 ( f,'! Eff,o7W7 D,_,(l pm) 1
, H,n7W7 D7,(AAfAD)
Equation 10:
+f^#' EyllsorWr D7 ,(l pm) l H,o7Wr D,(AhfAD) \
!J [J1,7W7 D,,(l pm)
) l where:
=
IRF a n IRF for the activity median aerodynamic diameter (AMAD) ofinterest IRF ig, = Total body IRF for inhalation of 1 m AMAD aerosols (these IRFs are given in Appendix B to NUREG/CR-4884)
=
Er Summation over all tissues (and organs) T
'N-P, T-B, P =
The compartments or regions of deposition of the respiratory tract: the nasopharyngeal passage region (N-P), the tracheobronchial region (T-B), and the pulmonary region (P) fu.p,1,fr-B.T,fr.T = The fraction of committed dose equivalent in the tissue T resulting from deposition in the N-P, T-B, and P regions, respectively. (Values for l individual radionuclides are contained in the Supplements to Part 1 of ICRP-30) l
=
11 301 Committed dose eqitivalent for tissue (or organ) T per unit intake
= Tissue (or organ) weighting factor, from 10 CFR 20.1003 Wr l Du.p, Dr-8, De =
Regional deposition fractions for an aerosol entering the respiratory system. (Values presented in Table 1 below.) L-17 Draft NUREG - 1556, Vol. 9
APPENDIX L Equation 10 may not provide valid corrections for time periods shortly following intakes. The time after intake for which Equation 10 begins to yield satisfactory results is less than 1 day for Class D compounds. For Class W compounds, this time is about 7 days following intake, and for ; Class Y compounds, it is about 9 days following intake. l l Table L.3 Aerosol AMAD 0.2 m 0.5ya 0.7 y m 1.0 m Du., 0.05 0.16 0.23 0.30 Dr.a 0.08 0.08 0.08 0.08
' D, 0.50 0.35 0.30 0.25 i Total Deposition 0.63 0.59 0.61 0.63 2.0 m 5.0 m 7.0 m 10.0 m Du., 0.50 0.74 0.81 0.87 Dr., 0.08 0.08 0.08 0.08 D,_ 0.17 0.09 0.07 : 0.05 Total Deposition 0.75 0.91 0.96 1.00 Equation 10, for revising the IRF for different particle sizes, is applicable for the total body IRF.
ICRP-54 provides graphs ofIRF values for 0.1 m,I m, and 10 m AMAD particles for other tissues and excreta. Intake retention and excretion functions are derived for other AMAD particles based on the acceptable biokinetic modeling, as discussed in Regulatory Positions 4.2 and 4.3 of Regulatory Guide 8.9. It is acceptable to take into account particle size distribution and its effect on lung deposition and transfer in evaluating an individual's dose. ICRP-30 (with supplements) provides data and methods for use in evaluating the lung deposition and resultant doses for particle sizes between 0.1 and 20 m AMAD. For particles with AMADs greater than 20 m, complete deposition in the N-P region can be assumed. It is acceptable to compare the estimate ofintake for different particle sizes with the ALIs in Appendix B to ((20.1001-20.2401 for demonstrating compliance with intake limits. The ALIs are based on a particle size of 1 micrometer; however, modifying the ALI values for different particle size distributions requires prior NRC approval (10 CFR 20.1204(c)(2)). l Draft NUREG - 1556, Vol. 9 L-l8 i
l i APPENDIX L Use ofIndividual Specific Biokinetic Modeling Individual specific retention and excretion rates may be used in developing biokinetic models that differ from the reference man modeling (10 CFR 20.1204(c)). The quality and quantity of data used for this type ofindividual specific modeling should be sufficient to justify the revised model. Licensees should not attempt to develop individual specific retention and excretion fractions in the absence of actual biochemical and particle size information. Individual specific modeling is not required but may be developed; the modeling as presented above is acceptable for evaluating regulatory compliance. Calculating Dose From Estimates of Intake Regulatory Guide 8.34," Monitoring Criteria and Methods to Calculate Occupational Radiation j Doses," contains additional guidance on determining doses based on calculated intakes once the intake is determined.
)
i Recordkeeping i Records of measurement data, calculations ofintakes, and methods for calculating dose must be maintained as required by 10 CFR 20.1204(c),20.2103(b), and 20.2106(a). For additional information on recordkeeping and reporting occupational exposure data, including intakes, refer to Revision 1 of Regulatory Guide 8.7," Instructions for Recording and Reporting Occupational Radiation Exposure Data." implementation The purpose of this section is to provide information to applicants and licensees regarding the ; NRC staff's plans for using this appendix. Except in those cases in which an applicant proposes an acceptable alternative method for complying with specified portions of the Commission's regulations, the methods described in this appendix will used by the NRC staff for evaluating compliance with 10 CFR 20.1001-20.2401. Intake Re'.antion Fraction Examples Examples illustrating the use of retention and excretion functions for calculating intakes based on bioassay measurements are presented in Appendix A of Regulatory Guide 8.9. The data used for these examples are taken from NUREG/CR-4884, " Interpretation of Bioassay Measurements." l These exaraples do not illustrate the use of all possible bioassay or health physics measurements l that are available (e.g., excreta and air sampling measurements) during an exposure incident. The examples demonstrate the use of retention and excretion factors to:
- Estimate intake from one or several bioassay measurements; i
L-19 Draft NUREG - 1556, Vol. 9
! APPENDIX L
- Adjust intake estimates for multiple or continuous intakes; and a Correct intake estimates for particle size differences.
i I ( l l l Draft NUREG - 1556, Vol. 9 L-20
l l Appendix M i Guidance for Demonstrating that ! Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits l l i l l
( i l 1 j APPENDIX M I ! Guidann for Demonstrating that Individual Members of the Public Will Not leceive Doses Exceeding the Allowable Limits j Licensees must ensure that: The radiation dose received by individual members of the public does not exceed 1 mSv (100 l mrem) in one calendar year resulting from the licensee's possession and/or use oflicensed materials. Members of the public include persons who live, work, or may be near locations where licensed material is used or stored and employees whose assigned duties do not include the use of licensed materials and who work in the vicinity where it is used or stored. The radiation dose in unrestricted areas does not exceed 0.02 mSv (2 mrem) in any one hour. I 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. Licensees must show compliance with both portions of the regulation. 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. Calculation Method 8 I l The calculational method takes a tiered approach, going through a four-part process starting with a worst case situation and moving toward more realistic situations. It makes the following simplifications:
. licensed materialis a point source; a typical radiation levels encountered when the source is in the shielded position are taken from the manufacturer's literature; and . credit is taken for any shielding found between the licensed material and the unrestricted l areas.
l 3 For case of use, the examples in this Appendix use conventional units. The conversions to SI units are as follows: I foot (ft) = 0.305 meter; I mrem = 0.01 mSv. M1 Draft NUREG - 1556, Vol. 9 l
APPENDIX M Part 1 of the calculational method is simple but conservative. It assumes that an affected member of the public is present 24 hours a day and uses only the inverse square law to determine if the distance between the licensed material and the affected member of the public is sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but also the time that the affected member of the public is actually in the area under consideration. Part 3 considers the distance, the portion of time and dose rate during source exposure, the portion of time and dose rate while the source is in the shielded position, and the portion of time that the affected member of the public is present. Part c r onsiders the approach in Part 3 plus any additional shielding between the licensed material and the unrestricted area. Using this approach, licensees make only those calculations that are needed to demonstrate compliance. The results of these calculations typically result in higher radiation levels than would exist at typical facilities, but provide a method for estimating conservative doses that could be received. Example 1 To better understand the calculational method, we will examine Therapy Clinic, an HDR Afterloading Device licensee. Yesterday, the clinic's president noted that the new HDR facility is close to his secretary's desk and he asked Joe, the RSO, to determine if the clinic is complying with NRC's regulations. The secretary's desk is near the wall separating the reception area from the designated, locked HDR room where the clinic has located its unit. Joe measures the distance from the HDR unit to the wall and assumes that the device would have the maximum dose rate when the source is exposed: 5000 mrem per hour at one meter. This is the maimum dose rate during treatment time. Figure M.1 is Joe's sketch of the areas in question, and Table M.1 summarizes the information Joe has on the HDR unit. l Draft NUREG - 1556, Vol. 9 M2
APPENDIX M A Bird's Eye View of Office and HDR [ HDR Room q +- by , p >ns y _o g ,s,,
"M 3- ; .
q- 1 m >
% ,s .
x ,
, 3 \
- ' l
._=
Figure M.1 Diagram of Office and HDR Facility. This sketch shows the areas described in Examples 1 and 2. Table M.1 Information Known About the HDR Unit Description of Known Information Ir-192/HDR/10 Ci Dose rate in mrem / hour encountered at specified distance 5000 mrem / hour at I meter (3.28 ft) from the IIDR unit (from manufacturer) Distance in ft to secretary's chair. 15 ft Example 1: Part 1 1 Joe's first thought is that the distance between the HDR unit and the secretary's chair may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach, he assumes: (1) the HDR unit is constantly present with a patient being treated; and (2) the secretary is constantly sitting in the desk chair (i.e.,24 hours / day). Joe proceeds to calculate the dose she might receive hourly and yearly from the HDR unit as shown in Table M.2 below. l l M-3 Draft NUREG - 1556, Vol. 9
APPENDIX M Table M.2 Calculational Method, Part 1: Hourly and Annual Dose Received From the HDR Unit Step Description Input D3ta Results l No. 1 Dose received in an hour at known distance from the HDR 5000 5000 unit (e.g., from the manufacturer), in mrem / hour 2 Square of the distance (ft) at which the Step 1 rate was'- (3.28)2 10.8 measured,in ft: 3 Square of the distance (fl) from the HDR unit to the (15.0)2 225 secretary's desk in an unrestricted area, in ft 2 4 Multiply the results of Step 1 by the results of Step 2 (this is 5000 x 10.8 54000 an intermediate result) 5 Divide the result of Step 4 by the result of Step 3 to calculate 54000/225 240 the dose received by an individual at the secretary's desk, HOURLY DOSE RECEIVED FROM THE HDR UNIT, in mrem in an hour 6 Multiply the result of Step 5 by 24 hours / day x 366 (leap 240 x 24 x 366 2108000 year) days / year = MAXIMUM ANNUAL DOSE RECEIVED FROM THE HDR UNIT, in mrem in a year Note: The result in Step 5 does not demonstrate compliance with the 2 mrem in any one hour limit. Also, if the result in Step 6 exceeds 100 mrem / year, proceed to Part 2 of the calculational method. At this point, Joe notes that the total dose that an individual could receive in any one hour greatly exceeds 2 mrem in an hour (i.e.,240 mrem in an hour) and notes that an individual could receive a dose of 2108000 mrem in a year, much higher than the 100 mrem limit. Example 1: Part 2 1 Joe reviews his assumptions and recognizes that the secretary is not at the desk 24 hours / day. He decides to make a realistic estimate of the number of hours the secretary sits in the chair at the I desk, keeping his other assumptions constant (i.e., the HDR unit is constantly present and in use l (i.e.,24 hours / day). He then recalculates the annual dose received.
)
l l Draft NUREG - 1556, Vol. 9 M-4
l APPENDIX M Table M.3 Calculational Method, Part 2: Annual Dose Received From the ) HDR Unit l Step Description Results ! No. i 7 A. Average number of hours per day that individual spends in 5.0 area of concern (e.g., secretary sits at desk 5 hours / day; the l remainder of the day the secretary is away from the desk area copying, filing, etc.) B. Average number of days per week in area (e.g., secretary is 3.0 part time and works 3 days / week) C. Average number of weeks per year in area (e.g., secretary 52 works all year )
- 8. Multiply the results of Step 7.A. by the results of Step 7.B. by the 5.0 x 3.0 x 52 = 780 results _of Step 7.C. = AVERAGE NUMBER OF HOURS IN AREA OF CONCERN PER YEAR l 9 Multiply the results in Step 5 by the results of Step 8 = ANNUAL 240 x 780 = 187000 DOSE RECEIVED FROM THE HDR UNIT CONSIDERING ;
REALISTIC ESTIMATE OF TIME SPENT IN AREA GF l CONCERN,in mrem in a year Note: If Step 9 exceeds 100 mrem in a year, proceed to Part 3 of the calculational method. l Although Joe is pleased to note that the calculated annual dose received is significantly lower, he l realizes it still greatly exceeds the 100 mrem in a year limit. Example 1: Part 3 Again Joe reviews his assumptions and recognizes that the HDR unit is not constantly in use when the secretary is seated at the desk. As he examines the situation, he realizes he must take these factors into account. Table M.4 Calculational Method, Part 3: Summary of information Step Description Input
' No. -
10 Dose rate while the source is in the shielded position, in mrem per hour at 3.28 ft 0.02 from the HDR (from manufacturer) M-5 Draft NUREG - 1556, Vol. 9
APPENDIX M l Step Description' Input No. I1 Dose rate while patient is being treated, in mrem per hour at 3.28 ft from the 5000 IIDR 12 Maximum number of patients treated per hour 2 13 Maximum treatment time,in minutes 1 14 From Table M.1, distance from HDR to secretary, in feet 15 15 From Step 8, average number of hours that secretary is in area of concern, 780 per year Table M.5 Calculational Method, Part 3: Annual Dose Received from HDR Step Description . Result No. 16 [60 minus the input from Step 12 multiplied by (the input from Step 13 )) 0.97 divided by 60 = [60 - 2 x (1)] / 60 = [60 - 2] / 60 = FRACTION OF TIME THE SOURCE IS IN THE SHIELDED POSITION 17 1.0 minus the result from Step 16 = 1 - 0.97 = FRACTION OF TIME THE 0.03 HDR UNIT IS USED 18 (The input from Step 10 multiplied by the result from Step 16) plus (the input 150 from Step 11 multiplied by the result from Step 17) = (0.02 x 0.97) + (5000 x 0.03) = 0.02 + 150 = AVERAGE DOSE ENCOUNTERED AT 3.28 FEET FROM THE HDR UNIT,in mrem in an hour. 19 The result from Step 18 multiplied by (3.28 squared divided by the input from 7.20 Step 14 squared) = 150 x (3.282 /152) = 150 x (10.8 / 225) = AVERAGE DOSE RATE ENCOUNTERED BY THE SECRETARY,in mrem per hour. 20 The result from Step 19 multiplied by the input from Step 15 = 780 x 7.20 = 5600 ANNUAL DOSE RECEIVED FROM HDR UNIT CONSIDERING REALISTIC ESTIMATES OF TIME SPENT IN AREA OF CONCERN, i DOSE RATES, AND HDR UNIT USAGE,in mrem in a year. I I l Note: If the result in Step 20 is greater than 100 mrem /yr, the licensee must take corrective j actions. Corrective action may include shielding the HDR treatment room. ) 1 Although, Joe notes that the result in Step 20 is significantly lower, he realizes that the result still l exceeds the 100 mrem in a year limit and that he must consider additional corrective actions. As Draft NUREG - 1556, Vol. 9 M-6
APPENDIX M he reviews the situation, he realizes that the walls of the treatment room consist of approximately 10.5 inches of concrete. He decides to take this into account. Example 1: Part 4 Table M.6 Calculational Method, Part 4: Summary of Information l Step Description Input No. 21 Tenth Value Layer for Iridium 192 in concrete in inches 3.5 I v 22 Thickness of concrete in wall- 10.5 23 Annual dose received from HDR unit from Step No. 20, in mrem in a year. 5600 Table M.7 Calculational Method, Part 4: Annual Does Received from HDR 1 Step Description Result No. 24 [ Input from Step 22 divided by the input from Step 21] = [10.5/3.5] = 3.0 NUMBER OF TENTH VALUE LAYERS 25- [ Input from Step 23 divided by 10 raised to the result from Step 24] = 5600/10' 5.6
= ANNUAL DOSE RECEIVED FROM HDR UNIT CONSIDERING REALISTIC ESTIMATES OF TIME SPENT IN AREA OF CONCERN, DOSE RATES, HDR UNIT USAGE, AND TREATMENT ROOM SHIELDING,in areas in a year Joe is glad to see that the results in Step 25 show compliance with the 100 mrem in a year limit.
Had the result in Step 25 been higher than 100 mrem in a year, then Joe could have done one or more of the following:
. Consider whether the assumptions used to determine occupancy are accurate, revise the assumptions as needed, and recalculate using the new assumptions
- Calculate the effect of any additional shielding dlocated between the HDR unit and the secretarial workstation I
l
- NCRP Report No. 49," Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV," contains helpful information. It is available from the National Council on Radiation Protection and Measurements,7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814.
