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Consolidated Guidance About Materials Licenses PROGRAM- Specific Guidance About 10CFR Part 36 Irradiator Licenses. Draft Report for Comment
	ML20236S655
Person / Time
Issue date:	03/31/1998
From:	Jackie Jones, Wade Loo, Reber E, Schwartz M, Vacca P; NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	;
References
	NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V6-DRF-FC, NUDOCS 9807270151
	Download: ML20236S655 (191)
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NOREG Repo81S "t "

J Consolidated Guidance About Materials Licenses Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses Draft Report for Comment U.S. Nuclear Regulatory Commission

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AVAILABILITY NOTICE Availability of Reference Materials Cited in NRC Publications Most documents cited in NRC publications 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 Washington, DC 20402-9328 3.

The National Technical Information Service, Springfield. VA 22101-0002 Although the hsting that fo!!ows represents the majority of documents cited in NRC publica-tionr. it ir rc: ur:nt'cc' te De eheustive.

Referenced documents availabio hr inspection and copying for a ice from the NRC Public Document Room include NRC correspondence and internal NRC memoranda; NRC bulletins, circulars, information notices, inspection and investigation notices; licensee event reports; vendor reports and correspondence; Comnyssion papers; and applicant and licensee docu-ments and correspondence.

The f ollowing documents in the NUREG series are ava:Obie for purchase from the Covernment Printing Office: formal NR3 staff and contractor reportc. NRC-sponsored conference pro-coedings, international agreement reports, grantee reportr, and NRC booklets and bro-chures. Also available are regulatory guides, NRC regulations in ?he 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 Federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Comm; sion.

Documents available from public and special technical libraries include all open literature items, such as books, journal articles, and transactions. Federal Register notices, Federal and State legislation, and congressional reports can usually be obtained from these libraries.

Documents such as theses, dissertations, foreign reports and translations, and non-NRC con-forence proceedings are available for purchase from the organization sponsoring the publica-tion cited.

Singts copies of NRC draft reports are available free, to the extent of supply, upon written request to the Office of Administration, Distribution and Mail Services Section, U.S. Nuclear Regulatory Commission Washington 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 purchased from the originating organization or, if they are American National Standards, from the American National Standards institute,1430 Broadway, New York, NY 10018-3308.

NUREG-1556 Vol. 6 I

j Consolidated Guidance About Materials Licenses i

Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses l

l Draft Report for Comment Manuscript Completed: March 1998 Date Published: March 1998 l

l Prepared by J.D. Jones, W.T. Loo, E.H. Reber, M.E. Schwartz, P.C. Vacca i

I I

1 Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Wcshington, DC 20555-0001 g%,...../

1 l

l COMMENTS ON DRAFT REPORT Any interested party may submit comments on this report for consideration by the NRC staff.

Please specify the report number, draft NUREG-1556, Vol. 6, in your comments, and send them by the due date published in the Federal Register notice to:

Chief, Rules Review and Directives Branch Office of Administration Mail Stop T6-D59 l

Washington, DC 20555-0001 l

i

ABSTRACT As part ofits redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, " Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses," dated March 1998, is the sixth 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 Draft Regulatory Guide DG-0003, " Guide for the Preparation of Applications for Licenses for Non-Self-Contained Irradiators," dated January 1994, and NMSS Policy and Guidance Directive, FC 84-23, " Standard Review Plan for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage, and Panoramic Wet Source-Storage Irradiators,"

dated December 27,1984. This draft report, where applicable, provides a more risk-informed, performance-based approach to licensing 10 CFR Part 36 irradiators consistent with the current regulations. Note that this document is strictly for public comment and is not for use in preparation or review of 10 CFR Part 36 irradiator licenses until it is published in final form.

l l

l t

h iii Draft NUREG - 1556, Vol. 6

= _

i CONTENTS l

8.9.08 POWER FAILURES........'.................................. 8-32 8.10 ITEM 10: RADIATION SAFETY PROGRAM................................. 8-3 3 8.10.01 AUDIT PROGRAM.......

........................................833 I

l 8.10.02 INSTRUMENTS.

......... 8-3 5 l

8.10.03 MATERIAL RECEIPT AND ACCOUNTABILITY........................ 8-39 t

8.10.04 OCCUPATIONAL DOSIMETRY.

....................................8-41 8.10.05 ITEM 10: RADIATION SAFETY PROGRAM - PUBLIC DOSE............. 8-43 8.10.06 OPERATING PROCEDURES...............................

..... 8-45 0.10.07 EMERGENCY PROCEDURES..........

................. 8-4 9 8.10.08 LEAK TESTS...............................................

8-52 8.10.09 INSPECTION AND MAINTENANCE CllECKS...........................

8-55 8.10.10 TRANSPORTATION......

8-56 i

8.10.11 MINIMIZATION OF CONTAMINATION..

..........................8-58 8.11 ITEM 11: WASTE MANAGEMENT..........

............................8-58

)

8.11.01 SEALED SOURCE DISPOSAL AND TRANSFER........................

8-58 8.12 I TEM 12 : FEES..................... -.................

8-59 1

8.13 ITEM 13: CERTIFICATION.........................

................... 8-60

/

9 AM ENDM ENTS AND RENEWALS TO A LICENSE...................................... 9-1 10 APPLICATIONS FOR EX EM PTIONS................................................. 10-1 11 TERMINATION OF ACTIVITIES...................................................... I l-1 1

i i

k APPENDICES l

i A List of Documents Considered in Development of this Draft NUREG...................... A-1 B NRC Form 313...................

....................... B-1 i

C Suggested Format for Providing Information Requested in items 5 through !I of NRC Form 313....... C-1 D Information Needed for Transfer of Control Application.......................

...... D-1 E Suggested Wording for a Statement ofIntent for a Government Licensee E-1 i

F Irradiation of Explosive Materials or Greater Than Small Quantities of Flammable Materials........ F-1 j

G Training for Radiation Safety Officers and Irradiator Operators..........

...................G-1 11 Typical Duties and Responsibilities of the Radiation Safety Officer..........................

11-1 1

Information Needed to Support Applicant's Request to Perform Non-Routine Operations.............

1-1 J

Construction Monitoring and Acceptance Testing........................................ J-l K Suggested Audit Checklist for 10 CFR Part 36 Irradiators....

......................K-1 l

L Model Survey Instrument Calibration Program.............

.... L-1 l-M Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits M-1 N Guidance for Demonstrating that Individual Members of the Public will not Receive Doses Exceeding the Allowable Limits..................................

........................N-1 I

l Draft NUREG - 1556, Vol. 6 vi l

l CONTENTS A BSTRA CT..................... -........................................................ iii FOREWORD....................................-.........................................lx A C KNOW LE DG M ENTS........................................,............................ x i A B BREVI ATION S........................................................................ x iii 1

PURPOSE OF DRA FT REPORT....................................................... 1-1 2 A G RE E M ENT STATES...............................................................

2-1 3 MANAG EM ENT RESPONSIBILITY.................................................... 3 1 4 APPLICA BLE REG ULATIONS........................................................ 4-1 5 H OW TO FI L E......................................................................

5-1 5.1 PAPER APPLIC ATION..................................................... 5-1 5.2 ELECTRONIC APPLICATION................................................

5-2 6 W H E RE TO FI LE....................................................................

6-1 7 LIC E N S E FE ES......................................................................

7-1 8 CONTENTS OF AN APPLICATION.................................................... 8-1 8.1 ITEM I: LICENSE ACTION TYPE...............................

.. 8-1 8.2 ITEM 2: APPLICANTS NAME AND MAILING ADDRESS......................

8 1 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED.. L3 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION 8-4 8.5 ITEM S: RADIOACTIVE MATERIAL.......

.............. 8-5 8.5.01 SEALED SOURCES AND DEVICES.................................... 8-5 8.542 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING. 8-6 8.6 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED............., 8-9 8.7 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM........ 8-10 8.7.01 RADIATION SAFETY OFFICER (RSO) TRAINING AND EXPERIENCE........ 8 10 8.7.02 RSO RESPONSIBILITIES AND AUTHORITIES.......................... 8-12 8.8 ITEM 8: INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS..... 8-13 8.8.01 INITIAL TRAINING AND EXPERIENCE FOR 1RRADIATOR OPERATORS..... 8-13 8.8.02 ANNUAL SAFETY REVIEWS AND PERFORMANCE EVALUATIONS FOR 1RRADIATOR OPERATORS.................

........ 8-16 8.8.03 TRAINING FOR INDIVIDUALS WHO REQUIRE UNESCORTED ACCESS...... 8-17 8.8.04 TRAINING FOR INDIVIDUALS WHO MUST BE PREPARED TO RESPOND TO ALARMS.....

. 8 18 8.9 ITEM 9: FACILITIES AND EQUIPMENT......................

.... 8-19 8.9,01 GENERAL DESCRIPTION OF THE FACILITY AND SITE.............. 8-19 8.9.02 ACCESS CONTROL..

........... 8-20 8.9.03 SHIELDING

.... 8-24 8.9.04 FIRE PROTECTION.........................

8-26 8.9.05 RADIATION MONITORS...........

8-2 7 8.9.06 1RRADIATOR POOI.S..........

8-29

[

8.9.07 SOURCE RACK..............

8-31

(

v Draft NUREG.1556, Vol. 6

CONTENTS N Typical NRC incident Notifications Required for Irradiator Licensees.......................... O-l P Model Leak Test Program For Dry-Source-Storage Irradiator Scaled Sources...........

. P-1 Q Transportation.........

......... Q-1 R Exemptions for Teletherapy Units Converted to Non-Human Use.......................... R-1 S Sample Licenses for 10 CFR Part 36 Irradiators............................................ S-1 l

l 1

FIGURES i

Figure 1.1 Teletherapy Unit Converted to Non-Human Use................................... 1-2 Figure 1.2 Underwaer irradiator........

... 1-3

)

t Figure 1.3 Commercial Wet-Source-Storage Irradiator........

.... 1-3 i

Figure 2.1 U.S. M ap..............

.. 2-2 Figure 8.1 Location o f Use...........................................................

8-4 Figure 8.2 Financial Assurance for Decommissioning..................................... 8-7 Figure 8.3 Records important to Decommissionir.g.......................................... 8-8 Figure 8.4 RSO Re possibilities................................................. 8-13 Figure 8.5 General Description of Facility.............................................. 8 20 l.

Figure 8.6 Radiation Detection Instruments...................

........................8-37 Figure 8.7 Material Receipt and Accountability........................................ 8-3 9 Figure 8.8 Annual Dose Limits for Radiation Workers...........

............. 8 -4 2 Fip.ure 8.9 Proper Handling ofincident...

.... 8-50 Figure 8.10 Leak Testing.......................................................... 8-53 Figure J.I Construction Monitoring and Acceptance Testing.................................. J l I

TABLES Table 1.1 Categories and Types of 10 CFR Pan 36 Irradiators......................

..........12 Table 2.1 Who Regulates the Activity 7................................................. 2-1 Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance..................... 8-7 Table S.2 Requirements for Radiation Monitors........................................

8-36 1

Table 8.3 Elements of Accountability Procedure......................

... 8-40 Table 8.4 Receipt, Transfer and Disposal Record Maintenance............

... 8-40 l

Table 8.5 Requirements for Occupational Dosimetry........

.......... 8-41 1

Table 8.6 Radiation Limits Specified in 10 CFR 36.25.....................

......... 8-44 Table 8.7 Operating Procedures..........

8-4 6 Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance Directives............ A-1 Table A.2 List of In formMion Notices......................................

...............A-2 l

I vii Draft NUREG - 1556, Vol. 6 l

l 1

CONTENTS

)

l l

Table A.3 List of Technical Assistance Requests........

...........................A3 Table A.4 Miscellaneous NRC Documents.......................................... A-4 Table J.1 Construction Monitoring and Acceptance Testing.........

J-l l

Table N.1 Information Known about Dose at the Shield of the Irradiator.......................... N-3 Table N.2 Combination Measurement. Calculational Method. Part 1: Hourly and Annual Dose Received from Irradiator....................................

....... N-4 Table N.3 Combination Measurement - Calculational Method, Part 2: Annual Dose Received from a 10 CFR Part 36 Irradiator

. N-5 Table 0.1 Typical NRC incident Notifications Required for Irradiator Licensees

............. O-l Draft NUREG - 1556, Vol. 6 viii

i FOREWORD The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign," (April 1996). A critical element of the new process is consolidating and updating numerous guidance domments into a NUREG-series of reports. Below is a list of volumes currently included in the MUREG-1556 series:

VolNo, Volume Title Status 1

Program-Specific Guidance About Portable Gauge Final Report Licenses 2

Program-Specific Guidance About Radiography Draft for Use and Comment Licenses 3

Applications for Sealed Source and Device Evaluation Draft for Comment and Registration 4

Program-Specific Guidance About Fixed Gauges Draft for Comment 5

Program-Specific Guidance About Self-Shielded Draft for Comment Irradiators The current document, draft NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiators," dated March 1998,is the sixth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC hcense reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in Draft Regulatory Guide DG-0003,

" Guide for the Preparation of Applications for Licenses for Non-Self-Contained Irradiators,"

dated January 1994, and the guidance for licensing staff previously found in NMSS Policy and Guidance Directive, FC 84-23, " Standard Review Plan for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage, and Panoramic Wet Source-Storage Irradiators," dated December 27,1984. In addition, this dran report also contains pertinent information found in Technical Assistance Requests and Information Notices. See Appendix A for a list of the documents considered in the preparation of this draft report.

This draft report takes, where applicable, a risk-informed, performance-based approach to licensing 10 CFR Part 36 irradiators consistent with the current regulations. A team composed of NRC staff from regional offices and headquarters drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to irradiators. A representative of NRC's Office of the General Counsel provided a legal perspective.

ix Draft NUREG - 1556, Vol. 6

i FOREWORD Draft NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiators," dated March 1998, represents a step in the transition from the current paper-based process to the new electronic process. This draft document is available on the Intemet at the following address:

http://www.nrc. gov /NRC/NUREGS/SR1556/V6/index.html.

l This draft report is strictly for public comment and is not for use in preparing or reviewing i

applications for 10 CFR Part 36 licenses until it is published in final form. It is being distributed for comment to encourage public participation in its development. NRC is requesting comments on the integration of prescriptive guidance and more performance-based approach to licensing in section 8. Please submit comments within 90 days of the draft report's publication. Comments received after that time will be considered if practicable.

Address comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office 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 Intemet by addressing electronic mail to diml@nrc. gov.

Draft NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36Irradiators," dated March 1998, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this draft report are provided for information and comment only.

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Donald A. Cool, Directof Division ofindustrial and Medical Nuclear Safety Oflice of Nuclear Material Safety and Safeguards I

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Draft NUREG - 1556, Vol. 6 x

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ACKNOWLEDGMENTS The writing team thanks the individuals listed below for assisting in the development and review of the draft report. All participants provided valuable insights, observations, and recommendations.

The team also thanks Kay Avery, Judy Boykin, Kathryn M. LaViolette, Grace S. Lee, Steven W.

Schawaroch, and Gina'G. Thompson of Computer Sciences Corporation; the management and staff ofirradiators operated by Baxter Healthcare Corporation in Aibonito, Puerto Rico, and Isomedix Operations, Inc., in Vega Alta, Puerto Rico; Glenn Calvert and Jon Young ofIsomedix j

Operations, Inc., in Whippany, New Jersey; Joseph Stirling, Graham Rose, and Michael Wynnyk of MDS Nordion, Kanata, Ontario, Canada; Eric Beers, Chairman, American National Standards Committee N43.10; Bob Williams, II, National Institute of Standards and Technology; and B. J.

Smith from the State of Mississippi.

The Participants Broaddus, Douglas A.

Buckley, John T.

Camper, Larry W.

Caniano, Roy J.

Combs, Frederick C.

Hickey, John W.

Jones, John D.

Loo, Wade T.

Merchant, Sally L.

Pangbum, George C.

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Reber, Eric H.

Roe, Mary Louise Schwartz, Maria E.

l Treby, Stuart A.

Vacca, Patricia C.

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xi Drafi NUREG - 1556, Vol. 6 E_ __

ABBREVIATIONS l

ACI American Concrete Institute ALARA As Low As Is Reasonably Achievable ANSI

American National Standard Institute -

'bkg

Background

l BPR

- Business Process Redesign Bq.

Becquerel l

'BSR-Bulk Shielding Reactor C

Celsius iS CaF Calcium Fluoride CFR Code of Federal Regulations C/kg.

Coulomb per kilogram L

cm Centimeter Co-60 Cobalt-60 cpm Counts per minute l

Cs-137 Cesium-137 d

Day DOE United States Department of Energy DOT United States Department of Transportation F

Fahrenheit ft Foot G-M Geiger-Mueller GPO Government Printing Office lu Hour IN Information Notice IP Inspection Procedure kg Kilogram j

LiF Lithium Fluoride m

Meter M C.

' Manual Chapter min Minute mR Milliroentgen mrem Millirem mSv Millisievert 1

MOU Memorandum of Understanding NaI(TI)

Sodium Iodide (Thallium-activated)

NCRP National Council on Radiation Protection and Measurements NFPA National Fire Protection Association h

NIST National Institute of Standards and Technology NLTNIF National Low-Temperature Neutron Irradiation Facility NMSS Office of Nuclear Material Safety and Safeguards NRC United States Nuclear Regulatory Commission xiii Draft NUREG - 1556, Vol. 6

ABBREVIATIONS NVLAP National Voluntary Laboratory Accreditation Program OCFO Office of the Chief Financial Officer OCR Optical Character Reader OMB Office of Management and Budget ORNL Oak Ridge National Laboratory OSHA Occupational Safety and Health Administration OSP Office of State Programs P&GD' Policy and Guidance Directive RG Regulatory Guide RQ Reportable Quantities RSO Radiation Safety Officer SI International System of Units (abbreviated from the French Le Systeme International d' Unites)

SSD Sealed Source and Device std Standard Sv Sievert TAR Technical Assistance Request TEDE Total Effective Dose Equivalent TI Transportation Index TLD Thermoluminescent Dosimeters URL Uniform Resource Locator wk Week yr Year l

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DraA NUREG - 1556, Vol. 6 xiv

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1 PURPOSE OF DRAFT REPORT l

This document is strictly for public comment and is not for use in preparing or reviewing applications for 10 CFR Part 36 irradiators* until this document is published in final form.

