ML20198G224
| ML20198G224 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/1997 |
| From: | Dan Collins, Matthew Mitchell, Radcliffe W, Schwartz M, Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V5-DRF-FC, NUDOCS 9801120276 | |
| Download: ML20198G224 (180) | |
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i l AVAILABILITY NOTICE
- Availability of Ref5rence Materials Cited in NRC Publications Most documents cited in NRC publi@ns will be available from one of the following sources:
1, The NRC Public Document Room - 2120 L Street, NW.; Lower Level, Washington, DC 20555-0001 2.- The Superintendent of Documents, U.S. Government Printing Office P. O. Box 37082,5 Washington, DC 20402-9328
- 3. The National Technical Information Service, Springfield, VA 22161-0002 Although the listing that follows represents the rnajority of documents cited in NRC publica. -
tions, it is not intended to be exhausthre. Referenced documents available for inspection and copying for a fee from the NRC Public Document Room include NRC correspondence and internal NRC memorands; NRC bulletins, circulars, information notices, inspection and investigation notices; licensee event reports:-
- vendor reports and correspondence; Commission papers; and appilcant and licensee docu-- 3 ments and correspondence.
The following documents in the NUREG series are available for purchase from the Govemment Printing Office: formal NRC staff and contractor reports, NRC-sponsored conference pro-ceedings, International agreement reports, grantee reports, and NRC booklets and bro -
. churos. Also avellable are regulatory guides, NRC regulations in the Code of Federal Regula-tions, and Nuclear Regulatory Commission Issuances, Documents available from the National Technical information Service include NUREG-series reports and technical reports prepared by other FeJeral agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission.
Documents available from public and special technical libraries include all open literature
' Items, such as bocks, journal articles, and transactions. Federal Register notices Federal and State legislation, and congressional re,, orts can usually be obtained from these libraries.
Documents such as theses, dissertations, foreign reports and trans*"'ons, and non-NRC co7-ference proceedings are available for purchaso from the organization sponsoring the publica-tion cited. f Single copies of NRC draft reports are available free, to the extent of supply, upon written request to the Office of Administration, Distribution and Mall Services Section, U.S. Nuclear Regulatory Commission. Wash'ngton DC 20555-0001. Copies of industry codes and standards used in a substantive manner in the NRC regulatory process are maintained at the NRC Library, Two White Flint North,11545 Rockville Pike, Rock-ville, MD 20852-2738,'for use by the public. Codes and standards are usually copyrighted and may be purchat,ad from the originating organization or, if they are American National Standards, from the An'ican National Standards Institute,1430 Broadway. New York, NY 10018-3308.-
NUREG-1556 Vol. 5 l l Consolidated Guidance About Materials Licenses l Program-Specific Guidance About Self-Shielded Irradiator Licenses l Draft Report for Comment , I I
- Manuscript Completed: October 1997 i
Date Published: October 1997 l l Prepared by P. C. Vacca, D. J. Collins, M. W. Mitchell, W. II. Radclifre, M. E. Schwartz Division ofIndustrial and Medical Nuclear Safety OfUce of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 [ 7"'%
%.....A
[ l
COMMENTS ON DRAFT REPORT Any interested party may submit comments on this report for consideration by the NRC stafE Please specify the report number, draft NUREG-1556, Vol. 5, in your comments, and send them - by the due date published in the Federal Register notice to: Chief, Rules Review and Directives Branch OfTice of Administratiot. Mail Stop T6-DS9 Washington, DC 20555-0001 3,
)
L
-i ABSTRACT t As part ofits redesign of the materials licensing process, NRC is consolidating and updating numercus 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 drah NUREO-1541, " Process and Design for Consolidating
- and Updating Materials Licensing Guidance," dated April 1996. NUREO-1556, Vol. 5, _
" Consolidated Guidance about Materials Licenses: Program Specific Guidance about Self- ;
1 Shielded Irradiator Licenses," dated October 1997, is the fifth program-specific guidance devekpd for the new process and is intended for use by applicants, licensees, and NRC staff and will ai:a be available to Agreement States. Thir document combines and updates the guidance found in Regulatory Guide 10.9, Revision 1, " Guide for the 1%p.igion of Applications for Licenses for the Use of Self-Contained Dry Source Storage Gamma Irradiators," dated - December 1988, and in NMSS Policy and Guidance Directive FC 84-16, Revision 1, " Standard
' Review Plan for Applications for Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated January 26,1989. This draft report tah more risk informed, performance-based approach to licensing self shielded irradiators, and rwwes the information (amount and -
level of detail) needed to support an application to use these devices. Note that this document is strictly for public comment and is not for use in preparing or reviewing self-shielded irradiator licenses until it is published in final form. l 4 4 I ' s i iii Draft NUREG - 1556, Vol. 5 L- I
TABLE OF CONTENTS A B STRA CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii FOREWORD...............................................................................ix
- A CKNOWLEDG MENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
- A BB REVIATION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x iii i PURPOSE OF DRAFT REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 A G REEMENT STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 3 MANAG EMENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 4 APPLICABLE REGULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 5 HO W
................................................................51 5.1TO FILE PAPER . . . . . . . .dATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPLt 5.2 ELECTRONIC APPLICATION . . . . . . . . . . . . . . . . . . . . ..............................52 6 WH E RE 'ID FI LE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1 7 LI CEN S E FE E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1 8 CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 8.1 ITEM 1: LICEN SE ACTION TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE U S ED OR POSS ES SED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION . . . . . . . . . . . . . . . . . . 8 3 8.5 ITEM 5: RADIOACTIVE MATERIAL SEALED SOURCES AND DEVICES . . . . . . . . . . . . . 8-4 8.6 ITEM 5: RADIOACTIVE MATERIAL FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 8.7 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WI LL B E USED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 7 8.8 ITEM 7: INDIVIDUAL (S) RESPCNSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE - RADIATION SAFETY OFF1 C ER ( RSO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 8 8.9 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS (INSTRUCTIONS TO WORKERS) . . . . . . . , , , . . . . . . . 8 10 8.10 ITEM 9: FACILITIES AND EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11 8.11 ITEM 10: RADIATION SAFETY PROGR?.M - AUDIT PROGRAM . . . . . . . . . . . . . . . . . . . . 8-13 8.12 ITEM 10: RADIATION SAFETY PROGRAM - RADIATION MONITORING IN STRU MENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 14 8.13 ITEM 10: RADIATION SAFETY PROGRAM - MATERIAL RECEIPT AND ACCOUNTABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 16 8.14 ITEM 10: RADIATION SAFETY PROGRAM - OCCUPATIONAL DOSIMETRY . . . . . . . . . 8-18 8.15 ITEM 10: RADIATION SAFETY PROGRAM - PUBLIC DOSE . . . . . . . . . . . . . . . . . . . . . . . 8 21 8.16 ITEM 10: RADIATION SAFETY PROGRAM OPERATING AND EMERGENCY PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23 8.17 ITEM 10: RADIATION SAFETY PROGRAM LEAK TESTS . . . . . . . . . . . . . . , . . . . . . . . . 8 26 8.18 ITEM 10: RADIATION SAFETY PROGRAM - MAINTENANCE . . . . . . . . . . . . . . . . . . . . . 8-27 8.19 ITEM 10: RADIATION SAFETY PROGRAM - TRANSPORTATION . . . . . . . . . . . . . . . . . . 8 30 8.20 ITEM 10: RADIATION SAFETY PROGRAM - MINIMIZATION OF CONTAMIN ATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 2 8.21 ITEM 11: WASTE MANAGEMENT- SELF-SHIELDED IRRADIATOR DISPOSAL AND TRAN S FER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 2 8.22 ITEM 12 : FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8- 3 3 8.23 ITEM 13 : CERTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 3 v Draft NUREG - 1556, Vol. 5
s TABLE OF CONTENTS -- 9 AMENDMENTS AND RENEWALS TO A LICENSE . . . .. . . . . . . . . . . . . . . . . . . . c. . . . . . . . . . . . . . . . . . 9 : 10 TERMINATION OF ACTIVITIES . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . =. 10 1 j List of Appendices- '
.En8s I A List of Documents Considered in the Preparation of this DraA NUREO Report . . . . . . . . . . . . . . . . . . . . . . . A 1
. B United States Nuclear Regulatory Commlesion Form 313 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B 1 C Suggested Format for Providing Information Requested in Items 5 through 1I of NRC Form 313 . . . . . . . . . C-1 i D Information Needed for Transfer of Control Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D.! l E J. L. Shepherd Order , . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . - E 1 F Guidance on Financial Assurance' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F 1 O Model Training Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . 0 1 H Typical Duties and Responsib!!ities of the Radiation Safety Oftu.er . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . H 1
- I Information Needed to Support Applicant's Request to Perform Nonmoutme Maintenance .............11 J Suggested Self. Shielded Irradiah-A udit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . J-l :
- K Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program . . . . . . K 1 L Guidance nor Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent
. of the Allowable Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . L- 1
- M Guidance for Demonstrating that Individual Members of the Public will not Receive Dooes Exceeding
. the A llowable Lim its . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M 1 N Information for Applicants to Consider When Developing Operating and Emergency Procedures for Self. Shielded Irradiators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ' N- 1 O Model Lenk Test Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~ . . . . . . . . . . . . . . . . . . . . O l P Transportation
- Part 1 Mqjor DOTRegulations '. .........................................................Pl Part 2-Sample BillofL.ading Part .1 - Irrodiators Built Before 10 CFR Part il Regulation' im Q Sample Self Shielded Irradiator License . . . . . . . ....................................Q-1 . . . . . . . . . . .plementation R Checklist for Self Shielded Irradiator Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R 1 List of Figures Paan
- . Figure 1.1 Types of Irradiators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2
- = Figure 2.1 U . S. Map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Figure 8.1 RSO Responsibilities . , , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 9 -
Figure 8.2 Material Receipt and Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17 Figure 8.3 Annual Dose Limits for Radiation Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 19 Figure 8.4 Proper Location ofIrradiator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21
- Figure 8.5 Proper Handling of Incident . . . . . n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 24
' Figure 8.6 Routine Maintenance and Lubrication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28 l Figure 8.7 Non-Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . . . . 8-2 9 figure M.I Diagram of Office and Irradiator Area '. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M 3 I
i n
- DraA NUREG - 1556. Vol. 5 vi l .
t L'
s .... . . . . , - . __ _ P
;-,I_t--
.1 q
- sm TABLE OF CONTENTS ,
? Ust of Tatdes-- +
Table 2.1 Who Regulates the Activity't . .- . . . ~. . . . , . . . , 2 . . . . . . . . . . . . . . . . .-. . . . . =. . . . . . . . . . . . . . . . . 2 1 Table 8.1 - Minimum inventory Quantity Requiring Financial Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 i . Table 8.2 Record Maintenaace . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 18 :
- Table A.1 = List of Documents Considered in the Preparation of this DraA Report . . . . . . . . . . . . . . . . . . . . . . . . A I
~ Table F.1 Worksheet for Determining Need for Financial Assurance for Self-Shielded Irradiators . . . . . . . . . . . F-1 -*
Table L 1 Dosimetry Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - L 3 -
- t Table M.1 Information Known about the Self-Shielded irradiator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M 3 -
Table M.2 Calculatium) Method. Part 1: Hourly and Annual Dose Received from Self Shielded Irradiator . . . M 4 Table M.3 Calcutshonal Method. Part 2: Annual Dose Received from Self. Shielded Irradiator . . . . . . . . . . . . M 5 - Tabk M.4 Calculational Method, Part 3: Summary of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c. . M-6 Table M.5 Calculational Method, Part 3: Annual Dose Received from Irradiator . . . . . . . . . . . . . . . . . . . . . , . . M-6 Table M.6 Combination Measurement Calculational Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . M-9 1
.i-J f
4 4 i vil DraA NUREG - 1556, Vol. 5 t
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+
FOREWORD. . The United States Nuclear Reinlatory Commission (NRC) is using Business Process Redesign : l (BPR)iechniques to redesign its materials licensing process. This effort is described in NUREOc
;1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated -
~
2 April 1996. A critical element of the new process la consolidating and updating ~munerous
- guidance documents into a NUREO series of reports. = Below is a list of volumes curtently included in the NUREO 1556 series:
VolummTitle Status Vol No. .
-1 Program Specific Guidance About Portable Gauge Licenses Final Report J 2 Program-Specific Guidance About Radiography Licenses DraR for Comment i 3- Applications for Scaled Source and Device Evaluation and DraR for Comment j Registration l, 4 Program Specific Guidance About Fixed Osuge Licenses Draft for Comment l The current document,' draft NUREG 1556, Vol.~ 5, " Consolidated Guidance about Materials i ' Licenses: Program Specific Guidance about Self Shielded Irradiators," dated October 1997,is the fifth program-specific guidance developed for the new process. It is intended for use by- ,
applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in Regulatory Guide 10.9, Revision 1,
" Guide for the Preparation of Applicatioru for Licenses for the Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated December 1988, and the guidance for licensing staff previously found in Policy and Guidance Directive FC 84-16, Revision 1, " Standard Review Plan for Applicatio'is for Use of Self-Contained Dry Source Storage Gamma Irradiators,". dated January 26,1989. In addition, this draft report also contains pertment information found in Technical Assistance Requests and Infonnation Notices, as listed in Appendix A.
4 Since this draft report takes a risk informed, performance-based approach to licensing self-shielded irradiators, it reduces the amount ofinformation needed from an applicant seeldng to possess and use a relatively safe device. These self-shielded irradiators containing sealed sources of radioactive material incorporate features engineered to enhance their safety. NRC's . ' considerable experience with these licensees indicates that radiation exposures to workers'are generally low, if the irradiators operate as designed and workers follow basic safety procedures.
! A team composed of NRC staff from headquarters and regional offices drafted this document, drawing on their collectiw experience in radiation safety in general and as specifically applied to self-shielded irradiators.- A representative of NRC's Office of the General Counsel provided a ,
- legal perspective.
e ix Draft NUREG - 1556, Vol 5 4 r ew... -- - - , - - --
* .- Y + w---- - - - - - - - - m. +- - - - --- -- ---------e* 1-- - - - - - - - - - - - - - - -
- - - . - -. - - - - - - -~ -. ., .-. - - - - .
P i FOREWORD - 1 Dran NUREO-1556, Vol. 5, " Consolidated Guidance about Materials Licenses: Program . . Specific Guidance about _Self Shielded Irradiators Licenses," dated October 1997, i+ats a step in the transition from the current paper-based process to the t ew electronic process. This - draA document is available on the Internet at the following addressi http://www.nre. gov /NRC/NUREGS/SR1556/V5/index.html. 1 This dran report is strictly for public comment and is not for use in preparing or reviewing applications for self shielded irradiators until it is published in final form. It is being distributed for comment to encourage public participation in its development. NRC is requesting comments such as whether a risk-informed, performance-based approach to licensing is valid, as well as , comments on the information provided about self-shielded irradiators. Please submit comments . j within 90 days of the draA report's publication. Comments received aRer that time will be
-considered if practicable.
' Address comments to: Chief, Rules and Directives Branch, Division of Administrative Services, OHice of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Hand deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to diml@nrc. gov. DraR NUREG-1556, Vol. 5, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiator Licenses," dated October 1997, is not a substi:ute for NRC regulations, and compliance is not required. The approaches and ~ methods described in this draR report are provided for information and comment only. 1 r
,/
1 ll 1
^s
( , V
@nald'A. Coo , Director l Division ofIndustrial and Medical huclear Safety Ofice of Nuclear Material Safety and Safeguards
- Draft NUREO - 1556, Vol. 5 - x 3
", . , . ~ . . - - - = '*
ACKNOWLEDGMENTS The writing team thanks the individuals listed below for assisting in the development and reviev-of the draft report. All participants pnivided valuable insights, observations, and recommendations. The team also thanks Kay Avery, Eric Bazerghi, Veronica Bellone, Judy Boykin, Elaine Gerdine, C. Harris Huckabee, Tina Jordan, Kathryn M. LaViolette, Alyce J. Martin, Steven W. Schawaroch, and Tim Woods of Computer Sciences Corporation, Angela S. Case oflotal Systems Solutions, Inc., Paul M. Tyree of CIS-US, Inc., Mary F. Shepherd of J.L. Shepherd and Associates, and Tham Tran of MDS Nordion. The
Participants:
Broaddus, Douglas A. Mitchell, Mark W. Camper, Larry W. Osgood, Nancy L. Chappell, Cass R. Piccone, Josephine M. Collins, David J. Radcliffe, William H. Cook, John R. Rothschild, Marjorie U. Cool, Donald A. Roe, Mary Louise Hosey, Charles M. Schwartz, Maria E. Jensen, E. Neil Tiktinsky, David H. Kinneman, John D. Treby, Stuart A. Lewis, Stephen H. Vacca, Patricia C. Merchant, Sally L. White, Duncan Whitten, Jack E. xi Draft NUREG - 1556, Vol. 5
ABBREVIATIONS ALARA Aslow as is reasonably achievable ANSI American National Standards Institute bkg Background BPR Business Process Redesign Bq Becquerel CFR Code of federal Regulations epm Counts per minute DOE United States Department of Energy DOT United States Department of f ransportation FDA United States Food and Drug Administration G-M Geiger-Mueller GPO Government Printing Office IN Information Notice mGy Milligray car Milliroentgen mrem Millirem mSv Millisievert NCRP National Council on Radiation Protection and Measurements NIST National Institute of Standards and Technology NMSS Oflice 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 OCR Optical character reader OMB Office of Management and Budget OSP Office of State Programs QA Quality Assurance REV Revision RG Regulatory Guide RQ Reportable Quantities RSO Radiation Safety Officer SDE Shallow Dose Equivalent SFPO Spent Fuel Project Office xiii Draft NUPEG - 1556, Vol. 5
\
l
- ABBREVIATIONS SI Inteknatisnal System of Units (abbreviated S1 from the French Le Systeme -
Intemationale d' Unites) -
-SSD- - Scaled Source and Device std Standard Sv Sievert TAR Technical Assistance Request TEDE- Total efrective dose equivalent TI Transportation Index TLD Thermoluminescent dosimeters USDA- United States Department of Agriculture -
e i DraA NUREG 1556, Vol. 5 - xiv o . , , _m. ~ , .. - . . _. s.__._, - .,--U.
1 PURPOSE OF DRAFT REPORT 3his document is strictly for public comment and is not for use in preparing or revi ing applications for self-shielded irradiators until this document is published in final form. This draft report provides guidance to an applicant in preparing a self shielded irradiator license application as well as NRC criteria for evaluatitig a self shielded irradiator license application. I J is not intended to address the research and development or the commercial aspects of manufacturing, distribution, and service of self shielded irrsdiators and their associated sources. Within this document, the phrases or terms, "self-shielded irradiator," "self-contained irradiators," or "irradiators" are used interchangea9y. Irradiators are used for a variety of purposes in research, indust.y, and other fields, Typical uses are:
. Sterilizing or reducing microbes in medical and pharmaceutical supplies . Preserving foodstuffs
- Studying radiation effects
. Synthesizing and modifying chemicals and polymers + Eradicating insects through sterile male release programs
- Calibrating thermoluminescent dosimeters (TLDs).
The American National Standards Institute (ANSI) has developed and published safety standards for gamma irradiators. In determining basic safety requirements, ANSI divided all gamma irradiators into four general categories. This draft NUREG report deals with the type of irradiator discussed in ANSI Standard N433.1," Safe Design and Use of Self-Contained, Dry Source Storage Gamma Irradiatcrs (Category I)."' This draft report also uses the same definition of a self-shielded irradiator as the ANSI defmition for a Category I irradiator: "[a]n irradiator in whi;h the scaled source (s) is completely contained in a dry container constructed of solid materials, the scaled source (s) is shielded at all times, and human access to the sealed source (s) and the volume (s) undergoing irradiation is not physically possiole in its Gesigned configuration."
. Depending on the design, the radiation source within the irradiator may be in a fixed position or may be movable. In the latter case, interlocks are used to ensure that the source does not move into a position that, during normal use of the imuliators, may cause a radiation hazard to any
' Copies may be obtained from the American National Standards Institute,1430 Broadway, New. York, NY 10018, or ordered electmnically at the following address.
www. ansi.org. Copies are also available from the National Ts chnical Information Service,5285 Port Royal Road, Springfield, VA 22161 (1-800-553-6847). 11 Draft NUREG - 1556, Vol 5 4
PURPOSE OF DRAFT REPORT individual. Bypassing or failure of an interlock could ca.ase persons to be exposed to high levels ofradiation. Examples of Self-Shl61ded Irradiators [Jnan%q h,MdnYt!
~ ,y 0 l :
.j _
%y@g 02 ppt 7 9128101b
,. %~wre-060997 Figure 1.1 Typts ofIrradiators. The irradiator on thefar left is usedto calibrate dosimetry devices, while the other two units are research irradiators.
Self shielded irradiators typically contain several hundred to several thousand terabecquerels (curies) of cesium-137 (Cs-137) or cobalt-60 (Co-60) and range in weight from several hundred to several thousand kilograms (pounds). Other irradiators contain megabecquerel (millicurie) quantities of strontium-90 (Sr-90), a beta emitter, and are used primarily for thermoluminescent dosimeter (TLD) calibration. The NRC's past practice was to issue a separate licer.se to authorize the possession and use of self-shielded irradiators if any of the units exceeded 37 terabecquerels (1,000 curies). NRC will now authorize self-shielded irradiators on the same license as the licensee's other licensed material. This draft report identifies the information needed to complete NRC Form 313 (Appendix B), " Application for Material License," for the use ofscaled sources in self-shielded irradiators. The information collection requirements in 10 CFR Part 30 and NRC Form 313 have been approved under the OIYice of Management and Budget (OMB) Clearance Nos. 3150-0017, and 3150 0120, rerpectively. Draft NUREG 1556, Vol. 5 12
PURPOSE OF DRAFT REPORT
- The format within this document for each item 9f technical information is as follows:
Regulations ~ references the regulations applicable to the item;
*- Criteria - outlines the criteria used to judge the akquacy of the applicant's response;
'
- Discussion - provides additioral information on the topic sufficient to meet the needs of-most readers; and y
- Response from Applicant - provides suggested msponse(s), offers the option of an '
al;emative reply, or indicates that ne response is needed on that topic during the licensing process. Notes and References are self-explanatory and may not be found for each item on NRC Fomi 313.
- NRC Form 313 does not have sufficient space fer applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets cf paper and submitted with the completed NRC Form 313. For the convenience of applicants and for streamlined handling of self shielded irradiator applications in the new materials licensing process, use Appendix C to provide supporting information, attach it to NRC Form 313, and submit them to NRC.
Appendixes D through P contain additional information on various radiation safety topice.
- Appendix Q is a sample self-shielded irradiator license; it contains the conditions most often found on these licenses, although not all licenses will have all conditions. Appendix R is a checklist that NRC staff uses to review applications and applicants can use to che::k for completeness.
- 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 equivahnt. These terms are defined in 10 CFR Part 20.' Rem, and its SI equivalent Sievert (I rem = 0.01 Sievert (Sv)), is used to describe units of radiation exposure or dose. This is - because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen, and the sealed sources used in irradiators emit beta and gamma rays, which means that I roentgen = 1 rad = i- 1rern 13 Draft NUREG - 1556. Vol. 5 .
. __ _ , . ~ . . ___ _ . _ _ . - _ _ _ _ _ _ _ _.._ _ _ _ _
j l j I
. .2 AGREEMENT STATES u
Certain states, called Agreement States (see Figure 3.1), have enteml into agreements with the q
- NRC that give them the authority to license sad inspect byproduct, source, or special nuclear q materials used or possessed within their borders.L Any alglicant other than a Federal agency who j 4
; wishes to possess _ or_ use licensed material in one of these' Agreement States needs to contact the '
l responsible omcials in that State for guidance on preparing an application; file these applications . with State omcials, not with the NRC. 3
+ i
- 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 order to determine whether NRC or the Agreement
- State has regulatory authority. NRC has regulatory authority over land determined to be
" exclusive F*iaaljurisdiction," while the Agreement State hasjurisdiction over non-exclusive ,
Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional ' status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract - _ ' - omcer, base environmental health omcer, district omce staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with . l NRC or Agreement State regulatory requirements, as r.pppriate. Additional guidance on ,- determiningjurisdictional status is found in All Agreement States Letter, SP-%-022, dated February 16,1996, which is available from NRC upon re luest. - Table 2.1 provides a quick way to check on which agency has regulatory authority. Table 2.11%o Regulates the Activity? . REGULigTORY . APPLICANT AND PROPOSED LOCATION OF WORK
- AGENCY MNIEW SWE181RestMassughNh k;@p@%#dM@
W99 . - [$300 lent,asesressadisemanthuses.daiigelman @ NOM $$ assne
@tenteemeingMOE3R.$$$N6% (g;4$@@se@p .
. Non Federal entity in non-Agreement State, US territory, or possession NRC (Neededesel enlityEAgdMuset Smas'at NEFedessNy hele@9 .
Agreement StateA
- Non-Federal entity in Agreement State at Federally-controlled site not - Agreement State ;
subject to exclusive Federaljurisdiction - Nemes'desele%iApsidemSunatPedsimEy'-esimonadiisijobjecti NRCN{ W' U 1 iteousiesivePederaljasisdictiesiMk MM % W : % &q 94 2-t Draft NUREG - 1556. Vol 5
i l AGREEMENT STATES Locations of NRC Offices and Agreement Stal,s Region IV
, Region til gg SD oK AK 1 An Street SW. Sune 23T85
.At (Pg M 2 00 -800 577 4510 nvre Road e Roemelotnce g Headquarters NOI6 9 95 f400-522-3025 R lonIV (approx 0A s) 1 C. 20555 0001 r1 60 1 e' g (,,p .000
,, ,,,,,, W 30 27 0. 0 m u: .ir%TX=. -.052*n licensee) R lon i Walnut Creek FP,td OtMe 5 1 3 1156 6 . 0 72
., .,jg Figure 2.1 U.S. Map. Location ofNRC Ofices and Agreement States. As ofOctober 1,1998, the Walnu! Creek Field Ofice will close. All communications should beforwarded to Region IV.
References:
A current list of Agreement States (including names, addresses, and telephone numbers of responsible omeials) may be obtained upon request from NRC's Regional or Field Omces. Or visit the NRC Omce of State Programs'(OSP's) Home Page (http://www.hstd.ornl. gov /itrc/home.htm) and choose " Directories." 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.omt. gov /ntc/home.htm), choose "NRC-State Communications," then choose "All of the Above," and follow the directions for submitting a query for "SP96022." Draft NUREO - 1556, Vol. 5 2-2
3 MANAGEMENT RESPONSIBILITY 'Ihe NRC recognizes that effective radiation safety program management is vital to achieving - safe and compliant operations. NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely. NRC also believes that effective management will result in increased safety and compliance. I
" Management" 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.