NCRP's telephone numbers are: (301) 657-2652 or 1 800-229-2652. i M7 Draft NUREG - 1556, Vol. 9
APPENDIX M
. Take corrective action (e.g., move the secretarial workstation) and perform new calculations to demonstrate compliance Designate the area outside the use area as a restricted area and the secretary as an occupationally exposed individual. This would require controlling access to the area for purposes of radiation protection and training the secretary as required by 10 CFR 19.12 Note that in the example, Joe evaluated the unrestricted area outside only one wall of the HDR facility. Licensees also need to make similar evaluations for other unrestricted areas and to keep in mind the ALARA principle, taking reasonable steps to keep radiation dose received below regulatory requirements. In addition, licensees need to be alert to changes in situations (e.g.,
changing the secretary to a full-time worker, or changing the estimate of the portion of time spent at the desk) and to perform additional evaluations, as needed. RECORDKEEPING: 10 CFR 20.2107 requires licensees to maintain records demonstrating compliance with the dose limits for individual members of the public. Combination Measurement - Calculational Method This method, which allows the licensee to take credit for shielding between the HDR unit and the area in question, begins by measuring radiation levels in the areas, as opposed to using manufacturer-supplied rates at a specified distance from the unit. These measurements must be made with calibrated survey meters sufficiently sensitive to measure background levels of radiation; however, licensees must exercise caution when making these measurements, and they must use currently calibrated radiation survey instruments. A maximum dose of 1 mSv (100 mrem) received by an individual over a period of 2080 hours (i.e., a " work year" of 40 hours / week for 52 weeks / year) is equal to less than 0.5 microsievert (0.05 mrem) per hour. This rate is well below the minimum sensitivity of most commonly available G-M survey instruments. Instruments used to make measurements for calculations must be sufficiently sensitive. An instrument equipped with a scintillation-type detector (e.g., NaI(TI)) or a micro-R meter used in making very low gamma radiation measurements should be adequate. j l 1 l Draft NUREG - 1556, Vol. 9 M-8
APPENDIX M Licensees may also choose to use environmental TLDss in unrestricted areas next to the HDR unit for monitoring. This direct measurement method would provide a definitive measurement of actual radiation levels in unrestricted areas without any restrictive assumptions. Records of these measurements can then be evaluated to ensure that rates in unrestricted areas do not exceed the 1 mSv/ year (100 mrem / year) limit. Example 2 As in Example 1, Joe is the RSO for Therapy Clinic a liDR licensee. The clinic has one liDR unit in a designated, locked area that adjoins an unrestricted area where a secretarial work station is located. See Figure M-1 and Table M-2 for information. Joe wants to see if the clinic complies with the public dose limits at the secretarial station. Joe placed an environmental TLD badge in the secretarial work space for 30 days. The TLD processor sent Joe a report indicating the TLD received I mSv (100 mrem). Example 2: Part 1 Table M.8 Combination Measurement-Calculational Method Step Description Input Data and Results No. 1 Dose received by TLD,in mrem 100 2 Total hours TLD exposed 24 hours / day x 30 days / month = 720 3 Divide the results of Step i by the results of Step 100/720 = 0.14 2 = IIOURLY DOSE RECEIVED,in mrem in an hour 4 Multiply the results of Step 3 by 366 days / year 366 x 24 x 0.14 = 8784 x 0.14 = 1230 [ leap year] x 24 hours / day = 8760 hours in one year = MAXIMUM ANNUAL DOSE RECEIVED FROM THE HDR UNIT,in mrem in a year 5 TLDs used for personnel monitoring (e.g., LiF) may not have sufficient sensitivity for this purpose. Generally, the minimum reportable dose received is 0.1 mSv (10 mrem). Suppose a TLD monitors dose received and is changed once a month. If the measurements are at the minimum reportable level, the annual dose received could have been about 1.2 mSv (120 mrem), a value in excess of the 1 mSv/ year (100 mrem / year) limit. Iflicensees use TLDs to evaluate compliance with the public dose limits, they should consult with their TLD supplier and choose more sensitive TLDs, such as those containing CaF2 that are used for environmental monitoring. M-9 Draft NUREG - 1556, Vol. 9
APPENDIX M ( Note: For the conditions described above, Step 3 indicates that the dose received in any one hour is less than the 2 mrem in any one hour limit. Ilowever, if there are any changes, then the licensee will need to reevaluate the potential doses that could be received in any one hour. Step 4 indicates that the annual dose received would be much greater than the 100 mrem in a year allowed by the regulations, j Example 2: Part 2 l 1 At this point Joe can adjust for a realistic estimate of the time the secretary spends in the area and ) the time the liDR unit was operating, as he did in Parts 2 and 3 of Example 1. Example 2: Part 3 If the results of Joe's evaluation in Part 2 show that the annual dose received in a year exceeds 100 mrem, then he may have to consider moving the secretary's desk or adding additional shielding to the wall. i i Draft NUREG - 1556, Vol. 9 M-10
Appendix N Emergency Procedures
l l APPENDIX N Emergency Procedures Model Spill Procedures - Low and High Dose Unsealed Sources Minor Spills of Liquids and Solids
- 1. Notify persons in the area that a spill has occurred.
- 2. Prevent the spread of contamination by covering the spill with absorbent paper.
- 3. Clean up the spill using disposable gloves and absorbent paper. Carefully fold the absorbent paper with the clean side out and place in a plastic bag for transfer to a radioactive waste container. Also put contaminated gloves and any other contaminated
. disposable material in the bag.
- 4. Survey the area with a low-range radiation detector survey meter. Check the area around the spill. Also check your hands, clothing, and shoes for contamination.
- 5. Report the incident to the RSO.
Major Spills of Liquids and Solids
- 1. Clear the area. Notify all persons not involved in the spill to vacate the room.
- 2. Prevent the spread of contamination by covering the spill with absorbent paper, but do not attempt to clean it up. To prevent the spread of contamination, limit the movement of all personnel who may be contaminated.
- 3. Shield the source if possible. Do this only ifit can be done without further contamination or a significant increase in radiation exposure.
- 4. Close the room and lock or otherwise secure the area to prevent entry.
- 5. Notify the RSO immediately.
1
- 6. Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water, then washing with mild soap. If contamination remains, induce perspiration by covering the area with plastic. Then wash the affected area again to remove L any contamination that was released by the perspiration. j l
The decision to implement a major spill procedure instead of a minor spill procedure depends on
'many incident-specific variables, such as the number ofindividuals affected, other hazards l
N-1 Draft NUREG - 1556, Vol. 9 I i
APPENDIX N riesent, likelihood of contamination spread, types of surfaces contaminated and radiotoxicity of the spilled material. For some spills of short-lived radionuclides, the best spill procedure may be restricted access pending complete decay. Use Table N-1 as general guidance to determine whether a major spill procedure or a minor spill procedure should be implemented. Estimate the amount of radioactivity spilled. Initiate a major or minor spill procedure, based on the following information. Spills above these mci amounts are considered major, and below are considered minor. Table N.1 Relative Hazards of Common Radionuclides Radionuclides Millicuries Radionuclides Millicuries P-32 1 Tc-99m 100 Cr-51 100 In-111- 10 Co-57 10 1-123 10 Co-58 10 I-125 1 Fe-59 1 I-131 1 Co-60 1 Sm-153 10-Ga-67 10 Yb-169 10 Se-75 1 Hg-197 10 l Sr-85 10 Au-198 10 j Sr-89 1 TI-201 100 , Spill Kit You may also want to consider assembling a spill kit that contains: 6 pairs of disposable gloves, I pair housekeeping gloves . 2 disposable lab coats . 2 paper hats . 2 pairs shoe covers 1 roll absorbent paper with plastic backing . 6 plastic trash bags with twist ties Draft NUREG - 1556, Vol. 9 N-2
APPENDIX N
. " Radioactive Material" labeling tape t
L * - I china pencil or marking pen i
.' 3 pre-strung " Radioactive Material" labeling tags . Supplies for 10 contamination wipe samples . Instructions for" Emergency Procedures"- . Clipboard with one copy of Radioactive Spill Report Form
- Pencil' Emergency Surgery of Patients Who Have Received Therapeutic Amounts of
- Radionuclides If AUs or other personnel involved in the surgical procedure are likely to receive exposures exceeding the nonoccupational permissible dose limits specified in 10 CFR 20.1301, we will ,
follow the procedures below: j
- 1. If emergency surgery is performed within the first 24 hours following the administration of I-131 sodium iodide, fluids (e.g., blood, urine, etc.,) will be carefully removed and contained in a closed system.
- 2. The surgeon and the personnel involved in the surgical procedures will wear protective gear for the protection of the eyes from possible splashing of foreign materials, as well as from beta radiation.
- 3. The RSO will direct personnel in methods to keep doses ALARA during surgical procedures.
- 4. 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. The RSO will be informed of any possible radiation hazard. Autopsy of Patients Who Have Received Therapeutic Amounts of Radionuclides ] If AUs or other personnel involved in the autopsy are likely to receive exposures exceeding the 1 nonoccupational permissible dose limits specified in 10 CFR 20.1301, we will follow the ; procedures below: ( 'l. Upon the death of the therapy patient, the AU in charge and the RSO will be notified immediately. ! I. N3 Draft NUREG - 1556, Vol. 9
APPENDIX N
- 2. An autopsy will be performed only after consultation and permission from the RSO.
- 3. Protective eye wear will be worn by the pathologist and his assistants for protection from possible splashing of foreign materials and exposure from beta radiation.
- 4. If an entire block of tissue containing the radionuclides can be removed during autopsy, this will be done first. The remainder of the autopsy can then proceed as usual.
- 5. The RSO will evaluate the radiation hazard (s), direct personnel in safety and protection, 1 and suggest suitable procedures in order to keep doses ALARA during the autopsy.
- 6. When possible, separate organs will be promptly removed from the body, and detailed dissection will be carried out a safe distance away from the body.
- 7. After selected small samples have been removed, the radioactive tissues that are retained will promptly be either placed in appropriately shielded vessels for storage or disposed of according to procedures deemed appropriate by the RSO and in accordance with the regulations.
- 8. If an injury occurs during the autopsy which results in a cut or tear in the glove, the individual will be monitored to determine if radioactive material was introduced into the wound. The RSO'will be informed on any possible radiation hazard.
Model Emergency Procedures for Teletherapy Units Containing Sealed Sources- . Emergency Procedures for Beam Control Failure or Malfunction If the light signals or beam-on monitor indicates that the beam control mechanism has failed to terminate the exposure at the end of the pre-set time (e.g., if the red light stays on and the green ' light is off, or if both the red and the green lights stay on for more than a few seconds), the source may still be in the exposed position. The following steps are to be carried out promptly:
. Open the door to the treatment room. . Tell an ambulatory patient to leave the room. . If the patient is not ambulatory, enter the treatment room but avoid exposure to the direct beam. Pull the treatment table as far away from the direct beam as possible. Transfer the patient to a stretcher and remove the patient from the room.
Close the door and secure the area by locking the door to the treatment room or posting a I guard at the entrance. Turn off the main switch at the control panel. I Draft NUREG - 1556, Vol. 9 N-4
I I i APPENDIX N
- Notify the AU and RSO at once.
- Conspicuously post a sign in the area to warn others of the problem.
- Authorized User:
Phone No.: On Duty: OffDuty: i* Radiation Safety Officer:
; Phone No.: On Duty Off Duty:
S l-
- N5 Draft NUREG - 1556, Vol. 9
Appendix O Model Procedures for Ordering and Receiving Packages
APPENDIX O Model Procedures for Ordering and Receiving Packages i i Model Guidance
)
- We will, through a designee (e.g., RSO), authorize each order of radioactive materials and ensure that the requested materials and quantities are authorized by the license for use by the requesting AU and that possession limits are not exceeded. l
. We will establish and maintain a system for ordering and receiving radioactive material. The i system will contain the following information: )
- Written records that identify the AU or department, radionuclides, physical and/or chemical form, activity, and supplier Confirmation, through the above records, that material received was ordered through proper channels. l l
. For deliveries during normal working hours, we will inform carriers to deliver radioactive packages directly to a specified area.
. For deliveries during off-duty hours, we will inform 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 Division, provided below. We will develop a similar memorandum for delivery of packages to other divisions.
Sample Memorandum MEMO TO: ChiefofSecurity l FROM: Radiation Safety Officer
SUBJECT:
Receipt of Packages Containing Radioactive Material The security guard on duty shall accept delivery of radioactive material that arrives outside normal working hours. Pt.ckages should be placed on a cart or wheelchair and taken ! immediately to the Nuclear Medicine Division, Room . Unlock the door, place the package on top of the counter, 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 . O-1 Draft NUREG - 1556, Vol. 9 l l
APPENDIX O Name Home Telephone Radiation Safety Officer: Director oiNuclear Medicine: Nuclear Medicine Technologist Supervisor: Nuclear Medicine Technologist on call (call page operator at extension 1 Nuclear Medicine Physician on call (call page operator at extension ) l l 1 Draft NUREG - 1556, Vol. 9 O-2
Appendix P Model Procedure for Safely Opening Packages Containing Radioactive
- Material
APPENDIX P l Model Procedure for Safely Opaning Packages Containing Radioactive Material Special requirements must be followed for packages containing quantities of radioactive material in excess of the Type A quantity limits specified in 49 CFR 173.433 or in Table A-1 of 10 CFR Part 71 (e.g.,13.5 curies of Mo-99, Cs-137, Ir-192; 54.1 curies ofI-125; 54I curies of Xe- I 133, or 216 curies of Tc-99m). Such packages must be received expeditiously when the carrier . l offers it for delivery or when the carrier notifies the licensee that the package has arrived at the carrier's terminal. For these and other packages that are so required, monitoring for external radiation levels and surface contamination must be performed within 3 hours after 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). The NRC Regional Office and the final delivery carrier must be notified if:
. Removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i)
[i.e. 22 dpm/ centimeter squared (cm2 ) of beta and gamma emitting photons and 2.2 dpm/cm 2 of alpha]; and
. External radiation levels exceed the limits of 10 CFR 71.47.
We will implement the following procedure for opening each package containing radioactive l material received pursuant to our NRC license:
- 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 notify the RSO immediately.
- 3. Monitor the external surfaces of a labeled 6 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.
- 4. Monitor the extemal 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 to 10 CFR Part 71.
- 5. 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.
I
- Labeled with a Radioactive White I, Yellow II, or Yellow Ill label as specified in DOT regulations, 49 CFR 172.403 and 172.436-440.
l I P-1 Draft NUREG - 1556, Vol. 9
APPENDIX P i
- 6. Remove the packing slip..
- 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 of any broken seals or vials, loss ofliquid, condensation, or discoloration of the packing material.
- 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. An appropriate instrument with sufficient sensitivity will be used to assay the sample. For example, a NaI(TI) crystal and ratemeter, a liquid scimillation counter, or a proportional flow counter may be used for these assays. The detection efficiency will be determined to convert wipe sample counts per minute to disintegrations per minute. Note: a dose calibrator is not sufficiently sensitivefor this measurement. Take precautions against the potential spread of contamination.
I1. 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 detection survey meter before discarding. If contaminated, treat this material as radioactive waste. If not contaminated, remove or obliterate the radiation labels before discarding in in-house trash.
- 13. Make a record of the receipt.
For packages received under the general license in Section 31.11, we will 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 immediately.
- 2. Check to ensure that the material received is the material that was ordered.
I l l l Draft NUREG - 1556, Vol. 9 P2
Appendix Q Model Leak Test Program
l APPENDIX Q l Model Leak Test Program Fecilities and Equipment 1 e To ensure achieving the required sensitivity of measurements, leak tests should be analyzed in a low-background area.
- Consider using a Nal(TI) well counter system with a single or multichannel analyzer to ;
analyze samples obtained from gamma-emitting sources (e.g., Cs-137). Consider using a liquid scintillation or gas-flow proportional counting system to analyze samples obtained from beta-emitting sources (e.g., Sr-90). { I e Instrumentation used to analyze leak test samples must be capable of detecting 0.005 microcurie of radioactivity, j l Model Procedure for Performing Leak Testing and Analysis i e For each source to be tested, list identifying information such as sealed source serial number, radionuclides, and activity. l e Use 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.
a e Obtain samples at the most accessible area where contamination would accumulate if the sealed source were leaking.
- Measure the background count rate and record.
o Check the instrument's counting efficiency, using either a standard source of the same radionuclides as the source being tested or one with similar energy characteristics. Accuracy of standards should be within
- 5% of the stated value and traceable to a primary radiation standard, such as those maintained by NIST.
- Calculate efficiency of the instrument. l 1
For example: I(com from std) (com from bke)] = efficiency in cpm / microcurie i activity of std in microcuries .I where: cpm = counts per minute
]
std = standard bkg = background I
- Analyze each wipe sample to determine net count rate. j i i i
Q-1 Draft NUREG - 1556, Vol. 9 l I l L
APPENDIX Q . For each sample, calculate the activity in microcuries and record. 1 For example: [(com from wine samnle)-(com from bkcll = microcuries on wipe sample efriciency in cpm / microcurie = Leak test records will be retained in accordance with 10 CFR 35.2067 for three years. The records must contain:
- The model number and serial number (if assigned) of each source tested,
- The identity of each source radionuclides and its estimated activity,
- The measured activity of each test sample expressed in microcuries,
- A description of the method used to measure each test sample,
- The date of the test, and
- The name of the individual who performed the test.
. If the wipe test activity is 0.005 microcurie or greater:
- 1. Immediately withdraw the sealed source from use and either store the source, dispose of the saurce, or cause the source to be repaired, in accordance with the requirements in 10 CFR Parts 20 and 30.
- 2. File a report within five days of the leakage test with the appropriate NRC Regional Office listed in 10 CFR 30.6.
1 Draft NUREG - 1556, Vol. 9 Q-2
1 1
)
i i c l Appendix R l Model Procedure for Area Surveys i
APPENDIX R Model Procedure for Area Surveys Facilities and Equipment e To ensure achieving the required sensitivity of measurements, survey samples should be analyzed in a low-background area.