'Ihis draft report provides guidance to an applicant in preparing a license application for 10 CFR l

Part 36 irradiators' as well as NRC criteria for evaluating a license application. It is not intended to address the research and development or the commercial aspects of manufacturing, distributing, and servicing 10 CFR Part 36 irradiators and their associated sources. Within this document, the phrases or terms, "10 CFR Part 36 irradiators," "irradiators," or "irradiators subject I

to the requirements of 10 CFR Part 36" are used interchangeably.

This draft report addresses the variety of radirfion safety issues associated with irradiators, of various designs, whose dose rates exceed 5 grays (500 rads) per hour at one meter from the' radioactive sealed sources in air or in water, as applicable to the irradiator's design. Table 1.1 describes the characteristics of commonly authorized irradiators. Figures 1.1,1.2, and 1.3 illustrate several irradiators. Because of differences in design,' manufacturers provide appropriate written instructions and recommendations for proper operation and rnaintenance.

3 Self-shicided irradiators are not subject to the requirements of 10 CFR Part 36 and are discussed in draft NUREG-1556, Vol. 5," Consolidated Guidance About Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiators," dated October 1997.

3-1 Draft NUREG - 1556, Vol. 6

PURPOSE OF DRAFT REPORT Table 1.1 Categories and Types of 10 CFR Part 36 Irradiators Irradiator Type Panoramic Panoramic Dry-Panoramic Wet-Pool

' Underwater Source-Storage Source-Storage Sources stored in pool and removed y

g g

to irradiate package / product Sources stored in pool and V

V package / product lowered into pool to be irradiated Dry source storage and in-air j

g irradiation of package / product Teletherapy unit converted to non-V V

human use

'm

/

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M w.=g; Figure 1.1 Teletherapy Unit Converted to Non-IIuman Use. A teletherapy unit usedfor research is an example ofa panoramic dry-source-storage irradiator.

Draft NUREG - 1556, Vol.6 l2

PURPOSE OF DRAFT REPORT l

w

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t Figure 1.3 Commercial Wet-Source-Storage Irradiator. The sealedsources are storedin water and raised into the air to irradiate a product that may be moved into the irradiation room on a conveyor system. This is an example ofapanoramic wet-source-storage irradiator.

This draft report identifies the information needed to complete NRC Form 313 (Appendix B),

" Application for Material License," for the use of sealed sources in 10 CFR Part 36 irradiators.

1-3 Draft NUREG - 1556, Vol. 6

PURPOSE OF DRAFT REPORT The information collection requirements in 10 CFR Parts 30 and 36 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 3150-0158, and 3150-0120, respectively.

The format within this document for each item of technical information is as follows:

Regulations - references the regulations applicable to the item

. Criteria-outlines the criteria used to judge the adequacy of the applicant's response

. Discussion - provides additional information on the topic sufficient to meet the needs of most readers Response from Applicant - provides suggested response (s), offers the option of an alternative a

reply, or indicates that no response is needed on that topic during the licensing process.

Notes and References are self-explanatory and may not be necessary for each item on NRC Form 313.

Appendix C provides a format to respond to items 5 through 11 on NRC Form 313, which is shown as Appendix B. Applicants can also use it to check their applications for completeness; NRC staff can use it in reviewing applications. Applicants who use Appendix C to provide supporting information should attach it to NRC Form 313, and submit them to NRC. Otherwise, as indicated on NRC Form 313, the answers to those items 5 through 11 are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. Appendices D through R provide additional information on a variety of topics. Appendix S contains sample licenses for several types of irradiators subject to 10 CFR Part 36. The sample licenses contain the conditions most often found on these licenses, although not all licenses will have all conditions.

In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent. These terms are defined in 10 CFR Part 20. Rem, and its SI equivalent Sievert (I 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 are designed to emit gamma rays, which means that I roentgen = 1 rad = 1 rem.

Draft NUREG - 1556, Vol. 6 1-4

l 2 AGREEMENT STATES Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant other than a Federal agency who wishes to possess or use licensed material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application; file these applications with State officials, not with the NRC.

In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know thejurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory autho-ity over land determined to be

" exclusive Federaljurisdiction," while the Agreement State hasjurisdiction over non-exclusive Federaljurisdiction land. Licensees are responsible for finding out, in advance, thejurisdictional 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 officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16,1996.

Table 2.1 provides a quick way to check on which agency has regulatory authority.

Table 2.1 Who Regulates the Activity?

Applicant and Proposed Location of Work Regulatory Agency Federal agency regardless oflocation (except that Department of Energy NRC

[ DOE] and, under most circumstances, its prime contractors are exempt from licensing (10 CFR 30.12])

Non-Federal entity in non-Agreement State, US territory, or possession NRC Non-Federal entity in Agreement State at non-Federally controlled site Agreement State Non-Federal entity in Agreement State at Federally-controlled site not Agreement State subject to exclusive Federal jurisdiction Non-Federal entity in Agreement State at Federally-controlled site NRC subject to exclusive Federaljurisdiction 2-1 Draft NUREG - 1556, Vol. 6

AGREEMENT STATES

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Locations of NRC Offices and Agreement States Region IV Region 111 y

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Street. Sulla 23TB5 AK 00 -804 577-8510 Q

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Headquarters 1

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'T70E1 a00 36s 564:

M E00 T$ E.9e77

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30i 0 20 Non-^9reemeni states (approx 6,00016 censes) not.: A e.n. He

.,e a,tge,,,e, afg=?Je*'d o'a=

In Region IV, Puerto Rco and Virge King of Prussa. PA 194061415 Weinut Creek, CA 94596 5368 Islands m Regaan il 610-337-5000,1-804432-1156 510 975-0200,1 804 882 4 672 624n44 4e Figure 2.t U.S. Map. Location ofNRC Offices and Agreement States. As ofOctober 1,1998, the Walnut Creek Field Ofice will close. All communicationspreviously involving the Field Ofice should be addressed to Region IV,

Reference:

A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional or Field Offices. Or visit the NRC Office of State Programs' (OSP's) Home Page (http://www.hsrd.ornl. gov /ntc) and choose " Directories" and then " State Program Directors."

All Agreement Stctes Letter, SP-96-022, dated February 16,1996, is available by calling OSP; call NRC's toll f number (800) 368-5642 and then ask for extension 415-3340. Or visit OSP's Home Page (htt! ' uww.hsrd.oml. gov /ntc), choose "NRC-State Communications," and then Swn to find "1996" and then "SP-96-022."

choose "Other";

Draft NUREG - 1556, Vol. 6 2-2

3 MANAGEMENT RESPONSIBILITY The 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.

" 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 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 licensee's operating and emergency procedures

. Commitment to provide adequate res'ources (including space, equipment, personnel, time, and, if needed, contractors) to the radiation protection program to ensure that the public and L

workers are protected from radiation hazards and meticulous compliance with regulations is maintained

. Selection and assigmnent of a qualified individual to serve as the Radiation Safety Officer (RSO) with responsibility for the overall radiation safety program

. Selection of management representative (s) (e.g., RSO) with authority to stop unsafe operation

. Prohibition against discrimination of employees engaged in protected activities (10 CFR 30.7)

. Commitment to provide information to employees regarding the employee protection and deliberate misconduct provisions in 10 CFR 30.7 and 10 CFR 30.10, respectively.

For information on NRC inspection, investigation, enforcement, and other compliance programs, see NUREG-1600, " General Statement of Policy and Procedures for NRC Enforcement Actions,"

dated June 1995, Manual Chapter 2815, " Construction and Preoperational Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators," and Inspection Procedure 87100, Appendix F, " Commercial Irradiator Inspection Field Notes"; see Notice of Availability (on the inside front l

3-1 Draft NUREG - 1556, Vol. 6 t

MANAGEMENT RESPONSIBILITY j

i cover of this draft report). NUREG-1600 is also available on the Internet. Visit NRC's Home Page (http://www.nrc. gov), choose " Nuclear Materials," then " Enforcement," " Enforcement Guidance Documents," and then " Enforcement Policy."

. Draft NUREG - 1556, Vol. 6 3-2

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I 4 APPLICABLE REGULATIONS I

It is the applicant's or licensee's responsibility to have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation.

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The folloCng Parts of 10 CFR Chapter I contain regulations applicable to 10 CFR Part 36 irradiators:

10 CFR Part 2, " Rules of Practice for Domestic Licensing Proceedings and Issuance of l

Orders" 10 CFR Part 19, " Notices, Instructions and Reports to Workers: Inspection and l

Investigations"

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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 i

Material" 10 CFR Part 32, " Specific Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material" 10 CFR Part 36, " Licenses and Radiation Safety Requirements for Irradiators" 10 CFR Part 71, " Packaging and Transportation of Radioactive Material" l

Part 71 requires that licensees or applicants who transport licensed material or who may offer such material to a carrier for transport must comply with the applicable requirements of the i

United States Department of Transportation (DOT) that are found in 49 CFR Parts 170 through 189. Copies of DOT regulations can be ordered from the Government Printing Office (GPO) whose address and telephone number are listed below.

10 CFR Part 170, " Fees for Facilities, Materials, import and Export Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended" l

10 CFR Part 171, " Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC" To request copies of the above documents, call GPO's order desk in Washington, DC at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact GPO electronically at www.gpo. gov. Request single copies of the above documents from NRC's Regional or Field 4-1 Draft NUREG - 1556, Vol. 6

APPLICABLE REGULATIONS Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes amendments to its regulations in the Federal Register.

l Draft NUREG - 1556. Vol. 6 4-2

5 HOW TO FILE 5.1 PAPER APPLICATION

' Applicants for a materials license should do the following:

Be sure to use the most recent guidance in preparing an application.

. Complete NRC Form 313 (Appendix B) Items 1 through 4,12, and 13 on the form itself.

Complete NRC Form 313 Items 5 through 11 on supplementary pages or use Appendix C.

For each separate sheet, other than Appendix C, that is submitted with the application, identify and key it to the item number on the application or the topic to which it refers.

. Submit all documents, including drawings, if practicable, printed on 8-1/2 x 11 inch paper. If submission oflarger documents is necessary, fold them to 8-1/2 x 11 inches.

. Identify each drawing with drawing number, revision number, title, date, scale, and applicant's name. Clearly indicate if drawings have been reduced or enlarged.

. Avoid submitting proprietary information unless it is absolutely necessary.

. Submit an original application and one copy.

l

Retain one copy of the license application for future reference.

L As required by 10 CFR 30.32 (c), applications must be signed; see section on " Certification."

l Using the suggested wordmg of responses and committing to using the model procedures in this draft report will expedite NRC's review.

All license applications will be available for review by the general 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

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information to the public or substantial delays in processing the application. Employee personal j

i information, i.e., home address, home telephone number, social security number, date of birth, radiation dose information, should not be submitted unless specifically requested by NRC.

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. 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 l

will continue to accept paper applications. However, these will be scanned and put through an l

optical character reader (OCR) to convert them to electronic format. To ensuu a smooth transition, applicants are requested to follow these suggestions:

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51 Draft NUREG - 1556, Vol. 6

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HOW TO FILE Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed

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easily into the scanner.

. Choose typeface designs that are sans serif, such as Arial, Futura, Univers; the text of this document is in a serif font called Times New Roman.

Choose 12-point or larger font size.

Avoid ;;M ced characters such as script, italic, etc.

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Be sure the print is clear and sharp.

. Be sure there is high contrast between the ink and paper (black ink on white paper is best).

5.2 ELECTRONIC APPLICATION As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms 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.

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6 WHERE TO FILE l

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l 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 j

t for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four i

Regional Offices and their respective areas for licensing purposes and identifies Agreement I

States. The Walnut Creek, California, Field Office, can respond to routine telephone inquiries until September 30,1998. Effective October 1,1998, the Walnut Creek, California, Field Office l

will close and any communications previously involving that Field Office should be addressed to l

the Region IV Office.

In general, applicants wishing to possess or use licensed material in Agreements States must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine thejurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See " Agreement States" for additional information.

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7 LICENSE FEES Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application.

Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as "small entities."

Direct all questions about NRC's fees or completion ofItem 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC headquarters in Rockville, Maryland,(301) 415-7554. As an alternative, call NRC's toll free number (800) 368-5642 and then ask for extension 415-7554.

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8 CONTENTS OF AN APPLICATION The following comments apply to the indicated items on NRC Form 313 (Appendix B).

t 8.1 ITEM 1: LICENSE ACTION TYPE

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THIS IS AN APPLICATION FOR (Check appropriate item) l Type of Action -

l License No.

[ ] A. New License Not applicable

. [;] B. Amendment to License No.

XX-XXXXX XX

[ ] C. Renewal of License No.

XX-XXXXX-XX l

Check box A for a new license request.

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Check box B for an amendment to an existing license, and provide license number.

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Check box C for a renewal 2 of an existing license, and provide license munber.

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8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS i

List the legal name of the applicant's corporation or other legal entity with direct control over use l

of the radioactive material; a division or department within a legal entity may not be a licensee.

An individual may be designated as the applicant only if the individual is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A post office box number is an acceptable mailing address.

Notc: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC Information Notice (IN) 97-30, " Control of Licensed Material during Reorganizations, Employee-Management l

Disagreements, and Financial Crises," dated June 3,1997, discusses the potential for the security and control oflicensed material to be compromised during periods of organizational instability.

2 See " Amendments and Renewals to a License" later in this document.

8-1 Draft NUREG - 1556, Vol. 6 l

CONTENTS OF AN APPLICATION Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b).

Criteria: Licensees must provide full information and obtain NRC'sprior written consent before transferring control of the license, or, as some licensees call it, " transferring the license."

Discussion: Transfer of control may be the result of mergers, buyouts, or majority stock transfers. Although it is not NRC's intent to interfere with the business decisions oflicensees, it is necessary for licensees to obtain NRC's prior written consent. 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;

Persons using these materials are competent and committed to implementing appropriate radiological controls;

. A clear chain of custody is established to identify who is responsible for final disposal of licensed material; and

. Public health and safety are not compromised by the use of such materials.

Response from Applicant: None from an applicant for a new license; Appendix D, excerpted from IN 89-25, Revision 1, " Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7,1994, identifies the information to be provided about transfers of control.

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Reference:

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies ofIN 89-25, Revision 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.

Notification of Bankruptcy Proceedings Regulation: 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 wnting, identifying the bankruptcy court in which the petition was filed and the date of filing.

Draft NUREG - 1556, Vol. 6 8-2 l

CONTENTS OF AN APPLICATION Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains i

responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled and whether there are any public health and safety concerns (e.g.,

contaminated facility). NRC shares the results ofits determinations with other involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy actions are completed.

Response from Applicant: None at time of application for a new license. Generally, licensees should notify NRC within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of filing a bankruptcy petition.

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Reference:

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of Policy and Guidance Directive PG 8-11, "NMSS Procedures for Reviewing Declarations of Bankruptcy," (dated August 8,1996) and Inspection Procedure (IP) 87103, j

" Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing."

J 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED Specify the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each I

facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A Post Office Box address is not acceptable; see Figure 8.1.

An NRC license does not relieve a licensee from complying with other applicable Federal, State, or local requirements (e.g., local zoning requirements or local ordinances requiring registration of radioactive material).

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l 8-3 Draft NUREG - 1556, Vol. 6

I CONTENTS OF AN APPLICATION 1 m Wi) i

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Figure 8.1 Location oi Use. An acceptable location ofuse specifies street address, city, state, andzip code and does not include apost office box number.

Note: As discussed later in " Financial Assurance and Record Keeping for Decommissioning,"

licensees need to maintain permanent records on where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). For inadiator licensees, acceptable records are sketches or written descriptions of the specific locations where licensed material was used or stored and any information relevant to leaking radioactive sources.

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l 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION i

Identify the individual who can answer questions about the application and include his or her telephone number. This is typically the proposed radiation safety officer, unless the applicant has named a different person as the contact. The NRC will contact this individual if there are questions about the application.

I Notify NRC if the contact person or his or her telephone number changes so that NRC can contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment or a fee.

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Draft NUREG - 1556, Vol. 6 8-4

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Cold TENTS OF AN APPLICATION As indicated on NRC Form 313 (Appendix B), Items 5 through 11 should be submitted on separate sheets of paper. Altematively, 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 report will expedite NRC's review.

8.5 ITEM 5: RADIOACTIVE MATERIAL 8.5.01 SEALED SOURCES AND DEVICES Regulation: 10 CFR 30.32(g),10 CFR 30.33(a)(2),10 CFR 32.210,10 CFR 36.21.

Criteria: For each sealed source requested, applicants must identify the sealed source by radionuclides, manufacturer (or distributor), and model number. Applicants will be authorized to possess only those sealed sources specifically approved or registered by NRC or an Agreement State for use in the requested irradiator. Also, identify any depleted uranium that is used as shielding material (teletherapy units and other exposure devices may contain depleted uranium).

Discussion: 10 CFR 36.21 and 10 CFR 32.210 list criteria for sealed sources used in irradiators.

Normally, tests used to demonstrate that the criteria can be met are conducted by the scurce l

manufacturer (or distributor), not the applicant. The manufacturer (or distributor) then applies to the NRC or an Agreement State agency for approval for use in irradiators. The safety evaluation is documented in a Sealed Source and Device (SSD) Registration Certificate. Therefore, if sealed sources are approved for use in the requested irradiator by NRC or an Agreement State agency, the applicant need only note the manufacturer's (or distributor's) name and model f

number of the sources in its license application to demonstrate that the requirements are met.

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Before the SSD registration process was formalized, some older sealed sources may not have been evaluated in this way, but were specifically approved on a license. Licensees can continue to use sealed sources that are specifically listed on their licenses.