To ensure adequate management involvement, a management representative must sign the submitted application acknowledging management's commitments and responsibility for the I following:
+ Radiation safety, security and control of radioactive materials, and compliance with regulations;
- Completeness and accuracy of the radiation safety records and all information provided to NRC (10 CFR 30.9);
- Knowledge about the contents of the license and application;
- Meticulous compliance with current NRC and DOT regulations and the licenm'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 public and workers are protected from radiation hazards and meticulous compliance with regulations is maintained; and
- Selection and assigmnent of a qualified individual to serve as the Radiation Safety Oflicer (RSO) for licensed activities.
For information on NRC inspection. investigation, enforcement, and other compliance programs, see " General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, dated June 1995, and Manual Chapter 87110, Appendix A," Industrial / Academic /Research Inspection Fic!d Notes"; see Notice of Availability (on inside front cover of this draft report). NUREG-1600 is also available on the Intemet. Visit NRC's Home Page (http://www.nrc. gov), choose " Nuclear Materials," then " Enforcement," " Enforcement Guidance Documents," and then
" Enforcement Policy."
31 Draft NUREG - !$56. Vol. 5
t 4 APPLICABLE REGULATIONS-It is the applicant's or licensee's responsibility to have up-to-date copies ofapplicable regulations, read them, and abide by each applicable regulation. The following Parts of 10 CFR Chapter I contain regulations applicable to self-shielded irradiators:
. 10 CFR Part 2, " Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders"
- 10 CFR Part 19, " Notices, Ins
- ructions 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 Applicability to Domestic Licensing of Byproduct Material"
+ 10 CFR Part 33, ' Specific Domestic Licenses of Broad Scope for Byproduct Materh!"
. 10 CFR Part 71, " Packaging and Transportation of Radioactive Material" l
Part 71 requires that licensees who transport licensed material or who may offer such material ! to a carrier for transport must comply with the applicable requirements of the United States l Department of Transportation (DOT) that are found in 49 CFR Parts 170 through 189. Copies of DOT regulations can be ordered from the Govemment 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" l
- 10 CFR Part 171, " Annual fees for Reactor Operating Licenses, and Fuel Cycle Licenses l
and Materials Licenses, Inciuding 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, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at www.gpo. gov. Request single copies of the above documents from NRC's Regional or Field Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes l amendments to its regulations in the Federal Recister. 4-1 Draft NUREO - 1556, Vol. 5 1
5 HOW TO FILE 6.1 PAPER APPLICAllON~ 1 Applicants for a materials license should do the following:' { *
- Be sure to use the most recent guidance in preparing an application. - . .
6 i Complete NRC Form 313 (Appendix B) Items 1 through 4l12, and 13 on the form itself.: r 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, =
' 5
. identify and key it to the item number on the application or the topic to which it refers. '
- Submit all documents, typed, on 8-1/2 x 11 inch paper. . _
*- Avoid submitting proprietary information unless it is absolutely necessary.
. . Submit an original, signed application and one copy. '
- Retain one copy of the license application for future reference.
y . As required by 10 CFR 30.32(c), applications must be signed; see section on " Certification." :; Using the suggested wording of responses and committing to using the model procedures in this draft report will expedite NRC's review. p All license applications will be available for review by the ger.eral public in NRC's Public Document Rooms. Ifit 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 . 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, radiction dose information, should not be submitted unless specifically requested by NRC.
. _ As explained in the " Foreword," 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 Maaaad and put through an w optical character reader (OCR) to convert them to electronic format. To ensure a smooth -- transition, applicants are requested to follow these suggestions:
*- 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 Ariel, Futura, Univers; the text of
' this document is in a serif font called Times New Rosaan. ' '
*- Choose 12-point or_ larger font size.
*- Awid stylized characters such as script, italic, etc.
*J = Be sure the print is clear and sharp. ;
5-1 Draft NUREG - 1556. Vol. 5 i
HOW TO FILE
*- ~ Be sure there is high contrast bitween the ink and paper (black ink on white paper is best).
5.2 ELECTRONIC APPLICATION As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or 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. DraftNUREO 1556,Vol.5 5-2
6 WHERE TO FILE Applicants wishing to possess or use licensed material in any State or U.S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. The Walnut Creek, California, Field 0 . ice, can respond to routine telephone inquiries until September 30,1998. Effective October 1,1998, the Walnut Creek, California, Field Office will close and any communications previously involving that Field Office should be addressed to the Region IV Office. In general, applicants wishing to possess or use licensed material in 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 duermine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See the section on " Agreement States" for additional information. 6-1 Draft NUREG - 1556, Vol. 5
7 uCENSE FEES 4 1 Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical
- review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of a , application or the withdrawal of an application.
-l Most NRC licensee are also subject to annual fees; refer to 10 CFR 171.16. Cr nsult 10 CFR 171.11 for additiontJ 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) L'o the Oflice of the Chief Financial OfFeer (OCFO) at NRC headquarters in Rockville, Maryland,(301) 415-7554. You may also call NRC's toll free number (800) 368-5642 and then ask for extension 415-7554. t l l l l l 71 Draft NUREG 1556, Vol. 5
j- - - l 8 CONTENTS OF AN' APPLICATION
'The following comments apply to ths indicated items on NRC Form 313 (Appendix B).
8.1 ITEM 1: - LICENSE ACTION TYPE j 4 _ THIS IS AN APPLICATION FOR (Check appropriate iteas):
;TYPEOF ACTION, ~ /W wd*YfP MWk M NG.OME&W@?$d
[ ] A.-New Liceme Not applicable 4 h)n toLiesesEJ@@@hbeMb MN@NN$?ddM@MI [ ], C. Renewal of License No. XX-XXXXX-XX Check box A for a new license request. Check box B for an amendment 2. to an existing licen=e, and provide license number. Check bcx C for a renewal of an existing license, and provide license number. i 8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS . List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designa'ed as the applicant only if the individuel is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address. Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC IN 97-30, " Control of L Licensed Material during Reorganizations, Employee-Management Disagruments, and j' Financial Crises " dated June 3,1997, discusses the potential inr the security and control of ' I licensed material to be compromised during periods of organizconal instability. l 1; l - ;. 2See " Amendments and Renewals to a License" later in this document. Licer sces may request an amendment to an existing license to add authorization for a self shielded irradiator. 5-1 Draft NUREG - 1556. Vol. 5 - p l I;
. , _ . - , . , , ~ - -_. ,, _ __
L CONTENTS OF AN APPLICATION Timely Notincation of Transferring Control i Regulations: 10 CFR 30.34(b). , Criterh: Licensees must provide full information and obtain NRC'sprior written consent
' before transferring control of the license, or, as some licensees call it, " transferring ths license."
Disensolos: Transferring control may be the result of mergers, Fuyouts, or majority stockL
. transfers. Although it is not NRC's intent to interfere with the business decisions oflicensees, it
. is necessary for licensees to obtain prior NRC written consent. This is to ensure the following:
- Radioactive materials are possessed, used,'or controlled only by persons who have valid NRC licenses -
*: Materials are properly handled and secured C Persons using these materials are competent and committed to implementing appropriate radiological controls A clear chain of custody is estaMished to identify who is responsible for final disposal of the self shielded Lradiator
* ' Public health and safety are not compromised by the use of such materials.
Response from Applicaat: None from an applicant for a new license; Appendix D, excerpted from Infonnation Notice (IN) 89-25 (Rey,1), " Unauthorized Transfer of Ownership or Control .
- of Licensed Activities," dated December 7,1994, identifies the ir. formation to be provided about -
transferring control.-
References:
See the Notice of Availability (on the inside front cover of this draft report) to obtain copies ofIN 89-25 (Rev.1), " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, and IN 97-30, " Control of Licensed Material during : Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997. p Notincation'of Bankruptcy Proceedings Regulations: 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 which the petition was filed and the date of filing.
. Response froni Applicaat: None at time of application for a new license. Generally, licensees
- snould notify NRC within 24 hours of filing a bankruptcy petition.-
Draft NUREG - 1556, Vol. 5 - -- 8-2 i
. , , _ . - - , , , , _ , m, , , ,--
1 CONTENTS OF AN APPLICATION 8,3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED Specify the street address, city, and state or other de:,criptive address (e.g., on Highway 10,5 miles cast of the intersection ofliighway 10 and State Route 234, Anytown, State) for each . facility. He descriptive addiess should be sufficient to allow an NRC inspector to find the facility location. A Post Oflice 11ox address is not acceptable. To allow licensees greater flexibility, the applicant should not identify the self shielded irradiator location by mom numtver and should not submit drawings of the location within the facility. The acceptability of the irradiator's location will be reviewed during the inspection process; see section on " Facilities and Equipment" for additional information. When a new self shielded irradiator is acquired and will be used at the facility address listed in the license, the license need nat be amended. An NRC approved license amendment is requimd F % locating an irradiator at an address not already listed on the license, whether that irradiator it u. additional unit or a relocation of an existing unit. Ilcing granted an NRC license does not relieve a licensee from complying with other applical,le Federal, State, or local regulations (e.g., local zoning requirements; a local ordinance requiring registration of a radiation producing device). N6te: As discussed later under " Financial Assurance and Record Keeping for Decommissioning," licensees do need to maintain pemianent records on where licensed material was used or stored while the license was in force. This is impcirtant for making future d4,:rminations about the release of these locations for unrestricted use (e.g., before the license is terminated). For self shielded irradiator licensees, acceptable records are sketches or written descriptions of the specific locations where each irradiator is used or stored and any information relevant to damaged devices or leaking radioactive sources. 8,4 ; TEM 4: PERSON TO BE CONTACT ~:D 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 Oflicer (RSO), unless the applicant has named a different person as the contact. The NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or h!s 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 does not require a 1; cense amendmem or a fee. Draft NUREG 1556.Vol. 5
CONTENTS OF AN APPLICATION As indicated on NRC Form 313 (Appendix B), items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C for this purpose and should note that using the suggested wording of responses and committing to using the model procedures in this draft repo t will expedite NRC's review. 8.5 ITEM 5: RADIOACTIVE MATERIAL-SEALED SOURCES AND DEVICES Regulations:- 10 CFR 30.32(g),10 CFR 30.33(a)(2),10 CFR 32.210. Criteria: Applicants must provide the manufacturer's name and modd number for each requested scaled source and device. Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by NRC cr an Agreement State. Discussion: NRC or an Agreement State performs a safety evaluation of self-shielded irradiators before authorir.ing a manufacturer to distribute the irradiators to specific licensees. The safety evaluation is documented in a Sesled Source and Device (SSD) Registration Certificate. Before the formalization of the SSD registration process, some older irradiators may have been specifically approved on a license. I.icensees can continue to use those units specifically listed on their licensea. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in an SSD Registration Certificate or specifically approved on a license. As explained in an " Urgent Notice" with an enclosed Order, both dated July 3,1984 (see Appendix E), an NRC licensee identified a malfunction that could have resulted in a radiation overexposure. The malfunction involved an interlock mechanism which would have failed to prevent a shielded door from being opened after the source had moved out of the shielded position. The Order, which remains in eiTect, modifies licenses that au;horize J.L. Shepherd Mark I or Model 81-22 irradiators. Applicants wishing to use either of these models must comply with the Order's requirements. Consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible and conform to the scaled source and device designations registered with NRC or an Agreement State. Licensees may not make any changes to the scaled source, device, or source / device combination that would alter the description or specifications from those indicated in the respective registration certificates, without obtaining NRC's prior permission in a license mendment. To ensure that applicants use irradiators according to the registration certificates, they may want to get a copy of the certificate and review it or discuss it with the manufacturer. s DratiNUREO 1556,Vol.5 84
CONTENTS OF AN APPLICATION Response from Applicants . Identify each radionuclide that will be used in each source in the self shielded irradiators.
- Provide the manufacturer's name and model number for each scaled source and device requested.
- Confirm that each scaled source, device, and source / device combination is registered as an approved sealed source or device by NRC or an Agreement State.
. Confirm that the activity per source and maximum activity in each irradiator will not exceed the maximum activity listed on the approved certificate of registration issued by NRC or by an Agreement State. Norn For information on SSD registration certificates, contact the Registmtion Assistant by calling NRC's toll free number (800) 368 5642 and then asking for extension 415 7217. 8.6 ITEM 5: RADIOACTIVE MATERIAL - FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING Regulations: 10 CFR 30.34(b),10 CFR 30.35. Criteria: Self-shielded irradiator licensees authorized to possess scaled sources containing radioactive material in excess of the limits specified in 10 CFR 30.35 must provide evidence cf 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 irradiators are used or stored and to leaking sources. Licensees must transfer these records important to decommissioning either to ,he new licensee before licensed activities are transferred or assigned according to 10 CFR 30.34(b) or to the appropriate NRC regional office before the license is tenninated. Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most self shielded irradiator applicants and licensees do not need to take any action to comply w:th the financial assurance requirements because their total inventory o. .icensed material does not exceed the limits in 10 CFR 30.35. The limits for typical self shielded irradiator sealed sources are shown in Table 8.1. Applicants requesting more than one radionuclide need to use the sum of the ratios method to determine whether financial assurance is needed. See Appendix F for additional information. 85 Draft NUREO 1556, Vol. 5
_ - - = _ .- -__. . _- . . - _ - - _ - . _ -- --- f CONTENTS OF AN APPLICATION Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance ACTIVITY RADIONUCLIDE Gigaheequerels Curles _ Cs-137: 3.7x105 1 100,000-Co-60 3.7 x 105 10,000 lSr90 3.7 x:10' . 1,000' In most cases, a licensee would need to possess several irrediators before the financial assurance requirements would apply. Since the standard self shielded irradiator license does not specify the maximum number of irradiators that a licensee may possess (allowing flexibility in obtaining additional irradiators specifically authorized by the license without amending its li. cense), it contains a condition requiring the licensee to limit its possess lon of self shielded irradiators to quantities not requiring financial assurance for decommissioning. Applicants and licensees wanting to possess self shielded irradiators or irradiators and other licensed materials exceeding the limits in 10 CFR 30.35 must submit evidence of financial assurance or a decommissioning funding plan (10 CFR 30.35 (b)). Regulatory Guide (RG) 3.66,
" Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, contains apptoved wording for each mechanism authorized by the regulation to guarantee or secure funds except for the Statement ofIntent for government licensees. See Appendix F for the recommended wording for a Statement ofIntent.
NRC will authorize possession exceeding the limits shown in Table 8.1 without requiring decommissioning financial assurance, for the purpose of normal source exchange for no more than 30 days. The same regulation also requires that licensees maintain records important to decommissioning in an identified location.- All self shielded irradiator licensees need to maintain records of structures and equipment where each irradiator was used or stored. 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 description of the area) concerning the specific areas and locations. In addition, if self shielded irradiator licensees have experienced unusual occun ences (e.g., leaking sources, other incidents that involve spread of contamination), they also need to maintain records about contamination that remains after cleanup or that may have spread to inaccessible areas. I' rail NUREO 1556, Vol. 5 8-6
- i l
CONIENTS OF AN APPLICATION For self. shielded irradiator licensees whose sources have never leaked, acceptable records important to decommissioning are sketches or written descriptions of the specific locations where each irradiator was used or stored. Response from Appliennt: No resporse is needed from most applicants. If financial assurance is required, submit evidence as described in RO 3.66. Licensees must transfer records important to decommissioning either to the new licensee before licensed activities are transfened or assigned according te 10 CFR 30.34(b) or to the appropriate NRC regional office before the license is terminated.
References:
See the Notice of Availability (or the inside front cover of this draf) report) to obtain copies of Regulatory Guide 3.66, " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, and Policy and Guidance Directive FC 90 2 (Rev.1), " Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30,1991. 8.7 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED Regulations: 10 CFR 30.33(a)(1). Criteria: Proposed activity is authorized by the Atomic Energy Act of 1954, as amended, and l Irradiators will be used only for the purposes for which they were designed and according to the i manufacturer's recommendations and instructions for use as specified in an approved SSD Registration Certificate. Uses other than those already listed must not compromise the integrity of the source or source shielding or other components of the device critical to radiation safety. l Discussion: Allowed uses normally include irradiation of blood, insects, animals, biological l samples, and inanimate objects. Usually prohibited are irradiation of fiammable and explosive rnaterials which may harm the shielding or the scaled source containment, or other materials ! (e.g., unsealed containers of acids or corrosive liquids) which may interfere with the safe operation of the device. Irradiation of food for commercial distribution to the public is subject to regulations of the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) and will not be dis;ussed in this document. Requests to irradiate items not listed or prohibited in the SSD Registration Certificate will be l reviewed on a case-by-case basis. Applicants need to submit enough information to demonstrate that irradiation of the proposed items will not compromise the integrity of the source or source shielding, or other components critical to radiation safety of the device. Contact the appropriate l 87 Draft NUREO .1556, Vol. 5
g w q 1NTENTS OF AN APPLICATION k! y' NRC Regional Office (see Figure 2.1) for additional case specific guidance. Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or d- local regulations (e.g., FDA and USDA regulations about irradiation of food for commercial distribution). Response from Applicant: If the self shielded irradiator will be used for the purposes listed on the SSD Registration Certificate, state the following: "The self shielded irradiator(s) will be used for the purposes described in their respective SSD Registration Certificates." If the self-shielded irradiator will be used for purposes other than those listed on the SSD Registration Certificate, specify these purposes and submit safety analyses (and procedures, if needed) to support safe use. E 8.8 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE - RADIATION SAFETY OFFICER (RSO) Regulations: 10 CFR 30.33(a)(3). Criteria: RSOs must have adequate training and experience. Successful completion of training as described in Appendix 0 is evidence of adequate training and experience. Discussion: The person responsible for the radiation protection program is called the Radiation Safety Ollicer, or RSO. The RSO needs independent authority to stop operations that he or she considers unsafe. lie or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe manner. Typical RSO duties are illustrated in Figure 8.1 and described in Appendix 11. NRC requires the name of the RSO on the license to ensure that licensee management has always identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Draft NUREO 1$56, Vol. 5 8-8 . l
CONTENTS OF AN APPLICATION RSO
. Responsibilitles stop unseie scennes actraies Proper use and routine maintenance -
O inventory " O Leak Test O ra ing GI ustenet copose ,. , . O Records [ Y . {Qp sk- '4T . '7 y w 3 interact >0n wm NRC. 0ther authontes ,: o.. n w.. g , ,4 . d Recores maintenance g O r-
.>, .nyy, Figure 8.1 RSO Responsibilities. 7)picaldutics andresponsibilitics of RSOs.
Response from Applicant: Provide the following: . Name of the pr posed RSO AND EITilER: . Statement that: "Before obtaining licensed materials, the proposed RSO will have successfully completed training described in Appendix G in draft NUREG 1556, Vol. 5,
' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Self Shielded Irradiator Licenses,' dated October 1997";
AND + Statement that: "Before being named as the RSO, future RSOs will have successfully completed training described in Appendix G in draft NUREG 1556, Vol. 5, ' Consolidated Guidance about Materials Licenses: Program Specific Guidance about Self Shielded Irradiator Licenses,' dated October 1997. Within 30 days of naming a new RSO, we will submit the new RSO's name to NRC to include in our license." 89 Draft NUREG - 1556, Vol. 5
CONTENTS OF AN APPLICATION OR
+
Alternative information demonstrating the the proposed RSO is qualified by training and experience. Note:
+
lt is important to notify NRC, as soon as possible, of changes in the designation of the RSO; such notifications will be handled as administrative amendments not requiring fees as long as the application contains the commitment listed in the third bullet under
" Response from Applicant."
Alternative responses will be reviewed using the criteria listed above. 8.9 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS (INSTRUCTIONS TO WORKERS) Regulations: 10 CFR 19.11,10 CFR 19.12,10 CFR 19.13,10 CFR 30.7,10 CFR 30.9,10 CFR 30.10,10 CFR 30.33. Criteria: Individuals working with, as well as in the vicinity of, a self shielded irradiator must have adequate training and experience. For individuals working with irradiators, also known as authorized users, successful completion of training as described in Appendix 0 is evidence of adequate training and experience. For those individuals who are not authorized users yet work in the vicinity of a self shicided irradiator and, in the course of employment, are likely to receive in a year an occupational dose of radiation over 1 mSv (100 mrem), the licensee must provide training as required by 10 CFR 19.12. Discussion: Authorized users must ensure the proper use, security, and routine maintenance of self shielded irradiators containing licensed material. They must have appropriate training to provide reasonable assurance that they will use the irradiator safely, maintain security of and access to the irradiator, and respond appropriately to accidents and malfunctions. Individuals other than authorized users may perform routine maintenance on irradiators, llowever, if they have not received training as an authorized user, they must work under the supervision and in the direct physical presence of someone who has. Some licensees may have specific individuals trained to perform installations, relocations, non-routine maintenance, or repairs. Authorizations for these functions are separate from those for an authorized user or an individual who performs routine main,enance and will be specifically stated in a license condition. Appendix I contains suggested training for individuals who will conduct non routine maintenance. Draft NUREO - 1556. Vol. 5 8 10 l
CONTENTS OF AN APPLICATION Authorized users, individuals perfonning routine maintenance, and individuals perfonning installations, relocations, non routine maintenance, or repairs would be most likely to receive ; doses in excess of 1 mSv (100 mrem)in a year. Ilowever, potential radiation doses received by any individual working in or frequenting restricted areas must also be evaluated. All individuals working with or around licensed materials should receive training commensurate with their assigned duties, and ifit is likely they could receive doses over 1 mSv (100 mrem) in a year, they must receive instruction as specified by 10 CFR 19.12. For example, a licensee could determine that housekeeping staff, while not likely to receive doses over i mSv (100 mrem), need to be informed of the nature of the irradiator and the meaning of the radiation symbol, and need to be instructed not to touch the irradiator and to remain out of the room if the irradiator door is open. ; Response from Applicant: Provide either of the following:
- The statement: "Before using licensed material, authorized users will receive the training des:ribed in Appendix 0 in drafi NUREG 1556, Vol. 5,' Consolidated Guidance about Materials Licenses: Program Specific Ouldance about Self shielded Irradiator Licenses,'
dated October 1997"; OR
. A description of the training and experience for proposed authorized users.
Note: Alternative responses will be evaluated using the criteria listed above. 8.10 ITEM 9: FACILITIES AND EQUIPMENT Regulations: 10 CFR 30.33(a)(2). Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Discussion: Self shielded irradiators incorporate many engineering features to protect - individuals from unnecessary radiation exposure. These devices are usually designed for use in a laboratory environment, i.e., insin a building, protected from the weather, and without wide variations of temperature and humidity. For information to help applicants determine the location ofirradiators, see the sections on the SSD Registration Certificate entitled, " Conditions of Nonnal Use" and " Limitations and/or Other Considerations of Use." For example, if a proposed location for a self shielded irradiator is not within the conditions of normal use or the limitations of use, the applicant will need to provide adequate justification, in addition, the applicant will need to take compensatory measures (e.g., increased surveillance and 8 11 Draft NUREO 15$6, Vol. 5
i l CONTENTS OF AN APPLICATION-maintenance) to ensure that the irradiator operates as designed and provides the intended level of protection. IN 96 35, " Failure of Safety Systems on Self Shielded Irradiators Because of { Inadequate Maintenance and Training," dated June 11,1996, discusses an incident resulting from irradiator failure in which the lack of a climate controlled environment (i.e., loading dock) may have accelerated the degradation ofinternal components leading to a failed interlock and - ! excessive dose received by an irradiator operator. j n Self shielded irradiators vary in weight from several hundred to several thousand kilograms - 1 (pounds). Before installing an irradiator, licensees need to evaluate whether the floor in the i pioposed location can support the irradiator, Often licensees locate self shielded irradiators on a
- ground floor. Some smaller and lighter irradiators require additional security measures to i
prevent unauthorized semoval (e.g., locked in a room, bolted to the floor). For more information see " Radiation Safety Program - Operating and Emergency Procedures" and " Radiation Safety . Program Public Dose." The fire resistant properties of most irradiators should provide adequate radioactive material containment and shielding integrity in most situations; however, additional protection is ! desirable for some situations. For example, the room housing the irradiator should be equipped 4 with an automatically operated fire detection and control system (sprinkler, chemical, or gas), As an alternative, the self shielded irradiator should be located under conditions (e.g. , ground floor location in fire resistant building with little combustible material) and other controls (e.g., i coordination with and training of fire fighting personnel) that ensure a low level of radiation risk . attributable to fires. Response frone Applicant: Provide either of the following: The statement: "We will ensure that each area where a self shielded irradiator is located corresponds to the ' Conditions of Normal Use' and ' Limitations and/or Other Considerations of Use' on the applicable irradiator's Scaled Source and Device . Registration Certificate; the floor beneath the self shielded irradiator is adequate to support the weight of the irradiator; each self shielded irradiator is secured to prevent ; unauthorized access or removal; and each area where a self-shielded irradiator is located is equipped with an automatically operated fire detection and control system (sprinkler, chemical, or gas) or the location of the area and other controls ensure a low level radiation risk attributable to fires." OR '
+
Submit alternative information; be sure to includejustification for placing an irradiator in
- an area that does not correspond to the " Conditions of Normal Use" and the " Limitations and/or Other Considerations of Use."
DraftNUREO 1556,Vol.5 8 12 ' i
CONTENTSOF AN APPLICATION Nott Alternative information will be reviewed using the criteria listed above.
References:
See the Notice of Availability (on the inside front cover of this drat 1 report) to ' obtain a copy ofIN %-35, " Failure of Safety Systems on Self-Shielded Irn.diators Because of Inadequate Maintenance and Training," dated June 11,1996. 8.11 ITEM 10: RADIATION SAFETY PROGRAM - AUDIT PROGRAM Regulations: 10 CFR 20.1101,10 CFR 20.2102. Criteria: Licensees must review the content and implementation of their radiation protection programs annually 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 as low as Seasonably achievable (ALARA) (10 CFR 20.1101); and
- Records of audits and other reviews of program content are maintained for 3 years.
Discussion: Appendix J contains a suggested audit program that is specific to the use of self-shielded irradiatois and is acceptable to NRC. All areas indicated in Appendix J may not be applicable to every licensee and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit need not be reviewed at the next audit. Generally, audits are conducted at least once every 12 months. Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of irradiator users to determine if, for example, Operating and Emergency Procedures are available and are being followed. _ lt 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 Implementation of Corrective Action," dated May 1,1996, pmvides 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 a notice of violation, refer to " General Statement of Policy and Procedures for NRC Enforcement Actions," . (NUREG 1600, dated June 1995). 8 13 DraftNUREG 1$56,Vol. 5
-_ . =
l CONTENTS OF AN APPLICAT10N Licensees must inaintain 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 rollowing infonnation to be acceptable: date of audit, name of person (s) who conducted audit, persons contacted by the auditor (s), areas audited, audit findings, corrective actions, and followup. Response From: Applicant: The applicant is not required to, and should not, submit its audit program to the NRC for review during the licensing phase.
