ML20207L823
| ML20207L823 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/1999 |
| From: | Jackie Jones, Wade Loo, Reber E, Schwartz M, Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-1556, NUREG-1556-V06, NUREG-1556-V6, NUDOCS 9903180287 | |
| Download: ML20207L823 (250) | |
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NUREG-1556, Vol. 6 . < Censolidated Guidance About Materials Licenses Program-Specific Guidance About
.10 CFR Part 36 Irradiator Licenses Final Report Manuscript Completed: January 1999 l Date Published: January 1999 l Prepared by !
J.D. Jones, W.T. Loo, E.H. Reber, M.E. Schwartz, P.C. Vacca Div': ion ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 , , \ . y~ s a if I
\...../
ABSTRACT As part ofits redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539," Methodology and Findings of the 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. NUREG-1556, Vol. 6,
" Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses," dated January 1999, is the sixth program-specific guidance develop,:d for the new process and is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document updates the guidance found in NMSS Policy and Guidance Directive, FC 84-23," Standard Review Plan for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage, and Panoramic Wet Source-Storage Inadiators," dated December 27,1984. This report, where applicable, provides a more risk-informed, performance-based approach to licensing 10 CFR Part 36 irr-Jiators consistent with the current regulations. "This final report should be used in preparing ,
Part 36 Irradiator License Applications. NRC staff will use this final report in reviewing these l applications." ; l I l iii NUREG - 1556. Vol. 6
o , j CONTENTS A BSTRA CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii FOREWORD..............................................................................ix A CKN OWLEDG M ENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi A BBREVI ATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii 1 PU RPOSE OF REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 A G R EEM ENT STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 3 MANAGEM ENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 4 APPLICABLE REGULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 5 HOW TO FI LE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1 ; 5.1 PAPER A PPUCATION . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . , . . . . . . . . . . . . . . . . . . . . 5-1 5.2 ELECTRONIC APPUCATION ......... ... .s.... .... ...................... .. 5-2 6 WH E R E TO FI LE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6- 1 7 LI C EN S E FE ES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1 8 CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 8.1 ITEM I: UCENSE ACTION TYPE . . . . . . . ...... ....... .. .... .... .......... 8-1 I 8.2 ITEM 2: APPUCANT'S NAME AND MAIUNG ADDRESS . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED . 8-3 8.4 ITEM 4: PERSON TO BE CONTACTED AbOUT THIS APPUCATION . . . . . . . . . . . .... . 8-4 ) 8.5 l'IEM 5: RADIOACTIVE MATERIAL . . . . . . ........... .................... ...... 8-5 8.5.1 SEALED SOURCES AND DEVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 ) 8.5.2 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING , 8-6 8.6 ITEM 6: PURPOSE (S) FOR WHICH LICSNSED MATERIAL WILL BE USED . . . . . . . . . . . 8-9 8.7 ITEM 7: ITEM 7: INDIVIDUAL (S) REST ONSIBLE FOR RADIATION SAFETY PROGRAM . 8.11 8.7.1 RADIATION SAFETY OFFICLR (RSO) TRAINING AND EXPERIENCE . . ... 8-11 8.7.2 RADIATION SAFETY OFFICER (RSO) RESPONSIBIUTIES AND AUTH ORITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 12 8.8 ITEM 8: INDIVIDUALS W ORKING IN OR FREQUENTING RESTRICTED AREAS . . . . . . 8-14 8.8.1 INITIAL TRAINING AND EXPERIENCE FOR 1RRADIATOR OPERATORS . . 8-14 8.8.2 ANNUAL SAFETY REVIEWS AND PERFORMANCE EVALUATIONS FOR 1RRADIAMR OPERATORS ................. ....... .... ..... ....... 8-16 8.8.3 TRAINING FOR INDIVIDUALS WHO REQUIRE UNESCORTED ACCESS . . . 8-18 8.9 ITEM 9: FACIUTIES AND EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . ....... .. 8-19 8.9.1 GENERAL DESCRIPTION OF THE FACIUTY AND SITE . . . . . . . . . . . . . . . . 8- 19 j
. . . . . . 8-20 8.9.2 ACCESS CONTROL . . . . . . . . . . . . . . . . . . . . .... .............
8.9.3 SHIELDING . . . . . . . . . . . . . .......... ........... . . . . . . . . . . . . . . . . 8-23 8.9.4 FIRE PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . 8-25 8.9.5 RADIATION MONIMRS . . . . .. . . . . . . . . .. .. ... ... .. .. . . .. 8-26 8.9.6 IRRADI ATOR POOL 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28 8.9.7 S OURCE RACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......... . 8-30 8.9.8 POWER FAILURES . . ... .. ..... .... .. . . . . . . . . . . . . . . . 8-3 1 i 8.10 ITEM 10: RADIATION SAFETY PROGRAM ..... . ...... . .... .. .. . 8-32 8.10.1 AUDIT PROGRAM , . . . . . . . . . . . . . . . . . .. .... . . . . . . 8-3 2 , I i v NUREG .1556, Vol. 6 f tp L.
CONTENTS r 8.10.2 INSTRUMENTS . . . . . . . . . . . ... ........ ... . .... .... .. .... 8-34 8.10.3 MATERIAL RECEIPT AND ACCOUNTABILITY .....................8-38 ; 8.10.4 OCCUPATIONAL DOSIMETRY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 0 8.10.5 PUBLIC DOSE . . . . . . ... . .
.............................8-42 8.10.6 OPERATING PROCEDURES ... ............................8-44 8.10.7 PROCEDURE FOR IDENTIFYING AND REPOR11NG DEFECTS AND
. NON-COMPLIANCE AS REQUIRED BY 10 CFR PART 21 . . . . . . . . . . . . . . . . . 8-4 7 8.10.8 EMERGENCY PROCEDURES . . . . .. ....... .. . . . . . . . . . . . . . 8-4 8 +
8.10.9 LEA K TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . ...... . ..... . . . . . . . 8-51 i 8.10.10 INSPECTION AND MAINTENANCE CHECKS . . . . . . . . . . . . . . . . . . . . 8-54 ; 8.10.11 TRANSPORTATION .............................................8-55 I 8.10.12 MINIMIZATION OF CONTAMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-57 8.11 ITEM 11: WASTE MANAGEMENT . . . . . . . . ...... .. ... ........ ....... ... 8-57 l 8.11.1 SEALED SOURCE DISPOSAL AND TRANSFER .......................... 8-57 1 I 8.12 ITEM 12: FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 8 8.13 ITEM 13: CERTIFICATION .. ................ ......... . .... ....... . . . . . 8-59 9 AMENDMENTS AND RENEWA LS TO A LICENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1 10 APPLICATIONS FOR EXEMPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 1 , 1 11 TERMINATION OF A CTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1 l l 1 APPENDICES A List of Documents Considered in Development of this NUREG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 B NRC Form 313 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B - 1 C Suggested Format for Providing Information Requested in Items 5 through 1I of NRC Form 313 . . . . . . . C-1 D Information Needed for Transfer of Control Application . . . . . . . . . . . . . . . . . . ..................D-1 I E Suggested Wording for a Statement of Intent for a Government Licensee . . . . . . . . . . . . . . . . . . . . . . . . . . E-1 I F Irradiation of Explosive Materials or Greater Than Small Quantities of Flammable Materials . . . . . . . . . . . F-1 G Trair.ing for Radiation Safety Officers and Irradiator Operators . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . G-1 ! H Typical Duties and Responsibilities of the Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . H-1 I Information Needed to Support Applicant's Request to Perfonn Non-Routine Operations . . . . . . . . . . . 1-1 J Canstruction Monitoring and Acceptance Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-l K Sugested Audit Checklist for 10 CFR Part 36 Irradiators . . . . . . . . . . . . .....................K-1 L Model Survey Instrument Calibration Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1- 1 M Guidance for Demonstrating that Unmonitored Individuals vc Not Likely to Exceed 10 Percent of the A llowable Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M - 1 N. Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding l the Allowable Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . N- 1 : O Typical NRC Incident Notifications Required for Irradiator Licensees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O-1 P Model Leak Test Progrrm For Dry-Source-Storage Irradiator Scaled Sources . . . . . . . . . . . . ....... P-1 Q Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........................................Q-1 i 1 i 1 NUREG - 1556. Vol 6 vi
CONTF.NTS R' Exemptions for Teletherapy Units Converted to Non-Human Use . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . R.1 ! ) l
- S Samp' le Licenses for 10 CFR Part 36 Irradiators . . . . . . . . . . . . ..................... ........ S.1 T Addendum: Responses to Comments on Draft NUREG - 1556, Vol. 6. Dated March 1998 . . . . . . . . . . . . . T-1 ;
FIGURES Figure 1.1 - Teletherapy Unit Converted to Non-Human Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , 1-2 ! Figure 1.2 U nderwater irradiator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . 1 -? r Figure 1.3 Commercial Wet-Source-Storage Irradiator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ~ M Figure 2.1 U.S. Map.................................................................2-2 l Figure 8.1 Location of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 f Figure 8.2 Financial Assurance for Decommissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . 8-7 ! Figure 8.3 Records important to Decommissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 . Figure 8.4 RSO Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 13 Figure 8.5 General Description of Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19 l Figure 8.6 Radiation Detection Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-36 Figure 8.7 Material Receipt and Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 8 Figure 8.8 Annual Dose Limits for Radiation Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-41 Figure 8.9 Proper Handling of incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-49 Figure 8.10 leak Testin g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 2 Figure J.1 Construction Monitoring and Acceptance Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-l TABLES i l Table 1.1 Categories and Types ofl0 CFR Part 36 Irradiators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 Table 2.1 Who Regulates the Activity? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Table 8.2 Requirements for Radiation Monitors . . . . . . . . . . . . . . . . . -. . . . . . . . . . . . . . . . . . . . . . . . . . 8-35 Table 8.3 Elements of Accountability Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-39
- Table 8.4 Receipt. Transfer and Disposal Record Maintenance . . . . . . . .....................8-39 Table 8.5 Requirements for Occupational Dosimetry . . . . . . . . . . . . . . . . ..... .. . . . . . . . . 8-40 Table 8.6 Radiation Limits Specified in 10 CFR 36.25 . . ......................................8-43 Table 8.7 Operating Procedures . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44 i
Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance Directives . . . . . . . . . . . . A-1 j Table A.2 List of Information Notices . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A- 1 ! Table J.1 Construction Monitoring and Acceptance Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-l
- Table N.1 Information Known About Dose at the Shield of the Irradiator ..........................N-3 ;
Table N.2 Calculational Method, Part 1: Hourly and Annual Dose Received from Irradiator . . . . . . . . . . . . . N-3 l 1 Table N.3 - Calculational Method, Part 2: Annual Dose Received from a 10 CFR Part 36 Irradiator . . . . . . . N-4 1 vii n UREG - 1556. Vol. 6
1 l i l CON 1ENTS l Table T.1 Mark Smith, Corporate Manager of Technical Services, Sterigenics International, ' Dated May 18,1998... .. .... .... . .......... .. .. . ... ...... T-1 Table T.2 Joseph G. Klinger, Chief, Division of Radioactive Materials State of Illinois Dated July 8,1998 . . . . . . . . . . . . . . . . . ...... . ... . . . . . .. .. . . . . . . T- 12 1 I i i l l NUREG - 1556, Vol 6 viii
- FOREWORD' The NRC is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effon is described in NUREG-1539, " Methodology and Findings of the NRC's Materials Ucensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes cunently included in the NUREG-1556 series. Additional volumes are planned.
; vel ,.
Valmane11de o Semens 1 Program-Specific Guidance About Portable Gauge Ucenses Final Repon l2 Pmgram 6-E GManne AboutIndustrialRadiographyIh- Final Report 3 Applications for Scaled Source and Device Evaluation and Final Repon Registration 44 Pmgram-Specific Guidance' About Pixed Gauge Ucenses Final Report 5' Program-Specific Guidance About Self-Shielded Irradiator Final Repon . Licenses 6 Program-Specific GMance About 10 CPR Part 361rradiator , Final Report
- . w, ,
7 Program-Specific Guidance About Academic, Research and . Draft for Comment Development, and Other Ucenses of Umited Scope
~8 Pmgram-Specific Guidance about Ucenses for Exempt . Final Report Distributid 9 Program-Specific Guidance about Medical Use Ucenses Draft for Comment 110; Program-Specific Guidance About Master Materials Ucenses Draft for Camment 11 Program-Specific Guidance About Ucenses of Broad Scope Draft for Comment .__
l13; Pmgram-Specific Guidance About Commercial P=-C --'T Draft for Camment Ucenses' The current document, NUREG-1556, Vol. 6. " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiators," dated January 1999,is the sixth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It updates the guidance for applicants and licensees previously found in NMSS Policy and Guidance Directive, FC 84-23," Standard Review Plan for Ucenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage, and Panoramic Wet Source-Storage Irradiators," dated December 27,1984. In addition, this report also contains peninent information found in ix NUREG - 1556, Vol. 6
FOREWORD Technical Assistance Requests and Information Notices. See Appendix A for a list of the documents considered in the preparation of this report. In addition,it reflects consideration of the comments received during the comment period on draft NUREG-1556, Vol. 6. See the Addendum for summaries of comments, staff responses, and other changes. This report takes, where applicable, a risk-informed, performance-based approach to licensing 10 CFR Part 36 irradiators consistent with the current regulations. A team composed of NRC staff from regional offices and headquaners drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to irradiators. A representative of NRC's Office of the General Counsel provided a legal perspective. NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Pan 36 Irradiators," dated January 1999, represents a step in the transition from the current paper-based process to the new electronic process. This document is available on the Internet at the following address:
<htt p://www.nrc. gov /NRC/NUREGS/S R 1556/V6/index.html>.
Thi; report describes and makes available to the public information on: methods acceptable to the NRC staff for implementing specific parts of the Commission's regulations; techniques the staff uses in evaluating applications, including specific problems or postulated accidents; and data the NRC staff needs to review applications for licenses. NUREG-1556, Vol. 6,
" Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiators," dated January 1999, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this report are provided for information only. Methods and solutions different from those described in this repon will be acceptable if they provide a basis for the staff to make the detenninations needed to issue or continue a license.
/ S$
Donald ATool, Director
, Y Division ofIndustrial and Medical Nuclear Safety l Office of Nuclear M :terial Safety and Safeguards i
l NUREG - 1556, Vol 6 x
l t t ACKNOWLEDGMENTS l The writing team thanks the individuals listed below for assisting in the development and review l l of the report. All participants provided valuable insights, observations, and recommendations. The team also thanks Kay Avery, Judy Boykin, Agi Seaton, Steven W. Schawaroch, and l Gina G. Thompson of Computer Sciences Corporation; the management and staff of irradiators ; ( operated by Baxter Healthcare Corporation in Aibonito, Puerto Rico, and Isomedix Operations, l Inc.,in Vega Alta, Puerto Rico; Glenn Calvert and Jon Young ofIsomedix Operations,Inc., in l Whippany, New Jersey; Joseph Stirling, Graham Rose, and Michael Wynnyk of MDS Nordion, Kanata, Ontario, Canada; Eric Beers Chairman, American National Standards Committee ' N43.10; Bob Williams, II, National Institute of Standards and Technology; and B. J. Smith from the State of Mississippi. l The Participants i Broaddus, Douglas A. , Buckley, John T. : Camper, Larry W.
- Caniano, Roy J.
l Combs, Frederick C. I Cool, Donald A. i Hickey, John W. l Jones, John D. , 1.co, Wade T. l Merchant, Sally L. Pangbum, George C. Reber, Eric H. I Roe, Mary Louise Schwartz, Maria E. Treby, Stuart A. Vacca, Patricia C. l I l xi NUREG .1556, Vol. 6
ABBREVIATIONS ACI American Concrete Institute ALARA As IAw As Is Reasonably Achievable ANSI American National Standards Institute bkg Background j BPR Business Process Redesign Bq Becquerel l BSR Bulk Shielding Reactor C Celsius CaF2 Calcium Fluoride CFR Code of Federal Regulations ; t C/kg Coulomb per kilogram cm Centimeter Co-60 Cobalt-60 cpm Counts per minute Cs-137 Cesium-137 : d Day DOE United States Department of Energy DOT United States Department of Transportation F Fahrenheit ft Foot G-M Geiger-Mueller ' l GPO Government Printing Office l hr Hour IN Information Notice 4 IP Inspection Procedure I kg Kilogram LiF Lithium Fluoride m Meter . MC Manual Chapter f min Minute j mR Milliroentgen l mrem Millirem mSv Millisievert MOU Memorandum of Understanding NaI(TI) Sodium Iodide (Thallium-activated) NCRP National Council on Radiation Protection and Measurements NFPA National Fire Protection Association NIST National Institute of Standards and Technology NLTNIF National Low-Temperature Neutron Irradiation Facility NMSS Office of Nuclear Material Safety and Safeguards NRC United States Nuclear Regulatory Commission NVLAP National Voluntary Laboratory Accreditation Program OCFO Office of the Chief Financial Officer xiii NUREG - 1556, Vol. 6
_ _ . . . _ . . . - . . .._.._ _ . .... _ _ _... ._.. _ . _ . ~ . __ . . . . -. . . . l dBB!'.EVIATIONS OCR Optical Character Reader OMB Office of Management and Budget -
'ORNL Oak Ridge National Laboratory -
OSHA Occupational Safety and Health Administration ; OSP Office of State Programs i P&GD Policy and Guidance Directive i RG. Regulatorf Guide RQ Reportable Quantities : RSO Radiation Safety Officer ! SI International System of Units (abbreviated from the French Le Systeme Internationale d' Unites) ; SSD Scaled Source and Device ; std Standard ; Sv Sievert ' TAR Technical Assistance Request ; TEDE Total Effective Dose Equivalent i TI Transponation Index l TLD Thermoluminescent Dosimeters : URL Uniform Resource Locator I wk Week yr Year . l l l l i. l i i i NUREG - 1556, Vol 6 xiv 1
1 PURPOSE OF REPORT This report provides guidance to an applicant in preparing a license application for 10 CFR ; Part 36 irradiators' as well as NRC criteria for evalmting a license application. It is not intended to address the research and development or the c <nercial aspects of manufacturing, distributing, and servicing 10 CFR Part 36 irradiators and their associated sources. Within this document, the phrases or terms, "10 CFR Part 36 irradiators," "irradiators," or "irradiators : subject to the requirements of 10 CFR Part 36" are used interchangeably. This report addresses the variety of radiation safety issues associated with irradiators, of various . designs, whose dose rates exceed 5 Gray (500 rads) per hour at one meter from the radioactive sealed sources in air or in water, as applicable to the irradiator's design. Table 1.1 describes the i characteristics of commonly authorized irradiators. Figures 1.1,1.2, and 1.3 illustrate several irradiators. Because of differences in design, manufacturers provide appropriate written ; instructions and recommendations for proper operation and maintenance. Table 1.1 Categories and Types of 10 CFR Part 36 Irradiators l Irradiator Type Panorande Panorande Panorande Pool Underwater - dry.eource-- wet-source- ) storage storage Sources stored in pool and removed to irradiate V v. v package / product Sources stored in pool and package / product p
. lowered into pool to be irradiateA Dry source storage and
. n-airirradiation of V .v package / product Teletherapy unit ..
converted to non-human v. v.; use-
' Self-shicided irradiators are not subject to the requirements of 10 CFR Pan 36 and are discussed in NUREG-1556, Vol. 5," Consolidated Guidance About Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiators," dated October 1998.
L 11 NUREG - 1556, Vol. 6 i -- _
PURPOSE OF REPORT
\
l@l
/ A\
'\
s2.e4.ea ge y Figure 1.1 Teletherapy Unit Converted to Non Human Use. A teletherapy unit usedfor research is an example of a panoramic dry source-storage irradiator. l t s e 62Js4_9N8_S12b i 111797 , Mgure 1.2 Underwater Irradiator. The sealed sources remain in the water at all times. The l product to be irradiated is placed in a water-tight container and lowered into the water. NUREG - 1556. W1. 6 12
1 PURPOSE OF REPORT i I I 1 1 i 4
""**NE Figure 1.3 Commercial Wet-Source-Storage Irradiator. The sealed sources are stored in l water and raised into the air to irradiate a product that may be moved into the irradiation room on a conveyor system. This is an example ofa panoramic wet-source-storage irradiator.
This report identifies the information needed to complete NRC Form 313 (Appendix B),
" Application for Material License," for the use of sealed sources in 10 CFR Part 36 irradiators.
The information collection requirements in 10 CFR Parts 30 and 36 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 31504)l58, and 3150-0120, respectively. The format within this document for each item of technical information is as follows:
- Regulations - references the regulations applicable to the item
- Criteria-outlines the criteria used tojudge the adequacy of the applicant's response
- Discussion - provides additional information on the topic sufficient to meet the needs of most readers
- Response from Applicant-provides suggested response (s), offers the option of an altemative reply, or indicates that no response is needed on that topic during the licensing process.
Notes and References are self-explanatory and may not be necessary for each item on NRC Form 313. 13 NUREG - 1556, Vol. 6
PURPOSE OF REPORT Appendix C provides a format to respond to items 5 through 11 on NRC Form 313, which is shown as Appendix B. Applicants can also use it to check their applications for completeness; NRC staff can use it in reviewing applications. Applicants who use Appendix C to provide supporting information should attach it to NRC Form 313, and submit them to NRC. Otherwise, , as indicated on NRC Form 313, the answers to those items 5 through 11 are to be provided on ; separate sheets of paper and submitted with the completed NRC Form 313. Appendices D through R provide additional information on a variety of topics. Appendix S contains sample licenses for several types ofirradiators subject to 10 CFR Part 36. The sample licenses contain the conditions most often found on these licenses, although not all licenses will have all ; conditions. 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. These terms are defined in 10 CFR Part 20. Rem, and its SI equivalent Sievert i 'l rem = 0.01 Sievert (Sv)),is used to describe units of radiation exposure or dose. This is beause 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen, and the sealed sources used in irradiators are designed to emit gamma rays, which means that ; I roentgen = 1 rad = 1 rem. NUREG - 1556, Vol. 6 14
l l l l 2 AGRE2 MENT 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 l responsible officials in that State for guidance on preparing an application; file these applications j with State officials, not with the NRC. In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in or ler to determine whether NRC or the Agreement i State has regulatory authority. NRC has regulatory authority over land determined to be : " exclusive Federaljurisdiction," while the Agreement State hasjurisdiction over non-exclusive ) Federaljurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC reconunends l 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 NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determiningjurisdictional status is found in All Agreement States Letter, SP-96-022, dated Febmary 16,1996. Table 2.1 provides a quick way to check on which agency has regulatory authority. l 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 j [ DOE] and, under most circumstances, its prime contractors are exempt ; fromlicensing [10 CFR 30.12]) Non-Federal entity in non-Agreement State, US territory, or possession NRC Non-Federal entity in Agreement State at non-Federally controlvsite 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 NRC to exclusive Federaljurisdiction 2-1 NUREG - 1556, Vol. 6
l AGREEMENTSTATES Locations of NRC Offices and Agreement States Region IV y Region til ug MT VT SD M MA N "I P IN y, D.C. DE MD OK HI 4l7
- O Region 11 Region H PR 61 Forsyth Street SW, Suite 23T85 Atlanta,GA 30303 9 R*gionalOf6ce Q Headquarters 404-562 4400, 1-800-577-8510 W 30 Agreement States Region lH i (approx.15,800 Scensees) Headquarters 801 Warrenville Road C 20 A m t* Washington, D.C. 205554001 Usle, IL 60532-4351 s) 301 415-7000, 1-800-368-5642 630-829-9500, 1-800 522-3025 Note: Alaska and Hawall are included in Region i Region IV Region IV, Puerto Rico and Virgin Islands 475 Allendale Road 611 Ryan Plaza Drive. Suite 400 in Region 11. The District of Columbia in King of Prussia, PA 19406-1415 Arlington. TX 760118064 Region i 610-337-5000,1-800-432-1156 817-860-8100, 1-800-952 9677 Yo20ee Figure 2.1 U.S. Map. Location ofNRC Offices and Agreement States.
1
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 Offices. Or visit the NRC Office of State Programs' (OSP's) Home Page <http://www.hstd.ornl. gov /ntc> and choose " Directories" and then " State Program Directors." All Agreement States letter, SP-96-022, dated February 16,1996, is available by calling OSP; call NRC's toll free number (800) 368-5642 and then ask for extension 415-3340. Or visit OSP's Home Page <http://www.hstd.ornl. gov /ntc>, choose "NRC-State Communications," and I then choose "Other"; scroll down to find "1996" and then "SP-96-022." NUREG - 1556 Vol. 6 2-2 i
L 3 MANAGEMENT RESPONSIBILITY l j The NRC recognizes that effective radiation safety program inanagement is vital to achieving l l safe and compliant operations. NRC believes that consistent compliance with its regulations i l provides reasonable assurance that licensed activities will be conducted safely. NRC also ! believes that effective management will result in increased safety and compliance. I l
"Maaagement" refers to the processes for conducting and controlling the radiation safety ,
program and to the individuals who are responsible for those processes and who have authority to provide necessary resources to achieve regulatory compliance. , 1 To ensure adequate management involvement, a management representative must sign the i l submitted application acknowledging management's commitments and responsibility for the following: l
= Radiation safety, security and control of radioactive materials, and compliance with regulations ,
l . Completeness and accuracy of the radiation safety records and all information provided to ; l NRC (10 CFR 30.9) , 1
- Knowledge about the contents of the license and application j
- = Meticulous compliance with current NRC and DOT regulations and the licensee's operating and emergency procedures
. Commitment to provide adequate resources (including space, equipment, personnel, time, and, if needed, contractors) to the radiation protection program to ensure that the public and J workers are protected from radiation hazards and meticulous compliance with regulations is l maintained . Selectior, and assignment of a qualified individual to serve as the Radiation Safety Officer (RSO) with responsibility for the overall radiation safety program . Selection of management representative (s) (e.g., RSO) with authority to stop unsafe operation
- Prohibition against discrimination of employees engaged in protected activities (10 CFR 30.7)
= Commitment to provide information to employees regarding the employee protection and deliberate misconduct provisions in 10 CFR 30.7 and 10 CFR 30.10, respectively.
- Obtaining NRC's prior written consent before transferring control of the license; and a Notifying appropriate NRC regional administrator in writing, immediately following filing of petition for voluntary or involuntary bankruptcy.
For information on NRC inspection, investigation, enforcement, and other compliance programs, see current version of NUREG-1600, " General Statement of Policy and Procedures for NRC
- Enforcement Actions,", Manual Chapter 2815, " Construction and Preoperational Inspection of 3-1 NUREG - 1556, Vol. 6 l
l I t l MANAGEMENT RESPONSIBIIJTY ! Panoramic, Wet-Source-Storage Gamma Irradiators," and Inspection Procedure 87100, [ Appendix F, " Commercial Irradiator Inspection Field Notes"; see Notice of Availability (on the . , inside front cover of this report). NUREG-1600 is also available on the Internet. Visit NRC's ' Home Page <http://www.nrc. gov >, choose " Nuclear Materials," then " Enforcement," I
" Enforcement Guidance Documents," and then " Enforcement Policy."
l t t i l i r t i I
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l I 1 j l NUREG - 1556, Vol. 6 3-2 .l
4 APPLICABLE REGULATIONS It is the applicant's or licensee's responsibility to have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation. The following Parts of 10 CFR Chapter I contain regulations applicable to 10 CFR Part 36 irradiators: 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" 10 CFR Part 30," Rules of General Applicabili;y to Domestic Licensing of Byproduct Material" 10 CFR Pan 32," Specific Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material" 10 CFR Part 36, " Licenses and Radiation Safety Requirements for Irradiators" 10 CFR Part 71, " Packaging and Transportation of Radioactive Material" l
)
Part 71 requires that licensees or applicants who transport licensed material or who may offer such material to a carrier for transpon must comply with the applicable requirements of the United States Department of Transportation (DOT) that are found in 49 CFR Parts 170 through 189. In addition, the licensee may need to be familiar with Food and Drug Administration (FDA) regulations found in 29 CFR Part 17. Copies of DOT regulations can be ordered from the Government Printing Office (GPO) whose address and telephone number are listed below. 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 Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC" To request copies of the above documents, call GPO's order desk in Washington, DC at (202).512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, i Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, ! Pittsburgh, Pennsylvania 15250-7954. You may also contact GPO electronically at
<http://www.gpo. gov >. Request single copies of the above documents from NRC's Regional i
41 NUREG - 1556, Vol. 6
. APPLICABLEREGULATIONS
' Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes amendments to its regulations in the Federal Register.
i i l r P I i i 1 l t 4 i s l i l l
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I 1 l NUREG - 1556 Vol. 6 4-2
i 5 HOW TO FILE 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 1 through 4,12, and 13 on the form itself. . Complete NRC Form 313 Items 5 through 11 on supplementary pages or use Appendix C. . 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 on 8-1/2 x 11 inch paper. . Avoid submitting proprietary information unless it is absolutely necessary. ! . Submit an original application and one copy. . Retain one copy of the license application for future reference.
As required by 10 CFR 30.32 (c), applications must be signed by a duly authorized representative; see section in this report entitled " Certification." Using the suggested wording of responses and committing to using the model procedures in this report will expedite NRC's review. All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary i 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, , radiation dose information, should not be submitted unless specifically requested by NRC. l As explained in the Foreword to this document, 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) to convert them to electronic format. To , ensure a smooth transition, applicants are requested to follow these suggestions: l l
- 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, Futura, Univers; the text of this document is in a serif font called Times New Roman. .
51 NUREG - 1556, Vol. 6
7-- HOW TO FILE 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 i As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms ! for filing applications via diskettes or compact disk with read-only memory (CD-ROM), and ; through the Intemet. Additional filing instructions will be provided as these new mechanisms , become available. The existing paper process will be used until the electronic process is available. - i l l I l l l
.\
l l i i NUREG - 1556, Vol. 6 5-2
"s p
i 6 WHERE TO FILE ! k Applicants wishing to possess or use licensed material in any state or U.S. territory or possession i subject to NRCjurisdiction 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 Regional ! Offices and their respective areas for licensing purposes and identifies Agreement States.
~
In gea.;ral, applicants wishing to possess or use licensed material in Agreement States 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 the jurisdictional
- status of the land in order to determine whether NRC or the Agreement State has mgulatory ;
authority. See the section on " Agreement States" for additional information. i I t I
}
f I i I 1 l i i l 6-1 NUREG - 1556, Vol. 6 i
h 7 LICENSE FEES i 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 l 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. 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." , Direct all questions about NRC's fees or completion ofItem 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC headquarters in Rockville, Maryl.md, (301) 415-7554. As an alternative, call NRC's toll free number (800) 368-5642 and ) l then ask for extension 415-7554. l l 1 ? l 1 i i I l i l 7-1 NUREG - 1556, Vol. 6
8 CONTENTS OF AN APPLICATION The following comments apply to the indicated items on NRC Form 313 (Appendix B). 8.1 ITEM 1: LICENSE ACTION TYPE THIS IS AN APPLICATION FOR (Check appropriate item) I License No. Type of Action Not Applicable [ ] A. New License XX-XXXXX-XX [ ] B. Amendment to License No. Xf-XXXXX-XX [ ] C. Renewal of License No. Check box A for a new license request. Chek box B for an amendment to an existing license, and provide license number. 2 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 divisian 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 materialis not connected with employment in a corporation or other legal ct::ity. Provide the mailing address where correspondence should b sent. A post office box number is an acceptable mailing address. Notify NRC of changes in mailing address; these changes do not require a fee. Note: NRC must be notified before control of the license is transferred or bankruptcy proceedings I; ave been initiated; see below for more details. NRC Information Notice (IN) 97-30," Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3,1997, discusses the potential for the s and control of licensed material to be compromised during periods of organizational instability. 2 See " Amendments and Renewals to a License" later in this document. ! NUREG - 1556, Vol. 6 8-1
e CON 1FNTS OF AN APPLICAT10N Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written conse before transferring control of the license, or, as some licensees call it, " transferrin Discussion: Transfer of control may be the result of mergers, buyouts, or majorit transfers. Although it is not NRC's intent to interfere with the business decisions of li is necessary for licensees to obtain NRC's prior written consent before the transaction is finalized. This is to ensure the following: Radioactive licenses; materials are possessed, used, or controlled only by persons who ha
= Materials are prope:ly handled and secured;
- Persons using these materials are competent and committed to implementing radiological controls;
. Alicensed clearmaterial chainandofrecords; custodyand is established to identify who is responsil'! for final disp
. Public health and safety are not compromised by the use of such materials.