Licensees may not make any changes to the sealed sources that would alter the description or

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specifications from those indicated in the respective registration certificates without obtaining NRC's prior permission in a license amendment. A custom registration review may also be required. This would increase the time needed to process a licensing action.

h Response from Applicant:

I Identify each radionuclides that will be used in each irradiator.

Identify the manufacturer (or distributor) and model number of each sealed source.

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8-5 Draft NUREG - 1556, Vol. 6

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l i

CONTENTS OF AN APPLICATION Identify the manufacturer (or distributor) and model number of each irradiator, if applicable.

For dry-source-storage irradiators, specify the maximum activity per source.

Specify the maximum activity per irradiator.

l

= If depleted uranium is used as shielding material (e.g., teletherapy units and other exposure devices may contain depleted uranium), specify the total amount (in kilograms).

Note:

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. For information on SSD registration certificates, contact the Registration Assistant by calling NRC's toll free number (800) 368-5642 and then asking for extension 415-7217.

i

. SSD reviews are not required for exposure devices in irradiators subject to 10 CFR Part 36.

However, for some dry-source-storage panoramic irradiators (e.g., teletherapy units converted to non-human use), a review has been perfonned at the manufacturer's (or distributor's) request and this information may be useful in evaluating an application. If the irradiator has l

an exposure device for which a SSD review has been performed, the applicant should state that such a review has been performed and provide the registered name of the manufacturer (or distributor) and model number of the device.

8.5.02 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING Regulations: 10 CFR 30.35,10 CFR 30.34(b).

l l

Criteria: Irradiator licensees authorized to possess sealed sources containing radioactive material in excess of the limits specified in 10 CFR 30.35 must provide evidence of financial l

assurance for decommissioning.

Even if no financial assurance is required, licensees are required to maintain, in an identified l

location, decommissioning records related to structures and equipment where licensed materials j

l are used or stored and to leaking sources. Pursuant to 10 CFR 30.35, licensees must transfer these records important to decommissioning to either of the following-i

. The new licensee before licensed activities are transferred or assigned in accordance with 10 1

CFR 30.34(b)

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. The appropriate NRC regional office before the license is terminated.

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I Draft NUREG - 1556. Vol. 6 8-6 j

CONTENTS OF AN APPLICATION Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most irradiator applicants and licensees need to take action to comply with the financial ass.urance requirements because their total inventory of licensed material exceeds the limits in 10 CFR 30.35(d); see Figure 8.2. The limits for typical radionuclides used for irradiator sealed sources are shown in Table 8.1.

Surety g

Bond

_ m Tf Statement dintent Agreement Certifcate 4

j Guaranty

%g aw_.g Figure 8.2 Financial Assurance for Decommissioning. Most 10 CFR Part 36 irradiator licensees need to providefinancial assurancefor decommissioning and can use one ofseveral approvedfinancialmechanisms.

Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance Padionuclide Activity in Gigabecquerels Activity in Curies (5ealed Sources)

Co-60 3.7 x 105 10,000 Cs-137 3.7 x 106 100,000 Regulatory Guide 3.66, " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, contains approved wording for each of the mechanisms authorized by the regulation to guarantee or secure funds except for the Statement ofIntent for govenunent licensees. See Appendix E for the recommended wording for a Statement ofIntent.

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8-7 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION l

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24.ddddit st.p4_s2ss s Figure 8.3 Records Important to Decommissioning. Allirradiator licensees must maintain records important to decommissioning, regardless ofwhether they needfinancial assurancefor decommissioning.

Figure 8.3 illustrates the 10 CFR 30.35(g) requirements that licensees maintain records important to decommissioning in an identified location (i.e., licensees must know the locations of all documents). All irradiator licensees need to maintain records of structures and equipment for each irradiator. As-built drawings with modifications of structures and equipment shown as appropriate fulfill this requirement. If drawings are not available, licensees may substitute appropriate records (e.g., a sketch of the room or building or a narrative description of the area) concerning the specific areas and locations. In addition, if die applicant experiences unusual occurrences (e.g., leaking sources), they also need to maintain records about contamination that remains aller cleanup or that may have spread to inaccessible areas.

For irradiator licensees whose sources have never leaked, sketches or written descriptions that include the location of each irradiator are considered acceptable records important to decommissioning.

Response from Applicants: A response is needed from most applicants. If financial assurance is required, submit documentation required by 10 CFR 30.35.

l Draft NUREG - 1556, Vol. 6 8-8

l CONTENTS OF AN APPLICATION l

10 CFR 30.35(g) Requirements for Disposition of Records Important to Decommissioning

. Before licensed activities are transferred or assigned according to 10 CFR 30.34(b), transfer to the new licensee OR

. Before the license is terminated, transfer records to the appropriate NRC regional office.

Reference:

See Notice of Availability (on the inside front cover of this draft report) to obtain copies of Regulatory Guide 3.66, " Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, and Policy and Guidance Directive FC 90-2, Revision 1, " Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30,1991.

8.6 ITEM 6: PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED Regulation: 10 CFR 30.33(a)(1).

Criteria: The proposed purpose is authorized by the Atomic Energy Act of 1954, as amended.

Scaled sources that are used in irradiators should be used only for the purposes for which they were designed, according to the manufacturer's written recommendations and instructions, as specified in an approved SSD Registration Certificate, and as authorized on an NRC or Agreement State license.

Discussion: Requests to use sealed sources in irradiators for purposes not listed in the SSD Registration Certificate will be reviewed on a case-by-case basis. Examples might include irradiation of greater than small quantities of flammable materials with a flash point below 60 C (140 F), expiasive materials, or cryogenic materials.

If an applicant wants to irradiate greater than small quantities of flammable materials with a flash point below 60 C (140 F), see Appendix F. In addition, irradiation of explosives is generally prohibited; however, if an applicant wants to request irradiation of explosives, see Appendix F.

Applicants need to submit sufficient information to demonstrate that the proposed use will not compromise the integrity of the source or source shielding, or other radiation safety-critical components of the device. NRC will evaluate the radiation safety program for each type and use f

cf sealw sources in each irradiator requested.

I 8-9 Draft NUREG - 1556, Vol. 6 m

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CONTENTS OF AN APPLICATION Irradiation of food intended for conunercial distribution to the public is also subject to the regulations of the Food and Drug Administration (FDA) and U. S. Department of Agriculture (USDA). Contact these agencies for further information. An NRC licensee must also comply with applicable FDA or USDA regulations.

i Response from Applicant: Provide either of the following:

. A specific description of use for each type ofirradiator requested, e.g., "for use in irradiation of products or food. There will be no irradiation of explosives and no irradiation of more than small quantities of flammable materials with a flash point below 60 C (140 F) without specific written authorization from NRC."

OR

. If the irradiator will be used for purposes other than irradiation of food or products for human or research purposes, description of these purposes and safety analyses (and procedures, if needed) to support safe use.

Note:

Allowed uses ofirradiators normally include the irradiation of food or products for human or research purposes.

. Unusual uses will be evaluated on a case-by-case basis and the authorized use condition will reflect approved uses.

f 8.7 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM 8.7.01 RADIATION SAFETY OFFICER (RSO) TRAINING AND EXPERIENCE i

I Regulations: 10 CFR 30.33(a)(3),10 CFR 36.13(d).

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Criteria: A Radiation Safety Officer (RSO) must have adequate training and experience.

Successful completion of training as described in Appendix G is evidence of adequate training

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and experience.

I Draft NUREG - 1556, Vol. 6 8-10

CONTENTS OF AN APPLICATION Discussion: The person responsible for the radiation protection program is called the RSO. The application must include the name and a description of the training and experience of the proposed RSO. This is to determine whether the individual is qualified to function as the RSO.

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Consistent with the NRC staffs long-standing guidance, if the RSO has had neither previous formal training in health physics nor certification by the American Board of Health Physics, the RSO should complete a radiation safety course. Training should include approximately 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months covering the following topics:

Radioactivity and radioactive decay

. - Interactions of radiation with matter

Biological effects ofradiation

Radiation detection using radiation detection instruments and personnel dosimeters

Basic radiation protection principles and good safety practices (including time, distance, and l

shielding)

Radiation protection regulations l

The course should include a written test or evaluation of the individual's comprehension of these l

topics.

In addition to the above general course, if the RSO was previously an RSO at a similar licensee or l

was trained as an irradiator operator but has not had experience working at an irradiator, he or she l

should have the equivalent of at least 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months in self-study or directed study on information directly applicable to radiation safety at irradiators. This should include applicable regulations

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(10 CFR Parts 20 and 36) and reports or studies describing case histories of accidents or problems l

at irradiators; see Appendix A. The license application should list the documents studied or to be

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' applicant will evaluate the individual's comprehension of the information studied.

studied in the description of the training of the proposed RSO and should describe how the l

The RSO should have at least 3 months (full-time equivalent) of experience at the applicant's l

l irradiator or at another irradiator of a similar type. The 3 months of experience may include preoperational involvement, such as acceptance testing, while the irradiator is being constructed.

However, to allow flexibility, the NRC will determine the adequacy of the RSO's training and

. experience on a case-by-case basis, looking at his or her actual qualifications and drawing on the l

p NRC staffs experience in reviewing such qualifications.

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8-11 Draft NUREG - 1556, Vol. 6 h

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CONTENTS OF AN APPLICATION Response from Applicant: Provide the following:

Name of the proposed RSO

. Description of the proposed RSO's training and experience specific to the irradiator that the applicant intends to use.

j Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. If the replacement is sudden, the licensee should contact the NRC Regional Office as soon as possible. While the amendment request is being reviewed by NRC, the proposed RSO may assume the responsibilities of RSO if NRC is given adequate information to ensure that the proposed individual will meet the required training.

8.7.02 RSO RESPONSIBILITIES AND AUTHORITIES Regulations: 10 CFR 30.33(a)(3),10 CFR 36.13(d).

Criteria: RSOs must be in a position within the licensee's organization to have adequate authority over radiation safety activities and responsibility for regulatory compliance and protection of public health and safety.

Discussion: Consistent with the staffs long-standing guidance, the RSO should have independent authority to stop operations that he or she considers unsafe and to conduct necessary tests or measurements. The RSO should be relatively independent of production responsibilities, to the extent practicable, considering the size of the staff at the facility. The RSO should report directly to the facility manager. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that licensed materials are used in a safe manner. Typical RSO duties are illustrated in Figure 8.4 and described in Appendix H.

NRC requires the name of the RSO on the license to ensure that licensee management has always

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identified a responsible, qualified person and that the named individual knows of his or her designation as RSO.

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Draft NUREG - 1556, Vol. 6 8-12

CONTENTS OF AN APPLICATION l

stopping unsafe licensed activities y

ww Proper use and routine maintenance k

Mat'l Accountability l.!;;

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Leak Tests g

Audits security oflicensed material f

g h, C Records Training g

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Y Materialdisposal p.

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1 interaction with NRC. other authorities Records maintenance 4

Annual program audit f

Maintenance -inspection checks Personnet training investigation of abnormal events

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s2* egg Figure 8.4 RSO Responsibilities. Typicalduties andresponsibilities ofRSOs.

Response from Applicant: Describe the organizational structure for managing the irradiator, l

specifically the radiation safety responsibilities and authorities of the RSO and other management personnel who have important radiation safety responsibilities and authorities. In particular, the l

application should describe who has the authority to stop unsafe operations.

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8.8 ITEM 8: INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS i

8.8.01 INITIAL TRAINING AND EXPERIENCE FOR IRRADIATOR OPERATORS Regulations: 10 CFR 19.12,10 CFR 30.7,10 CFR 30.9,10 CFR 30.10,10 CFR 30.33, 10 CFR 36.13(b),10 CFR 36.51(a),10 CFR 36.51(b),10 CFR 36.51(c).

8-13 Draft NUREG - 1556, Vol. 6 l

CONTENTS OF AN APPLICATION Criteria: Irradiator operators must have adequate training and experience. Successful completion of one of the following is evidence of adequate training and experience:

Irradiator manufacturer's course for operators specific to the irradiator that the applicant intends to use i

OR

. Training course as described in Appendix G.

The training provided to individuals to qualify them to be irradiator operators must in.:lude:

. Instruction

. On-the-job or simubtor training (i.e., supervised experience)

. Means employed by the applicant to test each individual's understanding of the Commission's regulations and licensing requirements and the irradiator operating and emergency procedures Minimum training and experience of personnel who may provide training.

a Applicants requesting to perform non-routine operations such as loading and unloading sources must provide additional training. For more information see Appendix I.

Discussion: Irradiator operators have the responsibility to ensure the proper use and security of irradiators containing licensed material. Irradiator operators must receive training and instruction, and be tested before being permitted to operate an irradiator.

Training should be commensurate with the complexity of the irradiator design and potential radiation hazard (e.g., approximately 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months ofinstruction for pool-type panoramic irradiators and approximately 20 to 30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months ofinstruction for underwater irradiators). Up to 50 percent of that instruction may be self-study or reading. The written test should cover the range of topics addressed in the instruction.

On-the-job training should be super ised by an experienced operator and should last at least I month full-time (170 hours0.00197 days 0.0472 hours 2.810847e-4 weeks 6.4685e-5 months ). If an approved operator does not operate the irradiator for more than a year, his or her performance during operation should:

g I

. Be audited for at least I day before he or she is permitted to operate the irradiator l

independently; and

. Receive a safety review regarding the irradiator.

l Draft NUREG - 1556, Vol. 6 8-14

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CONTENTS OF AN APPLICATION The requirements in 10 CFR 36.51(a), (b), and (c) are for an individual to become qualified initially as an irradiator operator. They do not apply to individuals qualified to be operators before July 1,1993, the effective date of 10 CFR Part 36. The safety reviews and evaluation requirements of 10 CFR 36.51(d) and (e), however, apply to all irradiator operators. Current

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licensees should conduct safety reviews to discuss the new 10 CFR Part 36 regulations and any resulting changes in operating and emergency procedures. Licensees should also conduct safety reviews at intervals not to exceed 12 months thereafter.

Individuals must be trained in the following subjects to become an irradiator operator:

. The fundamentals of radiation safety as they apply to irradiators l

- The goal is to provide the individual with the necessary foundation to perform his or her task safely and to help the individual worker understand the basis for the safety requirements and procedures that will be taught.

l

. The requirements of 10 CFR Parts 19 and 36

- The operator is not expected to be an expert on NRC regulations or to be able to determine whether a given procedure is adequate to meet NRC regulations. Instead, operators should be instructed on NRC requirements that are directly applicable to their responsibilities.

l l

The operation of the licensee's irradiator i

- The objective is to help the person understand the operating and emergency procedures, not i

to become an engineer.

1 Licensee operating and emergency procedures that the individual will be required to perform l

- This is the most important part of the training because operating the irradiator safely l

depends on following these procedures correctly. The objective is that the operator l

correctly perform his or her assigned tasks. The training does not have to include procedures that the individual will not perform.

Case histories of accidents and problems involving irradiators

- The individual should be taught about situations that could lead to problems associated with irradiator operations. Instruction material on accidents is often difficult to obtain.

However, NUREG-1345, " Review of Events at Large Pool-Type Irradiators," provides some relevant information. See also Appendix A for a list ofInformation Notices (IN) describing irradiator events.

Additional training is required for irradiator operators if they will per form non-routine operations. For more information see Appendix 1.

8-15 Draft NUREG - 1556, Vol. 6

)

CONTENTS OF AN APPLICATION Response from Applicant: Provide either of the following-I The statement: "Before using licensed materials, irradiator operators will have successfully completed one of the training courses described in Criteria in the section entitled ' Initial Training and Experience for Irradiator Operators' in draft NUREG-1556, Vol. 6, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 f

Irradiator Licenses,' dated March 1998.";

OR

. A description of the initial training program for irradiator operators that demonstrates compliance with the requirements of 10 CFR 36.51(a), (b), and (c).

Note: Alternative responses will be evaluated using the criteria listed above.

Reference:

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of NUREG-1345, " Review of Events at Large Pool-Type Irradiators," dated March 1989 or other documents listed in Appendix A.

8.8.02 ANNUAL SAFETY REVIEWS AND PERFORMANCE EVALUATIONS FOR IRRADIATOR OPERATORS Regulations: 10 CFR 19.12,10 CFR 30.33,10 CFR 36.51(d),10 CFR 36.51(e).

Criteria: Licensees must conduct safety reviews for irradiator operators annually. Licensees must also evaluate the safety performance of each irradiator operator annually.

Discussion: Licensees must provide refresher training called a safety review to irradiator operators as well as evaluate the safety aspects of each irradiator operator's performance (i.e.,

performance evaluation).

Annual Safety Reviews Safety reviews must include, as appropriate, each of the following areas:

. Changes in operating and emergency procedures since the last review Changes in regulations and license conditions since the last review a

Repons on recent accidents, mistakes, or problems that have occurred at irradiator facilities Draft NUREG - 1556, Vol. 6 8-16

CONTENTS OF AN APPLICATION

. Relevant results ofinspections' of operator safety performance

. Relevant results of the facility's inspection and maintenance checks

)

. A drill to practice an emergency or abnormal event procedure.

Also, each operator must be given a brief written test on the information.

The duration of safety reviews should be commensurate with the complexity of the irradiator's design and potential radiation hazard (e.g., approximately 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months for panoramic wet-source-storage irradiators and 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months for dry-source-storage and underwater irradiators). Safety reviews may be conducted at intervals not to exceed 12 months or throughout the calendar year on an as-necessary basis.

The " drill" referenced in 10 CFR 36.51(d)(6) means actually going through a procedure using the actual equipment in as realistic a manner as practical. For example, for a drill on the response to a fire alarm it is not necessary that the alarm actually be enunciated if sounding the alarm would be disruptive. Operators may also correct errors as they occur rather than waiting until the drill is over. Each operator need not go through the drill, but may watch or critique as another operator does.