References:
See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of: Manual Chapter 87110, Appendix A," Industrial / Academic /Research inspection Field Notes," NUREO 1600, " General Statement of Policy and Procedures on NRC Enforcement Actions," dated June 1995, and IN 96 28, " Suggested Guidance Relating to Development and implementation of Corrective Action," dated May .1,1996. NUREO 1600 is also available on the Intemet. Visit NRC's Home Page (http://www.nrc. gov), choose " Nuclear Materials," then " Enforcement," " Enforcement Guidance Documents," and then " Enforcement Policy." 8.12 ITEM 10: RADIATION SAFETY PROGRAM - RADIATION MONITORING INSTRUMENTS Regulationst 10 CFR 20.1501,10 CFR 20.2103(a),10 CFR 30.33(a)(2). Criteria: Licensees must possess, or have access to, radiation monitoring instruments which are necessary to protect health and minimize danger to life or property. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured. t , Discussion: All licensees possessing self shielded irradiators should have, or have access to, calibrated radiation detection instruments to determine radiation levels in areas adjacent to the irradiator. Usually it is not necessary for a licensee to have a survey meter solely for use during irradiator operations since it is not expected that a survey be performed each time a sample is irradiated. In these cases it is acceptable for the meter to be available on short notice in the event l of an accident or malfunction that could reduce the shielding of the scaled source (s). Surveys l may be required to verify source integrity and to ensure that dose rates in unrestricted areas and public and occupational doses are within regulatory limits.
-Ilowever, as explained in an " Urgent Notice" with an enclosed Order, both dated July 3,1984 (see Appendix E), an NRC licensee identified a malfunction that could have resulted in a radiation overexposure. The malfunction involved an interlock mechanism which would have l failed to prevent a shielded door from being opened after the source had moved out of the I
shielded position. The Order, which remains in effect, modifies licenses which authorize J. L. Dnf) NUREO 1556, Vol. 5 8 14
CONTENTS OF AN APPLICATION
- S@;d Mark I or Model 81 22 irradiators and requires licensee to provide either a calibrated and operable radiation survey meter or room monitor for use with either of these irradiators.
Although not required for all licensees possessing moving source inadiators, it would be pmdent for these licensees to une either a calibrated survey meter or room monitor to ensure that the sources are in the shielded position whenever a sample is not undergoing irradiation. The NRC requires that survey meter calibrations be performed by the instrument manufacturer or a person specifically authe ized by the NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey meter calibrations must submit additional information for review. See Appendix K for more ; ! information. Response freen Applicast: Provide one of the following: l A statement that: . "We will use instruments that meet the radiation monitoring instmment specifications published in Appendix K to draA NUREO 1556, Vol. 5,' Consolidated Guidance about Materials Licenses: Program Specific Guidance about Self Shielded , I Irradiator Licenses,' dated October 1997. Additionally, each survey meter will have been calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations no more than 12 aonths before the date the meter is used." , t OR ;
- A statement that: "We will use instruments that meet the radiation monitoring instrument t i
specifications p9hlished in Appendix K to drah NUREO 1556, Vol. 5,' Consolidated Guidance about Materials Licenses: Program Specific Guidance about Self Shielded Irradiator Licenses,' dated October 1997. Additionally, we will implement the model survey meter calibration program published in Appendix K to drah NUREG 1556, Vol. f,' Consolidated Guidance about Materials Licenses: Program Specific Ouldance about Self Shielded Irradiator Licenses,' dated October 1997, and we will ensure that each survey meter will have been calibrated no more than 12 months before the date the meter , is used," l i OR
- A description of alternative equipment and/or procedures for ensuring that interlocks function, as required, to retum moving self shleided ir:adiator sources to the shielded position and/or determining source shielding integrity aner an incident involving the self- !
shielded irradiator. , k 8 15 Dmft NUREO l$$6.Vol. 5 i
,,,.L, ,m . - , ,,.,A,- , . - ._.,_, . . _ . _, J- ~ _ _ _ .- -__. . _
CONTENTS OF AN APPLICATlON Note
- Attemative responses will be reviewed using the criteria listed above.
- Licenses authorizing J. L. Shepherd Mark I or Model 81 22 irradiators will be conditioned to require compliance with the terms of the Order in Appendix E. Applicants requesting these irradiators must ensure that their radiation detection instruments meet these requirements.
- Applicants who plan to perform non routine maintenance that will affect safety-critical components (e.g., sealed source, radiation shielding, source movement control or mechanism, interlocks) will need to possess and use appropriate, calibrated radiation survey meters. Refer to the section on " Radiation Safety Program Maintenance,"
Appendix I, and Appendix K for more information.
- Required calibration records must be retained for a minimum of 3 years.
8.13 ITEM 10: RADIATION SAFETY PROGRAM - MATERIAL RECEIPT AND ACCOUNTABILITY Regulations: 10 CFR 30.34(e),10 CFR 30.41,10 CFR 30.51,10 CFR 20.1801, 10 CFR 20.1802,10 CFR 20.2201,10 CFR 30.35(g)(2). Criteria: Licensees must do the following:
- Maintain accountability for self shielded i Tadiators by conducting physical inventories at intervals not to exceed 6 months (or as justified by the applicant) to account for all scaled tources.
- Maintain records of receipt, transfer, and disposal of self shielded irradiators.
Discussion: While loss, theft or misplacement of most self shielded irradiators is unlikely because of their size and weight, accountability for licensed materials must be ensured; see Figure 8.2. Many licensees record use of self shielded irradiators in a log book. Licensees are also required to conduct leak tests ofirradiator scaled source (s) at the frequency specified in the SSD Registration Certificate. Since both of these activities require that an individual approach the irradiator, records of use and leak tests may be used as part of an accountability program. For more information, see " Radiation Safety Program - Operating and Emergency Procedures" and
" Radiation Safety Program - Leak Tests" in this draf) report. However, since some irradiators may not be in use or are used rarely, NRC expects licensees to physically approach and account for all sealed sources at least every 6 months.
Draft NUREO 1556, Vol. 5 8 16 l l
j CONTENTS OF AN APPLICATlON Cradle to Grave Accountability l I-
)
Disposal or transfer [ Receipt
.,_...,,=
l Figure 8.2 Material Receipt and Accountability. Licensees must maintain records of receipt, transfer, and disposal and conduct semIannualphysical inventories Receipt, transfer, and disposal records must be maintained for the times specified in Table 8.2. Typically, these records contain the following types ofinfonnation:
- Radionuclide and activity (in units of becquerels or curies) of byproduct material in each sealed source
+ Manufacturer's name, model number, and serial number (if appropriate) of each device containing byproduct material
. Location of each scaled scurce and device
- For materials 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 name and model number, serial number). Information on locations where irradiators are used or stored are records important to decommissioning and required by 10 CFR 30.35(g)(2). I 8.I7 Draft NUREO - 1556, Vol. 5
l l CONTENTS OF AN APPLICATION Table 8.2 Record Maintenance
' Type of Raeemi How Lems Record Meet be Maintained 4 Receipt For as long as the material is possessed until 3 years after transfer or disposal
[Transihr # .. s . iFor 3 { ears aner transfbr> w' F > s Disposal Until NRC terminates the license limportant to ! >
; Until the site is rolessed for unrestricted use - -
Ldecanunissioning '- 1i Response from Applicant: Provide either of the following: A statement that: " Physical inventories will be conducted at intervals not to exceed 6 months, to account for all scaled sources and devices received and possessed under the lleense." OR
+
A description of procedures for ensuring that no self shielded irradiator has been lost, stolen, or misplaced and how often this will be done. Noft: Altemative responses will be evaluated using the criteria listed above. 8.14 ITEM 10: RADIATION SAFETY PROGRAM - OCCUPATIONAL DOSIMETRY Regulations: 10 CFR 20.1502,10 CFR 20.1201,10 CFR 20.1207,10 CFR 20,1208. Criteria: Applicants must do either of the following:
+
Maintain, for inspection by NRC, documentation demonstrating that unmonitored individaals are not likely to receive, in one year, a radiation dose in excess of 10 percent of the allowable limits as shown in Figure 8.3. OR
+
Provide dosimetry as follows: Draft NUREO 1$56, Vol. 5 8 18
CONTENTS OF AN APPLICATION
- 1. Personnel dosimeters which are processed and evaluated by a National Voluntary Laboratory Accreditation Program (NVLAP) approved processor and are exchanged at a frequency recommended by the processor; or
- 2. Direct or indirect reading pocket ionization chambers that:
- Arc assigned to a single individual whose accumulated dose is read, recorded, and the chamber recharged, as appropriate, before the chamber is assigned to another individual I
+ llave a range of 0 to at least 2 mSv (200 mrem)
+ Arc checked at intervals not to exceed one year for correct response to radiation
+ Read within *20% of the true radiation exposure l
- Are u:ed under a program that prescribes action to evaluate the individual's dose gg Eyes Annual Dose Limits 0 6 Sv 0.60 SV , e) for Radlatlon Worker I' '** *I (10 CFR 20.1201)
Elbows to hands 0.60 Sv Total effective dose equivalent TEDE (60 roms) (whole body) 0.06 Sv (6 roms) Knees to f'St 0.60 Sv (60 roms) es
- m s. o..
ioo m q y Figure 8.3 Annual Dose Limits for Radiation Workers. Discussion: Under conditions of routine use and maintenance, the typical self shielded irradiator user does not require a personnel monitoring device (dosimetry). Appendix L provides guidance on preparing a written evaluation demonstrating that self shielded irradiator users are not likely to exceed 10 percent of the applicable limits and thus, are not required to have personnel dosimetry. When personnel monitoring is need:d, most licensees use either film badges or thermoluminescent dosimeters (TLDs) that are supplied by a NVLAP approved processor. The exchange fregaency for film badges is usually monthly due to technical concems about film 8 19 Draft NUREO 1$56, Vol. $
i t CONIBNTS OF AN APPLICATION fading. The exchange frequency for TLDs is usually quarterly. Applicants should verif: that the processor is NVLAP approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use.- Some licensees use self reading dosimeters in lieu ofprocessed dosimetry. This is acceptable if i the criteria above are met. See ANSI N322, " Inspection and Test Specifications for Direct and
-Indirect Reading Quartz Fiber Pocket Dosimeters," for more information. I Response from Applicast: Provide either of the following:
A statement that: "Either we will maintain, for inspection by NRC, documentation demonstrating that unmonitored individuals are not likely to receive, in one year, a ; i radiation dose in exceu of 10 percent of the allowable limits in 10 CFR Part 20 or we ' will provide dosimetry that meets the Criteria in the section entitled 'kadiation Safety . Program Occupational Dosimetry' in draft NUREG 1556, Vol. 5,' Consolidated " Ouldance about Materials Licenses: Program Specific Ouldance about Self Shielded . Irradiator Licenses,' dated October 1997." l OR
^
+
A description of an alternative method for demonstrating compliance with the referenced regulations. Note
+
Alternative responses will be evaluated using the criteria listed above. '
+
Some licensees choose to provide personnel dosimetry to their workers for reasons other i than compliance with NRC requirements (e.g., to respond to worker requests).
References:
National Institute of Standards and Technology (NIST) Publication 810, " National Voluntary Laboratory Accreditation Program Directory," is published annually and is available for purchase from GPO and on the Intemet at the following address: http://ts.nist. gov /ts/htdocs/210/214/dosim.htm. Copies ofANSI N322 may be obtained from the American National Standards Institute,1430 Broadway, New York, NY 10018, or ordered electronically at the following address: www. ansi.org. i Draft NUREG I$56, Vol. 5 - 8-20 i _ _ _ . - - . . , - -.~.,-a- _ _ ~. ,._ - - . . - , _ . . _ , , , . - . . . . . - - _ , _ . - - . _ , _ . - _ - - ._ , u -_s
CONTENTS OF AN APPLICATlON f 8.15 ITEM 10: RADIATION SAFETY PROGRAM - PUBLIC DOSE Regulations: 10 CFR 20.130!,10 CF1120.1302, 80 CFR 20.1003,10 CFR 20.1801, l 10 CFR 20.'.302,10 CFR 20.2107. 1 Criteria: Licensees must do the following:
- Ensure that licensed self shielded irradiators will be used, trsnsported, and stored in such a way that members of the public will not receive more than 1 millislevert (msv) (100 l
millirem (miem)) in one year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour, from licensed operations.
- Control and maintain constant surveillance over self shielded irradiators that are not in stcrage and secure stored self shielded irradiators from unauthorized access, removal, or uSc.
Discussion: Members of the public include persons who work or may be near locations where self shielded irradiators are used or stored and employees whose assigned duties do not include the use of licensed materials and who work in the vicinity where irradiators are used or stored. Irradiator Location l l i j l Proper location: a sufficient distance from , l personnel and secured against unauthorized - access or removal oe3ogy Figure 8.4 Proper Location ofIrradiator. Irradiators 5hould be locatedmvayfrom occupied areas and secured to prevent unauthorized l use or removal, i 8 21 Draft NUREO I$56. Vol. 5
i
' CONTENTS OF AN APPt.lCAT10N- '
Security procedures described in " Facilities and Equipment" sad " Radiation Safety Program < . Operating and Emergency Procedures" should be effective in limiting the exposure to the public j ouring use or storage. See Figure 8.4. Public dose is controlled, in part, by ensuring that - ! Irradiators are secure (e.g., located in a locked area) to prevent unauthorized access or use. As [
. shown in Figure 1.1, most self shielded irradieors are massive (i.e., hundreds of kilograms !
(pounds) and the size of file cabinets), not Ic. ., to be easily removed from their intended ; location, and may not need to be in a locked area to prevent loss, theft, or unauthorized relocation.- ; However, smaller units such as those used to calibrate TLDs are more casily moved and should be located in a locked area or be bolted in place. Irradiator use is usually restricted by controlling ; accea to the keys nemled to operate the irrallator and/or to keys to the locked irradiator area. _ Only autherited users should have accen to these keys. : Public dose is also affected by the choice of storage and use locations and conditions. Since a actr.*hb!ded idadiator presents a mdistion field, it must be located so that the radiation level in an : Tsidevigsed stea (e.g., an office or the exterior surface of an outside wall) does not exceed 1 mSv l (100 muni) in a year or 0.02 mSv (2 mrem) in arr ne hour. Use the concepts of time, distance, , and shielding whe'uhoosing storage and use locations. Decreasing the time spent near an irradiator, increasing the distance from the irradiator, and using shielding (l.c., brick, concrete, ' lead, or other sclid walls) will reduce the radiation exposure. l
-. Licensees can determine the radiation levels adjacent to the irradiator location either by ,
calculations or a combination of direct measurements and .alculations using some or all of the following *ypical known radiation levels provided by the manufacturer, the " inverse square" law t to evaluate ine effect ofdistance on radiation levels, occupancy factor to account for the actual presence of the member of the public, and limits on the use of self shleided irradiator(s). See
- Appendix M for an example.
1 If, after making an initial evaluation, a licensee changes the conditions used for the evaluation (e.g., changs the location ofirradiators, changes the type or frequency ofirradiator use, adds self-shielded irradiators, changes the occupancy of adjacent areas), !. hen the licensee must perform a new evaluation to ensure that the public dose limits are not exceeded and take corrective action, as needed. i During NRC inspections, licensees must be able to provide documentation demonstrating, by ' measurement or calculation, that the total effective dose equivalent to the individual likely to , receive the highest dose from the licensed operation does not exceed the annual limit for members . of the public. See Appendix M for examples of methods to demonstrate compliance. p Response ihm Applicast: No response is required from the applicant in a license application, i l }ut this matter will be examined during inspection.
- DrQNUltE041556, Vol. $ s.22 I
l
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CONTENTS OF AN APPL.lCATION 8.16 ITEM 10: RADIATION SAFETY PROGRAM - OPERATING AND EMERGENCY PROCEDURES Regulations: 10 CFR 30.34(c),10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.22012203,10 CFR 30.50,10 CFR 21.21,10 CFR 19.11(a)(3). Criterlat Ilefore using an irradiator, licensees must do the following:
- Develop, implement, and maintain model.specine operating and emergency procedures containing the following elements:
- An analysis of each type of material to be place ' in the irradiator to ensure that it is compatible with the irradiator's design or to determine if any special safety procedures are needed
+ Instructions for using th: self shielded irradiator and performing rootine maintenance, according to the manufacturer's written recommendations and instructions
+ Instructions for maintaining security to prevent unauthorized use, access, or removal of self shielded irradiators and the associated scaled sources
. Steps to take to keep radiation exposures ALARA
+ Steps to maintain accountability
+ Steps to control access to a malfunctioning or damaged irradiator
+ Steps to take, and whom to contact (e.g., RSO, local officials), when an irradiator malfunctions or has been damaged.
AND
+ Provide copies of operating and emergency procedures to all uaers
- Maintain a current copy of operating and emergency procedures at each irradiator's control panel (or, if this is not practicable, post a notice describing the procedures and stating where they may be examined).
Discussion: When used as designed, properly functioning self shielded irradiators pose little radiation safety risk. Ilowever, improper maintenance, irradiating material incompatible with an irradiator's design, or operating an irradiator in an environment other than that recommended by the manufacturer, could lead to damage or malfunction of an irradiator and elevated exposure rates in the irradiator's immediate vicinity. Operating and emergency procedures should be developed to minimize these risks, while keeping radiation exposures ALARA. These procedures must be model specine to account for potentially significant differences in irradiator design and construction that lead to manufacturers providing different instmetions and recommendations for operating and maintaining irradiators. 8 23 Draft NUREG .1556, Vol. 5
i CONTENTS OF AN APPL.lCATION Sources contained in many self shielded irradiators are designed to deliver significant doses in short periods of time. Although self shielded irradiators are safe when used correctly, unauthorized access to the irradiator or the irradiator's sources by untrained individuals could lead i to a life threatening situation. 'Iherefore, operating procedures will also need to address access control and accountability. Many licensees achieve access control by permitting only authorized users or the RSO to have access to the keys for the irradiator and/or the irradiator area. Accountability of an operating irradiator may be ensured by using a log book to record irradiator use, maintenance, service calls, and scaled source leak tests. Each activity requires an individual to interact in some way with the irradiator and thereby verify its presence. For sources contained in irradiators that are not actively used, licensees would need to find other methods to maintain accountability, such as conducting inventories. Licensees must post current copies of the operating procedures applicable to licensed activities (e.g., at the irradiator control panel). If posting of a document is not practicable, the licensee may post a notice which describes the document and states where it may be examined. Proper Handling of incident n
- 1. Unautherleed som,le s. Drive mechentem jeme, 3.Prehlbite use and restricte irradiated storte nre secess to irredletor tres 4
eEColle to Rso end sit Ismesl. u.ie' r - a n,.me,og . 4.nso and ,ir. no,arim.nire.,end Figure 8.5 Proper llandling ofIncident. Licenseepersonnelimplement emergency
- procedures when aflammable sample catchesfire.
i I Dren NUREO .1556, Vol. 5 8 24 l I { l - -
- - .- - = _ . . ~ . _ - - _ - -- --- .. . . - . .- - - - - - - . .- .
l CONTENTS OF AN APPLICATlON ! Figme 8.5 illustrates pioper response to a fire in an irradiator. Emergency procedures should be .' developed to address a spectrum ofinciden's (e.g., interlock failure, flood, earthquake). Emergency response procedures should contain the following eierents:
- Leave the irradiator room to reduce radiation exposure
. . Control access (e.g., lock door) _
- Contact the individual responsible for the Irradiator program for further Instructions and to Initiate emergency response. (Telephone numbers for the responsible individual, the irradiator ,
manufacturer or representative, fire department, or other emergency response organization, : and the NRC should be posted or easily accessible.) l C Survey areas outside the irrullator room to determine whether further restriction of the area is - necessary to ensure that no one can enter the aiva if the radiation level exceeds 0.02 mSv (2 mrem) per hour,
- As appropriate, requin, timely reponing to NRC according to' 10 CFR 20.2201 20.2203,10 CFR 30.50, and 10 CFR 21.21.
'lhe NRC must be notified when a self shielded irradiator is lost, stolen, or other conditions occur. Ihe RSO must be proactive in evaluating whether NRC notification is required. Refer to the regulations (10 CFR 20.2201 20.2203,10 CFR 30.50, and 10 CFR 21.21) for a description of when and where notifications are required.
Appendix N provides information for applicants to consider when developing their procedures for self shicided irradiators. Response frons Applicast: Do either of the following:
. State: " Operating and emergency procedures will be developed, implemented, maintained, and distributed and will meet the Criteria in the section entitled ' Radiation Safety Program -
Operating and Emergency Procedures' in draft NUREO-1556, Vol. 5,' Consolidated Guidance about Materials Licenses: Program Sgcific Ouldance about Self Shielded Irradiator Licenses,' dated October 19"7." , OR
*- Submit alternative procedures, Neer:
- Altemative procedures will be reviewed using the criteria listed above.
o l i Licenses authorizing J. L. Shepherd Mark I or Model 31 22 irradiators will be conditioned to require compliance with the terms of the Order in Appendix E. Applic~ ants requesting these , 8-25 Draft NUREO l$$6,Vol. $ .
CONTENTTiOF AN APPL.lCATlON irradiators must ensure that their operating and emergency procedures address these requirements. Before using a new model irradiator, licensees need to revise operating and emergency procedures to include procedures specific to the new Irradiator. 8.17 ITEM 10: RADIATION SAFETY PROGRAM - LEAK TESTS Regulations: 10 C R 30.53,10 CFR 20.1501,10 CFR 20.2103. Criteria NRC require- % sting to determine whether there is any radioactive leakage from the source in the self shie rradiator. Records of test results must be maintained. Discussion: When issued, a license will require performance ofleak tests at intervals approved by the NRC or an Agreement State and specified in the SSD Registration Certificate. The measurement of the leak test sample is a quantitative analysis requiring that bstrumentation used to analyze the sample be capable of detecting 185 becquerels (0.005 microcurie) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State to either perform the entire leak test r,equence for other licensees or provide leak test kits to licensees. In the latter case, the licensee is expected to take the leak test sample according to the self shielded irradiator manufacturer's and the kit supplier's instmetions and retum it to the kit supplier for evaluation and reporting results. Leak test samples should be collected at the most accessible area where contamination would accumulate if the scaled source were leaking. Licensees may also be authorized to conduct the entire leak test sequence them. elves. Response from Applicant: Do one of the following: State: " Leak tests will be performed at intervals approved by the NRC or an Agreement State and specified in the Scaled Source and Device Registration Certificate. Leak tests will be performed by an organizat!on 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 authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the self shielded irradiator manufacturer's and kit supplier's instructions." OR State: " Leak tests will be performed at intervals approved by the NRC or an Agreement , State and specified in the Scaled Source and Device Registration Certificate. Leak tests will be performed by an organization authorized by NRC or an Agreement State to l provide leak testing services to other licensees or using a leak test kit supplied by an DraA NUREO .1$56, Voi,5 8 26
CONTENTS OF AN APPLICATION i organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the self shielded irradiator manufacturers and kit suppliefs instructions. As an alternative, we will implement the model leak test program published , in Appendix 0 to draft NUREG 1556, Vol. 5,' Consolidated Guidance about Materials Licenses: Program Specific Information about Self Shielded Irradiators,' datJ October 1997." OR
- A descriptio.. nf alternative equipment and/or procedures for determining whether there is radioactive leakage from sources contained in self shielded irradiators.
Now: Altemative responses will be reviewed using the criteria listed above. + If a self shielded irradiator is added to an existing license, that license might already authorize the licensee to perform the entire leak test sequence in this case, the licensee may perform the leak testing on the irradiator according to the procedures previously approved on its license.
References:
See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of DraR Regulatory Guide FC 412-4, " Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak Testing Services," dated June 1985. 8.18 ITEM 10: RADIATION SAFETY PROGRAM - MAINTENANCE Regulations: 10 CFR 20.1101,10 CFR 30.34(e). Criterlat Licensees must routinely maintain self shielded irradiators according to the manufacturers written recommendations and instructions; see Figure 8.6. For self shielded irradiators, radiation safety procedures for routine maintenance must consider ALARA and ensure that the irradiator functions as designed and source integrity is not compromised, in this draR report, "non-routine maintenance" means any repair, removal, replacement, or alteration involving: electrical and mechanical systems that control source or shielding movement, the irradiators shleiding or scaled source, safety interlocks, any component that may affect safe operation of the irradiator, or any other activities during which personnel could receive radiation doses exceeding NRC limits. Non-routine maintenance must be performed by the self shielded irradiator manufacturer or a person specifically authorized by NRC or an Agreement State; see Figure 8.7. Requests for 8-27 Draft NUREO 1556. Vol. 5
CONTENTS OF AN APPLICATION specific authorization to perform non routine maintenance (see Appendix I) must demonstrate that personnel performing the work do the following:
+ llave adequate training and experience +
Use equipment and procedures that ensure compliance with regulatory requirements, and consider ALARA 3nsure that the self shielded irradiator funct:ons as designed and that source integrity is not compromised. Discussion: NRC IN 96 35, " Failure of Saf:ty Systems on Self Shielded Irradiators because of Inadequate Maintenance and Training," dated June i 1,1996, describes two incidents in which safety interlocks on self shielded irradiators failed to prevent inadvertent exposure. NRC permits self shielded irradiator licensees M ne W e and N to perform routine enaintenance of the irradiator provided they folia 1he self-shielded irradiator manufacturer's written recommendations and instructions. Although
\ q Da'"' manufacturers may use different terms, M, " routine maintenance" includes, but is not rg*= limited to, cleaning, lubrication, changing
/ """*""
batteries, relays or fuses. Routir,e
- mainanance does not include any activities that involve the source, source drive
~S mechanism, or removing the shielding or Figure 8.6 Routine Maintenance and source and any other activities during which Lubrication. To ensureproper operation of personnel could receive radiation doses the unit, sel(-shleided irradiator licenseer need exceeding NRC limits.
toperform routine maintenance according to the manufacturer's written instructions and recommendations. Draft NUREO 1556, Vol. 5 8 28
l
)
l CONTENTS OF AN APPLICATION l The NRC license will require that non-NWh routine maintenance (as defined above) be performed only by the manufacturer or other l persons specifically licensed by the ! Commission or an Agreement State to "M"
**** perfonn such services. Most licensees do not 1
cand p.* form non routine maintenance because YM th.y must have specialized equipment and
.g. V W technical exputise to perform these activities.
V W Applicants seeking authorintion to perform non routine maintenance must submit w ummummuns
,, specific procedures for review, See o= Appendix I for more information.
Figure 8.7 Non Routine Maintenance. For non-routine maintenance, most licensee.: rely on the manufacturer or other service companies. Response from Applicant: Routine Maintenance: Submit either of the following:
- A statement that: "We will implement and maintain procedures for routine maintenance of our self shielded irradiators according to each manufacturer's written recommendations and instructions."
OR
- Altemative procedures for NRC's review.