Response from Applicant: from IN 89 25, Revision 1, " Unauthorized Transfer of Ownershi Activities," control. dated December 7,1994, identifies the information to be provided about t
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain copies ofIN 89-25, Revision 1, " Unauthorized Transfer of Ownership or Control of Licen Activities," dated December 7,1994, and IN 97-30, " Control of Licensed Material Reorganizations, June 3,1997. Employee-Management Disagreements, and Financial Criser," dated Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h). ) Criteria: Immediately following filing of voluntary or involuntary petition for bankr against a licensee, the licensee must notify the appropriate NRC Regional Administrat writing, identifying the bankmptcy court in which the petition was filed and the d NUREG - 1556, Vol. 6 ? 8-2
8 CONTENTS OF AN APPLICATION The following commer ts apply to the indicated items on NRC Form 313 (Appendix B). i i 8.1 ITEM 1: LICENSE ACTION TYPE i THIS IS AN APPLICATION FOR (Check appropriate item) Type of Action Ih No. _ j [ ] A. New License Not Applicable [ ]' B. Amendment to Ucense No. XX-XXXXX-XX [ ] C. Renewal of License No. XI-XXXXX-XX l Check box A for a new liccase request. ; i Check box B for an amendment2 to an existing license, and provide license number. l 2 Check box C for a renewal of an existing license, and provide license number. 8.2 ITEM 2: APPL! CANT'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. Notify NRC of changes in mailing address; these changes do not require a fee. Note: NRC must be notified before control of the license is transferred or bankruptcy proceedings have been initiated; see below foi more details. NRC Information Notice (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. 2 See " Amendments and Renewals to a License" later in this document. 8-1 NUREG - lim . Vol. 6
CONTENTS OF AN APPLICATION Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, or, as some licensees call it " transferring the license." Discussion: Transfer of control may be the result of mergers, buyouts, or majority stock transfeu. Although it is not NRC's intent to interfere with the business decisions oflicensees, it is necessary for licensees to obtain NRC's prior written consent before the transaction is finalized. This is to ensure the following:
- Radioactive materials are possessed, used, or controlled only by persons who have valid NRC licenses;
- Materials are properly handlea and secured;
- Persons using these materials are competent and committed to implementing appropriate radiological controls;
- A clear chain of custody is established to identify who is responsible for final disposal of licensed material and records; and
. Public health and safety are not compromised by the use of such materials. Response from Applicant: None from an applicant for a new license; Appendix D, excerpted from IN 89-25, Revision 1, " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, identifies the information to be provided about transfers of control.
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain copies ofIN 89-25, Revision I, " 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. Notification of Bankruptcy Proceedings Reg 12 tion: 10 CFR 30.34(h). Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in v/hich the petition was filed and the date of filing. NUREG - 1556, Vol. 6 8-2
l CONTENTS OF AN APPLICATION Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and j adequately controlled and whether there are any public health and safety concerns (e.g., contaminated facility). NRC shares the results ofits determinations with other involved entities (e.g., tmstee) so that health and safety issues can be resolved before bankruptcy actions are completed. Response from Applicant: None at time of applicatica for a new license. Generally, licensees should notify NRC within 24 hours of filing a banbuptcy petition.
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain copies of Policy and Guidance Directive PG 8-11,"NMSS Procedures for Reviewing Declarations of Bankruptcy," (dated August 8,1996) and Inspection Procedure (IP) 87103,
" Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing."
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 l facility location. A Post Office Box address is not acceptable; see Figure 8.1. An NRC license does not relieve a licensee from complying with other applicable Federal, State, or local requirements (e.g., local zoning requirements or local ordinances requiring registration of radioactive material). ! l 8-3 NUREG - 1556, Vol. 6 i
CONTENTS OF AN APPLICATION I q.3 5 J 32 Elm St. P.O.P;g ity, ST 12345 City, 2345 W ,
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Figure 8.1 Location of Use. An acceptable location ofuse specifies street address, city, state, and zip code and does not include a post ofice box number. Note: As discussed later in the section " Financial Assurance and Record Keeping for Decommissioning," licensees need to maintain permanent records on where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e 4, b: fore the license is terminated). For irradiator licensees, acceptable records are sketches or w ritten descriptions of the specific locations where licensed material was used or stored and any iaformation relevant to leaking radioactive sources. 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION Identify the individual who can answer questions about the application and include his or her telephone number. This is typically the proposed radiation safety officer, 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 contact the applicant or licensee in the future with questions, concems, or information. This notice is for "information only" and doea not require a license amendment or a fee. NUREG - 1556, Vol. 6 8-4
l 1 CONTENTS OF AN APPLICATION 1 As indicated on NRC Form 313 (Appendix B), Items 5 through 11 should be submitted on separam sheets of paper. Alternatively, applicants may use Appendix C for this purpose and ! should note that using the suggested wording of responses and committing to using the model procedures in this report will expedite NRC's review. 8.5 ITEM 5: RADIOACTIVE MATERIAL 8.5.1 SEALED SOURCES AND DEVICES Regulation: 10 CFR 30.32(g),10 CFR 30.33(a)(2),10 CFR 32.210,10 CFR 36.21. Criteria: For each sealed source requested, applicants must identify the sealed source by radionuclide, manufacturer (or distributor), and model number. Applicants will be authorized :o possess only those sealed sources specifically approved or registered by NRC or an Agreement State for use in the requested irradiator. Also, identify any depleted uranium that is used as shielding material (teletherapy units and other exposure devices may contain depleted uranium). Discussion: 10 CFR 36.21 and 10 CFR 32.210 list criteria for sealed sources used in irradiators. Normally, tests used to demonstrate that the criteria can be met are conducted by the source manufacturer (or distributor), not the applicant. The manufacturer (or distributor) then applies to ! the NRC or an Agreement State agency for approval for use in irradiators. The safety evaluation ) is documented in a Sealed Source and Device (SSD) Registration Certificate. Therefore, if sealed sources are approved for use in the requested irradiator by NRC or an Agreement State agency, the applicant need only note the manufacturer's (or distributor's) name and model number of the sources in its license application to demonstrate that the requirements are met. Before the SSD registration process was formalized, some older sealed sources may not have been evaluated in this way, but were specifically approved on a license. Licensees can continue to use sealed sources that are specifically listed on their licenses. If a licensee wishes to install sealed sources that are not currently listed on the license, the new sources must meet the requirements of 10 CFR 36.21. Licensees may not make any changes to the sealed sources that would alter the description or specifications from those indicated in the respective registration certificates without obtaining NRC's prior permission in a license amendment. A custom registration review may also be required. This would increase the time needed to process a licensing action. Response from Applicant: . Identify each radionuclide that will be used in each irradiator. Identify the manufacturer (or distributor) and model number of each sealed source. 8-5 NUREG - 1556. Vol. 6
e CONTENTS OFc N APPLICATION
- Identify the manufacturer (or distributor) and model number of each irradiator, if applicable.
- For dry-source-storage irradiators, specify the maximum activity per source.
- Specify the maximum activity per irradiator.
- If depleted uranium is used as shielding material (e.g., teletherapy units and other exposure devices may contain depleted uranium), specify the total amoimt (in kilograms).
Note:
- For information on SSD registration certificates, contact the Registration Assistant by calling NRC's toll free number (800) 368-5642 and then asking for extension 415-7217.
- SSD reviews are not required for exposure devices in irradiators subject to 1.0 CFR Pan 36.
However, for some dry-source-storage panoramic irradiators (e.g., teletherapy units corverted to non-human use), a review has been performed at the manufacturer's (or distributor's) request and this information may be useful in evaluating an application. If the irradiator has an exposure device for which a SSD review has been performed, the applicant should state that such a review has been performed and provide the registered name of the manufacturer (or distributor) and model number of the device. 8.5.2 FINANCIAL ASSURANCE AND RECORD KEEPING FOR , DECOMMISSIONING Regulations: 10 CFR 30.35,10 CFR 30.34(b). Criteria: Irradiator licensees authorized to possess sealed sources containing radioactive 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, in an identified location, decommissioning records related to structures and equipment where licensed materials are used or stored and to leaking sources. Pursuant to 10 CFR 30.35, licensees must transfer these records important to decommissioning to either of the following:
- The new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b)
. The appropriate NRC regional office before the license is terminated.
Discussion: The requirements for fm' ancial assurance are specific to the types and quantities of byproduct material authorized on a license. Most irradiator applicants and licensees need to take NUREG - 1556. Vol. 6 8-6
CON'IENTS OF AN APPLICATION action to comply with the financial assurance requirements because their total inventory of i licensed material exceeds the limit in 10 CFR 30.35(d); see Figure 8.2. The limits for typical ! radionuclides used for irradiator sealed sources are shown in Table 8.1. l J Surety E Bond M Trust statement Agreement ofintent Parent Certificate Company l of Guarany - j Deposit i suvag ; Figure 8.2 Financial Assurance for Decommissioning. Most 10 CFR Part 36 irradiator licensees need to providefinancial assurancefor decommissioning and can use one of several approvedfinancialmechanisms. l l Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance 1 l Radionuclide Activity in Gigabecquerels Activity in Curles I (Sealed Sources) Co-60 3.7 x 10 5 10,000 Cs-137 - 3.7 x 10 6 100,000 l l 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, contains approved wording for each of the mechanisms 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 of Intent. l l l 8-7 NUREG - 1556, Vol. 6
CONTFNTS OF AN APPLICATION
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e u w e ge Flgure 8.3 Records Important to Decommissioning. Allirradiator licensees must maintain l records important to decommissioning, regardless of whether they needfinancial assurancefor l decommissioning. Figure 8.3 illustrates the 10 CFR 30.35(g) requirements that licensees maintain records important j to decommissioning in an identified location (i.e., licensees must know the locations of all j documents). All irradiator licensees need to maintain records of structures and equipment for ; each irradiator. As-built drawings with modifications of structures and equipment shown as ! appropriate fulfill this requirement. If drawings are not available, licensees may substitute appropriate records (e.g., a sketch of the room or building or a narrative description of the area) conceming the specific areas and locations. In addition,if the applicant experiences unusual j occurrences (e.g., leaking sources), they also need to maintain records about contamination that remains after cleanup or that may have spread to inaccessible areas. For irradiator licensees whose sources have never leaked, sketches or written descriptions that include the location of each irradiator are considered acceptable records important to decommissioning. Response from Applicants: A response is needed from most applicants. If financial assurance is required, submit documentation required by 10 CFR 30.35. Regulatory Guide 3.66," Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under NUREG - 1556, Vol. 6 8-8
CONTENTS OF AN APPLICATION 10 CFR Parts 30,40,70, and 72," dated June 1990, contains approved wording for each of the mechanisms authorized by the regulation to guarantee or secure funds except for the Statement of Intent for Government licensees. See Appendix E for the recommended wording for a Statement of Intent. 10 CFR 30.35(g), Requirements for Disposition of Records Important to Decommissioning Before licensed activities are transferred or assigned according to 10 CFR 30.34(b), transfer to the new licensee OR
=
Before the license is terminated, transfer records to the appropria:e NRC regional office.
Reference:
See Notice of Availability (on the inside front cover of this 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, Revision 1. " Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30,1991. 8.6 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED Regulation: 10 CFR 30.33(a)(1),10 CFR 36.69. Criteria: The proposed purpose is authorized by the Atomic Energy Act of 1954, as amended. Sealed sources that are used in irradiators should be used only for the purposes for which they were designed, according to the manufacturer's written recommendations and instmetions, as specified in an approved SSD Registration Cenificate, and as authorized on an NRC or Agreement State license. Discussion: Requests to use sealed sources in irradiators for purposes not listed in the SSD Registration Certificate will be reviewed on a case-by-case basis. Examples might include greater than small quantities of flammable materials with a flash point below 60 C (140 F), irradiation of explosive material, or cryogenic material5 . 8 Under certain conditions panicular irradiated cryogenic material can explode. 8-9 NUREG - 1556, Vol. 6
- m. . _ _ _ . _ ..__._ _ _ _ __ _._ _ _.___ _ _.__ ._ __._.
1 CONTENTS OF AN APPLICA"I1ON If an applicant wants to irradiate greater than small quantities of flammable materials with a i flash point below 60"C (140 F), see Appendix F. In addition, irradiation of explosives is ! generally prohibited; however, if an applicant wants to request irradiation of explosives, see Appendix F.
' Applicants need to submit sufficient information to demonstrate that the proposed use will not ;
compromise the integrity of the source or source shielding, or other radiation safety-critical components of the' device. NRC will evaluate the radiation safety program for each type and use : of scaled sources in each irradiator requested. ! i
?
Irradiation of food and cenain other products intended for commercial distribution to the public ! are also subject to the regulations of the Food and Drug Administration (FDA) and U. S. Depanment of Agriculture (USDA). Contact these agencies for funher infonnation. An NRC , licensee must also comply with applicable FDA or USDA regulations. l t i Response from Applicant: Provide either of the following-I
. A specific description of use for each type of irradiator requested, e.g., "for use in irradiation of products or food. There will be no irradiation of explosives and no irradiation of more than i small quantities of flammable materials with a flash point below 60 C (140 F) without specific ;
written authorization from NRC." l l a OR
. If :he irradiator will be used for purposes other than irradiation'of food or products for humwi consumption or research purposes, description of these purposes and safety analyses (and procedures, if needed) to support safe use.
Note:
. - Allowed uses ofirradiators normally include the irradiation of food or products for human consumption or research purposes.
- Unusual uses will be evaluated on a case-by-case basis and the authorized use condition will reflect approved uses.
i 1 NUREG - 1556, Vol. 6 8-10
I I CONTENTS OF AN APPLICATION 8.7 ITEM 7: INDdVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM 8.7.1 RADIATION SAFETY OFFICER (RSO) TRAINING AND 1 I EXPERIENCE Regulations: 10 CFR 30.33(a)(3),10 CFR 36.13(d). ) Criteria: A Radiation Safety Officer (RSO) must have adequate training and experience. Successful completion of training as described in Appendix G is evidence of adequate training : and experience. Discussion: The person responsible for the radiation protection program is called the RSO. The application must include the name and a description of the training and experience of the 1 proposed RSO. This is to determine whether the individual is qualified to function as the RSO. Consistent with the NRC staff's long-standing guidance, if the RSO has had neither previous formal training in health physics nor certification by the American Board of Health Physics, the RSO should complete a radiation safety course. Training should include approximately 40 hours covering the following topics:
- Radioactivity and radioactive decay
. Interactions of radiation with matter . Biological effects of radiation . Radiation detection using radiation detection instruments and personnel dosimeters . Basic radiation protection principles and good safety practices (including time, distance, and l shielding)
- Radiation protection regulations.
The course should include a written test or evaluation of the individual's comprehension of these topics. In addition to the above general course,if the RSO was previously an RSO at a similar licensee or was trained as an irradiator operator but has not had experience working at an irradiator, he or she should have the equivalent of at least 40 hours in self-study or directed study on information directly applicable to radiation safety at irradiators. This should include applicable regulations (10 CFR Parts 20 and 36) and reports or studies describing case histories of accidents or problems at irradiators; see Appendix G. The license application should list the documents studied or to be studied in the description of the training of the proposed RSO and should 8-11 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION describe how the applicant will evaluate the individual's comprehension of the information studied. The RSO should have at least 3 months (full-time equivalent) of experience at the applicant's irradiator or at another irradiator of a similar type. The 3 months of experience may include , preoperational involvement, such as acceptance testing, while the irradiator is being constructed. However, to allow flexibility, the NRC will determine the adequacy of the RSO's training and experience on a case-by-case basis, looking at his or her actual qualifications and drawing on the NRC staff's experience in reviewing such qualifications._ Response from Applicant: Provide the following:
- Name of the proposed RSO
= Describe the proposed RSO's training and experience specific to the irradiator that the applicant intenda to use.
Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. If the replacement is sudden, the licensee should contact the NRC Regional Office as soon as possible. While the amendment request is being reviewed by NRC, the proposed RSO may assume the responsibilities of RSO if NRC is given adequate information to ensure that the proposed individual will meet the required training. 8.7.2 RADIATION SAFETY OFFICER (RSO) RESPONSIBILITIES AND AUTHORITIES Regulations: 10 CFR 30.33(a)(3),10 CFR 36.13(d). Criteria: RSOs must be in a position within the licensee's organization to have adequate authority over radiation safety activities and responsibility for regulatory compliance and protection of public health and safety. Discussion: Consistent with the staff's long-standing guidance, the RSO should have independent authority to stop operations that he or she considers unsafe and to conduct necessary , tests or measurements. The RSO should be relatively independent of production responsibilities, l to the extent practicable, considering the size of the staff at the facility. The RSO should report l directly to the facility manager. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that licensed materials are used l in a safe manner. Typical RSO duties are illu" rated in Figure 8.4 and described in Appendix H. ! NRC requires the name of the RSO on the license to ensure that licensee management has always NUREG - 1556, Vol. 6 8-12
CONTENTS OF AN APPLICATION identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Stopping Unsafe Ucensed Activities Proper Use and Routine Maintenance C LaekTests
& Security of Ucensed Material C Audits C Training Material Disposal emww Interaction with NRC, Other Authorities us Records Maintenance Annual Program Audit Maintenance . Inspection Checks PersonnelTraining Investigation of Abnorrnal Events
% C3-@eMy Figure 8.4 RSO Responsibilities. Typical duties and responsibilities of RSOs.
Response from Applicant: Describe the organizational stmeture for managing the irradiator, specifically the radiation safety responsibilities and authorities of the RSO and other managemert personnel who have important radiation safety responsibilities and authorities. In particular, the application should describe who has the authority to stop unsafe operations. 8-13 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION 8.8 ITEM 8: INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS i 8.8.1 INITIAL TRAINING AND EXPERIENCE FOR 1RRADIATOR OPERATORS Regulations: 10 CFR 19.12,10 CFR 30.7,10 CFR 30.9,10 CFR 30.10,10 CFR 30.33, 10 CFR 36.13(b),10 CFR 36.23(b),10 CFR 36.51(a),10 CFR 36.51(b),10 CFR 36.51(c). Criteria: Irradiator operators must have adequate training and experience. Successful completion of one of the following is evidence of adequate training and experience:
. Irradiator manufacturer's course for operators specific to the irradiator that the applicant intends to use OR =
Training course as described in Appendix G. The training provided to individuals to qualify them to be irradiator operators must include: 1
- Instruction l On-the-job or simulator training (i.e., supervised experience)
Means employed by the applicant to test each individual's understanding of the Commission's regulations and licensing requirements and the irradiator operating and emergency procedures a Minimum training and experience of personnel who may provide training. ; In addition, instruction must be provided to at least one other individual who will be on site during operations on how to respond to the independent backup access control alarm and to promptly render or summon assistance. Applicants requesting to perform non-routine operations such as loading and unloading sources must provide ad litional training. For more information see Appendix 1. Discussion: Irradiator operators have the responsibility to ensure the proper use and security of l irradiators containing licensed material. Irradiator operators must receive training and instruction, and be tested before being permitted to operate an irradiator. 1 Training should be commensurate with the complexity of the irradiator design and potential radiation hazard (e.g., approximately 40 hours ofinstruction for pool-type panoramic irradiators and approximately 20 to 30 hours ofinstmction for underwater irradiators). Up to 50% of that NUREG - 1556, Vol. 6 8-14
~. - .. - - . . .-~ . -- .-.- - -_- - - -.- - -_.-.
CONTE.NTS OF AN APPLICATION f instruction may be self-study or reading. The written test should cover the range of topics addressed in the instruction. On-the-job training should be supervised by an experienced operator and should last at least 1 month full-time. If an approved operator does not operate the irradiator for more than a year, his or her performance during operation should: l
. Be audited for at least I day before he or she is permitted to operate the irradiator independently; and
. Receive a sa'ety review regarding the irradiator.
The reouirements in 10 CFR 36.51(a), (b), and (c) are for an individual to become qualified i initially as an irradiator operator. They do not apply to individuals qualified to be operators l oefore July 1,1993, the effective da'e of 10 CFR Part 36. The safety reviews and evaluation i requirements of 10 CFR 36.51(d) and (c), however, apply to all irradiator operators. Current l licensees should conduct safety reviews to discuss the new 10 CFR Part 36 regulations and any i resulting changes in operating and emergency procedures. Licensees should also conduct safety - reviews at intervals not to exceed 12 months thereafter. )
- Individuals must be trained in the following subjects to become an irradiator operator
. The fundamentals'of radiation safety as they apply to irradiators
- The goal is to provide the individual with the necessary foundation to perform his or her task safely and to help the individual worker understand the basis for the safety requirements and procedures that will be taught.
- The requirements of 10 CFR Pmts 19 and 36
- The operator is not expected to be an expert on NRC regulations or to be able to determine whether a given procedure is adequate to meet NRC regulations. Instead, operators should be instructed on NRC requirements that are directly applicable to their responsibilities.
. The operation of the licensee's irradiator
- The objective is to help the person understand the operating and emergency procedures, not to become an engineer.
l l
. ~ Licensee operating and emergency procedures that the individual will be required to perform !
u
- This is the most important part of the training because operating the irradiator safely l depends on following these procedures correctly. The objective is that the operator ]
I 8-15 NUREG - 1556. Vol. 6 l
CONTENTS OF AN APPLICATION correctly perform his or her assigned tasks. The training does not have to include procedures that the individual will not perform. I
. Case histories of accidents and problems involving irradiators ;
l
- The individual should be taught about situations that could lead to problems associated l with irradiator operations. Instruction material on accidents is often difficult to obtain.
However, NUREG-1345, " Review of Events at Large Pool-Type Irradiators," provides sorne relevant information. See also Appendix A for a list ofInformation Notices (IN) , describing irradiator events. Additional training is required for irradiator operators if they will' perform non-routine : operations. For more information see Appendix 1. Response from Applicant: Provide either of the following:
- The statement: "Before using licensed materials, irradiator operators will have successfully completed one of the training courses described in Criteria in the section entitled ' Initial Training and Experience for Irradiator Operators' in NUREG-1556, Vol. 6, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 '
Irradiator Licenses,' dated January 1999."; OR . A description of the initial training program for irradiator operators that demonstrates compliance with the requirements of 10 CFR 36.51(a), (b), and (c). Note: Altemative responses will be evaluated using the criteria listed above.
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain copies of NUREG-1345, " Review of Events at Large Pool-Type Irradiators," dated March 1989 ; or other documents listed in Appendix A. l 8.8.2 ANNUAL SAFETY REVIEWS AND PERFORMANCE EVALUATIONS FOR 1RRADIATOR OPERATORS Regulations: 10 CFR 19.12, its CFR 30.33,10 CFR 36.51(d),10 CFR 36.51(e). Criteria: Licensees must conduct safety reviews for irradiator operators annually. Licensees must also evaluate the safety performance of each irradiator operator annually. J NUREG - 1556 Vol. 6 8-16 I
CONTENTS OF AN APPLICATION l Discussion: Licensees must provide refresher training called a safety review to irradiator
- operators as well as evaluate the safety aspects of each irradiator operator's performance (i.e.,
l performance evaluation). Annual Safety Reviews ; l 1 Safety reviews must include, as appropriate, each of the following areas: I
- Changes in operating and emergency procedures since the last review e Changes in regulations and license conditions since the last review e Reports on recent accidents, mistakes, or problems that have occurred at irradiator facilities d
- Relevant results ofinspections of operator safety performance
- Relevant results of the facility's inspection and maintenance checks
- A drill to practice an emergency or abnormal event procedure. ,
l Also, each operator must be given a brief written test on the information covered during the i safety myiew (See 10 CFR 36.51(d)). ! The duration of safety reviews should be commensurate with the complexity of the irradiator's design and potential radiation hazard (e.g., approximately 4 hours for panoramic wet-source-storage irradiators and 2 hours for dry-source-storage and underwater irradiators). Safety reviews may be conducted at intervals not to exceed 12 months or throughout the calendar year on an as-necessary basis. The " drill" referenced in 10 CFR 36.51(d)(6) means actually going through a procedure using the actual equipment in as realistic a manner as practical. For example, for a drill on the response to j a fire alarm it is not necessary that the alarm actually be enunciated if sounding the alarm would be disruptive. Operators may also correct errors as they occur rather than waiting until the drill is over. Each operator need not go through the drill, but may watch or critique as another operator does. Annual Performance Evaluations The safety performance of each irradiator operator must be evaluated and reviewed at least every twelve months to ensure that regulations, license conditions, and operating and emergency procedures are followed. In addition, the results of the evaluation must be discussed with each l operator along with instructions on how to correct any mistakes or deficiencies obsen'ed.
- The word " inspections" in 10 CFR 36.51(d)(4) neans the " evaluations" performed under 10 CFR 36.51(c).
8 17 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION Individuals, e.g., the RSO or senior operators, conducting these reviews must have adequate training and experience to conduct such evaluations. Response from Applicant: Describe program for annual safety reviews and performance i evaluations ofirradiator operators that demonstrates compliance with 10 CFR 36.51(d) and (e). ; I l i 8.8.3 TRAINING FOR INDIVIDUALS WHO REQUIRE UNESCORTED ACCESS i Regulations: 10 CFR 19.12,10 CFR 30.7,10 CFR 30.9,10 CFR 30.10,10 CFR 30.33, .10 CFR 36.51(f). Criteria: Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for irradiator operators and the RSO, must be instmeted and tested in precautions to avoid radiation exposure, procedures listed in 10 CFR 36.53 that they must i perform or comply with, and their proper response to alarms. ! Discussion: According to 10 CFR 19.12, all individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) must receive appropriate instruction on radiation safety. However, in some facilities certain individuals other than irradiator operators may require unescorted access to the radiation room of an irradiator. The applicant should identify those individuals (e.g., individuals who perform inspection and l maintenance checks) and train them according to 10 CFR 36.51(f). Training may include the subjects described in Appendix G. Individuals should be tested on 1 procedures which require unescorted access to conduct. Tests may be given orally. Applicants must develop and implement a program for instructing and testing individuals requiring unescorted access. Response from Applicant: The applicant's program for instructing and testing unescorted individuals (other than irradiator operators) will be examined during inspections, but should not be submitted in the license application. 4 NUREG - 1556, Vol. 6 8-18
CONTENTS OF AN APPLICATION , 8.9 ITEM 9: FACILITIES AND EQUIPMENT 4 8.9.1 GENERAL DESCRIPTION OF THE FACILITY AND SITE Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.39(j). Criteria: Facilities and equipment must be adequate to protect public health and safety and to minimize danger to life or property. The application must include a diagram of the facility that shows the locations of all required interlocks and radiation monitors. Discussion: A diagram of the facility must be submitted for review with enough detail l designating the location of required interlocks and radiation monitors to be used at the facility (e.g., blueprints with interlock and radiation monitor locations identified). See Figure 8.5. In addition, the diagram should include a general layout of the entire facility identifying areas surrounding the irradiator room. An applicant should provide a schedule for construction activities associated with the irradiator. This will allow the NRC to inspect and ensure constmction activities are according to design . requirements as described in NRC Manual Chapter 2815 titled " Construction and Preoperational Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators." s M@pE.- y
- . . j
"^""d2 Figure 8.5 General Description of Facility. Diagrams, drawings, sketches, or blueprints of facilities are neededfor a clear understanding of thefacility's design and its relationship to adjacentproperties.
8-19 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION Response from Applicant: Describe the irradiator including drawings, diagrams, sketches, and photographs, as appropriate. Show locations of safety-related equipment and features as required in 10 CFR Part 36.
- Provide a construction schedule for the irradiator.
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain a l copy of NRC Manual Chapter 2815 titled " Construction and Preoperational Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators." This standard is also available for purchase from the American Concrete Institute (ACI), P. O. Box 9094, Farmington Hills, Michigan 48333. ACI's telephone number is (248) 848-3700 and its URL is
<http://www.aci-int.org>.
8.9.2 ACCESS CONTROL Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.23,10 CFR 36.31(a), 10 CFR 36.39(g),10 CFR 36.41(g). Criteria: Irradiator facilities rnust have access controls to prevent inadvertent entry into the radiation room, as required by 10 CFR 36.23. Discussion: This section discusses two categories ofirradiators: f
. panoramic irradiators (dry-source-storage, wet-source storage) . underwaterirradiators.
Panoramic Irradiators ' The door or barrier that serves as the primary access control system must have devices that will:
- 1) prevent the source from being moved out ofits shielded position if the door or barrier were [
open; and 2) cause the source to return to its shielded position if the door or barrier were opened while the source was exposed. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier l NUREG - 1556, Vol. 6 8-20
CONTENTS OF AN APPLICATION must have a lock that is operated by the same key used to move the sources. The doors and baniers must not prevent any individual in the radiation room from leaving. The backup access control system must be able to detect entry while the source is exposed. If entry is detected, the system must: 1) automatically cause the source to return to its shielded position; and 2) activate audible and visible alarms. Detection of entry while the sources are exposed must cause the sources to return to their fully shidded position and must also activate a visible and audible alarm to alen any individual entering the room to the hazard. The alarm must also alert at least one other individual who is onsite and prepared to render or summon assistance promptly. A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted entry while the monitor measures high radiation levels must activate the alarm described in 10 CFR 36.23(b). The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam (e.g., an area of the maze that may expose the instrument directly to the irradiator sources when in the unshielded position). The requirement in 10 CFR 36.23 for a door or other physical barrier applies to each entrance of the radiation room, whether intended for personnel or product entrance or exit. A conveyor , system could meet the requirement by providing a clearance large enough for a package, but too small for a person by using barriers that would require unusual exertion to bypass. A photoelectric system cannot be considered a physical banier. The purpose of this requirement is to prevent someone from carelessly or accidentally entering the radiation room while the sources am exposed. This section also requires an independent backup access control system to provide a redundant means of preventing a person from being accidentally exposed to the source. In case of a failure of the interlocks on the door or barrier combined with a failure to follow operating procedures, the backt:p system should warn the person entering the radiation room of the danger and automatically cause the sources to return to their shielded position. The backup system could use phatoclectric cells in an entrance maze, pressure mats on the floor, or similar means of detection. : The system must also alert another trained person who is onsite and prepared to render or summon assistance. The mechanism that moves the sources must require a key to actuate it. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any one time, and only irradiator operators or facility management may have access to it. The key must be attached to a calibrated portable radiation survey meter by a chain or cable. In addition, the lock for source control movement must be , designed so that the key may not be removed if the sources are in an unshielded position. Also, the door to the radiation room must require the same key to open it. This redundant feature will I I 82i NUREG - 1556, Vol. 6 l l
P CONTENTS OF AN APPLICATION ensure that the sources are in the shielded position prior to an individual entering the radiation room. It will also ensure that any individual entering the radiation room will have in his or her possession a calibrated portable radiation survey instrument for monitoring radiation levels in the radiation room in the event the sources were not in the shielded position. Irradiators can produce ozone in concentrations exceeding those permitted by regulations of the Occupational Safety and Health Administration (OSHA) at 29 CFR 1910.1000, " Air Contaminants." Nitrogen oxides can also be produced, although concentrations would not be expected to exceed OSHA's limits. To control these gases, irradiators with large sources are typically equipped with ventilation systems to exhaust the gases before personnel entry. OSHA regulates exposure to ozone and other noxious gases in the workplace, and the U.S. Environmental Protection Agency regulates emissions offsite. If NRC personnel observe problems with noxious gases at an irradiator during an inspection, NRC will notify OSHA of the problem under the terms of the " Memorandum of Understanding Between the Nuclear Regulatory Commission and the Occupational Safety and Health Administration; Worker Protection at NRC-Licensed Facilities," signed October 21,1988. The radiation room must be equipped with a device integrated with the control system ensuring that the sources cannot be exposed unless the access door and other interlocks are engaged within a preset time of activating the control. The irradiator must be equipped with a safety timer that will automatically generate visible and audible wamings to alert personnel in the radiation room that the startup sequence has begun and provide sufficient time to leave the area or operate a clearly identified emergency stop device which will abort the startup sequence. The safety timer must be integrated with the control system so that the source cannot be exposed unless the startup sequence is complete within the preset time and the control console indicates that it is safe to expose the source. For panoramic irradiators whose construction begins after July 1,1993, the licensee must verify ) from the design and logic diagram that the access control system will meet the requirements of 10 CFR 36.23. Before loading sources, the licensee must test the completed access control system to ensure that it functions as designed and that all alarms, controls, and interlocks work properly. For more information see Appendix J," Construction Monitoring and Acceptance Testing." i Underwater Irradiators l The pool must be within an area surrounded by a personnel access barrier with an intrusion alarm when the facility is not operating. Only operators and facility management may have access to keys to the personnel access barrier. The intmsion alarm must be able to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an l NUREG 1556, Vol. 6 8-22
r CONTENTS OF AN APPL.ICATION individual (not necessarily onsite) who is prepared to respond or summon assistance when the alarm is activated. Response from Applicant:
. Submit specific information describing the access control system and how it works that demonstrates compliance with the requirements of 10 CFR 36.23. Specific drawings or sketches should be submitted, as appropriate. . For panoramic irradiators, describe the facility alarm systems. . For panoramic irradiators, describe the lock and key system for controlling source movement and discuss how it meets the requirements of 10 CFR 36.31(a).