Annual Performance Evaluations The safety performance of each irradiator operator must be evaluated and reviewed with each operator at least every twelve months to ensure that regulations, license conditions, and operating and emergency procedures are followed. In addition, the results of the evaluation must be discussed with each operator along with instructions on how to correct any mistakes or deficiencies observed. Individuals conducting these reviews must have adequate training and experience to conduct such training.

I Response from Applicant: Describe program for annual safety reviews and performance evaluations ofirradiator operators that demonstrates compliance with 10 CFR 36.51(d) and (e).

8.8.03 TRAINING FOR INDIVIDUALS WHO REQUIRE UNESCORTED ACCESS Regulations: 10 CFR 19.12,10 CFR 30.7,10 CFR 30.9,10 CFR 30.10,10 CFR 30.33, 10 CFR 36.51(f).

3 The word " inspections" in 10 CFR 36.51(d)(4) means the " evaluations" performed under 10 CFR 36.51(e).

8-17 Draft NUREG - 1556, Vol. 6

l CONTENTS OF AN APPLICATION Criteria: Individuals who will be permitted unescorted access to the radiation room of the I

irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for irradiator operators and the RSO, must be instructed and tested in precautions to avoid radiation exposure, procedures listed in 10 CFR 36.53 that they must perform or comply with, and their proper response to alarms.

Discussion: According to 10 CFR 19.12, all individuals who work in or frequent restricted areas must receive appropriate instruction on radiation safety. However, in some facilities certain individuals other than irradiator operators may require unescorted access to the radiation room of an irradiator. The applicant should identify those individuals (e.g., individuals who perform inspection and maintenance checks) and train them according to 10 CFR 36.51(f).

Training may include the subjects described in Appendix G. Individuals should be tested on procedures which require unescorted access to conduct. Tests may be given orally. Applicants must develop and implement a program for instructing and testing individuals requiring unescorted access.

Response from Applicant: The applicant's program for instructing and testing unescorted individuals (other than irradiator operators) will be examined during inspections, but should not be submitted in the license application.

8.8.04 TRAINING FOR INDIVIDUALS WHO MUST BE PREPARED TO RESPOND TO ALARMS Regulations: 10 CFR 19.12,10 CFR 30.33,10 CFR 36.23(b),10 CFR 36.23(i),

10 CFR 36.27(a),10 CFR 36.29(a),10 CFR 36.29(b),10 CFR 36.51(g),10 CFR 36.59(b).

Criteria: Individuals who must be prepared to respond to alarms must be trained and tested at least once a year on how to respond to such alarms.

Discussion: Individuals designated to respond to alarms (e.g., security personnel) in irradiator facilities must be trained and tested in licensee procedures developed for responding to such alarms. These designated individuals must be retested at least every twelve months. These tests may be oral.

Applicants need to identify categories ofindividuals designated to respond to alarms and develop and implement a program for instructing and testing these individuals. Testing of non-facility employees (e.g., a local fire department) is not expected.

Draft NUREG - 1556, Vol. 6 8-18

i CONTENTS OF AN APPLICATION Response from Applicant: The applicant's program for instructing and testing, as applicable, individuals designated to respond to alarms will be examined during inspections, but should not be submitted in the license application.

8.9 ITEM 9: FACILITIES AND EQUIPMENT 8.9.01 GENERAL DESCRIPTION OF THE FACILITY AND SITE Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.39(j).

Criteria: Facilities and equipment must be adequate to protect public health and safety and to minimize danger to life or property. The application must include a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

Discussion: A diagram of the facility must be submitted for review with enough detail designating the location of required interlocks and radiation monitors to be used at the facility (e.g., blueprints with interlock and radiation monitor locations identified). See Figure 8.5. In addition, the diagram should include a general layout of the entire facility identifying areas surrounding the irradiator room. Also, applicants should submit a general layout of the properties adjacent to the facility.

For panoramic irradiators built in seismic areas whose construction started after July 1,1993, the applicant must design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, " Building Code Requirements for Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," or local building codes,if current.

Applicant should provide a schedule for any construction activities not yet completed. This will allow the NRC to inspect and ensure construction activities are according to design requirements as described in NRC Manual Chapter 2815 " Construction and Preoperational Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators."

8-19 Draft NUREG - 1556, Vol. 6

l l

CONTENTS OF AN APPLICATION 1

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{jf:Q h h y, 9 e QiG swn.,g Figure 8.5 General Description oiFacility. Diagrams, drawings, sketches, or blueprints of facilities are neededfor a clear understanding ofthefacility's design and its relationship to adjacentproperties.

Response from Applicant:

Describe the irradiator including drawings, diagrams, sketches, and photographs, as appropriate.

Show locations of safety-related equipment and features as required in 10 CFR Part 36.

Provide a sketch and describe the uses of property adjacent to the proposed facility.

Provide a construction schedule for the irradiator.

Reference:

See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of NRC Manual Chapter 2815 " Construction and Preoperational Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators." American Concrete Institute (ACI) standards are also available for purchase from the ACI, P. O. Box 9094, Farmington Hills, Michigan 48333. ACI's telephone number is (248) 848-3700 and its URL is http://www.aci-int.org.

8.9.02 ACCESS CONTROL Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.23,10 CFR 36.31(a),

10 CFR 36.39(g),10 CFR 36.41(g).

Draft NUREG - 1556, Vol. 6 8-20

CONTENTS OF AN APPLICATION Criteria: Irradiator facilities must have access controls to prevent inadvertent entry into the radiation room, as required by 10 CFR 36.23.

Discussion: This section discusses two categories ofirradiators:

. panoramic irradiators (dry-source-storage, wet-source storage)

+ underwater irradiators.

Panoramic Irradiators The door or barrier that serves as the primary access control system must have devices that will:

1) prevent the source from being moved out ofits shielded position if the door or barrier were open; and 2) cause the source to return to its shielded position if the door or barrier were opened while the source was exposed.

Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving.

The backup access control system must be able to detect entry while the source is exposed. If entry is detected, the system must: 1) automatically cause the source to return to its shielded position; and 2) activate audible and visible alarms.

Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to alert any individual entering the room to the hazard. The alarm must also alert at least one other individual who is onsite and prepared to render or summon assistance promptly.

A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted entry while the monitor measures high radiation levels must activate the alarm described in 10 CFR 36.23(b).

The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

The requirement in 10 CFR 36.23 for a door or other physical barrier applies to each entrance of the radiation room, whether intended for personnel o product entrance or exit. A conveyor 8-21 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION system could meet the requirement by providing a clearance large enough for a package, but too small for a person by using barriers that would require unusual exertion to bypass. A photoelectric system cannot be considered a physical barrier. The purpose of this requirement is to prevent someone from carelessly or accidentally entering the radiation room while the sources l

are exposed.

l This section also requires an independent backup access control system to provide a redt.ndant means of preventing a person from being accidentally exposed to the source. In case of a failure of the interlocks on the door or barrier combined with a failure to follow operating procedures, the backup system should warn the person entering the radiation room of the danger and automatically cause the sources to return to their shielded position. The backup system could use photoelectric cells in an entrance maze, pressure mats on the floor, or similar means of detection.

The system must also alert another trained person who is onsite and prepared to render or summon assistance.

The mechanism that moves the sources must require a key to actuate it. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any one time, and only irradiator operators or facility

-management may have access to it. The key must be attached to a calibrated portable radiation i

survey meter by a chain or cable. In addition, the lock for source control movement must be designed so that the key may not be removed if the sources are in an unshielded position. Also, the door to the radiation room must require the same key to open it. This redundant feature will.

ensure that the sources are in the shielded position prior to an individual entering the radiation room. It will also ensure that any individual entering the radiation room will have in his or her

]

possession a calibrated portable radiation survey instrument for monitoring radiation levels in the radiation room in the event the sources were not in the shielded position.

The radiation room must have a radiation monitor with alarms and interlock on the personnel y

access door. This is to provide an additional level of protection in case of some failure of the source movement mechanism combined with a failure of the operator to make the required radiation survey upon entry into the radiation room.

i f

i Draft NUREG - 1556, Vol. 6 8-22 1

L-

CONTENTS OF AN APPLICATION Irradiators can produce ozone in concentrations exceeding those permitted by regulations of the Occupational Safety and Health Administration (OSHA) at 29 CFR 1910.1000, " Air Contaminants." Nitrogen oxides can also be produced, although concentrations would not be expected to exceed OSHA's limits. To control these gases, irradiators with large sources are typically equipped with ventilation systems to exhaust the gases before personnel entry.

OSHA regulates exposure to ozone and other noxious gases in the workplace, and the U. S.

l Environmental Protection Agency regulates emissions offsite. If NRC personnel observe problems with noxious gases at an irradiator during an inspection, NRC will notify OSHA of the problem under the terms of the " Memorandum of Understanding Between the Nuclear Regulatory Commission and the Occupational Safety and Health Administration; Worker Protection at NRC-Licensed Facilities," signed October 21,1988.

The radiation room must be equipped with a device integrated with the control system ensuring that the sources cannot be exposed unless the access door and other interlocks are engaged within a preset time of activating the control. The irradiator must be equipped with a safety timer that will automatically generate visible and audible warnings to alert personnel in the radiation room that the startup sequence has begun and provide sufficient time to leave the area or operate a clearly identified emergency stop device which will abort the startup sequence. The safety timer must be integrated with the control system so that the source cannot be exposed unless the startup sequence is complete within the preset time and the control console indicates that it is safe to expose the source.

Underwater Irradiators The pool must be within an area surrounded by a personnel access barrier with an intrusion alarm when the facility is not operating. Only operators and facility management may have access to keys to the personnel access barrier. The intrusion alarm must be able to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance when the alarm is activated.

For panoramic irradiators whose construction begins after July 1,1993, the licensee must verify from the design and logic diagram that the access control system will meet the requirements of 10 CFR 36.23. Before loading sources, the licensee must test the completed access control system to ensure that it functions as designed and that all alarms, controls, and interlocks work properly. For more information see Appendix J, " Construction Monitoring and Acceptance Testing."

8-23 Draft NUREG - 1556, Vol. 6 I

l CONTENTS OF AN APPLICATION 1

i Response from Applicant:

)

1 Submit specific information describing the access control system and how it works that demonstrates compliance with the requirements of 10 CFR 36.23. Specific drawings or sketches should be submitted, as appropriate.

For panoramic irradiators, describe the facility alarm systems.

For panoramic irradiators, describe the lock and key system for controlling source movement and discuss how it meets the requirements of 10 CFR 36.31(a).

References:

See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of the " Memorandum of Understanding Between the Nuclear Regulatory 1

Commission and the Occupational Safety and Health Administration; Worker Protection at NRC-Licensed Facilities," signed October 21,1988.

8.9.03 SHIELDING Regulations: 10 CFR 30.33(a)(2),10 CFR 36.25,10 CFR 36.39(a),10 CFR 36.41(a).

Criteria: Irradiator shielding must meet the requirements as described in 10 CFR 36.25 and the requirements oflocal building codes or other appropriate sources.

Discussion: The applicant must design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entranceways to meet the radiation shielding requirements of 10 CFR 36.25. If the irradiator will use more than 2 X 10" becquerels (Bq) (5 million curies)4 of activity, the applicant must evaluate the effects of heating of the shielding walls by the irradiator sources.

For panoramic irradiators, the licensee must monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete. See Appendix J, " Construction Monitoring and Acceptance Testing."

The radiation dose rate in areas that are normally occupied during operation of a panommic irradiator may not exceed 0.02 millisievert (mSv) (2 millirems (mrem)) per hour at any location 30 centimeters (cm) or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no linear 4 10 CFR Part 36 uses one significant figure in converting becquerels to curies.

Draft NUREG - 1556, Vol. 6 8-24

CO'NTENTS OF AN APPLICATION dimension greater than 20 cm. The maximum dose rate of 0.02 mSv (2 mrem) per hour is considered practical to achieve. Areas where the radiation dose rate exceeds 0.02 mSv (2 mrem) per hour must be locked, roped off, or posted. These may include areas not normally occupied such as the equipment access area on the roof of the irradiator.

l The radiation dose at 30 cm over the edge of the pool of a pool irradiator may not exceed 0.02 mSv (2 mrem) per hour when the sources are in the fully shielded position.

The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 mSv (2 mrem) per hour and at 30 cm from the shield may not exceed 0.2 mSv (20 mrems) per hour.

The intent of 10 CFR Part 36 is that shield walls retain their integrity in the event of an earthquake by requiring that they be designed to meet the seismic requirements oflocal building codes or other appropriate sources. For irradiators whose construction starts after July 1,1993, and that are not located in seismic areas (as dermed in 10 CFR 36.2), it is acceptable that shielding meet generally accepted building code requirements for reinforced concrete, for example, American Concrete Institute Standard ACI 318-89, " Building Code Requirements for Reinforced Concrete."

In seismic areas, local building codes are likely to specify requirements such as spacing of reinforcing bars, how to tie reinforcing bars together, preferred arrangements for reinforcing bars, i

and requirements forjoining reinforcing bars to floor slabs. Iflocal building codes do not contain seismic requirements, "other appropriate sources" could include Chapter 21, "Special Provisions for Seismic Design," of the American Concrete Institute Standard ACI 318-89,

" Building Code Requirements for Reinforced Concrete."

Response from Applicant:

For panoramic irradiators:

- Describe the shielding to be used and its composition

- Submit a diagram showing the configuration of shielding walls and indicate the thickness of each and penetrations in the shield wall

- If any accessible areas outside the shield are expected to have a dose rate exceeding 0.02

- mSv (2 mrem) per hour, identify the areas and explain how access will be controlled

- For requests to possess more than 2 x 10" Bq (5,000,000 curies), describe how cooling of the shielding walls will be accomplished [see 10 CFR 36.39(a)].

8-25 Draft NUREG - 1556, Vol. 6

)

i

- CONTENTS OF AN APPLICATION

. For underwater irradiators, no response is required from the applicant in a license application.

Note:

. The NRC does not approve irradiator shield designs. Instead, NRC conducts inspections to

)

ensure that the maximum dose rate outside the completed shield is according to NRC requirements.

j

. For panoramic irradiators whose construction will start after July 1,1993, the applicant should identify building code requirements to which shielding walls will be built and inspections of '

the construction that will be performed by local authorities so that the license reviewer can ensure that they do not adversely impact the NRC requirements.

Reference:

The American Concrete Institute Standard ACI 318-89," Building Code Requirements for Reinforced Concrete," is available for purchase from ACI, P. O. Box 9094,-

Farmington Hills, Michigan 48333. ACI's telephone number is (248) 848-3700 and its URL is http://www.aci-int.org.

8.9.04 FIRE PROTECTION Regulations: 10 CFR 36.27,10 CFR 36.39(h),10 CFR 36.41(h).

Criteria: Panor.unic irradiators must have smoke and heat detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded to meet the requirements as described in 10 CFR 36.27 and 36.39(h).

Discussion: The radiation room must have heat and smoke detectors that activate an audible alarm capable of alerting a person who can summon assistance promptly. The sources must become fully shielded automatically if a fire is detected.

The applicant must verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The applicant must verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage.

The radiation room must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

DraA NUREG - 1556, Vol. 6.

8 26

CONTENTS OF AN APPLICATION The fire extinguishing system is required because a fire could disable the access control system or could prevent the sources from being shielded, thereby lowering the margin of safety. The fire extinguishing system must be operable without entry into the room. During a fire, there would be no means of assuring that the access control systems and source position indicators or the mechanism that returns the source to the shielded position had operated properly.

The licensee must test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. In addition, the licensee must test the operability of the fire extinguishing system. For more information see

" Radiation Safety Program - Inspection and Maintenance Checks" and Appendix J,

" Construction Monitoring and Acceptance Testing."

Response from Applicant:

For panoramic irradiators, describe:

i

- the type and location of the heat and smoke detectors to be used to detect a fire in the radiation room

- the 41a r.is to alert personnel trained to summon assistance

- how the sources will automatically become fully shielded if a fire is detected

-- how the heat and smoke detectors will be tested.

= For underwater irradiators, no response is required, since the sources are always underwater and not subject to damage by fire.

8.9.05 RADIATION MONITORS Regulations: 10 CFR 30.33(a)(2),10 CFR 36.13(e),10 CFR 36.23(c),10 CFR 36.29, 10 CFR 36.39(e),10 CFR 36.41(e),10 CFR 36.59(b).

Criteria: Irradiator facilities must have radiation monitors to detect radiation levels and sources as described in 10 CFR Part 36.

Discussion: This section will only discuss the evaluation of the location of radiation monitors.

l For information regarding the calibration, sensitivity, and testing of monitors, see " Radiation Safety Program - Instruments."

8-27 Draft NUREG - 1556, Vol. 6 L

CONTENTS OF AN APPLICATION i

For allirradiators:

i

The licensee must ensure that the location and sensitivity of the monitor used to detect sources carried by the product conveyor system are appropriate j

The licensee must verify that the product conveyor is designed to stop before a source on it could cause a radiation overexposure to any person

. Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting a trained individual in the facility who is prepared to summon assistance.

AND i

The licensee must verify the proper operation of the monitor to detect sources carried on the

. product conveyor system and the related alarms and interlocks.

For panoramic irradiators:

= The licensee must verify the proper operation of the radiation monitors and the related alarms if used to meet 10 CFR 36.59(b). A monitor must be provided to detect the radiation levelin the radiation rcom when the source is indicated to be in the fully shielded position.- The monitor must be integrated with the personnel access door interlocks, as applicable, to prevent room access when the monitor detects an elevated radiation level for which the alarm set point is as low as practical but high enough to avoid false alarms. Room access must also be prevented if the monitor malfunctions or is tumed off.