Non Routine Maintenance: Submit either of the following:
- A statement that: "We will have the self shielded irmdiator manufacturer or other person authorized by NRC or an Agreement State perform non routine maintenance."
OR
- The information listed in Appendix i supporting a request for authorization to perfomt this work.
8 29 Draft NUREO 1556, W. 5
CONTENTS OF AN APPL.lCAT10N Note:
- Altemative procedures for performing routine maintenance will be reviewed using the criteria listed above.
+
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 maintenance.
References:
See the Notice of Availability (on the inside front cover of this drafi report) to obtain a copy of NRC IN 96 35, " Failure of Safety Systems on Self Shielded Irradiators because ofinadequate Maintenance and Training," dated June 11,1996. 8.19 ITEM 10: RADIATION SAFETY PROGRAM - 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 11 of 10 CFR Part 71,49 CFR Parts 171 178,10 CFR 20.1101,10 CFR 30.41,10 CFR 30.51. Criterla: Applicants must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and DOT regulations. Discussion: The general license in 10 CFR 71.12 provides the authorization used by most licensees to transport, or offer for transport, packages of radioactive material and specifies certain conditions. Most self shielded irradiators contain quantitles of radioactive material that iequire uslag a Typ: " package. Before offering a Type B package for shipment, the licensee needs to be registered as a user of the package and have an NRC approved quality assurance (QA) plan, two of the requirement ur. der the 10 CFR 71.12 general license. For information about QA plans, see Revision 1 of Regul tory 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 review, contact NRC's Spent Fuel Project Office (SFPO) by calling NRC's toll free munber 800 368-5642 and asking for ex" .sion 415-8500. For information about associated fees, contact NRC's Office of the Chief Fi,-icial Ollicer by calling NRC's toll free number 800-368 5642 and asking for extension 415 7:54. Some irradia:or licensees who rarely ship radioactive material 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 irradiator at temporary job sites (e.g., at the irradiator location) Draft NUREO 1556. Vol. $ 8 30 y
CONTENTS OF AN APPLICATION
. Actually takes possession of the irradiator under its license
- Uses an cpproved Type B package
- Is registered with NRC as a user of the Type B package a lias 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 L QT mgalations. 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. Part 1 of
.\ppendix P lists major DOT regulations and Part 2 contains a sample bill oflading.
Before the adoption of the requirements of 10 CFR Part 71 in 1966, self-shielded irradiators cauld be transported without being evaluated under the hypothetical accident conditions that are now incorporated in 10 CFR l' art 71. Because pre-1966 irradiators are not certified shipping packages, transporting them may require transferring the sealed source from the irradiator to a certified Type B package or using a certified package for the irradiator containing the scaled sources. Only if these eptions are not viable will NRC consider a licensee's request for an exemptivu for a one-time shipment according to 10 CFR 71.8. Exemption requests should contain the information described in Part 3 of Appendix P. In addition to an NRC exemption, the licensee may also need a DOT exemption; contact DOTS Office of Hazardous Materials Technology at 202-366-4545 for additional information. Response from Applicant No response is needed from applicants during the licensing phase. Ilowever, before offering a Type B package for shipment, a licensee needs to have registered with NRC as a user of the package and obtained NRC's approval ofits QA program. Transportation issues will be reviewed during inspection.
References:
"A Review of Department of Transportation Regulations for Transportation of Radioactive Materials (1983 revision)" can be obtained be calling DOTS Office ofllazardous Materir.1 Initiatives and Training at (202) 366-4425. See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of the Memorandum of Understanding with DOT on the Transportation of Radioactive Material, signed June 6,1979, and Revisien 1 of Regulatory Guide 7.10, " Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986.
8-31 Draft NUREG - 1556, Vol. 5 i
' CONTENTS OF AN APPLICATION 8,20 ITEM 10: RADIATION SAFETY PROGRAM - 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 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. Scaled sources and devices that are approved by NRC or an Agreement State and located and used according to their SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in the SSD Registration Certificate should identify defective sources. Leaking sources must be immediately withdrawn from un and decontaminated, repaired, or disposed of according to NRC requirements. 'Ihese steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. Response from Applicant: 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 in the following sectyns: " Radioactive Material - Scaled Sources and Devices," " Facilities and Equipment," " Radiation Safety Program - Operating and Emergency Procedures," " Radiation Safety Program - Leak Tests," and " Waste Management - Self Shielded Irradiator Transfer and Disposal." 8.21 ITEM 11: WASTE MANAGEMENT - SELF-SHIELDED IRRADIATOR DISPOSAL AND TRANSFER Regulations: 10 CFR 20.2001,10 CFR 30.41,10 CFR 30.51. Criteria: Licensed materials must be disposed of according to NRC requirements by transfer to an authorized recipient. Appropriate records must be maintained. Draft NUREO - 1556, Vol. 5 8-32
-I a
CONTENTS OF AN APPLICATION ' s Discussion: When disposing of self-shielded irradiators, licensees must transfer them to an
- authorized recipient. Authorized recipients are the original manufacturer of the_irradiator, a c
commercial firm licensed by the NRC or an Agreement State to accept radioactive waste from - l - other persons, or another specific licensee authorized to possess the licensed material (i.e., its license specifically authorizes the same radionuclide, form, anxi use).-
; 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 . 3 Licensees should promptly dispose of unused irradiators to minimize potential problems of ' access by unauthorized individuals, use for inappropriate purposes, or improper disposal. Response frons Applicast: The applicant does not need to provide a resnonse to this item during the licensing phase. 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 part of a purchase agreement, The next two items on NRC Form 313 are to be completed on the form itself. 8.22 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.
- 8.23 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 oficial documents on behalfofthe applicant. As discussed previous)y .
E in " Management Responsibility," signing the application acknowledges management's
/ commitment and responsibilities for the radiation protection program. NRC will return all unsigned applicationsfor proper signature.
8-33 Draft NUREO - 1556, Vol. 5
~. CONTENTS OF AN APPLICATION Note:
It is a enminal 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 1:quirements, i Draft NUREO - 1556, Vol. 5 8 34
9 AMENDMENTS AND RENEWALS TO A LICENSE lt is the licensee's obligation to keep the license current. If any of the information provided in the original application is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license aner 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)). Applications for license amendnunt, in addition to the following, snust provide the appropriate fee. For renewal and amendmen; requests applicants must do the following:
- Be sure to use the most recent guidance in preparing an amendment or renewal request.
- Submit in duplicate, either an NRC Form 313 or a letter requesting amendment or renewal. . Provide the license number.
- For renewalrspmvide 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. As an altemative, describe clearly the exact nature of the changes, additions, and deletions.
Using the suggested wording of responses and committing to using the aodel procedures in this dran report will expedite NRC's review. 9-1 Draft NUREG - 1556, Vol. 5
10 TERMINATION OF ACTIVITIES Regulations: 10 CFR 20.1402,10 CFR 20.1403,10 CFR 30.34(b),10 CFR 30.35(g),10 CFR 30.36(d) and (j),10 CFR 30.51(f). Criteria: The licensee must do the following:
- Notify NRC, in writing, within 60 days, when its license has expired or a decision has been made to permanently cease licensed activities at the entire site regardless of contamination levels.
- Notify NRC, in writing, within 60 days, when principal activities have not been conducted for 24 months or a decision has been made to permanently cease licensed activities in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.
- Certify the disposition oflicensed materials by submission of NRC Form 314, " Certificate of Disposition of Materials" or equivalent information.
- Before a license is terminated, send the records important to decommissioning (as required by 10 CFR 30.35(g)) to the appropriate NRC regional office, iflicensed activities are transferred or assigned accading to 10 CFR 30.34(b), transfer records important to decommissioning to the new licensee.
Discussion: Licensees are not required to notify NRC when principal activities have not been conducted for 24 months or a decision has been made to permanently cease licensed activities in any separate building or outdoor area, unless the separate building or outdoor area contains residual radiosctivity making it unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection. For guidance on the disposition oflicensed material, see the section on " Waste Management - Self-Shielded Irradiator Disposal or Transfer " For guidance on decommissioning records, see the section on " Radioactive Materials - Financial Assurance and Record Keeping for Decommissioning." Licensees should promptly dispose of unused inadiators to minimize potential problems of access by unauthorized individuals, use for inappropriate purposes, or improper disposal. bsponse 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 the applicant must perform decommissioning activities and submit NRC Form 314 or equivalent information.
References:
Copies of NRC Fonn 314, " Certificate of Disposition of Materials," are available upon request from NRC's Regional or Field Offices; see Figure 2.1. 10-1 Draft NUREG - 1556, Vol. 5
Appendix A List of Documents Considered in the Preparation of this Draft NUREG Report
APPENDIX A List of Documents Considered in the Preparation of this Draft NUREG Report This draft report incorporates and updates the guidance previously found in the Regulatory Guides (RO), Policy and Guidance Directives (P&GD), Information Notices (IN), and Technical Assistance Requests (TAR) listed in Table A.I. When this draft report is issued in final fonn, the documents in Table A.1 will be considered superseded and should not be used. Table A.1 List of Documents Considered in the Preparation of this Draft Report Document Title Pate Identification RO 10.9 Ouide for the Preparation of Applications for Licenses for the 12/88 Use of Self-Contained Dry Source-Storage Gamma Irradiators, Rev.1 P&OD Standard Review Plan for Applications for Licenses for the Use 10/84 FC 8416 of Self-Contained Source-Storage Irradiators, Rev.1 P&OD Transportation ofIrradiator License Units Not Meeting Current 11/84 FC 84-18 Requirements of 10 CFR Part 71 IN 96-35 Failure of Safety Systems on Self Shielded Irradiators Because of 6/11/% Inadequate Maintenance and Training sR University of Pittsburgn 1/17/91 TAR University of Wisconsin and Maintenance of J. L. Shepherd Mark 8/8/94 IIrradiators A-1 Draft NUREG - 1556, Vol. 5 l
L l ' l i I i 1 Appendix B
- United States Nuclear Regulatory Commission Form 313
___m__._.____________ - . . - . . . . , . , , . , _ , , - , - . - , , , _
APPENDIX B APPRcPm0 eV cus. NO. steso saPassamm NRC FORM 313 U. S. NUCLEAR fWGULATORY COMMIS$10N e,e e., m E n , m e,.e . e ,,,, W 10CPR R 82.M .movest
.e e T . hope $u.bm. es.o e sr.9 epphugh.an
- m-r. sense,y I.B d.e m u a = m - 40 ,uM , e o. es ., F e w.A e e
- 9. bem,mseen and Rose,ee Managems.t tremh (T,4 F3% U S Nuesmer rc a **"'*'a c'"*****""*
APPLICATION FOR MATERIAL LICENSE - **'"se"n Roeus "u'"s"e"s P g "01904130L Okse er"Ms soment and Obsesst 4 ' Wenne DC 20008 estC may not ennesst e.r asenmar. and a ponen a not momed to supe. to. e amassaan er vesm non unesse a espanye e e.ney vand Oest earcel number INSTRUCTIONS: SEE THE APPROPRIATE UCENSE APPUCATION Gul0E FOR DETAILED INSTRUCTIONS FOR CO SEND TWO COPIES OF THE ENTIRE COMPLETED APPUCATION TO THE NRC OFFICE SPECIFIED SELOW. y YOU ARs LOCAvec es; APPuCATom POR OneTReUTi0s: Or SamsPT PR00ucTS Fila APPucAficess wmt S15e018, BetAftA 10WA, ImCeGOAN, GININGOOT A, tele 00URL ONIO, oft Wm'mW DMaiON OF NtAleTRiAL AfC MEDICAL NUCLEAR 4AFETY OFFICE OF NUCLEAft MAT 3ftlALS SAFETY AND SAF90UARDS ggg gppyggggggg yg 1 U S MUCLEAR REOULATORY e-naam MATSRAS UCENONO SECTION WAaHMGTOK OC 30ee64001 ALL OTNER Pgmecset FILE APPUCAficent AS POLLOWS. USLE,t.One M R1 F YOU AR$ LOCAT90 let AAA8MA, ARIBOILA, ARIEANGAS,CAUPOReeACOLORADO,NAWAA,SANO,RANGAS, 00NNECTICUT, DELAWAflR, OsSTRICT OP 00LualbtA, IRAndE, etARYLAND, LfiJie84feA,310erTAseA, a'an==a" IIEVADA, NEW RAEXICO, te0RTM DAMOTA, laAmeACNuoETTs, espw NAsspeNetE, seeW JesteEY, NEW YORR, PessNSYLVAseA, 000,ANonsA OReecet, PacIPIC TRUST TemftrT0ftSS,90UTN DAMOTA TERA 4, UTAN, RNDOE ISLANO, OR YWmescoff, OSNO APPUCAftDRIS TO WasNIIsSTON, OR WY0alue$, 3910 APPUCATIONS TO UCENANG A&elSTANT SECf10N NUCLEAR MATERA8 SAFETY BRANCH NUCLEAR MATERAS UCENSNQ SFCTION U S NUCLEAR ltE0VLAT08tY emammannes, REOs0N I U & NUCLEAR REOULATORY PNahmMp(, M(QQN fy 011 RYAN PLAZA DetfvE, SUITE 400 aTS ALLENDALE ROAD suMG OF PRue01A, PA 1940dL1418 ARuNGTON, TX T00114008 A8 Amaata FLORIDA, Ge0RetA, RONTVCMY,Im84000dPPI, es0RTN raan maa puggtTO ReCO, DOUTN CAROLusA, TW=samas vimosaA, vlRear ans sama OR WEST WWhe84A, tese0 APPUCAvicess 70: NUCLEAR MATERLALS UCENepeQ SECTION U S NUCLEAR REOULATCdW PMhannah% RE0 ION G 101 IAARETT A STREET. NN. SuTE 3e00 ATLANT A. QA 303234100 Pette 0NG LOCATSD pt AeRegastNT STATSS teNO APPUCAT100s0 TO THE U S. am mam ReeULAT0ftY 00010110000N ONLY IF THEY WIGN TO P000S$4 AN teAfssinAL IN ST AT54 $UtJSCT TO U S.esuCLEAR ReeULAT0ftY 00asageGION #.#I001C710188. 2 NAnsE ANDMA4NG A00ftEASOF APPUCANT hesAsseZe,aosle/ t 1 THIS S AN APPUCAflON FOR (Chace apperuse eu,Q A I Q UCENSE 8 AMEN 0hsENT TO UCENSE NUMSER C RENEW AL OF UCENSE NUMBER a NmE oF% won 70 mE CONTACTED As0uf Das AooREsa(Es> wHERE uCENsEn MATERA Wu aE ueED oR ma==n APPUCAfl0N TELEPHONE NUMBER standit ffEles 5 THROUGH 11 ON 6112 X 11' PAPER THE TYPE AND SCOPE OF NFORMAT1DN TO BE PRowmED E DESCpteED N THE UCENGE APPUCATION OUIDE. g RAQsOACTNE hsATERLAL
& PURPCeE(S) FCft WMCN UCEN8ED MATERA WILL DE USED e Element.and
.n ., i. ps ae mene number on,one man 6 enemiend eneer pegenceltunn, and A massmum emawt T NorvouAusatePoNeetE FoR RADIATON SAFETY PROQRM AND THEM 8 TRAINNO FOR peOMDUALS WOR 90NO N OR FREQUENTING RESTRICTED AREAS N EXPER N 10 RA0hATION SAFETY NtOOftAM S P ACILff1E$ AND EQUIPMENT q UCENSEE FEES (See 90 CPR f 70and Sassen f 70 3fJ g AesOUNT 11 W AsTE MANAGEMENT. FEE CATEGORY IENC10eED $
18 CERTIFICA110N (tfuseto.-- ey appemeng THE APPUCANT UNDERSTANDS THAT ALL STATEhdENTS AND REPRESENTATIONS IAADE N THIS APPUCATION ARE SMONG UPONTHE APPUCANT THE APpVCANT AND ANY OFFICIAL EXECUTNG THS CERTFICATION ON BEHALF OF D4E APPUCANT, NAAIED H ITEM 2. CERT 1FY THAT TMS APPUCATION $ P8tE/ARED CONFOstheTY Wmd TTTLE 14 CODE OF FEDERAL REOULATIONS, PARTS 3(L 32,33, u,36,30. 30 AND 40, AND THAT ALL INFORMATION CONTANED HEREN S TRUE ANO CORRECT TO THE GEST OF TMim sesOWLEDGE AND GELEP. W ARNedo 10 U S C SECTION 1001 ACT OFJUNE 381ede 02 STAT T4e MAME8 ff A CResNAL OFFENSE TO MANE A Wt1AA.LY FALSE S ANY DEPARTMENT OR AGENCY OF THE UNrTED ST ATES AS TO ANY MATTER WmeN ITS JURie01CT10M SIONA11JRE DATE CEstTFYING CFFICER - TYPECfMtWTED NAnsE AND TITLE FOR NRC USE ONLY FEELoo FEE CATEcoRY AnsauMT RECErvuD CHECM MuueER COMMENTS TvPs ce FaE S DATE AmiovfD sY PftNTED ON RECYCLED PAPER 884C708Inf 313 (788) B-1 Draft NUREG - 1556, Vol. 5
l l l t l Appendix C l l l Suggested Format e for ! Providing information
- Requested in items 5 through 11 of NRC Form 313 .
l A a
l APPENDIX C IIEMS 5 & 6: MATERIALS TO BE POSSESSED AND PROPOSED USES USE AS LISTED SPECIFY OTHER YES NO RADIONUCLIDE MANUFACTURER'S QUANTITY N AME AND ON SSD USES NOT LISTED MODEL NUMBER REGISTRATION ON SSD CERTIFICATE REGISTRATION CERTIFICATE Each of the following Not to exceed Yes [] [] Not applicable Cesium-137 ---------- requested sealed either the sources, devices, and maximum () Uses are: source / device activity per combinations is the source or subject of an approved maximum activity per (Submit safety Scaled Source and Device Registration device as analysis supporting Certificate: specified in safe use) Sealed source Scaled Source manufacturer's name and Device and model number: Registration Certificate Device manufacturer's name and model number: Each of the following Not to exceed Yes [] [] Not applicable Cobalt-60 -------- requested scaled either the sources, devices, and maximum []Uses are: source / device activity per combinations is the source or subject of an approved maximum (Submit safety activity per analysis supporting Serled Source and Device Registration device as safe use) Certificate: specified in S--led source Scaled Source manufacturer's name and Device and modelnumber: Registration Certificate Device manufacturer's name and model number: C-1 Draft NUREG - 1556, Vol. 5
l l APPENDIX C YES NO RADIONUCLIDE MANUFACTURER'S QUANTITY ' USE AS LISTED : SPECIFY OTHER NAME AND - ON SSD USES NOT LISTED MODEL NUMBER REGISTRATION ON SSD .
,c CERTIFICATE REGISTRATION -
CERTIFICATE Strontium 90 Each of the following Not to exceed Yes [] [] Not applicable requested sealed either the ------- sources, devices, and maximum [] Uses are: source / device activity per combinations is the source or subject of an approved maximum (Submit safety Scaled Source and activity per analysis supporting Device Registration device as safe use) Certificate: specified in Scaled source Scaled Source manufacturer's name and Device and model number: Registration Certificate Device manufacturer's name and model number: Other(specify)- FINANCIAL ASSURANCE REQUIRED AND EF7DENCE OF FINANCL4L ASSUR4NCE PROF 1DED I l ( l l l Draft NUREG - 1556, Vol. 5 C2
APPENDIX C ITEMS 7 THROUGH 11: TRAINING AND EXPERIENCE. FACILITIES ANQ EQUIPMENT. RADIATION SAFETY PROGRAM. AND WASTE DISPOSAL ITEM NO AND TITLE SUGGESTED RESPONSE YES ALTERNATIVE PROCEDURES ATTACHED YINDIVIDUAL(S) Before obtaining licensed materials, the proposed [] [] RESPONSIBLE FOR RSO will have successfully completed the RADIATION SAFETY training described in Appendix G in draft PROGRAM ANDTHEIR NUREG 1556, Vol. 5, dated October 1997. TRAINING AND AND EXPERIENCE - Before being named as the RSO, future RSO s RADIATION SAFETY will have successfully completed the training OFFICER (RSO) described in Appendix G in draft NUREG-1556, Vol. 5, dated October 1997. Within 30 days of Name: naming a new RSO, we will submit the RSO's name to NRC for inclusion in our license.
- 8. TRAINING FOR Before using licensed material, authorized users [] []
INDIVIDUALS will receive the training described in Appendix G WORKING IN OR in draft NUREG 1556, Vol,5, dated October FREQUENTING 1997-RESTRICTED AREAS
- 9. FACILITIES AND We will ensure that each area where a self- [] []
EQUIPMENT shielded irradiator is located corresponds to the
" Conditions of Normal Use" and " Limitations and'or Other Considerations of Use" on the applicable irradiator's Scaled Source and Device Registration Certificate; the floor beneath a self-shielded irradiator is adequate to rapport the weight of the irradiator; each self shielded irradiator is secured to prevent unauthorized access or removal; and each area where a self-shielded irradiator is located is equipped with an automatically operated fire detection and control system (sprinkler, chemical, or gas) or the hxation of the area and other controls ensure a low-level radiation risk attributable to fires.
- 10. RADIATION The applicant is not required to, and should not, Need Not Be Submitted With SAFETY PROGRAM - submit its audit program to the NRC for review App" cation AUDIT PROGRAM during the licensing phase.
C-3 Draft NUREG - 1556 Vol. 5
l l APPENDIX C ITEMNO. AND11Tir SUGGESTED RESPONSE -YES ALTERNATIVE
, PROCEDURES ATTACHED
- 10. RADIATION SAFETY PROGRAM-We will use instruments that meet the radiation [] []
monitoring instrument specifications published RADIATION in Appendix K to draA NUREG 1556, Vol. 5, MONITORING dned Ouober 1997. Additionally, each survey INSTRUMENTS meter will have been calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations no more than 12 months before the date the meter is used. OR We will use instruments that meet the radiation monitoring instrument specifications published in Appendix K to draA NUREG-1556, Vol. 5, dated October 1997. Additionally, we will implement the model survey meter calibration program published in Appendix K to draR NUREG 155u, Vol. 5, dated October 1997, and we will ensure that each survey meter will have been calibrated no more than 12 months before the date the meter is used.
- 10. RADIATIONJ.
? SAFETY PROGRAM -
Physical inventories will be conducted at . [] [] intervals not to exceed 6 :nonths to account for i MATERIAL RECEIPT? all r,ealed sources and devices received and -
' AND ACCOUNTABILITY g-- - M under the licensec
- 10. RADIATION SAFETY PROGRAM -
Either we will maintain, for inspection by NRC, [] [] documentation demonstrating that unmonitored OCCUPATIONAL individuals are not likely to receive, in one year, DOSIMETRY a radiation dose in excess of 10% of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the Criteria in the section entitled " Radiation Safety Program - Occupational Dosimetry" in draR NUREG-1556, Vol. 5, dated Octcber 1997.
- 10. RADIATION ' c The applicant is not required to submit a Need Not Be Submitted With -
iSAFETY PROGRAM-; evsponse to the public dose section during the . Application :
- PUBLIC DOSE , '
licensing phase. This matter will be examined ' durina i= c' ion. Dran NUREG 1556, Vol. 5 C-4
APPENDIX C
- ITEM NO, AND TITLE - SUGGESTED RESPONSE' YES; E ALTERNA11VE-1 PROCEDURES
- ATTACHED
- 10. RADIATION Operating and emergency procedures will be [] []
SAFETY PROGRAM - developed, implemented, maintained, and distributed OPERATING & and will meet the Criteria in the section entitled EMERGENCY " Radiation Safety Program Operating and Emergency PROCEDURES Procedures" in draft NUREG 1556, Vol. 5, dated October 1997. [10. RADIATION imk tests will be peMrmed at intervals approved by
~
[]t& []__ A
- +
SAFETY PROGRAM - the NRC or an Ayen.ent State and specified in the I EAK' LISTS Sealed Source and unice Registration Certificate. Leek tests will be performed by an organisatir= _ 1 authorised by NRC or an Ayeomoot State to provide -- ,
> o
' leek testing services for other licensees or nains a leek ' 7
~"
test kit supplied by an organlastion authe, ,by NRC
- 1 or an Agreement State to provide look test , s to other _
licensees and WM to the self-shielded irradiator
. r -
manufheturer's and kit supplier's instructions.
~ *' '
ORE _ < . 4. Leek tests will be performed at intervals approved by 4 the NRC or an Agreement State and specified in the , Sealed Source and Device Registration Certificate. Leak tests will be pe formed by an organiastion ,
- authorized by NRC or en Agreement State to provide ;
~
leek testag services for other licensess'or using a leek < test kit supplied by an organization authorimod by NRC
+
or an Ayooment State to provide leek test kits to other licensees and accordag to the self-shielded irradiator manufacturer's and kit supplier's instructions. As an - ahernative, we will implement the model leak test -
' ' program published in Appendix 0 to draft NUREG.
1556. Vol; 5, dated October 1997.
- 10. RADIATION ROUTINE CLEANING & LUBRICATION SAFETY PROGRAM-MAINTENANCE We will implement and maintain procedures for [] []
routine maintenance of our self shielded irradiators according to each manufacturer's written recommendations and instructions. NON-ROUTINE MAINTEN ANCE [] [] The information listed in We will have the self shielded irradiator manufacturer Appendix I supporting a or other person authorized by NRC or an Agreement request to perform non. State perform non-routine maintenance, routine maintenance in-house is attached. C-5 Draft NUREG - 1556, Vol. 5
1 APPENDD( C
)
hIlJWIMO. ANDTITLE SUGGESTED RESPONSE - YES ALTERNATIVE
. -4t n ,
' ' PROCEDURES ATTACHED
- 10. ftADIATION The applicant is not required to submit its response to Need Not Be Submitted With SAFETY PROGP,,AM- the transportation section during the licensing phase. Application TRANSPORTATION llowever, this issue will be reviewed during inspection.
; 10.- P.ADIATION . .. The applicant is not required to submit a response to : Need Not Be Submitted With 4 t SAFETY PROGRAM * - the minimization'of contamination noction if the : Application . ! MINIM 12AT10N OF applicant's responses most the criteria for the - !CONTAMINATIONL following sections:. "P adiaamive Material . Sealed - -
h , Sources and Devices,"" Facilities and Equipment." K ,
" Radiation Safety Program . Operating and Emergency k'- .
Procedures,"" Radiation Safety Program Lenk Tests," t ,, and " Waste Managenwat - Self-Shielded inediator
- i. < Transfer and Disposal"-
- 11. WASTE The applicant is not required to submit a response to Need Not Be Submitted With MANAGEMENT- the waste management section during the licensing Application SELF-SHIELDED phase, flowever, the licensee should develop, IRRADIATOR implement, and maintain self shielded irradiator DISPOSAL & transfer and disposal procedures in its radiation safety TRANSITR program.
l Draft NUREG - 1556, Vol. 5 C-6
1 I l i 1 i 1 ! Appendix D Information Needed for Transfer of
- Control Application e
l a 4 E I
. ..~ . - . . -- - . - - _~..