References:
See the Notice of Availability (on the inside front cover of this report) to obtain a copy of the " Memorandum of Understanding Between the Nuclear Regulatory Commission and the Occupational Safety and Health Administration; Worker Protection at NRC-Licensed Facilities," signed October 21,1988. > 8.9.3 SHIELDING Regulations: 10 CFR 30.33(a)(2),10 CFR 36.25,10 CFR 36.39(a),10 CFR 36.41(a). Criteria: Irradiator shielding must meet the requirements as described in 10 CFR 36.25 and the requirements of local building codes or other appropriate sources. 1 Discussion: The radiation dose rate in areas that are normally occupied during operation of a j panoramic irradiator may not exceed 0.02 millisieven (mSv) (2 millirems (mrem)) per hour at any location 30 centimeters (cm) or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 cm. The maximum dose rate of 0.02 mSv (2 mrem) per hour is considered practical to achieve. Areas where the radiation dose rate exceeds l 0.02 mSv (2 mrem) per hour must be locked, roped off, or posted. These may include areas not normally occupied such as the equipment access area on the roof of the irradiator. The radiation dose at 30 cm over the edge of the pool of a pool irradiator may not exceed l 0.02 mSv (2 mrem) per hour when the sources are in the fully shielded positso 1. l l The radiation dose rate at I meter from the shield of a dry-source storage panoramic irradiator when the source is shielded may not exceed 0.02 mSv (2 mrem) per hour and at 30 cm from the shield may not exceed 0.2 mSv (20 mrems) per hour. 8-23 NUREG - 1556. Vol. 6
CONTENTS OF AN APPLICA110N For panoramic irradiators whose construction starts after July 1,1993:
. If not built in seismic areas,it is acceptable that shielding meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and j entranceways to meet the radiation shielding requirements of 10 CFR 36.25. l
. If built in seismic areas, the applicant must design the reinforced concrete radiation shields to
. retain their integrity in the event of an earthquake by designing to the seismic requirements l of an appropriate source such as American Concrete Institute Standard ACI 318-89,
" Building Code Requirements for Reinforced Concrete," Chapter 21,"Special Provisions for Seismic Design," or local building codes, if current. !
. ANSI Standard 43.10 (last issued 1984) paragraph 8.25 discusses geologic and seismic site ,
considerations which should be evaluated prior to building a panoramic irradiator. i
. The licensee must monitor the construction of the shielding to verify that its construction i meets design specifications and generally accepted building code requirements for reinforced ;
concrete. See Appendix J," Construction Moniiaring and Acceptance Testing." If the irradiator will use more than 2 X 10" becquerels (Bq) (5 million curies) of activity, the ! applicant must evaluate the effects of heating of the shielding walls by the irradiator sources ; (e.g., thermal effects on concrete). : i Response from Applicant:
- For panoramic irradiators: !
- Describe the shielding to be used and its composition !
- Submit a diagram showing the configuration of shielding including walls and the ceiling I and indicate the thickness of each and penetrations in the shielding
- If any accessible areas outside the shield are expected to have a dose rate exceeding 0.02 mSv (2 mrem) per hour, identify the areas and explair. Low access will be controlled
- For requests to possess more than 2 x 10" Bq (5,000,000 cuies), submit an evaluation of the effects of heating of the shielding walls by the irradiator sources i For underwater irradiators, no response is required from the applicant in a license application.
Note i l
- The NRC does not approve irradiator shield designs. Instead, NRC conducts inspections to ;
ensure that tne maximum dose rate outside the completed shield is according to NRC ! requirements. . NUREG - 1556. Vol. 6 8-24 l l
. - - .-~ ~- . - . -. . -.
CONTENTS OF AN APPUCATION
- For panoramic irradiators whose construction will start after July 1,1993, the applicant should identify building code requirements to which shielding walls will be built and inspections of the construction that will be performed by local authorities so that the license reviewer can ensure that they do not adversely impact the NRC requirements.
Reference:
See the Notice of. Availability (on the inside front cover of this report) to obtain a copy of the American Concrete Institute Standard ACI 318-89," Building Code Requirements for I Reinforced Concrete." This standard is also available for purchase from the American Concrete Institute (ACI), P.O. Box 9094, Farmington Hills, Michigan 48333. ACI's telephone number is (248) 848-3700 and its URL is <http://www.aci-int.org>. 8.9.4 FIRE PROTECTION i Regulations: 10 CFR 36.27,10 CFR 36.39(h),10 CFR 36.41(h). Criteria: Panoramic irradiators must have smoke and heat detectors to detect a fire, to activate i alarms, and to cause the source rack to automatically become fully shielded to meet the requirements as described in 10 CFR 36.27 and 36.39(h). Discussion: The radiation room must have heat and smoke detectors that activate an audible alarm capable of alerting a person who can summon assistance promptly. The sources must become fully shielded automatically if a fire is detected. The radiation room must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas. The fire extinguishing system is required because a fire could disable the access control system or could prevent the sources from being shielded, thereby lowering the margin of safety. The fire extinguishing system must be operable without entry into the room. During a fire, there would be no means of assuring that the access control systems and source position indicators or the mechanism that returns the source to the shielded position had operated properly. 8-25 NUREG - 1556, Vol. 6
- CON 111NTS OF AN APPLICA'llON For panoramic irradiators whose construction starts after July 1,1993:
The applicant must verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The applicant must verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities. md low characteristics for I complete coverage of the radiation room and that the system is protected from mechanical and radiation damage. j
= The licensee must test the ability of the heat and smoke detectors to detect a fire, to activate ;
alarms, and to cause the source rack to automatically become fully shielded. In addition, the licensee must test the operability of the fire extinguishing system. It is not required that licensees turn on extinguishers (i.e., water or chemicals) during tests of the operability of their fire protection systems. For more information see " Radiation Safety Program - Inspection and Maintenance Checks" and Appendix J," Construction Monitoring and Acceptance Testing." Response from Applicant:
- For panoramic irradiators, describe:
- the type and location of the heat and smoke detectors to be used to detect a fire in the radiation room
- the alarms to alert personnel trained to summon assistance
- how the sources will automatically become fully shielded if a fire is detected
- how the heat and smoke detectors will be tested. l
= For underwater irradiators, no response is required, since the sources are always underwatcr i and not subject to damage by fire.
8.9.5 RADIATION MONITORS Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.23(c),10 CFR 36.29, 10 CFR 36.39(e),10 CFR 36.41(e),10 CFR 36.59(b). Criteria: Irradiator facilities must have radiation monitors to detect radiation levels and sources as described in 10 CFR Part 36. I I Discussion: This section will only discuss the evaluation of the location of radiation neitors. For information regarding the calibration, sensitivity, and testing of monitors, see " Radiation Safety Program - Instruments." NUREG .1556, Vol. 6 8-26
)
CONTENTS OF AN APPLICATION For irradiators with automatic product conveyor systems: The irradiator must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting a trained individual in the facility who is prepared to summon assistance. For punoramic inadiators: A monitor must be provided to detect the radiation level in the radiation room when the source is indicated to be in the fully shielded position. The monitor must be integrated with the personnel access door interlocks, as applicable, to prevent room access when the manitor detects an elevated radiation level for which the alarm set point is as low as practical but high enough to avoid false alarms. Room access must also be prevented if the monitor malfunctions or is turned off. For underwater irradiators that are not in a shielded radiation room: There must be a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly (e.g., prevent movement of irradiated product out of pool in the event water is contaminated). For all irradiators whose construction begins after July 1,1993: . The licensee must ensure that the location and sensitivity of the monitor used to detect sources carried by the product conveyor system are appropriate
- The licensee must verify that the product conveyor is designed to stop before a source on it could cause a radiation overexposure to any person For pool irradiators whose construction begins after July 1,1993:
. If the licensee uses radiation monitors to detect contamination under 10 CFR 36.59(b), the licensee must verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate. For all irradiators whose constmetion begins after July 1,1993, the licensee must verify the operability of radiation monitors and related alarms and interlocks prior to loading sources. For more information see Appendix J," Construction Monitoring and Acceptance Testing." 8-27 NUREG - 1556, Vol. 6
1
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CONTENTS OF AN APPLICATION Response from Applicant: Describe the location and type of radiatioa monitors that will be used to meet the requirements of 10 CFR 36.23(c),36.29, and 36.59(b). Describe the location and types of alarms and those individuals who are trained to respond to those alarms. Diagrams and sketches should be used, as appropriate.
. Discuss the alarm set-points or the methods for establishing the alarm set-points.
For irradiators whose construction begins after July 1,1993, describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and sensitivity and the acceptance testing that will be performed to meet 10 CFR 36.41(e). Note: Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the mquirements of 10 CFR 36.29. 8.9.6 IRRADIATOR POOLS Regulations: 10 CFR 30.33(a)(2),10 CFR 36.23(i),10 CFR 36.33,10 CFR 36.39(c), 10 CFR 36.39(d),10 CFR 36.41(c),10 CFR 36.41(d). Criteria: Irradiator facilities with pools must be designed and equipped as described in 10 CFR Part 36. Discussion: For facilities initially licensed after July 1,1993, NRC requires EITHER A water-tight stainless steel liner (or a liner metallurgically compatible with other components in the pool) OR Construction preventing substantial leakage and a pool surface designed to facilitate decontamination.. The purpose of the requirement is to reduce the likelihood of the pool leaking water that may be contaminated or used for shielding purposes. In either case, the licensee must have a method to store the sources safely dur% tepairs of the _ irradiator pool. NUREG - 1556, Vol. 6 8-28
i l CONTENTS OF AN APPLICATION l For all licenses initially issued after July 1,1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as ' siphons must have breakers to prevent siphoning. Irradiator pools must have a means to i replenish water that is lost. The means to replenish the water does not have to be automatic. Irradiator pools must also have a clearly visible indicator to show if the pool water level is above or below the normal low water level. For all poolirradiators: ! A physical barrier, such as a railing or cover, must be used around or over irradiator pools , during normal operation to prevent personnel from accidentally falling into the pool. The ; barrier may be removed during maintenance, inspection, and service operations. Also, this ensures compatibility with OSHA requirements and ANSI standards.
- Irradiator pools must be equipped with a purification system capable of maintaining the water l during normal operation at a conductivity of 20 microsiemens per centimeter or less and with !
enough clarity to allow for inspection of the source and source rack for damage and proper j position. The water purification system is needed to minimize the probability of corrosion of ) the sealed sources and the source rack. l . The 0.02 mSv (2 mrem) per hour limit on the dose rates for poles and long-handled tools to be used in irradiator pools is imposed to prevent radiation streaming. Hollow and low-density poles and tools can have either vent holes to allow shielding water to enter or sufficient bends to prevent radiation levels at handling areas of the tools from exceeding 0.02 mSv (2 mrem) per hour. l For panoramic irradiators whose construction began after July 1,1993, the licensee must verify l that the pool design ensures its integrity as required by 10 CFR 36.39(c) and that the design of the water purification system is adequate. The licensee must also conduct inspections and tests of the pool and water handling systems to meet the requirements of 10 CFR 36.41(c) and (d). See Appendix J," Construction Monitoring and Acceptance Testing." __ Response from Applicant: Pravide the following:
- For all poolirradiators, describe:
- The high and low water-level indicators and their locations - The purification system for the pool with an explanation of why it is capable of maintaining pool water conductivity less than 20 microsiemens per centimeter - The means to replenish pool water - The barrier used during normal operation to prevent personnel from falling into the pool 8-29 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION
- How high radiation doses from radiation streaming will be avoid :d when using long-handled tools or poles (use sketches if appropriate). - If the pool has outlets more than 0.5 meter below the surface that could allow water to drain out of the pool, the means of preventing inadvertent excessive loss of pool water (in this context outlets do not include transfer tubes between adjacent pools because the transfer tubes do not provide a means to allow water to drain out of the pools).
For irradiators licensed after July 1,1993, describe:
- The pool liner. If no water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool is used, explain why the pool has a low likelihood of substantial leakage and how decontamination could be accomplished if necessary.
8.9.7 SOURCE RACK Regulations: 10 CFR 30.33(a)(2),10 CFR 36.35,10 CFR 36.39(f),10 CFR 36.41(f). i Criteria: Systems must be in place to protect the source rack. Discussion: An important element in a radiation safety program is providing systems to protect the source rack and the mechanism that raises and lowers the sources. For all irradiators, if the product to be irradiated moves on a product conveyor system, the source rack and the mecnanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism. For irradiators whose construction begins after July 1,1993:
- For pool irradiators, the licensee must verify that there are no crevices on the source or between the source and source rack that would promote corrosion on a critical area of the j source (e.g., crevice corrosion, an inaccessible location in or around the sources or rack with low oxygen concentrations).
For panoramic irradiators, the licensee must determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss ofintegrity of sealed sources. In addition, licensees should review the potential of sealed sources to become dislodged from the source rack when dropped as a result of loss of power, failure of cables, or other alternate means of support. NUREG - 1556, Vol. 6 8-30
~ .- .- . . - - - - . . -
5 CONTENTS OF AN APPLICATION
= For panoramic irradiators, the licensee must review the design of the mechanism that moves the sources to ensure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to frei t with minimal risk to personnel.
For irradiators whose construction begins after July 1,1993:
. For panoramic irradiators, the licensee must test the movement of the source racks for proper [
operation prior to source loading; testing must include source rack lowering due to simulated l loss of power.
- For all irradiators with product conveyor systems, the licensee must observe and test the operation of the conveyor system to ensure that the requirements in 10 CFR 36.35 are met for protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.
See Appendix J," Construction Monitoring and Acceptance Testing." Response from Applicant: Submit procedures for ensuring source rack protection. If the product moves on a product conveyer system, describe the source rack protection to be provided ! to prevent products and product carriers from touching the source rack or mechanism that moves ! the rack. Provide &. grams or sketches of those systems, if appropriate. l 8.9.8 POWER FAILURES Regulations: 10 CFR 30.33(a)(2),10 CFR 36.37,10 CFR 36.39(i),10 CFR 36.41(i), 10 CFR 36.41(j). Criteria: If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically retum to the shielded position. In addition, the lock on the door of the radiation room of a panoramic irradiator must not be deactivated by a power failure. , Discussion: Automatic source retraction in case of power loss must be accomplis' ::d without , offsite power. The loss of offsite power may occur at irradiator facilities due to means outside l the control of the licensee. In those cases where loss of offsite power occurs, the licensee is ! responsible for ensuring that the sources automatically return to the shielded position in accordance with 10 CFR 36.37(a). This is normally accomplished by an irradiator design that i does not need electrical energy to retract the sources. In addition,10 CFR 36.37(b) requires that the lock on the door of the radiation room may not be deactivated as the result of a power failure. It also requires that during a power failure, the licensee must ensure that anyone entering the area 8-31 NUREG - 1556, Vol. 6
)
I CONTENTS OF AN APPLICATION of any irradiator where sources are located must use an operable and calibrated radiation survey meter. The licensee needs to demonstrate how the source rack would be retracted into the shielded position in the event of a power outage and what effects the loss of power would be on the lock of the door to the radiation room that contains the sources. If the locks on the doors did not function as designed and allowed entry into the radiation room, the licensee would need to have procedures in place to ensure that safety features would prevent an individual from being exposed to the sources if they did no' retract to the shielded position. Backup power is not required as long as loss of power will cause the source to return to its shielded position, e.g., the source returns to the shielded position due to gravity. For panoramic irradiators whose construction began after July 1,1993, the licensee must test the ability of the source rack to return to its shielded position during a power loss greater than ! 10 seconds. For more information; see Appendix J," Construction Monitoring and Acceptance i Testing." E Response from Applicant: For panoramic irradiators whose construction began after July 1,1993, describe how the sources are automatically retumed to the shielded position if offsite power is lost for longer than 10 seconds.
- For all panoramic irradiators, describe how loss of power will affect the lock on the doors in the radiation room.
For underwater irradiators, no response is required from the applicant in a license application. 8.10 ITEM 10: RADIATION SAFETY PROGRAM 8.10.1 AUDIT PROGRAM i l Regulations: 10 CFR 20.1101,10 CFR 20.2102. Criteria: Licensees must review the content and implementation of their radiation protection programs at least every 12 months to ensure the following: Compliance with NRC and DOT regulations (as applicable), and the terms and conditions of the license;
. Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101); and NUREG - 1556, Vol. 6 8-32
CONTENTS OF AN APPLICATION
. Records of audits and other reviews of program content are maintained for 3 years.
Discussion: Applicants must develop and implement an audit program. Appendix K contains a suggested audit program that is specific to the use ofirradiators and is acceptable to NRC. All areas indicated in Appendix K may not be applicable to every licensee and all items 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. Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a pan of their audit programs, applicants should consider performing unannounced audits of irradiator operators to determine if, for example, Operating and Emergency Procedures are available and are being followed. It is essential that once identified, problems be corrected comprehensively and in a timely manner; Information Notice (IN) 96-28, " Suggested Guidance Relating to Development and Implementction of Corrective Action," provides guidance on this subject. The NRC will review the licensee s audit results and determine if corrective actions are thorough, timely, and sufficient to prevent recurrence. If violations are identified by the licensee and these steps are taken, the NRC can 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 violations, refer to the current version of" General Statement of Policy and Procedmes for NRC Enforcement Actions," (NUREG 1600). Licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. NRC has found audit records that contain the following information to be acceptable: date of audit, name of person (s) who conducted audit, persons contacted by the auditor (s), areas audited, audit fm' dings, corrective actions, and followup. Response From Applicant: The applicant's program for reviewing the content and implementation of its radiation protection program will be examined during inspections, but should not be submitted in the license application.
References:
See the Notice of Availability (on the inside front cover of this repon) to obtain copies of: Manual Chapter 87100, Appendix F," Commercial Irradiator Field Notes," the current version of NUREG-1600, " General Statement of Policy and Procedures on NRC Enforcement ; Actions," and IN 96-28," Suggested Guidance Relating ta Development and Implementation of I Corrective Action," dated May 1,1996. NUREG-1600 is also available on the Internet. Visit NRC's Home Page <http://www.nrc. gov >, choose " Nuclear Materia!s," then " Enforcement," " Enforcement Guidance Documents," and then " Enforcement Policy." S-33 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION 8.1.0.2 INSTRUMENTS Regulations: 10 CFR 20.1501,10 CFR 20.2103(a),10 CFR 30.33(a)(2),10 CFR 36.57(c), 10 CFR 36.57(e),10 CFR 36.81(f),10 CFR 36.63(b),10 CFR 36.23(c),10 CFR 36.27(a), 10 CFR 36.29. Criteria: NRC requires specific types ofinstruments to perform radiation surveys and to monitor certain activities. , i Survey instruments Surveys that are required before and during operation of all types of irradiators require using survey instruments whi::h:
- measure the type of radiation expected l e are calibrated:
- at least every 12 months - using a source of radiation simih r to that found in the irradiator - after any servicing or repair (other than a simple battery exchange) - to ensure that exposum rates indicated by the meter do not vary from the actual exposure rates by more than 20% on each scale - by the instrument manufacturer or person specifically authorized by the NRC or an Agreement State to calibrate survey instmments e do not saturate and read zero at high radiation dose rates.
Radiation Monitors The requirements for use of radiation monitors cre shown in Table 8.2. NUREG - 1556, Vol. 6 8-34
. 1 CONTENTS OF AN APPLICATION
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Tatne8.2 Requirements for Radiation Monitors i l Type ofIrradiator Moultor Baguired Purpose of Monitor Required Checks Panorarnic pool Gamma sensing Detects presence of Periodic checks with i integrated with ' high radiation in radioactive check personnel access radiation room to - source to confirm l locks. Must activate prevent room access operability alarmif entry is when rad levels are . attempted while high' ! sensing radiation. ( 10 CFR 36.23(c) i All pool types Gamnu sensing of Detects a possible Periodic checks with- : (required unless water pool circulating leaking sealed source radioactive check: ) is checked daily by system. Must activate source to confirm , l analysis of a sample of an alarm set-point as . operability and :: ! , ' ' ' pool. water) _, low as practical when sensitivity ; l poolis contaminated. l o l 10 CFR 36.59(b) l' Underwater type not in Gamma sensing Detects abnormal Periodic checks with ! a shielded radiation mounted over the radiation levels radioactive check { L room pool. Must have an source to confirm i l ' audible alarm capable operability and of alerting an sensitivity , s authorized individual. 10 CFR 36.29(b)
-- Anyirradiator using a Gamma sensing to Must stop conveyor . Periodic checks with pro.luct conveyor detect and stop the befone a source on the radioactive check
~
systeen productconveyorif a conveyor can cause a source to confirm
~
source is present. radiation - operability. The
, 10 CFR 36.29(a) overexposure to any location and sensitivity 10 CFR 36.39(e) person. of tiu monitor to -
r detect sources carried' L by the product .
~~
- i. conveyor must be n evaluated.~
- Discussion: Irradiator licensees must have survey instruments and radiation monitors as shown Lin Figure 8.6. i I 8-35 NUREG - 1556. Vol. 6
, a- , --
,e ~ ,- __ ,
CONTENTS OF AN APPLICATION O.. s g Survey Meter Area Monitor nornut >ac Figure 8.6 Radiation Detection Instruments. Irradiator licensees must have a variety of l radiation detection instruments including portable survey instruments as well asfixed radiation monitors. l Survey instruments The survey instruments should measure at least 0.05 mR through 200 mR per hour (2 mSv) and l be checked for functionality with a source of radiation at the beginning of each day of use (e.g., l with a check source). Plans to conduct non-routine operations such as installation, initial ' radiation sorycy, repair, and maintenance of components related to the radiological safety of the I irradiator, sealed source relocation, replacement, and disposal of sealed sources, alignment or l removal of a sealed sources frorn service must include an evaluation of the type of survey ! instrument to be used because some of these operations may increase the individual's risk of radiation exposure. These operations should be carefully monitored with an appropriate survey meter. Furthermore, proper calibration of a survey meter is imponant for initial surveys since they can be used as a basis for public dose estimates. For those licensees requesting authorization to calibrate their own survey instmments, Appendix L contains calibration procedures acceptable to the NRC. Radiation Monitors Fixed radiation monitors are used to detect the presence of radiation for various purposes at irradiator facilities. They are vital to access control systems because they provide electronic signals used to activate both audible and visual alarms when radiation is present. Monitors that warn individuals of the . presence of high radiation or which are integrated with personnel access > door locks tn prevent room access under high radiation conditions should be designed to pmvide fail-safe operation, i.e., if the radiation monitor for any reason fails to respond to radiation, the system should provide for a backup warning system. l 1 NUREG - 1556, Vol. 6 8-36 l l
en CONTENTS OF AN APPLICATION , 1 Response from Applicant: 1 For Survey Instruments: Provide one of the following:
- A statement that,"We will use survey instruments that meet the Criteria in the section entitled
' Radiation Safety Program - Instruments' in NUREG-1556, Vol. 6, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses,' dated January 1999."
1 s AND ONE OF THE FOLLOWING:
. A statement that, "Each survey meter will be calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations."
OR
. A statement that,"We will implement the model survey meter ctdibration program published in Appendix L entitled ' Survey Instrument Calibration' in NUREG-1556, Vol. 6,
' Consolidated Guidance about Materials Licenses. Program-Specific Guidance about 10 CFR Part 36 Irradir for Licenses,' dated January 1999."
t OR Submit alternative calibration procedures for NRC review. OR,IN LIEU OF ALL OF THE ABOVE, SUBMIT:
- A description of an alternative method to perform surveys pursuant to 10 CFR 20.1501.
1 For Radiation Monitors: Describe the type of monitors used to meet the requirements of l 10 CFR 36.23(c),36.29, and 36.59(b). (The location of these monitors and alarm set-points were described in the response to " Facilities and Equipment - Radiation Monitors.") l l Notes:
. Alternative responses will ta evaluated using the criteria listed above. I . The NRC license will state that survey meter calibrations will be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State to j calibrate instruments, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey meter calibrations must submit additional information for review. See Appendix L for more information.
l 8-37 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION
- Regardless of whether an applicant is authorized to calibrate survey meters or contracts an authorized firm to perform calibrations, the licensee must retain calibration records for at least 3 years.
8.10.3 MATER:AL RECEIPT AND ACCOUNTABILITY Regulations: 10 CFR 30.34(e),10 CFR 30.35(g),10 CFR 30.41,10 CFR 30.51, l 10 CFR 20.1501(a),10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.2201. j Criteria: Licensees must do the following:
- Develop, maintain, and implement procedure to account for licensed material.
- Maintain records of receipi, transfer, and disposal oflicensed material (i.e., sealed sources). ;
Discussion: While loss, theft, or misplacement oflicrnsed material at most irradiator facilities is unlikely because oflimited access to sealed sources and the hazards involved with approaching unshielded sources, accountability for licensed materials must be ensured. As illustrated in , I Figure 8.7, licensed materials must be tracked from " cradle to grave" in order to ensure accountability and ensure that possession limits listed on the license are not exceeded. ! I p y , __ wyy Receipt Disposal or transfer ranomj \ Figure 8.7 Material Receipt and Accountability. Licensees must maintain records of receipt, transfer and disposal and implement an accountability procedure. l Because this report covers various types ofirradiators, it is not possible to prescribe a specific procedure for material accountability that will apply to every situation. In developing a licensed material accountability program, the upplicant should take into consideration the specific I NUREG - 1556, Vol. 6 8-38
CONTENTS OF AN APPLICATION conditions at its facility. Table 8.3 includes elements that may be included in the accountability procedure for various facilities. Table 8.3 Elements of Accountabliity Procedure Irradiator Type Items to be Addressed in Accountability Procedure Pool hradiator - Verify that no sources have been lost when sources are added to, reraaved from, or moved within the irradiator or, at a minimum, every 3 years Maintenance of records that include sealed source serial numbers and location of each source Panoramic Dry-Source-Storage 12ak tests Irradiator (Including Teletherapy Verify that no sources have been lost when sources are ' Units Converted toIrradiators) added to, removed from, or moved within the irradiatv: or, at a minimum, every 3 years Maintenance of records that include sealed source serial , numbers and location of each source , Receipt, transfer, and disposal records must be maintaii ied for the times specified in Table 8.4. Typically, these records contain the following types of nformation:
- Radionuclide, activity (in units of becquerels or curies), and date of measurement of byproduct materialin each sealed source
- Manufacturer's (or distributor's) name, model number, and serial number of each sealed source containing byproduct material
. IAcation of each sealed source
- For materialt, transferred or disposed of, the date of the transfer or disposal, name and license number of the recipient, description of the affected radioactive material (e.g., radionuclide, activity, manufacturer's (or distributor's) name and model number, serial number).
Table 8.4 Receipt, Transfer and Disposal Record Maintenance TypeofRecent How Long Record Must be Maintalawl Receipt For as long as the material is possessed until 3 years after transfer or disposal Transfer For 3 yean after transfer . ._ 8-39 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION Type of Record How Long Record Must be Maintained Disposal Until NRC terminates the license Important to Decommissioning
- Until the site is released for unrestricted use
*See the section entitial" Financial Assurance and Recordkeeping for Decommissioning."
Response from Applicant: Submit a description of procedure (s) for ensuring material accountability. 8.10.4 OCCUPATIONAL DOSIMETRY l Regulations: 10 CFR 36.55,10 CFR 20.1502,10 CFR 20.1201,10 CFR 20.1207, l 10 CFR 20.1208,10 CFR 20.1501(c). Criteria: The requirements for occupational dosimetry are shown in Table 8.5. l
)
Table 8.5 Requirements for Ocr.upational Dosimetry Type of Category of Persor,nel Type of Doshnetry When Dosimetry Must Irradiator Requind Be Worn Panoramic Irradiator Operators Film or TLD When operating irradiator (10 CFR 36.55(a)) Underwater Inadiator Operators Film or TLD When in area around pool . (10 CFR 36.55(n)) Panoramic Other individuals, Por Ket dosimeter, film, or When entering or in including visitors (for TLD (10 CFR 36.55(a)) radiation room groups of visitors, only two must be monitored) - All Anyone who could Pocket dosimeter, film, or As directed by the RSO receive,in one year, a TLD (10 CFR 20.1501 based on 10 CFR 20.1502-- radiation dosein am and 10 CFR 20.1502) of 10% of the ak abh limits as shown i.. . We 8.8.*
- The licensee must maintain, for inspection by NRC, documentation demonstrating that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits as shown in Figure 8.8.
NUREG 1556,Vol.6 8-40
CONTENTS OF AN APPLICATION skin Eyes Annual Dose Limits 0.50 sv ,,ms) for Radiation Worker
# '***' QSs (10 CFR 20.1201)
Elbows to hands l kl 0.50 Sv Total effective dose equivalent TEDE (50 rems) (whole body) 0.05 Sv (5 rems) Knees to feet 0.50 Sv (50 rems) ( y "oEA Figure 8.8 Annual Dose Limits for Radiation Workers. Discussion: The requirements for most individuals are described in Table 8.5. Other individuals who perform certain non-routine operations (e.g., source loading, unloading, ar.d repositioning; troubleshooting the control console; clearing stuck source racks; investigating /remediating removable contamination / leaking sources; (re) installing source cables; and any other activity ! during which personnel could receive radiation doses exceeding NRC limits) are likely to exceed l 10% of the limits as shown in Figure 8.8 (see Appendix I). Applicants will also be required to j 1 provide dosimetry (whole body and perhaps extremity monitors) to individuals performing such
- services.
4 When personnel monitoring h. needed, most licensees use either film badges or thermoluminescent dosimeten (TLDs) that are supplied by a NVLAP-approved processor. The exchange frequency for film badges is usually monthly due to technical concerns about film fading. The exchange frequency for TLDs is usually quarterly. Applicants should verify that the i processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange fxquency and proper use. Some workers, e.g., package handlers, shipping personnel, and custodial personnel, may work near the irradiator but are not likely to exceed 10% of the limits. Refer to Appendix M for guidance for demonstrating that an unmonitored individual will not exceed 10% of the limits. Response from Applicant: The applicant's occupational dosimetry program required by 10 CFR Parts 20 and 36 will be examined during inspection, but should not be submitted in the license application. 8-41 NUREG - 1556, VoI. 6
m CON'IENTS OF AN APPLICATION As of this moment, NRC is considering the use of NAVLAP approved Optically Stimulated Luminescent Dosimeters (OSL). Licensees will be informed of their acceptability via an NRC generic communication. I
.8.10.5 PUBLIC DOSE
~-
)
i Regulations:- 10 CFR 20.1301,10 CFR 20.1302,10 CFR 20.1003,10 CFR 20.1801, ! 10 CFR 20.1802,10 CFR 20.2107,10 CFR 36.25. i Criteria: Licensees must do the following:
. Ensure that irradiators and their sealed sources will be used, transported, and stored in such a ;
way that individual members of the public will not receive more than 1 millisievert (mSv) [100 millirem (mrem)] in one year, and the dose in any unrestricted area will not exceed j 0.02 mSv (2 mrem) in any one hour, from licensed operations.