For poolirradiators:

. If the licensee uses radiation monitors to detect contamination under 10 CFR 36.59(b), the licensee must verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate. The system should be equipped with a continuous radiation monitoring device with an alarm which will stop all pool water recirculation should the radiation reach a preset alarm level. Each time the irradiator operates, the licensee should measure for radioactive contamination in the pool water with an appropriate radiation detector. An accumulation of radioactivity in the filter or resin beds will most likely be the first evidence of a source leakage.

i Draft NUREG - 1556, Vol. 6 8-28 i

- - - - - _ - - - _. _ -. - -. _ _ _ _ _ - - _ _ - _ _ ~ _ _. _ _ _. _ - _ _ _ _.. - - _ _. _ _ _. - _ _ - - -

CONTENTS OF AN APPLICATION For underwater irradiators that are not in a shielded radiation room:

. There must be a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly (e.g., prevent movement ofirradiated product out of pool in the event water is contaminated).

AND

. The licensee must verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by 10 CFR 36.29(b).

For all irradiators, the licensee must verify the operability of radiation monitors and related alarms and interlocks. For more information see Appendix J, " Construction Monitoring and Acceptance Testing."

Response from Applicant:

Describe the location and type of radiation monitors that will be used to meet the requirements of 10 CFR 36.23(c),10 FR 36.29, and 10 CFR 36.59(b).

Describe the location and types of alarms and those individuals who are trained to respond to those alarms. Diagrams and sketches should be used, as appropriate.

Discuss the alarm set-points or the methods for establishing the alarm set-points.

For irradiators whose construction begins after July 1,1993, describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and sensitivity and the acceptance testing that will be performed to meet 10 CFR 36.41(e).

Note: Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of 10 CFR 36.29.

8.9.06 IRRADIATOR POOLS Regulations: 10 CFR 30.33(a)(2),10 CFR 36.23(i),10 CFR 36.33,10 CFR 36.39(c),

10 CFR 36.39(d),10 CFR 36.41(c),10 CFR 36.41(d).

Criteria: Irradiator facilities with pools must be designed and equipped as described in 10 CFR Part 36.

8-29 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION Discussion: For facilities initially licensed after July 1,1993, NRC requires EITHER A water-tight stainless steel liner (or a liner metallurgically compatible with other components in the pool)

OR Construction preventing substantial leakage and a pool surface designed to facilitate decontamination.

The purpose of the requirement is to reduce the likelihood of the pool leaking contaminated water.

In either case, the licensee must have a method to store the sources safely during repairs of the irradiator pool.

For licenses initially issued after July 1,1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as '

siphons must have breakers to prevent siphoning. Irradiator pools must have a means to replenish water that is lost. The means to replenish the water does not have to be automatic.

Irradiator pools must also have a clearly visible indicator to show if the pool water level is above or below the normallow water level.

A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations. Also, this ensures compatibility with OSHA requirements and ANSI standards.

Irradiator pools must be equipped with a purification system capable of maintaining the water

' during normal operation at a conductivity of 20 microsiemens per centimeter or less and with enough clarity to allow for inspection of the source and source rack for damage and proper position. The water purification system is needed to prevent corrosion of the sealed sources and the source rack.

The 0.02 mSv (2 mrem) per hour limit on the dose rates for poles and long-handled tools to be used in inadiator pools is imposed to prevent radiation streaming. Hollow and low-density poles and tools can have either vent holes to allow shielding water to enter or sufficient bends to prevent radiation levels at handling areas of the tools from exceeding 0.02 mSv (2 mrem) per I

hour.

l Draft NUREG - 1556, Vol. 6 8-30

CONTENTS OF AN APPLICATION For panoramic irradiators, the licensee must verify that the pool design ensures its integrity as i

required by 10 CFR 36.39(c) and that the design of the water purification system is adequate.

The licensee must also conduct inspections and tests of the pool and water handling systems to meet the requirements of 10 CFR 36.41(c) and (d). See Appendix J, " Construction Monitoring and Acceptance Testing."

Response from Applicant: Provide the following:

For irradiators licensed before July 1,1993, write "Not applicable."

For irradiators licensed after July 1,1993, describe:

- The pool liner. If no water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool is used, explain why the pool has a low likelihood of substantial leakage and how decontamination could be accomplished if necessary

- The high and low water-level indicators and their locations

- The purification system for the pool and explain why it is considered capable of maintaining pool water conductivity less than 20 microsiemens per centimeter

- The means to replenish pool water

- The barrier used during normal operation to prevent personnel from falling into the pool

- How high radiation doses from radiation streaming will be avoided when using long-handled tools or poles (use sketches if appropriate)

- If the pool has outlets more than 0.5 meter below the surface that could allow water to drain out of the pool, the means of preventing inadvertent excessive loss of pool water (in this context outlets do not include transfer tubes between adjacent pools because the transfer tubes do not provide a means to allow water to drain out of the pools).

8.9.07 SOURCE RACK Regulations: 10 CFR 30.33(a)(2),10 CFR 36.35.10 CFR 36.39(f),10 CFR 36.41(f).

i Criteria: Systems must be in place to protect the source rack.

i Discussion: An important element in a radiation safety program is providing systems to protect the source rack and the mechanism that raises and lowers the sources.

8-3i Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

For pool irradiators, the licensee must verify that there are no crevices on the source or between the source and source rack that would promote corrosion on a critical area of the source. For panoramic irradiators, the licensee must determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss ofintegrity of sealed sources. For panoramic irradiators, the licensee must review the design of the mechanism that moves the sources to ensure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

For panoramic irradiators, the licensee must test the r:avement of the source racks for proper operation prior to source loading; testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee must observe and test the operation of the conveyor system to ensure that the requirements in 10 CFR 36.35 are met for protection of the source rack and the mechanism that moves the rack. Testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers. See Appendix J, " Construction Monitoring and Acceptance Testing."

Response from Applicant: Submit procedures for ensuring source rack protection. If the product moves on a product conveyer system, describe the source rack protection to be provided to prevent products and product carriers from touching the source rack or mechanism that moves the rack. Provide diagrams or sketches of those systems, if appropriate.

8.9.08 POWER FAILURES Regulations: 10 CFR 30.33(a)(2),10 CFR 36.37,10 CFR 36.39(i),10 CFR 36.41(i),

10 CFR 36.41(j).

Criteria: If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the shielded position. In addition, the lock on the door of the radiation room of a panoramic irradiator must not be deactivated by a power failure.

Discussion: Automatic source retraction in case of power loss must be accomplished without offsite power. The loss of offsite power may occur at irradiator facilities due to means outside the control of the licensee. In those cases where loss of offsite power occurs, the licensee is responsible for ensuring that an alternate means of power is available to meet the criteria outlined i

Draft NUREG - 1556, Vol. 6 8-32

CONTENTS OF AN APPLICATION in 10 CFR 36.37. This may include an onsite generator that would supply power to the facility to ensure that safety systems for the facility would remain operable to prevent an individual from being exposed to the sources.

If maintaining power to the facility is not feasible, then the licensee needs to demonstrate how the source rack would be retracted into the shielded position and what effects the loss of power would be on the lock of the door to the radiation room that contains the sources. If the locks on the doors did not function as designed and allowed entry into the radiation room, the licensee would need to have procedures in place to ensure that safety features would prevent an individual from being exposed to the sources if they did not retract to the shielded position. Backup power is not required as long as loss ofpower will cause the source to retum to its shielded position, e.g., the source returns to the shielded position due to gravity.

For panoramic irradiators, the licensee must test the ability of the source rack to return to its shielded position during a power loss greater than 10 seconds. For more information; see Appendix J, " Construction Monitoring and Acceptance Testing."

Response from Applicant:

For panoramic irradiators, describe:

- How the sources are automatically returned to the shielded position if offsite power is lost for longer than 10 seconds.

- How loss of power will affect the lock on the doors in the radiation room for a panoramic irradiator.

. For underwater irradiators, no response is required from the applicant in a license application.

8.10 ITEM 10: RADIATION SAFETY PROGRAM 8.10.01 AUDIT PROGRAM Regulations: 10 CFR 20.1101,10 CFR 20.2102.

Criteria: Licensees must review the content and implementation of their radiation protection programs at least every 12 months to ensure the following:

8-33 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION

. ' Compliance with NRC and DOT regulations (as applicable), and the terms and conditions of the license;

. Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101); and

. Records of audits and other reviews of program content are maintained for 3 years.

Discussion: Applicants must develop and implement an audit program. Appendix K contains a suggested audit program that is specific to the use ofirradiators and is acceptable to NRC. All areas indicated in Appendix K may not be applicable to every licensee and all items may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit need not be reviewed at the next audit.

Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits ofirradiator operators to determine if, for example, Operating and Emergency Procedures are available and are being followed.

It is essential that once identified, problems be corrected comprehensively and in a timely manner; Information Notice (IN) 96-28, " Suggested Guidance Relating to Development and Implementation of Corrective Action," provides guidance on this subject. The NRC will review the licensee's audit results and determine if corrective actions are thorough, timely, and sufficient to prevent recurrence. If violations are identified by the licensee and these steps are taken, the

'NRC can exercise discretion and may elect not to cite a violation. The NRC's goal is to encourage prompt identification and prompt, comprehensive correction of violations and deficiencies. For additional information on NRC's use of discretion on issuing violations, refer to General Statement of Policy and Procedures for NRC Enforcement Actions," (NUREG 1600).

Licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. NRC has found audit records that contain the following information to be acceptable: date of audit, name of person (s) who conducted audit, persons contacted by the auditor (s), areas audited, audit findings, corrective actions, and followup.

Response From Applicant: The applicant's program for reviewing the content and implementation ofits radiation protection program will be examined during inspections, but should not be submitted in the license application.

References:

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of: Manual Chapter 87100, Appendix F, " Commercial Irradiator Field Notes,"

l Draft NUREG - 1556, Vol. 6 8-34

CONTENTS OF AN APPLICATION NUREG-1600, " General Statement of Policy and Procedures on NRC Enforcement Actions,"

dated June 1995, and IN 96-28, " Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1,1996. NUREG-1600 is also available on the Internet. Visit NRC's Home Page (http://www.nrc. gov), choose " Nuclear Materials," then

" Enforcement," " Enforcement Guidance Documents," and then " Enforcement Policy."

l 8.10.02 INSTRUMENTS Regulations: 10 CFR 20.1501,10 CFR 20.2103(a),10 CFR 30.33(a)(2),10 CFR 36.57(c),10 i

CFR 36.57(e),10 CFR 36.81(f),10 CFR 36.63(b),10 CFR 36.23(c),10 CFR 36.27(a),10 CFR 36.29.

Criteria: NRC requires specific types ofinstruments to perfomi radiation surveys and to t

monitor certain activities.

Survey Instruments Surveys that are required before and during operation of all types of irradiators require using survey instruments which:

measure the type of radiation expected

are calibrated:

- at least every 12 months

- using a source of radiation similar to that found in the irradiator

- after 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% on each scale

- by the instrument manufacturer or person specifically authorized by the NRC or an Agreement State to calibrate survey instruments do not saturate and read zero at high radiation dose rates.

5 Radiation Monitors The requirements for use of radiation monitors are shown in Table 8.2.

8-35 Draft NUREG - 1556, Vol. 6 l

CONTENTS OF AN APPLICATION Tabie 8.2 Requirements for Radiation Monitors Type ofIrradiator Monitor Required Purpose of Monitor Required Cheeks Panoramic pool Gamma sensing Detects presence of Periodic checks with integrated with high radiation in radioactive check personnel access radiation room to source to confirm locks. Must activate prevent room access operability alarm if entry is when radiation levels attempted while are high sensing radiation.

10 CFR 36.23(c)

Allpool types Gamma sensing of -

Detects a possible Periodic checks with (required unless water pool circulating leaking sealed source -

radioactive check -

is checked daily by system. 'Must activate source to confirm analysis of a sample of an alarm set-point as operability'and poolwater) low as practical when sensitivity pool wateris contaminated.

10 CFR 36.59(b)

Underwater type not Gamma sensing Detects abnormal Periodic checks with in a shielded radiation mounted over the radiation levels radioactive check room pool. Must have an source to e ' firm audible alarm capable operability and of alerting an sensitivity authorized individual.

10 CFR 36.29(b)

Any irradiator using a Gamma sensing to Must stop conveyor Periodic checks with product conveyor -

detect and stop the '

before a source on the radioactive check system product conveyor if a conveyor can cause a source to confirm source is present. -

radiation overexposure operability. The i

10 CFR 36.29(a) to any person.

location and 10 CFR 36.39(e) sensitivity of the monitor to detect sources carried by the product conveyor must be evaluated.

j 1

l Discussion: Irradiator licensees must have survey instruments and radiation monitors such as i

are shown in Figure 8.6.

l I

Draft NUREG - 1556, Vol. 6 8-36

t l

l CONTENTS OF AN APPLICATION

__J h..

.sm

_e Survey Meter Area Monitor n

Figure 8.6 Radiation Detection Instruments. Irradiator licensees must have a variety of radiation detection instruments includingportable survey instruments as well asfixed radiation monitors.

Survey Instruments The survey instruments should measure at least 0.3 mR through 200 mR per hour (50 microcoulomb per kilogram / hour) and be checked for functionality with a source of radiation at the beginning of each day of use (e.g., with a check source). Plans to conduct non-routine operations such as installation, initial radiation survey, repair, and maintenance of components related to the radiological safety of the irradiator, sealed source relocation, replacement, and disposal of sealed sources, alignment or removal of a sealed sources from service must include an evaluation of the type of survey instrument to be used because some of these operations may increase the individual's risk of radiation exposure. Individuals performing these operations should be carefully monitored with an appropriate survey meter. Furthermore, proper calibration of a survey meter is important for initial surveys since they can be used as a basis for public dose estimates. For those licensees requesting authorization to calibrate their own survey instruments, Appendix L contains calibration procedures acceptable to the NRC.

Radiation Monitors Fixed radiation monitors are used to detect the presence of radiation for various purposes at irradiator facilities. They are vital to access control systems because they provide electronic signals used to activate both audible and visual alarms when radiation is present. Monitors that I

warn individuals of the presence of high radiation or which are integrated with personnel access door locks to prevent room access under high radiation conditions should be designed to provide fail-safe operation, i.e., if the radiation munitor for any reason fails to respond to radiation, the system should provide for a backup warning system.

1 8-37 Draft NUREG - 1556, Vol. 6 1

L CONTENTS OF AN APPLICATION 1

Response from Applicant:

For Survey Instruments: Provide one of the following:

. A statement that, "We will use surve instruments that meet the Criteria in the section entitled

' Radiation Safety Program - Instruments' in draft NUREG-1556, Vol. 6, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licensea,' dated March 1998."

AND ONE OF THE FOLLOWING:

. A statement that, "Each survey meter will be calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations."

OR

. A statement that, "We will, implement the model survey meter calibration program published in Appendix L in draft NUREG-1556, Vol. 6, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses,' dated March 1998".

OR Submit alternative calibration procedures for NRC review.

OR,IN LIEU OF ALL OF THE ABOVE, SUBMIT:

. A description of an alternative method to perform surveys pursuant to 10 CFR 20.1501.

For Radiation Monitors: Describe the type of monitors used to meet the requirements of 10 CFR 36.23(c),10 CFR 36.29, and 10 CFR 36.59(b). (The location of these monitors and alarm set-points were described in the response to " Facilities and Equipment - Radiation Monitors.")

Notes:

Alternative responses will be evaluated using the criteria listed above.

. The NRC license will state that survey meter calibrations will be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State to calibrate instruments, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey meter calibrations must submit additional information

~

for review. See Appendix L for more information.

. Regardless of whether an applicant is authorized to calibrate survey meters or contracts an authorized firm to perform calibrations, the licensee must retain calibration records for at least 3 years.

Draft NUREG - 1556, Vol. 6 8-38

l l

CONTENTS OF AN APPLICATION 8.10.03 MATERIAL RECEIPT AND ACCOUNTABILITY Regulations: 10 CFR 30.34(e),10 CFR 30.35(g),10 CFR 30.41,10 CFR 30.51, 10 CFR 20.1501(a),10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.2201.

Criteria: Licensees must do the following:

i Develop, maintain, and implement a procedure to account for licensed material.

Maintain records of receipt, transfer, and disposal oflicensed material (i.e., sealed sources).

Discussion: While loss, theft, or misplacement oflicensed material at most irradiator facilities is l

unlikely because oflimited access to sealed sources and the hazards involved with approaching unshielded sources, accountability for licensed materials must be ensured. As illustrated in Figure 8.7, licensed materials must be tracked from " cradle to grave" in order to ensure accountability and ensure that possession limits listed on the license are not exceeded.

(

4 Material cr W

D p, e

y m __

Receipt Disposal or transfer s2,442ss sa2d Figure 8.7 Material Receipt and Accountability. Licensees must maintain records ofreceipt, transfer and disposal and implement an accountabilityprocedure.

Because this draft report covers various types ofirradiators, it is not possible to describe a specific procedure for material accountability that will apply to every situation. In developing a licensed material accountability program, the applicant should take into consideration the j

specific conditions at its facility. Table 8.3 includes elements that may be included in the accountability procedure for various facilities.

l 8-39 Draft NUREG - 1556, Vol. 6 J

CONTENTS OF AN APPLICATION Table 8.3 Elements of Accountability Procedure Irradiator Type Items to be Addressed in Accountability Procedure 6-month general visual inspection (i.e., a brieflook to see that Pool Irradiato-generally nothing has changed)

. Maintenance of records that include sealed source serial numbers and irradiator location (if more than one irradiator is authorized)

Panoramic Dry-Source-

. Irradiator use log books

. Storage Irradiator

. Leak tests (Including Teletherapy Units Converted to 6-month physicalinventory Irradiators)

. Maintenance of records that include sealed source serial

' numbers and irradiator location (if more than one irradiator is authorized)

Receipt, transfer, and disposal records must be maintained for the times specified in Table 8.4.

Typically, these records contain the following types ofinformation:

. Radionuclides, activity (in units of becquerels or curies), and date of measurement of byproduct material in each sealed source

. Manufacturer's (or distributor's) name, model number, and serial number of each sealed source containing byproduct material

. Location of each scaled source

. For materials transferred or disposed of, the date of the transfer or disposal, name and license number of the recipient, description of the afTected radioactive material (e.g., radionuclides, activity, manufacturer's (or distributor's) name and model number, serial number).