4 1 4
- APPENDIX D - ..;
information Needed for Transfer of Control Application Licensees must provide full information and obtAin NRC's prior written consent before j
- transferring control of the license; some licensees refer to this as " transferring the license." l
- Provide the following information conceming 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. 4
. 3. - Any chaages 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 whc' r 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 counul 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 emergency procedures).
-7. A detailed description of any changes in the use, possession, 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. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, i- - surveys, inventorir.s, and acccuntability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records.
- 10. - Confirmation that all records concerning the safe and effective decommissioning of the
; facility, purs,uant to 10 CFR 30.35(g),40.36(f),70.25(g), and 72.30(d); public dose; and D-1 Draft NUREG - 1556, Vol. 5 f
'------L--.-_. _ - - - - - - -- --s - - - , , - . -- - - , - w w , - m
APPENDIX D waste disposal by release to sewers, incineration, radioactive matcrial spills, and on-site : burials, have been transferred to the new licensee, if liccased activities will continue at the same location, or to the NRC for license terminations. '
- 11. A description of the status of the facilhy. Specifically, ti e presence or abs ence of '
contamiaation should be documented. If ontamination is present, will decontambation occur before transfer? If not, does the successor company agree to assumo full liability for
- the decontwination 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 r
about how the transferee ar.d transferor propou to divide the trans eror's assets, and responsibility for any clearsup needed at the time of transfer. 13. Confirmation that the transfers 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 adequa te 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 confinn, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferee proposes alternative 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 transferring control of the licensed material and activity, and the conditions of transfer; and the transferee is made awcre 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, requiremcats, 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.
Draft NUREG 1556, Vol. 5 D-2
, ~ _ , _ - . . . , _ . . _ ., m. , _ _. . _ , ., _ __ ._ _ -_ _ .
\
)
Appendix E J. L. Shepherd Order
1 l APPENDIX E J. L Shepherd Order JULY 3,1984 UNITED STATES e NUCLEAR REOULATORY COMMISSION URGENT NOTlCE TO ALL LICENSEES WHO POSSESS J. L. SHEPHERD IRRADIATORS An N' C licensee recently identified a malfunction in the lock mechanism ofits J. L. Shepherd self-shielded irradiator which could have resulted in a radiation overexposure. Although no overexposure appears to have occurred, the potential hazard warrants immediate preventive action. Therefore, we have prepared the enclosed Order which requires the use of radiation survey equipment when the irradiators are being used, if you possess a J. L. Shepherd Mark I or Model 81-22 self shielded irradiator, do not use it unless you provide appropriate radiation monitoring as specified in the Order. If you do not currently possess the appropriate equipment, you must obtain it before you resume use of your irradiator. Also, you should report any problems to your nearest NRC regional office immediately. Do not attempt to repair an irradiatcr, or allow anyone else to attempt repairs, unless specific authorization for repair of the irradiator which you possess is provided in an NRC license. We suggest that you review who has access to your irradiator, and establish strict controls to assure that no untrained personnel have access. Trained persons who continue to use the irradiator should conduct careful radiation surveys as specified in the Order. Irradiator doors should be opened slowlv, to minimize any accidental exposure and to avoid " blanking out" of instruments due to high exposure rates. Any unusual meter reading should be taken as evidence of a problem. We are including in this mailing certain licensees about which we are uncertain whether they possess J. L. Shepherd irradiators. If you do not possess a J. L. Shepherd irradiator, please disregard this notice. E-l Draft NUREG - 1556, Vol. 5
APPENDIX E Because this Order is effective immediately, it is important that you notify your radiation safety personnel immediately, and retain this Order with your license records. Questions and comments > may be directed to your nearest NRC regional office. . Sincerely, Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
Enclosure:
Order Modifying License I 4 I l
- DraA NUREG - 1$56, Vol. 5 E-2 I
- APPENDIX E:
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION: OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS L
- WASHINGTON, D. C. 20555 :
ORDER MODIFYING CERTAIN LICENSES (EFFECTIVE IMMEDIATELY) I - Recently, the Nuclear Regulatory Commission (NRC) staff was notified by a licensee of : the failure of a locking mechanism on a self shielded irradiator which could have resulted in a radiation overexposure. ("Self-shielded" irradiators are designed so that the radioactive source - remains in a shielded position at all times, both during storage and during irradiations. Therefore, the irradiators need not be placed in a shielded room.) . The irradiator is a J. L. Shepherd Mark I, containing about 6,000 curies of cesium 137. The unit is operated as follows: (1) With the source in its shielded storage position, the shielded door is opened, (2) materials to be irradiated are placed inside the irradiator chamber, (3) the - shielded door is closed, (4) the radioactive source is raised into the irradiation chamber, (5) after irradiation is complete, the source is lowered, and (6) the door is opened for removal ofirradiated < materials. The shielded door is interlocked so that it should not open when the radioactive source is in the irradiation chamber. Howeve . .. the case reported to NRC, the lock mechanism failed. In such a situation, an operator who opens the shielded door with the source raised could be subjected to substantial radiation exposure. The J. L. Shepherd Model 81-22 irradiator employs an interlock similar to the Mark I. The NRC staff has examined the irradiator in question and confirmed the defect. Furthermore, a New York City inspector checking a J. L. Shepherd Mark I irradiator in New York reported a malfunctioning interlock system. NRC and the Agreement States are studying the problem further to assess its generic implications Based on the foregoing, I have concluded that the possibility of failure oflocking - mechanisms and/or mechanical timers on J. L. Shepherd Mark I and Model 81-22 irradiators - represents a potential radiation hazard warranting immediate preventive action pending further investigation.~ I have_ determined, therefore, that the public health, safety, and interest require that
' the restrictions'on the use of such irradiators as prescribed in Section II of this Order should be made immediately effective.
E-3 Draft NUREO - 1556, Vol. 5
- . ~- _ . _ _
APPENDIX E 11
' Accordingly, pursuant to Sections 81,116 I,162 o, and 182 of the Atomic Energy Act of 1954, as amended, and 10 CFR Parts 2 and 30 of the Commission's regulations, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT:
Each license that authorizes possession of byproduct material in a J. L. Shepherd Mark I or Model 81 22 self shielded irradiator is hereby amended to add the following conditions:
- 1. The J. L. Shepherd irradiator shall not be used unless the licensee provides a ~ calibrated and operable radiation survey meter or room monitor for use with the irradiator.-
' 2. De irradiator door sha'l not be opened until the operator has checked visual indicators to verify that the source has etumed to its safe storage position.
3.- Each room monitor (a) shall be operable at all times when the irradiator is in use, (b) shall activate a visible and audible alarm when radiation levels exceed 2 millirems per hour, (c) shall be located to detect any radiation escaping from the irradiator door, and (d) shall be located so that it is visible to the irradiator user when he is next to the irradiator.
- 4. If a room monitor is not installed, a survey meter shall be used (a) to determine the radiation level at the irradiator door when the door is closed, and (b) to check for any
-increase in radiation levels each time the irradiator door is opened. In conducting such
- checks, operators shall position themselves so as to minimize exposure to my radiation escaping from the open door.
- 5. If abnormal radiation levels or any malfunction of the irradiator are detected at any time, the licensee shall stop use of the irradiator and i nmediately notify the appropriate NRC regional office by telephone.
- 6. The licensee shall not attempt repair or authorize others to attempt repair of the irradictor except as specifically authorized in a license issued by NRC.
! -III-
-.Any affected licensee may request a hearing on this Order. A request for a hearing shat!
be submitted within twenty (20) days of the date of this Order to Mr. R. E. Cunningham, . Director, Division of Fuel Cycle and Material Safety, U.= S. Nuclear Regulatory Commission, , - Washington, D. C. 20555, with a copy to the Executive Legal Director, U. S. Nuclear Regulatory L Commission, Washington, D. C. 20555. ANY REQUEST FOR A HEARING SHALL NOT l STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER. l Draft NUREG - 1556, Vol.5 E4 l
4w - &- 4---- 4i1-v L .- 4 a4 _-4 < _ .-- --# # l-Je,4--+4-++.e +.WM.4- - - - - - - - - - . - --b+-- % Ar APPENDIX E 2-IV If a hearing is requested, the Commission will issue an Order designating the time and place of any such heering. If a hearing is held the issue to be considered at such a hearing will b6: Whether, on the basis of the matters set forth in Section 1 and 11 of this Order, this Order should be sustained. FOR THE NUCLEAR REGULATORY COMMISSION Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety Office ofNuclear Material Safety and Safeguards Dated at Bethesda, Maryland this 3rd day ofJuly,1984 l l l i i-4 I E-5 Draft NUREG - 1556, Vol. 5
i I l Appendix F l Guidance on Financial Assurance l l l t I 1 l l I
---*r-- -e% -.._.__-v -. _, , , , , , , _ _ _ _ _
APPENDIX F Determining Need for Financial Assurance If the only radioactive materials possessed are sealed sources in self shielded irradiators, use Table F.1 to determine if f'mancial assurance is required.
- Table F.1 Worksheet for Determining Need for Financial Assurance for Self-Shielded irradiators
} goap No,i ~- Ibssesipise ?J 'CebeI640 lCostaan 1MkN80seestman 903 11 Activity possessed,in Curies' y - . . . , + , . - , ~ ~
nm ~ n ~
. y@p%,.R ,W ? Aedvity 4- M, ,
,.h.
0001 4e m\10,m,t /100,000.;,.+1 owmq me <x 1,1A00;m. r 9 M hg % - M assuramos,' 3ggy lay;)y:;n., gjggp
@gg g g g g hff/3 p
~
. Curies f ., V y,A givi;; nh NR L mi 3 Divide data in Step 1 by
' data in Step 2 =
! FRACTION j 45 x m 1 Add the tactions' 1 (doestmined' wd &s@$wewhWA4H57 irises'p'3h[ Ag" DN Mdf M:lY%6Wbf.O - ;9) l- hl e ~F @ ( j If the sum of the fractions is greater than or equal to 1,' the applicant will need to submit l certification of financial assurance or a deconunissioning funding plan (10 CFR 30.35(e)). Regulatory Guide 3.66,2 " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated Jur.e 1990, provides sample documents for financial mechanisms. The recommended wording ior a Statement ofIntent for government licensees is shown below. ll
' For case of use by most irradiator licensees, this table uses only conventional units. The conversion to SI l .
- units is: 1 Curie = 37 gigabecquerels.
l l j 'See the Notice of Availability (on inside front cover of this draft report) to obtain copies of Regulatory Guide 3.66,"Standnd Format and Content of Financial Assurance Mechanisms Required for Decommissioning l L; , Under 10 CFR Farts 30,40,70, at.. !,"(dated June 1990). l !- F1 Draft NUREG - 1556, Vol. 5 l i
i AP"CNDIX T Suggested Wording for a Statement of Intent for a Government Licensee [DATE) TO: U. S. NUCLEAR REGULATORY COMMISSION ' WASillNOTON, 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 authorind by U. S. Nuclear Regulatory Commission Material Licen.ac No. [ License Number) This authority is established by [Name of Documem(s) Ooveming 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 authorind to represent [ Licensee Name) in this transaction. [ SIGNATURE] [NAME) [ TITLE)
Attachment:
As stated i Draft NUREO 1$56. Vol. 5 F-2 l
Appendix G Model Training Program
APPENDIX 0 Model Training Program COURSE CONTENT Training may be in the form oflecture, videotape, or self study, and emphasizes practical subjects important to the safe use of the self shielded irradiator:
- Radiation Safety
. Radiation vs. contamination
- Internal vs. external exposure
. 131ological effects of radiation i
- Types and relative hazards of radioactive material possessed
- ALARA concept
- Use of time, distance, and shielding to minimize exposure
- Use of radiation detection instrutnents.
- Regulatory Requirements
- Locations of use and storage of radioactive materials
- Material control and accountability
- Annual audit of radiation safety program
- License conditions, amendments, renewals
- Transfer and disposal
- Record keeping
- llandling incidents
- Licensing and inspection by regulatory agency
- Need for complete and accurate information
- Employee protection
- Deliberate misconduct.
- Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensec
- Routino vs. non-routine maintenance
- Operating and emergency procedures
- Prior events involving self-shleided irradiators.
INSTRUCTOR'S QUALIFICATIONS The individus1 preparing ard conducting training is qualified as RSO or authorized user on a self shielded irradiator licamse before giving training. O1 DraA NUREO 1556,Vol.5
=_
y4 - - - - y
f APPENDIX 0 i TRAINING ASSESSMENT Management will ensure that potential RSO: and authorized users are qualified to work [ independently with each type of the licensee's irradiators. This may be demonstrated by written or oral examination or by observation.- l I k l i t DrsA NUREO .1556, Vol,5 02 s w , m..- '- 7 a y yevy -r7 -e, -p w g.s, - - - -. +g-w-.,
i i l 1 1 I 1 i Appendix H 1 Typical Duties and Responsibilities of the Radiation Safety Officer
--,-.----v - - - , a -- - , - - -
.- - . . = - -
APPL:NDIX H Typical Dution and Responsibilities of the Radiation Safety Officer The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license; see Figure 8.1. Typically, these duties and responsibilities include ensuring the following:
- Activities involving licensed material that the RSO considers unsafe are stopped
+ Radiation exposures are ALARA + Development, distribution, implementation, and maintenance of up-to-date operating and emergency procedures
- Possession, installation, relocation, use, storage, repair, and maintenance of self shielded irradiators are consistent with the limitations in the license, the Scaled Source and Device Registration Certificate (s), and manufacturer's written recommendations and instructions
+ Saf;ty consequences are analyzed before conducting any activities involving repair, use, maintenance, installation, or relocation, which were never previously analyzed . Individuals installing, iclocating, using, maintaining, or repairing self shielded irradiators are trained and authorized (as described in the license application)
+ Documentation is maintained to demonstrate that individuals are not likely to receive, in one year, a radiation dose in excess of 10 percent of the allowable limits or personnel monitoring devices are provided + When necessary, personnel monitoring devices are used and exchanged at the proper intervals, and records of the results of such monitoring are maintained
- Self shielded irradiators are properly secured
+ Documentation is maintained to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public + Proper authorities are notified ofincidents such as damage to or malfunction of self-shleided irradiators, fire, or theft H1 Draft NUREO .1556, Vol. 5
l APPENDIX H
+
Unusual occurrences involving the self shielded irradiators (e.g., malfunctions or damage) are investigated, cause(s) and appropriate corrective action (s) are identified, and ; timely corrective action (s) are taken - Radiation safety program audits are performed at least annually and docurnented f i
+
When the licensee identifies violations of regulations or license conditions or program , weaknesses, the licensee develops, implements, and documents corrective actions l Licensed material is transported in accordance with all applicable DOT requirements . r
- Licensed material is disposed of properly
- Appropriate records are maintained e Up to-date license is maintained and amendment arul renewal requests are submitted in a timely manner i
k l i I r Draft NUREG 1556 Voi, $ H.2 r r.w .5 ..wr.-s,.e'..w--,v. - - ,= - ,r-w .5. 5 es U- ______-l---_----
i
; i r
i l ! Appendix I : i information Needed to l l Support Applicant's Request ' ' to Perform Non-Routine Maintenance l l 1
f APPENDIX 1 Information Needed to Support Applicant's Request to Perform Non-Routine j Maintenance Non routine maintenance includes repairs, removal, replacement, or alterations involving:
- Electrical and mechanical systems and components that control source or shleiding movement
. Sc!f shielded irradiator's shielding or scaled source (s)
- Safety interlocks
- Any other component which may affect safe operation of the device "
- Any other activities during which personnel could receive radiation doses exceeding NRC limits.
See Figure 8.7.- If this maintenance or repair is not performed properly with attention to radiation safety principles, the self shielded irradiator may not operate as designed and personnel performing these tasks could receive radiation doses exceeding NRC limits. Non routine maintenance should be perfomied only by qualified and specifically authorized individuals. Self shielded irradiator licensees should conduct these operations only after their procedures have been evaluated and specifically approved by license condition. Also, any non manufacturer supplied replacement components need to be evaluated to ensure that they do not degrade the engineering safety analysis performed and accepted as part of the device registration. Accordingly, applicants wishing to perform non routine maintenance must provide the following information, as appropriate: ,
- Describe the types of non routine maintenance to be performed, The principal reason for obtaining this information is to assist in the evaluation of the quallilcations ofindividuals who will conduct the work and the radiation safety procedures they will follow.
. Identify who will perfonn non routine maintenance, their training and experience, and why they are competent to perform non routine maintenance. Adequate training and t
experience includes the following:
+ previous experience in non routine maintenance and radiation safety training
+ vendor maintenance certification
+ technician (s) using pre-planned procedures with direct health physics supervision.
- Submit procedures for non routine maintenance. These procedures should ensum the following:
- doses to personnel and members of the pub!!c are within regulatory limits and ALARA- ,
Il DraftNUREO 1556,Vol.$
. . . _. . . . _ _ _ - - ~ . _ _ . . _ _ - . . _ . . _ _ _ . _ _ _ _ _ .. _ ._
9 f
- APPENDIX I
.- the source is secured against unauthorized access or removal
- appropriate labels and signs ase used -
-_ manufacturer's written instructions and recommendations are followed ;
the self shielded irradiator functions as designed and source integrity is not - compromised any non manufacturer supplied replacement components are evaluated to ensure _ ! that they do not degrade the e' gineering safety analysis performed and accepted as part of the device registration. ; Confirm that individuals performing non routine maintenance on inediators will always
- wear both whole body and extremity monitoring devices. ,
Verify possession of at least one instmment that meets the description for survey meters , used with moving source inadiators in the " Radiation Monitoring Instrument ! Specifications" section of Appendix K in draft NUREG 1556, Vol. 5,
- Consolidated .
Ouldance about Materials Licenses: Program Specific Guidance about Self-shielded j Irradiator Licenses," dated October 1997
- Describe steps to be taken to ensure that radiation levels in areas where non routine maintenance 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 (as described above); e specify where and when surveys will be conducted during non routine maintenance; 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, instrument used, measured radiation levels correlated to location of those measurements), as required by 10 CFR 20.2103. l ! t Drafn NUREO 'I$$6, Vol. $ l.2 3
. -.-~...,..--....,--....-,..~m~,_-~_----...m._.--.u.....m , . , , -. a .- . . , _ . - _ _ - , - ,.~..m..___. . .. u. . . . _
J l . 1 Appendix J Suggested Self-Shielded Irradiator Audit Checklist I I I l.
APPENDIX J Annual Radiation Protection Self4hlalded Irradiator Audit Nede 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 arer.s which do not apply to the licensee's activities and activities which have not occurred since the Int audit need not be reviewed at the next audit. Date of This Audit Date of Last Audit Next Audit Date Auditor: Date (Signature) Management Review Date (Signature) A. AUDIT HISTORY
- 1. Were previous audits conducted annually? [10 CFR 20.1101]
- 2. Were records of previous audits maintained? (10 CFR 20.2102)
- 3. Were any deficiencies identified during last two audits or two years, whichever is longer?
- 4. Were corrective actions taken? (Look for repeated deficiencies).
H. ORGANIZATION AND SCOPE OF PROGRAM
- 1. Radiation Safeiy Oflicer
- a. If the RSO was changed, was license amended?
- b. Does new RSO meet NRC training requirements?
- c. . Is RSO fulfilling his/her duties?
- d. To whom does RSO report?
- 2. Licensed Material
- a. Does the license authorize all of the NRC regulated radioactive material contained in self shielded irradiators?
- b. Does the total amount of radioactive material possessed require financial assurance? (10 CFR 30.35(a)]
- 3. Are the self shielded irradiators as described in the Scaled Source and Device (SSD) Registration Certificate? liave copies of(or access to) SSD Certificates?
llave manufacturers' manuals for operation and maintenance? (10 CFR 32.210) Jl DraftNUREO 1556,Vol.5 l 1
- . _ ~_ . .
I APPENDIX J
- 4. Are the actual uses of self shielded irradiators consistent with the authorized uses listed on the license?
- 5. If the malling address or places of use changed, was the license amended?
- 6. If control oflicense transferred or bankruptcy filed, was NRC prior consent obtained or notification made, respectively?
C. TRAINING AND INSTRUCTIONS TO WORKERS
- 1. Were all workers who are likely to exceed I mSv (100 mrem) in a year instructed per [10 CFR 19.12]? Was refresher training provided, as needed [10 CFR 19.12]?
- 2. Did each authorized user and person independently performing routine or non-routine maintenance attend license required training before working with self.
shielded irradiators?
- 3. Are training records maintained for each individual?
- 4. - Did interviews with workers reveal that they know the emergency procedures and repair, maintenance, and relocation limitations?
- 5. Did this audit include observations of operators using the self shielded irradiators? Performing routine or other authorized maintenance?
- 6. Did the audit identify any operato crror in reporting maintenance and repair or operation issues to the RSO for review before starting work?
D. RADIATION SURVEY INSTRUMENTS
- 1. Describe the survey instruments possessed:
- a. Do they meet the NRC's criteria?
- b. Are they appropriate for the source type (s)?
- c. Are they checked for function before use?
- d. If they are used with moving source irradiators or during non routine maintenance, are they calibrated as required? [10 CFR 20.1501)
- 2. If the licensee does not possess a survey meter, are specific plans made to have one available?
Location: Location / Operation verified:
- 3. Are calibration records, if required, maintained? [10 CFR 20.2103(a))
- 4. For J. L. Shepherd Mark I or Model 81 22 irradiator: check for compliance with license condition E. SELF-SHIELDED IRRADIATOR INVENTORY AND LOCATION
- 1. Is a accord kept showing the receipt of each self shielded irradiator?
[10 CFR 30.51(a)(1)] l 2. lias the location (s) changed since the last audit? l Draft NUREO .1556. Vol. 5 J.2
I APPENDIX J l F, PERSONNEL RADIATION PROTECTION 1
- 1. - Are ALARA considerations incorporated into the radiation protection program? l
[10 CFR 20.1101(b)) _
- 2. Is documentation kept showing that unmonitored users receive $10% oflimit? l
[10 CFR 20.1502(a))
- 3. Did unmonitored users' activities change during the year which could put them ;
~ over 10% oflimit?
- 4. If yes to 3. above, was a new ALARA evaluation perfarmed?
- 5. Is extemal dosimetry required (user receiving >10% oflimit)? Is dosimetry j provided to users? !
- a. If processed dosimetry:- .
j
- l. Is the dosimetry supplier NVLAP approved? [10 CFR 20.1501(c)] ;
- 11. Are dosimetry reports reviewed by the RSO when they are ;
received? - ;
- b. If self reading dosimeters. ,
- 1. Have a range of zero to at least 2 mSv (200 mrem)? :
, 11. Are checked at periods not to exceed one year for conect response i to radiation? ; 111. Are read within 120% of the true radiation exposure? : iv. Are used under a program that prescribes action to evaluate the j individual's dose? :
- 6. Are the dosimeters exchanged or read at the license required frequency?
- 7. Are the records NRC Forms or equivalent? (10 CFR 20.2104(d), l 10 CFR 20.2106(c)]
- a. NRC-4 " Cumulative Occupational Exposure History" completed? _l
- b. NRC 5 " Occupational Exposure Record for a Monitoring Period" completed?
- 8. Declared pregnant worker / embryo / fetus *
!- a. If a worker declared her pregnancy, did licwx comply with t 10 CFR 20.12087 -
- b. Were records kept of embryo / fetus dose per 10 CFR 20.2106(e)?
i 9.- Are records of exposures, surveys, monitoring, and evaluations maintained (10 CFR 20.2102,10 CFR 20. 2103,10 CFR 20. 2106) , G. - PUBLIC DOSE
- 1. Are self shicided irradiators located and used in a manner to keep doses below l
- 1 mSv (100 mrem) in a year? [10 CFR 20.1301(a)(1)] '
- 2. lias a survey or evaluation been performed per 10 CFR 20.1501(a)?
- 3. llave there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation?
^
J3 DraftNUREO 1556.Vol.5 i t _,_m_- .m.-.-_-_-._-,.,-.-,-.,.-._.-__ . _ - ~ . _ . . , _ , , . - . , . - - . . _ . _ , . _ . . . - , _ _ ._._,...,_i
APPENDIX J
- 4. Do unrestricted area radiat'on levels exceed 0.02 mSv (2 mrem) in any one hour?
[10 CFR 20.1301(a)(2))
- 5. Are self shielded irradiators being used or stored in a manner that would prevent unauthorized access or removal? [10 CFR 20.1801] i
- 6. Records maintained? [10 CFR 20.2103,10 CFR 20.2107]
H. OPERATING AND EMERGENCY PROCEDURES :
- 1. l{ ave operating and emergency procedures been developed?
- 2. Do they contain the required elements?
- 3. Does each operator have a current copy of the operating and emergency procedures? Maintain copy at each irradiator's control panel or post notice indicating where to obtain copy?
- 4. Did any emergencies occur?
- a. If so, were they handled properly by operator?
- b. Were appropriate corrective actions taken? ,
- c. Was NRC notification or reporting required? (10 CFR 20.2201, 10 CFR 20.2202,10 CFR 20.2203)
- 5. For J.L. Shepherd Mark I or Model 81 22 Irradiator: check for compliance with license condition I. LEAK TESTS
- 1. Was each scaled source leak tested every 6 months (or at other license prescribed intervals)?
- 2. Was the leak test performed as described in correspondence with NRC and
- according to the license?
l 3. Are records of results retained with the appropriate information included? l 4. Were any sources found leaking and if yes, was NRC notified? l J. MAINTENANCE OF SELF SHIELDED IRRADIATORS
- 1. Are manufacturer's written procedures followed for routine (not safety critical) cleaning and lubrication and mechanical / electrical maintenance and repair of self-shielded irradiators?
l 2. Was non routine maintenance perfonned? l 3. If yes, was it performed according to license requirements (e.g., extent of work, i individuals performing the work, procedures, dosimetry, survey instmment, compliance with dose limits)?
- 4. Since the last audit, did operator (s) report a need for non routine rnaintenance and repair to the RSO before requesting or conducting the work?
1 Draft NUREO 1556.Vol.5 J4 t
-, m --
APPENDIX J K. TRANSPORTATION
- 1. Were self shielded irradiator(s) or sources shipped since the last audit?
- 2. If so, were 10 CFR Part 71 requirements followed?
- a. 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?