- Control and maintain constant surveillance over licensed material that is not in storage and secure stored licensed material from unauthorized access, removal, or use. l i
1 Discussion: Members of the public include all persons who are not radiation workers. This includes 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 oflicensed materials and who work in the vicinity where licensed material is used or stored. Security procedures described in " Facilities and Equipment - Access Control,"" Radiation Safety Program - Operating Procedures," and " Radiation Safety Program - Emergency Procedures" should be sufficient to limit the exposure to the public during use or storage. Public dose is controlled, in part, by ensuring that irradiators are secure (e.g., irradiator is locked or located in a locked area) to prevent unauthorized access or use. Irradiator use is usually restricted by controlling access to the keys needed to operate the irradiator and/or to keys to the locked irradiator area. Only authorized users should have access to these keys. Public dose is also affected by the choice of storage and use locations and conditions. Since an irradiator produces a radiation field, it must be located and constructed so that the dose in an j unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed l 0.02 mSv (2 mrem) in any one hour and the dose to an individual does not exceed 1 mSv
~
]
(100 mrem) in a year. Use the concepts of time, distance, and shielding when choosing storage and use locations. Decreasing the time spent near an irradiator, increasing the distance from the l irradiator, and using shielding (i.e., brick, concrete, lead, or other solid walls) will reduce the radiation exposure. Licensees must determine the radiation levels in unrestricted areas that are normally occupied during operation of an irradiator as specified in Table 8.6. NUREG - 1556, Vol. 6 8-42
CONTENTS OF AN APPLICATION Table 8.6 Radiation Limita Specified in 10 CFR 36.25 Irradiator Type Lindt Where Measured Source ! Positieu ! Panoramic 0.02 mSv (2 mrem) per 30 centimeters or more Exposed
)
hour from the wall (of the room where the sources are exposed)in areas normally occupied Poolirradiator(including - 0.02 mSv (2 mrem) per 30 centimeters over the Shielded panoramic poolirradiators hour edge of the poolinadiator and underwater l irradiators)- Dry-source-storage 0.02 mSv (2 mrem) per 1 meter from the shield of Shielded panoramic irradiator hour a dry-source-storage panoramic irradiator Dry-source-storage 0.2 mSv (20 mrem) per 5 centimeters from the' Shielded , panoramic irradiator hour shield Doses adjacent to the irradiator location can be determined by direct measurements and calculations using the " inverse square" law to evaluate the effect of distance on radiation levels, and occupancy factor to account for the actual presence of the member of the public. If, after making an initial evaluation, a licensee changes the conditions used for the evaluation (e.g., changes the shielding of the irradiator, increases the source strength, changes the type or frequency ofirradiator 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. During NRC inspections, licensees must be able to provide documentation demonstrating. by measurement or a combination of measurement and calculation, that the total effective riose eqpivalent to the ind$idual likely to receive the highest dose from the licensed operation does j not exceed the annual limit for members of the public. See Appendix N for examples of methods l to demonstrate compliance. Response from Applicant: The applicant's program to control doses received by individual members of the public will be examined during inspection, but should not be submitted in a license application. l I 8-43 NUREG - 1556, Vol. 6 l i
7.. CObrIENTS OF AN APPLICATION 8.10.6 OPERATING PROCEDURES Regulations: 10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.2201-2203, 10 CFR 30.50,10 CFR 21.21,10 CFR 19.11(a)(3),10 CFR 36.13(c),10 CFR 36.31, 10 CFR 36.53. Criteria: The applicant must have and follow written operating procedures for items specified l in 10 CFR 36.53(a). i Discussion: Operating procedures must be developed, maintained, and implemented to ensure that irradiators are used only as they were designed to be used, and radiation doses received by occupational workers and members of the pubhc are ALARA. Copies of operating procedures l should be provided to all irradiator operators. In addition, the applicant must post cunent copies of operating procedures applicable to licensed activities at each site. If posting of procedures is not practicable, the licensee may post a notice which describes the documents and states where they may be examined. I improper operation could lead to the damage or malfunction of an irradiator and potentially lethal l radiation overexposures to individuals. The applicant will provide summaries of the written operating procedures describing their important radiation safety aspects. The level of detail should be sufficient to demonstrate that regulatory requirements have been addressed. Table 8.7 lists the procedures that must be developed, maintained, and implemented, as well as important radiation safety aspects that should be addressed in the outline (i.e., description) that must be submitted in the application. Table 8.7 Operating Procedures l Requhed Pmcedures Items to be Addressed in Description of Procedures Operation of the irradiator, including The d:scription should be detailed enough to show how entering and leaving the radiation licensee will comply with 10 CFR 36.67, " Entering and room Leaving the Radiation Room," and should describe the i initial entry and survey after an irradiation. Describe : how the applicant will prevent access to keys by individuals who have not been qualified to be operators, as required by 10 CFR 36.31(a). For panoramic irradiators, when product movement is occurring, the description should address the required presence (10 CFR 36.65) of an irradiator operator and another person who is trained on how to respond and prepared to render or summon assistance if the access alarm sounds. For static irradiations, a person who is trained to respond to alarms must be onsite.t NUREG - 1556, Vol. 6 8-44
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l CONTENTS OF AN APPLICATION Required Procedures Items to be Addressed in Description of Procedures ' Use of personnel dosimeters See " Radiation Safety Program - Occupational Dosimetry" Surveying the shielding of panoramic See " Facilities and Equipment - Shielding" irradiators Monitoring pool water for See " Facilities and Equipment - Radiation Monitors" contam.ination while the wateris in j the pool and before release of pool water to unrestricted areas leak testing of sources See " Radiation Safety Program - Izak Tests" and Appendix P Inspection and maintenance checks See " Radiation Safety Program - Inspection and ,
. required by 10 CFR 36.61 Maintenance Checks" Loading, unloading, and If these procedures will be performed by the applicant, repositioning sources,if the see Appendix I,"Infonnation Needed to Support operations will be performed by the Applicant's Request to Perform Non-Routine licensee; and Op' rations" Inspection of movable shielding Describe inspection of roof plugs or other movable !
required by 10 CFR 36.23(V,if shielding required by 10 CFR 36.23(h), if applicable.* l applicable.*
- In 10 CFR 36.65, the term "onsite"is intended to give flexibility to licensees. For ex.unple, for a research irradiator at a university, the person onsite could be a guard located on campus but not in the building containing the irradiator, provided the guard would hear the alarm and was trained as required by 10 CFR 36.51(g). The guard would not have to be trained as an irradiator operator.
If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the inadiator unless the shielding is ir) its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection ofshielding before operating. Normally, the manufacturer or a person specifically authorized by NRC or an Agreement State 1 will perform non-routine operations involving, source loading, unloading and repositioning; troubleshooting the control console; clearing stuck source racks; investigating /remediating removable contamination / leaking sources; (re) installing source cables; and other critical operations requiring special skills or the potential for radiation overexposures. If these operations are not performed properly with attention to good radiation safety principles, the irradiator may not operate as designed and personnel performing the operations could receive potentially lethal exposures. If the applicant wishes to perform non-routine operations, the information in Appendix I should be provided. 8-45 NUREG - 1556 Vol. 6
L CONTENTS OF AN APPLICATION-Repair and Preventive Maintenance Outlines of maintenance, service, and repair procedures are not required. However, these should
- be done according to the manufacturer's written instructions, where applicable, by qualified personnel using their knowledge, experience, judgment, and skills to respond to each particular situation. '
Improper repairs or maintenance not be'ng performed in a timely fashion was identified as a contributing cause of many of the incidents reviewed in NUREG-1345, " Review of Events at ,
. Large Pool-Type Irradiators." Therefore, malfunctions and defects found during inspection and b
maintenance checks must be repa ed without undue delay. It is understood that it may be necessary to obtain a special part, piece of equipment, or particular skilled labor that may not be readily available. Licensees are allowed some flexibility in making noncritical repairs. As long : as a reasonable effort is made, the licens: e will meet the intent of the requirement. However, e some repairs are critical and not subject to the latitude in 10 CFR 36.61(b). For example, licensees must make repairs to the access control system before operating the irradiator to ensure compliance with 10 CFR 36.23. Preventive maintenance should be performed according to the manufacturer's written - instructions. If manufacturer's written instructions are not available, the applicant should perform a review of the systems comprising the irradiator in consultation with knowledgeable . individuals and determine and implement an appropriate schedule for preventive maintenance. Security of Licensed Material NRC considers security of licensed material extremely important and lack of security is a significant violation for which licensees may be subject to enforcement action. Although it is generally difficult to access sealed sources used in most 10 CFR Part 36 irradiators, the applicant should develop, maintain, and implement procedures to prevent unauthorized access, removal, or i use of the licensed material. Also, procedures should require that all areas associated with ! irradiator operations, particularly control and interlock systems, be locked and secured against i unauthorized access. Revision of Procedures The licensee may revise opersing procedures without NRC approval only if all of the following conditions are met:
- The revisions do not reduce the safety of the facility
- The revisions are consistent with the outline or summary of procedures submitted with the license application NUREG - 1556, Vol. 6 8-46
CONTENTS OF AN APPLICATION . The revisions have been reviewed and approved by the RSO + The users or operators are instructed and tested on the revised procedures before they are put l into use. Response from Applicant: For routine operations: Provide an outline that specifically states the radiation safety aspects of the written operating procedures listed in Table 8.7 (i.e., those procedures listed in 10 CFR 36.53(a)). For items where other sections of this guide are referenced, respond to the ; applicable section. For non-routine operations: Submit either of the following:
- A statement that: "The irradiator manufacturer or other person authorized by NRC or an Agreement State will perform non-routine operations such as source loading, unloading and repositioning, electrical troubleshooting of the control console, clearing stuck source racks, i investigating /remediating removable contamination / leaking sources, (re) installing source !
cables, and other critical operations requiring special skills or the potential for radiation overexposures." OR i . The information listed in Appendix I supporting a request to perform this work "ia . house." i Note: Information requested in Appendix I will be reviewed on a case-by-case basis; if approved, the license will contain a condition authorizing the licensee to perform non-routine operations.
Reference:
See the Notice of Availability (on the inside front cover of this report) to obtain a copy of NUREG-1345," Review of Events at Large Pool-Type Irradiators," dated March 1989 or IN 83-09: " Safety and Security of Irradiators," dated March 9,1983. l 8.10.7 PROCEDURE FOR IDENTIFYING AND REPORTING DEFECTS AND NON-COMPLIANCE AS REQUIRED BY 10 CFR PART 21 Regulations: 10 CFR Part 21,10 CFR 30.50,10 CFR 36.83. Criteria: Licensees must notify NRC if defects and failures are found in a basic component that could create a substantial safety hazard. 8-47 NUREG - 1556. Vol. 6
CONTENTS OF AN APPLIC ATION Discussion: Equipment defects that could create a substantial safety hazard, or equipment failures involving NRC-regulated activities must be reported to NRC. For example, a failure of an access control system such that a person could enter the radiation room during a time when the sources are exposed in a panoramic irradiator, or a defect in an interlock that prevents the operation of a panoramic irradiator in the event a roof plug or other movable shielding is not in place. Operating personnel should be instructed to report any malfunction or defect in irradiator equipment to management so that management can take appropriate action. Response from the Applicant: None required. 8.10.8 EMERGENCY PROCEDURES 3 Regulations: 10 CFR 19.11(a)(3),10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802, 10 CFR 20.2201-2203,10 CFR 21.21,10 CFR 30.50,10 CFR 36.13(c),10 CFR 36.37(c), 10 CFR 36.53,10 CFR 36.67, and 10 CFR 36.83. Criteria: The licensee must have and follow emergency or abnormal event procedures, appropriate for items listed in 10 CFR 36.53(b). Emergency procedures should include notifying the NRC during and after emergencies and abnormal events. Discussion: Figure 8.9 illustrates proper handling of one type ofincident (i.e., broken source rack cable). NUREG - 1556, Vol. 6 8-48
- . - - - . - - - - . . - . . . - . . - - ~ - - - . . - . . . ... . . .
CONTENTS OF AN APPLICATION
- 1. Event 2. Source movement Indicated indefinitely 5: .N 1;gI ,y a
d i i i 4- : A. , , < . ,
% - )
.;ujk. qg;;%, 3
~~~ i
- 3. Something le wrong! 4. Call RSO s N
\
1 ( f wy Figure 8.9 Proper Handling ofIncident. Licenseepersonnelimplement emergency procedures when a source rack cable breaks. Licensees must have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for: e Sources stuck in the unshielded position e Personnel overexposures
- A radiation alarm from the product exit portal monitor or pool monitor e Detection ofleaking sources, pool contamination, or alarm caused by contamination of pool water (include 10 CFR 36.59(c) requirements)
. A low- or high-water level indicator, an abnormal water loss, or leakage from the source storage pool 8-49 NUREG - 1556, Vol. 6
CONTENTS OF AN APPLICATION . A prolonged loss of electrical power (include 10 CFR 36.37 and 36.67(c) requirements) . A fire alarm or explosion in the radiation room . An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area . Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility . The jamming of automatic conveyor systems. The applicant should consider other events which may require emergency or abnormal event procedures (e.g., abnormally high radiation levels indicated by the area radiation monitor, collision with the source (s) or source rack). Emergency and abnormal event procedures should include who will be notified of the event, the role of the RSO, and what records of the event will be kept. The procedures should clearly identify telephone numbers of the RSO or other individuals who can provide assistance including the irradiator manufacturer (or distributor) and state and local agencies. The procedures should include actions to be taken immediately after discovering the emergency or abnormal event. Emergency procedures should also include notifying the NRC when events specified in Appendix O occur. The RSO must be proactive in evaluating whether NRC notification is required. Refer to Appendix 0 and the regulations (10 CFR 20.2201-20.2203,10 CFR 30.51, and 10 CFR 36.83 for descriptions of when and where notifications are required. ; Emergency procedures generally should not include post-emergency corrective actions and repairs, since there will be time to carefully consider such actions on a case-by-case basis after the situation is under control. Copies of emergency procedures should be provided to all i irradiator operators. In addition, licensees must post current copies of emergency procedures j applicable to licensed activities at each site. If posting of procedures is not practicable, the l licensee may post a notice which describes the documents and states where they may be examined. j Emergency procedures for personnel overexposures, fire alarms, explosion in the radiation room, and natural phenomena may involve emergency responders outside the applicant's : organization. The applicant should inform and/or train individuals in these organizations j regarding the unique concerns and hazards associated with emergencies at the irradiator facility. For instance, hospitals should be informed about the different radiation accidents that could occur at the facility (i.e., overexposure vs. personnel contamination incident). I NUREG - 1556, Vol. 6 8-50
CONTENTS OF AN APPLICATION The licensee may revise emergency procedures without NRC approval only if all of the following conditions are met: ,
- The revisions do not reduce the safety of the facility e The revisions are consistent with the outline or summary of procedures submitted with the license application
- The revisions have been reviewed and approved by the RSO e The users or operators are instructed and tested on the revised procedures before they are put into use. !
Response from Applicant: Provide an outline that specifically states the radiation safety aspects of the writteu emergency procedures listed in the " Discussion" section (i.e., those , procedures listed in 10 CFR 36.53(b)). t 8.10.9 LEAK TESTS Regulations: 10 CFR 36.59,10 CFR 36.81(h),10 CFR 36.83. I Criteria: NRC requires testing to determine whether there is any radioactive leakage from the i sources in the irradiator. Records of the test results must be maintained. Discussion: Dry-Source-Storage Sealed Sources Each dry-source-storage sealed source must be tested for leakage at 6-month intervals. 10 CFR 36.59(a) prohibits sources from being used unless the licensee tests the sources for leaks or has a certificate from a transferor that leak tests have been performed within 6 months before the transfer. The measurement of the leak test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 200 becquerels (0.005 microcurie)5 of , radioactivity and must be performed by a person approved by the NRC or an Agreement State to ) l perform the test. In general, the sensitivity required can be obtained with a thin-window G-M i probe. ; 1 l i 5 10 CFR Part 36 uses one significant figure in converting becquerels to microcurie. l 8-51 NUREG 1556. Vol. 6
CON'ENTS OF AN APPUCAT10N Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State to either perform the entire leak test sequence for other licensees or provide leak test kits to dry-source-storage licensees. In the latter case, the licensee is expected to take the leak test sample according to the irradiator manufacturer's (or distributo.r's) and the kit supplier's instructions and retum it to the kit supplier for evaluation and reporting results. Leak test i samples should be collected at the most accessible area where contamination would accumulate I if the sealed source were leaking. See Figure 8.10 below. Licensees may also be authorized to I conduct the entire leak test sequence themselves. Appendix P contains a model leak test program. l l Radiation Monitor l Testing Near Source on Water Circulation System Water Test l l l mummmanammme um y~% b R"4T"lEPRh a
"*""O Figure 8.10 Leak Testing. The panel on thefar left illustrates leak testing a dry-source-storage irradiator source, while the other two panels illustrate two way: of monitoring pool l water to determine if wet-source-storage sources are leaking. '
Pool irradiators ' For pool irradiators,10 CFR 36.59(b) prohibits sources from being put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that leak tests have been performed within 6 months before the transfer. After placing sources in the pool, the water must be checked for contamination each day the irradiator operates. For pool irradiators, leak testing sources by wipe-testing is not highly sensitive or effective. The check may be done either by using a radiation monitor on a pool water circuating system or by analyzing a sample of pool water. If analyzing a sample of pool water, the results must be available within 24 hours. l Whether the applicant desires to check for contamination by analyzing a pool water sample daily, or by continuous monitoring, the procedures and sensitivity of the equipment to be used should be detailed in the application. If collecting a pool sample, use a sensitive detector, such as a sodium iodide detector, to ve rify the absence of detectable contamination in the sample. If using the continuous monitoring method, applicants may use a less sensitive detector such as a G-M detector affixed to a filter /demineralizer where radioactive material would be concentrated. NUREG - 1556, Vol. 6 8-52
CONTENTS OF AN APPLICATION If the licensee detects a leaking source, the licensee must promptly check personnel, equipment, facilities, and irradiated products for contamination. If any personnel or product are found to be contaminated, decontamination must be performed immediately. If a source is found to be leaking, the licensee must arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. If the pool is contaminated, the licensee must arrange to clean the pool until the concentration levels do not exceed the appropriate concentration in Table 2, Column 2, Appendix B to Part 20. See 10 CFR 30.50 for reporting requirements. Upon detection of leaking sources, licenseu should consider immediately stopping irradiator operations to minimize spread of contamination. Response from Applicant: For dry-source-storage irradiators: Submit one of the following three alternatives:
- A statement that: " leak tests will be performed at intervals not to exceed 6 months. Ieak tests will be performed by an organization authorized by NRC or an Agrecmr-* ' ; 'te to provide leak testing services to other licensees or using a leak test kit supplied by a organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the irradiator manufacturer's (or distributor's) and kit supplier's instructions. Records of leak test results will be maintained."
OR
- A statement that: "We will implement the model leak test program published in Appendix P to NUREG-1556 Vol. 6, ' Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses,' dated Janur.ry 1999."
OR
- A description of alternative equipment and/or procedures for determining whether there is any radioactive leakage from sources contained in the irradiator.
For poolirradiators: Submit either of the following:
- A description of equipment, procedures, and sensitivity of method that will be used to check for contamination by analysis of a sample of pool water.
OR
- A description of equipment, prcredures, and sensitivity of method that will be used to check for contamination by condnuous monitoring.
8-53 NUREG - 1556, Vol. 6
, , m_ 4 --4-..+.--
CONTENTS OF AN APPLICATION Note: Requests for authorization to perform leak testing and sample analysis will be reviewed and,if approved, NRC staff will authorize via a license condition.
References:
See the Notice of Availability (on the inside front cover of this report) to obtain ; copies of Draft Regulatory Guide FC 412-4, " Guide for the Preparation of Applications for the l Use of Radioactive Materials in Leak-Testing Services," dated June 1985. 8.10.10 INSPECTION AND MAINTENANCE CHECKS Regulations: 10 CFR 20.1101,10 CFR 36.13(c) and (h),10 CFR 36.53(a)(6),10 CFR 36.61. Criteria: The applicant must have and follow written procedures for insp:ction and maintenance checks for items specified in 10 CFR 36.61. Discussion: Applicants must periodically make inspection and maintenance checks to ensure proper operation of the irradiator. The applicant must have and follow procedures for inspection , and maintenance checks. The frequency of checks is not stated in the regulations because it will be site-specific depending on the design of the facility. However, the frequency of checks must be specified in the application. In the applicant's description of the procedures, specify the frequency of the following items-l Operability of each aspect of the access control system required by 10 CFR 36.23 : a Functioning of the source position indicator as required by 10 CFR 36.31(b) Operability of the radiation monitor for radioactive contamination in pool water required by 10 CFR 36.59(b), using a radiation check source, if applicable j Operability of the over-pool radiation monitor at underwater irradiators as required by 10 CFR 36.29(b) Operability of the product exit monitor required by 10 CFR 36.29(a) Operability of the emergency source return control required by 10 CFR 36.31(c) l
- Leak-tightness of systems through which pool water circulates (visual inspection)
Operability of the heat and smoke detectors and extinguisher system required by 10 CFR 36.27 (but without tuming extinguishers on) j = Operability of the means of pool water replenishment required by 10 CFR 36.33(c) ! Operability of the indicators of high and low pool-water levels required by 10 CFR 36.33(d) ; = Operability of the intrusion alarm required by 10 CFR 36.23(i),if applicable a Functioning and wear of the system, mechanisms, and cables used to raise and lower sources NUREG - 1556, Vol. 6 8-54
i CONTENTS OF AN APPLICATION
- Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 10 CFR 36.35
- Amount of water added to the pool to determine whether the pool is leaking.
. Electrical wiring on required safety systems for radiation damage
. Pool water conductivity measurements as required by 10 CFR 36.63.
The applicant should keep in mind that these are the minimum items to be checked based on requirements in 10 CFR 36.61, and that the licensee should develop and implement procedures for other necessary checks as appropriate (e.g., as recommended by the manufacturer). For instance, if applicable, the applicant should have and follow written procedures for inspection and maintenance checks to ensure that all product positioning system components, product boxes, or carriers continue to meet design specification and are not likely to cause an irradiator malfunction. Response from Applicant: Describe inspection and maintenance checks, including the frequency of the che,cks listed in the " Discussion" section (10 CFR 36.61). 8.10.11 TRANSPORTATION Regulations: 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 Pan 71,49 CFR Parts 171-178,10 CFR 20.1101, 10 CFR 30.41,10 CFR 30.51. Criteria: Applicants must develop, implement, and maintain safety programs for transpon of radioactive ma*erial 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. Transporting licensed materials originating at irradiator facilities normally involves quantities of radioactive material that require a Type B package. Because of the special requirements involved in shipping Type B packages, most irradiator licensees have chosen to transfer possession of radioactive materials to an irradiator manufacturer (or service 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 (i.e., at the irradiator location) 8-55 NUREG - 1556, Vol. 6 l-
CONTENTS OF AN APPLICA' HON
-. Actually takes possession of the licensed material under its license
[
= " Uses an approved Type B package
. Is registered with NRC as a user of the Type B package
. Has 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. If a licensee plans to make shipments oflicensed materials in Type B packages en its own, the licensee must 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 of Regulatory Guide 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 rc view, contact NRC's Spent Fuel Project Office (SFPO) by calling NRC's toll-free number 800-368-5642 and asking for extension 415-8500. For information about associated fees, contact NRC's Office of the Controller by calling NRC's toll-free number 800-368-5642 and asking for extension 415-7554. 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 irradiator licensees. Appendix Q lists major DOT regulations.
Response from Applicant: No response is needed from applicants during the licensing phase. However, before making shipments of licensed materials on its own in Type B packages, a licensee reeds to have registered with NRC as a user of the package and obtained NRC's approval ofits QA program. Transportation issues will be reviewed during inspection.
References:
"A Review of Department of Wanbottation Regulations for Transportation of Radioactive Materials" can be obtained be calling DCif's Office of Hazardous Material Initiatives and Training at (202) 366-4425. See tit Notice of Availability (en the inside front cover of this report) to obtain a copy of the " Memorandum of Understanding with DOT on the Transportation of Radioactive Material" and the current version of Regula*ory Guide 7.10, "Estabhshing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material."
NUREG 1556,Vol.6 8-56
CONTENTS OF AN APPLICATION 8.10.12 MINIMlZATION OF CONTAMINATION Regulations: 10 CFR 20.1406. : Criteria: Applicants for new licenses must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. Discussion: All applicants for new licenses need to consider the importance of designing and operating their facilities so as to minimize the amount of radioactive contamination generated at , the site during its operating lifetime and to minimize the generation of radioactive waste during decontamination. Irradiator applicants usually do not need to address these issues as a separate item since they are included in responses to other items of the application. Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their respective SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in 10 CFR 36.59 should identify defective l sources. Leaking sources must be withdrawn from use and decontaminated, repaired, or disposed i of according to NRC requirements. These steps minimize the spread of contamination and l reduce radioactive waste associated with decontamination efforts. Other efforts to minimize l radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. i Response from Applicant: The applicant does not need to provide a response to this item under the following condition. NRC will consider that the above criteria have been met if the applicant's responses meet the criteria for the following sections: " Radioactive Material - Sealed Sources and Devices,"" Facilities and Equipment -Irradiator Pools"(if applicable)," Radiation Safety Program - Operating Procedures," " Radiation Safety Program - Emergency Procedures,"
" Radiation Safety Program - leak Tests," and "' Waste Management - Sealed Source Transfer and Disposal."
8.11 ITEM 11: WASTE MANAGEMENT i 8.11.1 SEALED SOURCE DISPOSAL AND TRANSFER Regulations: 10 CFR 20.2001,10 CFR 30.41,10 CFR 30.51,10 CFR 30.36,10 CFR 36.59. Criteria: Licensed materials must be disposed of scording ta NRC requirements by trt efer to , an authorized recipient. Appropriate records must be maintained. i 8-57 NUREG - 1556, Vol. 6
CONTENTS OF Ah APPLICATION Discussion: When disposing of scaled sources or contaminated items (caused by leaking sources), licensees must transfer them to an authorized recipient. Authorized recipients are the original manufacturer (or distributor) of the sources, 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., its license specifically authorizes the same radionuclide, form, and use). If a product of the irradiator that may have been inadvertently contaminated has been shipped, the licensee must arrange to locate and survey the product for contamination. If contaminated equipment, facilities, or products are found, the licensee must arrange to have them decontaminated or properly disposed of by an NRC or Agreement State licensee authorized to provide these services. If the pool is contaminated, the licensee must arrange to clean up the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Cclumn 2 Appendix B to 10 CFR Pan 20 (10 CFR 36.59(c)). Before transferring radioactive material, a licensee must verify that the recipient is properly authorized to receive it using one of the methods described in 10 CFR 30.41. In addition, all packages containing radioactive sources must be prepared and shipped according to NRC and DOT regulations. Records of the transfer must be maintained as required by 10 CFR 30.51. Response from Applicant: The applicant does not need to provide a respoase to this item during the licensing process. However, the licensee should establish and include waste disposal procedures in its radiation safety program. Because of the difficulties and costs associated with disposal of sealed sources, applicants should preplan the disposal. Applicants may want to consider contractual arrangements with ; the source supplier as pan of a purchase agreement. l l I The next two items on NRC Form 313 are to be completed on the form itself. 8.12 ITEM 12: FEES On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of , the fee enclosed with the application. l I An application and required fee must be submitted before start of construction (see 10 CFR 36.15). This will allow regulatory agencies to inspect the construction of the facihty as ! it is being built. NUREG - 1556. Vol. 6 8-58
1 i CONTENTS OF AN APPLICATION 8.13 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. Representatives signing an application must be authorized to make binding commitments and to sign officialdocuments on behalfof the applicant. As discussed previously in " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applicationsforproper signature. l Note:
- It is a criminal offense to make a willful false statement or representation on applications or correspondence (18 U.S.C.1001).
- When the application references commitments, those items become part of the licensing conditions and regulatory requirements.
I l 1 i 1 l 1 8-59 NUREG - 1556, Vol. 6
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 (except as permitted by 10 CFR 36.53(c)), 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)) i l Applications for license amendment, in addition to the following, must provide the appropriate fee. For renewal and amendment requests applicants must do the following-
. Be sure to use the most recent guidance in preparing an amendment or renee' request - Submit in duplicate, either an NRC Form 313 or a letter requesting amendment o renewal . Provide the license number . For renewals, provide a complete and up-to-date application if many outdated documents are 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. ; Using the suggested wording of responses and committing to using the model procedures in this , report will expedite NRC's review. ( I i l I 9-1 NUREG - 1556, Vol. 6 l
10 APPLICATIONS FOR EXEMPTIONS Various sections of NRC's regulations address requests for exemptions (e.g.,10 CFR 19.31, 10 CFR 20.2301,10 CFR 30.11(a),10 CFR 36.17(a)). These regulations state that NRC may grant an exemption, acting on its own initiative or on an application from an interested person. Key considerations are whether the exemption is authorized by law, will endanger life or property or the common defense and security, and is otherwise in the public interest. 't Until NRC has granted an exemption in writing, NRC expects strict compliance with all applicable regulations. Exemptions are not intended to revise regulations, are not intended for large classes of licenses, and are generally limited to unique situations. Exemption requests must be accompanied by descriptions of the following: Exemption and why it is needed Proposed compensatory safety measures inter ded to provide a level of her'th and safety equivalent to the regulation for which the exemption is being requested Altern -tive methods for complying with the regulation and why they are not feasible. When NRC codified its requirements in 10 CFR Part 36 for irradiators, NRC recognized the special case of teletherapy-type units converted from human use to use for the irradiation of materials or objects. 10 CFR 36.17(b) permits these licensees to propose alternatives to the requirements of 10 CFR Part 36 provided that there is an adequate rationale and the alternatives provide an adequate level of safety for workers and the public. For converteJ teletherapy units, Appendix R lists specific sections of the regulations, the rationale and acceptable altematives, and the wording of the license condition granting the exemption. The Regions may grant exemption requests shown in Appendix R without consulting NMSS. Exemption requests other than those described in Appendix R must be coordinated with NMSS. 10-1 NUREG - 1556, Vol. 6
11 TERMINATION OF ACTIVITIES Regulations: 10 CFR 30.34(b),10 CFR 30.35(g),10 CFR 30.36(d),10 CFR 30.36(g), 10 CFR 30.36(h),10 CFR 30.36(j),10 CFR 30.51(f). Criteria: The licensee must do the following:
. Notify NRC, in writing, within 60 days of:
- the expiration ofits license
- a decision to permanently cease licensed activities at the entire site (regardless of contamina..on levels)
- a decision 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
- no principal activities having been conducted at the entire site under the license for a period of 24 months
- no principal activities having not been conducted for a period of 24 months in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.
Submit decommissioning plan, if required by 10 CFR 30.36(g).
- Conduct decommissioning, as required by 10 CFR 30.36(h) and 10 CFR 30.36(j).
- Submit, to tne appropriate NRC regional office, completed NRC Form 314, "Cenificate of Disposition of Materials" (or equivalent information) and a demonstration that the premises are suitable for release for unrestricted use (e.g., results of final survey). . Before a license is terminated, send the records important to decommissioning to the appropriate NRC regional office. Iflicensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), transfer records important to decommissioning to the new licensee.
Discussion: As noted in several instances discussed in " Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A lic+ 2e's determination that a facility is not cor.taminated is subject to verification by NRC inspewon. For guidance on the disposition oflicensed material, see the section on " Waste Management - Scaled Source Disposal or Transfer." For guidance on decommissioning records, see the section on " Radioactive Materials - Financial Assurance and Record Keeping for Decommissioning." Il-1 NUREG - 1556. Vol. 6 l l
m . TERMINATION OF ACTIVITIES Response from Applicant: 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 any necessary decommissioning activities must be undertaken, NRC Form 314 or equivalent information must be submitted, and other actions must be taken as summarized in the Criteria.
Reference:
Copies of NRC Form 314, " Certificate of Disposition of Materials," are available upon request from NRC's Regional Offices. (See Figure 2.1 for addresses and telephone numbers). l l i I l l i 1 NUREG - 1556, Vol. 6 11 2
i i 4 i e i I 1 1 I i I il i ! j Appendix A i , 1 l 1 l l List of Documents Considered in l ! Development of this NUREG k l i i 1 1 i i I i
}
s 4 4
L j-i l APPENDIX A J [ 4 List of Documents Considered in Development of this NUREG This report incorporates and updates the guidance previously found in the NUREG reports, j_ Regulatory Guides (RGs), Policy and Guidance Directives (P& gds), and Information Notices
; (ins) listed below. Other NRC documents such as Manual Chapters (MCs), Inspection
! Procedures (IPs), and Memoranda of Understanding (MOU) were also consulted during the j- preparation of this report. The documents marked with an asterisk (*) will be considered { superseded and shouldnot be used.
! Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance l l Directives l l
i Documnemt Tide Date 3 I umman mma l j NUREG-1345 Review of Events at Large Pool-Type Irradiators 3/89 i :RG 3.66 L Standard Format and Content of Financial Assurance Mechanisms 0690 l > Required for Decommissioning Under 10 CFR Parts 30,40,70, - j- and 72 - " I I l RG 7.10 Establishing Quality Assurance Programs for Packaging Used in 6/86 i (Rev.1) the Transport of Radioactive Material i !*P&GD Standard Review Plan for Licenses for the Use of Panoramic Dry . 12/84, l i PC 84-23 Source-Storage Irradiators, Self r's.w Wet Source-Storage
- l. Irradiators, and Panoramic Wet Source-Storage Irradiators '
j *P&GD Licensing of Large Irradiators 11/84 i FC 84-25
! P&OD Standard Review Plan for Evaluating CW- with 04/3091-
} FC 90 02 Decommissioning RequimmentsE . I Rev.1: ' P&GD Processing of Exemptions for Material Licensees 07/25/97 PG 1-26 P&OD . NMSS Procedures for Reviewing Declarations'of Bankmptcy , OlW0lW96 PO 8-11" i
- Table A.2 - List of information Notices Documeest -
Title , - Date l IN 83-09 Safety and Security ofIrradiators 03/09/83 A-1 NUREG - 1556, Vol. 6 j 1 l
APPENDIX A Doc ===nt Title Date Idenamentina l *IN 85-01 Continuous Supervision ofInadiators 01/10/85 IN 85 Malfunction of a Dry-Storage, Panoramic, Gamma Exposure 05/09/85 Irradiator l IN 89-25 Unauthorized Transfer of Ownership or Control of Licensed, 12/07/97 l Rev.1 Activities ; i l IN 89-82 Recent Safety-Related Incidents at Large Inadiators 12/07/89 l l IN 91-14 Recent Safety-Related Incidents at Large Irradiators 03/05/91 IN 94-89 Equipment Failures at Irradiator Facilities 12/28/94 i IN 96-28 Suggested Guidance Relating to Development and 05/01/96 Implementation of Corrective Action IN 96-54 Vulnerability of Stainless Steel to Corrosion When 10/17/96-Sensitized IN 97-30 Control of Licensed Material during Reorganizations, 06/03/97 Employee-Management Disagreements, and Financial Crises i i i i 1 l i l l l NUREG - 1556, Vol. 6 A-2
4 i ) i ) l 4 2 Appendix B NRC Form 313
_ _ __ _ _ .__ -_ _ _ _ __ _ - _ _ > , .__ __ __ m- _ NRC FORM 313 U,8, NUCLEAR REGULATORY CORAIAISSION APPROvue eYOue: NO. 31eo41ae ExPutES: Tr3visse (6-1SDD Estuvisted bunten per response to comply we fue pdwmaken CcGechen ' 10 CF2 30,32,33 row T hows. Submatal of tie e a necesesry to desarmes pist 34,36,38,30 and 40 Die appicare is omieled and eint sess>me procoeses einst to preemd pio
- pelt heem and safety Forward commente regandrig tween estmens to wie 4
benrmahon and Records Management Brwich (T4 F33), U S. Nudeur APPLICATION FOR MATERIAL LICENSE a**-v ca="a== === " 2aa=". =aa a '= *==='a Reduchon Proped (3156.0120). Omco of Management and SudgmL l Washeigiort DC 20003. NRC may riot contact er aponsor, and a parten is t not tweed to respond io, en odormanun **m unises a es,emye e curarey vand OMO carew nummer. i
; INSTRUCTIONS; SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING
- APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.
APPUCAftON POR DISTfuBUTIOef OP ExeasPT PRODUCTS PILE APPU.,AftONS WFTH: IF YOU ARE IJDCATec m: , 4 DMSION OF INDUSTRIAL AND MEDICAL NUCLEAR SAFETY m i mansa IIIDIA80A,IOusA MICleGAN, tatspIESOTA,IIIS00UIW, ONIO, OR 44 Para' anna OFFCE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS SEBfD APPUCATIOpes 70-I 4 U S. NUCLEAR REOULATORY COMMISSION l I WASHMGTON, DC 20666 4001 MATERIALS UCENSING SECTION 1 g, U S NUCLEAN REGULATORY COMMIS$10N. REGION lil 801 WARftENVILLE RD. i ! IF YOU ARE LOCATED W: USLE. IL 00632 4 361 CONNECTICUT, DELAWARE, DISTfuCT OF COLUIBOLA, GRAINE MARYLAND. ALA08% AfWZONA ARMA88 RAS, CAUFOftMA, COLOflADO, HAWAll, IDAHO, KANSAS, 4 IAAGSACHUGETTS, NEW MAtePSeeRE, NEW JERGEY, NEW YORM, PSHNSYLVANIA, LOUIglANA, MOtffANA, namenamara isEVADA,IdEW 10ENCO,leOftTM DAKOTA, NH00E BOLAND, Oft VEflAIONT, SEND APPUCATIOess TO: OKLANOttA, OREGON, PACIPIC TftUST TEstfuTOINES, SOUTH DAMOTA, TEXAS, UTAH, WASM180CTON, OR WYOlslesG, SENO APPUCATIOtet TO: 4 LICENSING ASSISTMdT SEi, TION NUCLEAR MATERIALS SAFETY SRANCH NUCLEAR MATERIALS LCENSING SECTION l U S NUCLEAR REGULATORY COMtmS$10N. REGION 1 U S. NUCLEAR REGULATORY ColmWS$10N. REGION N 476 ALLENDALE ROAD S11 RYAN PLAZA DRfVE, SUITE 400 , 10NG OF PRUSSIA, PA 19400 1415 ARUNGTON, TX 70011 4064 ALAaAanA, PLOslIDA, OROmesA, KENTUCKY, RN00s000PPI, NORTM CAROUNA PUEATO RCO. SOUTH raand una Tmansseems VIRGINIA, VIRO 0N ama anana Oft WESTVIR0lNLA, SEND APPUCAMOest TO: ATLANTA FEDERAL CENTER , a U. 8 NUCLEAR REGULATORY COMMISSION, REG 80N N !
$1 FOR$YTH STitEET, S W., SUITE 23T86 !
ATLANTA GEORGIA 30303 3415 PEft00est LOCATED W AGREEIBENT STATES SEND APPUCADONS TO THE U.S.18UCLEAR fifGULATOftY COGNesSteON ONLY !F THEY WISH TO Pf'ISSESS AND USE LICENSED IRATERIAL M STATES SUBJECT TO U.S. NUCLEAR NEGULATOftY COtBIIISSION JulWSDICTIONS. l
- 1. _THIS IB AN APPUCATION FOR (Chace appropnado aern) 2. NAME AND MAILNG ADDRESS OF APPLICANT (Jaciuse & codef A NEWLCENSE I l
S AMFNDMENT TO LEENSE NUMBER C. RENEWAL OF LCENSE NUMBER
- 3. ADORESS(ES)MHERE LCENSED MATERIAL WILL SE USED OR POSSESSED 4 NAME OF PER*Cae 10 i2 CONTACTED ABOUT THIS APPUCATION Tf'LEPHONE NUMBER SUOMIT ITEMS 5 THROUGH 11 ON 0112 X 11' PAPER THE TfPE AND SCOPE OF INFORMATION TO SE PROVIDEO IS DESCRSEQ IN THE UCENSE APPLsCATION OU4DE.
8, RADIOACTIVE MATERIAL. e Element and mass viumber; b chemcel ensor physcal form; and c. man:enum amount 8 PURPOSE (S) FOR WHCH UCENSED MATERIAL WILL SE USED.
.hei .e ne e a any one ime.
T. INDMOUAMS) RESPONSOLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDMDUALS WORKING N OR FREOUENTNG RESTRCTED AREAS TRAIDeHQ EXPERENCE. l
- 9. FACUTES AND EQUIPMENT. 10 RADLATION SAFETY PROGRAM.
12 LCENSEE FEES (See to CFR f 70 amf Secean f 70.3f)
- 11. WASTE MANAGEMENT. IAMOUNT FEE CATEGORY l ENCLOSED S
- 13. CERTIFCATION (Must be conipNeedbyappkann THE APPUCANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE M THIS APPUCATION ARE SINDING UPON THE APPUCANT.
THE APPUCANT AND ANY OFFCIAL EXECUTING THIS CERTFICATION ON DEHALF OF THE APPUCANT, NAMED M ITEM 2. CERTFY THAT THIS APPUCATIOel18 PREPARED IN CONFORhWTY wtTH TTTLE 10. CODE OF FEDERAL PtEGULATIONS, PARTS 30,32,33,34,35,38,30 AND 40. AND THAT ALL INFORMATION CONTAINED HEREN IS TRUE AND CORRECT TO THE SEST OF THEWt KNOWLEDGE AND BELEF. WARNING: 18 U $ C SECTION 1001 ACT OFJUNE 25.1940 82 STAT. T49 MAKES IT A CRihMNAL OFFENSE TO MAKE A WILLFULtY FALEE STr.TEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHW ITS JURISDICTION f ERTFYMG OFFICER - TYPEO9'RINTED NAME AND TITLE SIGNATURE DATE FOR NRC USE ONLY Tyre Or rEE rEE LOG rEE CATEGORY AMOUNT RitCtivED CHECx HuueER COuMENTS APPftOVED SY OATE NRC FORed 313 (5-1957) PRefTED ON RECYCLED PAPER B-1 NUREG - 1556, Vol. 6
i i i i j l Appendix C i l Suggested Format for Providing information Requested in i Items 5 through 11 of NRC Form 313
APPENDIX C Suggested Format for Providing Information Requested in items 5 l through 11 of NRC Form 313 l
~
Item , Title and Criteria Yes Description , No. Attached ) 5 RADIOACTIVE MATERIAL ! Sealed Sources And Devices
. Identify each radionuclide that will be used in each irradiator. []
. Identify the manufacturer (or distributor) and model number of []
each sealed source.
. Identify the manufacturer (or distributor) and model number of []
each irndiator,if applicable.
. For dry-source-storage irradiators, specify the maximum activity []
per source. []
. Specify the maximum activity per irradiator.
. If depleted uranium is used as shielding material, specify the total []
amount (in kilograms). Financial Assurance and Record Keeping for Deconunissioning
. If financial assurance is required [ possession greater than []
10,000 curies Co-60 or 100,000 curies Cs-137], submit documentation required by 10 CFR 30.35. i i l l l C-1 NUREG - 1556, Vol. 6 w
l l APPENDIX C hems lille and Cdteda Yes Desedytion
' No, #
- Asanchad 6 PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED
- Provide either of the following
) ! . A specific description of use for each type ofirradiator requested, [] e.g.,"For use in irradiation of products or food. There will be no irradiation of explosives and no irradiation of more than small quantities of flammable materials with a flash point below 60 degrees C (140 degrees F) without specific written authorization 1 from NRC." t l OR If the irradiator will be used for purposes other than irradiation of [] food or products for human or research purposes, description of these purposes and safety analyses (and procedures, if needed) to l support safe use. t f l J INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM Radia*Ia= Safety Offleer (RSO) l Tralains and Expedence , l
.n State the name of the proposed RSO _
[]L
- i Describe the proposed RSO's training and experience specific to
[). the irradimar that the applicant intends to use ' nW and Autbodiles
.c Describe the organizational structure for managing the irradiatar. [). ;
.! Specify the radiation safety responsibilities and authonties of the - '[] i RSO. '
. : My other management personnel who have impostant , []
rachation safety moponsibilities and authorities.'
~
.: Describe who has the authonty to stop unsafe operations! []
i i NUREG - 1556, Vol. 6 C-2
l l APPENDIX C ! Itens Title and Criteria Yes Description No. Attached 8 INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS l Initial Training for Irradiator Operators l
= Before using licensed materials irradiator operators will have []
successfully completed one of the training courses described in Criteria in the section entitled " Initial Training for Irradiator Operators," in NUREG-1556, Vol. 6, dated January 1999. OR
= Provide a description of the initial training program for irradiator []
operators that demonstrates compliance with the requirements of 10 CFR 36.51(a),(b), and (c). Annual Training Regarding Safety Reviews for Irradiator l Operators
- Describe program for annual safety reviews and performance []
evaluations of irradiator operators that demonstrates compliance with 10 CFR 36.51(d) and (e). Training for Individuals Who Require Unescorted Access
. The applicant's program for instnicting and testing unescorted N/A N/A I
individuals (other than irradiator operators) will be examined during inspections, but should not be submitted in the license application. Training for Individuals Who Must Be Prepared to Respond to Alarms The applicant's program for instructing and testing, as applicable, N/A N/A individuals designated to respond to alarms will be examined during inspections, but should not be submitted in the license application. l l C-3 NUREG - 1556, Vol. 6
em APPENDIX C Item Title and Criteria Yes Description Ns. Attached 9 FACILITIES AND EQUIPMENT General Description Describe the irradiator including diagrams, sketches, and [] photographs, as appropriate. Show locations of safety-related equipment and features as [] : required in 10 CFR Part 36. Provide a construction schedule for the irradiator. [] Access Control
. Submit specific information describing the access control system ()
and how it works that demonstrates compliance with the requirements of 10 CFR 36.23. Specific drawings or sketches should be submitted, as appropriate.
=
For panoramic irradiators, describe the facility alarm systems. [] For panoramic irradiators, describe the lock and key system for [] controlling source movement and discuss how it meets the requirements of 10 CFR 36.31(a). Shielding for Panoramic Irradiators Describe the shielding to be used and its composition. [] Submit a diagram showing the configuration of shielding [] including walls and the ceiling and indicate the thickness of each I and penetrations in the shielding
. If any accessible areas outside the shield are expected to have a []
dose rate exceeding 0.02 mSv (2 mrem) per hour, identify the 1 areas and tell how access to those areas will be controlled. ! []
. For requests to possess more than 2 x 10ri becquerels.
(5,000,000 curies), submit an evaluation of the effects of heating of the shield walls by the irradiator sources [see 10 CFR 36.39(a)]. i Note: For underwater irradiators, no response is required from the N/A N/A applicant in a license application. NUREG - 1556, Vol. 6 C-4
i i APPENDIX C l i' , IIteini - 11dle and Criteria ' Yes Descripeten i No. '
- - Attached 9- FACILITIES AND EQUIPMENT (Cont'd)
Fire Protection for Panoramic Irradiators i Describe:' ; i
. Type and location of the heat and smoke detectors to be used to [] '
detect a fire in the radiation room'
. Alarms to alert personnel who will be trained to summon []
assistance
. How the sources will automatically became fully shielded if a []
- fire is detected
- How the heat and smoke detectors will be tested. []
Note: For an underwater irradiator, no response is required, since N/A N/A the sources are always underwater and not subject to damage by fire. j Radiation Monitors !
. Describe the location and type of radiation monitors that will be [] I used to meet the requirements of 10 CFR 36.23(c),36.29, and 36.59(b).
. Describe the location and types of alarms and those individuals []
who are trained to respond to those alarms. Diagrams and sketches should be used, as appivyriate.
. Discuss the alarm set-points or the methods for establishing the []
alarm set-points.
. For irradiators whose construction begins after July 1,1993, []
describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and sensitivity and the acceptance testing that will be performed to meet 10 CFR 36.41(c). t Note: Underwater irradiators in which the product moves within an N/A N/A enclosed stationary tube are exempt from the requirements of 10 CFR 36.29. C-5 NUREG - 1556, Vol. 6
A.TENDIX C
~
Itsen ey <g Tide and Cdearia v . Yes Desedpelen d No;. Attached 9 FACILITIES AND EQUIPMENT (Cont'd) Irradiator Pools For irradiators licensed before July 1,1993, write "Not applicable." [] j I For irradiators licensed after July 1,1993, describe:
. The pool liner [If no water-tight stainless steel liner or a liner . [] l metallurgically compatible with other components in the pool is used, explain why the pool has a low likelihood of substantial leakage and how decontamination could be accomplished if necessary]
. The high and low water-level indicators and their locations []
The purification system for the pool and explain why the [] purification system is considered capable of maintaining pool , water conductivity less than 20 microsiemens per centimeter The means to replenish pool water [] The barrier used during normal operation to prevent personnel [] from fallinginto the pool , How high radiation doses from radiation streaming will be [] avoided when using long-handled tools or poles (use sketches if appropriate) .
. If the pool has outlets more than 0.5 meter below the surface that []
could allow water to drain out of the pool, the means of preventing inadvertent excessive loss of pool water (in this context outlets do not include transfer tubes between adjacent pools Waim the transfer tubes do not provide a means to allow water to $ rain out of the pools). NURBO - 1556, Vol. 6 C-6
1 APPENDIX C Itsen , Title and Criteria Yes Description l No. Attached 9 FACILITIES AND EQUIPMENT (Cont'd) i Source Rack
. Submit procedures for ensuring source rack protection. If the [] l product moves on a product conveyer system, describe the source rack protection to be provided to prevent products and product carriers from touching the source rack or mechanism that moves the rack. Provide diagrams or sketches of those systems,if '
appropriate. Power Failures for Panoramic Irradiators
. Describe how the sources are automatically returned to the []
shielded position if offsite power is lost for longer than 10 seconds.
- Describe how loss of power will affect the lock on the doors in []
the radiation room for a panoramic irradiator. Note: For underwater irradiators, no response is required from the N/A N/A applicant in a license application. 10 RADIATION SAFETY PROGRAM - Audit Program Need Not be Sub'mitted'with The applicant's program for reviewing the content and: Application implementation of its radiation protection program will be examined during inspections, but should not be submitted in the license - application. - 1 C-7 NUREG - 1556. Vol. 6
APPENDIX C Itesa Title and Criteria Yes Deecription No.~ Attached 10 RADIATION SAFETY PROGRAM Instruments ' Survey Instruments *
. We will use survey instmments that meet the Criteria in the []
section entitled " Radiation Safety Program - Instruments" in l NUREG-1556, Vol. 6, dated January 1999. AND ONE OF THE FOLLOWING ,
- Each survey meter will be calibrated by the manufacturer or other [] l person authorized by the NRC or an Agreement State to perform I survey meter calibrations.
i OR r
- We will implement the model survey meter calibration program [] l published in Appendix L entitled " Survey Instrument Calibration" in NUREG-1556, Vol. 6, dated January 1999. l OR I i
. Submit alternative calibration procedures for NRC review. []
OR,IN LIEU OF ALL OF THE ABOVE, SUBMIT.
. A description of an alternative method to perform surveys []
pursuant to 10 CFR 20.1501. Radiation Monitors
. - Describe the type of monitors used to meet the requirements of []
10 CFR 36.23(c),36.29, and 36.59(b). Material Accountability
. Submit a description of procedure (s) for ensuring material [] ;
accountability. NUREO - 1556, Vol. 6 - C-8
, i i ! ! APPENDIX C l !- i Bass ,
- s. . . lids and CWends 1. c v- Yes Basedynom -
y '% - m l l
~ 10 ' RADIATION SAFETY PROGRAM (Cont'd) !
! Occupational Doshnetry Need Not be . l Submitted with i 4 The applicant's occupational dosimetry program required by . Application 10 CFR Parts 20 and 36 will be examined during inspection, but should not be submitted in a license application. j Public Dose Need Not be ' The applicant's program to control doses received by individual Submitted with ; members of the public will be examined during inspection, but Application ; should not be submitted in a license applica' tion. ! Operating Procedures l Routine Operations
- Provide an outline that specifically states the radiation safety []
aspects of the written operating procedures listed in 10 CFR 36.53(a)). Non-Routine Operations Submit either of the following:
- The irradiator manufacturer or other person authorized by NRC. []
or an Agreement State will perform non-routine operations such as source loading, unloading and repositioning, electrical troubleshooting of the control console, clearing stuck source racks, investigatinghemediating removable contamination / leaking sources, (re) installing source cables, and :
- other critical operations requiring special skills or having the i potential for radiation overexposures. I i
OR
- The information listed in Appendix Iin NUREG-1556, Vol. 6, [] 4 dated January 1999.
C-9 NUREG - 1556. Vol. 6
APPENDIX C
; Item Title and Criteda Yes Desedption No. At*N 10 RADIATION SAFETY PROGRAM (Cont'd)
Emergency Procedures
=
Provide an outline that specifically states the radiation safety [] aspects of the written emergency procedures listed in the
" Discussion" section (i.e., those procedures listed in 10 CFR 36.53(b)). >
Leak Tests For Dry-Source-Storage Irradiators Provide one of the following three altematives: I.zak tests will be performed at intervals not to exceed 6 months. [] Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization 3 authorized by NRC or an Agreement State to provide leak test l kits to other licensees and according to the irradiator l manufacturer's (or distributor's) and the kit supplier's i instructions. Records ofleak test results will be maintained. l OR 1
- We will implement the model leak test program published in [] l Appendix P in NUREG-1556, Vol. 6, dated January 1999.
OR
. A description of alternative equipment and/or procedures for []
determining whether there is any radioactive leakage from sources contained in the irradiator. NUREG - 1556, Vol. 6 - C-10
APPENDIX C Iten Title and Criteria Yes Description No. Attached i 10 RADIATION SAFETY PROGRAM (Cont'd) i Leak Tests For PoolIrradiators Submit either of the following: I A description of equipment, procedures, and sensitivity of [] ! method that will be used to check for contamination by analysis ofa sample ofpool water. ; OR !
. A description of equipment, procedures, and sensitivity of []
method that will be used to check for contamination by continuous monitoring. Inspection and Maintenance Describe inspection and maintenance checks, including the [] frequency of the checks listed in 10 CFR 36.61. Transportation No response is needed from applicants during the licensing phase. Need Not be However, before making shipments oflicensed materials on its own Submitted with in Type B packages, a licensee needs to have registered with NRC as Application a user of the package and obtained NRC's approval of its QA program. Transportation issues will be reviewed during inspection. Minimization of Contamination The applicant does not need to provide a response to this item under the following condition. NRC will consider that the criteria have been met if the applicant's responses meet the criteria for the Need Not be following sections: " Radioactive Material - Sealed Sources and Submitted with Devices," " Facilities and Equipment - Irradiator Pools" (if Application applicable), " Radiation Safety Program - Operating Procedures,"
" Radiation Safety Program - Emergency Procedures," " Radiation Safety Program - Leak Tests," and " Waste Management - Sealed Source Transfer and Disposal."
C-11 NUREG - 1556, Vol. 6
_ . _ _ _ _ _ - _ _ _ _ _ _ _ _ .. _ _-.___ ...___ .-.~._ __ __ _ _ _ ..._.-_ _ .._._-.. _ _ d d J APPENDIX C A i Itsen Title and Criteria , Yes Description No. Attached 11 WASTE MANAGEMENT Sealed Source Disposal and Transfer . Need Not be l Submitted with - The applicant does not need to provide a response to this item A PPlication during the licensing process. However, the licensee should establish and include waste disposal procedures in its radiation safety program. l l l l l l l I l i l NUREG - 1556, Vol. 6 C-12
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i t i i i Appendix D 4
- Information Needed for Transfer of Control Application
APPENDIX D Information Needed for (ansfer of Control Application NRC has just published Draft Guidance on Bankruptcy and Transfer of Control (January 1999) in NUREG 1556, Vol.15. NRC will inform licensees of the availability of the Final Guidance via generic communication. Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as " transferring the license." Provide the following information concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state.
- 1. The new name of the licensed organization. If there is no change, the licensee should so 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 radiation safety officer, authorized users, or any other persons identified in previous license applications as responsible for radiation safety or use oflicensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals.
- 4. An indication of whether the transferor will remain in non-licensed business without the 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.
- 6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or eme ';;ency procedures).
- 7. A detailed description of any changes in the use, possetsion, location, or storage of the licensed materials.
- 8. Any changes in organization, location, facilities, equipment, procedures, or personnel that would require a license amendment even without transferring control.
- 9. Ar. indication of whether all surveillance items anJ records (e.g., calibrations, leak tests, surveys, inventories, and accountability requireme.its) will be current at the time of transfer.
l Provide a descripilon of the status of all surveillance requirements and records. D-1 NUREG - 1556. Vol. 6
APPENDIX D
- 10. Confirmation that all records conceming the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g),40.36(f),70.25(g), and 72.30(d); 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.
I 1. 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?
- 12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35,40.36, and 70.25. Include 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.
- 13. 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, that it accepts full responsibility for open inspection items and/or any resulting enforcement actic,ns; or the transferec proposes attemative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer.
- 14. Documentation that the transferor and transferee agree to wansfer control of the licensed material and activity, and the conditions of transier; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions.
- 15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description ofits program, to ensure compliance with the license and regulations.
NUREG - 1556. Vol. 6 D-2
i APPENDIX D !
Reference:
The information above is contained in IN 89-25, Revision 1, " Unauthorized Transfer j of Ownership or Control of Licensed Activities." See the Notice of Availability (on the inside < front cover of this report) to obtain copies. ; i i r b l r h 1 I D-3 NUREG - 1556, Vol. 6
9 i i I b 3 Appendix E Suggested Wording for a Statement of intent for a Government Licensee i 4 4 e d n
l 1 l APPENDIX E l 1 Suggested Wording for a Statement of Intent for a Government Licensee i l J [DATE] TO: U.S. NUCLEAR REGULATORY COMMISSION i 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. [ 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. l [ SIGNATURE] [NAME) [ TITLE] l l l E-1 NUREG - 1556, Vol. 6
l ! l
)
l i i Appendix F Irradiation of Explosive Materials or Greater Than Small Quantities of Flammable Materials b
APPENDIX F Irradiation of Explosive Materials or Greater Than Small Quantities of Flammable Materials Explosive Materials Irradiation of explosive materials is prohibited under 10 CFR Part 36 unless the applicant has received prior written authorization from the NRC. If an applicant requests authorization to irradiate explosive materials, he or she must be able to demonstrate that detonation of the explosive would not rupture the irradiator sealed sources, injure personnel, damage safety systems, or cause radiation overexposure of personnel. Greater Than Small Quentities of Flammable Materials Prior written authorization from NRC is required by 10 CFR 36.69(b) before irradiat'on of more than small quantities of flammable materials with a flash point below 60"C (140 F)in a panoramic irradiator. As defined in the National Fire Code NFPA 30," Flammable and 6 Combustible Liquids Code," published by the National Fire Protection Association the flash point is "the minimum temperature at which a liquid gives off vapor in sufficient concentration to form an ignitable mixture with air near the surface of the liquid..." According to the NFPA 30 classification system, Class I and Class II liquids have flash points below 60' C (140"F). The flash points of many substances are tabulated in National Fire Code NFPA 325M," Fire Hazard Properties of Flammable Liquids, Gases, and Volatile Solids."' Flash points are also specified on the Material Safety Data Sheets for industrial chemicals, when applicable. Examples of common flammable liquids with a flash point below 60 C (140"F) are acetone, benzene, most alcohols, number two fuel oil, gasoline, kerosene, toluene, turpentine, and any flammable gas. j NRC is concemed about irradiating flammable materials which may cause an explosion. If the flash point of a flammable liquid is exceeded, the concentration of the vapor in air could exceed , the flammable limit and the potential for an explosion could exist. The NRC considers that compliance with the requirements in 10 CFR 36.21,36.27,36.35, 36.39(h),36.41(h), and 36.53(b)(7) will provide adequate protection against radiological impacts arising from a fire. With an energetic explosion, however, applicants should consider the possibility of direct damage to the source encapsulation or to the source rack preventing it from i being lowered to the shielded position. A "small quantity" of flammable material can be defined as a quantity of flammable material that, when dispersed evenly throughout the radiation room with no loss to ventilation, would have a concentration below the lower flammable limit concentration. Although local
- Copies may be obtained from the National Fire Protection Association,1 Batterymarch Park, P. O. Box 9146, Quincy, MA 02269-9959 (Telephone No. 1-800-344-3555).
F-1 NUREG - 1556, Vol. 6 :
APPENDIX F concentrations could exceed the average room concentration, the movement of air into and out of the radiation room provides a margin of safety. In addition, the time required to vaporize all the material also adds to the margin of safety. Funher, small pockets of flammable vapor will contain quantities of energy too small to provide a force strong enough to significantly damage the irradiator. Given these factors, the definition of small quantity is considered to be conservative enough to ensure safe operation of an irradiator. Special precautions must be taken when irradiating cryogenic material. The hazard from cryogenic irradiation occurs when air condenses or freezes (possibly insidiously without detection) on cold surfaces during irradiation. While the exact details are uncertain, oxygen in the air is convened by the radiation to ozone. Under certain circumstances (often during a subsequent warm-up), the ozone decomposes or reacts with other agents explosively. If cryogen; material is to be irradiated the applicant must submit procedures for ensuring the safe handling of such material.7 Example of determining a small quantity of flammable material: This example considers the irradiation of isopropyl alcohol in a radiation room whose tal volume is 100 m'. NFPA 325M states that the lower flammable limit for isopropyl alcohol is 2% by volume, the specific gravity of the liquid is 0.8, and the vapor density relative to that of air is 3 2.1. The density of air is 1.293 kg/m . The volume ofisopropyl alcohol in the room at the lower flammable limit will be 2% of 100 m', which is equal to 2 m'. The weight will be 2 m3 x 1.293 kg/m' x 2.1 (density relative to air) = 5.43 kg. With a specific gravity of 0.8, the volume of the liquid isopropyl alcohol would be 6.79 liters. If the liquid mixture were 70% isopropyl alcohol and 30% water, the volume of a small quantity would be 6.79/0.7 = 9.7 liters. Thus,in a radiation room with a volume of 100 m', a volume less than 9.7 liters of 70% pure isopropyl alcohol (exposed to the direct radiation beam) can be considered a small quantity because the flammable limit could not be reached in any significant volume even if there were no ventilation. If the applicant irradiates small quantities of flammable material, the licensee's records should demonstrate that the above criterion for small quantities has been met, including how the licensee limited the quantity of flammable material in the radiation room at one time. 1 If the quantity to be exposed to the direct beam at any one time would exceed a small quantity, it is necessary to consider whether the concentration of flammable vapor in the room air could exceed the lower flammable limit. If product movement through the irradiator stopped and the radiation sources could not be returned to the shielded posidon, the temperature of the irradiated product would rise, the vapor pressure of the flammable material would increase, and that pressure might cause the containers to leak and release flammable vapor into the room air. If
'Ihis inforrnation was taken from Oak Ridge National laboratory Report ORN11M-260, DE87 002877, " Safety Analysis Report for the National Low-Temperature Neutron Irradiation Facility (NLTNIF) at the ORNL Bulk Shielding Reactor (BSR)," June 1986.
NUREG - 1556, Vol. 6 F-2
APPENDIX F i I ventilation were insufficient, the flammable vapor concentration might exceed the lower : flammable limit and a spark could cause the mixture to explode, i Requests for approval to irradiate more than small quantitles of Hammable material: The applicant must demonstrate that it is unlikely that the concentration of flammable vapor in air in a significant volume of the room would exceed the lower flammable limit. There are two methods to do this. The first method is to demonstrate that no single failure would be likely to cause the product to become immobilized in the radiation room and prevent the sources from l being returned to the shielded position. Such a situation theoretically might arise if the product carriers became jammed and pushed into the source rack preventing its retum to the shielded ! position. The second method is to demonstrate that even if the product became immobilized and j the source rack could not be retumed to the shielded position, the ventilation system would ; prevent the concentration of flammable vapor in a significant volume of the room air from j reaching the lower flammable limit. j If an applicant is applying for authorization to irradiate more than a small quantity of flammable material, the application should include all of the following infom1ation: ; . Name of the flammable material that has a flash point below 60C (140*F) and its flash point } = Its flammable limit as percent by volume in air i . Its specific gravity as a liquid . Its vapor density relative to that of air ! . Maximum quantity to be in the direct radiation beam in the radiation room at any one time I . Description of the packaging for the product. . t In addition, the application should: EITHER Describe why a single failure is unlikely to cause immobilization of the product being irradiated ; with the simultaneous inability to return the sources to the shielded position. j OR Describe why the ventilation system will prevent the concentration of vapor in air from ; exceeding the lower flammable limit in a significant volume of the room if the product is immobilized and the sources cannot be returned to the shielded position. If this second approach is taken, the applicant should also provide a procedure to return the source to the shielded position and remove the product from the radiation room if the ventilation system fails. The procedure should also identify the means to detect ventilation system failure. F-3 NUREG - 1556, Vol. 6
8 i 1 i i I i 4 4 i
- Appendix G Training for Radiation Safety Officers and Irradiator Operators 4
i
APPENDIX G Training for Radiation Safety Officers cad irradiator Operators Course Content Instmction may be in the form of lecture, videotape, or self-study emphasizing practical subjects important to safe use of irradiators:
- Radiation Safety:
- Extemal radiation vs. radioactive contamination
- Internal vs. external exposure ,
- Biological effects of radiation (e.g., why large radiation doses must be avoided)
- Units of radiation dose
- Types and relative hazards of radioactive material possessed
- ALARA concept
- Use of time, distance, and shielding to minimize exposure (e.g., how shielding and access controls prevent large doses)
- Proper use of survey meters and personnel dosimeters.
Regulatory Requirements:
- Applicable regulations
- NRC dose limits
- License conditions, amendments, renewals
- Locations of use and storage of radioactive materials
- Material control and accountability
- Annual audit of radiation safety program
- Transfer and disposal
- Record keeping
- Case histories of accidents or problems involving irradiators
- Handlingincidents I - Recognizing and ensuring that radiation warning signs are visible and legible
- Licensing and inspection by regulatory agency
- Need for complete and accurate information (10 CFR 30.9)
G-1 NUREG - 1556, Vol. 6
_ ._. _ . _ . . . . . _ . _ __ _ _.._. _ ._ _ _ _ ._ . _ _ _ _.-_ ~ _ _ _ _ _ 'l APPENDIX G
- Employee protection (10 CFR 30.7)'
- Deliberate misconduct (10 CFR 30.10).