- Consider using a gamma counter system with a single or multi-channel analyzer to count i samples containing gamma-emitters (e.g., Cs-137, Co-60).
e Consider using either a liquid scintillation or a gas-flow proportional counting system to count samples containing alpha-emitters, beta-emitters, and gamma-emitters (if efficiency is great enough to achieve the required sensitivity for measurements). Ambient Radiation Level Surveys We will implement the following procedure for ambient radiation level surveys:
. Dose-rate surveys, at a minimum, will be performed in locations where:
workers are exposed to radiation levels that might result in radiation doses in excess of 10% of the occupational dose limits, or I
- an individual is working in an environment with a dose rate of 2.5 mrem / hour or more (5 rem / year divided by 2,000 hour / year).
i e 10 CFR 20.1301 requires that the TEDE to an individual member of the public from the l licensed operation does not exceed 1 mSv (0.1 rem) in a year, and that the dose in any
= unrestricted area from extemal sources does not exceed 0.02 mSv (0.002 rem) in any one j hour. Appropriate surveys will be conducted to assure that the requirements of i 10 CFR 20.1301 are met.
)
e Radiation level surveys will consist of measurements with a survey meter sufficiently sensitive to detect 0.1 milliroentgen (mR) per hour. The following areas and frequencies will be followed: f
- Survey at the end of each day of use for all radiopharmaceutical elution, preparation, assay and administration areas (except patient rooms should be surveyed at the end of the
- therapy instead of on the day of administration) when using radiopharmaceuticals l requiring a written directive (e.g., all therapy dosages and any iodine-131 dosage l
. exceeding 30 Ci).
f
- Survey monthly all laboratory areas where only small quantities of gamma-emitting radioactive material are used (< 200 pCi at a time).
R-1 Draft NUREG - 1556, Vol. 9
APPENDIX R
- Survey weekly all radionuclides use, storage, and waste storage areas. If diagnostic administrations are occasionally made in patients' rooms (e.g., bone scan injections, Tc-99m heart agents, etc.) and special care is taken to remove all paraphernalia, those rooms need not be surveyed.
- Survey quarterly all sealed source and brachytherapy source storage areas.
. The RSO will be notified immediately of radiation levels that exceed trigger levels. Trigger levels for restricted and unrestricted areas are presented in Table R-1.
Table R.1 Ambient Dose Rate Trigger Levels Type of Survey ' Area Surveyed . - Trigger Level Amtient Dose Rate Unrestricted 0.05 mR/hr
' Ambicat Dose Rate Restricted 5.0 mR/hr Contamination Surveys We will implement the following procedure for contamination surveys:
l
. Contamination surveys should be sufficient to identify areas of contamination that might result in doses to workers or to the public. Combined removable and fixed contamination should be surveyed using appropriate radiation detection equipment. Removable contamination can be detected and measured through use of 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.
- Contamination surveys should be performed:
- to evaluate radioactive contamination that could be present on surfaces of floors, walls, laboratory furniture, and equipment
- after any spill or contamination event i
when procedures or processes have changed
- to evaluate contamination of users and the immediate work area, at the end of the day, when licensed materialis 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.
Draft NUREG - 1556, Vol. 9 R-2 J
APPENDIX R
- Personnel will survey for contamination in locations where individuals are working with an unsealed form of radioactive material, in an amount greater than or equal to 10% of the smallest annual limit on intake (ALI) (either the inhalation or ingestion AL1) listed for that radionuclides in 10 CFR Part 20. These surveys will be done at a frequency appropriate to the types and quantities of radioactive materials in use, but at least monthly. If amounts are used that are greater than or equal to the smallest ALIlisted for that radionuclides in 10 CFR Part 20, then detailed documented surveys should be performed at least weekly.
- The method for performing removable contamination surveys must be sumciently sensitiw to detect the most restrictive isotope used and listed in Table R.2 for restricted areas and R.3 for unrestricted areas (e.g.,200 dpm/100 cm2 for isotopes ofiodine-131 in unrestricted areas).
Removable contamination survey samples should be measured in a low-background area. The following areas and frequencies will be followed:
- Removable contamination surveys weekly for radiopharmaceutical eh. tion, preparation, assay, and administration areas. If diagnostic administrations are occasionally made in patients' rooms (i.e., bone scan injections, Tc-99m heart agents, etc.), with special care taken to remove all paraphernalia, those rooms need not be surveyed.
- Removable contamination surveys monthly oflaboratory areas where only small quantities of photon-emitting radioactive material are used (< 200 microcuries at a time).
- Removable contamination surveys weekly for radionuclides storage and radionuclides waste storage areas.
- A radioactive source with a known amount of activity will be used to convert sample measurements (usually in cpm) to dpm.
- The area will be either decontaminated, shielded, or posted and restricted from use if unable to decontaminate.
- The RSO will be immediately notified of contamination levels in excess of the trigger levels.
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. When it is not possible to get to background levels, we will ensure that the amounts do not exceed the contamination levels listed in Table R-3. 1 R-3 Drat 1 NUREG - 1556, Vol. 9 L__________________________________..___________________--------------
APPENDIX R Table R.2 Acceptable Surface Contamination Levels in Restricted Areas in l dpm/100 cm 2 Area, clothing, skin if P-32, Co-58, Fe-59, Co-60, Se- Cr-51, Co-57, Ga-67, Tc-99m,
' indicated 75, Sr-85, In-111, I-123, I-125, Hg-197, TI-201 I-131, Yb-169, Au-198 Restricted areas, protective 2000 20000 clothing used only in restricted areas, skin Table R.3 Acceptable Surface Contamination Levels in Unrestricted Areas in ;
dpm/100 cm' I Nuclide' Average2 2 ' Maximum2 ^' Removable2 5' I-125, I-129, Transuranic 100 300 20 I-126,1-131, I-l33, Sr 1,000 3,000 200 Beta-gamma emitters (nuclides with decay 5,000 15,000 1,000 modes other than alpha emission or spontaneous fission) except Sr-90 and others noted above.
' Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for alpha- and beta-gamma-emitting nuclides should apply independently.
2 As used in this table, 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. 8 Measurements of average contaminant should not be averaged over more than I square meter. For objects of less surface area, the average should be derived for each such object.
- The maximum contamination level applies to an area of not more than 100 cm2 ,
5 The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area with 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.
- The average and maximum radiation levels associated with surface contamination resulting from beta-gamma emitters should not exceed 0.2 millirad / hour at I cm and 1.0 millirad / hour at I centimeter, respectively, measured through not more than 7 milligrams per square centimeter of total absorber.
- When equipment or facilitates that are potentially contaminated are to be released to unrestricted areas, the above table provides the maximum acceptable residual levels. To the extent practicable and consistent with the ALARA principle, it is appropriate to decontaminate Draft NUREG - 1556, Vol. 9 R4
APPENDIX R to below these levels. Surface contamination surveys will be conducted for both removable and fixed contamination before these facilities or equipment are released from restricted to unrestricted use to ensure that they meet these limits.
)
. A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removable contamination. {
j Alternate .%rv, y Frequency { Classification diLaboratories: l Survey Frequency Category i JGroup- Lo'w I Medium: High l
- r. ;
1 < 0.1 mci 0.1 mci to 1 mci > 1 mci 2 < 1 mci 1 mci to 10 mci.- > 10 mci 3 < 100 mci 100 mci to 1 Ci >1 Ci 4: < 10 Ci 10 Cito 100 Ci > 100 Ci Proportional fractions are to be used for more than one isotope.
= Modifying Factors Factors .
Simple storage x 100
;Very simple wet operations (e.g., preparation of aliquots of stock solutions) x 10 Normal chemical operations (e.g., analysis, simple chemical preparations) x1 Complex wet operations (e.g., multiple operations, or operations with complex glass ' x0.1 apparatus) L l
l Simple dry operations (e.g., manipulation of powders) and work with volatile x0.1 radioactive compounds Fy-e of non-occupational persons (including patients)
- x0.1 Dry and dusty operations (e.g., grinding) x 0.01 The object is to determine how often to survey the laboratory. To do this, multiply the activity l range under LOW, MEDIUM, and HIGH survey frequency by the appropriate Modifying Factor to construct a new set of. mci ranges for LOW, MEDIUM, and HIGH survey frequency.
l l R-5 Draft NUREG - 1556, Vol. 9 i
APPENDIX R Survey Frequency:
. Low-Not less than once a month
. Medium -Not less than once per week
. High - Not less than once per normal working day.
Group 1 Pb-210. Po-210. Ra-223 Ra-226 Ra-228 Ac-227 Th-227 Th-228 Th-230 , Pa-231 U-230 U-232 U-233" U-234 Np-237: Pu-238 Pu-239 Pu-240 Pu-241 ) Pu-242 - Am-241 Am-243. Cm-242 Cm-243 Cm-244 L Cm-245 Cm-246 l Cf-249 Cf-250 Cf-252 Group 2 Na-22 Cl-36 Ca Sc-46 Mn-54 Co-56 Co-60 Sr-89 Sr-90 Y-91' Zr-95 Ru-106 Ag-llom Cd-115m In-114m - Sb-124 Sb-125 Te-127m Te-129m I-124 I-126 I-131 I-133 ; Cs-134 ,Cs-137 Ba-140 Ce-144 Eu-l52 (13 y) Eu-154. Tb-160 Tm-170 Hf-181 Ta-182 Ir-192 TI-204 Bi-207 Bi-210 At-211 Pb-212 Ra-224 Ac-228 Pa-230 7h-234 U-236 Bk-249 l Group 3 Be-7 L C-14 ..F-18. Na-24; Cl-38 7 Si-31 P-32 S A-41 K-42 K-43 Ca Sc-47 L Sc-48 . V-48 Cr-51 ,Mn-52 l Mn-56 Fe-52 Fe-55' Fe-59 Co-57 Co-58 Ni-63 Ni-65 Cu-64'-Zn-65; Zn-69m Ga-72 As-73 :'As-74 -As-76 As-77 Se-75 :Br-82: Kr-85m Kr-87 Rb86 : Sr Sr-91 J Y-90 .Y-92 Y-93 Zr-97 ' Nb-93m :Nb-95 Mo-99;Tc-96 Tc-97m Tc-97 Tc-99 Ru-97 ; Ru-103 ..Ru-105 ' Rh-105 '. Pd-103 L Pd-109 ; Ag-105. fag-lli Cd-109 Cd-ll5 In-115m - Sn-113 Sn-125 - Sb-122 Te-125m- Te-127. Te-129 = Te-131m oTe-132 I-130 I-l32 I-134 I-135 Xe-135; Cs-131 Cs-136 Ba-131 La-140 Ce-141 Ce-143 Pr-142 Pr-143 'Nd-147 Nd-149 Pm-147 Pm-149 Sm-151 Sm-153 Eu-152 Eu-155 Gd-153 f Gd-159 l Dy-165. Dy-166 Ho-166. Er-169 5 Er-171- (9.2 hr); Tm-171 Yb-1751Lu-177' W-181,W-185 W-187 Re-183 Re-186; Re-188 Os-185-Os-191. Os-193 Ir-190 'Ir-194 : Pt-191 Pt-193. Pt-197 Au-196 Au-198 Au-199' Hg-197; Hg-1970 aHg-203. T1-200 TI-201J T1-202 Pb-203 Bi-206 Bi-212 Rn-220 Rn-222 Th-231 Pa-233 Np-239 Group 4 H-3 0-15 A-37 Co-58m . Ni-59 Zn-69 Ge-71 Kr-85 Sr-85m Rb-87 Y-91m Zr-93 Nb-97 Tc-%m Tc-99m Rh-103m In-113m I-129 Xe-131m Xe-133 Cs-134m Cs-135 Sm-147 Re-187 Os-191m Pt-193m Pt-197m Th-232 Th-Nat U-235 U-238 U-Nat. Draft NUREG - 1556, Vol. 9 R-6
i i APPENDIX R Survey Record Requirements Each survey report should include the following:
- A diagram of the area surveyed
.. . A list ofitems and equipment surveyed
- Specific locations on the survey diagram where wipe tests were taken
- Ambient radiation levels with appropriate units a Contamination levels with appropriate units
- Make and model number ofinstruments used
. Backgroundlevels
- 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 ofindividuals. The record should include names ofindividuals 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 surveyor's signature. R7 Draft NUREG - 1556, Vol. 9 I I J
Appendix S Procedures for Developing, Maintaining, and implementing Written Directives i i
APPENDIX S Procedures for Developing, Maintaining, and Implementing Written Directives Written Directive Procedures This model provides guidance to licensees and applicants for developing, maintaining, and implementing procedures for administrations that require written directives (WD). This model
-' does not limit you from using other guidance in developing procedures for administrations requiring a WD, e.g., information available from the Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology.
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 J number ofindividuals may be involved in the delivery process. For example, in an oncology j department when the AU prescribes a teletherapy treatment, the delivery process may involve a ! team of medical professionals such as an AMP, a dosimetrist, and a radiation therapist. Conducting the treatment plan may involve a number of measurements, calculations, computer-generated treatment plans, patient simulations, portal film verifications, and beam-modifying devices 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. In addition,10 CFR 35.27(c) requires that licensees establish a policy for all supervised individuals to request clarification, as needed, about instructions, including procedures requiring a WD. The administration of radioactive materials can involve a number of treatment modalities, e.g., radiopharmaceutical therapy, teletherapy, brachytherapy, gamma stereotactic radiosurgery, and future emerging technologies. For each modality, the licensee shall develop procedures for WDs to meet the objectives of 10 CFR 35.40 and 35.41 (as applicable to the type of medical use), j outlined below:
. Have an authorized user prepare, date, and sign a written directive prior to the administration,
. Verify the patient's or human research subject's identity prior to each administration, i
. Verify that the specific details of the administration are in accordance with the written
- directive and the treatment plan, l
. Check both manual and computer-generated dose calculations, S-1 Draft NUREG - 1556, Vol. 9 w____ _
APPENDIX S
. Verify that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical devices, and
. Record the radiopharmaceutical dosage or radiation dose actually administered.
The WD must be prepared for any administration ofI-131 sodium iodide greater than 1.11 MBq (30 Ci), 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. The licensee shall retain the WD in accordance with 10 CFR 35.2040. Suggested Policies and Procedures for Any Therapeutic Dose or Dosage of a Radionuclides or Any Dosage of Quantities Greater than 30 Microcuries of Sodium lodide I-131 We will establish the following policies and procedures: A. An AU must prepare, date, and sign a WD prior to the administration of any dose or dosage. This is required by 10 CFR 35.40. B. Prior to administering a dose or dosage, the patient's or human research subject's identity will be verified as the individual named in the WD. Examples of patient identity verification ' include the patient's ID bracelet, hospital ID card, driver's license or social security card. C. Before administering the dose or dosage, the specific details of the administration will be verified in accordance with the WD or treatment plan. All components of the WD (radionuclides, total dose or dosage, etc.) will be confirmed by the person administering the dose or dosage to verify agreement with the WD. Appropriate verification methods include: measuring the activity in the dose calibrator, checking the serial number of the sealed sources behind an appropriate shield, using color-coded vials or sealed sources, or using clearly marked storage locations. The verification will be performed by at least one qualified person (e.g., an oncology physician, AMP, nuclear medicine technologist, or radiation therapist) preferably other than the individual who prepared the dose or dosage or the treatment plan. D. All workers will be instructed 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 done, prior to administration, rather than continuing a procedure when there is any doubt.
. Draft NUREG - 1556, Vol. 9 S-2
APPENDIX S Additional Suggested Policies and Procedures for Sealed Therapeutic Sources and Devices Containing Sealed Therapeutic Sources We will establish the additional following policies and procedures: A. To ensure that the dose is delivered in accordance with the WD, the AU (and the neurosurgeon for GSR therapy) must approve a treatment plan that provides sufficient information and direction to meet the objectives of the WD. Suggested guidelines for information to be included in the treatment plan may be obtained from the American College ofRadiology. B. For sealed sources inserted into the patient's 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; however, some brachytherapy procedures may require the use of various fixed geometry applicators (e.g., appliances or templates) to establish the location of the temporary sources and 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). C. 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, oncology physician, dosimetrist, or radiation therapist), preferably one who did not make the original calculations, will check the dose calculations. The responsibilities and conditions of supervision are contained in 10 CFR 35.27. Suggested methods for checking the calculations include the following:
- 1. Computer-generated dose calculations will be checked by examining the computer printout to verify that correct input data for the patient were used in the calculations (e.g., source strength and positions).
- 2. The computer-generated dose calculations for input into the therapy console will be checked to verify correct transfer of data from the computer (e.g., channel numbers, source positions, and treatment times). ,
I
- 3. Manual dose calculations will be checked for: i i
- a. Arithmetic errors,
- b. Appropriate transfer of data from the WD, treatment plan, tables and graphs,
- c. Appropriate use of nomograms (when applicable), and
- d. Appropriate use of all pertinent data in the calculations l i
S-3 Draft NUREG 1556, Vol. 9
APPENDIX S If possible, 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 l performed using computer-generated outputs (or vice versa), particular emphasis should be placed on verifying 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). Parameters such as the transmission factors for wedges and applicators and the source strength of the sealed source used in the dose calculations should be checked. D. After insertion of permanent implant brachytherapy sources, we will have an AU promptly record the actual number of radioactive sources implanted and sign or initial the patient's chart or other appropriate record. E. 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. Acceptance testing shall 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 our specific needs and applications. Acceptance testing will also be considered after each source replacement or when spot-check measurements indicated that the source output differed by more than 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay. F. Independent checks on full calibration measurements will be performed when possible. 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:
- 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
- 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%.