- b. Package performance test records on file? [49 CFR 173.415(a))
- c. Special form sources documentation? [49 CFR 173.476(a))
- d. Package has 2 labels (ex. Yellow II) with TI, Nuclide, Acti' ity, and llazard Class? [49 CFR 172.403,49 CFR 173.441)
- e. Package properly marked? [49 CFR 172.301,49 CFR 172.304, 49 CFR 172.310, 49 CFR 172.324]
- f. Package closed and sealed during transport? [49 CFR 173.475(f)]
- g. Shipping papers prepared, used, and maintained? [49 CFR 172.200(a))
- h. Shipping papers contain proper entries? (Shipping name, Hazard Class, Identification Number (UN Number), Total Quantity Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, Activity, Categary 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 )
- 1. Secured against movement? [49 CFR 177. 834 )
J. Placarded on vehicle, if needed? [49 CFR 172.504]
- k. Proper overpacks, if used? [',9 CFR 173.25]
- 1. Any incidents reported to DOT 7 [49 CFR 171.15,49 CD 171.16]
- m. Irradiators manufactured before 1966
- 1. Were any shipped?
- 11. Were NRC and DOT exemptions, if needed, received la advance?
L. AUDITOR'S INDEPENDENT SURVEY MEASUREMENTS (IF MADE)
- 1. Describe the type, location, and results of measurements.
- 2. Do any radiation Imis exceed regulatory limits?
M. NOTIFICATIONS AND REPORTS
- 1. Was any radioactive material lost or stolen? Were reports made?
[10 CFR 20.2201,10 CFR 30.50]
- 2. Did any reportable incidents occur? Were reports made? [10 CFR 20.2202, 10 CFR 30.50]
J5 Draft NUREO 1556, Vol. 5
l l AltENDIX J
- 3. Did any overexposures and high radiation levels occur? Reported? l (10 CFR 20.2203,10 CFR 30.50]
- 4. If any events (as described in items a through e above) did occur, what was root r cause? Were corrective actions appropriate?
- 5. Is the licensee aware of telephone number for NRC Emergency Operations Center? [(301) 816 5100]
N. POSTING AND LABELING
- 1. NRC 3 " Notice to Workers" posted? [10 CFR 19.11]
- 2. NRC regs., license documents posted or a notice posted? [10 CFR 19.11, 10 CFR 21.6]
- 3. Other posting rad labeling? [10 CFR 20.1902,10 CFR 20.1904,10 CFR Part 21]
O. RECORD KEEPING FOR DECOMMISSIONING
- 1. Records kept ofinformation important to decommissioning? [10 CFR 30.35(g)]
- 2. Records include all information outlined in [10 CFR 30.35(g)]?
P HULLETINS AND INFORMATION NOTICES
- 1. NRC Bulletins, NRC Information Notices, NMSS Newsletters, received?
- 2. Appropriate training and action taken in response?
Q. SPECIAL LICENSE CONDITIONS OR ISSUES
- 1. Did auditor review any special license conditions?
- 2. Did auditor review any other issues (e.g., non routine maintenance)?
R. DEFICIENCIESIDENTIFIEDIN AUDIT CORRECTIVE ACTIONS
- 1. Surnmarize problems / deficiencies identified during audit.
- 2. If problems / deficiencies identified in this audit, describe corrective action.=
planned or taken include date(s) when corrective actions are implemented.
- 3. Provide any other recommendations for improvement. 1 S. EVALUATION OF OTl4ER FACTORS
- 1. Senior licensee management is appropriately involved with the radiation protection program and/or Radiation Safety Oflicer (RSO) oversight?
- 2. RSO has sufficient time to perform his/her radiation safety duties?
- 3. Licensee has sufTicient staff to support the radistion praection progrran?
Draft NUREG 1$56. Vol. $ J6
1 I 1 l 1 1 i i ! i i i ; j i t l i i i i Appendix K i l l Radiation Monitoring Instrument Specifications and Model Survey \ instrument Calibration Program . S 3 i b
--..m ry,, - . , _ , .
APPENDIX K Radiation Monitoring instrument Specifications instrument (s) used with moving source gamma irradiators must meet the following criteria:
* - The instrument is a rivey meter capable of detecting gamma radiation up to reveral hundred milliroentgens (mR)(more than 50 microcoulombs/ kilogram) per hour which is:
t
- In the licensee's possession
- Checked with a source of radiation at the beginning of each day of use to ensure that it will respond consistently to radiation i
- Celibrated with a source of radiation annually and aner any senicing or repair (other than a slaple bactery exchange), to ensure that exposure rates indicated by the meter de not vary from the actual exposure rates by more than
- 20%.
Calibrations must be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State. OR
- The instrument is a room monitor which:
+ ls in the licensee's possession
+ is checked with a source of radiation at the beginning of each day of use to ensure that it will respond accurately to radiation and alarm at 0.02 mSv (2 mrem) per hour
- Activates a visible and audible alarm when radiation levels exceed 0.02 mSv (2 mrem) per hour
+ la positioned so it will detect any radiation escaping from the irradiator door yet still be visible to the irradiator operator when t. sing the irradiator.
l Instmment(s) used with fixed. source gamma irradiators (or beta irradiators) are: t-
- A survey meter capable of detecting gamma radiation (or beta radiation, as appropriate) t
- In the licensee's possession or readily accessible in the event of an accident or malfunction which could reduce the shielding for the scaled source (s)
- Checked with a source of radiation at the beginning of each day of use to ensure that it will respond consistently to radiation
+ Calibrated with a source of radiation annually and aner any servicing or repair (other than ,
a simple battery exchange), to ensure that exposure rates indicated by the meter do not , vary from the actual exposure rates by more than
- 20%. Calibrations must be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State.
K.I Draft NUREO .1$56, Vol. 5 i
I APPENDIX K Model Survey instrument Calibration Program Training Before allowing an individual to perform survey instrumert calibrations, the RSO will ensure that the individual has suflicient classroom and on the job training to show competency in performing independent survey instrument calibrations. 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 using instruments
- Mathematics and calculations basic to using and measuring radioactivity t
- Diological effects of radiation.
Appropriate on-the job training consists of:
- Observing authorized personnel performing survey instrument calibratiori
. Conductirig survey meter calibrations under the supervision and in the physical presence of an individual authorized to perfomi calibrations.
Faellities and Equipment
. 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. -
Model Procedure for Calibrating Survey lustruments
+
A radioactive scaled source (s) used for calibrating survey instruments will:
- Approximate a point source
+
llave its apparent source activity or the exposure rate at a given distance traceable by documented measurements to a standard certified to be within
- 5% accuracy by National Institutes of Standards and Technology (NIST)
- Approximate the same photon energy (Cs 137, Co-60) as the environment in which the calibrated device will be employed Draft NUREO - 1556, Vol. 5 K2 l
- . . . , - - _ _ . _ _ , , ~ . . . . . . . . - - - . -__ __ -
APPENDIX K
+ Be strong enough to give an exposure rate of at least about 30 mR/hr (7.7 microcoulcmbs/ kilogram per hour) at 100 cm (e.g.,3.1 gigabecquerels (85 i millicuries) of Cs 137 or 780 megabecquerels (21 millicuries) of Co-60). l
- Le inverse square and radioactive decay law must be used to correct changes in exoosurt. rate due to changes in distance or source decay. -
- A record must be made of each survey meter calibration and retained for 3 years after
. cach record is made (10 CFR 20.2103(a)). + A single point on a survey meter scale may be considered satisfactorily calibrated if the indicated exposure rate difTers from the calculated exposure rate by less than *20%. - The three kinds of scales frequently used on radiation survey meters are calibrated as !
follows:
. Meters on which the user selects a linear scale must be calibrated at not fewer than two poltts 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 d:gital display device for indicating exposure rates must be calibrated at one peint (at the least) on each decade and at no fewer than two points on one of the decades. Those rcints will be at approximately 1/3 and 2/3 of the decade.
- Readings above 1000 mR/br (250 microcoulombs/k!!ogram per hour) need not be calibrated, liowever, such scales should be checked for operation and approximately correct response.
- Survey meter calibration reports will indicate the procedure used and the Ata obtained.
The description of the calibration will include:
- The owner or user of the instrument
. A description of the lastrument including the manufacturer's name, model number, serial number, and type ofdetector
- A description of the calibration source, including the exposure rate at a specified distance on a specified date, and the calibration procedure
*- For each calibration point, the calculated exposure rate, the indicated exposwe rate, the deduced correction factor (the calculated exposure rate divided by the indicated exposure rate), and the scale selected on the instrument K3 Draft NUREO l$56, Vol. 5 '
APPENDIX K
- 1he exposure reading indicated with the instmment in the " battery check" mode (if . f available on the instmment) t j
- For instruments with extemal detectors, the angle between the radiation flux field and the detector (i.e., parallel or perpendicular) .
- For instruments with intemal detectors, the angle between radiation flux field and a specified surface of the instrument - . !
- For detectors with removable shielding, an indication whether the shielding was in
- place or removed during the calibration procedure [
- The exposure mte from a check rource, if used l
- The person's name who perfonned the calibration and the date it was performed i
- The following information will be attached to the instrument as a calibration sticker or l tag: ;
i . !
- The source that was used to calibrate the instrument t
- The proper deflection in the battery check mode (unless this F clearly indicated on - d the instrument)
- For each scale or decade not calibrated, an indication that the scale or decade was checked only for function but not calibrated. . 1
* = The date of calibration and the next calibration due date ,
- The apparent exposure rate from the check source, if used.- !
i Referseess: Detailed information about survey instrument calibration may be obtained by l referring to ANSI N323 1978, " Radiation Protection Instrumentation Test and Calibration." : Copies may be obtained from the American National Standards Institute,' 1430 Broadway, New : York, NY 10018 or ordered electronically at the following address: www. ansi.org. l See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of : Draft Regulatory Oulde FC 413 4, "Oulde for the Preparation of Applicatiora for Licenses for ! the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring lustruments," I dated June 1985.
\
I i 1 DreA NUREO .1$56 Vol. $ K4 I i
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I i i ! b 1, ? i : l i l l 1 I ! Appendix L l Guidance for Demonstrating that Unmonitored Individuals are Not Likely . to Exceed 10 Percent of the Allowable Limits l
* .+e. _ _
APPENDIX L 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. To demonstrate that dosimetry is not required, a licensee needs to have available, for inspection, an evaluation to demonstrate that its workers are not likely to exceed 10% of the applicable annual limits. The most common way that individuals might exceed 10% of the applicable limits is by performing frequent routine maintenance on the irradiator. However, for most new Irradiators even these activities result in the individual's rec iving minimal doses. A licensee will need to evaluate the does which its workers might receive in performing these tasks to assess whether dosintetty is required. EXAMPLE The following is an example of an estimate of the dose received by the extremities and whole body of a person performing routine maintenance (cleaning and lubrication) on a self shielded irradiator rotating drawer drive chain. The estimate is based on observations ofindividuals performing the recommended procedure according to good radiation safety practices. The manufacturer can provide the following types ofinformation:
- Time needed to perform the entire procedure (e.g.,20 min) t . Extremity dose rate received by an individual, associated with the shielded source (e.g.,
0.02 mSv/hr [2 mrem /hr) at contact with the shield)
+ Time the hands were exposed to the shielded source (e.g.,3 min) + Whole body dose rate received by an individual, associated with the shielded source (e.g.,
0.01 mSv/hr [1 mrem /hr] at contact with the shield)
- Time the whole body is exposed to the shielded source (e.g.,20 min)
From this information, an estimate of the doses that the individual performing this procedure could receive is as follows: 0.001 mSv [0.1 mrem] to the hands
- Less than 0.0033 mSv [0.33 mrem] TEDE (whole body).
The applicable TEDE (whole body) limit is 50 mSv (5 rems) per year and 10% of that value is 5 mSv (500 mrems) per year, if one of these procedures delivers 0.0033 mSv (0.33 mrem), then an individual could perform 1,515 of these procedures each year and remain witin 10% of the applicable limit. Ll Draft NUREG 1556, Vol. 5
i APPENDIX L The applicable SDE (extremitics)is 500 mSv (50 rems) per year and 10% of that value is 50 mSv (5 rems or 5000 mrems) per year. If one of these procedures delivers 0.001 mSv (0.1 mrem), then an individual could perform 50,000 of these procedures each year and remain within 10% of the applicable limit. Based on the above specific situation, no dosimetry is required if a licensee performs fewer then 1,515 reatine maintenante procedures per year. GUIDANCE TO LICENSEES Licensees who wish to demonstrate that they are not required to provide dosimetry to their workers need to prepare a written evaluation similar to that shown in the example above. The expected dose rates, times, and distances used in the above example may not be appropriate to individual licensee situations, in their evaluations, licensees need to use information appropriate to the type (s) of self-shic!ded irradiator(s) they intend to use; this information is generally available from the irradiator manufacturer or the SSD Registration Certificate maintained by the NRC and Agreement States. Table L.1 may be helpful in docurr :nting a licensee's evaluation.' Licensees should review evaluations periodically and revise them as needed. Licensees need to check assumptions used in their evaluations to ensure that they continue to be up-to-date and accurate. For example, if workers become lax in following good radiation safety practices, perform the task more slowly than estimated, work with new irradiators containing sources of different activities or radionuclides, or use modified procedures, the licensee would need to conduct a new evriluation.
'For case of use by most irradiator licensees, this table uses conventional units. The conver. ion to Si units I is: 1 mrem = 0.01 mSv 1
Draft NUREG 1556, Vol. 5 L-2 l i
- _ . - _ . . _ _ __ _ _ _ _ _ __ _ _ _ _ _ _ m._. _ _ _ _ . _ _ .-
+
APPENDIX L i Table L.1 Dosimetry Evaluation : Decimwery Evaluation for Model = Self-Shielded imdieter,' a-A. Time needed to perform the entire (minutes /60) hour routine maintenance procedure. Expected whole body done rete. mesm/hrt I B.. ' received by theindividual, - i determined using exposee rates a" -2
, messmed.on contact with tho' 3f~
, a ,
; ]
irradiator while the sealed source is in. , I. ' the shielded position. , r' C. Time the hands were exposed to the ---(minutes /60) hour unshielded source. f D. Expected extremity dose rate mrom/hr received by the individual,. , ; ec determined using exposure mtes ~
., measured at the typic (distar;oe that
- 4 ye the hands would be from the maled .
source during the routiac - =i maintenance procedure. - . Formulet ( # hours in Row A) x ( mrem /hr in Ro.y H) = ( mrem per routine procedure) x ( # of routine maintenance procedures each year) = mrem *Whole Body Dose t j:Formules ( - # hours la Row C) x (' anrean/hrla Row D)= (c usrom per swetime procedure)_x (- # of routine maintemenet procedures each year) = - t areas **Extrendy Dose
- Expected Whole Body Doses less tasa 500 mrem requires no dosimetry
" Expected Extremity Doses less than 5000 mrem requires no dosimetry L3 Drafi NUREO .1556, Vol. $
l-1
l 1 i l d i i
)
l 5 I Appendix M i i Guidance for Demonstrating that ; l Individual Members of the Public will not Receive Doses Exceeding the Allowable Limits i
APPENDIX M Guidance for Demonstrating that Individual Members of the Public will not ' Receive Dosos Exceeding the Aliowable Limits Licci sees must ensure that:
- The radiation dose received by individual memb:rs of the pubhc doce not exceed I millislevert (mSv) (100 millirem (mrem)1 F q calendar year resulting from the licensee's possession and/or use oflicensee serials.
Members of the public include persons who live, work, or may be near locations where , self-shielded irradiator devices are used or stored and employees whose assigned duties do not include the use oflicensed materials and who work in the vicinity where irradiators are used or stored.
- The radiation dose in tmrestricted areas does not exceed 0.02 mSv (2 mrem) in any one hour.
'i;,Lal umstricted ucas may include ofEes, shops, laboratories, areas outside buildings, property, and nonradioactive equipment storage areas. The licensee does not control access to these areas for purposes of controlling exposure to radiation or radioactive materials. liowever, the licensee may control axess to these areas for other reasons such as security.
Licensees must show compliance with both portions of the regulation. For areas around self-shielded irradiator facilities, calculations or a combination of calculations and measurements (e.g., using an environmental TLD) are often used to prove compliance. CALCULATIONAL MET 90D' The calculational method takes a tiered approach, going through a three-part process starting with a worst case situation and moving toward more realistic situations, it makes the following simplifications: (1) eaci, irradiator is a point source; (2) typical radiation levels encountered when the source is in the shielded position are taken from either the Scaled Source and Device (SSD) Registration Certificate, ANSI N433.1,2 " Safe Design and Use of Self Contained, Dry Source
' I'or case of use by most self-shielded irtadiator licensees, the examples in this Appendix use conventional units. The conversions to SI um.s are as follow s: 1 A = 0.30$ m; I mrem = 0 01 mSv.
2 Copies may be obtained fmm the American National Standards institute,1430 Broadway. New York, NY 10018, or ordered electronically at the following address: www. ansi org. Copics are clso available from the National Technical Information Service, $285 Port Royal Road, Spring'icid, VA 22161 1 800 S$3 6847. M1 Draft NUREO - I$56, Vol. 5
APPENDIX M I f torage Gamma Irradiator (Category 1)," or the manufacturer's literature; and (3) no credit is taken for any shielding found between the irradiator and the unrestricted areas. Part 1 of the calculational method is simple but conservative. It assumes that an affected memb of the public is present 24 hours a day and uses only the inverse sc . ze law to determine if the distance between the itTadiator and the affected member of the pub; . is sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but also the time that the affected member of the public is actually in the area under consideration. Part 3 considers the distance, the pot a of time and dose rate while the sample is in transit, the portion of time and dose rate while the sample is not in transit, and the poG;on of time that the affected member of th public is present. Using this approach, licensees make only those calculations that are needed to demonstrate compliance. in many cases licensees will need to use the calculational method through Part 1 or Part 2. The results of these calculations typically result in higher s radiation levd than would exist at typical facilities, but provide a method for estimating conservative doses whica could be received. EXAMPil1 To better understand the calculational method, we will examine Bugs Away, Inc., a self-shielded irradiator licensee. Yesterday, the company's president noted that the new irradiator area is close t to his secretary's desk and he asked Joe, the Radiation Safety Officer (RSO), to determine if the company is complying with NRC's regulations. The secretary's desk is near the wall separating the reception area from the designated, locked se shielded irradiator rem. vhere the company has located its irradiator. Joe measures the distance from the self shielded inAtor to the wall and assumes that the irradiator would hav maximum dose rate allowed under the ANSI N433.1: 10 mrem per hour at one meter. This is the maxiwn dose rate permitted while the sample is in transit (i.e., moving into or out of the irradiation positiont Figure M.) is Joe's sketch of the areas in question, and Table M.' summarize: we ink mation Joe has on the irradiator. Draft NUREG - 1556, Vol. 5 M2
\ ..
APPENDIX M A Bird's Eye View of Office and irradiator Area t adiator Room c # 15 Feet en 1 % ,s o
& u::,jn pgfA g/gWMRPW? vnp [
k W d M f$$ N lAlgh;mOWFYN Figure M.1 Diagram of Office and Irradiator Area. This sketch shows the arcas described in Examples 1 and 2. Table M.1 Information Known about the Self Shielded Irradiator
, Description of Known Information'- Cs-137 Self-Shielded Irradiators i Dose rate in mrem /hr encountered at specified distance 10 mrem /hr at I meter (3.28 ft) from the irradiator (from ANSI N433.1) ! Distance in feet to secretary's chair " 15 ft 1
EXAMPLE 1: PART I Joe's first thought is that the distance between the irradiator and the secretary's chair may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach, he assumes: 1) the self-shielded irradiator is constantly present (i.e.,24 hr/d) with the samples constantly in transit, and 2) the secretary is constantly sitting in the desk chair (i.e.,24 hr/d). Joe proceeds to calculate the dose she might receive hourly and yearly from the self-shielded irradiator as shown in Table M.2 below. I j l M3 Draft NUREG - 1556, Vol. 5
APPENDIX M Table M.2 Cilculational Method, Part 1: Hourly and Annual Dose Received from Self-Shielded Irradiator Step Description Input Data Resu:t No. 1 Dose rectived in an hour at known distance from 10 10 irradiator (e.g., from ANSI N433.1), in mrem /hr
-2 Square of the distance (ft) at which the Step 1 rate was (3.28)2 10.8 measured,in ft2 3 Square of the distance (ft) from the irradiator to the (15.0)2 225 secretary's desk in an unrestrhted area, in fl2 .4 Multiply the results of Step 1 by the results of Step 2 10 x 10.8 108 (this is an intermediate result) (rounded to 110) 5 Divide the result of Step 4 by the result of Step 3 to 110/225 0.48 I
calculate the dose received by an individual at the secretary's desk, IlOURLY DOSE RECEIVED FROM SELF-SillELDED IRRADI ATOR, in mrem in an hour 6 Multiply the result of Step 5 by 24 hr/d x 366 (leap year) 0.48 x 24 x 4200 d/yr- MAXIMUM ANNUAL DOSE RECEIVED 366 FROM SELF-SHIELDED IRRADIATOR, in mrem in-a year Note: The result in Step 5 demonstrates compliance with the 2 mrem in any one hour limit. Reevaluate if assumptions change if the result in Step 6 eseceds 100 mremlyr, proceed to Part 2 of the calculational method. At this point, Joe is pleased to see that the total dose that an individual could receive in any one hour is only 0.48 mrem in an hour, but notes that an ir.dividual could receive a dose of 4,200 mrem in a year, much higher than the 100 mrem limit. EXAMPLE 1: PART2 Joe reviews his assumptions and recognizes that the secretary is not at the desk 24 hr/d. He decides to make a realistic estimate of the number of hours the secretary sits in the chair at the desk, keeping his other assumptions constant (i.e., the self-shielded irradiator is constantly present (i.e.,24 hr/d) with the samples constantly in transit). lie then recalculates the annual dose received. Draft NUREG - 1556. Vol. 5 M-4
1 APPENDIX M Table M.3 Calculational Method, Part 2: Annual Dose Received from Self-Shielded Irradiator f gesp , * - Demeription , Result"
.. ~
A. Average number of hours per day that individual spends in 5.0 7 area of concem (e.g., secretary sits at desk 5 hr/ day; the remainder of the day the secretary is away from the desk area copying, filing, etc.) B. Average number of days per week in area (e.g., secretary is 3.0 part time and works 3 days / week) C. Average number of weeks per year in area (e.g., secretary 52 l works all year) i+2 8M Multiply the results of Step 7.A. by thei results of Step 7.B. b the 5.0 ? x 3.0 x 52 W results of Step 7.C. = AVERAGE NUMBER OF HO.URS IN ' . 780f f -y E :i9 " "-
, >9 : AREA OF CONCERN PER YCAR X" _
i 9 Multiply the results in Step 5 by the results of Step S = ANNUAL 0.40 x 780 = 370 DOSE RECEIVED FROM IRRADI ATOR CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN AREA OF CONCERN, in mrem in a year -
^
i INeart If Step 9 anseeds 100 area is a year, proceed to Par3 t of the estestatiossi method. Although Joe is pleased to note that the calculated annual dose received is significantly lower, he realizes it still exceeds the 100 mrem in a year limit. EXAMPLE 1: PART 3 Again Joe reviews his assumptions and recognizes that the irradiator is not constantly in use nor
' is the sample continuously in transit during an irradiation cycle when the secretary is seated at the desk.- As he examines the situation, he realizes he must take these factors into account.
i. l M-5 Draft NUREG - 1556, Vol. 5
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APPENDIX M _ Table MA Calculational Method, Part 3: Summary ofinformation: I ' t 10 Dose rate while the irradiator is idle, in mrem per hour at 3.28 2.0 feet from the irradiator: i Dose'mts while tse'ameple is in' transit,_in mism psihour At : ; 10c
!.11 : - ~
c3.28 feet Domibe inadiator - 12 Dose rate while sample is irradiated, in mrem per hour at 3.28 2.0 . feet from the irradiator i13:-- 0i Maximan ==ml= ofirradiations per hourj s 1 m .,% x E 5.0? /i 14 Maximum irradiation time, in minutes 3.0 fl5 ' % i Time that the sample is in transit, in minutse per irradiation , - l 0.'20 m > w . gn , , n g , , _, 4 .
; w a 16- From Table M.1, distance from irradiator to secretary, in feet 15.
Y17Uik . (Freni Step 8,- sivenge number ofhouri that' secretary is'in mea t 7801~ j,+ 9< . ofconcern, per years e . . ' i" M 'M'M ' Table M.5 Calculational Method, Part 3: Annual Dose Received from Irradiator l s gggy gg,J. :A jy % . .
%a 4 .
l 7 - - ..
, ,u <
g,gggg '.,
-18 [60 minus the input from Step 13 multiplied by (the input from 0.73 Step 14 plus the input from Step 15)] divided by 60 = [60. - 5.0 x (3.0 + 0.20)] / 60. = [60. - 16.] / 60 = FRACTION OF TlME THE IRRADIATOR IS IDLE
- 19) .(The input Anni Stop 13 multiplied by the input from Stop 15) j 0.017_ n
++ divided by 609 (5.0 x 0.20) / 60 = 1/60 e FRACTION OF TIME *
- THE SAMPLE IS IN TRANSITT '* ~ ^
20 1.0 minus the result from Step 18 minus the result from Step 19 = 0.253 1 - 0.73 - 0.017 = FRACTION OF TIME THE IRRADIATOR IS IN USE i DraftNUREO 1556,Vol.5 M-6 v
I APPENDIX M Description , Result - Step No. (The input from Step 10 multiplied by the result from Step 18) plus 2.136 21 (the input from Step 11 multiplied by the result from Step 19) plus
' (the input from Step 12 multiplied by the result from Step 20) =
(2.0 x 0.73) + ( 10. x 0.017) + (2.0 x 0.253) = 1.46 + 0.17 + 0.506
= AVERAGE DOSE RATE ENCOUNTERED AT 3.28 FEET FROM TiiE IRRADI ATOR, in mrem in aa hour.
The result from Step 21 multiplied by'(3.28 squared divided by the 0.10
'22 input from Step 16 squared) = 2.136 x (3.282 /152) = 2.136 x (10.8
/ 225) = AVERAGE DOSE RATE ENCOUNTERED BY THE SECRETARY,in mrem'per hour.
The result from Step 22 multiplied by the input from Step 17 = 780 78. 23 x 0.10 = ANNUAL DOSE RECEIVED FROM IRRADIATOR CONSIDERING REALISTIC ESTIMATES OF TIME SPENT IN AREA OF CONCERN, DOSE RATES, AND IRRADIATOR USAGE,in mrem in a year. i Nedr: If the result la Step 23 is greater than 100 mrom/yr, the liceasse must take corrective actions. - Joe is glad to see that the results in Step 23 show compliance with the 100 mrem in a year limit. Ilad the result in Step 23 been higher than 100 mrem in a year, then Joe could have done one or more of the following:
- Consider whether the assumptions used to determine occupancy are accurate, revise the assumptions as needed, and recalculate using the new assumptions
. Calculate the effect of any shielding' located between the irradiator area and the secretarial workstation -- such calculation is beyond the scope of this Appendix . Take corrective action (e.g., move irradiator within the use area, move the use area, move the secretarial workstation) and perform new calculations to demonstrate compliance . Designate the area outside the use area as a restricted area and the secretary as an occupationally exposed individual. This would require controlling access to the area for purposes of radiation protection and training the secretary as required by 10 CFR 19.12 Mational Council on Radiation Protection and Measurements (NCRP) Report No. 49. " Structural Shiciding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 McV." contains helpful information. It is available from NCRP. 7910 Woodmont Avenue. Suite 800. Bethesda, Maryland 20814. NCRPs telephone numbers are: (301) 657 2652 or 1800-229-2652.