. Practical Explanation of the Theory and Operation for Irradiators:
- Basic function of the irradiator
- Radiation safety features of an irradiator
- Operating and emergency procedures which the individual is responsible for performing
. Routine vs. non-routine maintenance
- Lock-out procedures
- How an irradiator is designed to prevent contamination.
1 l On-the-job or simulator training must be d'one under the supervision of a qualified irradiator - operator:- i t Supervised Hands-on Experience Performing: l
- Operating procedures which the individual is responsible for performing
- Test runs of emergency procedures which the individual is responsible for performing j
- Routine maintenance l l
- Lock-out procedures. !
i Training for an RSO should include at least 3 months (full-time equivalent) of experience at the applicant's irradiator or at another irradiator of a similar type. The 3 months of experience may include preoperational involvement, such as acceptance testing, while the irradiator is r being constructed.
. Course Examination
= Written examin ion designed to verify an individual's competency and understanding of the subject matte ~ ,.g.,25 to 50 question, closed-book written test with 70% as passing grade
- Emphasis on radiation safety of irradiator operations and maintenance, licensee operating and emergency procedures that the individual will be responsible for performing, and other .
Operations necessary to safely operate the irradiator without supervision 1
. NUREG - 15M, Vol. 6 G-2 i , - - , , ~ _ - - -- . . _ _ _ _ _ _ . __ -
l 4 APPENDIX G Review of correct answers to missed questions with prospective irradiator operators immediately following the scoring of the test. i Training Assessment I i Management will ensure that potential RSOs and authorized operators are qualified to work j independently with irradiators. This must be demonstrated by written ernmination and by direct observations. j Course Instructor Qualifications Instructor should have either: 1
- Bachelor's degree in a physical or life science or engmeenng
- Successful completion of an irradiator manufacturer's course for users (or equivalent)
- Successful completion of an 8 hour radiation safety course AND i l
- 8 hours hands-on experience with irradiators '
1 OR
+ Successful completion of an irradiator manufacturer's course for users (or equivalent)
- Successful completion of 40 hour radiation safety course; and e 30 hours of hands-on experience with irradiators.
Note: ,
- Licensees must maintain records of training (10 CFR 36.81(b)). !
- Additional training is required for those applicants intending to perform non-routine operations such as source loading and unloading. See Appendix I, "Non-Routine Operations."
l G-3 FUREG - 1556, Vol. 6
I l i i i J i 4 , l !. l 3 i 4 e } l App,endix H l Typical Duties and Responsibilities i of the . l l Radiation Safety Officer ! l i i ! I i
APPENDIX H Typical Duties and Responsibilities of the Radiation Safety Officer The RSO's duties and responsibilities include ensuring radiological safety and compliance with both NRC regulations and the conditions of the license. Typically, the RSO's duties and responsibilities include:
- Stopping activities that the RSO considers unsafe e Keeping exposures ALARA e Developing, maintaining, distributing, and implementing up-to-date operating and emergency procedures J
. Ensuring that individuals associated with irradiator operations are properly trained and evaluated
- Ensuring that non-routine operations (See Appendix I) for irradiators are consistent with the ,
limitations in the iicense, the Sealed Source and Device Registration Certificate (s), and the l manufacturer's written recommendations and instructions
- Analyzing potential safety consequences of non-routine operations before conducting any such ,
activities that have not been previously analyzed ! I' e Ensuring non-routine operations are performed by the manufacturer or person specifically authorized by the NRC or an Agreement State to perform those operations
- Ensuring that personnel monitoring devices are used and exchanged at the proper intervals, and records of the results of such monitoring are maintained by the licensee j e Maintaining documentation that unmonitored individuals are not likely to receive, in one year, l a radiation dose in excess of 10% of the allowable limits or provide personnel monitoring devices
. Notifying proper authorities of incidents such as damage to or malfunction ofirradiators, fire, loss or theft oflicensed materials (See also Al)pendix 0) e Investigating emergencies and abnormal events involving the irradiators (e.g., malfunctions or damage), identifying cause(s), implement appropriate and timely corrective action (s) e Performing radiation safety program audits at least every 12 months and developing, implementing, and documenting timely corrective actions
- Ensuring transport oflicensed material according to all applicable DOT requirements
- Ensuring proper disposal oflicensed material
- Maintaining appropriate records associated with irradiator operations
- Maintaining an up-to-date license and timely submission of aa adment and renewal requests H-1 NUREG - 1556, Vol. 6
APPENDIX H '
. Ensuring that when the licensee identifies violations of regulations or license conditions or program weaknesses, corrective actions are developed, implemented, and documented i
l 1 i l i i l i l
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l i l l I I I . NUREG - 1556, Vol. 6 H-2
i i i l I i I t l Appendix I 4 4 Information Needed to Support Applicant's Request to Perform Non-Routine Operations
APPENDIX 1 Information Needed to Support Applicant's Request to Perform Non-Routine Operations Non-routine operations may include the following:
- Source loading, unloading and repositioning
- Troubleshooting the control console
- Clearing stuck source racks
- Investigating /remediating removable contamination / leaking sources
- (Re) installing source cables
- Any other activity during which personnel could receive radiation doses exceeding NRC limits.
If these operations are not performed properly with attention to radiation safety principles, the , irradiator may not operate as designed and personnel performing these tasks could receive lethal I radiation doses. l Applicants wishing to perform non-routine operations must use personnel with special training and follow appropriate procedures consistent with the manufacturer's written instructions and recommendations that address radiation safety concerns (e.g., use of radiation survey meter, personnel dosimetry). Accordingly, provide the following information:
- Describe which non-routine operations will be performed. The principal reason for obtaining this information is to assist in the evaluation of the qualifications of individuals who will conduct the work and the radiation safety procedures they will follow.
- Identify who will perform non-routine operations and their training and experience applicable to these operations. Acceptable training would include manufacturers' courses for non-routine operations or equivalent, e Submit procedures for non-routine operations. These procedures should ensure the following:
- doses to personnel and members of the public are within regulatory limits and ALARA (e.g., use of shielding and adequate planning when working with unshielded sources) - manufacturer's written instructions and recommendations are followed - planned special exposure requirements (10 CFR 20.1206), if applicable, are met - operations involving source loadiug, unloading, and repositioning include recording the rack position of each source and surveying all empty or loaded source transport containers for removable contamination to prevent the introduction of radioactive contaminants into the inadiator.
1-1 NUREG - 1556, Vol. 6
.. _ ..__ _ _ _ . _ _ . . .__ _ _ . _ . _ _ _ _ . . ..______ ~...
APPENDIX I,
. Confirm that individuals performing non-routine operations will wear whole body radiation -
dosimetry,if appropriate. Describe steps to be taken to ensure that radiation levels in areas where non-routine operations
- will take place do not exceed 10 CFR 20.1301 limits. For example, applicants can do the following:
- commit to performing surveys with a survey instrument;
- specify where and when surveys will be conducted during non-routine operations; and
- commit to maintaining, for 3 years from the date of the survey, records of the survey (e.g.,
who performed the survey, date of the survey, instmment used, measured radiation levels correlated to location of those measurements), as required by 10 CFR 20.2103. , I I l l I J l J 1 l l t l t i f l I l i i i
-1 l
NUREG - 1556, Vol. 6 I-2 h wwa9
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Appendix J Construction Monitoring and Acceptance Testing
-,- , , . , _ . ~ .
l APPENDIX J l Construction Monitoring and Acceptance Testing To ensure that irradiators and their components are built and installed as designed,10 CFR 36.41 requires that, for irradiators whose constmction began after July 1,1993, licensees conduct monitoring and acceptance testing before loading sealed sources. Figure J.1 illustrates this point i and Table J.1 correlates the components to be checked and the types of tests with the type of irradiator to which the requirement applies. i
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, r..;.a i as :q i umanm i tuer l Figure J.1 Construction Monitoring and Acceptance Testing. Before loading sealed sources, irradiator licensees must ensure that the as-built irradiator meets design criteria.
i l 4 Table J.1 Construction Monitoring and Acceptance Testing ! 1 4 l Irradiator Irradiator Type Licensee Requirement Elements 1 Shielding Panoramic Monitor the construction of the shielding to make sure i that its construction meets design specifications and i generally accepted building code requirements for reinforced concrete. 4 i Foundations Panoramic. Monitor the construction of the foundations to verify that their construction meets design specifications. PoolIntegrity Pool Verify that the pool meets design specifications including
! requirements in 10 CFR 36.33(a) and test the integrity of the pool.
Verify that outlets and pipes meet the requirements of i 10 CFR 36.33(b). l J-1 NUREG - 1556, Vol. 6
. - - _ .. - . - - . - . -.~.- -.- ---.-.- -
APPENDIX J Irradiator Irradiator Type Ll==== Requimmerit - - Elamamanes W ater Pool- Verify that the water purification system, the conductivity Handling meter, and the water level indicators operate properly System - (water level controls should be checked, if installed).
' Radiation All - Verify the proper operation of the monitor to detect ' Monitors sources carried on the prbduct conveyor system and the' related alarms and interlocks mquimd by !
10 CPR 36.29(a). '. , , i l Pool = Verify the pmper operation of the, radiation monitors and - I m the related alarm if used to ineet 10 CFR 36.59(b). j Underwater Verify the proper operation of the over-the.-pool monitor,~ l alarms, and interlocks tequired by 10 CFR 36.29(b). l Source Rack Panoramic Test the movement of the source racks for proper j operation prior to source loading; testing must include i source rack lowering due to simulated loss of power. j Irradiator with Observe and test the operation of the conveyor system to l Product Conveyor ensure that the requirements in 10 CFR 36.35 :re met for j Systems ' protection of the source rack and the mechanism that f moves the rack; testing must include tests of any limit ! switches and interlocks used to protect the source rack i and mechanism that moves the rack from moving product ! carriers. l Access Control Panoramic Test the completed access control system 'to ensure that it l functions as designed and that all alarms, controls, and ;
.iaterlocks work properly.- 4 Fire Protection Panoramic Test the ability of the heat and smoke detectors to detect a ;
fire, to activate alarms, and to cause the source rack to - automatically become fully shielded. The licensee must ; test the operability of the fire extinguishing system. It is : not necessary that licensees turn on extinguishers (i.e., - water or chemicals) during tests of the operability of their * ! fire protection systems. i Source Return Panoramic Demonstrate that the source racks can be returned to their ' r I fully shielded positions without offsite power. l l l l NUREG - 1556, Vol. 6 J-2
. . . .-.-- .-.. - -.-- -.-...- .-.~...-.. - . . . - . - - . - . . - - .
APPENDIX J l Irradeter IrrameterType , Ih Requiremnemt Elemments - Computer Panoramic, that Verify that the access control system will operate Systems use a computer properly if offsite power is lost and verify that the system to control computer has security features that prevent an irradiator the access control operator from commanding the computer to override the system access control system when it is required to be operable. Wiring Panoramic Verify that the electrical wiring and AwM equipment : that were installed meet the' design specifications (e.g. radiation-resistant wiring installed in appropriate ; locations and according to code). ) l 1 I l l I i J l l J3 NUREG - 1556, Vol. 6 i I
1 l l f b 4
. Appendix K Suggested Audit Checklist for 10 CFR Part 36 Irradiators 1 - - - _ _ _ _ _ _ _ _ _ . _ _ - . . _
APPENDIX K i Suggested Audit Checklist for 10 CFR Part 36 Irradiators 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 their activities and activities which have not occurred since the last audit need not be reviewed at the next audit. Licensee's name: License No. Date of This Audit L Date (Auditor Signature) l Date (Management Signature) l Audit History l A. Last audit of this location conducted on (date) B. Were previous audits conducted at intervals not to exceed least every 12 months? [10 CFR 20.1101] C. Were records of previous audits maintained? [10 CFR 20.2102] D. Were any deficiencies identified during last two audits or two years, whichever is longer? E. Were corrective actions taken? (I.cok for repeated deficiencies). Organization And Scope of Program A. If the mailing address or places of use changed, was the license amended? B. If ownership changed or bankmptcy filed, was NRC prior consent obtained or was NRC notified? l C. Radiation Safety Officer
- 1. If the RSO was changed, was license amended?
- 2. Does new RSO meet the licensee's training requirements?
K-1 NUREG - 1556, Vol. 6
APPENDIX K
- 3. Is RSO fulfilling his/her duties?
- 4. To whom does RSO repon?
D. If the designated contact person for NRC changed, was NRC notified? E. Scaled Sources and Devices
- 1. Does the license authorize all of the NRC regulated radionuclides contained in irradiators? -
- 2. Have copies cf(or access to) SSD Cenificates? -
- 3. Are the sealed sources, and if applicable, devices in accordance with the description in l the Scaled Source and Device (SSD) Registration Cenificates? [10 CFR 32.210]
- 4. Have manufacturers' manuals for operation and maintenance?
- 5. Are the actual uses of the irradiator consistent with the authorized uses listed on the license?
- 6. Are the sealed sources used under conditions specified in the " Conditions of Normal !
Use" and " Limitations and/or Other Considerations of Use" on the SSD Registration Cenificates? Training and instructions to Workers . A. Were all workers who are likely to exceed I mSv (100 mrem) in a year instructed per [10 CFR 19.12]? Refresher training provided, as needed? Records maintained? B. Did each individual permitted to operate the irradiator without a supervisor present,' receive instmetion according to the license commitments and 10 CFR 36.51 before opemting the irradiator? C. Are records of training, tests, safety reviews, and annual evaluations maintained for each authorized irradiator operator? [10 CFR 36.81(b), (c)] D. ~ Did individuals who perform non-routine operations receive training before performing these , operations? E. Did inteniews reveat that individuals know the emergency procedures? F. Did this audit include observations ofirradiator operations? G. Do workers know requirements for the following:
- 1. the radiation safety program
- 2. annualdoselimits
- 3. new Form NRC 4 and 5 NUREG - 1556. Vol. 6 K-2
APPENDIX K
- 4. 10% monitoring threshold
- 5. dose limits to embryo / fetus and declared pregnant worker
- 6. grave danger posting?
Radiation Survey Instruments And Radiation Monitors A. Are all portable survey meters calibrated at least annually to an accuracy ofi 20% for the gamma energy of the sources in use? [10 CFR 36.57(c)] B. Are portable survey meters of a type that does not saturate and read zero at high dose rates? - [10 CFR 36.57(c)] C. Are calibration records maintained? D. Are all operable survey instruments able to detect 0.5 microsievert (0.05 mrem) per hour? E. Has the licensee evaluated the location and sensitivity of the radiation monitor to detect , sources carried by the product conveyor system for automatic conveyor systems? 4 [10 CFR 36.29(a)] F. Has the licensee tested the operability and sensitivity of monitor used to detect the presence of high radiation levels in the radiation room before personnel entry at frequency specified in license application? G. Has the licensee tested the operability and sensitivity of monitor used to detect contamination of pool water due to leaking sources? (frequency of checks as specified in license application?) H. For underwater irradiators not in a shielded radiation room, has the licensee tested the ) operability and sensitivity of monitor used to detect abnormal radiation levels? (frequency of ! l checks as specified in license application?) Conductivity Meters A. Are appropriate operable conductivity meters possessed and used? B. Are conductivity meters calibrated at least annually? [10 CFR 36.63(b)] , I Sealed Source Accountability Program A. Are records maintained showing the receipt, location, transfer, and disposal of each sealed source? [10 CFR 30.51(a)(1)] B. Is material accountability program as described in application being implemented? K-3 NUREG - 1556. Vol. 6
APPENDIX K Personnel Radiation Protection A. Are ALARA considerations incorporated into the radiation protection program? [10 CFR 20.1101(b)] B. Is documentation kept showing that unmonitored individuals receive s 10% oflimit? [10 CFR 20.1502(a)] C. Did unmonitored individuals' activities change during the year which could put them over 10% oflimit? D. If yes to C above, was a new evaluation perfonned? E. Is extemal dosimetry provided to individua!s as required by 10 CFR 36.55 and to individuals likely to receive >10% oflimit?
- 1. Irradiator Operators: Is the dosimetry supplier NVLAP approved? [10 CFR 20.1501(c)]
- 2. Are the dosimeters exchanged monthly for film badges and quarterly for TLDs?
- 3. Are dosimetry reports reviewed by the RSO upon receipt?
- 4. Are dosimeters provided to persons who enter the radim-ion room of a panoramic irradiator? [10 CFR 36.55(b)]
- 5. Annual checks of accuracy of pocket dosimeters performed? [10 CFR 36.55(b)]
6.- Are the records NRC Forms or equivalent? [10 CFR 20.2104(d),10 CFR 20.2106(c)]
- a. NRC-Form 4 " Cumulative Occupational Exposure History" completed? '
- b. NRC-Form 5 " Occupational Exposure Record for a Monitoring Period" completed?
- 7. Declared pregnant worker / embryo / fetus
- a. If a worker declared her pregnancy, did licensee comply with [10 CFR 20.1208]?
- b. Were records kept of embryo / fetus dose per [10 CFR 20.2106(e)]?
F. Are records of exposures, surveys, monitoring, and evaluations maintained [10 CFR 20.2102, 10 CFR 20. 2103,10 CFR 20. 2106,10 CFR 36.57(a)]' Public Dose m A. Is public access controlled in a manner to keep doses below I mSv (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)? Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation? NUREG .1556, Vol. 6 K.4
l l l \ ! APPENDIX K l C. Do unrestricted area radiation levels exceed 0.02 mSv (:t mrem) in any one hour? [10 CFR 20.1301(a)(2)] D. Is access to sealed sources controlled in a manner that would prevent unauthorized use or l removal? [10 CFR 20.1801] E. Records maintained? [10 CFR 20.2103,10 CFR 20.2107] Operating And Emergency Procedures A. Have operating and emergency procedures been developed? [10 CFR 36.53] , 1 B. Do they contain the required elements? ; C. Does each individual working with the sealed sources have a current copy of the operating and emergency procedures (including emergency telephone numbers)? D. Din any emergencies occur?
- 1. If so. were they handled properly? !
- 2. Were appropriate corrective actions taken?
- 3. Was NRC notification or reporting required? [10 CFR 20.2201,2202,2203, 10 CFR 30.50 and 10 CFR 36.83]
Leak rests A. Were scaled sources leak tested at prescribed intervals? 10 CFR 36.59 B. Was the leak test performed according to regulatory requirements? 10 CFR 36.59 C. Are records of results retained with the appropriate information included?
]
D. Were any sealed sources found leaking and if yes, were appropriate actions taken and was NRC notified? [10 CFR 20.2201,10 CFR 20.2203,10 CFR 21.21,10 CFR 30.50, 10 CFR 36.59,10 CFR 36.83] j l Inspection and Maints..ance Checks A. Are all procedures for maintenance of the irradiator being followed where applicable? B. Are all checks to determine proper functioning and wear of the source movement systems performed at frequencies as gecified in & license application? i l C. Are labels, signs, and postings clean and legible? i l \ l K-5 NUREG - 1556, Vol. 6 i
APPENDIX K D. Are checks for operability as mquired by 10 CFR 36.61(a) ( not included in item 4.) performed at frequencies and according to procedures described in license application:
- 1. Each aspect of the access control system
- 2. Emergency source retum control
- 3. Heat / smoke detectors, extinguisher system
- 4. Pool water mplacement system high and low water indicators
- 5. For underwater irradiators, was the intrusion alarm tested for operability? (frequency of . )
checks as specified in license application? E. Are checks for functioning and condition of equipment performed at required frequencies and according to procedures described in license application:
- 1. Assessment of the condition and operability of the source rack protector are performed at the required frequencies [10 CFR 36.61(a)].
- 2. Assessment of water added to the pool to determine if there is pool leakage are performed at required frequencies as required by [10 CFR 36.61(a)(14)].
- 3. Assessment of radiation damage to electrical wiring are performed at required frequencies I as required by [10 CFR 36.61(a)(15)]. j
- 4. Water conductivity and analysis are performed at required frequencies [10 CFR 36.63]
- 5. Confirmation that water circulation system is leak tight. [10 CFR 36.61(a)(7)] '
- 6. Functioning of the source position indicator [10 CFR 36.61(a)(2)] .
1
- 7. 12ak tightness of water circulation system, visual inspection [10 CFR 36.61(a)(7)] i Repair and Preventive Maintenance A. Are repair and maintenance of components related to the radiological safety of the irradiator performed by the manufacturer or person specifically authorized by the NRC or an :
Agreement State and according to license requirements (e.g., extent of work, procedures, dosimetry, survey instrument, compliance with 10 CFR 20.1301 limits)? ' B. Malfunctions and defects found during inspection and maintenance checks are repaired without undue delay.
~ Transportstion Note: This section will not apply if you have not transported sealed sources during the period covered by this audit.-
NUREG - 1556, Vol. 6 K-6
APPFEDIX K , A. Were sources shipped since the last audit? I B. If so, were 10 CFR Part 71 requirements followed?
]'
C. DOT-Type A or Type B packages used? [10 CFR Part 71,49 CFR 173.415, 49 CFR 173.416(b)] If Type B, NRC Certificate of Compliance granted before shipment or ; shipper is registered as a user of the Type B package? NRC-approved QA program? D. Package performance test records on file? [49 CFR 173.415(a)] E. Special form scarces documentation? [49 CFR 173.476(a)] l F. Package has 2 labels (ex. Yellow-II) with TI, Nuclide, Activity, and Hazard Cless? l [49 CFR 172.403,49 CFR 173.441] l G. Package properly marked? [49 CFR 172.301,49 CFR 172.304,49 CFR 172.310, 49 CFR 172.324] i H. Package closed and sealed during transpon? [49 CFR 173.475(f)] I. Shipping papers prepared, used, and maintained? [49 CFR 172.200(a)] J. Shipping papers contain proper entries? { Shipping name, Hazard Class, Identification Number (UN Number), Total Quantity, Package Type, Nuclide, RQ, R.adioactive Material, Physical and Chemical Form, Activity, category of label, TI, Shipper's Name, Certification and Signature, Emergency Response Phone Number, Cargo Aircraft Only (if applicable)] [49 CFR 172.200,49 CFR 172.201,49 CFR 172.202,49 CFR 172.203,49 CFR 172.204, 49 CFR 172.604] K. Secured against movement? [49 CFR 177. 834 ] i L Placarded on vehicle,if needed? [49 CFR 172.504] M. Proper overpacks, if used? [49 CFR 173.25] N. Any incidents reported to DOT? [49 CFR 171.15,49 CFR 171.16] l Auditor's Independent Survey Measurements ) l A. Describe the type, location, and results of measurements. Does any radiation level exceed regulatory limits [10 CFR 20.1501(a) & 1502(a)]? ; Notification and Reports
- A. Was a telephone report made within 24 hours as described in l
10 CFR 36.83(b),10 CFR 30.50(c)(1), and a written report within 30 days as described in ; j 10 CFR 30.50(c)(2) of any of the following:
- 1. Source stuck in an unshielded position K-7 NUREG - 1556, Vol. 6
APPENDIX K
- 2. Any fire or explosion in a radiation room
- 3. Damage to the source rack
' 4. Failure of the cable or drive mechanism used to move the source racks a
- 5. Inoperability of the access control system
- 6. Detection of radioactive contamination attJbutable to licensed radioactive material
- 7. Detection of radioactive contamination attributable to licensed radioactive material'
- 8. Structural damage to the pool liner or wr.Ils
- 9. Abnormal water loss or leakage from the source storage pool
- 10. Pool water conductivity exceeding 100 microsiemens per centimeter.
B. Was any radioactive material lost or stolen? Were reports made? [10 CFR 20.2201, 10 CFR 30.50] C. Did any reportable incidents occur? Were reports made? [10 CFR 20.2202,10 CFR 30.50] D. Did any overexposures and high radiation levels occur? Reported? [10 CFR 20.2203, 10 CFR 30.50] E. If any events (as described in items a through c above) did occur, what was root cause? Were corrective actions appropriate? F. Is the management /RSO/ shift foreman licensee aware of telephone number for NRC Emcrgency Operations Center? [(301) 816-5100] Posting and Labeling A. NRC-Form 3 " Notice to Workers" posted? [10 CFR 19.11] B. NRC regulations, license documents posted or a notice posted? [10 CFR 19.11 10 CFR 21.6] C. Other posting and labeling? [10 CFR 20.1902,10 CFR 20.1904] According to 10 CFR 36.23(g), the radiation room of a panoramic irradiator must be posted as a "high radiation area." However,10 CFR 20.1902(c) requires that the area be posted as a "very high radiation area." There has been an oversight in not adopting in 10 CFR Part 36 the "very high radiation area" concept that is contained in 10 CFR Part 20. The NRC plans to change 10 CFR 36.23(g) to require posting as a "very high radiation area." 19 the meantime, the preferred posting is "very high radiation area," and irradiators posted in this manner will not be subject to enforcement action under 10 CFR 36.23(g). NUREG - 1556. Vol. 6 K8
APPENDIX K l Record Keeping for Decommissioning A. Records kept ofinformation important to decommissioning? [10 CFR 30.35(g)] I B. . Records include all information outlined in [10 CFR 30.35(g)]? l l 1 Gulletins And information Notices A. NRC Bulletins. NRC Information NotiecI., NMSS Newsletters. received? B. Appropriate training and action taken in response? Special Licens2 Conditions or lasues A. Did auditor review special license conditions or other issues (e.g., non-routine operations)? 1 Deficiencies identified in Audit; Corrective Actions ' A. Summarize problems / deficiencies identified during audit. 1 B. If problems /deficierten:s identified in this audit, describe corrective actions planned er taken. ! Are corrective actions planned or taken at ALL licensed locations (not just location audited)? Include date(s) when corrective actions are implemented. C. Provide any other recommendations for improvement. Evaluation of Other Factors A. Senior licensee management is appropriately involved with the radiation protection program and/or Radiation Safety Officer (RSO) oversight? B. RSO has sufficient time to perform his/her radiation safety duties? C. Licensee ha sufficient staff to support the radiation protection program? l l l l l K-9 NUREG - 1556. Vol. 6
4 1 1 i I i 4 I l i 4 i i i 1 .a 1 1 i 3 2 4 i I j Appendix L 4 1 i l Model Survey Instrument Calibration .! Program .i i i 1 1 4 l i l
, APPENDIX L Model Survey Instrument Calibration Program Training Before calibrating survey instruments independently, the individual should complete both classroom and on-the-job training as follows:
- Classroom training may be in the form oflecture, videotape, or self-study and will cover the following subject areas:
- Principles and practices of radiation protection
- Radioactivity measurements, monitoring techniques, and the use ofinstmments
- Mathematics and calculations basic to using and measuring radioactivity
- Biological effects of radiation. !
- On-the-job-training will be considered complete if the individual has:
- Observed authorized personnel performing survey instrument calibration, and
- Conducted survey meter calibrations under the supervision, and in the physical presence of an individual already authorized to perform calibrations.
. 1 Facilities and Equipment j e To reduce doses received by individuals not calibrating instruments, calibrations will 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
- Individuals conducting calibrations will use a calibrated and operable survey instrument to ensure that unexpected changes in exposure rates are identified and corrected.
i Model Procedure for Calibrating Survey Instruments
- 1. A radioactive sealed source (s) will be used for calibrating survey instruments, and this source 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 i 5% accuracy by National Institutes of Standards and Technology (NIST)
L-1 NUREG - 1556, Vol. 6
i- APPENDIX L
. Contain a radionuclide which emits photons ofidentical or similar energy as the sealed -
sources that the instrument will measure
. Be strong enough to give an' exposure rate of at least 30 mR/ hour (7.7 microcoulomb / kilogram per hour) at 100 cm [e.g.,3.1 gigabecquerels (85 millicuries) of Cs-137 or 780 megabecquerels (21 millicuries) of Co-60].
- 2. Inverse square and radioactive decay laws must be used to correct changes in exposum rate due to changes in distance or source decay.
- 3. A record must be made of each survey meter calibration.
- 4. A single point on a survey meter scale may be considered satisfactorily calibrated if the.
indicated exposure rate differs from the calculated exposure rate by less than *20%. l
- 5. There are three kinds of scales frequently used on radiation survey meters. They are )
calibrated as follows:
. Meters on which the user selects a linear scale must be calibrated at not fewer that two points on each scale. The points will be at approximately 1/3 and 2/3 of the decade.
. -- Meters that have a multidecade logarithmic scale must be calibrated at one point (at the least) on each decade and not fewer than two points on one of the decades. - Those points will be approximately 1/3 and 2/3 of the decade.
Meters that have an automatically ranging digital display device for indicating exposure rates must be calibrated at one point (at the least) on each decade and at no fewer than two points on one of the decades. Those points should be at approximately 1/3 and 2/3 of the decade.
- 6. Readings above 200 mR/ hour (50 microcoulomb / kilogram per hour) need not be calibrated.
However, higher scales should be checked for operation and approximately correct , response. 7.' Survey meter calibration reports will indicate the procedure used and the results of the calibration. The reports will include:
]
. The owner or user of the instrument '
]
. A description of the instrument that includes the manufacturer's name, model number, serial number, and type of detector '
A description of the calibration source, including the exposure rate at a specified distance on a specified date, and the calibration procedure 1 NUREG - 1556, Vol. 6 L-2 I __u_.___..____-_-_ , _ _
I l APPENDIX L l l
- For each calibration point, the calculated exposure rate, the indicated exposure rate, the
' deduced correction factor (the calculated exposure rate divided by the indicated exposure ,
rate), and the scale selected on the instrument
. The exposure reading indicated with the instrument in the " battery check" mode (if available on the instmment)
]
- For instruments with external detectors, the angle between the radiation flux field and l the detector.(i.e., parallel or perpendicular) l r
. For instruments with internal detectors, the angle between radiation flux field and a j specified surface of the instrument - i
. For detectors with removable shielding, an indication whether the shielding was in place or removed during the calibration procedure j 1
e The exposure rate from a check source, if used
. The signature of the individual who performed the calibration and the date on which the ,
calibration was performed.
]
l
- 8. The following information will be attached to the instrument as a calibration sticker or tag:
. ' The o cce that was used to calibrate the instrument
. The proper deflection in the battery check mode (unless this is clearly indicated on the instrument)
. For each scale or decade not calibrated, an indication that the scale or decade was checked only for function but not calibrated
. The date of calibration and the next calibration due date
. The apparent exposure rate from the check source, if used.