G. Full calibration measurements will include the determination of transmission factors for trays, wedges, applicators, etc. Transmission factors for other beam-modifying devices (e.g., nonrecastable blocks, recastable block material, bolus and compensator materials, and split-beam blocking devices) will be determined before the first medical use of the beam-modifying device and after replacement of the source. H. For GSR, particular emphasis will be directed toward verifying that the stereoscopic frame coordinates on the patient's skull match those of the treatment plan. I. A physical measurement of the teletherapy output will be made under applicable conditions prior to administration of the first teletherapy fractional dose, if the patient's treatment plan Draft NUREG - 1556, Vol. 9 S-4
4 APPENDIX S includes (1) field sizes or treatment distances that fall outside the range of those measured in the most recent full calibration or (2) 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. J. If possible, a weekly chart check will be performed by a qualified person under the supervision of an AU (e.g., an AMP, dosimetrist, oncology physician, or radiation therapist) to detect mistakes (e.g., arithmetic errors, miscalculations, or incorrect transfer of data) that may 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. Review of Administrations Requiring a Written Directive The licensee should consider establishing procedures to conduct periodic reviews of each applicable program area, e.g., radiopharmaceutical therapy, high-dose-rate brachytherapy, implant brachytherapy, teletherapy, gamma stereotactic radiosurgery and emerging technologies. The number of patient cases to be sampled should be based on the principles of statistical acceptance sampling and should represent each treatment modality performed in the institution, e.g., radiopharmaceutical, teletherapy, brachytherapy and gamma stereotactic radiosurgery. For example, using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate (or lot tolerance percent defective) of 2%: { } Lot Size { } Sample Size { } Acceptance No. I to 75 All 0 76 to 100 70 0 101 to 200 85 0 l201 to 300 95 0 30l to 400 100 0 401 to 600 105 0 601 to 800 110 0 l -801 to 4000 115 0 l 1 l In order to eliminate any bias in the sample, the patient cases to be reviewed should be selected j randomly. If the number of errors in the sample does not exceed the acceptance number in the j appropriate Sampling Table, the lot should be accepted. For each patient's case, a comparison should be made between what was administered versus what was prescribed in the WD. If the difference between what was administered and what was prescribed exceeds the criteria for a S-5 Draft NUREG - 1556, Vol. 9
APPENDIX S medical event, that comparison is unacceptable. The number of unacceptable comparisons allowed for each sample size and lot tolerance percent defective is provided in the acceptance sampling tables of 10 CFR 32.110. 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. The licensee or designee should regularly review the findings of the periodic reviews to ensure that the procedures for administrations requiring a WD are effective. For each patient case reviewed, the licensee shall determine whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the WD or treatment plan, as applicable. For each patient case reviewed, the licensee should identify deviations from the , WD, the cause of each deviation, and the action required to prevent recurrence. ! Records of Medical Events You shall maintain a record of medical events for three years as required by 10 CFR 35.2045. The licensee shall notify by telephone the NRC Operations Center7 no later than the next calendar day after discovery of the medical event and shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after the discovery of the medical event, as required by 10 CFR 35.3045. t
' The commercial telephone number of the NRC Operations Center is (301) 951-0550.
Draft NUREG - 1556, Vol. 9 S-6
l i i I < 1 l 1 (. Appendix T i Model Procedures for Safe Use of Licensed Material ( 1 l l l
APPENDIX T Model Procedures for Safe Use of Licensed Material Model Procedures for Safe Use of Radionuclides
. Wear laboratory coats or other protective clothing at all times in areas where radioactive materials are used. . - Wear disposable gloves at all times while handling radioactive materials. . Either after each procedure or before leaving the area, monitor your hands for contamination in a low-background area using an appropriate survey instrument.
- . . Use syringe shields for reconstitution of radiopharmaceutical kits and administration of radiopharmaceuticals to patients, except in those circumstances in which their use is contraindicated (e.g., recessed veins, infants). In these exceptional cases, consider the use of other protective methods such as remote delivery of the dose (e.g., through use of a butterfly needle.)
- Do not eat, store food, drink, smoke, or apply cosmetics in any area where licensed material is stored or used.
L
- Wear personnel monitoring devices, if required, at all times while in creas where radioactive materials are used or stored. These devices shall be worn as prescribed by the RSO. When not being worn to monitor occupational exposures, personnel monitoring devices shall be stored in the work place in a designated low-background area.
. Wear a finger exposure monitor (TLD), if required, during the elution of generators; during the preparation, assay, and injection of radiopharmaceuticals; when performing camera quality control; when holding patients during procedures; and when handling radioactive material. . Dispose of radioactive waste only in designated, labeled, and properly shielded receptacles. . Never pipette by mouth.
a Consider wipe testing unsealed byproduct material storage, preparation, and administration areas weekly for contamination. If necessary, decontaminate or secure the srea for decay.
. Consider surveying with a radiation detection survey meter, all areas oflicensed material use, including the generator storage, kit preparation, and injection areas daily for contamination. If I
necessary, decontaminate or secure the area for decay as appropriate. Areas used to prepare and administer therapy quantities of radiopharmaceuticals must be surveyed daily in ! accordance with 10 CFR 35.70 (except when administering therapy dosages in patients' rooms).
. Store radioactive solutions in shielded containers that au clearly labeled.
l T-1 Draft NUREG - 1556, Vol. 9
l APPENDIX T
- Radiopharmaceutical multidose diagnostic and therapy vials must be labeled in accordance with 10 CFR 35.69 and 10 CFR 20.1904, with the radionuclides, the activity, the date for which the activity is estimated, and the kinds of materials (i.e., radiopharmaceutical).
- Syringes and unit dosages must be labeled in accordance with 10 CFR 35.69 and 10 CFR 20.1904, with the radionuclides, the activity, the date for which the activity is estimated, and the kinds of materials (i.e., radiopharmaceutical). If the container is holding less than the quantities listed in Appendix C to Part 20, the syringe or vial need only be labeled as containing radioactive material and the radiopharmaceutical (10 CFR 35.69).
Consider also labeling the syringe with the type of study and the patient's name.
- For prepared dosages, assay each patient dosage in the dose calibrator (or instrument) before administering it (10 CFR 35.63).
- Do not use a dosage ifit is greater than 20% off from the prescribed dosage, except for prescribed dosages ofless than 30 microcuries or as approved by an authorized user.
= When measuring the dosage, you need not consider the radioactivity that adheres to the syringe wall or remains in the needle.
- Consider checking the patient's name and identification number and the prescribed radionuclides, chemical form, and dosage before administering. If the prescribed dosage requires a written directive, the patient's identity must be verified and the administration must be in accordance with the written directive (10 CFR 35.41).
- Always keep flood sources, syringes, waste, and other radioactive material in shielded containers.
- Consider using a cart or wheelchair to move flood sources, waste, and other radioactive material, since sources with small amounts of radioactivity exhibit a high dose rate on contact.
- Secure all licensed material when not under the constant surveillance and immediate control -
of the authorized user (s). l Draft NUREG - 1556, Vol. 9 T-2
?
l Appendix U Release of Patients or Human Research i Subjects Administered Radioactive Materials l l
l l l APPENDIX U Release of Patients or Human Research Subjects Administered Radioactive Materials Section 35.75, " Release ofIndividuals Containing Radiopharmaceuticals or Permanent Implants," of 10 CFR Part 35, " Medical Use of Byproduct Material," permits licensees to
" authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem)."
In this appendix, the individual or human research subject to whom the radioactive material has been administered is called the " patient." Release Equation The activities at which patients could be released were calculated by using, as a starting point, the method discussed in the National Council on Radiation Protection and Measurements (NCRP) Report No. 37," Precautions in the Management of Patients who Have Received Therapeutic Amounts of Radionuclides." NCRP Report No. 37 uses the following equation to calculate the exposure until time t at a distance r from the patient: Equation U.1: 34.6 F Q, T, (1 - e "h p(f) _ r Where D(t) = Accumulated exposure at time t, in roentgens, 34.6 = Conversion factor of 24 hrs / day times the total integration of decay (1.44), F = Specific ganuna ray constant for a point source, R/ mci-hr at I cm, l Qo
= Initial activity of the point source in millicuries, at the time of the release, 1
T, = Physical half-life in days,
]
r = Distance from the point source to the point ofinterest, in centimeters, I t = Exposure time in days. j U-l Draft NUREG - 1556, Vol. 9 i
APPENDIX U This appendix uses the NCRP equation (Equation U.1) in the following manner to calculate the activities at which patients may be released.
. The dose to an individual likely to receive the highest dose from exposure to the patient is taken to be the dose to total de' c ay. Therefore, (1-e "3"P ) is set equal to 1. . It is assumed that I roentgen is equal to 10 millisieverts (I rem).
- The exposure rate constants and physical half-lives for radionuclides typically used in nuclear medicine and brachytherapy procedures are given in Supplement A to this Appendix.
. Default activities at which patients may be released are calculated using the physical half-lives of the radionuclides and do not account for the biological half-lives of the radionuclides. . When release is based on biological elimination (i.e., the effective half-life) rather than just the physical half-!:k of the radionuclides, Equation U.1 is modified to account for the uptake and retention of the radionuclides by the patient, as discussed in Supplement B.2. . For radionuclides with a physical half-life greater than I day and no consideration of biological elimination, it is assumed that the individual likely to receive the highest dose from exposure to the patient would receive a dose of 25% of the dose to total decay (0.25 in Equation 2), at a distance of 1 meter. Selection of 25% of the dose to total decay at 1 meter for estimating the dose is based on measurements discussed in the supporting regulatory analysis that indicate the dose calculated using an occupancy factor, E, of 25% at I meter is conservative in most normal situations. . For radionuclides with a physical half-life less than or equal to 1 day, it is difficult to justify an occupancy factor of 0.25, because relatively long-term averaging of behavior cannot be assumed. Under this situation, occupancy factors from 0.75 to 1.0 may be more appropriate.
Thus, for radionuclides with a physical half-life greater than 1 day: i 34.6 F Go T# (0.25) Equation U.2: D(=) = (100 cm)2 For radionuclides with a physical half-life less than or equal to 1 day, and if an occupancy factor of 1.0 is used: 34.6 F Go T# (1) Equation U.3: D(=) = (100 cm)2 Equations U.2 and U.3 calculate the dose from external exposure to gamma radiation. These equations do not include the dose from internal intake by household members and members of the public, because the dose from intake by other individuals is expected to be small for most radiopharmaceuticals (less than a few percent), relative to the external gamma dose (see " Internal Draft NUREG - 1556, Vol. 9 U-2
l i APPENDIX U 1 Dose,"of Supplement B). Further, the equations above do not apply to the dose to breast-feeding l infants or children who continue to breast-feed. Patients who are breact-feeding an infant or child must be considered separately, as discussed in Regulatory Position 1.1," Release of Patients Based on Administered Activity." Regulatory Position 1 Release Criteria l Licensees should use one of the following options to release a patient who has been administered radiopharmaceuticals or implants containing radioactive material in accordance with regulatory I requirements. 1.1 Release of Patients Based on Administered Activity In compliance with the dose limit in 10 CFR 35.75(a), licensees may release patients from licensee control if the activity administered is no greater than the activity in Column 1 of Table U.l. The activities in Table U.1 are based on a total effective dose equivalent of 5 millisieverts (0.5 rem) to an individual using conservative assumptions of l
- administered activity;
= physical half-life; . occupancy factor of 0.25 at I meter for physical half-lives greater than I day, and, for conservatism, an occupancy factor of 1 at 1 meter for physical half-lives less than or equal to 1 day,and = no shielding by tissue.
The total effective dose equivalent is approximately equal to extemal dose because the internal dose is a small fraction of the external dose (see Section B.3, " Internal Dose," of Supplement B). In this case, no record of the release of the patient is required unless the patient is breast-feeding
- an infant or child, as discussed in Regulatory Position 3.2, " Records ofInstructions for l Breast-Feeding Patients " The licensee may demonstrate compliance by using the records of activity that are already required by 10 CFR 35.40 and 35.63.
I If the activity administered exceeds the activity in Column 1 of Table U.1, the licensee may t release the patient when the activity has decayed to the activity in Column 1 of Table U.l. In this case, a record is required by 10 CFR 35.75(c) because the patient's release is based on the retained activity rather than the administered activity. The activities in Column 1 of Table U.1 U-3 Draft NUREG - 1556, Vol. 9 I b
APPENDIX U l were calculated using either Equation U.2 or U.3, depending on the physical half-life of the radionuclides. If a radionuclides not listed in Table U.1 is administered, the licensee can demonstrate compliance with the regulation by maintaining, for NRC inspection, calculation of the release activity that corresponds to the dose limit of 5 millisieverts (0.5 rem). Equation U.2 or U.3 may be used, as appropriate, to calculate the activity Q corresponding to 5 millisieverts (0.5 rem). The release activities in Column 1 of Table U.1 do not include consideration of the dose to a breast-feeding infant or child from ingestion of radiopharmaceuticals contained in a patient's breast milk. When the patient is breast-feeding an infant or child, the activities in Column 1 of Table U.1 are not applicable to the infant or child. In this case, it may be necessary to give instructions as described in Regulatory Positions 2.2 and 2.3 as a condition for release. If failure to interrupt or discontinue could result in a dose to the breast-feeding infant or child in excess of 5 millisieverts (0.5 rem), a record that instructions were provided is required by 10 CFR 35.75(d). 1.2 Release of Patients Based on Measured Dose Rate Licensees may release patients to whom radionuclides have been administered in amounts greater than the activities listed in Column 1 of Table U.1, provided the measured dose rate at 1 meter (from the surface of the patient) is no greater than the value in Column 2 of Table U.1 for that radionuclides. In this case, however,10 CFR 35.75(c) requires a record because the release is based on considering shielding by tissue. If a radionuclides not listed in Table U.1 is administered and the licensee chooses to release a patient based on the measured dose rate, the licensee should first calculate a dose rate that corresponds to the 5 millisievert (0.5 rem) dose limit. If the measured dose rate at 1 meter is no greater than the calculated dose rate, the patient may be released. A record of the release is required by 10 CFR 35.75(c). The dose rate at I meter may be calculated from Equation U.2 or 2 U.3, as appropriate, because the dose rate at 1 meter is equal to 1 Q/10,000 cm , 1.3 Release of Patients Based on Patient-Specific Dose Calculations Licensees may release patients based on Dose Calculations using patient-specific parameters. With this method, based on 10 CFR 35.75(a), the licensee must calculate the maximum likely dose to an individual exposed to the patient on a case-by-case basis. If the calculated maximum likely dose to an individual is no greater than 5 millisieverts (0.5 rem), the patient may be released. Using this method, licensees may be able to release patients with activities greater than those listed in Column 1 of Table U.1 by taking irto account the effective half-life of the radioactive material and other factors that may be relevant to the particular case. In this case, a record of the release is required by 10 CFR 35.75(c). If the dose calculation considered retained Draft NUREG - 1556, Vol. 9 U-4
( APPENDIX U activity, an occupancy factor less than 0.25 at I meter, effective half-life, or shielding by tissue, a record of the basis for the release is required by 10 CFR 35.75(c). l Supplement B contains procedures for performing patient-specific dose calculations, and it describes how various factors may be considered in the calculations. l Table U.1 Activities and Dose Rates for Authorizing Patient Release t l l COLUMN 1 COLUMN 2 Activity at or below Which Patients Dose Rate at 1 Meter, at or below l Radionuclides May Be released Which Patients May Be released
- l (GBq) (mCl) (mSv/hr) (mrem /br) -
Ag-l11 19 520 0.08 8 Au-198 3.5 93 0.21 21 l Cr-51 4.8 130 0.02 2 ! Cu-64 8.4 230 0.27 27 l Cu-67 14 390 0.22 22 Ga-67 S.7 240 0.18 18 1-123 6.0 160 0.26 26 I-125: 0.25 7 0.01 1 l l-125 implant 0.33 9 0.01 1 1-131 1.2 - 33 0.07 7 In-111 2.4 64 0.2 20 l Ir-192 implant 0.074 2 0.008 0.8 P-32 ** ** ** ** Pd-103 implant 1.5 40 0.03- 3 l Re-186 28 770 0.15 15 Re-188 29- 790 0.20 20 Sc-47 11 310 0.17 17 Se 0.089 2 0.005 0.5 Sm-153 26 700 0.3 30 Sn-117m 1.1 29 0.04' 4 U-5 Draft NUREG - 1556, Vol. 9
APPENDIX U COLUMN 1 COLUMN 2 Activity at or below Which Patients Dose Rate at 1 Meter, at or below May Be released Which Patients May Be released
- Radionuclides {
I (GBq) (mci) (mSv/hr) (mrem /hr) Sr-89 28 760 0.58 58 Tc-99m 16 430 0.19 19 TI-201 i Y-90 0.37 10 0.02 2 Yb-169 t The activity values were computed based on 5 millisieverts (0.5 rem) total effective dose equivalent.