Table 8.4 Receipt, Transfer and Disposal Record Maintenance L Type of Record How Long Record Must be Maintained Receipt For as long as the material is possessed until 3 years after transfer or disnosal Transfer ~

For 3 yean after transfer Disposal Until NRC terminates the license Draft NUREG - 1556, Vol. 6 8-40

l CONTENTS OF AN APPLICATION j

Response from Applicant: Submit a description of procedure (s) for ensuring material accountability.

8.10.04 OCCUPATIONAL DOSIMETRY Regulations: 10 CFR 36.55,10 CFR 20.1502,10 CFR 20.1201,10 CFR 20.1207,10 CFR 20.1208,10 CFR 20.1501(c).

Criteria: The requirements for occupational dosimetry are shown in Table 8.5.

Table 8.5 Requirements for Occupational Dosimetry

. Type ofIrradiator Category of Personnel Type of Dosimetry When Dosimetry Required Must Be Worn Panoramic Irradiator Operators Film or TLD When operating (10 CFR 36.55(a))

irradiator

Underwater Irradiator Operators Film orTLD When in area amund -

(10 CFR 36.55(a))

pool Panoramic Otherindividuals, Pocket dosimeter, film, When entering or in including visitors (for or TLD (10 CFR radiation room groups of visitors, only 36.55(a))

two must be monitored)

All Anyone who could.

Pocket dosimeter, film, As directed by the receive,in one yect, a -

or TLD (10 CFR' RSO based on 10 CFR radiation dose in 20.1501 and 10 CFR 20.1502.

i excess of10 percent of 20.150'2):

l i

the allowable limits as i

shown in Figure 8.8.*

The licensee must maintain, for inspection by NRC, documentation demonstrating that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10 percent of the allowable limits as shown in l

Figure 8.8.

f l

l l

8-41 Draft NUREG - 1556, Vol. 6

{L -- -------

CONTENTS OF AN APPLICATION

~5F~" Eyes Annual Dose Limits

!.N.

h y $58V Sv for Radiation Worker 7,,)

(5 '***)

(10 CFR 20.1201)

Elbows to hands 0.50 Sv Total effective dose equivalent TEDE (50 rems)

{

(whole body) 0.05 Sv (5 rems) f Knees P5 to feet

[.s 0.50 Sv f

(50 rems)

Q h

e2-pwois2-32omb

'~

w a

Figure 8.8 Annual Dose Limits for Radiation Workers.

Discussion: The requirements for most individuals are described in the Table 8.5 above. Other individuals who perform certain non-routine operations (e.g., source loading, unloading, and repositioning; troubleshooting the control console; clearing stuck source racks; investigating /n nediating removable contamination / leaking sources;(re) installing source cables; and any other activity during which personnel could receive radiation doses exceeding NRC limits) are likely to exceed 10 percent of the limits as shown in Figure 8.8 (see Appendix I).

Applicants will also be required to provide dosimetry (whole body and perhaps extremity monitors) to individuals performing such services.

When personnel monitoring is needed, most licensees use either film badges or thermoluminescent dosimeters (TLDs) that are supplied by a NVLAP-approved processor. The exchange frequency for film badges is usually monthly due to technical concerns about film fading. The exchange frequency for TLDs is usually quarterly. Applicants should verify that the processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use.

Some workers, e.g., package handlers, shipping personnel, and custodial personnel, may work near the irradiator but are not likely to exceed 10 percent of the limits. Refer to Appendix M for guidance for demonstrating that an unmonitored individual will not exceed 10 percent of the limits.

a Response from Applicant: The applicant's occupational dosimetry program required by 10 CFR Parts 20 and 36 will be examined during inspection, but should not be submitted in a license application.

Draft NUREG - 1556, Vol. 6 8-42

CONTENTS OF AN APPLICATION 8.10.05 ITEM 10: RADIATION SAFETY PROGRAM - PUBLIC DOSE Regulations: 10 CFR 20.1301,10 CFR 20.1302,10 CFR 20.1003,10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.2107,10 CFR 36.25.

Criteria: Licensees must do the following:

. Ensure that irradiators and their sealed sources will be used, transported, and stored in such a way that individual members of the public will not receive more than 1 millisievert (mSv)

[100 millirem (mrem)] in one year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour, from licensed operations.

Control and maintain constant surveillance over licensed material that is not in storage and secure stored licensed material from unauthorized access, removal, or use.

l 1

Discussion: Members of the public include all persons who are not radiation workers. This includes persons who work or may be near locations where licensed material is used or stored and employees whose assigned duties do not include the use oflicensed materials and who work in the vicinity where licensed material is used or stored.

Security procedures described in " Facilities and Equipment - Access Control," " Radiation Safety Program - Operating Procedures," and " Radiation Safety Program - Emergency Procedures" should be sufficient to limit the exposure to the public during use or storage. Public dose is controlled, in part, by ensuring that irradiators are secure (e.g., irradiator is locked or located in a locked area) to prevent unauthorized access or use. Irradiator use is usually restricted by controlling access to the keys needed to operate the irradiator and/or to keys to the locked irradiator area. Only authorized users should have access to these keys.

i Public dose is also affected by the choice of storage and use locations and conditions. Since an j

irradiator produces a radiation field, it must be located and constructed so that the dose in an unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed 0.02 mSv (2 mrem) in any one hour and the dose to an individual does not exceed 1 mSv (100 mrem) in a year. Use the concepts of time, distance, and shielding when choosing storage and use locations. Decreasing the time spent near an irradiator, increasing the distance from the irradiator, and using shielding (i.e., brick, concrete, lead, or other solid walls) will reduce the radiation exposure. Licensees must determine the radiation levels in unrestricted areas that are normally occupied during operation of an irradiator as specified in Table 8.6.

8-43 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION l

Table 8.6. Radiation Limits Specified in 10 CFR 36.25 Irradiator Type Limit Where Measured Source Position Panoramic 0.02 mSv 30 centimeters or more Exposed (2 mrem) per hour from the wall (of the room where the sources are exposed)in areas normally occupied Poolirradiator(including 0.02 mSv 30 centimeters over the Shielded panoramic pool (2 mrem)per hour edge of the poolirradiator irradiators and underwaterirradiators)

Dry-source-storage 0.02 mSv 1 meter from the shield of Shielded panoramic irradiator (2 mrem)per hour a dry-source-storage panoramic irradiator Dry-source-storage.

0.2 mSv 5 centimeters fram the Shielded panoramic irradiator (20 mem)per hour shield Doses adjacent to the irradiator location can be determined by direct measurements and calculations using the " inverse square" law to evaluate the effect of distance on radiation levels, and occupancy factor to account for the actual presence of the member of the public.

If, after making an initial evaluation, a licensee changes the conditions used for the evaluation (e.g., changes the shielding of the irradiator, increases the source strength, changes the type or frequency ofirradiator use, or changes the occupancy of adjacent areas), then the licensee must perform a new evaluation to ensure that the public dose limits are not exceeded and take corrective action, as needed.

During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or a combination of measurement and calculation, that the total effective 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 N for examples of methods to demonstrate compliance.

Response from Appliennt: The applicant's program to control doses received by individual members of the public will be examined during inspection, but should not be submitted in a license application.

1 Draft NUREG - 1556, Vol. 6 8-44

.____1

i CONTENTS OF AN APPLICATION 8.10.06 OPERATING PROCEDURES Regulations: 10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802,10 CFR '/.0.2201-2203,10 CFR 30.50,10 CFR 21.21,10 CFR 19.11(a)(3),10 CFR 36.13(c),10 CFR 36.31,10 CFR 36.53.

Criteria: The applicant must have and follow written operating procedures for items specified in 10 CFR 36.53(a).

Discussion: Operating procedures must be developed, maintained, and implemented to ensure that irradiators are used only as they were designed to be used, and radiation doses received by occupational workers and members of the public are ALARA. Copies of operating procedures should be provided to all irradiator operators. In addition, the applicant must post current copies of operating procedures applicable to licensed activities at each site. If posting of procedures is not practicable, the licensee may post a notice which describes the documents and states where they may be examined.

Improper operation could lead to the damage or malfunction of an irradiator and potentially lethal radiation overexposure to individuals. The applicant will provide summaries of the written operating procedures describing their important radiation safety aspects. The level of detail should be sufficient to demonstrate that regulatory requirements have been addressed.

Table 8.7 lists the procedures that must be developed, maintained, and implemented, as well as important radiation safety aspects that should be addressed in the outline (i.e., description) that must be submitted in the apphcation.

l 8-45 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION Table 8.7 Operating Procedures Required Procedures.

Items to be Addressed in Description of Procedures Operation of the irradiator, The description should be detailed enough to show how including entering and leaving licensee will comply with 10 CFR 36.67, " Entering and the radiation room Leaving the Radiation Room," and should describe the initial entry and survey after an irradiation. Describe how the applicant will prevent access to keys by individuals who have not been qualified to be operators, as required by 10 CFR 36.31(a). For panoramic irradiators, when product movement is occurring, the description should address the required presence (10 CFR 36.65) of an irradiator operator and another person who is trained on how to respond and prepared to render or sununon assistance if the access alarm sounds. For static irradiations, a person who is trained to respond to alarms must be onsite.

Use of personnel dosimeters See " Radiation Safety Program - Occupational Dosimetry" Surveying the shielding of See " Facilities and Equipment - Shielding" panoramic irradiators Monitoring pool water for See " Facilities and Equipment - Radiation Monitors" contamination while the water is in the pool and before release of pool water to unrestricted areas Leak testing of sources See " Radiation Safety Program - Leak Tests" and Appendix P Inspection and maintenance See " Radiation Safety Program - Inspection and Maintenance checks required by 10 CFR Checks" 36.61 Loading, unloading, and If these procedures will be performed by the applicant, see repositioning sources,if the Appendix I,"Information Needed to Support Applicant's operations will be performed by Request to Perform Non-Routine Operations" the licensee; and Inspection ofmovable shielding Describe inspection of roof plugs or other movable shielding required by 10 CFR 36.23(h),if required by 10 CFR 36.23(h), if applicable.*

applicable.*

in 10 CFR 36.65, the term "onsite" is intended to give flexibility to licensees. For example, for a research irradiator at'a university, the person onsite could be a guard located on campus but not in the building containing Draft NUREG - 1556, Vol. 6 8-46

CONTENTS OF AN APPLICATION the irradiator, provided the guard would hear the alarm and was trained as required by 10 CFR 36.51(g). The guard would not have to be trained as an irradiator operator.

If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operatingprocedure requiring inspection of shielding before operating.

Normally, the manufacturer or a person specifically authorized by NRC or an Agreement State will perform non-routine operations involving, source loading, unloading and repositioning; troubleshooting the control console; clearing stuck source racks; investigating /remediating l

removable contamination / leaking sources; (re) installing source cables; and other critical operations requiring special skills or the potential for radiation overexposure. If these i

operations are not performed properly with attention to good radiation safety principles, the irradiator may not operate as designed and personnel performing the operr.tions could receive potentially lethal exposures. If the applicant wishes to perform non-routine operations, the information in Appendix I should be provided.

Repair and Preventive Maintenance Outlines of maintenance, service, and repair procedures are not required. However, these should be done according to the manufacturer's written instructions, where applicable, by qualified personnel using their knowledge, experience, judgment, and skills to respond to each particular situation.

Improper repairs or maintenance not being performed in a timely fashion was identified as a contributing cause of many of the incidents reviewed in NUREG-1345, " Review of Events at Large Pool-Type Irradiators." Therefore, malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay. It is understood that it may be necessary to obtain a special part, piece of equipment, or particular skilled labor that may not be readily available. Licensees are allowed some flexibility in making noncritical repairs. As long as a reasonable effort is made, the licensee will meet the intent of the requirement. However, some repairs are critical and not subject to the latitude in 10 CFR 36.61(b). For example, licensees must make repairs to the access control system before operating the irradiator to ensure compliance with 10 CFR 36.23.

Preventive maintenance should be performed according to the manufacturer's written instructions. If manufacturer's written instructions are not available, the applicant should i

. perform a review of the systems comprising the irradiator in consultation with knowledgeable individuals and determine and implement an appropriate schedule for preventive maintenance.

8-47 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION Security of Licensed Material NRC considers security oflicensed material extremely important and lack of security is a significant violation for which licensees may be subject to enforcement action. Although it is generally difficult to access sealed sources used in most 10 CFR Part 36 irradiators, the applicant should develop, maintain, and implement procedures to prevent unauthorized access, removal, or use of the licensed material. Also, procedures should require that all areas associated with irradiator operations, particularly control and interlock systems, be locked and secured against unauthorized access.

Revision of Procedures The licensee may revise operating procedures without NRC approval only if all of the following conditions are met:

. The revisions do not reduce the safety of the facility

. The revisions are consistent with the outline or summary of procedures submitted with the license application

. The revisions have been reviewed and approved by the RSO

= The users or operators are instructed and tested on the revised procedures before they are put into use.

Response from Applicant:

For routine operations: Provide an outline that specifically states the radiation safety aspects of the written operating procedures listed in Table 8.7 (i.e., those procedures listed in 10 CFR 36.53(a)). For items where other sections of this guide are referenced, respond to the applicable section.

For non-routine operations: Submit either of the following:

. A statement that: "The irradiator manufacturer or other person authorized by NRC or an Agreement State will perform non-routine operations such as source loading, unloading and repositioning, electrical troubleshooting of the control console, clearing stuck source racks, investigating /remediating removable contamination / leaking sources, (re) installing source cables, and other critical operations requiring special skills or having the potential for radiation overexposure."

Draft NUREG - 1556, Vol. 6 8-48

]

CONTENTS OF AN APPLICATION OR

= The information listed in Appendix I supporting a request to perform this work "in-house."

Note: Information requested in Appendix I will be reviewed on a case-by-case basis; if approved, the license will contain a condition authorizing the licensee to perform non-routine operations.

Reference:

See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of NUREG-1345, " Review of Events at Large Pool-Type Irradiators," da:ed March 1989 or IN 83-09, " Safety and Security ofIrradiators," dated March 9,1983.

8.10.07 EMERGENCY PROCEDURES Regulations: 10 CFR 19.ll(a)(3),10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802, 10 CFR 20.2201-2203,10 CFR 21.21,10 CFR 30.50,10 CFR 36.13(c),10 CFR 36.37(c),

10 CFR 36.53,10 CFR 36.67, and 10 CFR 36.83.

Criteria: The licensee must have and follow emergency or abnormal event procedures, appropriate for items listed in 10 CFR 36.53(b). Emergency procedures should include notifying j

the NRC during and after emergencies and abnormal events.

l Discussion: Figure 8.9 illustrates proper handling of one type ofincident (i.e., broken source j

rack cable).

i 8-49 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION

2. Source movement

1. Event indicated indefinitely i

W,; m.,

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s

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- ~

m:

s

1-dil T

m

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+:,2

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3. Something is wrong!

4. Call RSO 1

+

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u u nessa, 010996 Figure 8.9 Proper Handling ofIncident. Licenseepersonnelimplement emergency procedures when a source rack cable breaks.

Licensees must have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:

. Sources stuck in the unshielded position

. Personnel overexposure

. A radiation alarm from the product exit portal monitor or pool monitor

Detection ofleaking sources, pool contamination, or alarm caused by contamination of pool water (include 10 CFR 36.59(c) requirements)

A low-or high-water level indicator, an abnormal water loss, or leakage from the source storage pool A prolonged loss of electrical power (include 10 CFR 36.37 and 10 CFR 36.67(c) requirements)

A fire alat m or explosion in the radiation room Draft NUREG - 1556, Vol. 6 8-50

1 CONTENTS OF AN APPLICATION l'

An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area -

i j-

. Natural phenomena, including an earthquake, a tomado, flooding, or other phenomena as appropriate for the gmgraphical location of the facility

. Thejamming of automatic conveyor systems.

The applicant should consider other events which may require emergency or abnormal event procedures (e.g., abnormally high radiation levels indicated by the area radiation monitor, collision with the source (s) or source rack).

i j

Emergency and abnormal event procedures should include who will be notified of the event, the l

role of the RSO, and what records of the event will be kept. The procedures should clearly -

l-identify telephone numbers of the RSO or other individuals who can provide assistance including the irradiator manufacturer (or distributor) and state and local agencies. The procedures should

~ include actions to be taken immediately after discovering the emergency or abnormal event.

Emergency procedures should also include notifying the NRC when events specified in Appendix 0 occur.

The RSO must be proactive in evaluating whether NRC notification is required. Refer to Appendix O and the regulations (10 CFR 20.2201-20.2203,10 CFR 30.51, and 10 CFR 36.83)

L for descriptions of when and where notifications are required.

Emergency procedures generally should not include post-emergency corrective actions and l

repairs, since there will be time to carefully consider such actions on a case-by-case basis after the situation is under control. Copies of emergency procedures should be provided to all irradiator operators. In addition, licensees must post current copies of emergency procedures

. applicable to licensed activities at each site. If posting of procedures is not practicable, the licensee may post a notice which describes the documents and states where they may be l-examined.

Emergency procedures for personnel overexposure, fire alarms, explosion in the radiation room, and natural phenomena may involve emergency responders outside the applicant's organization. The applicant should inform and/or train individuals in these organizations regarding the unique concems and hazards associated with emergencies at the irradiator facility.

For instance, hospitals should be informed about the different radiation accidents that could occur at the facility (i.e., overexposure vs. personnel contamination incident).

8-51 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION The licensee may revise emergency procedures without NRC approval only if all of the following conditions are met:

The revisions do not reduce the safety of the facility The revisions are consistent with the outline or summary of procedures submitted with the license application

. The revisions have been reviewed and approved by the RSO

. The users or operators are instructed and tested on the revised procedures before they are put into use.

Response from Applicant: Provide an outline that specifically states the radiation safety aspects of the written emergency procedures listed in the " Discussion" section (i.e., those procedures listed in 10 CFR 36.53(b)).