References:
Detailed information about survey instrument calibration may be obtained by referring to ANSI N323-1978, " Radiation Protection Instrumentation Test and Calibration." Copies may be obtained from the American National Standards Institute,1430 Broadway, New j York, NY 10018 or ordered electronically at the following address: <http://www. ansi.org>. i See the Notice of Availability (on the inside front cover of this report) to obtain copies of Draft Regulatory Guide 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. ! I i L-3 NUREG - 1556, Vol. 6 l
a i 1 J l a i l l 5 i. l Appendix M 4 ! Guidance for Demonstrating that ! Unmonitored Individuals are Not Likely i to Exceed 10 Percent of the Allowable L.imits i 4 i 1 l 1 t 4 i i
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44 4,e .'-'-,,444M,6+. f i 1 i 1 L I i I I i l I, I T I n i i b l i l 1 1 I I'W'- m- mt, , ,,
i
- APPENDIX M Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits Dosimetry is required for individuals likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the applicable regulatory limits in 10 CFR 20.1201. However, irradiator operators are required by 10 CFR 36.55(a) to wear either a film badge or a thermoluminescent dosimeter (TLD) while operating a panoramic irradiator or while in the area around the pool of an underwater inadiator. Also, other individuals who enter the radiation room i of a panoramic irradiator must wear a dosimeter, which may be a pocket dosimeter. When j groups of visitors enter the radiation room at least two people must wear dosimeters. In those l instances where pocket chambers are used instead of film badges or TLDs, a check of the ;
response of the dosimeters to radiation must be made at least annually. Acceptable dosimeters l must read within plus or minus 30% of the true radiation dose. To demonstrate that dosimetry is j not required for other workers, a licensee needs to have available, for inspection, an evaluation to j demonstrate that its workers are not likely to exceed 10% of the applicable annual limits. l The most common way that individuals might exceed 10% of the applicable limits is by l i performing work near the irradiator shield or areas of cable or equipment penetration of the shield of the irradiator. However, for most irradiators even these activities result in the individual receiving minimal doses. A licensee will need to evaluate the doses which its workers might receive in performing these tasks to assess whether dosimetry is required. The evaluation may be done by carefully measuring the dose rates when the source is in the irradiate position using techniques similar those as described in Appendix N. An evaluation of the actual time workers spend in the area can provide the information needed to estimate the annual dose of the workers. The applicable TEDE (whole body) limit is 50 mSv (5 rems) per year and 10% of that value is , 5 mSv (500 millirems) per year. Example: A careful measurement of the highest dose rate at the face of the shield of a panoramic irradiator is found to be 0.015 mSv/hr (1.5 mrem /hr). An individual is expected to i spend no more than 3 hours per week in the area near the shield. Based on the dose rate, assuming the source is continuously in the irradiate position while the work is being performed, the annual dose is expected to be less than 2.34 mSv (234 mrem) (i.e.,3 hr/wk x 1.5 mrenVhr x 52 wk/yr). Based on the above specific information, no dosimetry is required if the individual performs work in the area less than 6.4 hours per week. l M. , NUREG - 1556, Vol. 6
l l l t J Appendix N Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits
APPENDIX N Cuidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits Licensees must ensure that: e The radiation dose received by individual members of the public does not exceed 1 millisievert (mSv) [100 millirem (mrem)] in one calendar year resulting from the licensee's ' possession and/or use oflicensed materials. , 1 Members of the public include persons who live, work, or may be near locations where an irradiator is used or where the sealed sources for the irradiator are stored and employees whose i assigned duties do not include the use oflicensed materials and who work in the vicinity where irradiators are used or source. 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 j 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. i i Licensees must show compliance with both portions of the regulation. For areas around i irradiator facilities, a combination of calculations and measurements (e.g., using an environmental TLD) is often used to prove compliance. Combined Measurement - Calculational Method 8 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 hr/wk for 52 wk/yr) is equal to less than 0.5 microsievent (0.05 mrem) per hour. This rate is well below the minimum sensitivity of most commonly available G-M survey instruments. l I i 8 For case of use, the examples in this Appendix use conventional units. 'Ihe conversions to SI units are as ! follows: 1 ft = 0305 m; I mrem = 0.01 mSv. N-1 NUREG - 1556, Vol. 6 l
APPENDIX N Instruments used to make measurements for calculations must be sufficiently sensitive. An instmment equipped with a scintillation-type detector (e.g., Nal(TI)) or a micro-R meter used in making very low gamma radiation measurements should be adequate. Licensees may also choose to use environmental TLDs' in unrestricted areas next to the irradiator area 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/yr (100 mrem /yr) limit. The combined measurement-calculational method may be used to estimate the maximum dose to a member of the public. Since 10 CFR Part 36 irradiators are designed so that the maximum dose rate in any public area is less than 0.02 mSv (2 mrem) in any one hour, the licensee will , generally be able to show by calculation that the maximum dose to an individual will be less than the 1 mSv/yr (100 mrem /yr) limit. The combined measurement-calculational method takes a tiered approach, going through a two-part process starting with a worst case situation and moving , toward more realistic situations. It makes the following simplifications: (1) each irradiatoris a l point source; (2) typical radiation levels encountered when the source is in the unshielded position; and (3) no credit is taken for any shielding found between the irradiator shield and the ' unrestricted areas. The method is only valid for the source activity at the time of measurement and must be repeated if the source strength or shielding is changed. Even though most large irradiators approximate a planar source, the results obtained from a point source assumption will be conservative and therefore may be used. Part 1 of the combined meaturement-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 irradiator and the affected member of the public is sufficient to show compliance with the public dose limits. Pan 2 considers not only distance, but l also the time that the affected member of the public is actually in the area under consideration. l Using this approach, licensees make only those calculations that are needed to demonstrate j 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 which could be received. l ' 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 I mSv/yr (100 mrem /yr) limit. If licensees use TLDs to evaluate compliance with the public dose limits, they should consult with their 'ILD supplier and choose more sensitive TLDs, such as those containing CaF: that are used for environmental monitoring. NUREG - 1556, Vol. 6 N-2 l
- _. - - . - _ _ _ - - = - .
i i APPENDIX N Example To better understand the combined measurement-calculational method, we will examine Food-Safe, Inc., an irradiator licensee. Yesterday, the company's president noted that the shield of the new irradiator area is close to an area used by workers whose assigned duties do not include the use oflicensed materials and he asked Leslie, the Radiation Safety Officer (RSO), to determine if the company is complying with NRC's regulations. The area in question is near the wall which constitutes the primary shield of the irradiator. Leslie , measures the distance from the shield to the center of the area in question and, using a calibrated survey instrument, measures the highest dose rate at one foot from the shield, to be 2 rmem per hour. Table N.1 summarizes the information leslie has on the irradiator. Table N.1 Information Known About Dose at the Shield of the Irradiator Description of Known Information Co-60 Panoramic Irradiator Dose rate encountered at I foot from the face of the shield, in 2 mrem /hr. mrem /hr. Distance from the face of the shield to the nearest occupied 4 ft work area, in ft. Example: Part 1 leslie's first thought is that the distance between the irradiator shield and the area in question may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach, he assumes: 1) the irradiator fs constantly in use (i.e.,24 hr/d), and 2) the i workers are constantly in the unrestricted work area (i.e.,24 hr/d). I2slie proceeds to calculate the dose the workers might receive hourly and yearly from the irradiator as shown in Table N-2 i below ! Table N.2 Calculational Method, Part 1: Hourly and Annual Dose Received from irradiator Step No. Description Input Data Results 1 Multiply the measured dose rate measured at 1.0 ft from the 2 x (1)2 2 face of the shield wall in mrem /hr by the square of the l l distance (ft) at which the measurement was made (e.g., I foot from the face of the shield) Square of the distance (ft) from the face of the shield to the (4)2 16 2 nearest unrestricted area, in ft2 I N-3 NUREG - 1555, Vol. 6
. .. - - . . . . - . - . - . . . ~ . . . . - - - - . - - - - - . - . - . ~ - - - APPENDIX N Step No. Description Input Data Resuks 3 Divide the result of Step 1 by the result of Step 2 to calculate 2/16 0.125 the dose received by an individual in the area near the shield. HOURLY DOSE RECEIVED FROM IRRADIATOR, in mrem in an hour
-4 Multiply the msult of Step 5 by 40 hr/ work week x 52 - 0.125 X 40 260 weeks / year = MAXIMUlk ANNUAL DOSE RECEIVED X 52 FROM IRRADIATOR,in miem in a year Note: The result in Step 3 demonstrates compliance with the 2 mrem in any one hour limit.
Reevaluate if assumptions change. If the result in Step 4 exceeds 100 mrem /yr, proceed to Part 2 of the calculational method. . At this point, Leslie is pleased to see that the total dose that an individual could receive in any one hour is only 0.125 mrem in an hour, less than the 2 mrem in any one hour limit but notes that an individual could receive a dose of 260 mrem in a year, higher than the 100 mrem limit. Example: Part 2 Leslie reviews the assumptions and recognizes that the workers are not in area near the shield all of the time. A realistic estimate of the number of hours the workers spend in the area is made, keeping the other assumptions constant (i.e., the irradiator is in constant use (i.e.,24 hr/d). The annual dose received is then recalculated. Table N.3 Calculational Method, Part 2: Annual Dose Received from a 10 CFR Part 36 Irradiator , Step Description Results ! No. l 5 A. Average number of hours per day an individual spends in area of 1.5 concern (e.g., a non-radiation worker spends 1.5 hr/ day in the j area near the shield; the remainder of the day the workers are - , away from the area assigned to jobs unrelated to radiation.
- (painting, grounds keeping, desk jobs, etc.) ,
B. Average number of days per week in area 5 l C. Average number of weeks per year in area (e.g., full time 52 ' workers) l NUREG - 1556. Vol. 6 N-4 i
APPENDIX N Step Description Results No. 6 Multiply the results of Step 5.A. by the results of Step 5.B. by the 1.5 x 5 x 52 = 390 results of Step 5.C. = AVERAGE NUMBER OF HOURS IN AREA OF CONCERN PER YEAR 7 Multiply the results in Step 3 by the results of Step 6 = ANNUAL 0.125 x 390 = 49 , DOSE RECEIVED FROM IRRADIATOR CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN AREA OF CONCERN,in mremin a year Ieslie is pleased to note that the calculated annual dose received is significantly lower, and does not exceed the 100 mrem in a year limit. Since most irradiators are in use a majority of the time, and down time is usually unpredictable, generally no additional allowance for irradiator duty cycle is made. Ieslie is glad to see that the results in Step 7 show compliance with the 100 mrem in a year limit. Had the result in Step 7 been higher than 100 mrem in a year, then leslie 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 shielding'8 located between the irradiator shield and the public area
- such calculation is beyond the scope of this Appendix Take corrective action (e.g., change work patterns to reduce the time spent in the area near the shield) and perform new calculations to demonstrate compliance Designate the area inside the use area as a restricted area and the workers as occupationally exposed individuals. This would require controlling access to the area for purposes of radiation protection and training the workers as required by 10 CFR 19.12 Note that in the example, Leslie evaluated the unrestricted area outside only one wall of the irradiator area. 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
- National Council on Radiation Protection anF ~ turements (NCRP) Report No. 49, " Structural Shielding Design and Evaluation for Medical Use of X Rap ad Gamma Rays of Energies Up to 10 MeV," contains helpful information. It is available from NCRP,7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814. NCRP's telephone numbers are: (301) 657 2652 or 1-800-229-2652.
N-5 NUREG - 1556, Vol. 6
e +i4 - &34& 4 44 JJ & -.4-i 4-
- APPENDIX N (e.g., adding sources to the irradiator, changing the work habits of the workers, or otherwise changing the estimate of the ponion of time spent in th area in question) 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. i l i i b e NUREG - 1556, Vol. 6 N-6 I i
l l l l l t Appendix 0 Typical NRC incident Notifications Required for Irradiator Licensees d I
.,.4,a-,w., - -
l APPENDIX O ! h Typical NRC incid'ent Notifications Required for Irradiator Licensees l l L Event : Telephone Written Regulatory Requirennent i Notification Report l Theft orloss of material. immediate 30 days 10 CFR 20.2201(a)(1)(i) l Whole body dose greater than 0.25 Sv.' immediate 30 days 10 CFR 20.2202(aXIXi) ! (25 sems) ; Extremity dose greater than 2.5 Sv . immediate 30 days" 10 CFR 20.2202(aXI)(iii) j (250 rems) 4 l Whole bodydose greater than 0.05 Sv ' ; 24 hours ~30 days 10 CFR 20.2202(bXIXi) !
'(5 rems)in 24 hours [
Extremity dose greater than 0.5 Sv 24 hours 30 days 10 CFR 20.2202(b)(1)(iii) (50 rems)in 24 hours : Whole body dose greater than 0.05 Sv-- none- 30 days ~ 10 CFR 20.2203(aX2)(i) !
~
($ rems) . , ! l Dose to individual member of public ' none 30 days 10 CFR 20.2203(a)(2)(iv) f
~
l greater than 1 mSv (100 mrems) Defect in equipment that could create a 2 days - 30 days ' 10 CFR 21.21(dX3Xi) i substantial safety hazard l Event that prevents immediate protective immediate 30 days 10 CFR 30.50(a) l l actions necessary to avoid exposure to l radioactive materials that could exceed l l regulatory limits l Equipment is disabled or fails to function 24 hours ~ 30 days 10 CFR 30.50(bX2) l i ias designed when required to prevent ! ; j fradiation exposure in excess of regulatory,
.. l Unplanned fire or explosion that affects 24 hours 30 days 10 CFR 30.50(b)(4)
- the integrity of any licensed material or
- device, container, or equipment with licensed material -
l Source stuck in an unshielded position' 24 hours 30 days 10 CFR 36.83(aXI).
~ Any fire or explosion in a radiation room 24 hours 30 days 10 CFR 36.83(a)(2)
Damage to the source racks- 24 hours 30 days 10 CFR 36.83(aX3) i 1 0-1 NUREG - 1556, Vol. 6 I
APPENDIX O
< Event . Telephone Written Regulatory Requirement Netincation Report Failure of the cable or drive mechanism 24 hours 30 days 10 CFR 36.83(a)(4) used to move the source racks
- Inoperability of the' access control system 24 hours 30 days _ 10 CFR 36.83(a)(5)-
Detection of radiation source by the 24 hours 30 days 10 CFR 36.83(a)(6) product exit monitor Detection of radioactive contamination . 24 hours 30 days 10 CFR 36.83(a)(7) attributable to licensed radioactive
' material .
Structural damage to the pool liner or 24 hours 30 days 10 CFR 36.83(a)(8) . walls l Abnormal water less or leakage from the 24 hours 30 days 10 CFR 36.83(a)(9) source storage pool Pool water conductivity exceeding 24 hours 30 days 10 CFR 36.83(a)(10) 100 microsiemens per centimeter I Note: Telephone notifications shall be made to the NRC Operations Center at 301-951-0550 j except as noted., l 1 l t i i [ l 1 l i NUREG - 1556, Vol. 6 O-2 j
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i i i i Appendix P Model Leak Test Program For Dry-Source-Storage Irradiator Sealed Sources i i l i
APPENDIX P l l Model Leak Test Program For Dry-Source-Storage Irradiator Sealed Sources j Training Before allowing an individual to perform leak testing, the RSO will ensure that he or she has sufficient classroom and on-the-job training to show competency in performing leak tests independently. Cassroom training may be in the form oflecture, videotape, or self-study and will cover the following subject areas:
. Principles and practices of radiation protection . Radioactivity measurements, monitoring techniques, and the use ofinstruments . Mathematics and calculations basic to the use and measurement of radioactivity j . Biological effects of radiation. !
Appropriate on-the-job-training consists of:
- Observing authorized personnel collecting and analyzing leak test samples
- Collecting and analyzing leak test samples under the supervision and in the physical presence of an individual authorized to perform leak tests.
Facilities and Equipment
. To ensure achieving the required sensitivity of measurements, leak tests will be analyzed in a low-background area. . Individuals conducting leak tests will use'a calibrated and operable survey instrument to check leak test samples for gross contamination before they are analyzed. . A Nal(TI) well counter system with a single or multichannel analyzer will be used to count samples from sealed sources containing gamma-emitters (e.g., Cs-137, Co-60).
Frequency for Conducting Leak Tests of Sealed Sources
. leak tests will be conducted at least every 6 months.
P-1 NUREG - 1556, Vol. 6
APPENDIX P Model Procedure for Performing Leak Testing and Analysis
. For each source to be tested, list identifying information such as serial number, radionuclide, activity. . If available, use a survey meter to monitor exposure.
- Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source."
. Number each wipe to correlate with identifying information for each source. . Wipe the most accessible area where contamination would accumulate if the sealed source were leaking. . Select an instrument that is sensitive enough to detect 200 becquerels (0.005 microcurie)2 of the radionuclide. . Using the selected instrument, count and record background count rate.
- Check the instrument's counting efficiency using standard source of the same radionuclide as the source being tested or one with similar energy characteristics. Accuracy of standards .
should be within iS% of the stated value and traceable to a primary radiation standard such as l those maintained by the National Institutes of Standards and Technology (NIST). j
- Calculate efficiency. j For example: f(cpm from std)-(com from bkell = efficiency in cpm /Bq l activity of std in Bq where: cpm = counts per minute l
std = standard ! bkg = background Bq = Becquerel l Count each wipe sample; determine net count rate. For each sample, calculate and record estimated activity in becquerels (or microcuries). ! For example: f(epm from wine samole)-(cpm from bkell = Bq on wipe sample efficiencyin cpm /Bq Sign and date the list of sources, data and calculations. Retain records for 3 yer:s. 1 " Prepare one swipe per irradiator,if more than one source is contained in the same enclosure. '8 10 CFR Part 36 uses one significant figure in converting becquerels to microcurie. NUREG - 1556, Vol. 6 P-2
, .. -. -. __=- - _...... - .- . . - - . . _ - . . . - . . . . - - . . . . . - . . .
1 r APPENDIX P
. If the wipe test activity is 200 becquerels (0.005 microcurie) or greater, notify the RSO, so that l the source can be withdrawn from use and disposed of properly. Also notify NRC.
i I i i P-3 NUREG - 1556, Vol. 6
Appendix Q Transportation 4 D
APPENDIX Q Transportation Major DOT Regulations The major areas in the DOT regulations that are most relevant for transportation oflicensed materials used in irradiators are as follows:
- 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 packaging, 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: Generallabeling requirements, prohibited labeling, radioactive materials, placement of labels, 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 4 1
= Training, Subpart H,49 CFR 172.702,49 CFR 172.704: Applicability and responsibility for training and testing, training requireme..'ts
- Radiation Protection Program for Shippers and Carriers, Subpart I,49 CFR 172.800, etc.
. Shippers - General Requirements for Shipments and Packaging, Subpart I,49 CFR 173.403, i 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 173.415,49 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 Ai and A 2 . table of A i and A values 2 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 Q-1 NUREG - 1556, Vol. 6
APPENDIX Q
- Carriage by Public Highway 49 CFR 177.816,49 CFR 177.617,49 CFR 177.834(a),
49 CFR 177.842: Driver training, shipping paper, general requirements (secured against movement), Class 7 (radioactive) material. l l J f l I t i i r i I t i i i NUREG - 1556, V01. 6 Q t l ' i i )
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Appendix R Exemptions for Teletherapy Units Converted to Non-Human Use ; I ) l
APPENDIX R Exemptions for Teletherapy Units Converted to Non-Human Use The following are technicaljustifications and commitments which are acceptable to exempt licensees from specific sections of 10 CFR Part 36. The Regions may gram the exemptions shown below without prior coordination with NMSS. Acceptable license conditions are also shown below.
- 1. 10 CFR 36.23(a) "The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources."
For converted teletherapy units, the use of a single key or even several keys on a key-ring may be impractical. The key-switch on many control panels is a 3-position switch which controls electrical power to the teletherapy unit. The key can only be inserted / removed in the "off" position, and in this position the main power and control circuits are without electrical power. Power is required to move collimators, activate field lights, align system, etc. Requiring a single key would not allow the licensee to operate these powered systems. Therefore, a licensee may be exempted from this requirement, provided that the lic:nsee commits to have the operator present for the entire period of time that the key is in the control panel. The following license condition should be used:
"Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may use separate keys to operate the lock on the personnel entrance door or barrier and to move the sources in occordance with procedures described in the letter / application dated ."
- 2. 10 CFR 36.23(b) "...each entrance to a radiation room at a panoramic irradiator must i
have an independent backup access control to detect personnel entry while sources are exposed." The licensee may be granted an exemption from this requirement provided that the licensee has an electrical interlock system meeting all of the conditions specified in i 10 CFR 35.615(b) on each entrance to the radiation room. Alterations of the electrical I interlocks of the teletherapy unit to meet the requirements of 10 CFR 36.23(b) may cause the interlock system to function incorrectly. A working electrical interlock system on each entrance suffices to prevent personnel entry while the source is exposed. The licensee should commit in its application to each of the conditions of 10 CFR 35.615(b). In addition, the licensee should commit to having an operator present during the entire irradiation who can visually observe the entrance, and to having a radiation monitor that can be read before entering the radiation area. R-1 NUREG - 1556, Vol. 6
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APPENDIX R i l l The following license condition should be used: t "Notwithstanding the requirements of 10 CFR 36.23(b), the licensee is exempt from having . an independent backup access control to detect personnel entry while sources are exposed i based on the commitments described in the letter / application dated ." i ! 3. 10 CFR 36.23(c) "...The monitor must be integrated with persormel access door locks to ! ! prevent room access when radiation levels are high." l l Alteration of the interlock system to meet this requirement.would pievent entry to the ! l treatment room to remove a patient in the event of a stuck source. The region may grant the ! licensee an exemption from this requirement provided that the licensee has an electrical -
. interlock system which will retract the source, upon opening access doors to the radiation ;
l room and commits to its use. In addition, the licensee must commit to having an operator I
- present and having a radiation monitor in the room as described above. I l
The following license condition should be used:
"Notwithstanding the requirements of 10 CFR 36.23(c), the licensee is exempt from having i
the monitor integrated with personnel access door locks to prevent room access when radiation levels are high based on the commitments described in the letter / application I dated .
- 4. 10 CFR 36.23(d) "... visible and audible alarms to alert people in the radiation room that J j the sources will be moved from their shielded position."
i l An acceptable justification is that an audible alarm within the treatment room may cause [ undue distress to the patients (human or animal). If the licensee commits to having a visual i alann provided on the outside of the treatment room, and to having the operator visually check the room before starting treatments, the regions may grant the licensee an exemption. The following license condition should be used: L "Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exempt from having an audible alarm w.ithin the treatment area, based on the commitments described in the letter / application dated .
- 5. 10 CFR 36.23(f) "Each radiation room at a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door...has been closed within a preset time..."
Exemptions may be granted to licensees having teletherapy units that are being used for irradiation of materials only (no patients), provided that the licensee conunits to the , operator visually verifying that the room is not occupied before closing the door, and that i l i NUREG - 1556, Vol. 6 R-2
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I APPENDIX R the convened teletherapy unit (irradiator) activates a visual and audible alarm in the teletherapy room for at least 15 seconds before moving the source from the shielded position. This visual / audible alarm must be interlocked with the teletherapy unit such that the source will not move to the exposed position until the visual / audible alana has been ! activated and is finished alarming. The use of a visual / audible alarm in a patient treatment l room may cause anxiety for patients. Therefore, licensees having teletherapy units that are l being used for both patient treatment (human or animal) and object or material inadiation may be authorized an exemption from 10 CFR 36.23(f) without the need to have a l visual / audible alarm, if the licensee commits to having an operator visually verify that the room is not occupied beforc closing the door and if the licensee has a means of visually ! observing the areas required in 10 CFR 35.615(e). If the unit is not used for patients, then l tha audible / visible alarm described above is required. The following license condition should be used: i "Notwithstanding the requirements of 10 CFR 36.23(f), the licensee is exempt from having a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed
~
within a preset time based on the cmunitments dscribed in the letter / application l dated . j l
- 6. 10 CFR 36.27(a) "...The sources must automatically become shielded if a fire is detected."
10 CFR 36.27(b) "...be equipped with a fire extinguishing systems capable of extinguishing a fire without entry of personnel. The system must have a shutoff valve to control flooding into unrestricted areas." The Statements of Consideration state that the purpose of the fire extinguishing system is to prevent a fire from damaging the access control system or preventing the sources from , i being shielded. Most converted teletherapy units are designed to retract the source when the electrical power fails, as may occur during a fire. The licensee may be granted an exemption from these requirements provided that the licensee commits to the following:
. Having smoke detectors, fire extinguishers and a fire alarm at the site to detect and fight small fires Alening authorities of the fire ;
- Having a means of measuring the radiation levels in the radiation room during an electrical failure
. Instmeting the operators to retract the source before exiting for a fire involving major portions of the facility, provided this action does not jeopardize the operator's safety.
R-3 NUREG - 1556, Vol. 6
APPENDIX R The following license condition should be used:
"Notwithstanding the requirements of 10 CFR 36.27(a) and (b), the licensee is exempt from (as reauested by the licensee) based on the commitments described in letter / application dated ."
- 7. 10 CFR 36.31(a) "The key must be attached to a portable radiation survey meter by a chain or cable... The door to the radiation room must require the same key."
Converted telethempy units require that the source activation key be inserted in the console to provide power to the unit to activate field lights and align the head. Therefore, the region may grant the licensee an exemption from this requirement provided that the licensee commits to havisq; administrative controls in plcce to ensure that personnel entering the radiation room use a portable survey meter to verify that the source has retracted. The licensee must also commit to attach the survey meter to the exposure room door key. The following license condition should be used:
"Notwithstanding the requirements of 10 CFR 36.31(a), the licensee is exempt from the requirement to have console key attached to a portable survey meter by a chain or cable and that the door to the radiation room require the same key, based on the commitments described in the letter / application dated . The radiation room door key shall be attached to the portable survey meter."
- 8. 10 CFR 36.31(b) ".. .The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in... transit."
In converted teletherapy units the source is movdd nearly instantaneously from the shielded to the exposed position. Most teletherapy units are designed with two indicator lights - green indicates the source is in the fully shielded position, red indicates the source is exposed. During transit both lights are "on" indicating that the source is in transit. To require that the licensee install an electronic system to indicate "in transit" for the period of time the source is in transit, less than a second, does not provide any additional protection. l Therefore, the region may grant this exemption provided the licensee submits a description j ofits device indicators.
~
The following license condition should be used: ! l "Notwithstanding the requirements of 10 CFR 36.31(b), the licensee is exempt from the ! requirement to have a separate position indicator to indicate when the source is in transit, in accordance with letter / application dated . NUREG - 1556, Vol. 6 R-4
r-APPENDIX R
- 9. 10 CFR 36.67(b)(2) "...the irradiator operator...must activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control."
Because of the risk of n/alfunction associated with alterations to the existing electrical l interlocks of the teletherapy unit, and considering the licensee's commitment to administratively control access to the room to meet the intent of this regulation, the region may grant this exemption, if the licensee demonstrates that a retrofit to install such a control would not be possible with the teletherapy unit and a licensee commits to the following: The operator will close the doors immediately upon completion of the visual inspection required by 10 CFR 36.67(b)(1). The operator will verify that each door has locked automatically before stepping to the control panel. The following license condition should be used:
"Notwithstanding the requirements of 10 CFR 36.67(b)(2), the licensee is exempt from the requirement to have a control in the rediation room which must be activated prior to irradiation which would not allow the source to be moved from the shielded position unless the door to the radiation room is locked witain a preset time, based on the commitments i described in the letter / application dated - ."
i 1 l l R-5 NUREG - 1556, Vol. 6 i
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1 l I I I i l i j Appendix S i d
- Sample Licenses for i
10 CFR Part 36 Irradiators i 4 l 4 i 4 4 6 i 4 ) i a
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APPENDIX S Sample Licenses for 10 CFR Part 36 Irradiators ! J i This appendix contains examples ofirradiator licenses that the NRC would issue to an applicant ! who meets the requirements in 10 CFR Part 36. The three types are:
- Dry-source-storage panora nic e Wet source-storage panorau;c e Underwater type irradiator.
The authorizations in the sample licenses do not necessarily reflect those normally provided to an applicant. For example, any authorizations for exemptions to 10 CFR Part 36 would require the , applicant to have specific procedures approved by the NRC, following a specific request for an ! exemption. I
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I I l S-1 NUREG - 1556, Vol. 6
NRC FORM 374 U.s. NUCLEAR RE2ULAT!Ri 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 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 authorizir.g 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 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license ch:.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 applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee g
- 1. Best Research Institute s. Ucense N 1'9-12345-01
- 2. 1234 Main Street N UExpirdMSepternber 30,2007 Anywhere, USA 20000 ([g h b R 5.
gocketyp%2345 I Ro(erence N@
- 6. Byproduct, source, and/or special' 7. Chemical and/or forrn NAkMaximum amount that licensee may nuclear material 0)
Qf Q3 g Wy
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ossess at any one time under this
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- cense b
A. Cobalt - 60 T hS sobrha b gcontalriedio,(XYZ T
@ 2,000 curies L t N CapsuleType X-145) O_
G) 6 f k L % k ? p
- 9. Authorized use ggygpy ty% % Gvg d
h5*gM y , y* i g& O > A. For use in XYZ Pinto-22 teletherapy unit to perform irradistfon studies on cell cultures and small animals, excludind explosi0es iflamr'nables,. of coiTAS!(es: C6
\Mj'd "% ( @?b ph' 3.*
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- 10. Licensed material may be used only at the llcense,e's facilities located at 432 Main Street, Anywhere, USA. n *'
- 11. A. Licensed material shall be used by, or under the supervision of, individuals designated in writing by the Radiation Safety Committee. The licensee shall maintain records of individuals designated as users for three years after the last use of licensed material by the individual.
B. The Radiation Safety Officer for this license is Enrico Foomie. I l
- 12. Sealed sources containing licensed material shall not be opened or sources removed from source holders or detector cells by the licensee. ;
13, The licensee is authorized to collect leak test samples for analysis by the licensee. Alternatively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission ; or an Agreement State to perform such services. NUREG - 1556, Vol. 6 S-2
l 1 l l' NRC FORM 374A U.S. NUCLEAR REGULATORY Commission PAGE 2 of 2 PAGEs ~" License Number 08-12345-01 ) MATERIALS LICENSE Docket or Reference Number l 030-12345 SUPPLEMENTARY SHEET Amendment No. l
- 14. Th] licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or cccess to the licensed material. Removal, replacement, and disposal of sealed sources in the irradiator l sh:ll be performed by persons specifically licensed by the Commission or an Agreement State to perform such services. 6
- 15. Licensed material shall not be used i r gg,n%hmad b3ings. ,
7 Th3 licensee is authorized<-to%transport licensed material w in acc/ordarloe'wHh 4' the provisions
- 16.
- V "P ckaging and Transportation'of Y Radioactive N Material."%[%
- 17. The procedures contained;in the manufacturer's i ma.. or t6e irradiator authorized by this lic:nse shall be followed~and a copy of this mantfdahall *e mad 6'availdble.to each person using or h;ving responsibility% ff:r' % tile M us'ect% the c: device.% o %(,[:
- 18. Except as specifically'provided otherwise% this license.he licensee shall conduct its program in s l cccordance with the 5tatements, ripresentat$rd[a'Ypro' n edures c containddljn the documents, including l cny enclosures, listed below. TheMucidar f%eduldit&y Cornmission's regulitions shall govern unless the statements, represen't'ations, aldpro6'edures 19 the licensee'd ppplication and correspondence are m0re restrictive than the regtMationsg[h,%dpf' i O g Q#" O# g g} Wy ' (/)
A. Application dated Sepi be 1 -- Q, GW,'ap[y
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1 y k t C 'i ju r l Dita By John O. Reviewer, Health Physicist Nuclear Materials Licensing Branch NRC Region City, Statt. 54321 S-3 NUREG - 1555. Vol. 6
NRC FORM 374 U.s. NUCLEAR RE!ULAToRY CoMZissi!N PAGE 1 oF 3 PAGEs i 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, 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 deliver or transfer such materialto persons authorized to receive it in accordance with the regulations of th 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 j applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified l below. Licensee l
- 1. Underwater Irradiator Inc. am License 8- 345-01 !
- 2. 1234 Main Street g b lt ' Sti ri ,2007 Anywhere, USA 20000 (j 5.
piky. 5 rence ;
- 6. Byproduct, source, and/or s 'ai 7. Chemical and/ _ 'o 8. Maximum amount that licensee may nuclear material , yssess at any one time under this
.// 7 Rense A. Cobalt-60 '
'A') 80,000 curies Y N G4 Q b . 5 B. Cobalt-60 87 2,000,000 curies Q eidr'cos'(ZYff[/
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- 9. Authorized use '% A r' A. and B. For irradiation of materials other than explosives or corrosive materials.
C. For use in the calibration of the licensee's radiation detection equipment. CONDITIONS
- 10. A. Licensed material may be used at the licensee's facilities located at 1234 Main Street, Anywhere, U.S.A.
- 11. A. Licensed material shall be used by, or under the supervision of individuals who have satisfactorily completed the training and examination described, in the application dated January 29,1997 and have been designated in writing, by the Radiation Safety Officer. The licensee shall maintain NUREG - 1556 Vol. 6 S-4
NRC FORM 374A U.s, NUCLEAR REGULATORY Commission PAGE 2 of 3 PAGEs License Number 08-12345-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030 12345 Amendment No. l i 1 have been designated in writing, by the Radiation Safety Officer. The licensee shall maintain records of individuals designated as users for 3 years following the last use of licensed material by the individual. M B. The Radiation Safety Officer for this license is A. Loyd Webtieri ffp j _ qfn n c (g( , y g d g !
- 12. A. Sealed sources containing lic'ensed material specifiedin item 6.0 shall be tested for leakage and/or S
contamination at intervals the certificate of registration referred to in ridt 10 CFR to3,2!2{0, exceed notjo six months exceed 8pt three years. sE5t3 [ Note: The j[he calibration source 7, c. is not covered ,%h. by the leak ~
.A- test req)uirenient in 1 B. In the absence o a certificate from a transferor indicating that a leak test has been made within tha intervals specified'in the ceSficate'of rehistr5tiorfiskued b the U.S.' Nuclear Regulatory
~
Commission un[ddr 10 CFR 32.210 oEunder hg0lvalent
- rdgulations ofin Agreement State, prior to transfer, a sealbil source received}roniadother person shall not be put into use until tested and the test results rec 5ivAd. hO% bV 4 .7<
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. ".I C. Scaled sources need not be tested if they are in's>torage'and are not being used. However, when they are removed'f'rorn siorage forjshor transfefred,tof$nother pe}5on, and have not been tested sh'all be tested before use or transfer. No sealed source within the required Ifuk' test shall be stored for a)eriod 6f mor5~tha'ri jnterval, they(1'Oye' irs without bein'glested contamination. O' V 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, the licensee shall immediately remove the source from service, to report to the Nuclear Regulatory Commission according to 10 CFR 30.50(b)(2) and (c)(1), and have the source i decontaminated, repaired, or disposed of according to Commission regulations. The licensee shall file a written report according to 10 CFR 30.50(c)(2).