- If the release is based on the dose rate at 1 meter in Column 2, the licensee must maintain a record as required by 10 CFR 35.75(c), because the measurement includes shielding by tissue. See Regulatory Position 3.1,
" Records of Release," for information on records. " Activity and dose rate limits are not applicable in this case because of the minimal exposures to members of the public resulting from activities normally administered for diagnostic or therapeutic purposes.
Notes: The millicurie values were calculated using Equations U.2 or U.3 and the physical half-life. The gigabecquerel values were calculated based on the millicurie values and the conversion factor from millicuries to gigabecquerels. The dose rate values are calculated based on the millicurie values and the exposure rate constants. In general, the values are rounded to two significant figures; however, values less than 0.37 gigabecquerel (10 millicuries) or 0.1 millisieven (10 millirems) per hour are rounded to one significant figure. Details of the calculations are provided in NUREG-1492. Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is included in this regulatory guide for the convenience of the licensee. Agreement State regulations may vary. Agreement State licensees should check with their State regulations prior to using these values. Draft NUREG - 1556, Vol. 9 U-6
APPENDIX U 2 Instructions 2.1 Activities and Dose Rates Requiring Instructions Based on 10 CFR 35.75(b), for some administrations, the released patients must be given instructions, including written instructions, on how to maintain doses to other individucts as low as is reasonably achievable after the patients are released.' Column 1 of Table U.2 provides the activity above which instructions must be given to patients. Column 2 provides corresponding dose rates at 1 meter, based on the activities in Column 1. The activities or dose rates in Table U.2 may be used for determining when instructions must be given. If the patient is breast-feeding an infant or child, additional instructions may be necessary (see Regulatory Position 2.2," Additional Instructions for Release of Patients Who Could be Breast-Feeding After Release"). When patient-specific calculations (as described in Supplement B) are used, instructions must be j provided if the calculation indicates a dose that is greater than 1 millisieven (0.1 rem). ; 1 4 If a radionuclides not listed in Table U.2 is administered, the licensee may calculate the activity or dose rate that corresponds to 1 millisievert (0.1 rem). Equation U.2 or U.3, as appropriate, may be used. 2.2 Additional Instructions for Release of Patients Who Could be Breast-Feeding After Release The requirement in 10 CFR 35.75(b) that a licensee provide instructions on the discontinuation or the interruption period of breast-feeding, and the consequences of failing to follow the recommendation, presumes that the licensee will inquire, as appropriate, regarding the breast-feeding status of the patient.' The purpose of the instructions (e.g., on interruption or discontinuation) is to permit licensees to release a patient who could be breast-feeding an infant or child when the dose to the infant or child could exceed 5 millisieverts (0.5 rem) if there is no interruption of breast-feeding. If the patient could be breast-feeding an infant or child after release, and if the patient was administered a radiopharmaceutical with an activity above the value stated in Column 1 of , Table U.3, instructions on discontinuation or on the interruption period for breast-feeding and the consequences of failing to follow the recommendation must be provided. The patient should also be informed if there would be no consequences to the breast-feeding infant or child. Table U.3 also provides recommendations for interrupting or discontinuing breast-feeding to minimize the dose to below I millisievert (0.1 rem) if the patient has received certain radiopharmaceutical 8 The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility to do so. l U-7 Draft NUREG - 1556, Vol. 9 l
APPENDIX U - doses. The radiopharmaceuticals listed in Table U.3 are commonly used in medical diagnosis and treatment. If a radiopharmaceutical not listed in Table U.3 is administered to a patient who could be breast-feeding, the licensee should evaluate whether instructions or records (or both) are required. Ifinformation on the excretion of the radiopharmaceutical is not available, an acceptable method is to assume that 50% of the administered activity is excreted in the breast l milk. The dose to the infant or child can be calculated by using the dose conversion factors given for a newbom infant by Stabin. 2.3 Content of instructions i The instructions should be specific to the type of treatment given, such as permanent implants or l I radioiodine for hyperthyroidism or thyroid carcinoma, and they may include additional information for individual situations; however, the instructions should not interfere with or contradict the best medical judgment of physicians. The instructions may include the name of a knowledgeable contact person and that person's telephone number, in case the patient has any questions. Additional instructions appropriate for each modality, as shown in examples below, may be provided (refer to 2.3.1 and 2.3.2). Table U.2 Activities and Dose Rates Above Which Instructions Should be Given When Authorizing Patient Release
- COLUMN 1 .
COLUMN 2 Activity above Which lastructions Dose Rate at 1 Meter above Which Radionuclides are Required . Instructions are Required (GBq) (mCl) (mSv/br) (arem/br) Ag-111 3.8 100 0.02 2 Au-198 0.69 19 0.04 4' Cr-51 0.96 26 0.004 0.4 Cu-64 1.7 45 0.05 5 Cu-67 2.9 77 0.04 4 Ga-67 1.7 47 0.04 - 4 I-123 1.2 33 0.05 5 I-125 0.05 1 0.002 0.2 1-125 implant 0.074 2 0.002 0.2 I-131 0.24 7 0.02 2 Draft NUREG - 1556, Vol. 9 U-8
l APPENDIX U i COLUMN 1 COLUMN 2 Activity above Which Instructions Dose Rate at 1 Meter above Which Radionuclides are Required Instructions are Required l l (GBq) (MCI) (mSv/br) (mrem /br) In-111 0.47 13 0.04 4 1 Ir-192 implant 0.011 0.3 0.002 0.2 P-32 ** " " " Pd-103 implant 0.3 8 0.007 0.7 l Re-186 5.7 150 0.03 3 Re-188 5.8 160 0.04- 4 Sc-47 2.3 62 0.03 3 l Se-75 0.018 0.5 0.001 0.1 Sm-153 5.2 140 0.06 6 Sn-117m 0.21 6 0.009 0.9 Sr-89 " ** " ** Tc-99m 5.6 150 0.12- 12 ( TI-201 3.1 85 0.04 4 y.90 .. .. .. .. ! Yb-169 0.073 2 0.004 0.4
- The activity values were computed based on 1 millisievert (0.1 rem) total effective dose equivalent.
, " Activity and dose rate limits are not applicable in this case, because of the minimal exposures to members of l the public resulting from activities normally administered for diagnostic or therapeutic purposes. Notest The millicurie values were calculated using Equations U.2 or U.3 and the physical half life. The gigabecquerel values were calculated based on millicurie values and the conversion factor from millicuries to gigabecquerels. The dose rate values were calculated based on millicurie values and exposure rate constants, in general, values are rounded to two significant figures; however, values less than 0.37 gigabecquerel (10 millicuries) or 0.1 millisievert (10 millirems) per hour are rounded to one significant figure. Details of the calculations are provided in NUREG-1492. Although non-byproduct materials are not regulated by the NRC, information on non byproduct material is included in this regulatory guide for the convenience of the licensee. Agreement State regulations may vary. Agreement State licensees should check with their State regulations prior to using these values. U9 Draft NUREG - 1556, Vol. 9 I I l __ --
APPENDIX U Table U.3 Activities of Radiopharmaceuticals that Require instructions and Records When Administered to Patients Who are Breast-Feeding an Infant or Child , Radionuclides COLUMN 1 COLUMN 2 COLUMN 3 Activity above Which Activity above Which . Examples of Instructions are a Record is required. Recommended Required Duration of Interruption of Breast-Feeding * (MBq) (mci) - (MBq) (mci) 1-131 Nal 0.01 0.0004 0.07 0.002 Complete cessation (for this infant or child) 1-123 Nal 20 0.5 100 3 I-123 OlH 100 4 700 20 I-123 MIBG 70 2 400 10 24 hr for 370 MBq (10 mci) 12 hr for 150 MBq (4 mci) 1-125 OIH 3 0.08 10 0.4 l I-131 OIH 10 0.30 60 1.5 Tc-99m DTPA 1000 30 6000 150 Tc-99m MAA 50 1.3 200 6.5 12.6 hr for 150 MBq (4 mci) Tc-99m 100 3 600 15 24 hr for 1,100 MBq Pertechnetate (30 mci) 12 hr for 440 MBq(12 mci) Tc-99m DISIDA 1000 30 6000 150 Tc-99m 1000 30 6000 170 Glucoheptonate Tc-99m MIBI 1000 30 6000 150 . Tc-99m MDP 1000 30 6000 150 t { Tc-99m PYP 900 25 4000 120 Draft NUREG - 1556, Vol. 9 U-10 ______________ _______ ____-. - _________________-___________a
APPENDIX U Radiennelide l COLUMN 1 COLUMN 2 COLUM'N 3 Activity above Which Activity above Which Examples of Instructions are a Record is required Recommended Required Duration of Interruption of Breast-Feeding
- i (MBq) (MCI) (MBq) (mci) i Tc-99m Red 400 10 2000 50 6 hr for 740 MBq(20 l
Blood CellIn mci) Vivo Labeling Tc-99m Red - 1000 30 6000 150 Blood CellIn l Vitro Labeling Tc-99m Sulphur 300 7 1000 35 6 hr for 440 MBq (12 I Colloid mci) { Tc-99m DTPA 1000 30 6000 150 Aerosol t Tc-99m MAG 3 1000 30 6000 150 Tc-99m White 100 4 600 15 24 hr for 1,100 MBq Blood Cells (30 mci) 12 hr for 440 MBq (12 mci) Ga-67 Citrate 1 0.04 7 0.2 1 month for 150 MBq (4 mci) 2 weeks for 50 MBq (1.3 mci) I week for 7 MBq (0.2 mci) l Cr-51 EDTA 60 1.6 300 8 i U-li Draft NUREG - 1556, Vol. 9
' APPENDIX U Radionnelide COLUMN 1 COLUMN 2 COLUMN 3 Aedvity above Which Aedvity above Which Examples'of Instruedoms are a Record is required Recommended Required Duration of =
Interrupdom ofi
- Bewest-Feeding *
(MBq) (MCI) (MBq) (mCl)1 In-111 White 10 0.2 40 1 1 week for 20 MBq , Blood Cells (0.5 mci) I
,TI-201 Chloride - 40. 1 ,
200' 5- 2 weeks for 110 MBq ; (3 mci) > 1
- The duration ofinterruption of breast-feeding is selected to reduce the maximum dose to a newborn infant to less than 1 millisievert (0.1 rem), although the regulatory limit is 5 millisieverts (0.5 rem). The actual doses that would be received by most infants would be far below I millisievert (0.1 rem). Of course, the physician may use discretion in the recommendation, increasing er decreasing the duration ofinterruption.
Neder: Activities are rounded to one significant figure, except when it was considered appropriate to use two significant figures. Details of the calculations are shown in NUREG-1492," Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material." If there is no recommendation in Column 3 of this table, the maximum activity normally administered is below the activities that require instructions on interruption or discontinuation of breast feeding. Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is 1 included in this regulatory guide for the convenience of the licensee. Agreement State regulations may vary. Agreement State licensees should check with their State regulations prior to using these values. 2.3.1 Instructions Regarding Radiopha maceutical Administrations For procedures involving radiopharmaceuticals, additional instructions may include the following:
=
Maintaining distance from other persons, including separate sleeping arrangements. Minimizing time in public places (e.g., public transportation, grocery stores, shopping centers, theaters, restaurants, sporting events).
- Precautions to reduce the spread of radioactive contamination.
- The length of time each of the precautions should be in effect.
The Society of Nuclear Medicine published a pamphlet in 1987 that provides information for l patients receiving treatment with radioiodine. This pamphlet was preparedjointly by the Society i of Nuclear Medicine and the NRC. The pamphlet contains blanks, for the physician to fill in the length of time that each instruction should be followed. While this pamphlet was written for the release of patients to whom less than 1,110 mega becquerels (30 millicuries) ofiodine-131 had l Draft NUREG - 1556, Vol. 9 U-12
APPENDIX U been administered, the NRC still considers the instructions in this pamphlet to be an acceptable method for meeting the requirements of 10 CFR 35.75(b), provided the times filled in the blanks are appropriate for the activity and the medical condition. l If additional instructions are required because the patient is breast-feeding, the instructions l should include appropriate recommendations on whether to interrupt breast-feeding, the length of
- time to interrupt breast-feeding, or, if necessary, the discontinuation of breast-feeding. The instructions should include information on the consequences of failure to follow the !
recommendation to interrupt or discontinue breast-feeding. The consequences should be explained so that the patient will understand that, in some cases, breast-feeding after an administration of certain radionuclides should be avoided. For example, a consequence of l procedures involving iodine-131 is that continued breast-feeding could harm the infant's or l l child's thyroid. Most diagnostic procedures involve radionuclides other than radiciodine and . ) i there would be no consequences; guidance should simply address avoiding any unnecessary l radiation exposure to the infant or child from breast-feeding. If the Society of Nuclear Medicine's pamphlet is given at release to a patient who is breast-feeding an infant or child, the pamphlet should be supplemented with information specified in 10 CFR 35.75(b)(1) and (2). The requirement of 10 CFR 35.75(b) regarding written instructions to patients who could be J breast-feeding an infant or child does not in any way interfere with the discretion andjudgment of the physician in specifying the detailed instructions and recommendations. I l l
)
l
)
J 4 r U-13 Draft NUREG 1556, Vol. 9 l l _
APPENDIX U 2.3.2 Instructions Regarding Implants For patients who have received implants, additional instructions may include the following: A small radioactive source has been placed (implanted) inside your body. The source is actually many small metallic pellets or seeds, which are each about 1/3 to 1/4 of an inch long, similar in size and shape to a grain of rice. To minimize exposure to radiation to others from the source inside your body, you should do the following for days.
. Stay at a distance of feet from . . Maintain separate sleeping arrangements. . Minimize time with children and pregnant women. . Do not hold or cuddle children. . Avoid public transportation.
Examine any bandages or linens that come into contact with the implant site for any pellets or seeds that may have come out of the implant site.
. Ifyou find a seed or pellet that falls out: . Do not handle it with your fingers. Use something like a spoon or tweezers to place it in a jar or other container that you can close with a lid.
- Place the container with the seed or pellet in a location away from people. i
. Notify at telephone number .
l 3 Records 3.1 Records of Release There is no requirement for recordkeeping on the release of patients who were released in accordance with Column 1 of Table U.1; however, if the release of the patient is based on a dose i calculation that considered retained activity, an occupancy factor less than 0.25 at 1 meter, effective half-life, or shielding by tissue, a record of the basis for the release is required by 10 CFR 35.75(c). This record should include the patient identifier (in a way that ensures that confidential patient information is not traceable or attributable to a specific patient), the 1 radioactive material administered, the administered activity, and the date of the administration. l In addition, depending on the basis for release, records should include the following information: 1 1 For Immediate Release of a Patient Based on a Patient-Specific Calculation: The l equation used, including the patient-specific factors and their bases that were used m l Draft NUREG - 1556, Vol. 9 U 14 1 1 l - I
APPENDIX U calculating the dose to the person exposed to the patient, and the calculated dose. The patient-specific factors (see Supplement B of this Appendix) include the effective half-life and uptake fraction for each component of the biokinetic model, the time that the physical half-life was assumed to apply to retention, and the occupancy factor. The basis for selecting each of these values should be included in the record.
. For Immediate Release of a Patient Based on Measured Dose Rate: The results of the measurement, the specific survey instrument used, and the name of the individual performing the survey. . For Delayed Release of a Patient Based on Radioactive Decay Calculation: The time of the administration, date and time of release, and the results of the decay calculation. . For Delayed Release of a Patient Based on Measured Dose Rate: The results of the survey meter measurement, the specific survey instrument used, and the name of the individual performing the survey.
In some situations, a calculation may be case-specific for a class of patients who all have the same patient-specific factors. In this case, the record for a particular patient's release may reference the calculation for the class of patients. Records, as required by 10 CFR 35.75(c), should be kept in a manner that ensures the patient's confidentiality, that is, the records should not contain the patient's name or any other information that could lead to identification of the patient. These recordkeeping requirements may also be used to verify that licensees have proper procedures in place for assessing potential third-party exposure associated with and arising from exposure to patients who were administered radioactive material. 3.2 Records of instructions for Breast-Feeding Patients If failure to interrupt or discontinue breast-feeding could result in a dose to the infant or child in excess of 5 millisieverts (0.5 rem), a record that instructions were provided is required by 10 CFR 35.75(d). Column 2 of Table U.3 states, for the radiopharmaceuticals commonly used in medical diagnosis and treatment, the activities that would require such records when { administered to patients who are breast-feeding. The record should include the patient's identifier (in a way that ensures that confidential patient information is not traceable or attributable to a specific patient), the radiopharmaceutical ; administered, the administered activity, the date of the administration, and whether instructions I were provided to the patient who could be breast-feeding an infant or child. ( 1 U-15 Draft NUREG - 1556, Vol. 9 l I
APPENDIX U 4 Summary Table 1 Table U.4 summarizes the criteria for releasing patients and the requirements for providing l instructions and maintaining records. j I Table U.4 Summary of Release Criteria, Required instructions to Patients, and I Records to Be Maintained Patient Group Basis for Criteria for Instructions Release Records Release - Release Needed? Required? All patients, Administered Administered Yes,if administered No including activity activity activity > Column 1 i patients who sColumn 1 of ofTable U.2 are breast- Table U.1 Retained - Retained Yes,ifretained Yes f or hild activity activity activity > Column 1 sColumn 1 of ofTable U.2 Table U.1 Measured Measured dose Yes, if dose rate > Yes dose rate rate sColumn 2 Column 2 of Table of Table U.1 U.2 Patient- Calculated dose Yes,ifcalculated Yes specific s5 mSv (0.5 dose > 1 mSv (0.1 l calculations rem) rem) Patients who All of the Additional Records that are breast- above bases instructions required instructions were feeding an for release if: provided are required infant or child if: Administered activity
> Column 1 of Administered activity Table U.3 > Column 2 of Table U.3 OR OR Licensee calculated dose from breast- Licensee calculated feeding >l mSv (0.1 dose from continued rem) to the infant or breast-feeding > 5 child mSv (0.5 rem) to the l
infant or child Draft NUREG - 1556, Vol. 9 U-16
APPENDIX U Implementation The purpose of this section is to provide information to licensees and applicants regarding the NRC staffs plans for using this appendix. Except in those cases in which a licensee proposes an acceptable alternative method for complying with 10 CFR 35.75, the methods described in this appendix will be used in the evaluation of a licensee's compliance with 10 CFR 35.75. References National Council on Radiation Protection and Measurements (NCRP), " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37, October 1,1970. (Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.) S. Schneider and S. A. McGuire," Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material," NUREG- 1492 (Final Report), NRC, February 1997. M. Stabin," Internal Dosimetry in Pediatric Nuclear Medicine," in Pediatric Nuclear Afedicine, Edited by S. Treves, Springer Verlag, New York,1995.