8.10.08 LEAK TESTS Regulations: 10 CFR 36.59,10 CFR 36.81(h),10 CFR 36.83.

Criteria: NRC requires testing to determine whether there is any radioactive leakage from the sources in the irradiator, Records of the test results must be maintained.

Discussion:

Dry-Source-Storage Sealed Sources Each dry-source-storage sealed source must be tested for leakage at 6-month intervals. 10 CFR 36.59(a) prohibits sources from being used unless the licensee tests the sources for leaks or has a certificate from a transferor that leak tests have been performed within 6 months before the transfer.

The measurement of the leak test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 200 becquerels (0.005 microcurie)5 of radioactivity and must be performed by a person approved by the NRC or an Agreement State to perform the test. In general, the sensitivity required can be obtained with a thin-window G-M probe.

8 ' 10 CFR Pan 36 uses one significant figure in converting becquerels to microcurie.

Draft NUREG - 1556, Vol. 6 8-52

r I

l CONTENTS OF AN APPLICATION Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State to either perform the entire leak test sequence for other licensees or provide leak test kits to dry-source-storage licensees. In the latter case, the licensee is expected to take the leak test sample according to the irradiator manufacturer's (or distributor's) and the kit supplier's instructions and return 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 sealed source were leaking. See Figure 8.10 below. Licensees may also be authorized to i

conduct the entire leak test sequence themselves. Appendix P contains a model leak test program.

Radiation Monitor Testing Near Source on Water Circulation System Water Test y{

}M q

L MWf m

WG%c::&

i

"*" 2 i

Figure 8.10 Lenk Testing. The panel on thefar left illustrates leak testing a dry-source-storage irradiator source, while the other two panels illustrate two ways ofmonitoringpool water to determine ifwet-source-storage sources are leaking.

l l

Pool Irradiators For pool irradiators,10 CFR 36.59(b) prohibits sources from being put into the pool unless the l

licensee tests the sources for leaks or has a certificate from a transferor that leak tests have been l

performed within 6 months before the transfer. After placing sources in the pool, the water must be checked for contamination each day the irradiator operates. For pool irradiators, leak testing l

sources by wipe-testing is not highly sensitive or effective. The check may be done either by j

using a radiation monitor on a pool water circulating system or by analyzing a sample of pool water. If analyzing a sample of pool water, the results must be available within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months .

Whether the applicant desires to check for contamination by analyzing a pool water sample daily, or by continuous monitoring, the procedures and sensitivity of the equipment to be used should be detailed in the application. If collecting a pool sample, use a sensitive detector, such as a sodium iodide detector, to verify the absence of detectable contamination in the sample. If using i

the continuous monitoring method, applicants may use a less sensitive detector such as a G-M detector affixed to a filter / demineralized where radioactive material would be concentrated.

8-53 Draft NUREG - 1556, Vol. 6 l

CONTENTS OF AN APPLICATION r

If the licensee detects a leaking source, the licensee must promptly check personnel, equipment, facilities, and irradiated products for contamination. If any personnel or product are found to be contaminated, decontamination must be performed immediately. If a source is found to be leaking, the licensee must arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. If the pool is contaminated, the licensee must arrange to clean the pool until the concentration levels do not exceed the appropriate concentration in Table 2, Column 2, Appendix B to Part 20. See 10 CFR 30.50 for reporting requirements.

Upon detection ofleaking sources, licensees should consider immediately stopping irradiator operations to minimize spreud of contamination.

Response from Applicant:

For dry-source-storage irradiators: Submit one of the following three alternatives:

. A statement that: " Leak tests will be performed at intervals not to exceed 6 months. Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the irradiator manufacturer's (or distributor's) and kit supplier's instructions. Records ofleak test results will be maintained."

OR

. A statement that: "We will implement the model leak test program published in Appendix P to draft NUREG,1556 Vol. 6, ' Consolidated Guidance about Material Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses,' dated March 1998."

OR

. A description of attemative equipment and/or procedures for determining whether there is any radioactive leakage from sources contained in the irradiator.

For poolirradiators: Submit either of the following:

A description of equipment, procedures, and sensitivity of method that will be used to check for contamination by analysis ofa sample of pool water.

OR A description of equipment, procedures, and sensitivity of method that will be used to check

=

for contamination by continuous monitoring of pool water.

Draft NUREG - 1556, Vol. 6 8-54

CONTENTS OF AN APPLICATION Note: Requests for authorization to perform leak testing and sample analysis will be reviewed and, if approved, NRC staff will authorize via a license condition.

References:

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of Draft Regulatory Guide FC 412-4, " Guide for the Preparation of Applications i

for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985.

8.10.09 INSPECTION AND MAINTENANCE CHECKS Regulations: 10 CFR 20.1101,10 CFR 36.13(c) and (h),10 CFR 36.53(a)(6),10 CFR 36.61.

I Criteria: The applicant must have and follow written procedures for inspection and maintenance checks for items specified in 10 CFR 36.61.

Discussion: Applicants must periodically make inspection and maintenance checks to ensure proper operation of the irradiator. The applicant must have and follow procedures for inspection and maintenance checks. The frequency of checks is not stated in the regulations because it will be site-specific depending on the design of the facility. However, the frequency of checks must be specified in the application. In the applicant's description of the procedures, specify the frequency of the following items:

Operability of each aspect of the access control system required by 10 CFR 36.23 Functioning of the source position indicator as required by 10 CFR 36.31(b)

Operability of the radia. ion monitor for radioactive contamination in pool water required by 10 CFR 36.59(b), usivg a radiation check source, if applicable Operability of the over-pool radiation monitor at underwater irradiators as required by 10 CFR 36.29(b)

Operability of the product exit monitor required by 10 CFR 36.29(a) l

. Operability of the emergency source return control required by 10 CFR 36.31(c)

. Leak-tightness of systems through which pool water circulates (visual inspection)

. Operability of the heat and smoke detectors and extinguisher system required by 10 CFR 36.27 (but without turning extinguishers on)

. Operability of the means of pool water replenishment required by 10 CFR 36.33(c)

. Operability of the indicators of high and low pool-water levels required by 10 CFR 36.33(d)

Operability of the intrusion alarm required by 10 CFR 36.23(i), if applicable l

l 8-55 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION Functioning and wear of the system, mechanisms, and cables used to raise and lower sources Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 10 CFR 36.35

Amount of water added to the pool to determine whether the pool is leaking

. Electrical wiring on required safety systems for radiation damage

Pool water conductivity measurements as required by 10 CFR 36.63.

The applicant should keep in mind that these are the minimum items to be checked based on requirements in 10 CFR 36.61, and that the licensee should develop and implement procedures for other necessary checks as appropriate (e.g., as recommended by the manufacturer). For instance, if applicable, the applicant should have and follow written procedures for inspection and maintenance checks to ensure that all product positioning system components, product boxes, or carriers continue to meet design specification and are not likely to cause an irradiator malfunction.

Response from Applicant: Describe inspection and maintenance checks, including the frequency of the checks listed in the " Discussion" section (10 CFR 36.61).

8.10.10 TRANSPORTATION Regulations: 10 CFR 71.5,10 CFR 71.12,10 CFR 71.13,10 CFR 71.14,10 CFR 71.37,10 CFR 71.38, Subpart H of 10 CFR Part 71,49 CFR Parts 171-178,10 CFR 20.1101,10 CFR 30.41,10 CFR 30.51.

Criteria: Applicants must develop, implement, and maintain safety programs for 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. Transporting licensed materials originating at irradiator facilities normally involves quantities of radioactive material that require a Type B package. Because of the special requirements involved in shipping Type B packages, most irradiator licensees have chosen to transfer possession of radioactive materials to an irradiator manufacturer (or service licensee) with an NRC or Agreement State license who then acts as the shipper. The manufacturer (or service licensee), who is subject to th;: 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):

Draft NUREG - 1556, Vol. 6 8-56

CONTENTS OF AN APPLICATION f

. Is authorized to possess the licensed material at temporary job sites (i.e., at the irradiator l

location)

. Actually takes possession cf the licensed material under its license

)

= Uses an approved Type B package

Is registered with NRC as a user of the Type B package l

l

. Has an NRC-approved QA plan.

l For each shipment, it must be clear who possesses the licensed material and is responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations.

l If a licensee plans to make shipments oflicensed materials in Type B packages on its own, the licensee must be registered as a user of the package and have an NRC-approved quality assurance (QA) plan, two of the requirements under the 10 CFR 71.12 general license. For information about QA plans, see Revision 1 of Regulatory Guide 7.10, " Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," (dated June 1986). For further information about registering as a user of a package or submitting a QA program for review, contact NRC's Spent Fuel Project Office (SFPO) by calling NRC's toll-free number 800-368-5642 and asking for extension 415-8500. For information about associated fees, contact NRC's Office of the Chief Financial Officer by calling NRC's toll-free number 800-368-5642 and asking for extension 415-7554.

i During an inspection, NRC uses the provisions of 10 CFR 71.5 and a " Memorandum of Understanding with DOT on the Transportation of Radioactive Material" (signed June 6,1979) to examine and enforce various DOT requirements applicable to irradiator licensees. Appendix Q lists major DOT regulations.

l Response from Applicant: No response is needed from applicants during the licensing phase.

However, before making shipments oflicensed materials on its own in Type B packages, a l

licensec needs to have re;;istered with NRC as a user of the package and obtained NRC's l

approval ofits QA program. Transportation issues will be reviewed during inspection.

l

References:

"A Review of Department of Transportation Regulations for Transportation of l

Radioactive Materials (1983 revision)" can be obtained be calling DOT's Office of Hazardous l

' Material Initiatives and Training at (202) 366-4425. See the Notice of Availability (on the inside l

front cover of this draft report) to obtain a copy of the " Memorandum of Understanding with DOT on the Transportation of Radioactive Material" (signed June 6,1979) and Revision 1 of Regulatory Guide 7.10, " Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material,"(dated June 1986).

l 8-57 Draft NUREG - 1556, Vol. 6

CONTENTS OF AN APPLICATION 8.10.11 MINIMIZATION OF CONTAMINATION Regulations: 10 CFR 20.1406 Criteria: Applicants for new licenses must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.

Discussion: All applicants for new licenses need to consider the importance of designing and operating their facilities so as to minimize the amount of radioactive contamination generated at the site during its operating lifetime and to minimize the generation of radioactive waste during decontamination. Irradiator applicants usually do not need to address these issues as a separate item since they are included in respons:s to other items of the application.

Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their respective SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in 10 CFR 36.59 should identify defective sources. Leaking sources must be withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked.

Response from Applicant: The applicant does not need to provide a response to this item under the following condition. NRC will consider that the above criteria have been met if the applicant's responses meet the criteria for the following sections: " Radioactive Material-Scaled Sources and Devices," " Facilities and Equipment - Irradiator Pools" (if applicable), " Radiation Safety Program - Operating Procedures," " Radiation Safety Program - Emergency Procedures,"

" Radiation Safety Program - Leak Tests," and " Waste Management - Sealed Source Transfer and Disposal."

8.11 ITEM 11: WASTE MANAGEMENT 8.11.01 SEALED SOURCE DISPOSAL AND TRANSFER l

Regulations: 10 CFR 20.2001,10 CFR 30.41,10 CFR 30.51,10 CFR 30.36,10 CFR 36.59.

Draft NUREG - 1556, Vol.6 8-58 u___

CONTENTS OF AN APPLICATION Cr:teria: Licensed materials must be disposed of according to NRC requbnents by transfer to an authorized recipient. Appropriate records must be maintained.

Discussion: When disposing of sealed sources or contaminated items (caused by leaking soluces), licensees must transfer them to an authorized recipient. Authorized recipients are the original manufacturer (or distributor) of the sources, a commercial firm licensed by the NRC or an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material (i.e., its license specifically authorizes the same radionuclides, form, and use).

If a product of the irradiator that may have been inadvertently contaminated has been shipped, the licensee must arrange to locate and survey the product for contamination. If contaminated equipment, facilities, or products are found, the licensee must arrange to have them decontaminated or properly disposed of by an NRC or Agreement State licensee authorized to provide these services. If the pool is contaminated, the licensee must arrange to clean up the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Column 2, Appendix B to 10 CFR Part 20 (10 CFR 36.59(c)).

Before transferring radioactive material, a licensee must verify that the recipient is properly l

authorized to receive it using one of the methods described in 10 CFR 30.41. In addition, all packages containing radioactive sources must be prepared and shipped according to NRC and DOT regulations. Records of the transfer must be maintained as required by 10 CFR 30.51.

Response fri m Applicant: The applicant does not need to provide a response to this item during the licensing process. However, the licensee should establish and include waste disposal l

procedures in its radiation safety program.

l 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 Fonn 313 are to be completed on the form itself.

8.12 ITEM 12: FEES On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application.

8-59 Draft NUREG - 1$56, Vol. 6

CONTENTS OF AN APPLICATION An application and required fee must be submitted before start of construction (see 10 CFR 36.15). This will allow regulatory agencies to inspect the construction of the facility as it is being built.

8.13 ITEM 13: CERTIFICATION Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application must be authorized to make binding commitments and to sign official documents on behalfofthe applicant. As discussed previously in " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applicationsfor proper signature.

Note:

. It is a criminal offense to make a willful false statement or representation on applications or correspondence (18 U.S.C.1001).

. When the application references commitments, those items become part of the licensing conditions and regulatory requirements.

DraA NUREG - 1556, Vol. 6 8-60 l

a

9 AMENDMENTS AND RENEWALS TO A LICENSE It is the licensee's obligation to keep the license current. If any of the information provided in the original application is to be modified or changed (except as permitted by 10 CFR 36.53(c)), the licensee must submit an application for a license amendment before the change takes place.

Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109,10 CFR 30.36(a))

Applications for license amendment, in addition to the following, must provide the appropriate fee. For renewal and amendment requests applicants must do the following:

Be sure to use the most recent guidance in preparing an amendment or renewal request

Submit in duplicate, either an NRC Form 313 or a letter requesting amendment or renewal

. Provide the license number For renewals, provide a complete and up-to-date application if many outdated documents are referenced or there have been significant changes in regulatory requirements, NRC's guidance, the licensee's organization, or radiation protection program. Altematively, describe clearly the exact nature of the changes, additions, and deletions.

Using the suggested wording of responses and committing to using the model procedures in this draft report will expedite NRC's review.

l l

L I

9-1 Draft NUREG - 1556, Vol. 6

10 APPLICATIONS FOR EXEMPTIONS l

Various sections of NRC's regulations address requests for exemptions (e.g.,10 CFR 19.31,10 CFR 20.2301,10 CFR 30.11(a),10 CFR 36.17(a)). These regulations state that NRC may grant an exemption, acting on its own initiative or on an application from an interested person. Key considerations are whether the exemption is authorized by law, will endanger life or property or the common defense and security, and is otherwise in the public interest.

l i

Until NRC has granted an exemption in writing, NRC expects strict compliance with all applicable regulations.

Exemptions are not intended to revise regulations, are not intended for large classes oflicenses, and are generally limited to unique situations. Exemption requests must be accompanied by l

descriptions of the following:

. Exemption and why it is needed

)

. Proposed compensatory safety measures intended to provide a level of health and safety i

l equivalent to the regulation for which the exemption is being requested l

. Altemative methods for complying with the regulation and why they are not feasible.

When NRC codified its requirements in 10 CFR Part 36 for irradiators, NRC recognized the special case of teletherapy-type units converted from human use to use for the irradiation of materials or objects. 10 CFR 36.17(b) permits these licensees to propose alternatives to the requirements of 10 CFR Part 36 provided that there is an adequate rationale and the alternatives provide an adequate level of safety for workers and the public.

For converted teletherapy units, Appendix R lists specific sections of the regulations, the l

rationale and acceptable alternatives, and the wording of the license condition granting the exemption. The Regions may grant exemption requests shown in Appendix R without consulting NMSS.

Exemption requests other than those described in Appendix R must be coordinated with NMSS.

i l

10-1 Draft NUREG - 1556, Vol. 6

4 i

11 TERMINATION OF ACTIVITIES j

I Regulations: 10 CFR 30.34(b),10 CFR 30.35(g),10 CFR 30.36(d),10 CFR 30.36(g),10 CFR 30.36(h),10 CFR 30.360),10 CFR 30.51(f).

I Criteria: The licensee must do the following:

. Notify NRC, in writing, within 60 days of:

- the expiration ofits license

- a decision to permanently cease licensed activities at the entire site (regardless of contamination levels) l

- a decision to permanently cease licensed activities in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.

- no principal activities having been conducted at the entire site under the license for a period of 24 months

- no principal activities having not been conducted for a period of 24 months in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.

Submit decommissioning plan, if required by 10 CFR 30.36(g).

. Conduct decommissioning, as required by 10 CFR 30.36(h) and 10 CFR 30.360).

Submit, to the appropriate NRC regional office, completed NRC Form 314, " Certificate of Disposition of Materials" (or equivalent information) and a demonstration that the premises are suitable for release for unrestricted use (e.g., results of final survey).

. Before a license is terminated, send the records important to decommissioning to the appropriate NRC regional office. Iflicensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), transfer records important to decommissioning to the new licensee.

Discussion: As noted in several instances discussed in " Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection.

l For guidance on the disposition oflicensed material, see the section on " Waste Management -

Scaled Source Disposal or Transfer." For guidance on decommissioning records, see the section on " Radioactive Materials - Financial Assurance and Record Keeping for Decommissioning."

Il-1 Draft NUREG - 1556. Vol. 6

TERMINATION OF ACTIVITIES Response from Applicant: The applicant is not required to submit a response to the NRC during the initial application. However, when the license expires or at the time the licensee ceases operations, then any necessary decommissioning activities must be undertaken, NRC Form 314 or equivalent information must be submitted, and other actions must be taken as summarized in the Criteria.

Reference:

Copies of NRC Fonn 314, " Certificate of Disposition of Materials," are available upon request from NRC's Regional or Field Offices. (See Figure 2.1 for addresses and telephone numbers).