E. Tests for leakage and/or contamination, including leak test sample collection and analysis, shall be performed by the licensee or by persons specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to perform such services. l
- 13. Serled sources containing licensed material shall not be opened.
l S-5 NUREG - 1556, Vol. 6
NRC FORM 374A U.S. NUCLEAR REGULATORY COMMisSloN PAGE 3 of 3 PAGEs License Number 08-12345-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-12345 Amendment No.
- 14. The licensee shall implement the material accountability program described in letter dated March 8, 1997, to account for all sealed sources containing licensed material received and possessed under the license h
- 15. The licensee is authorized to transport licensed rnaterial in accordance,with the provisions of 10 CFR Part 71, " Packaging and Tranip8rtsi'on 9 Nd@ctive 'MetmM," 4
- 16. Irradiation ano distribution o,f f[ god's r human consumptie^nshali e ance with the rules and I regulations of the Food and Drug Administration and tlMOepgent of Agriculture.
Q
- 17. Except as specifically go,vided otherwise in this llegns%
h fA licensee shall' conduct its program in accordance with the statementsyepro6enta 'rMgocedures,containe,d,in the documents, including any enclosures,listedTelow. The}ludgr.R ' dimbission's regulations shall govern unless the statements, represefations and p[ see's application a@ correspondence are more restrictive than the regulations. . O c , 9 n d ,
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q p m i 8 w . , ; w . h ,. O n A. Application datedJanua,ry 5 j fIlM A A B. Letter received NI g) 98F3 4 {;i fj g Co
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I i For the U.S. Nuclear Regulatory Commission Dits By John O. Reviewer, Health Physicist Nuclear Materials Licensing Branch NRC Region City, State 54321 1 NUREG - 1556, Vol. 6 S-6
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NRC FORM 374 U.s. NUCLEAR RE2ULAToRY Commission PAGE 1 oF 2 PAGEs MATERIALS LICENSE }ursuint to the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code 50 Federrl Regulations, Chapter I, Parts %,31, 32, 33, 34, 35, 36, 39,40 and 70, and in reliance on statements and representations , her:,tofora made by the licensee, a liceNe is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, sourc3, tnd special nuclear material e asignated below; to use such material for the purpose (s) and at the place (s) designated below; to ' deliver or trcnsfer such material to peuns 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, aa 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 Rrily Big irradiator Inc. Ucense 1. p '3 194234-01
- s. 1234 Main Street 6 47 QElgatiMhtg)N5epjsmber 30,2005 5
Arrfwhere, USA 20000 5. Dock'et#d. . rence n
- 3. Byproduct, source, and/or special 7. Chemical and/ o 8 Maximum amount that licensee may nuclear material W # possess at any one time under this N/ kD / 1Teense kS A. Cobalt-60 ur (XYZ 1
'A) 3,000,000 curies
@182h G A2346) O ,
. 9. Authorized use
- N -Q4fjrq yW'J4 ;;>
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A. r for irradiation o,f m,,aterials;except explosives, flammables, l or use in an XYgMod or corrosives.
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- 10. Licensed material may the ligensee's fa locatedat~}1234 Main Street, Anywhere, USA.
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- 11. A. Licensed material shall be used' tIy, or under the super 9ision and in the physical presence of individuals who have satisfactorily co@!eISIti5Etraining and examination described in item 8 of application dated January 28,1997 and have been designated in writing by the Radiation Safety Officer. The licensee shall maintain records of individuals designated as users for 3 years following ,
the last use of licensed material by the individual l B. The Radiation Safety Officer for this license is Jayson M. Rutherford.
- 12. S aled sources containing licensed material shall not be opened by the licensee.
- 13. Tha licensee shall implement the material accountability program described in letter dated June 28,1997 to recount for all sealed sources containing licensed material received and possessed under the license.
- 14. Tha licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71," Packaging and Transportation of Radioactive Material."
l S.7 NUREG - 1556, Vol. 6 I l l
NRC FORM 374A U.S. NUCLEAR RE7ULATORY commission PAGE 2 of 2 PAGEs Ucense Number 08-12345-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-12345 Amendment No.
- 15. Irradiation and distribution of foods for human consumption shall be in accordance with the rules and regulations of the Food and Drug Administration and the U.S. Department of Agriculture.
- 16. The licensee is authorized to make modifications to the source rac requested in letter dated August 27,1997. The licensee shall test thefop#t of the s e for proper operation in accordance with 10 CFR 36.41(f) andfi) hi$r to Iourcebing. p
- 17. Except as specifically providQo rwise in this license, nduct its program in ice of accordance with the statements, representations, an ined in the documents, including any enclosures, listed bgo,w. The Nuclear Regul s regulations shall govern unless the -
statements, representatichs, and procedures in t e's atio04nd correspondence are more restrictive than the reg ii Q ~ui$tionsy}Q j 0 A. Application datfdune 28,1p7[ \ j{j) Q B. Letter dated A st 27,1997c * 'hJ ;w o 1l( f, $X l Dat) By John Q. Reviewer, Health Physicist Nuclear Materials Licensing Branch NRC Region City, State 54321 NUREG - 1556, Vol. 6 S.8 l l
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- l i
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i e Appendix T Addendum: Response to Comments on Draft NUREG - 1556, Vol. 6, Dated March 1998 l l
i l l l APPENDIX T I Addendum: Responses to Comments on Draft NUREG - 1556, Vol. 6, ; Dated March 1998 l Table T.1 Mark Smith, Corporate Manager of Technical Services, Storigenics International, Dated May 18,1998 Section Page ' Paragraph Comment ! 8.6 8-9 3rd from end The prohibition against cryogenic materials is not in 4 ofpage current regulations and is not well defined at this point. l Referring to Appendix F gives more information, but is i I still extremely limited. Considering that the NRC and Agreement States will use this guidance in reviewing , license applications, more guidance is necessary. For ] example, define the temperature of concern or specific : conditions under which the effect is noted. Some irradiator applications, such as tissue irradiation, use dry j ice to maintain low temperatures and maintain integrity of j the product. Broad use of the term" cryogenic" could ; result in prohibitions against this application, even though it would appear not to be included in the temperatures of concern (based on condensation of air). hnposing prohibitions that are not in the regulations through license application review is not a good method ) to ensure consistency in applying the interpretation. A better approach would be to' propose adding the cryogenic prohibition in the regulations, presenting the appropriate l data and making a final decision on the risks associated I with the practice, including considering the probability and mechanisms of occurrence. T-1 NUREG - 1556, Vol. 6
APPENDIX T Section Page Paragraph Comment NRC Staff Response: As recognized in the comment, irradiated cryogenic material may or may not become explosive dependent upon numerous factors some of which are not clearly understood. The guidance in Section 8.6 and Appendix F does not prohibit use of cryogenic materials in irradiators. In the text the guidance states that cryogenic materials are an example of materials not listed in the SSD registration certificate. The prohibition of irradiation of explosive material is contained in 10 CFR 36.69 and provides for NRC review on a case by case basis. The guidance provided is intended to alert licensee's to the fact that under certain conditions, irradiated cryogenic materials can explode. As stated in the guidance in Appendix F, the exact details of the phenomenon is uncertain. It is believed that oxygen in the air is converted by the radiation to ozone. Under cenain circumstances (often during a subsequent warm-up), the ozone decomposes or rexts with other agents explosively. Since the details of the conditions required for this phenomenon are uncertain but may lead to serious consequences, the licensee should carefully analyze any proposed irradiation of cryogenic material, design adequate safeguards and/or procedures, and submit its analysis for review by the NRC. The staff has for clarification, made minor revisions to the original text in Item 6: Purpose (s) for Which Licensed Material will be Used. 8.8.03 8-18 2nd (titled: The requirement is given for training all personnel who i
" Discussion") work in or frequent restricted areas. This does not agree with the current version of 10 CFR 19.12 (e.g., limited to those likely to receive annual occupational dose of 100 mrem). 4 NRC Staff Response: The first sentence in the first paragraph under " Discussion"in Item 8.8.03 has been revised and now states: "... According to 10 CFR 19.12, all individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (ImSv) must receive appropriate instmetion in radiation safety..."
NUREG - 1556, Vol. 6 T-2
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APPENDIX T Section Page Paragraph Comment 8.9.01 8-19 lst under Considering the shielding requirements and the low
" Discussion" probability of any offsite consequences from irradiator operations, the generallayout of properties adjacent to building should be of no panicular interest. It should bc .
sufficient for the licensee to verify that the facility is located in accordance with the local zoning restrictions (i.e.,"...in an area zoned industrial."). [This requirement is repeated on page 8-20.] NRC Staff Response: The last sentence in the first paragraph under " Discussion" and the third l bullet under " Response from Applicant"in Item 8.9.01 have been removed. As a reminder, it should be noted that as defined in 10 CFR 36.l(a) and Item 8.3, an NRC license does not , relieve the licensee from complying with other applicable Federal, State and local regulations goveming the siting, zoning, land use, and building code requirements for industrial facilities. ] 8.9.01 8-19 last on page Using the phrase "...any constmetion activities not yet completed..." is inaccurate for new facility licenses, since 10 CFR 36.15 states that the application has to be submitted prior to starting irradiator construction. The guidance should be to provide "...a schedule for construction of the irradiator." (It is stated correctly on page 8-20.) NRC Staff Response: The first sentence in the second paragraph under" Discussion"in Item ) 8.9.01 has been revised and now states: "... An applicant should provide a schedule for I l construction activities associated with the irradiator..." 1 I 8.9.02 8-21 last on page The term " direct radiation beam"is used. For a panoramic irradiator, which is what most of those covered by this guidance are, the concept needs to be explained. For example, does this mean that portion of the room that has no materials interposed between the sources and the area under consideration? The concept of a " beam" does not apply to panoramic irradiators in the traditional intetpretation of the term. An operational definition as to how that concept is to be applied would be useful in this guidance. T-3 NUREG - 1556, Vol. 6
. _ _ . . - .._..._ _ _._ . _._ _ . . _ _ _ . - . . .._ _ _ _.___ _ _. _ m. APPENDIX T Section Page Paragraph Comment NRC StaK Response: The NRC staff agrees with this comment; however,10 CFR 36.23(c) specifically states the sentence using the term " direct radiadon beam." In order to clarify this, the last sentence in the fifth paragraph under " Panoramic Irradiators" in item 8.9.02 has been revised and now states: ...The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam (e.g., an area of the maze that may expose the instrument directly to the irradiator sources when in the unshielded position..." 8.9.02 8-22 last This paragraph is unclear. I was unable to determine exactly what requirement was being considered and what the stated rationale was for it. This radiation monitor appears to be the one required under 10 CFR 36.23(b), but that was addressed on the previous page. If that was what was intended, then this paragraph should be deleted, as the pertinent requirements are covered earlier. If that is not what was intended, this paragraph would then appear I to be imposing a requirement for an additional radiation monitor not called for in either the pertinent ANSI documents or the NRC regulations. NRC StaK Response: The ninth paragraph under " Panoramic Irradiators" in Item 8.9.02 has been deleted. l NUREG - 1556, Vol. 6 T-4
_ . _ _ . . . - . ~ _ _ . _ . _ _ . _ . _ _ _ _ . _ . _ _ _ _ _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ . i a i APPENDIX T ! ]
!. l Section Page Paragraph Comment j lt j 8.9.03 8-24 1st under The guidance should clarify what effects are expected f
" Discussion" from heating in shield walls (i.e., how can an individual ,
j reviewing a license application determine if the NRC , i- concerns have been adequately addressed 7). The only ; i reasonable concern from the NRC perspective should be ! i for compromising radiation shielding or stmetural l l stability in the walls. Since these facilities with more than l l 5 mci are typically constmeted with 6 feet (or more) of. ! i concrete, it is hard to imagine any scenario in which j heating from the sources would compromise either the l l shielding or structure. However, since the requirement is j j in the regulations, it must be addressed in the guidance. l l As a minimum, the guidance should give direction to the - ! l license reviewer and applicant as to what evaluation l
- should be done and provide references to which either can go to find additional information.'..such as maximum ;
temperature tolerances for concrete and an explanation of the likely effects from exceeding those temperatures. 1 NRC Staff Response: The criteria for this requirement was based on industry standards and consensus at the time the final mie was amended to the regulations. Thermal effects are a concern because of its effects on shielding (e.g., deterioration of concrete walls when exposed i to high temperatures).~ As a result, licensees should conduct this evaluation to determine what j impact thermal effects would have on the type of shielding used at their facility. Licensees . should submit what additional engineering controls or designs that need to be implemented to prevent thermal effects that may damage shielding. In order to clarify this matter, the fourth bullet under the first box in Item 8.9.03 has Men revised and now states: s If the irradiator will use more than 2 X 10'7 (Bq) (5 million curies) of activity, the applicant must evaluate the effects of heating of the shielding walls by the irradiator sources (e.g., thermal effects on concrete)... 4 i d T-5 NUREG - 1556 Vol. 6
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APPENDIX T Section Page Paragraph Comment 8.9.03 8-25 last The guidance document says that possession limits of more than 5 mci requires the licensee provide a description of how cooling the shield walls will be done. The requirement of 10 CFR 36.39(a) is that, at that activity level, the licensee must evaluate possible heating effects. Cooling may not be required until much higher activity levels are loaded into the irradiator. NRC Staff Response: The fourth bullet under " Response from Applicant:
- For Panoramic Irradiators...
to Item 8.9.03 has been revised and now states: "...For requests to possess more than 2 X 10" Bq (5,000,000 curies), submit an evaluation of the effects of heating of the shield walls by the irradiator sources..." , 8.9.04 8-27 1st The last sentence of this paragraph is unclear. Whether ) the source position indicators, access control system, and l source return system operate properly in a fire does not l relate to having the fire extinguishing system operable l without entering the radiation room. The best approach l would be to delete that sentence, as it adds nothing to the t interpretation of the regulatory requirement. NRC Staff Response: The subject matter regarding fire protection was discussed in the
" Statements of Consideration" when 10 CFR Part 36 was made into a final mle. The sentence the commenter was referring to in the new guidance was the NRC's position regarding fire I protection at the time the final rule was amended to the regulations. Based on this position, the j guidance document was not revised in response to this comment. i i
l l l NUREG - 1556, Vol. 6 T-6 i w
l l l APPENDIX T _ Section Page Paragraph Comment 8.9.05 8-28 last 10 CFR 36.59 does not require that the water monitoring system be continuous. Later in the same paragraph, the statement is made that "Each time the irradiator operates, the licensee should measure for radioactive contamination in the pool water..." 10 CFR 36.59(b) states that monitoring is required "...each day the irradiator operates..."The irradiator may be operated several times , in one day (assuming a batch system) or in a continuous mode. The guidance should be changed to read "each day." NRC Staff Response: The second sentence in the bullet "For pool irradiators:" under
" Discussion" in Item 8.9.05 has been revised and now states: "...The system should be equipped with a radiation monitoring device with an alarm which will stop all pool water recirculation should the radiation reach a preset alarm level..."
The third sentence in the bullet "For pool irradiators:" under the " Discussion" in Item 8.9.05 has been revised and now states: "...Each day the irradiator operates,..." 8.9.06 8-30 sentence This states that the purpose for maintaining pool liner directly above integrity is to minimize the probability of contaminated , the box water leakage. In the absence of contamination, it is still desirable to minimize the possibility oflarge leaks, since the water provides shielding for the sources. NRC Staff Response: The second sentence under " Discussion" in Item 8.9.06 has been revised and now states: "...The purpose of the requirement is to reduce the likelihood of the pool leaking water that may be contaminated or used for shielding purposes..." next-to-last The phrase " prevent corrosion" is much too strong, I 8.9.06 8-30 considering recent debate as to whether conductivity alone is an adequate indicator of pool water quality. Better wording would be "... minimize the probability of Corrosion..." NRC Staff Response: The last sentence in the fifth paragraph under " Discussion" in item 8.9.06 has been revised and now states: "...The water purification system is needed to minimize the probability of corrosion of the sealed sources and the source rack..." 8.9.07 8-32 2nd paragraph The statement regarding "no crevices" needs to be clarified, i.e., what constitutes a crevice? T-7 NUREG - 1556, Vol. 6
APPENDIX T Section Page Paragraph Comment NRC Staff Response: The first sentence in the third paragraph under " Discussion"in Item 8.9.07 has been revised and now states: " ...For pool irradiators, the licensee must verify that there are no crevices on the source or between the source and source rack that would promote corrosion on a critical area of the source (e.g., crevice corrosion, an inaccessible location in or around the sources or rack with low oxygen concentrations). 8.9.07 8-32 2nd An additional concern should also be expressed regarding the potential for sources to be dislodged from the source rack during these drops. NRC Staff Response: The third sentence in the second paragraph under " Discussion" in Item 8.9.07 has been added and now states: ...In addition, licensees should review the potential of sealed sources to become dislodged from the source rack when dropped as a result ofloss of power, failure of cables or other alternate means of support..." 8.10.01 8-34 Iunder According to this sentence, the license application is
" Response supposed to address reviewing the "... content and {
from implementation..." of the program. No guidance is given ! Applicant" on criteria for reviewing content, only for implementation. NRC Staff Response: The first two pages of Appendix K provide guidance on reviewing the content of the program. Based on this, the guidance document was not revised. 8.10.02 8-37 under " Survey The guidance says that individuals performing source Instmments" - manipulations should be monitored with a survey instrument. This implies that they should be checked for personnel contamination. A better way to state this would be to say that the " operations" must be monitored. NRC Staff Response: The staff agrees with the comment and changes have been made to the text to indicate that operations must be monitored. 8.10.02 8-37 last This defines fail-safe radiation monitors as "a backup warning system." That is the definition for ,
" redundant,"not ' fail safe." Redundancy is not required for monitors, nor should it be. However, a fail-safe system is and should be required, with the definition being that failures of the system cause the same response as detection of a high radiation level. (e.g., the door remains locked)
NUREG - 1556. Vol. 6 T-8
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i l l 1 l ' APPENDIX T l Section Fase Paragraph Comment ) NRC StaK Response: The last sentence under the second heading of " Radiation Monitors" in Item 8.10.02 has been revised and now states: "... Monitors that warn individuals of the presence of high radiation or which are integrated with personnel access door locks to prevent l' room access under high radiation conditions should be designed to provide fail-safe operation,
- i.e., if the radiation monitor for any reason fails to respond to radiation, the door to the l irradiator room remains locked until it has been determined that the sources are in the shielded l position and safe for individuals to enter the room..." i Table 8.3 - 8-40 .. A ' semiannual visual inspection is of extremely limited . l l
value in terms of source accountability. The only ~ determination that could be made under such a procedure ! would be that sources are still in the source rack. L NRC StaN Response: A 6-month general visual inspection would be of little use m determining accountability of sources stored in the irradiator since the licensee would be unable to see ifindividual sources were missing. The concern that the team attempted to address with : the 6-month general visual inspections was that the licensee should be able to verify that no ! sources have been lost. Sources are added to many pool irradiators on an approximately annual basis. As an alternative, it was thought that it would be reasonable to have the licensee verify that no sources have been lost during source loadings. The team felt that, for licensees that do l not have sources loaded annually, it would be reasonable to verify that no sources have been l l lost at least every three years. The following was added as an item to be addressed in l accountability procedures: " verify that no sources have been lost each time sources are added l to, removed from, or moved within the irradiator or, at a minimum, every three years." Table 8.3 ' 8 The phrase "irradiator location (if more than one irradiator i is authorized)" should be replaced with " location of each - source." l NRC StaK Response: Table 8.3 has been amended as suggested. Table 8.3 8-40 The irradiator use log is also of limited value in terms of source accountability.. NRC StaN Response: Table 8.3 has been amended to remove "Irradiator use log books" as an element of accountability procedures for Panoramic Dry-Source-Storage Irradiators. I i f 1 i ( l T-9 NUREG - 1556, Vol. 6
APPENDIX T Section Page Paragraph Comment Table 8.3 8-40 A semiannual physical inventory in a dry-source-storage irradiator should not be a requirement, considering the difficulty in condteting such an inventory in a typical production model irradiator, where the source rack remains within its shield when not in operation and is not accessible during operations. However,it would be easy to conduct a physical inventory for teletherapy units convened to non-human use. NRC Staff Response: Table 8.3 has been amended to remove "6-month physical inventory" as an item to be addressed in accountability procedures. This is do to the fact that it is not-practical to visually observe sealed sources installed in Panoramic Dry-Source-Storage Irradiators. 8.10.06 8-45 1st paragraph The requirement should be to provide copies of under procedures "for" each operator, not "to" each operator.
" Discussion" Since internal procedures are typically controlled documents under ISO 9001/9002 registrations, having each operator of a production irradiator, particularly with !
multiple irradiator locations, results in too many controlled copies and increases the probability that outdated copies would be in circulation. Same comment applies on page 8-51, sect. 8.10.07. NRC Staff Response: Section 8.10.06, " Operating Procedures," has been changed as < suggested. 8.10.08 8-45 ist Guidance should be provided on when to consider that a source may be leaking. The traditional action level is 0.005 Ci, which is of course not applicable to pool water monitoring. Some guidelines for licensees as to what levels are considered indicative of source leakage would be beneficial. NRC Staff Response: Due to constant improvements in radiation detection technology, the j staff determined that additional guidance as to what levels are considered indicative of source leakage in a pool type irradiator is not warranted at this time. In effect any increase in the radioactivity in the pool water should alert the licensee to a possible leaking source or sources. ; Based on this position, the guidance was not revised in response la the comment. t NUREG - 1556, Vol. 6 T-10
l APPENDIX T Section Page Paragraph Comument Appendix F F-1 3rd The statement is made that the concern is for explosion during irradiator operations. However, the "small l quantity" discussion uses the lower flammable limit as the defining value. If explosion is of concern, then the lower : explosive limit should be used instead. l NRC Staff Response: With regards to the subject matter on flammable materials, the use of l
" lower explosive limits" as suggested by the cementer would not be appropriate in this case, m that, the lower flammable limit is appropriate when used in discussing this subject matter.
After careful consideration by the staffit was determined that if such terminology were used in l that context, it could be construed that it would be appropriate for licensees to irradiate l materials under conditions conducive for explosive conditions. The intent of this statement was that when irradiating flammable liquids as allowed by the negulations, licensees must evaluate products to ensure that when irradiated the flash point or lowest temperature at which the vapor of the liquid would ignite to create an environment susceptible to explosion. Based on this position, the guidance document was not revised in response to the comment. Appendix 0 0-2 3rd row of " product"is misspelled: " Detection of radiation source Table by the prodect [ sic] exit monitor" NRC Staff Response: The first column in the 17th row under Table O.1 in Appendix O ha-
. been revised and now states: "... Detection of radiation source by the product exit monito ./'
Appendix P P-2 3rd bullet Using a separate wipe for each source not practical in Item many dry source storage configurations. NRC Staff Response: The staff agrees with the comment and has changed the text to read,
" Prepare one swipe per irradiator, if more than one source is contained in the same enclosure."
i I i T-l1 NUREG - 1556, Vol. 6
APPENDIX T Table T.2 Joseph G. Klinger, Chief, Division of Radioactive Materials, State of Illinois Dated July 8,1998 Section Page Paragraph Comment N/A N/A N/A Many of the items discussed are already required by 10 CFR Part 36. Applicants should not have to submit information that is adequately covered by regulation. NRC StatT Response: Since no specific examples were given by the cementer ofinformation that should not be required of the licensee when filing a license application, it is difficult to respond directly to this suggestion. In general, the NRC appreciates the time and effort required to prepa e license applications. Therefore, only information necessary to adequately evaluate c. license application is requested. Document has not been revised in response to this comment 8.7.01 8-11 In Section, page three months does not seem to be enough practical experience to be named as an RSO for an irradiator facility. This should be increased to at least six ; months. I
~
\
NRC Staff Response: Staff experience indicates that three months is an adequate amount of practical experience to be named as an RSO at an irradiator facility. To date, no adverse outcomes have arisen from approving a RSO with tluce months of practical experience. Document has not been revised in response to this comment. 8.9 Section 8.9 discusses requirements for facilities constructed after July 1,1993, but does not clearly indicate if these requirements are applicable to facilities ! existing prior to this date. Obviously structural changes may be impossible, but systems such as radiation monitors, fire protection, access control, etc. should be updated. NRC Staff Response: The cementer's suggestion is derived from the document's handling of the design requirements in 10 CFR 36.39 for irradiators whose construction begins after July 1, 1993. Section 8.9.03 was changed to specify the requirements that to clearly indicate that those
)
design requirements that are applicable to irradiators whose construction begins after July 1, j 1993. The cementer also addresses the issue of backfitting existing irradiators to the new l standards. Since 10 CFR Part 36 does not address the issue of backfitting existing irradiators to the new standard, it is not addressed in this guide. l i NUREG 1556.Vol.6 T-12 i
. -= - -. .-. . _. ~ . - - - . . -
l APPENDIX T Section Page Paragraph Comment 8.9.03 8-25 Section 8.9.03, page 8-25. should clarify that diagrams ; showing the configuration of shielding and the thickness specifically for ceilings should be included. This information should also be added to page C-4. NRC Staff Response: Section 8.9.03 has been amended to request diagrams showing the configuration of shielding including walls and the ceiling, and the thickness specifically for ceilings. 8.9.04 Section 8.9.04 appears to contai n conflicting information as to whether the fire extinguishiag systems must actually be tested (e.g., with water spray and/or chemicals). Page 8-27 and Appendix J indicate testing of the fire , extinguishing system is required, but page 8-55 indicates l the fire extinguisner should not be turned on during the test. NRC Staff Response: It is not mquired that licensees turn on extinguishers (i.e., water or chemicals) during tests of the operability of their fire protection systems. Section 8.9.04 and Appendix J have been amended to make this clear. 8.9.06 8-30 Section 8.9.06, page 8-30 discusses pool water quality and the 20 microsiemens limit. Most of the manufacturers also require through their contracts for sale / warranties that the pH and chloride content also be monitored. These should be investigated for use in place of or in addition to l the 20 microsiemen limit. NRC Staff Response: Currently conductivity is the only regulated measure of pool water quality for irradiators (10 CFR 36.63). The NRC is concerned about the possible corrosion , problems that may be caused by dissolved chlorides in pool water and the effects oflow pH on sealed sources and irradiator components . However, since there are currently no regulatory limits for chloride content or pH, no monitoring of these qualities is suggested in this guidance document. Document has not been revised in response to this comment. T-13 NUREG - 1556, Vol. 6
b APPENDIX T Section Page MC Comunent
'8.10.02 8-37 Section 8.10.02, page 8-37 indicates survey instmments should measure at least 0.3 mR/hr through 200 mR/hr.
4 10 CFR 36.57 requires survey instmments to be capable - of measuring a minimum of 0.05 mR/hr.
' NRC StaKResponse: Section 8.10.02, page 8-37 has been changed as suggested.
N/A N/A A section should be added to the document which discusses limiting the cask activity limits and the length of time casks can be loaded at th maximum activity to ensure the manufacturer's recommended temperatures are not exceeded. Additionally,if the manufacturer's specifications for transpon containers have not been determined, tests should be performed to establish these limits. NRC StaK Response: As discussed in Section 8.10.10, "Trar.sportation," transponing licensed i materials originating at irradiator facilities normally involves quantities of radioactive material j that require a Type B package. Because of the special requirements involved in shipping Type B packages, most irradiator licensees have chosen to transfer possession of radioactive. ; materials to an irradiator manufacturer (or service licensee) with an NRC or Agreement State ; license who then acts as the shipper. The manufacturer (or Lervice licensee), who is subject to ! the provisions of 10 CFR 71.12 or 10 CFR71.14, as appropriate, then becomes responsible for pioper packaging of the radioactive materials and compliance with NRC and DOT regulations.- If a licensee plans to nake shipments oflicensed materials in Type B packages on its own, the .
- licensee must 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. :
Requirements for the issues identified by the cementer are normally found in Cenificates of . ! Compliance for Type B packages. QA plans are required to be implemented to assure that the' ! requirements of Certificates of Compliance are met. Section 8.10.10, ' Transportation," ! discusses guidance documents that adequately address QA Plans. Therefore, these issues have j been adequately addressed in Section 8.10.10, " Transportation," especially when one considers i that irradiator licensees do not normally transport licensed materials in Type B containers. Document has not been revised in response to this comment.
)
3 1 i i c NUREG - 1556, Vol. 6 T-14
F-APPENDIX T Section Page Paragraph Comment Appendix J Appendix J indicates what steps during pool irradiator construction the regulating agency should perform inspections to ensure the irradiator facility is being built to specification =. However, the t.ime frames and critical construction points to be observed should be specified (i.e., inspections for voids during pours of shielding walls vs. after pours, etc.). l NRC StaN Response: This comment has already been addmssed in Item 9: Facilities and Equipment. In the discussion, the applicant is directed to submit a construction schedule to allow the NRC to inspect such activities. The staff mcoguized the cementer's concern but after review determined that such activities vary from facility to facility based on designs and construction and would best be reviewed on a case-by<:ase basis. Providing the NRC a construction schedule would allow the NRC or other regulatory agency to make their own determinations as to when activities required inspection oversighi. The document was not revised in response to this comment. I T-15 NUREG - 1556, Vol. 6
NRc FORM 335 u.s. NUCLEAR REluLATORY COMMISION 1. FsEPORT NUMBER 3 49) (Assigned by NRC. Add Voi, Supp Rev., "7:2 3 Cl2LIOGRAPHIC DATA SHEET
*"d^'***'"""""**'*"*""
i NUREG-1556
- 2. TITLE AND SuSTtTLE yo!. 6 Consolidated Guidance About Materials Licenses
- 3. DATE REPORT PUBLISHED Progrim-Specific Guidance About 10 CFR Part 36 Irradiator Licenses MONTH YEAR l ;
Final Report January 1999 {
- 4. FIN OR GRANT NUMBER
- 5. AUTHOR (S) 6.TYFT ' REPORT J. D. Jones, W. T. Loo, E. H. Rober, M.E. Schwartz, P.C. Vacca, Final
- 7. PERIOD COVERED (inclusae Dares) l
- 8. PERFORMING ORGANIZATION NAME AND ADDRESF (#Nac, pnum owan, ofta a sepan. u s. Nucisar seguserary commasari, arur madng address; # contractor, powde name and maeng acuress J Offica of Nuclear Material Safety and Safeguards Division of industrial and Medicat Nuclear Safety U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 l
- 9. SPONSORING ORGANt2ATION NAME AND ADDRESS (#Nac, type "Same as abme; # contractor, pnmde Nnc Dason, one or sepan, u s Nucearseguistory commusen, j and manno adeess) 1 Same as above l
- 10. SUPPLEMENTARY NOTES
- 11. ABSTRACT poo wonss or has; NRC is using Business Process Redesign (BPR) techniques to redesign its materia is licensing process, as described in NURE'l 1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign." A critical element of the new process is consolidating and updating numerous guidance documents into a NUREC series of reports.
This NUREG report is the sixth program-specific guidance developed to support a n improved materials licensing process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the l guidance for applicants and licensees previously found in Draft Regulatory Guid e DG-0003, " Guide for the Preparation of Applications for Licenses for Non-Self-Contained Irradiators," dateo January 19 94, and the guidance for ficensing staff previously found in NMSS Policy and Gu. dance Directive. FC 84-23,
- Standard Review Plan for Licenses for the Use of l Panoramic Dry Source-Storage irradiators, Self Contained Wet Source-Storage, an o Panoramic Wet Source-Storage ;
trradiators
- deted December 27,1984. In addnion, this report also contains pertinent information found in Technical l Assistance Requests and Information Notices. j On April 23,1998,(63 FR 20224), NRC announced the availability of draft NUREG 1556, Vol. 6, and requested comments on it. Th final document contains a compilation of the comments and the staff's responses. The comments were considered in j preparing the final NUREG Report.
Applicants for NRC licenses should use this guidance when preparing application s for NRC licenses. NRC staff will use this finil report in reviewing these applications.
- 13. AVAILABluTY STATEMENT
- 12. KEY WORDS/DESCRIP TORS (ust eens or phrases shat we asset maeanmers e bearms ese report./
unlimited mat: rials M sEWRlWCLASSIRCADoN ficensees (D'* Page) irradiator risk-informed unciassified performance-based fn,,, nepo,,; program-specific unclassified
- 15. NUMBER OF PAGES
- 16. PRICE NHC NW X85 W48) The form was eweironcany produced by Ekte Federal Forms, Inc.
I l Printed on recycled paper Federal Recyding Program
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