" Guidelines for Patients Receiving Radioiodine Treatment," Society ofNuclear Afedicine,1987.
This pamphlet may be obtained from the Society of Nuclear Medicine,136 Madison Avenue,New York,NY 10016-6760. Supplement A Table U.5 Half-Lives and Exposure Rate Constants of R:Slonuclides Used in Medicine Radionuclides PhysicalHalf-Life (days)2 Exposure Rate Constant' (R/mCl-h at 1 cm) Ag-111 7.45 0.150 Au-198. 2.696 2.3 Cr-51 27.704 0.16 Cu-64 0.529 1.2 Cu-67 2.578 0.58 Ga-67 3.261 0.753 U-17 Draft NUREG - 1556, Vol. 9 L- __
APPENDIX U Radionuclides' Physical Half-Life (days)2 Exposure Rate Constant 3-(R/ mci-h at 1 cm) I-123 0.55 1.61 I-125 60.14 1.42 I-125 implant 60,14 1.11* I-l31 8.04 2.2 In-111 2.83 3.21 Ir-192 implant 74.02 4.5 94 P-32 14.29 NA6 Pd-103 implant 16.96 0.865 { Re-186 3.777 0.2 I Re-188 0.708 0.26 Sc-47 3.351 0.56 Se-75 119.8 2.0 Sm-153 1.946 0.425 Sn-117m 13.61 1.48 Sr-89 50.5 NA6 Tc-99m 0.251 0.756 T1-201 3.044 0.447 Yb-169 32.01 l.83 l l Draft NUREG - 1556, Vol. 9 U-l8
APPENDIX U Radionuclides' Physical Half-Life (days)2 Exposure Rate Constant3 (R/ mci-h at I cm) Y-90 2.67 NA6 Yb-169 32.01 1.83
' Although non-byproduct materials are not regulated by the NRC, information on non-byproduct material is included in this regulatory guide for the convenience of the licensee.
2 K.F. Eckerman, A.B. Wolbarst, and A.C.B. Richardson," Federal Guidance Report No. I 1, Limiting Values of Radicc :clide Intake and Air concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion," Report No. EPA-520/1-88-020, Office of Radiation Programs, U.S. Environmental Protection Agency, Washington, DC,1988. Values for the exposure rate constant for Au-198, Cr-51, Cu-64,1-131, Sc-47, and Se-75 were taken from the Radiological Health Handbook, U.S. Department of Health, Education, and Welfare, pg. 135,1970. For Cu-67, i 1-123, In-111, Re-186, and Re-188, the values for the exposure rate constant were taken from D.E. Barber, J.W. Baum, and C.B. Meinhold," Radiation Safety issues Related to Radiolabeled Antibodies," NUREG/CR-4444, U.S. NRC, Washington, DC,1991. For Ag-111, Ga-67,1-125, Sm-153, Sn-117m, Tc-99m, TI-201, and Yb-169, the exposure rate constants were calculated because the published values for these radionuclides were an approximation, presented as a range, or varied from one reference to another. Details of the calculation of the exposure rate constants are shown in Table A.2 of Appendix A to NUREG-1492,
" Regulatory Analysis on Criteria for the Release of patients Administered Radioactive Material," U.S. NRC, February 1997.
- R. Nath, A.S. Meigooni, and J.A. Meli," Dosimetry on Transverse Axes of *1 and a21r Interstitial Brachytherapy Sources," Medical Physics, Volume 17, Number 6, November / December 1990. Tl'e exposure rate constant given is a measured value averaged for several source models and takes into account the attenuation of gamma rays within the implant capsule itself.
5 A.S. Meigooni, S. Sabnis, R. Nath," Dosimetry of Palladium-103 Brachytherapy Sources for Permanent Implants," Endocurietherapy Hyperthermic Oncology, Volume 6, April la90. The exposure rate constant given is an " apparent" value (i.e., with respect to an apparent source activity) and takes into account the attenuation of gamma rays within the implant capsule itself.
- Not applicable (NA) because the release activity is not based on beta emissions.
Supplement B Procedures for Calculating Doses Based on Patient-Specific Factors l I A licensee may release a patient who has been administered an activity higher than the values listed in Column 1 of Table U.1 of this supplement, if dose calculations using patient-specific i parameters, which are less conservative than the conservative assumptions, show that the ! potential total efTective dose equivalent to any individual would be no greater than 5 millisieverts I (0.5 rem). l 4 U-19 Draft NUREG - 1556, Vol. 9
APPENDIX U If the release of a patient is based on a patient-specific calculation that considered retained activity, an occupancy factor less than 0.25 tt I meter, effective half-life, or shielding by tissue, a record of the basis of the release is required by 10 CFR 35.75(c). The following equation can be used to calculate doses: 34.6 F Q, TE ( - e **') Equation B-1: D(t) = r, Where D(t) = Accumulated dose to time t,in rems 34.6 = Conversion factor of 24 hrs / day times the total integration of decay (1.44) F = Exposure rate constant for a point source, R/ mci x hr at I cm Qo
= Initial activity at the start of the time interval T, = Physical half-life,in days E =
Occupancy factor that accounts for different occupancy times and distances when an individual is around a patient r = Distance in centimeters. This value is typically 100 cm t = exposure time in days B.1 Occupancy Factor B.1.1 Rationale for Occupancy Factors Used to Derive Table U.1 In Table U.1 in this Appendix, the activities at which patients could be released were calculated using the physical half-life of the radionuci a and an occupancy factor at I meter of either 0.25 ; (if the radionuclides has a half-life longer than 1 day) or 1.0 (if the radionuclides has a half-life less than or equal to 1 day). The basis for the occupancy factor of 0.25 at 1 meter is that measurements of doses to family members, as well as considerations of normal human behavior (as discussed in the supporting regulatory analysis (Ref. B-1)), suggest that an occupancy factor of 0.25 at 1 meter, when used in combination with the physical half-life, will produce a generally 3 conservative estimate of the dose to family members when instructions on minimizing doses to I others are given. Draft NUREG - 1556, Vol. 9 U-20
)
APPENDIX U An occupancy factor of 0.25 at 1 meter is not considered appropriate when the physical half-life is less than or equal to 1 day, and hence, the dose is delivered over a short time. Specifically, the assumptions regarding patient behavior that led to an occupancy factor of 0.25 at 1 meter include the assumption that the patient will not be in close proximity to other individuals for several days; however, when the dose is from a short-lived radionuclides, the time that individuals spend i in close proximity to the patient immediately following release will be most significant because the dose to other individuals could be a large fraction of the total dose from the short-lived j radionuclides. Thus, to be conservative when providing generally applicable release quantities ! that may be used with little consideration of the specific details of a particular patient's release, the values calculated in Table U.1 were based on an occupancy factor of I at 1 meter when the l half-life is less than or equal to 1 day, l B.1.2 Occupancy Factors to Consider for Patient- Specific Calculations The selection of an occupancy factor for patient-specific calculations will depend on whether the physical or effective half-life of the radionuclides is used and whether instructions are provided to
- the patient before release. The following occupancy factors, E, at I meter, may be used for l patient-specific calculations. (
l l
= E = 0.75 when a physical half-life, an effective half-life, or a specific time period under l consideration (e.g., bladder holding time) is less than or equal to 1 day.
. E = 0.25 when an effective half-life is greater than 1 day, if the patient has been given instructions, such as:
- Maintain a prudent distance from others for at least the first 2 days,
- Sleep alone in a room for at least the first night,
- Do not travel by airplane or mass transportation for at least the first day,
- Do not travel on a prolonged automobile trip with others for at least the first 2 days,
- Have sole use of a bathroom for at least the first 2 days,
- Drink plenty of fluids for at least the first 2 days.
. E = 0.125 when an effective half-life is greater than 1 day if the patient has been given instructions, such as: l
- Follow the instructions for E = 0.25 above,
- Live alone for at least the first 2 days,
- Have few visits by family or friends for at least the first 2 days.
. In a two-component model (e.g., uptake ofiodine-131 using thyroidal and extrathyroidal components), if the effective half-life associated with one component is less than or equal to U-21 Draft NUREG - 1556, Vol. 9 i
l l
APPENDIX U one day but is greater than one c ly for the other component, it is morejustifiable to use the ;
- occupancy factor associated with the dominant component for both components. j Example 1: Calculate the maximum likely dose to an individual exposed to a patient who has received 2,220 megabecquerels (60 millicuries) ofiodine-131. The patient has been provided with instructions to maintain a prudent distance from others for at least 2 days, lives alone, drives home alone, and stays at home for several days without visitors.
Solution: The dose to total decay (t = =) is calculated based on the physical half-life using Equation B-1. (This calculation illustrates the use of physical half-life. To account for biological elimination, calculations described in the next section should be used.) 34.6F 0, T, E D(=) = r, Since the patient has been provided with instructions for reducing exposure as recommended for an occupancy factor of E = 0.125, the occupancy factor of 0.125 at 1 meter may be used. 2 D(=) = 34.6 (2.2 R cm f,cf.hr)(60 mci)(8.04 d)(0.125) (100 cm)2 D (=) = 4.59 millisieverts (0.459 rem) Since the dose is less than 5 millisieverts (0.5 rem), the patient may be released, but 10 CFR 35.75(b) requires that instructions be given to the patient on maintaining doses to others as low as is reasonably achievable. A record of the calculation must be maintained, pursuant to 10 CFR 35.75(c), because an occupancy factor less than 0.25 at 1 meter was used. B.2 Effective Half-Life A licensee may take into account the effective half-life of the radioactive material to demonstrate compliance with the dose limits for individuals exposed to the patient that are stated in 10 CFR 35.75. The effective half-life is' defined as:' Draft NUREG - 1556, Vol. 9 ' U-22
i t APPENDIX U ! I T, X T Equation B-2: = T,f T, + T l Where ; 1 T3 = biological half-life of the radionuclides , I T, = physical half-life of the radionuclides. The behavior ofiodine-131 can be modeled ~using two components: extrathyroidal iodide (i.e., existing outside of the thyroid) and thyroidal iodide following uptake by the thyroid. The effective half-lives for the extrathyroidal and thyroidal fractions (i.e., F1 and F2, respectively) can be calculated with the following equations. T,, X T, Equation B-3: T,,, = Tg + T, T,, X T, Equation B-4: T,5 " 2 T,,+ T, Where T,3
= biological half-life for extrathyroidal iodide Tb2 = biological half-life ofidd$elollowing uptake by the thyroid Tp = physical half-life o'fiodine-131 However, simple exponential excretion models do not account for (a) the time for the iodine-131 to be absorbed from the stomach to the blood and (b) the holdup ofiodine in the urine while in the bladder. Failure to account for these factors could result in an under estimate of the dose to another individual. Therefore, this supplement makes a conservative approximation to account for these factors by assuming that, during the first 8 hours after the administration, about 80% of the iodine administered is removed from the body at a rate determined only by the physical half-life ofiodine-131.
l Thus, an equation to calculate the dose from a patient admini'stered iodine-131 may have three I components. First is the dose for the first 8-hours (0.33 day) after administration. This component comes directly from Equation B-1, using the physical half-life and a factor of 80%. Second is the dose from the extrathyroidal component from 8 hours to total decay. In this U-23 Draft NUREG - 1556, Vol. 9 i
APPENDIX U component, the first exponential factor represents the activity at t = 8 hours based on the physical half-life ofiodine-131. The second exponential factor represents the activity from t = 8 hours to total decay based on the effective half-life of the extrathyroidal component. The third component, the dose from the thyroidal component for 8 hours to total decay, is calculated in the same manner as the second component. The full equation is shown as Equation B-5. Equation B-5: D(=)= 34.61' Q (E,7 T (0.8)(1-e -as3(a33yrp) (100cm)2
+ ga693a33yr r E F T .n + e493a33yrF 2 i i EFTn 2 2 2 Where i
Fi = Extrathyroidal uptake fraction
-F 2 = Thyroidal uptake fraction {
Ei = Occupancy factor for the first 8 hours j 1 E2 = Occupancy factor from 8 hours to total decay All the other parameters are as defined in equations B-1, B-3, and B-4. Acceptable values for F i, T i .g, F2 , and T2 .nare shown in Table U.6 for thyroid ablation and treatment of thyroid remnants after surgical removal of the thyroid for thyroid cancer. If these values have been measured for a specific individual, the measured values may be used. The record of the patient's release required by 10 CFR 35.75(c)is described in Regulatory Position 3.1 of this appendix. Example 2, Thyroid Cancer: Calculate the maximum likely dose to an individual exposed to a patient who has been administc red 7,400 megabecquerels (200 millicuries) ofiodine-131 for the treatment of thyroid remnants and metastases. Solution: In this example, we will calculate the dose by using Equation B-5 to account for the ! elimination ofiodine-131 from the body, based on the effective half-lives appropriate for thyroid j cancer. The physical half-life and the exposure rate constant are from Table U.S. The uptake fractions and effective half-lives are from Table U.6. An occupancy factor, E, of 0.75 at 1 meter, l will be used for the first component because the time period under consideration is less than 1 l day; however, for the second and third components, an occupancy factor of 0.25 will be used, i because (1) the effective half-life associated with the dominant component is greater than 1 day, and (2) patient specific questions were provided to the patient tojustify the occupancy factor (see Draft NUREG - 1556, Vol. 9 U-24 i
APPENDIX U Section B.I.2, " Occupancy Factors to Consider for patient-Specific Calculations," of this Supplement B). Table U.6 Uptake Fractions and Effective Half-Lives for lodine-131 Treatments Extrathyroidal Conspeasst ThyroidalConsponent Medical Uptake Fraction Efective = Uptake Fraction - Efeettve Condities F Half-LIA Tua . Fs Half-Life Ts,,
- (day): t (day) !
Hyperthyroidism 0.20' O.3 22 0.80 5.2' Post' O.958- 0.322 ~ 0.058' 7.32
. thyroidectomy I l lforThyroid cancer ' M.G. Stabin et al.," Radiation Dosimetry for the Adult Female and Fetus from Iodine-131 Administration in l Hyperthyroidism," Journal ofNuclear Medicine, Volume 32, Number 5, May 1991. De thyroid uptake i fraction of 0.80 was selected as one that is seldom exceeded by the data shown in Figure 1 in this referenced l document. De effective half life of 5.2 days for the thyroidal component was derived from a biological half-life of 15 days, which was obtained from a straight-line fit that accounts for about 75% of the data points shown in Figure 1 of that Journal ofNuclear Medicine document.
8 Intemational Commission on Radiological Protection (ICRP), " Radiation Dose to Patients from Radiopharmaceuticals,"ICRP Publication No. 53, March 1987. (Available for sale from Pergamon Press,Inc., Elmsford, NY 10523.) ne data in that document suggest that the extrathyroidal component effective half-life I in normal subjects is about 0.32 days. Lacking other data, this value is applied to hyperthyroid and, thyroid cancer patients. . For thyroid cancer, the thyroidal component effective half-life of 7.3 days is based on a biological half-life of 80 days (adult thyroid), as suggested in the ICRP document. 8 The thyroidal uptake fraction of 0.05 was recommended by Dr. M. Pollycove, M.D., NRC medical visiting fellow, as an upper-limit postthyroidectomy for thyroid cancer. Substituting the appropriate values into Equation B-5, the dose to total decay is: 1 D(=) = 34.6 (2.2) (200){(0.75) (8.04) (0.8)(1 -e ~"3@33F*) l (100cm)2 l + e4 "*3D" (0.25)(0.95)(0.32) + e 4 "*33F* (0.25)(0.05)(7.3)} l t D(=)-4.53 millisieverts (0.453 rem) Therefore, thyroid cancer patients administered 7,400 megabecquerels (200 millicuries) of iodine-131 or less would not have to remain under licensee control and could be released under U-25 Draft NUREG - 1556, Vol. 9 l
APPENDIX U 10 CFR 35.75, assuming that the foregoing assumptions can be justified for the individual patient's case and that the patient is given instructions. Patients administered somewhat larger activities could also be released immediately if the dose is not greater than 5 millisieverts (0.5 rem). In the example above, the thyroidal fraction, F2= 0.05, is a conservative assumption for persons
- who have had surgery to remove thyroidal tissue. If F2has been measured for a specific patient, the measured value may be used.