M-7 Draft NUREG 1556. Vol. 5
APPENDIX M Note that in the example, Joe 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 radiadon dose received below regulatory requirements. In addition, licensees need to be alert to changes in situations (e.g., moving the self shielded irradiator closer to the secretarial workstation, adding a second irradiator, l changing the secretary to a full time worker, or changing the estimate of the portion of time spent
]
at the desk) and to perform additional evaluations, as needed. ' RECORD KEEPING: 10 CFR 20.2107 requires licensees to maintain records demonstrating compliance with the dose limits for individual members of the public. ; 1 COMBINATION MEASUREMENT-CALCULATIONAL METHOD ' I This method, which allows the licensee to take credit for shielding between the irradiator and the area in question, begins by measuring radiation levels in the areas, as opposed to using ANSI-N433,1 or manufacturer-supplied rates at a specified distance from each irradiator. These measurements must be made with calibrated survey meters sufficiently sensitive to measure background levels of radiation. Ilowever, 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 microsievert (0.05 mrem) per hour. This rate is well below the minimum sensitivity of most commonly available G-M survey instruments. Instruments used to make measurements for calculations must be sufficiently sensitive. An instrument equipped with a scintillation-type detector (e.g., Nal(Tl)) or a micro R meter used in making very low gamma radiation measurements should te adequate. 4 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.
'TLDs used for personnel monitoring (e.g., LIF) may not have suflicient 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. Iflicensees use TLDs to evaluate compliance with the public dose limits, they should consult with their TLD supplier and choose more sensitive TLDs. such as those containing CaF, that are used for environmental monitoring. Draft NUREG 1556, Vol. 5 M-8
APPENDIX M EXAMPLE 2 As in Example 1, Joe is the RSO for Bugs-Away, Inc., a self shielded irradiator licensee. The company has one irradiator in a designated, locked area that adjoins an unrestricted area where a secretarial work station is located. See Figure M.1 and Table M.2 for information. Joe wants to see if the company complies with the public dose limits at the secretarial station. Joe placed an environmental TLD badge in the secretarial work space for 30 days. The TLD processor sent Joe a report indicating the TLD received 100 mrem. Table M.6 Combination Measurement Calculational Method Description Input Data and Results Step No. PART1-Dose received by TLD,in mrem 100 1 Total hours TLD exposed 24 hr/d x 30 d/mo =_720 2 Divide the results of Step 1 by the results of 100/720 = 0.14 3 Step 2 = IlOURLY DOSE RECEIVED,in mrem in an hour Multiply the results .of Step 3 by 366 d/yr [ leap. 366 x 24 x 0.14 = 8784 x 0.141 i4~ ~ year] x 24 hr/d = 8784 hours in one year = .
=1230 MAXIMUM ANNUALDOSERECEIVED~
FROM 1RRADIATOR,in mrem in a year? Note: For the conditions described above, Step 3 indicates that the dose received in any one hour is less than the 2 mrem in any one hour limit. However, if there are any changes, then the licensee would need to reevaluate the potential doses which could be received in any one hour. Step 4 indicates that the annual dose received would be much greater than the 100 mrem in a year allowed by the regulations.
- PART 2 '
At this point Joe can adjust for a realistic estimate of the time the secretary spends in the area as he did in Part 2 of Example 1. PART3-f the results of Joe's evaluation in Part 2 show that the annual dose received in a year exceeds 100 mrem, then he may have to consider moving the self-shielded irradiator or the secretary's desk, or adding shielding to the wall. M-9 Draft NUREG - 1556, Vol. 5
i i i i
- Appendix N information for Applicant.s to Consider When Developing Operating and Emergency Procedures for Self-Shielded Irradiators
APPENDIX N Elements of Operating Procedures Applicable to All Types of Self-Shielded Irradiators
. Analyze each type of material to be placed in the irradiator to ensure that it is compatible with the irradiator's design or to determine whether special procedures in addition to those given by the manufacturer are required to ensure the safe operation of the irradiator.
- Prepare model-specific instructions for routine inspections, test procedures, and maintenance to ensure that all interlocks, devices, and components critical to the safe operation of the irradiator are functioning properly. (Prohibited actions such as changing the safety control system or removing the source should be stated.)
- Develop methods to maintain accountability (e.g., log book to record irradiator use) and to ensure that only authorized persons will use or have access to the irradiator (e.g.,
control access to the irradiator's keys or control access to the area where the irradiator is located).
. Define steps to take to keep radiation exposures ALARA. . For each model irradiator, define step-by-step procedures on how to operate the irradiator and how to perform routiae maintenance. Information may be extracted from the manufacturer's manual.
Specific Operating Procedures Applicable to Moving-Source Irradiators'
. The irradiator should not be used unless the licensee provides a calibrated and operable radiation survey meter or a room monitor for use with the irradiator.
. The irradiator door should not be opened until the operator has checked visual indicators to verify that the source has returned to its safe storage position.
. Each room monitor should:
. be operable at all times when the irradiator is in use
. activate a visible and audible alarm when radiation levels exceed 0.02 mSv (2 mem) per hour
. be located to detect any radiation escaping from the irradiator door
. be located so that it is visible to the irradiator user when next to the irradiator.
. If a room monitor is not installed, a survey meter should be used to:
. determine the radiation level at the irradiator door when the door is closed
'These procedures are required for licensees authorized for J. L. Shepherd Mark I or Model 81-22 irradiator.
N-1 Draft NUREG - 1556, Vol. 5
' APPENDIX N
.- check for any increase in radiation levels each time the irradiator door is opened.
In conducting such checks, operators should position themselves to minimize exposure to any radiation escaping from the open door. If abnormal radiation levels or any malfunction of the irradiator are detected at any time, the licensee should stop using the irradiator, restrict access to the area housing the irradiator, immediately notify the RSO, and determine if a report to NRC is required. The licensee should not attempt to repair or authorize others to attempt to repair the
- irradiator except as specifically authorized in a license issued by NRC.
Elements of Emergency Procedures Applicable to All Types of Self-Shielded Irradiators-a Leave the irradiator area (to reduce radiation exposure). Control access to the area (e.g., lock door).
- Contact responsible individuals (e.g., names, phone numbers of RSO, irradiator manufacturer, emergency response organizations such as fire department, NRC).
Take additional steps, dependent on the specific situations (e.g., surveys). As appropriate, require timely reporting to NRC Copies of operating and emergency procedures should be provided to all users. Post a current copy at each irradiator's control panel. If posting the procedures is not practicable, post a notice describing the document (s) and where it may be examined. Draft NUREG - 1556, Vol. 5 N-2
l l l Appendix O Model Leak Test Program l
APPENDIX O Model Leak Test Program - Training Before al'owing an individual to perform leak testing, the RSO will ensure that he or she has suflicient classroom r.nd on-the job training to show competency in performing leak tests independeutly. - 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 using instruments . Mathematics and calculations basic to using and measuring radioactivity . Biological etTects 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 NaI(TI) well counter system with a single or multi-channel analyzer will be used to count samples from irradiators containing gamma-emitters (e.g., Cs-137, Co-60). . A liquid scintillation or gas-flow proportional counting system will be used to count samples from irradiators containing beta-emitters (e.g., Sr-90).
Frequency for Conducting Leak Tests of Scaled Sources
. Leak tests will be conducted at the frequency specified in the respective SSD Registration Certificate.
Procedure for Performing Leak Testing and Analysis
. For each sou-ce to be tested, list identifying information such as self-shielded irradiator serial number, radionuclide, activity.
O-1 Draft NUREG - 1556, Vol. 5
h APPENDIX O
+. . 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 185 Becquerels (0.005 microcurie) , of the radioauclide in the irradiator. Using the selected instrument, count and record background count rate.
. Check the instrument's counting efficiency using a standard source of the same radionuclide as the source being tested or one with similar energy characteristics.
Accuracy of standards should be within *5% of the stated value and traceable to primary radiation standards such as those maintained by the National Institutes of Standards and Technology (NIST). ,
.- . Calculate efficiency. '
For example: f(enm fram stdic (enm from hke)]. = efficiency in cpm /Bq activity ofstd in Bq where: cpm = counts per minute std = standard bkg = background Bq = Becquerel
- Count each wipe sample; determine net count rate.-
For each sample, calculate and record estimated activity in becquerels (or microcuries). For example: [(enm fmm wine namnle)-(enm from hk@l = Bq on wipe sample efficiency in epm /Bq e Sign and date the list of sources, data, and calculations. Retain records for 3 pars (10 CFR 20.2103(a)).
. If the wipe test activity is 185 Bq (0.005 microcurie) or greater, notify the RSO, so that
- the source can be withdrawn from use and disposed of properly. Also notify NRC.
, . . l Draft NUREO - 1556, Vol. 5 O-2 I
, l l
( D I ! Appendix P i l Transportation l I l Part 1 - Major DOT Regulations l
I APPENDIX P A4lor DOT Regulations The major areas in the DOT regulations that are most relevant for transportation of typical self-shielded irradiators that are shipped as Type A or Type B quantities are as follows:
. Table of flazardous Materials and Special Provisions 49 CFR 172.101, and App A,
~
Table 2: liazardous materials table, list of hazardous substances and reportable quantitles
. Shipping Papers 49 CFR 172.200-204: general entries, description, additional description requirements, shipper's certification -.- Pa::kage Markings 49 CFR 172.300,49 CFR 172.301,49 CFR 172.303, 49 CFR 172.304,49 CFR 172.310,49 CFR 172.324: General marking requirements for non-bulk packagings, prohibited marking, marking requirements, radioactive material, hazardous substances in non bulk packaging . Package Labeling 49 CFR 172.400,49 CFR 172.401,49 CFR 172.403,49 CFR 172.406, '
49 CFR 172.407,49 CFR 172.436,49 CFR 172.438,49 CFR 172.440: Generallabeling requirements, prohibited labeling, radioactive materials, placement oflabels, specifications for radioactive labels
- Placarding of Vehicles 49 CFR 172.500,49 CFR 172.502,49 CFR 172.504,
! 49 CFR 172.506,49 CFR 172.516,49 CFR 172.519,49 CFR 172.556: Applicability, prohibited and permissive placarding, general placarding requirements, providing and
- affixing placards
- highway, visibility and display of placards, RADIOACTIVE placard
. Emergency Response Information, Subpart G,49 CFR 172.600,49 CFR 172.602, t
49 CFR 172.604: Applicability and general requirements, emergency response j mformation, emergency response telephone number l l . Training, Subpart 11,49 CFR 172.702,49 CFR 172.704: Applicability and responsibility l for training and testing, training requirements
. Radiation Protection Program for Shippers and Carriers, Subpart I,49 CFR 172.800, etc. . Shippers - General Requirements for Shipments and Packaging, Subpart I, l 49 CFR 173.403,49 CFR 173.410,49 CFR 173.411,49 CFR 173.412,49 CFR 173.413, _
49 CFR 173.415,49 CFR 173.416,49 CFR 173.433,49 CFR 173.435,49 CFR 173.441, 49 CFR 173.471,49 CFR 173.475,49 CFR 173.476: Definitions, general design requirements, industrial packages, additional design requirements for Type A packages, i requirements for Type B packages, authorized Type A packages, authorized Type B l l P1 Draft NUREO - 1556 Vol. 5
l APPENDIX P packages (including package certification requirements), requirement for determining A i and A2. ., table of As and A: values for radionuclides, radiation level limit, requirements
' for USNRC-approved packages (Type B), quality control requirements prior to each shipment..., approval of special form radioactive materials
- Carriage by Public Highway _49 CFR 177.816,49 CFR 177.817, 49 CFR 177.834(a),
49 CFR 177.842: Driver training, shipping paper, general requirements (secured against movement), Class 7 (radioactive) material, i l-Draft NUREG - 1556. Vol. 5 P-2
t N i d i Appendix P L Transportation Part 2 - Sample Bill of Lading l l
-, . n-, - ,- -- - , , - - - - , -- , . .
APPENDIX P STRAIGHT BILL OF LADIN3 oco at_ or soota.te % so. camerno. om e ._1_ _ .e 4 -.- .=> Paces, TS eb Irradiator Maker, Inc. ** s Irradiation Studies, Inc. ** ,
- m. -, .=
(cagagg.,g too ~. 1234 A Street, NW **
. 4321 Broad Street **
o Somewhere USA ** .co 12345** o+ Washington, DC 20001 ** v Re W
,,, h % Sa TOTAL OWAftfffY WWOstl ' CMAfeGtt HM % tsC,DESCsuPit08 -- =====
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1 RQ Radioactive material, special form, n.o.s., 7, UN2974 100 TBq (2700 Ci) Cs-137 ** 100 TBq ** RADI0 ACTIVE - YELLOW 11 ** T1 0.4 ** USA /1234/B(U) Type B Container ** Emergency Response Telephone No. 1-800-000- )000 (24 hr/d)
** SUBSTITUTE APPROPRIATE INFORMATION FOR YOUR SHIPMENT PLACARDS TENDERED:YES ONO @ Eo"o'
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i l I f i
- Appendix P i
Transportation I l Part 3 - Irradiators Built Before 10
- CFR Part 71 Regulation implementation l
l i l l l a l E__________________.__ -
l l APPENDIX P Irradiators Built Before 10 CFR Part 71 Regulation implementation before the adoption of the requirements of 10 CFR Part 71 in 1966, irradiators could be transported without being evaluated under the hypothetical accident conditions now incorporated in 10 CFR Part 71, Unlike most post-1966 irradiators, pre-1966 irradimors are not certified shipping packages. Transpont of pre-1966 units may require transferring the scaled source from the irradiator to a Type B package or the use of a certified package for the irradiator containing the scaled sources. NRC will consider a licensee's request for an exemption for a one-time shipment according to 10 CFR 71.8 only if these options are not viable. An exemption may be granted if the request is authorized by law and will not endanger life or property or the common defense and security. In this case, an exemption request should demonstrate the need for the exemption, describe why alternatives considered are not viable, specify from what requirement (s) an exemption is requested and the period for which the exemption is requested, and describe steps taken to ensure that the shipment will not endanger life or property or the common defense and security (e.g., steps to minimize accident risk and to respond to a transponation accident). Typically, approved requests are for a limited period (e.g., 30 days), Circumstances vary, but additional information supporting an exemption request may include the following:
- Manufacturer's name and model number of the irradiator, the type and activity of radioactive material to be transported, and brief description of proposed trip (starting and ,
v ending points and approximate distance)
- Engineering drawings ofirradiator
- Consideration of the following:
- DOT's hazardous material routing requirements
- Transport during time oflow road usage
- Use of good roads and avoidance of residential areas to maximum extent possible
- Accompaniment of shipment by escort knowledgeable in the use of radiation survey instruments
- Provision of escort with appropriate survey instruments and supplies to permit the establi.dunent of a radiation exclusion area
- Written nrocedures to be followed by the escort in an emergency situation.
- Use of e. .esive-use vehicle and shoring to limit movement of package during transport
' '-9 Draft NUREG - 1556, Vol. 5
(
APPENDIX P
*- Notification of State radiologica! health officials and local fire department of time and route of shipment.
- Planned date of shipment Before applying to the NRC for its appioval, the licensee should contact the radiological heal:h organiza:lon within each State through which the shipment will be made to confirm the points of contact and to discuss the proposed controls for the shipment. Contact NRC's regional offices (see Figure 2.1) for the name and telephone number of appropriate State officials. In several previous cases, short distance shipment ofirradiators have been successfully made with the cooperation of State officials.
NRC Headquarters staff must review these requests, which are typically requests to amend materials (Part 30) licenses. Licensees should address their requests, accompanied by the amendment fee specified in 10 CFR 170.31, to the appropriate Regional Office. The Regional Office will refer the request to NRC Headquarters staff for review by the Package Certification Section, Spent Fuel Froject Office (SFPO). If the exemption is approved, SFPO staff will provide the language for the license condition. In addition to an NRC exemption, the licensee may also need a DOT exemption; contact DOT's Omce of Hazardous Materials Technology at 202-366-4545 for additional information. Response from Applicant: Demon crate that the request is authorized by law and will not endanger life or property or the common defense and sectuity. AND The following: Establish that the irradiator was built before 1966 Explain why an approved package cannot be used, the altematives considered, and why each is not viable Specify from what requirement (s) an exemption is requested and the period for which the exemption is requested Describe procedures, controls, and other actions to be taken to ensure that the shipment will not endanger life or property or the common defense and security. Draft NUREG - 1556, Vol. 5 P-10 l l l
p i i Appendix Q l l Sample Self-Shielded Irradiator License 1 l
W - w w w w w w w w w w w w w w w w w w w = w - = = = = - - AYYthDIX PAG I Q---.-.-_______.N C# 7 PAGES g FORIJ 374 U.S.NUCLFAR MOULATORY COMh5SS40N f E MATERIALS LICENSE g p 5 f E g gll g Pursuant Federal to Regulations, the Chapter Atomic Energy Act I, Parts 30,31,32,33,34,35,36,39,40, of and1954, as 70, and in amended, reliance on statementsthe Energy Reorgani and representations g mad heretofore by the licensee, a license is hereby issued authorlaing the licensee to receive, acquire, possess, md transfer byproduct, source,g and s y material designated below; to use such nisterial for the purpose (s) and at the place (s) designated below; to deliver or transfer such,- n.ster l h permns specified authorized to receive it in accordance with the regulations of the applicable Part(s).This license shall be deemed to contain in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and E orde Nl E Nj Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. E
$ E p
i
'f Licensca E
Irradiation Studies, Inc. I. 3. License Number 08 00000-00 m is issued to read as follows: 5 E 1234 A Street, NW unsert a cate, last day of the
- 2. E Washington, DC 20001 7 g; 3 :4, Expiration Date month,10 yeart after issuance date) E e
- 5. Docket or ? E O="< Reference No.- 030-00000
- 6. Ilyproduct, Source, and/or 7. Chemical and/or Physical _ 8. Maximum Amount that Licensee E p
Special Nuclear Material . . Form !> May Possess at Any One Time
~
y y UnderThis License
- g
- l A, Cesium 137 ,
A. ~ Sealed sources (ABC A. Not to exceed either f Company Model CS-123) the maxim activity E t per source or the E maximum activity per i j . x device as specified in ' i d ;< - the certificate of
- 'y" c . ' "- ( . '
l
^ -
registration issued by i o 6 c, .- NRC or an Agreement i 1
- . State: see also E
, Condition 20.B. I
$ : ., . : 8 E
M g B. Cesium-137 .B. Sealed sources (J. L, B .' Not to exceed either i Shepherd and Associates the maximum activity I j I i Modeb6810). per source or the , I maximum activity per i device as specified in i the certificate of I registration issued by i I NRC or an Agreement State: see also l Condition 20.B. , i i i E k i N i N 8 9 , e I 5 Q-1 Draft NUREG - 1556, Vol. 5 I 4 .
-M m
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MATERIALS 1.JCENSE 08-00000-00 SUPPLEMENTARY SHEET %,g,%, ,,,, l 030-00000 l 1 l i ' l i I i' I i 6. Byproduct, Source, I
- 7. Chemical and/or 8. Maximus Amount that 3
and/or Special Nuclear I Phys! cal Form (Cont d) Licensee May Possess at Any l Material (Cont'd) l One Time Under This License p l (Cont'd) C. Cobalt-60 l C. Sealed sources (ABC C. Not to exceed either ! Company Model CO 456) the maximum activity i l g R r_ c per source or the 1 j i . max ,um ,ct3y3ty per l y ( ,\ p ,q A the certificate of device as specified in l i
' g Qregistrationissuedby i
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a I
' D. Strontium 90 N & N :d, ,
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* ' 20.B. I I
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'an Model SR-789) l ths maximum activity 8
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" ig;,[
1, maximum activity per n 7g : device as spcified in
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[,t j q t _t, he certificate of ( , n l [f t, d , ?
~
[7egistrationissuedby NRC or an Agreement i/ - State: see also l k i NOTE: O h( Condition 20.B. i I
' IFOTHERRADIONUCLIDESARERE%Sg,gEgAB0VEFORMATFOREACHAUTHORIZED RADIONUCLIDE. l i t i t i 9. Authorized Use a l A. 1 l
To be used for irradiation of materials, except explosive and flamable materials, in I an ABC Company Model 1 irradiator as specified in the device's Sealed Source and Device l s Registration Certificate issued by NRC pursuant to 10 CFR 32.210 or by an Agreement State. 8 l I B. To be used for irradiation of materials except explosive and flammable materials, ! in l a J. L. Shepherd and Associates Mark I 1rradiator as specified in the device's Sealed I l Source andState. Device Registration Certificate issued by NRC pursuant to 10 CFR l 32.210 j an Agreement i 8 i I 1 i P I I I p I f j Draft NUREG 1556, Vol. 5 f Q-2
}
p_---_--___-----_------------- DN_0 ._ ,,,,,,,,,,,m uncrymana u.s. NUCLE AR REOULATORY COMMISSM pgge 3 op 7 pgegg_ l i I l ($ H3 uwam mumwr 8 I 08-00000-00 I i MATERIALS LICENSE g,g,3,, ,,,w, I 3UPPLEMENTARY SHEET 030-00000 ! P I l i I i l Ites 9. Authorized Use (Contirued) I I C. To be used for irradiation of materials, except explosive and flamable materials n ! l p I en ABC Company Model C0 irradiator as specified in the device's Sealed Source and Device j Registration Certificate issued by NRC pursuant to 10 CFR 32.210 or by an Agreement l ~ p i State. b i D. To be used for irradiation of materials, except explosive and flamable materials, in l an ABC Company Model SR irracliator as specified in the device's Sealed Source and Device l l Registration Certificate issued by NR sub,t[,t(10CFR32.210orbyanAgreement 8 Stato, c,g'6 l l 7 , CONDITIONS
' 10. Licensed material beusehtthelicensee'sfacylitieslo'catedat(insert l addresses soecifi_ 'bv aool'ichnt)., !
.a ,
p i r6 i -
- 11. Licensed materialihall only1bs bsed by. or under the supervision and in the l l
l physical presence of, individu5M'who have received the training described in g (letter. aoolication) dated (fill in date), g l '~ > I ,. b d 12. The Radiation Safety.0fficer,.(RS0) for this .-
. license is (insert name of RS0),
9 p ,- . I 13. A. Sealed sources shall be tested for leakage and/or contamination at ir.tervals not to exceed the intprvhls specified' 'in'the certificate'of registration issued by ll
,4 a NRCunder10CFR32.Yl@orbyanAgreementStateN >
8 6 . lg B. In the absence of a certifidatd'fres*a tFansferor indicating that a leak test l has been made within the intervals specified in the certificate of registration N l prior to the transfer, a sealed source or detector cell received from another hl q person shall not be put into use until tested. p 9 4 y C. Sealed sources need not be tested if they are in storage and are not being used. I However, when they are removed from storage for use or transferred to another person, and have not been tested within the required leak test interval, they lq shall be tested before use or transfer. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or , lg contamination, y P 1 A 4 h 4 I 1 N e I F I E U Q-3 Draft NUREG - 1556, Vol. 5 k _____ ______________ _.2
.aum, ,__ ....- ------_- ------ D EO---------------
tac r .mA u.s. NuctsAn neoutAtony conewssioN paac 4 or 7
*m uo . - 6.,
caots. 4 i MATERIALS LICENSE *EW I 3,,,,,,,,,,,,,,,,,,,,, SUPPLEMENTARY SHEET 030 00000 h l I
' i Condition 13. (Continued) I r
D. The leak test shall be capable of detecting the presence of 0.005 microcurie of I radioactive material on the test sample. If the test reveals the presence of I 0.005 microcurie or more of removable contamination, the licensee shall
- 1mmediately remove the source from service, report to the Nuclear Regulatory
( i Commission according to 10 CFR 30.50(b)(2) and (c)(1), and have the source decontaminated, repaired, or disposed of according to Comission regulations. l r The licensee shall file a it% rd/p6 acc ding to 10 CFR 30.50(c)(2). j E. fgrmed by persons Tests k p specifically for licensedleakage anpk>r\ by the Commission ontamination or an Agree shall be [ services. In addtflon. the licensee is authorized to tollect leak test samples e but not perform;the analysis; analysis of leak test ' samples must be performed by I persons specific 611y licafiqed by the Comissior(or an Agreement State to parform l t such servicest.'(This condition is:used for Meen' sees not authorized to perform i leak test analysis.) T'
'Ql E.
st iOR A {c Tests for leakage and/or coht'ambiation shallibe performed by the licensee or l p other persons specifically licensed
' g by,)the Comission or an Agreem performsuchservices.EInaddif.1,'of;jth;licenseeisauth'orizedtocollectleak lM h
test samples forjanalysisiby personsispecifically licensed by the Commission or y an Agreement State to perform such'survices. 9This condition is used for d licensees authorized to collect m,;gnalyze leak test samples.) el, i .
- 14. Sealed sources containing iicensed material shall not b opened or sources removed from the self-shielded irradiater by the,licfnsee; except as specifically authorized '{p by license condition. &W r
- 15. The licensee shall conduct a physical inventory at intervals not to exceed 6 months to account for all sources and/or devices received and possessed under the license.