Example 3, Hyperthyroidism: Calculate the maximum likely dose to an individual exposed to a patient who has been administered 2,035 megabecquerels (55 millicuries) ofiodine-131 for the treatment of hyperthyroidism (i.e., thyroid ablation). Solution: In this example, we will again calculate the dose using Equation B-5, Table U.S, and Table U.6, to account for the elimination ofiodine-131 from the body by using the effective ) half-lives appropriate for hyperthyroidism. An occupancy factor, E, of 0.25 at 1 meter will be used for the second and third components of the equation because patient-specific instructions were provided to justify the occupancy factor (see Section B.I.2," Occupancy Factors to Consider for Patient-Specific Calculations"). Substituting the appropriate values into Equation B-5, the dose to total decay is: D(=) = 34.6 (2.2) (55)((0.75) (8.04) (0.8)(1 -e "3*33F8*) (100cm)2
+e46'3833F" (0.25)(0.20)(0.32) + e#6'3*33F8 ' (0.25)(0.80)(5.2))
D(=) = 4.86 mSv (0.486 rem) Therefore, hyperthyroid patients administered 2,035 megabecquerels (55 millicuries) of iodine-131 would not have to remain under licensee control and could be released under 10 CFR 35.75, once the occupancy factor of 0.25 in the second and third components of the equation isjustified. In the example above, the thyroidal fraction, F2 = 0.8, is a conservative assumption for persons who have this treatment for hyperthyroidism. If F has 2 been measured for a specific patient, the
- measured value may be used.
B.3 Internal Dose For some radionuclides, such as iodine-131, there may be concems that the intemal dose of an individual from exposure to a released patient could be significant. A rough estimate of the Draft NUREG - 1556, Vol. 9 U 26
l 1 1 APPENDIX U maximum likely committed effective dose equivalent from internal exposure can be calculated from Equation B-6. l t Equation B-6: D, = Q (10-5)(DCF) Where o 4 Di = Maximum likely internal committed effective dose equivalent to the f individual exposed to the patient in rems Q = ~ Activity administered to the patient in millicuries I 10-5 = - Assumed fractionalintake l DCF =- Dose conversion factor to convert an intake in millicuries to an internal committed effective dose equivalent (such as tabulated in Reference B-2). t Equation B-6 uses a value of 10-5 as the fraction of the activity administered to the patient that l would be taken in by the individual exposed to the patient. A common rule of thumb is to ( assume that no more than 1 millionth of the activity being handled will become an intake to an L individual working with the material. This rule of thumb was developed in reference'B-3 for L cases of worker intakes during normal workplace operations, worker intakes from accidental ' l ' exposures', and public intakes from accidental airborne releases from a facility, but it does not specifically apply for cases ofintake by an individual exposed to a patient. However, two studies (Refs. B-4 and B-5) regarding the intakes ofindividuals exposed to patients administered iodine-131 indicated that intakes were generally of the order of 1 millionth of the activity adminis;ered to the patient and that internal doses were far below external doses. To account for l; the most highly exposed individual and to add a degree of conservatism to the calculations, a ~~ fractional transfer of 10 5 has been assumed. i [ Example 4, Internal Dose: Using the ingestion pathway, calculate the maximum internal dose l to a person exposed to a patient who has been administered 1,221 megabecquerels (33 l
- millicuries) ofiodine-131. The ingestion pathway was selected since it is likely that most of the l L intake would be through the mouth or through the skin, which is most closely approximated by i L the ingestion pathway. )
. Solution: This is an example of the use of Equation B-6. The dose conversion factor DCF for l the ingestion pathway is 53 rems /inillicurie from Table 2.2 of Reference B-2.'
U 27 Draft NUREG - 1556. Vol. 9
l APPENDIX U ' Substituting the appropriate values into Equation B-6, the maximum intemal dose to the person is D, = (33 mci)(10-5)(53 rem / mci)
, D, = 0.17 mSv (0.017 rem)
In this case, the external dose to the other person would-be no greater than 5 millisieverts (0.5 rem), while the intemal dose would-be about 0.17 millisievert (0.017 rem). Thus, the internal dose is about 3% of the external gamma dose. Internal doses may be ignored in the calculations if they are likely to be less than 10% of the extemal dose, since the internal dose would be significantly less than the uncertainty in the external dose. The conclusion that internal contamination is relatively unimportant in the case of patient release was also reached by the NCRP. The NCRP addressed the risk ofintake of radionuclides from patients' secretions and excreta in NCRP Commentary No. I1, " Dose Limits for individuals Who Receive Exposure from Radionuclides Therapy Patients"(Ref. B-6). The NCRP concluded, .
"Thus, a contamination incident that could lead to a significant intake of radioactive material is . very unlikely." For additional discussion on the subject, see Reference B-1, ' References for Supplement B B-1. S. Schneider and S.A. McGuire, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material," USNRC, NUREG-1492, February 1997.
B-2. K.F. Eckerman, A.B. Wolbarst, and A.C.B. Richardson, " Limiting Values of Radionuclides Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion," Federal Guidance Report No.11, U. S. Environmental Protection Agency, Washington, DC,1988. B-3. A. Brodsky, "Resuspension Factors and Probabilities ofIntake of Material in Process (or
'Is 10~6 a Magic Number in Health Physics?')," Health Physics, Volume 39,
. Number 6,1980.
' B-4. ; R.C.T. Buchanan and J.M. Brindle, "Radioiodine Therapy to Out-patients - The l Contamination Hazard," British Journal of Radiology, Volume 43,1970.
l. B-5. A.P. Jacobson, P.A. Plato, and D. Toeroek, " Contamination of the Home Environment by
- Patients Treated with Iodine-131," American Joumal of Public Health, Volume 68, Number 3,1978.
Draft NUREG - 1556, Vol. 9 U-28
i APPENDIX U B-6. National Council on Radiation Protection and Measurements," Dose Limits for Individuals Who Receive Exposure from Radionuclides Therapy Patients," Commentary No. I1, February 28,1995.
- Regulatory Analysis 1
" Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" I (NUREG-1492, February 1997), provides the regulatory basis for this guide and examines the costs and benefits. A copy of NUREG-1492 is available for inspection and copying for a fee at l the NRC Public Document Room,2120 L Street NW., Washington, DC. Copies may be l l purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone (202)512-2249), or from the National Technical Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA 22161.
I l l U-29 Draft NUREG - 1556, Vol. 9
1 l Appendix V l Guidance for Mobile Services f
APPENDIX V Guidance for Mobile Services Mobile Services l Type and Location of Use There are three classes of mobile service. Class 1 mobile service is defined as transportation and use of byproduct material within a transport vehicle (e.g., in-van use). Class 2 mobile service is defined as transportation of byproduct material to a client's facility and use within a client's facility by the mobile service's employees (i.e., transport and use). Class 3 mobile service is defined as transportation of byproduct material to a client's facility and use of the byproduct material by the client's employees (i.e., transport only). Class 1 and 2 mobile service providers must apply for full service authorization. Class 3 mobile service providers need only apply for authorization for possession and transport of the byproduct material. For Class 3 mobile services, the client must possess a license for medical use of the byproduct material. For Class 3 mobile services, 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 their possession. For all classes, list the medical institutions, hospitals, or clinics and their addresses that comprise the client sites for mobile services. Licensed activities must be conducted in accordance with the regulations for compliance with 10 CFR 35.80(a), which states that we will obtain a letter signed by the management (i.e., chief executive officer or delegate) of each of our clients for which services are rendered. The letter will permit the use of byproduct material at the client's address and clearly delineate the authority and responsibility of each entity. This agreement must be applicable for the entire period of time over which the sersice is to be provided. The letter will be retained for three years after the last provision of service. Additionally, we will develop and implement survey procedures to ensure that all byproduct material, including radiophama euticals, sealed sources, and all associated wastes have been removed before leavlig each location of use as required by 10 CFR 35.80(d). Applicants for self-contained byproduct material services (i.e., Class 1) must provide the following facility information:
- A detailed description and diagram (s) of the proposed use facility (e.g., van) and associated equipment, in accordance with Items 8.16 through 8.20 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), to ensure security oflicensed material including controlling access to the van and storage area keys, and to 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 V-1 Draft NUREG - 1556, Vol. 9
APPENDIX V l areas, and identify all areas adjacent to restricted areas. The description of the van must address radiation levels in the van driver's compartment to demonstrate compliance with 10 CFR 20.1201, " Occupational dose limits for adults." For therapy treatments with byproduct material, submit a separate drawing for each client site showing the location of the treatment device / vehicle in relation to all nearby roads, sidewalks, structures, and any other locations accessible by members of the public. A signed agreement that location of the device / vehicle will be on client-owned or controlled property. Protection from vehicular traffic that could adversely affect patient treatment (s) should be provided. This 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 / site drawings provided. 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. Applicants who will provide transportable services to the client's site and use within the client's facility (i.e., Class 2) must provide the following facility information and commitment:
- A detailed description and diagram (s) of the proposed use facility (e.g., client site) and associated equipment in accordance with Items 8.16 through 8.20 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), to ensure security oflicensed material to prevent unauthorized access, and to 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.
- A commitment to retain a record establishing that the mobile service licensee has full control of the treatment room during byproduct material use for each client. This proof may be in either the form of a signed agreement or a lease agreement with the client, establishing full control of the treatment room by the applicant during all periods of use.
. The initial installation records of a remote afterloader device for each site of use, and function checks of the remote afterloader device.
Applicants for a Class 3 mobile service must ensure the following:
- Each cli:nt is properly licensed for medical use of byproduct material. If applicable, ensure that each client has received the necessary initial and, if appropriate, recurrent training for the Draft NUREG - 1556, Vol. 9 V2
APPENDIX V specific make and :nodel of the remote afterloader device being provided. If the above applicable conditions are not met, the mobile service licensee must not transfer the remote afterloader device to the client. . No signed agreement with a client may state nor imply any assumption of responsibility on the part of the mobile 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 service if 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. The responsibilities for supervision ofindividuals in the use of the byproduct material, set forth in 10 CFR 35.27, transfer to the client's AUs upon transfer of the device to the client by the mobile service provider. . The initial installation of a remote afterloader device at the client site may be performed by either the mobile 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). . A formal record of the transfer of control of the byproduct material from the mobile service provider to the client, and from the client back to the mobile service provider, must be made for each transfer of the byproduct material. A signed receipt of each transfer must be made and retained for inspection for a period of three years. Base Location The base location (e.g., central radiopharmaceutical laboratory) for the mobile service must be specified. The base facility may be located in a medical institution, non-instimtional medical practice, or commercial facility. As required by 10 CFR 30.33, submit a detailed description and diagram (s) of the proposed base facility and associated equipment in accordance with Items 8.16 through 8.20 of this report. The description and diagram of the proposed facility must demonstrate that the building is of adequate construction and design to protect its contents from the elements (e.g., high winds, rain), to ensure security oflicensed material to prevent unauthorized access, and to 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, including areas above and below the restricted areas. . The applicant may request multiple base locations. Radioactive material must be delivered only to a facility licensed to receive the type of radioactive material ordered. V-3 Draft NUREG - 1556, Vol. 9
APPENDIX V
. Base locations can include the use of a mobile van. In those cases in which the base facility is in the van, and there is no permanent structure for the byproduct material storage, we will have provisions for the following:
Secured off-street parking under licensee control. Public rights-of-way are not considered part of the address of the client;
- Secured storage facilities will be available for storage of byproduct material and radioactive waste should the van be disabled; and
- Byproduct material will be delivered (if necessary) directly to the van only if the van is occupied by licensee personnel at the time of delivery.
. If a base facility is located in a residential area, we will provide the following information:
Evidence of the requirement for the private residence location rather than for a commercial location.
- Documentation of the agreement between the residence owner and the licensee in the event of disagreements between these two entities. It is essential that the mobile service have access to the facility in the event ofcontamination. Included will be provisions for decontamination of the mobile service van, etc., on the client property, if necessary.
Documentation from both parties will illustrate the agreement between the client and the mobile service.
- A description of our program demonstrating compliance with 10 CFR 20.1301, " Dose limits for individual members of the public."
- Verification that restricted areas shall not contain residential quarters.
Training And Experience We will require the supervised individual to: follow the instructions of the supervising authorized user for medical uses of byproduct material; follow the written radiation protection and written directive procedures established by the licensee; and a comply with the regulations of 10 CFR 35.80,10 CFR 35.647 (if applicable) and the license conditions with respect to the mobile use of byproduct material. Draft NUREG - 1556, Vol. 9 V-4
APPENDIX V Training for Individuals Working in or Frequenting Restricted Areas 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), drivers and technologists (or therapists) will be properly trained in applicable transportation regulations and emergency procedures. The training records for these individuals will include (at a minimum) dates, topics discussed (e.g., DOT regulations, shielding, ALARA, basic radiation protection), attendees, and the instructor's name, and shall be maintained for 3 years for NRC review. Licensees may choose to retain records for longer periods. Survey Instrument & Done Measurement Instrument Checks We will check survey instruments for proper operation with a dedicated check source before use at each address of use. We will check dose measurement instruments (e.g., dose calibrator) as described in 10 CFR 35.60 or 10 CFR 35.62, as applicable, 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. Order and Receipt of Byproduct Material Byproduct material will be delivered by a supplier to the base location or to the client's address, if the client is licensed to receive the type of byproduct material ordered. Delivery of byproduct material to a van that is not occupied by the mobile service personnel will not be permitted. - Altematively, we will pick up the byproduct material (e.g., radiopharmaceuticals) from the supplier (e.g., nuclear pharmacy) en route to client facilities. Emergency Procedures We will develop and implement emergency procedures, in accordance with 10 CFR 20.1101, that, in part, will indicate that the RSO, AU, or a responsible designee, can be physically present at the client's address in response to incidents (e.g., accidents, spills, medical events) that occw at client facilities. We will indicate typical response times of the RSO and AU in the event of an incident. We will develop and implement procedures that include emergency response regarding an accident scenario. An accident is defined as a vehicle collision or other events, such as, wind, water or fire damage that results in damage to exterior or interior portions of the vehicle or the byproduct material used in the mobile service. The transportation emergency response plan will cover both the actions to be taken by the mobile service provider's headquarters emergency V-5 Draft NUREG - 1556, Vol. 9
APPENDIX V response personnel and the "on scene" hazmat trained personnel, and it will be readily available I to both transport vehicle personnel and headquarters emergency response contacts. At a ! minimum, this plan willinclude: l . A 24-hour emergency contact telephone number for the mobile service provider's emergency response personnel. Emergency contact number for NRC's 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. Procedures for retrieving and securing any byproduct material, including a sealed source that may become detached and/or dislodged to the extent that a radiological hazard is created. This may require one or more emergency shielded source containers. 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. Procedures to ensure that, following any accident, no patient treatments will occur until all systems pertaining to radiation safety have been tested and confirmed to be operational by the RSO or AMP. 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 10 CFR 30.50, will be provided to any Class 2 or 3 clients following any accident in which there is actual or possible damage to the facility or device. A calibrated, operational survey meter should be maintained in the cab of the transporting vehicle. Such a survey meter may be used at an accident scene for conducting surveys. Note: The type of response should be consistent with the level of the incident. The response may range from phone contact for minor spills, to prompt on-site response (less than 3 hours) to events such as a medical event or lost radioactive material. Transportation We will develop procedures to assure that: Radioactive material is transported in accordance with 49 CFR Parts 170-189. Procedures will include:
- use of approved packages Draft NUREG - 1556, Vol. 9 V-6
APPENDIX V i l - use of approved labeling l l
- conduct of proper surveys
! - complete and accurate shipping papers
- bracing of packages
- security provisions
. Management (or their 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 client's facilities.
. Radioactive waste is handled properly during transport. We will describe the method of storage and final disposal.
. The transport vehicle including the driver's 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 via 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. Radioactive Waste Management If waste will be stored in vans, the vans will be properly secured and posted as byproduct material storage locations. We will ensure that the van will be secured against unauthorized access and that the waste storage location will be posted as a byproduct material storage area. We will develop and implement final waste disposal procedures in accordance with Section 8.44 of this report. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material may be disposed of without regard to radioactivity ifit is discharged into the sanitary sewerage system, in accordance with 10 CFR 20.2003. However, excreta collected from patients in a rest room in a van with a holding tank, is not considered direct disposal into the sanitary sewerage system. If we will provide rest-room facilities on the van for patient use, we will 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 on the van, and the driver of the van. A description of procedures to assess the tank for possible leakage. A description, of any ventilation associated with the rest-room, will be provided if any I-131 will be held in the tank.
V-7 Draft NUREG - 1556, Vol. 9
APPENDIX V A description of procedures to ensure doses to occupational workers and members of the public will not exceed the exposure lin'its in 10 CFR 20.1201 and 20.1301. A description of procedures ensuring that doses to the general public do not exceed 100 mrem / year, that the external surfaces of the van do not exceed 2 mrem / hour, and that doses to members of the public and workers are maintained ALARA. We will include considerations of external dose rates in the rest-room due to 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. Precautions taken to minimize contamination in this process will be included.
Mobile Services With Remote Afterloader Devices In addition to the above procedures addressed in the mobile services section, we will develop and implement the following procedures regarding mobile remote afterloader service operations: Since 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, we will develop and implement the following procedures used to determine if the device is operating properly prior to the commencement of patient treatments:
- Safety checks conducted on a remote afterloader device and facility. The procedure will, as a minimum, include the periodic spot checks required by 10 CFR 35.643 (or 10 CFR 35.644) and the additional spot checks required by 10 CFR 35.647, prior to medical use following any relocation of the device. Additionally, the procedure must include provisions for prompt repair of any system identified as not operating properly.
- The retreatment operational function checks after each device move must also include a review of any device alarm / error messages and, if necessary, a resolution of problems indicated by such messages.
- Such tests, as indicated above, must be established by the AMP identified on the license authorizing patient treatments. (This would be the mobile service provider in Class 1 and 2 applications and the client in Class 3 applications.)
- The applicant must maintain records showing the results of the above safety checks for NRC inspection and review for a period of three years.
For Class 1 and 2 services, we will develop and implement a radiation survey procedure which includes results of radiation surveys conducted prior to initiation of the treatment program (baseline surveys). These baseline surveys must 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. Immediately following any relocation of the remote afterloader device, Draft NUREG - 1556, Vol. 9 V-8
APPENDIX V and prior to patient treatments, the licensee must conduct such surveys, as necessary, with a portable, calibrated survey meter, to assure the radiation dose rates obtained are comparable to l those obtained from the baseline surveys. Any significant increase in the dose rates found l after relocation from the baseline survey results suggests that the shielding integrity may have been compromised and must be investigated and resolved prior to use of the remote afterloader device. V-9 Draft NUREG - 1556, Vol. 9
Appendix W Transportation
APPENDIX W Transportation The major areas in the DOT regulations that are most relevant for transportation of Type A or l Type B quantities oflicensed material are:
- Table of Hazardous Materials and Special Provisions 49 CFR 172.101, and App. A, Table 2:
Hazardous materials table, list of hazardous substances, and reportable quantities
- Shipping Papers 49 CFR 172.200-204: General entries, description, additional description requirements, shipper's certification
- Package Markings 49 CFR 172.300,49 CFR 172.301,49 CFR 172.303,49 CFR 172.304, 49 CFR 172.310,49 CFR 172.324: General marking requirements for non-bulk packagings, prohibited marking, marking requirements, radioactive material, hazardous substances in non-bulk packaging
- Package Labeling 49 CFR 172.400,49 CFR 172.401,49 CFR 172.403,49 CFR 172.406, 49 CFR 172.407,49 CFR 172.436,49 CFR 172.438,49 CFR 172.440: General labeling requirements, prohibited labeling, radioactive materials, placement oflabels, specifications for radioactive labels
- Placarding of Vehicles 49 CFR 172.500,49 CFR 172.502,49 CFR 172.504,49 CFR 172.506, 49 CFR 172.516,49 CFR 172.519,49 CFR 172.556: Applicability, prohibited and permissive placarding, general placarding requirements, providing and affixing placards:
highway, visibility and display of placards, RADIOACTIVE placard
- Emergency Response Information, Subpart G,49 CFR 172.600,49 CFR 172.602, 49 CFR 172.604: Applicability and general requirements, emergency response information, emergency response telephone number
- Training, Subpart H,49 CFR 172.702,49 CFR 172.704: Applicability and responsibility for training and testing, training requirements
- Radiation Protection Program for Shippers and Carriers, Subpart 1,49 CFR 172.800, etc.
- Shippers - General Requirements for Shipments and Packaging, Subpart I,49 CFR 173.403, 49 CFR 173.410,49 CFR 173.411,49 CFR 173.412,49 CFR 173.413,49 CFR 173.415, 49 CFR 173.416,49 CFR 173.433,49 CFR 173.435,49 CFR 173.441,49 CFR 173.471, 49 CFR 173.475,49 CFR 173.476: Definitions, general design requirements, industrial packages, additional design requirements for Type A packages, requirements for Type B packages, authorized Type A packages, authorized Type B packages (including package certification requirements), requirement for determining Al and A2..., table of Al and A2 values for radionuclides, radiation level limit, requirements for USNRC-approved packages (Type B), quality control requirements prior to each shipment... approval of special form radioactive materials W-1 Draft NUREG - 1556, Vol. 9
APPENDIX W
- Carriage by Public liighway 49 CFR 177.816,49 CFR 177.817, 49 CFR 177.834(a),
49 CFR 177.842: Driver training, shipping paper, general requirements (secured against movement), Class 7 (radioactive) material. i Draft NUREG - 1556, Vol. 9 W-2
l Appendix X Model Procedure for Waste Disposal by Decay-In-Storage, Generator Return, and Licensed Material Return
APPENDIX X Model Procedure for Waste Disposal by Decay-In-Storage, Generator Return, and Licensed Material Return Model Procedure for Decay-In-Storage 10 CFR 35.92 describes the requirements for DIS. Short-term storage should be designed to allow for segregation of wastes with different half-lives (e.g., the use of multiple shielded containers). Containers should have shielded covers to maintain occupational exposure at ALARA levels. Storage area must be in a secure location.
. We will consider using 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 disposed of must not provide any radiation shielding for the material.
. When the container is full, we will seal it and attach an identification tag that includes the date sealed, and the longest-lived radionuclides in the container. The container may then be transferred to the DIS area.
. Prior to disposal as in-house waste, we will monitor and record the monitoring of each container as follows:
- Choose a survey instrument that is appropriate for the type and energy of the radiation being measured.
- Check the radiation detection survey meter for proper operation.
- Plan to monitor in a low-level radiation (< 0.05 millirem per hour) 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 immediately incinerated and instruction has been provided to the incinerator operator regarding radioactive labels and potential hazardsf.
- Discard as in-house waste only those containers that cannot be distinguished from background. Record the disposal date, the radionuclides disposed, 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.
- 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 re:ipient.
Note: Contact the appropriate NRC Regional Office for guidance in this area X-1 Draft NUREG - 1556, Vol. 9
APPENDIX X Model Procedure for Returning Generators to the Manufacturer Used Mo/Tc-99m generators may be returned to the manufacturer. This permission does not relieve licensees from the requirement to comply with 10 CFR Part 71 and DOT regulations. We l will perform the following when returning generators: Retain the records needed to demonstrate that the package qualifies as a DOT Specification 7A container (see DOT regulations, paragraph 173.415 (a) of 49 CFR Part 173).
. Assemble the package in accordance with the manufacturer's instructions.
Perform the dose rate and removable contamination measurements required by paragraph 173.475 (i) of 49 CFR Part 173.
- Label the package and complete the ship,ng papers in accordance with the manufacturer's instructions.
. Retain records of receipts and transfers in accordance with 10 CFR 30.51.
Model Procedure for Return of Licensed Material to Authorized Recipients We will perform the following 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 transferee's NRC 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 (see DOT regulations, paragraph 173.415 (a) of 49 CFR Part 173).
. Assemble the package in accordance with the manufacturer's instructions.
Perform the dose rate and removable contamination measurements required by paragraph 173.475 (i) of 49 CFR Part 173. Label the package and complete the shipping papers in accordance with the manufacturer's instructions.
- Retain records of receipts and transfers in accordance to with 10 CFR 30.51.
Drall NUREG - 1556, Vol. 9 X-2
Appendix Y NRC Form 314
NRC FORM 314 U.S. NUCLEAR REGULATORY COMMISSION AmavtD sY cua. No. 31504028 E W E5.06aos
'8 83)
ESTIMATED SWEEN PEA ESPONSE TO C0l#LT WITH Dis MAWA0RT IGOM4ATION f%LiCn0N to cFR So.30lcH1HM gout 37. 30 esNUTIS. THIS BlahETTAL 18 U8E0 ST NAC As PA2T Cf THE Basis 80A ITs to CFR ao.42tcH1HM DEftienAn0N THAT TNE FACluTV NAs 8Ein CLIAMD 08 RADIOACTIVE MATEMAL SEF0M THE to CFR 70.3sicH1HM factuTV is AELEASED FOR UNilESTECTED Ust. FOReAW C0taENT8 MGARDING OumEu ESTIMATE TO THE Ilf0 AMAN 04 AW EC048 MAllAGEMNT SAANCH (T 4 f33), U.S. RICL1AR CERTIFICATE OF DISPOSITION OF MATERIALS ==a' ca"a" "a*** oc 2aa a
^".a '"' = ="a PA0 JECT (3180 0028). OfRCE of Malla:EWNT AM 9000ET eA3 mil 8TOII. DC 20603. As AGENCT MAT NL T COEUCT OR SPONBoll AE A PEAS 0418 NOT MOUIE0 TO ESPONO T0. A ! INSTRUCTIONS: ALL ITEMS MUST BE COMPLETED ~ PRINT OR TYPE CaLECnn oiINFHManu m8s 17 DiSPLAn A CuAmETLOAu0 0M8 CMm1 mm SEND THE COMPLETED CERTIFICATE TO THE NPC OFFICE SPECIFIED ON THE REVERSE UCEN5EE hAME AND ADDHLbh LNtNbt NVMllER LICENSE EAPIRATlON DATE A. MATERIALS DATA (Check one and complete as necessary)
THE LICENSEE OR ANY INDIVIDUAL EXECUTING THIS CERTIFICATE ON BEHALF OF THE LICENSEE CERTIFIES THAT: (Check and/or complete the appropriate item (s) below.)
]1. NO MATERIALS HAVE EVER BEEN PROCURED OR POSSESSED BY THE LICENSEE UNDER THIS LICENSE.
OR
]2. ALL ACTIVITIES AUTHORIZED BY THE LICENSE HAVE CEASED AND ALL MATERIALS PROCURED AND/OR POSSESSED BY TH LICENSEE UNDER THE LICENSE NUMBER CITED ABOVE HAVE BEEN DISPOSED OF IN THE FOLLOWING MANNER. /// additional space is needed, use the reverse side or provide attachments.)
Describe specific material transfer actions and. if there were radioactive wastes generated in terminating this license, the disposal actions including the disposition of low leve'
- dioactive waste, mixed waste, Greater than-Class-C waste, and sealed sources, if applicable.
For transfers, specify the date of the transfer, the name of the licensed recipient, and the recipient's NRC license number or Agreement State name and license number. If materials were disposed of directly by the licensee rather than transferred to another licensee, licensed disposal site or waste contractor, describe the speelfic disposal procedures (e.g., decay in storage). S. ' OTHER DATA
]1. OUR LICENSE HAS NOT YET EXPIRED: PLEASE itiRMINATE IT.
- 2. A RADIATION SURVEY WAS CONDUCTED BY THE LICENSEE TO CONFIRM THE ABSENCE OF LICENSED RADIOACTIVE MATERIALS AND TO DETERMINE WHETHER ANY CONTAMINATION REMAINS ON THE PREMISES COVERED BY THE LICENSE. (Check ons/
NO (Attach explanation)
~YES, THE RESULTS / Check one/
ARE ATTACHED, or WERE FORWARDED TO NRC ON IDate)
- 3. THE PERSON TO BE CONTACTED REGARDING THE INFORMATION 1T"c"""
PROVIDED ON THIS FORM
- 4. MAIL ALL FUTURE CORRESPONDENCE REGARDING THIS LICENSE TO CERTIFYING OFFICIAL i CERTIFY UNDER PENALTY OF PERJURY THAT THE FOREGOING IS TRUE AND CORRECT PRINTED NAME AND TilLE SIGNATURE DATE WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJEC1 TO civil AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS. 18 U.S.C.
SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT.OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTIONS. NHC FOMM 3l4 (6 Sbi PRINTED oN RECYCLED PAPER
FILE CERTIFICATES AS FOLLOWS: IF YOU ARE LOCATED IN: IF YOU ARE A DISTRIBUTOR OF EXEMPT PRODUCTS, SEND TO: ILLINOIS, INDIANA, IOWA, MICHIG AN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, SEND APPLICATIONS TO: OlVISION OF INDUSTRIAL AND MEDICAL NUCLEAR SAFETY OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS MATERIALS LICENSING SECTION U.S. NUCLEAR REGULATORY COMMISSION U.S. NUCLEAR REGULATORY COMMIS$10N, REGION 111 WASHINGTON, DC 20555-0001 801 WARRENVILLE ROAD LISLE, IL 60532 4351 ALL OTHERS, IF YOU ARE LOCATED IN: ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, MAINE, HAWAll, IDAHO, KANSAS, LOUISIANA, MONTANA, NEBRASKA. MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW NEVADA, NEW MEXICO, NORTH DAKOTA, OKLAHOMA, JERSEV, NEW YORK, PENNSYLVANIA, RHODE ISLAND, OR OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, VERMONT, SEND APPLICATIONS TO: TEXAS, UTAH, WASHINGTON, OR WYOMING, SEND APPLICATIONS TO: LICENSING ASSISTANCE SECTION NUCLEAR MATERIALS SAFETY BRANCH RM WMM PWpm m@ S. NUCLEAR REGULATORY COMMISSION, REGION 1 RMWW NWSM RWW N 611 RYAN PLA TA DRIVE, SUITE 400 KING OF PRUSSIA, PA 19406-1415 ARLINGTON, TX 76011 8064 ALABAMA, FLORIDA, GEORGIA, KENTUCKY, MISSISSIPPI, NORVH CAROLINA, PUERTO RICO, SOUTH CAROLINA, VENNESSEE, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA, SEND APPLICATIONS TO: WUCLEAR MATERIALS SAFETY SECTION U.S. NUCLEAR REGULATORY COMMISSION, REGION 11 101 MARIETTA STREET NW, SUITE 2S00 ATLANTA, GA 30323-0199
NRC FORM 335 u.s. NUCLEAR REGULATORY Co%MisSloN 1. REPORT NUMBER (249) (Assigned by NRC, Add Vol., Supp., Rev., NRCM 1102. and Addendum Numbers. if any.) 32n 32o2 BIBLIOGRAPHIC DATA SHEET (Sa esinxtas oa the re=< e' NUREG-1556
- 2. TITLE AND SUBTITLE Vol. 9 Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Medical Use Licenses 3. DATE REPORT PuBUSHED MONTH YEAR
( Draft Report for Comment August ~ 1998
- 4. FIN oR GRANT NUMBER
- 5. AUTHOR (S) 6. TYPE OF REPORT P. A. Lanzisera, A. R. Jones, R. G. Gattone, R. D. Reid Draft 7 PERIOD COVERED (inclusae Dates)
- 6. PERFORMING ORGANIZATION - NAME AND ADDRESS (it NRc. powde Owsm. ornce or Rognon, u s Nucmar Regulatwy commessa, and matang address. dcontractor, powde name and me6ng address)
Office of Nuclear Material Safety and Safeguards Division of Industrial and Medical Nuclear Safety U.S. Nuclear Regulatory Commission Washington, DC 20555-0001
- 9. SPONSORING ORGANIZATION - NAME AND ADDRESS (If NRc. type 'Same as above'. dcontractor, prowde NRc Owsoon, ornce or Regron. U S Nuclear Regulatory commossa.
and me6ng acuress } Same as above
- 10. SUPPLEMENTARY NOrES
- 11. ABSTRACT (200 nords or Jess)
This draft guide has been developed in parallel with the proposed revision of 1") CFR Part 35, " Medical Use of Byproduct Material." Comments received in response to publication of this draft will be considered in developing the final guide. Finalization of the guidance will continue to parrallel the rulemaking; resulting in a guidance document that is consistent with the final rule. Draft NUREG-1556, Vol. 9. " Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Medical Use Licenses," dated July 1998, is the ninth program-specific guidance document developed for this guidance series, and is intended for use by applicants, licensees, and NRC staff and will also be available for use by Agreement States. This document combines and supersedes the guidance previously found in Regulatory Guide (RG) 10.8, Revision 2, " Guide for the Preparation of Applications for Medical Use Programs"; Appendix X to RG 10.8, aevision 2, " Guidance on Complying With New Part 20 Requirements"; Draft RG DG-0009, " Supplement to Regulatory Guide 10.8, Revision 2, Guide for the Preparation of Applications for Medical Use Programs"; Draft RG FC 414-4, " Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs"; Policy and Guidance Directive (P&GD) FC 87 2, " Standard Review Plan for License Applications for the Medical Use of Byproduct Material"; P&GD FC 86-4, Revision 1, "Information Required for Licensing Remote Afterloading Devices"; Addendum to Revision 1 to P&GD FC 86-4,"Information Required for Licensing Remote Afterloading Devices Increased Source Possession Limits"; P&GD 3-15, " Standard Review Plan for Review of Quality Management Programs"; RG 8.39, " Release of Patients Administered Radioactive Materials"; RG 8.33, " Quality Management Program"; P&GD 3-17, " Review of Training and Experience Documentation Submitted by Proposed Physician User Applicants"; and RG 8.23, " Radiation Safety Surveys at Medical Institutions, Revision 1". Note that this document is strictly for public comment and is NOT for use in preparation or review of medical use licenses until it is published in final form.
- 12. KEY WORDS/DESCRIPTORS (Ost nords or phrases that ma assist researchers m iocatmg the reporf) 13 Avan.Aelury srATEMENT materials unlimited licensees 14 SECURITY CL. OSSIFICATION risk-informed 'iTh,s page) performance-based program-specific unclassified (Thos Report) unclassified
- 15. NUMBER OF PAGES 16 price NRC FORM 335 (249)
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