(If licensee is to be authorized for frequencies other than 6 months, change the condition to specify the approved interval.) > W f 16. Except for maintaining labeling as required by 10 CFR Part 20 or 71, the licensee l shall obtain authorization from NRC before making any changes in the sealed source. I device, or source device combination that would alter the description or specifications in the respective Certificates of Registration issued either by the l p Comission pursuant to 10 CFR 32.210 or by an Agreement State. [ N h Dr ft NUREG - 1556, Vol. 5 q_4 >
--------mwa---. ---- _______---------- _____--------- J
APPFNDTY O p., =, um.g= - ma- -- - -_ - ff= ---r--------------==-----------------3 l I NRC ieem 37aA U.S. NUCLE AR REOULATORY COMMIS$10N ,$or 5 o, 7 **cr s - I 1. 8W Lkcense number I 08-00000-00 l ! - MATERIALS LICENSE %, ,,g,,, ,,, l SUPPLEMENTARY SHEET 030-00000 l 1 l I f I I I I i 17. The licensee shall not repair, remove, replace, or alter any of the following: u I electrical and mechanical systems that control source or shielding movevnt, the l l irradiator's shielding or sealed source, safety interlocks or any component that y I may affect safe operation of the irradiator. These activities shall be performed by I l a person specifically licensed by the Commission or an Agreement State to perform [ l such services. (This condition is used for licensees not authorized to perform non- ti j routine mainte.ance.) l p l OR I I 17. Ext pt for the repair or maintenagppeYadons pescribed in (letter. aoolication) l i dated (fill in the date).)he Deensee shall '6btdepa1[. remove, replace, or alter any of the following: e16ctPTcalandmechanicalsystemsthatcontrolsourceor y( shielding movement, ttplrradiator's shielding or seale(. source, safety interlocks, g l or any component thatg ey affect safe operation of the irradiator. These activities g i M I shall be performed by, a person specifically licensed by the'Comission or an l Agreement State toaerformyt{ch services.(This condition is used ' for licensees lW l
\
authorized to perform non croutik :e maintenance.) 1 a ,n; )( y l 18. For each J. L Shepherd MarkLI'o'r Model 81-22 cdsium-137 irrMietor installed and I I used, the licensee shall: 6- L E x [y r , Permit the use of the irradiator 'onb Nien a calibrated and operable radiation t t A. l survey meter or room monitor i.s_avajltb le; and ( h I B. Permit the irradi' tor a' door to be'opeqed=only'5fter the operator has checked j p g visual indicators'tojv rify that the source has returned to its safe storage 4 position: and ) 'S Eq ( w & g C. Have room monitors installed thk wYll: A l6 i (I) Operate at all times when the irradiator is in use: and l [! I t (ii) Activate a visible and audible alarm when radiation exceeds 2 millirem l l{l l l per hour; and y 1 hl (iii) Detect any radiation leaking from the madiator door; and ! I I (iv) Be visible to the irradiator user when the user is next to the l [l irradiator: or y p l al i li R lj h 5 i Draft NUREG - 1556, Vol. 5 {0 _ Q-5
gruar % anyug u i,.cm, nu u.s. uucu antoutuou cownsioN u...,
.m 6 or
_ _uu_ l i l MATERIALS LICENSE % g g , ,, , , ,, 08 00000-09 l SUPPLEMENTARY SHEET 1 l l Condition 18. l 4 (Continued) e D. If a room monitor is not installed, have available a calibrated and operable l l survey meter which will be used to: 8: L ,.- l (!) Determine the radiation level at the irradiator door when the door is a closed: and [ p (ii)
, Check 1 opened.
for any incregsgradi'aQlgels each time the irradiator door l q y r E. If abnormal radiatich levels or any malfunctions of'thq irradiator are detected l t , at any time, stoFifsing the irradiator, restrict acceskto the area housing the p n E 1rradiator, impjiately notify the Radiation Safety Offker, and if required by 10 CFR Parts 2(:21 or,30;-report to NRC. l lq T r _ q\ s .. // pg F. Not repair or authorize repa,1rs of the irradiitor except by the 'nanufacturer or other persons specifically authorized by the Commission or an Agreement State to (> perform such services. (This'conditinn is used on all licenses authorizirg M , l q possession and use ofsJ L. Shepherd. Hark I or model 81 22 1rradiators.)
[
>l k
f 19. In accordince with the requirements set forth in 10 CFR 30.36(d), the licensee shall y
;' notify the appropriate U. S' Nuclear Regulatorf Commission Regional office N,
' referencea in Appendix 0 of 10 CFR Dart 20, in writing, of.a decision not to
~
DI ( L q d complete the facility,' acgvire equipment, 'or possess and use authorized material.
/
[ ( 9
- 20. A. The licensee is exempted from decomissioning financial assurance requirements l for possession of licensed inatdrial/in SIaled sources in quantities greater than 4 the limits in 10 CFR 30.35 for the purpose of source changes only. This f exerytion is granted for no more than 30 days for any one source change.
1 b 3 B. In addition to the possession lirits in item 8 and except as permitted by
, I Condition 20 A., the lu.ensee shall further restrict the possession of l' censed >
y
, material to quantities below the minimum limit specified in 10 CFR 30.35(d) for q establishing decommissioning financial assurance. (Do not use this license l i
! E condition if applicant provides evidence of financial assurance.) I i p 4 )
)
9 Il > p P Draft NUREG - 1556, Vol. 5 Q-6 -
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APPr.NDIX Q - y ! r -me ae_. a .- _- .. _-me.m u.s. -Nucts_- -mea _m ma An atoutatony cession Pact 7 .- 3F 7 PAGtt I I g
*unc "I e.. i nu umw numtie: )
a 08 ')0000-00 l
! MATERIALS LICENSE ,,,g,,,,,,,,,
t SUPPLEMENT ARY sl4EET 030-00000 _h > i d i I i 21. Except as specifically provided otherwise in this license, the licensee shall D. I conduct its program in accordance with the statements, representations, and l
, procedures contained in the documents, including any enclosures, listed below. The y W
i Nuclear Regulatory Comission's regulations shall govern unless the statements. representations, and procedures in the licensee's application and correspondence are [ l i more restrictive than the regulations. >l l > l p i A. Application dated (insert date). I l, 4R R EFOR('itIE V.S. NUCLEAR REGULATORY [ U(b
) ,
.) (Original (1gned by f'p l BY: (insert reviewer's name)
- DATE: tinsert liccIlse..iSEue._drie) q O J- ),
< Qr s(
4 _.,(insert reviewer's name)
'3[,s I. ,,_.
l '-
, '}*
ii (insert reviewer's NRC addttss) >fl p
, p i
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4 ' I tc N Ii. l l y _.. + #;- g i r< s >pl' i .
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4 ' P 4 pl 4 b (! sit
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h 4 k E f((l 4' ( d W W (l > (l< ( ( I > E! E I Draft NUREG - 1556. Vol. 5 b . - --- - - - = = - = = a - - - - aver-r-- Q craw rw = 7 wd
Appendix R Checklist for Self-Shielded Irradiator Application
APPENDIX R ITEM lt ACTION TYPE ACTION TYPE: ADMINISTRATIVE REVIEW: []New [] Current guidance used [] Amendment [ ] References in application based on current regulations [ } Renewal [ ] All referenced attachments included [] Signature on application ITEM 2: 1.FGAL IDENTITY NAME: a ITEMS 2 & 3: ADDIESS LOCATION OF USE/ STORAGE MAILING ADDRESS: ADDRESS: ITEM 4: PERSON TO BE CONTACTED ABOUT TIIIS APPLICATION CONTACT PERSON:
~
. ELEPIIONE R1 DraftNUREG 1$56,Vol.5
l APPENDIX R l l l ITEMS 5 ANI) 6: SiATERIAL TO BE POSSESSED AND USES YES NO RAD!0NUCLIDE MANUFACTURER QUANTITY USE AS L'JED SPECIFY OTHER AND MODEL ON$$D USES NOT LISTED NUMBER REGISTRATION ON SSD CERTIFICATE REGISTRATION PB'BtT1FICATE Cesium 137 Lach of the following Not to exceed Yes l j l ] Not applicable requested scaled either the --- sources, det kes, and maximum activity ( ) Uses are: source / device per source or the combinations is the maximum activity (Submit safety analysis subject of an approved per des ke as supporting safe use) i SSD Registration specified in $$D l Certificate: Certilkate Scaled source manufacturer's name and model number: Device manufacturer's name and model number: DraftNUREO 1556 Vol.5 R2 l
APPENDIX R ITEMS 5 AND 6: NlATERIAL TO BE POSSESSED AND USES (Continued) RADIONUCLIDE MANUFACTURER QUANTITY USE AS LISTED SPECIFY OTHER YES NO AND MODEL ON SSD USES NOT LISTED NUMBER REGISTRATION ON SSD CERTIFICATE REGISTRATION CERTIFICATE Lach of the follow mg Not to escced Yes [] [ ] Not applicable Cobalt 60 requested scaled either the Sources, devices, and musimum activity [ ] Uses are: source / device per source or the masimum actigity (Submit safety analysis combinations is the subject of an approsed per devke as supponing safe use) 55D Registration specified in 55D is, Ocate: Registration j% i r.tce Certificate Meg ter's name and saw.:1 number: Desice manufacturer's name and model number: Each of the following Not to cacced Yes[] [] Not applicable Strontium 90 requested scaled either the sources, det,een, and maximum activity () Uses are: source / device per source or the maximum activity (Submit safety analysis combinations is the subject of an approved per device as supporting safe ure) SSD Registration specified in SSD Cenificate: Registration Scaled source Certificate manufacturer's name and model nurnber: Device manufacturer's ncme and model number: Other (specif)) FIN 4NCl4L ASSURANCE REQUIRED AND El1DENCE OF FIN 4NCL4L ASSUt4NCE PRO F1DLu R4 Draft NUREG 1556, Vol. 5
1 I l APPENDIX R ITEMS 7 THROUGH 11: TRAINING AND EXPERIENCE. FACILITIES AND EQUIPMENT, RADIATION SAFETY PROGRAM. AND.. WASTE MANAGEMENT ITEM NUMHEP SUGGESTED RESPONSE APPLICANT'S RESPONSE AND TITLE YES NO OTTIER YES NO IILM 7 Inefore obtaimng hcensed matenals, the proposed RSO will have INDIVIDUAL 45) successfully completed the training described in Appendix 0 in RESPONSillLE l'OR dran NURI O.1556, Vol. 5 dated October 1997. RADIA110N sal ~l:1T AND PROGRAM AND 1lll:lR 1 RAINING liefore being named as the RSO, future RSO: will have AND successfully completed the training described in Appendix 0 in EXPl:Rll:NCE . dran NURLO 1556, Vol. 5, dated October 1997. Within 30 RADIAllON sal'l:1Y days of naming a new RSO, we will submit the RSO's name to OliICI:R (RSO) NRC for inclusion in out license. NAME (ktienaLResvonse Criteria for Acceptable 1 raining for RSO and Self Shicided irrediaw Users Content:
- Radiation safety
- Regulatory requirements
- Practical explanation of theory and operation for each irradiator possessed by licensee Instructor's Quahfications:
Instructor is qualined as RSO or authorized user before providing training. Training Auessment: Management ensures that RSOs, users are qualined to work independently with each t)pe of the licensee's irradiators. Ill.M 8 lHore usmg hcensed material, authonred users w ill receive the TRAINING l'OR training described in Appendix 0 in drah NUREG 1556, Vol. 5, INDIVIDUALS dated October 1997. WORKING IN OR FRI:QUENTING Oorlonal Response RESTRIC11 D AREAS Resiew optional response arainst criteria listed under item 7. Draft NU'1EG - 1 $56, Vol. 5 R-4
i APPENDIX R ITEM NUMBER hUGGESTED RESPONSE APPLICANT'S RESPONSE AND TITLE YES NO OTHER YES NO llLM 9 % e wdi ensure that each area where a self shielded irradiator is l'ACILITILS AND located conesponds to the " Conditions of Normal Use" and LQUIPMENT " Limitations and'or Other Considerations of Use" on the applicable irradiator's SSD Registration Certificate, the Door beneath a self shielded irradiator is adequate to support the weight of the irradiator; each self shielded irradiator is secured to present unauthorired access or removal; and each area where a self shielded treadiator is located is equipped with an automatically operated fire detection and control system (sprinkler, chemical, gas) or the location of the area and other controls ensure a low les el radiation risk attributable to fires. Ortonal Rewonu e Corresponds to ConditionvConsiderations of Use on SSD Certificate or justification for location and compensatory measures (e g., increased sun cillance, maintenance) to ensure that unit operates as designed and prosides intended les el of protection e I'loor adequate to support ueight
. Secured to prevent unauthorized remos al(e g., locked room, bolted to Door)
. Automatic fire detection and control or low radiation risk from fire (e g,, ground floor, fire resistant building,little combustible material, trained fire Oghters) 11LM 10 l he applicant is not required to, and should not, submit its audit Need Not Bc hubmmed With RADIAT10N sal'ETY program to the NRC for review during the licensing phase. Application PROGRAM AUDIT PROGRAM R5 Draft NUREG 1556, Vol. 5
APPENDIX R ITEM NUMBER $UGGESTED RESPONSE APPLICANT'S RESPONSE AND TITLE YE8 NO- OTHER I YES NO l I l'lLM 10 We will use instruments that meet the radiation monitormg RADIATION SAIT.TY instrument specifications published in Appendix K to draA PROGRAM
- NUREG 1556, Vol. $, dated October 1997. Additionally, each '
RADIATION survey meter will have been calibrated by the manufacturer or i , MONITORINO other person authorired by the NRC or an Agreement State to INST 1tUMEN15 perform survey meter calibrations no more than 12 months before the date the meter is used. OR We will use instruments that meet the radiation monitoring instrument specifications published in Appendia K to draft i NUREG 15$6, Vrl. $ dated October 1997. Additionally, we uill implement the model sun ey meter calibration program published in Appendix K to draft NUREG IS$6, Vol. 5, dated October 1997, and we will ensure that each survey meter will have been calibrated no more than 12 months before the date the meter is used. NOTD Licenses authodiing J. L Shqherd Mara ior Model , 8122 Irrederer will conceln n conerlon erpidng relibrated surwy norrer or room monitor, AhdemalIfQeaAf A description of attemathe equipment anNor procedures for:
- ensuring that interlocks function, as required, to reture moving self shleided irradiator sources to the shielded position and/or
- determiaing source shiciding integrity after an incident involving the self shielded irradiator Request to perform instrument calibration contains information described in Appendix K:
personnel w/ adequate training and experience
- principles and practices of radiation protection
- radiation measurements and instruments
- math, calculations basic to use and measurement
- biological effects of radiation obsen ation and supervised hands on participation in instrument calibration facihties, equipment, and procedures ensure regulatory -
compliance and doses ALARA
- isolated area
- assigned dosimetry wom use of calibrated, operable survey meter to detect unexpected :
changes in eitposure rates Draft NUREO 1$$6, Vol. 5 R6 y q ww_ - w -p,i-, r, -.-- ...- g g.-+. .e - mP p.y e _ -- --,--r-4 ..- -
l APPENDIX R ITEM NUMilER SUGGESTED R13PONSE APPLICANT'S RESPONSE AND TITLE YES. NO OTilEd YES NO Ii1.M l0 oodonal Rewonse (condnut) RADIAllON SAITTY Model Procedure: PROGRAM . e source of radiauon is used which: RADIATION . is a point source accurate to 1$%, traceable to NIST MON 110RINO . uses same photon energy as the source in irradiator INSTRUMENIS . is strong enough to give 30 mlVhr at 100 cm (Continued) e inserse square law is used and decay corrections are made e each calibration recorded and records maintained for 3 yr (10 CI'R 20.2103(a)) e meter readings within 120% of actual values
. number, location of calibrated points dependent on scales
. scales for measurements greater than 1 R/hr - no calibration is required but check for operation and approximately correct response e calibration report a calibration tag or sticker placed on each meter indicates:
. type of radiation source used
. proper deflection for battery check
. an indication that a scale was checked for function only but not calibrated
. calibration date
. due date
. rate from check source, if used 11LM 10 Physical inventories will be conducted at mtervals not to exceed RADIATION sal'ETY 6 months, to account for all scaled sources and devices, received PROGRAM . and possessed under the license.
MATERIAL RECEIPT AND Octional Rewonse ACCOUNTAlllLITY A description of the frequency and procedures for ensuring that no irradiators has e been lost, stolen, or misplaced R7 Draft NUREG .1556, Val,5
i APPENDIX R 11EM NUMBER SUGGESTED RESPONSE APPLICANT'S RESPONSE AND TITLE YES NO OTilER YES NO Ill.M 10 Lather we w til mamtam, for inspection by NRC, documentation RADIATION SAFETY demonstrating that unmonitored individuals are not likely to PROGRAM . recch e, in one y ear, a radiation dose in excess of 10% of the OCCUPATIONAL allow able limits in 10 CFR Part 20 or we will provide dosimetry DOSIMElRY that meets the Criteria in the section entitled *' Radiation Safety Program . Occupational Dosimetry," in draft NUREG 1556, Vol.
$, dated October 1997.
Dotional Resoonse Processed dosimetry (e g., film, TLD):
- Processed, evaluated by NVEAP approved processor
- Exchange frequency as recommended by processor Pocket chambers:
- Assigned to single individual, dose is read, recorded, and chamber recharged, as appropriate, before chamber reassigned a Range of 0 200 mrem
- Checked for correct response to radiation at intenals not to exceedIyr
- Readings within 120%
- Program prescribes action to evaluate dose Ill.M 10 RADIAl ION I he applicant is not required to submit a response to pubhc dose Need Not Be Submitted sal'ETY PROGRAM - section during the licensing phase. This matter will be examined With Application .
PUlillC DOSE during inspection. Draft NUREO - 1556 Vol 5 R8
APPENDIX R ITEM NUMBER SUGGESTED RESPONSE APPLICANT'S RESPONSE AND TITLE YES NO OTilER YES NO 11 LM 10 RADIAIlON Operstmg and emergency procedures will be developed, SAFETY PROGRAM . implemented, maintained, and distributed and will meet the OPERATINO & Cheria in the section entitled " Radiation Safety Program . LMEROLNCY Operating and Emergency Procedures
- in draft NURLO lS$6.
PROCEDURES Vol. $, dated October 1997. OpdonalRemonse Develop, maintain, and implement model specific operating and emergency procedures w'nich contain:
- Anal fsis of each material to be irradiated to ensure compatihility and determine if special procedures are needed
- Procedure on how to operate and perform routine snaintenance according to manufacturer's written instructions and recommendations
- Security, access control (e g. cortrol Ley to irradiator room)
- Steps to take to keep radiation doses received ALARA
- Accountability (e g., log book, leak tests, inventor))
- Access control to damaged or malfunctioning irradiators e Steps to tale and whom to contact w hen irradiator malfunctions or is damaged AND Provide copies of operating and emergency procedures to all users, and maintain current copy at irradiator controt panei(or post notice describing where to find copy)
Lk enses authortdng J. L Shepherd Mark I or Model 8I4' trredator will contain shefollowing conMilons:
- Must have suney meter or room monitor
. Room monitor:
operable when irradiator is in use activates audiMe/ visible s's, at 2 mremhr Ic4 sted to detect radiation tMn irradiator door visible to irradiator user
. Survey meter:
used to determine radiation levels w hen door is closed and check for increased levels w henes er door is opened surveyor positioned to minimize radiation exposure
- Ilefore use, check visual indicator to ensure source is in safe stored position If shaormal radiation levels are detected or irradiator malfunctions
. stop irradiator use
. restrict access to irradiator notify RSO
. determine if NRC must be notified
- Repairs only by those specifically authorized by NRC R9 Draft NUREG .1556, Vol. 5
l l API'ENDIX R 11EM NUMHER SUGGESTED RESPONSE APPLICANT'S RESPONhE AND1ITLE YES NO OlllER YES NO - 11LM 10 1. cal tests =ill be performed at inten als apprmed by the NRC or RADIAllON an Agreement State and specified in the SSD Registration SAI ElY PROGRAM Certificate. I cal tests will be performed by an organisation
. LEAK 11:515 authorised by NRC or an Agreement State to prmide leak testing services for other licensees or using a leak test Lit supplied by an organitation authorlici by NRC or an Agreement State to prmide leak test Lits to other licensees and according to the self shielded irradiator manufacturer's and Lit supplier's instructions.
OR Leak tests will be performed at intervals apprm ed by the NRC or an Agreement State and specified in the SSD Registration Certincate. Leak tests will be performed by an organitation authorised by NRC or an Agreement State to provide leak testing senices for other licensees or using a leak test Lit supplied by an organisation authorired by NRC or an Agreemes,1 State to prmide leak test Lits to other licensees and according to the self shielded irradiator manufacturer's and Lit supplier's instructions. As an alternatise, we will implement the model leak test program published in Appendix 0 of draft NURI:01556, Vol. 5, dated October 1997, Optionalitycase Lsaluate altematise equipment / procedures for determining if there is leakage from scaled sources.
- Identify w ho w.ll make the analysis and qus*ifications to make quantitatise measurements; e 1. cal test frequency as speciDed in the appropriate SSD Registration Certificate; e llow and where test samples will be taken; e Materials to be used, e Methods of handling samples to present or minimite exposure to personnel, e T) pc of instrument (s) used, counting efficiency, and minimum lesels of detection for each radionuclide / Note: Aa instrument capable ofmaking quantitative measurements should be used; hand-held survey meters will not normally be com!dered adequatefor measurervntsl; e St*Mard calibration sources " -luding the following information for each source: e ,adionuclide, quantity, accuracy, and traceability to primary radiation standards l Note: Accuracy of standards should be within 25% of the stated value and traceable to a primary radiction standard such as those maintained by the Nationalinstitutes of Standards and Technology (NIST)];
- Sample calculations to com crt measurement data to becquerels (or microcuries);
- Instructions on actions to take and notifications to make regarding leaking sources.
Draft NUREO 1556, Vo'.. > RD l
APPENDIX R ITEM NUMBER SUGGEST ED RESPONSE APPLICANT'S EssEG,.i. AND TITLE YES NO. OTHER YES NO llLM 10 EDU1LNE Cl LANING A LUEkiCAllON RADIATION SAFETY PROGRAM We will implement and maintain procedures for routine
. MAINTENANCE maintenance of our self shielded irradiators according to each
- manufacturer's written recommendations and instructions.
ppdanal Ramanse . Raudar c'-- *-- A I uMr- '~~
- Considers ALARA
- Ensures irradiator functions as designed
- Ensures source integrity not compromised NON ROtfr1NE MAINTENANCE '
We will have the self shielded irradiator manufacturer or other person authortred by NRC or an Agreement State perform non-routine maintenance , p a-- a n_----- n> . &n. n~ d=> M n.>,,,,,o Provide the information listed in Appendix ! supporting a request to perform non routine maintenance in-house. ,
- T) pes of work te be performed
- Who will perform maintenance, training, experience, why competent (e g., previous experience and radiation safety ,
training; vendor maintenance certification; pre-planned procedures with direct health physics supervision) e llandling procedures: doses to public, personnel ALARA and regulatory limits; securi'y; posting; manufacturer's written instructions and recommendations; functions as designed, source integrity ensured; esaluation of non manufacturer supplied components to ensure no degradation of safety
- Use of whole body and extremity monitoring
- Possess survey instrument (detects gamma; range to several hundred mR/hr; checked before use; calibrated annually, after repair; readings w ithin 120%; calibrated by manufacturer or NRC or Agreement State licensee -moving source irradiator specifications in Appendix K )
- 10 CFR 201301 surveys (w ben and where instmment survey performed, records for 3 ) cars) 11LM 10 the applicant is not required to submit its response to the Need Not Be Submitted With RADIATION transportation section during the licensing phase. Ilowever, this Application SAFE 1Y PROGRAhl. issue will be resicwed during inspection.
TRANSPORTATION ?} R 11 Drall NUREO 1$$6, Vol. 5
i l APPENDIX R 11EM NUMilLR SUGGESI LD RESPONSE APPLICANT'S ROK)NSE AND TITLE YES NO OTilER YES NO 11LM 10 i he applicant is not required to submit a response to the Need Not Be Submitted With RADIAllON minimitation of contamination section if the anchcant's responses Application SAII:TY PROGRAM meet the criteria for the following sections: " Radioactive Material MINIMlZAllON Ol' . Scaled Sources and Devices,* *Tacilities and Equipment," CONTAMINAllON " Radiation Safety lyogram . Operating and Emergency Procedures,"" Radiation Safety (Yogram . Leak lests," and
" Waste Management . Self Shielded Irradiator Transfer and Disposal" lli.M 1I I he applicant is not required to submit a response to the w aste Need Not Be Sutaltted With WAS10 DISPOSAL . management section during the licensing phase. Ilowever, the Application sill' SillLLDI:D licensee should desclop, implement, and maintain self shielded IRRADIA10R irradiatar transfer and disposal prwedures in its radiation safety DISPOSAL & program.
TRANSI1:R Draft NUREO .1556, Vol. 5 ' R 12
peRc #osta 3)s u.s. NucLLAR Nt oVLATORV coticedisseON 1 Rf_ PORT NuMBLR ) CO on *I C L7,"ii.l,,,'v,e,.' @ "**' i
** BIBLIOGRAPHIC DATA SHEET see einwowe wi p.e . w NUREGiS%
e ntLL AND sublitti Vol. 5 Consolidated Guidance About Materlats Licenses oATE Ripont Puntissto
~
a Program Specific Guidance About Self Shielded irradiator Licenses _"" l Draft Report for Comment October 1997 4 fin OR GRANT NUMBER S AUTHOR (s) : TYPE OF REPORT P.C. Vacca, DJ. Collins, M.W. Mitchell, W.H. Radcliffe, M E. Schwart2 Drd r PERIOD COVERED isnctee Dees > e PL RF ORM'NQ ORGANIZATION . NAME AND ADDRL ss i# NRC. pende Deset oAo a He r .in, U s Nwww Repsewy Comoseon, se mow seess. # cwwwk, svar= w.ie w.a men eaten i Office of Nuclear Material Safety and Safeguards Division of industrial and Medical Nisclear Safety U.S. Nuclear Regulatory Commission Washington, DC 20$$$-0001 s $PON&oRING ORGANLZATION NAME AND ADDRE s$ (# MFC. type 'Sans as ekW. # twe<saw. prowde N*tc Demon, omco er hopea. U 8 Na*w mopwawy Comussen, eaamow emewa Same as above 10 SVPPLEMENTARY NOTE 6 11 abs 1RAci (200 ewos or ases) As part of its redesign of the materials licensing process, NRC la consolidating and apdating nurrerous Guidance documents into a single comprehenstve reposit as desenbed in NUREG 1539," Methodology and Findings of the NRC's Materials L6cens6ng Process Redesign,' dated ril 1996, and draft NUREG-1541,
- Process and Design for Consolidating and Updating Matertals Licensing Guldance,' dated pril 1996. NUREG-1550, Vol. 5.
- Consolidated Guidance about Materials Licenses:
Program-Spec 6tc Guidance about Self-Shielded irradiator Licenses," dated October 1997, is the fifth program-specific Guidance developed 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 combines and updates the Guidance found in Regulatory Guide 10 9. Revision 1 ' Guide for the Preparetton of Applicatiens for Licenses for the Use of Self-Contained Dry Source-Storage Gamma irradiators," dated December 1988, and in NMSS Policy and Guidance Directive FC 8416, Revision 1,
- Standard Review Plan for Applications for Use of Self-Contained Dry Source-Storage Gamma irradiators," dated January 26,1989. This draft repo*1 takes a more risk informed, performance-based approach to licensing self shleided irradiators, and reduces the information (amount and level of detail) needed to support an application to use these devices. Note that this document is strictly for public comment and is not for use in pieparing or reviewing self shielded Irradiator licenses until it is published in final form.
13 AWAiLABAITY &TATEMiNT 12 KLY WORDS/DESCRIPToRs (ver ooros or phreses Pet mis esost researrnera in brenny the m4pt J unlimited materials U I * 'E irr dia '"""*> nsk-informed unclassified performance-based program-specific ~ithin.Wo unclassified 16 NUMBER Of FAGES is price NMC f W 32 (2 80 73,,wm wee encirorug praesed by Iam Fesarer Forms me
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