I Draft NUREG - 1556, Vol. 6 11 2

Appendix A List of Documents Considered in Development of this Draft NUREG

)

l l

l

APPENDIX A List of NRC Documents Coneidered in the Preparation of this Draft NUREG Report l

l This draR report incorporates and updates the guidance previously found in the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives (P& gds), Information Notices (ins),

and Technical Assistance Requests (TARS) listed below. Other NRC documents such as Manual l

Chapters (MCs), Inspection Procedures (IPs), and Memoranda of Understanding (MOU) were also consulted during the preparation of this draft report. When this draft report is issuedinfinal form, the documents marked with an asterisk (*) will be considered superseded and should not be used.

Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance l

Directives Document Title Date

-Identification NUREG-1345 Review of Events at Large Pool-Type Irradiators 3/89

Draft RG Guide for the Preparation of Applications for Licenses for Non-1/94 DG-0003 Self-Contained hradiators

Draft RG Guide for the Preparation of Applications for Licenses for the Use 1/85 FC 403-4 of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet

]

Source-storage Irradiators, and Panoramic Wet Source-Storage l

Irradiators Dran RG Guide for the Preparation of Applications for the Use of 6/85 FC 412-4 Radioactive Materials in Leak-Testing Services Draft RG Guide for the Preparation of Applications for Licenses for the Use 6/85 FC 413-4 of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments, RG 3.66 Standard Format and Content of Financial Assurance Mechanisms-06/90 l

Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72 RG 7.10 Establishing Quality Assurance Programs for Packaging Used in 6/86 (Rev.1)

Ae Transport of Radioactive Material

P&dD '

Standard Review Plan for Licenses for the Use of Panoramic Dry 12/84 FC 84-23 Source-Storage Irradiators, Self-Contained Wet Source-Storage Irradiators, and Panoramic Wet Source-Storage Irradiators A-1 Draft NUREG - 1556, Vol. 6

APPENDIX A Document Title Date Identification

P&GD Licensing ofLarge Irradiators

5 W:4 FC 84-25 PAGD Standard Review Plan for Evaluating Compliance with 04/30/91 FC 90-02 Decommissioning Requirements Rev.1 PAGD' Processing of Exemptions for Material Licensees 07/25/97 PG l-26 P&GD NMSS Procedures for Reviewing Declarations of Bankruptcy 08/08/96 PG 8-11 Table A.2 List ofinformation Notices Document Title Date Identification IN 83-09 Safety and Security ofIrradiators 03/09/83

IN 85-01 Continuous Supervision ofIrradiators 01/10/85 IN 85-36 Malfunction of a Dry-Storage, Panoramic, Gamma Exposure 05/09/85 Irradiator IN 89225 Unauthorized Transfer of Ownership or Control of Licensed 12/7/94 Rev.1 Activities IN 89-82 Recent Safety-Related Incidents at Large Irradiators 12/07/89 IN 91-14 Recent Safety-Related Incidents at Large Irradiators 03/05/91 IN 94-89 Equipment Failures at Irradiator Facilities 12/28/94 IN 96-28 Suggested Guidance Relating to Development and Implementation 05/01/96 of Corrective Action IN 96-54 Vulnerability of Stainless Steel to Corrosion When Sensitized 10/17/96 IN 97-30 Control of Licensed Material during Reorganizations, Employee-06/03/97 Management Disagreements, and Financial Crises l

Draft NUREG - 1556, Vol. 6 A-2 l

l

__.-_.___-.._____.._u----__._-

APPENDIX A Table A.3 List of Technical Assistance Requests

' No.

Title.

TAR-Date '

l.

Exemption Request from the Personnel Access Barrier and Intrusion Alarm 01/24/ %

Requirements Set Forth in 10 CFR 36.23(I) 2.

Exemption Request from the Requimments of 10 CFR 36.63(a) and (b),

07/21/95 36.61; 36.65, and 36.67(b)(2) 1 3.

Exemption from Certain Provisions Specified in 10 CFR Part 36 05/23/95 4.*

Exemption Request from the Requirements of 10 CFR 36.23.

02/01/95 5.

Exemption from 10 CFR Part 36 Requirements for Teletherapy Unit 12/13/94 6.-

Exemption to 10 CFR 36 Teletherapy Unit for Veterinary Use 08/23/94 7.*

Exemption from 10 CFR 36.23(a), (b), (c), (f); 36.27(a), (b), 36.31(a) 08/02/94 8.*

Exemption to 10 CFR 36 Teletherapy Unit for Non-Human Use 07/08/94

. 9.*

Exemption to 10 CFR. 36.23(d),36.31(b), and 36.67(b)(2) 05/17/94

. 10.*

Exemptions to 10 CFR 36.23(a),36.23(d),36.27, and 36.31 05/16/94 11.

10 CFR Part 36 Exemption for a Non-Medical Use of a Teletherapy Unit 03/14/94 12.'

Exemptions to 10 CFR Part 36 -

11/08/93 l

13.*

Applicability of 10 CFR Part 36 to Programs Involving Use of Teletherapy 08/24/93 Units For Non-Medical Use (Georgetown University) 14.-

Exemption from 10 CFR 36.23(b):~ Armed Forces Radiobiology Institute '

08/06/93 15.*

Applicability of 10 CFR Part 36 to Programs Involving Use of Teletherapy 07/16/93-Units For Non-Medical Use (University of Wisconsin) 16.*

Regulatory Requirements for Panoramic / Beam Type Irradiator (MCV) 06/14/93.

l 17.*

Applicability of 10 CFR Part 36 to Programs Involving Use of Teletherapy 01/28/93 l

Units For Non-Medical Use (University of Pittsburgh)

. 18.*

Request to Irradiate Flammable Material (Small Scaled Foil Packets 01/19/93' Containing 4 ml of 86% Isopropyl Alcohol).

19.*

Irradiation of Medical Products in Foil Packets Which Also Contain 06/25/92 Isopropanol Mixture.

20.-

Irradiation ofChemical Compounds.

06/01/92

- A-3 Draft NUREG - 1556. Vol. 6

APPENDIX A No.

Title TAR Date 21.*

Pool Water Conductivity Level of 20 Microsiemens per Centimeter 05/20/92 22.

Interpretation of Requirement That " Persons Specifically Authorized" 01/06/92 Repair or Modify Irradiators.

23.

Irradiation of Flammable Material 11/25/91 24.*

Compliance with 10 CFR 20.203(cX6) and Leak Test Timeliness and 11/13/91 Reporting 25.*

Irradiation of Foil Wrapped Prep Pads Containing Alcohol and Pressurized 08/12/91 Aerosols Containing Alcohol, Isobutane and Propane (Flammable Material) 26.*

Exemption Request from the Requirements of 10 CFR 20.203(cX6)(ii) and.

04/22/91 10 CFR 20.203(c)(6)(iv) 27.

WESF Capsule Removal (Applied Radiant Energy Corp.)

04/02/91 Table A.4 Miscellaneous NRC Documents Document Title Date Identification IP 87100, Commercial Irradiator Inspection Field Notes 12/30/91 Appendix F IP 87103 Inspection of Material Licensees Involved in an Incident or 06/11/97 Bankruptcy Filing MC 2815 Construction and Preoperational Inspection of Panoramic, Wet-07/07/86 Source-Storage Gamma Irradiators

~

MOU Memorandum of Understanding with DOT on the Transportation of 06/06/79 Radioactive Material MOU Memorandum of Understanding Between the Nuclear Regulatory 10/21/88 Commission and the Occupational Health and Safety Administration; Worker Protection at NRC-Licensed Facilities Draft NUREG - 1556, Vol. 6 A-4

l l

l Appendix B NRC Form 313 l

l l

1

NRC FORM 313 U. S. NUCLEAR RELULATORY COMMISSION APPROVED CY CMS: DC. SW120 EAPWtES mise F88)

EnmeMa buroen per renoone to comNy we es ndormaan coincnon 10 CFR 30. 32,33 request ? Nurs Submeal af me sopicaban e necaneery to estermine met I

34,36,38 30 and 40 the appscont e gueteed s,nd that edeouses procedures most to peceect the public hoseln and esfaty Forward commente regerihn0 bureen esbmete to e4 escon sad Recores Management Brenen (T4 F33). U S Nuchner APPLICATION FOR MATERIAL LICENSE

- - "* c **** ***'**" oc 2"*".me'n*i a

* * * " ~

Re.uc.on Pro,eci o m i2m O=.

of Mene.

and Washengezn DC 20603 NRC may not conduct or sooneer and a person e not coowed e mooond to. e conectan of *Wormaton Urueso e espiers e curency ed OMB coreos nummer INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION.

SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.

APPUCATION POR DISTRIBUTION OF EAESIPT PRODUCTS PtLE APPUCATIONS WITH:

IF YOU ARE LOCATED IN.

OF DOUSTRIAL AND MEDCAL NUCLEAR SAFETY ILLMOtt, lesOlANA, IOWA, aseCHe0AN, helNesESOTA, MISSOURI, OHIO,04 WISCOesSW OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEOUARDS 98800 APPUCATmMS TO:

l U S. NUCLEAR REQULATORy ernamenorms l

WASMNGTON, DC 200850001 MATERIALS UCENSsNG SECTION MTNmPWISOpesM MCAM ASFm m U S NUCLEAR REGULATORY COMMISSION, REGION lli 801 W ARRENVILLE RD P VOU ARE LOCATE IIL i tea F g. 00632 4361 CONNECTICUT, DELAWARE, DeSTRICT OF COLUesetA, asAsset, laARYLAND.

ALASMA, ARIEOttA, ARMANSAS, CALIPO48HA, COLORADO, HAWAll,IDANO, MANSAS, IAASSACNUSETTS. NEW NAAIPONftE, NEW JERSEY, IIEW YORK, PENesSYLVAsetA, LOUIS &ANA IIONTANA, assaema ugyADA, NgW RIEAICO, NORTH DAKOTA IINDOE ISLAsID, OR VWlaAOeff,38000 APPUCATIOpes TO:

ONLANOetA, OREGON, PACIPIC TRUST TERRITORIES, SriUTH DAKOTA TEXAS, UTAH, WASHINGTOst, OR WYOesesO, SENO APPUCATIOseS 70:

NUCLEAR MATERIALS SAFETY BRANCH NUCLEAR MATERIALS LCENSING SECTION U S NUCLEAR REOULATORY COMMISSaON. REwN i U $ NUCLEAR REGULATORY COMMISSON. REGK,N rv 478 ALLENDALEROAD 011 RYAN PLAZA DRIVE, Suf7E 400 KING OF PRUSSIA. PA 19408 1415 ARLINGTON. TX 78011 4064 ALAS 4alA FLORIDA, OEOfHNA MENTUCKY, hetS46SSIPPt. NORTH CAROUNA PUERTO fleCO, SOUTH CAftOuteA, TEbeNESSEE, ViftoestA, VIst04N ISLANOS, OR WEST VWt0apenA SENO APPUCATIOseS TO:

NUCLEAR MATERIALS LCENSNG * 'CTION U S NUCLEAR REuulATORY CCanMsSSsON. REGaON N 101 MARIETTA STHEET, NW. Suf7E 2000 ATLANTA,CA 3032S0100 PERSOsts LOCATED N AGREEasENT STATES StesO APPUCATIONS TO THE U S. NUCLEAR REOULATORY COeseMSSION ONLY IF THEY WISH TO POSSESS AND USE UCENSED 14ATERIAL M STATES SUSJECT TO U.S. NUCLEAR REOULATOftY Cemaaanearma JUpt SOeCTIDees.

1 _THIS S AN APPLCATION FOft (Chece apartrees esm) 2 NAME AND MAILING ADORESS OF APPLCANT (picAmso 29 sodW

)

A.

NEW UCENSE AMENOMENT TO LCENSE NUMBER 9.

C.

RENEWAL OF LCENSE NUMBER

3. A00RESS(ES)WHERE LCENSED MATERIAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THis APPLCATION TELEPHONE NUMBER SUOMff ffEhls S THROUGH 11 ON EL1/2 X 11" PAPER THE TYPE AND SCOPE OF NFORMATinN TO BE PetOVIDED E DESCReED N THE UCENSE APPUCATON JIDE

$ RAOoACwE idArm

& Element and mens number; b chemsei ensor phyesel form, and g meesmum amount 8 PURPOSE (S) FOR WHCH LCENSED MATERIAL WILL BE USED meimei wu be paeseemed at any one eme T.

DN ftESPOsanule F FOR RADIATION SAFETY PROGRAM AND THEIR TRApardo N 5 TRAJNNO FOR INOfVOUALS WORIONG N OR FREQUENTDdG ftESTRCTED AftEAS 9 FACIUTIES AND EQUIPMENT 10 RADIATION SAFETY PetOORAM 12 UCD4SEE FEES (See f0 CFR f 70 and Sece.n f 70 3f)

11. WASTE MANAnssasNT aAMOUNT FEE CATEGORY l ENCLOSED $

13 mRTFCATION. (neuer to osmpassed By especea0 THE APPUCANT UNDERSTANDS THAT ALL STATEMENTS AND REPftESENTATIONS IAADE IN THIS APPUCAftON ARE BNDMG WON THE APPUCANT TDE APPUCANT AfC ANY OFFICIAL EXECUTING THIS CERTIFICATION ON behalf OF THE APPUCANT, NAnsED N ffEM 2. CERTFY THAT THl3 APPUCATION 8 PetEPARED N CONFORINTY WffH TTTLE 10, CODE OF FEDERAL REGULATIONS. PARTS 30,32,33. 34,38,30,30 AND 40, AND THAT ALL INFORMATON CONTAINED HEREIN 5 TRUE AfC CX3ftRECT TO Tl4 BEST OF THEst MMOWLSDOE AND asi iss WARNDeG 18 U S C SECTION 1001 ACT OFJUNE 25.1940 02 STAT Tag h4AMES IT A CRSmNAL OFFENSE TO MAKE A WIL1 FULLY F ALSE STATEMENT OR REP 8tESENTATON TO ANY DEPARTMENT Oft AGENCY OF THE Ue8TED STATES AS TO ANY htATTER WTTHIN Tr5 JURisOCTION CERTFYNO OFFICER - TYPEDP8 TINTED 84AME AND TTTLE es0NATtaftE DATE FOR NRC USE ONLY TYPE OF FEE FsE loo FEE CATEOORY AnsOuNT ftECErvED CHECx >= eamsR ermanasNTS S

APPROVED sY DATE 88tCPORes313 p og PWtWTED ON RECYCLED PAPER I

l Appendix C Suggested Format for Providing Information Requested in items 5 through 11 of NRC Form 313 1

I i

l l

APPENDIX C l

Item Title and Criteria Yes Description i

No.

Attached 5.

RADIOACTIVE MATERIAL-SEALED SOURCES AND DEVICES

Identify each radionuclides that will be used in each irradiator.

[]

. Identify the manufacturer (or distributor) and model number of

[]

each sealed source.

. Identify the manufacturer (or distributor) and model number of

[]

each irradiator, if applicable.

. For dry-source-storage irradiators, specify the maximum activity

[]

per source.

. Specify the maximum activity per irradiator.

[]

. If depleted uranium is used as shielding material, specify the total

[]

l amount (in kilograms).

5.

RADIOACTIVE MATERIAL - FINANCIAL ASSURANCE

]

AND RECORD KEEPING FOR DECOMMISSIONING

. If financial assurance is required [ possession greater than 10,000

[]

curies Co-60 or 100,000 curies Cs-137], submit documentation required by 10 CFR 30.35.

6.

PURPOSE (S) FOR WHICH LICENSED MATERIAL WILL BE USED Provide either of the following:

. A specific description of use for each type ofirradiator requested,

[]

e.g., "For use in irradiation of products or food. There will be no irradiation of explosives and no irradiation of more than small quantities of flammable materials with a flash point below 60 degrees C (140 degrees F) without specific written authorization from NRC."

OR

. If the irradiator will be used for purposes other than irradiation of

[]

food or products for human or research purposes, description of these purposes and safety analyses (and procedures, if needed) to i

support safe use.

t C-1 Draft NUREG - 1556, Vol. 6

APPENDIX C Item Title and Criteria Yes Description No.

Attached 7.

INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM - RADIATION SAFETY OFFICER (RSO)-

TRAINING AND EXPERIENCE

. State the name of the proposed RSO.

[]

= Describe the proposed RSO's training and experience specific to

[]

the irradiator that the applicant intends to use.

7.

INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM-RSO-RESPONSIBILITIES AND AUTHORITIES

. Describe the organizational structure for managing the irradiator.

[]

. Specify the radiation safety responsibilities and authorities of the

[]

RSO.

. Specify other management personnel who have important

[]

radiation safety responsibilities and authorities.

. Describe who has the authority to stop unsafe operations.

[]

8.

INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS Initial Training and Experience for Irradiator Operators

. Before using licensed materials irradiator operators will have

[]

successfully completed one of the training courses described in Criteria in the section entitled " Initial Training for Irradiator Operators,"in draft NUREG-1556, Vol. 6, dated March 1998.

OR

. Provide a description of the initial training program for irradiator

[]

operators that demonstrates compliance with the requirements of l

10 CFR 36.51(a), (b), and (c).

Draft NUREG - 1556. Vol. 6 C-2 i

I APPENDIX C Item Title sad Criteria Yes Description' No.

Attached.

8.

Annual Safety Reviews and Performance Evaluations for Irradiator Operators

. Describe program for annual safety reviews and performance

[]

evaluations ofirradiator operators that demonstrates compliance with 10 CFR 36.51(d) and (e).

8.

Training for Individuals Who Require Unescorted Access Need Not Be '

Sabanitted with

. The applicant's program for instructing and testing unescorted Application individuals (other than irradiator operators) will be examined during inspections, but should not be submitted in the license application.

8.

Training for Individuals Who Must Be Prepared to Respond to Need Not Be Alarms Submitted with

The applicant's program for instructing and testing, as applicable, individuals designated to respond to alarms will be examined j

during inspections, but should not be submitted in the license application.

. 9.

FACILITIES AND EQUIPMENT GeneralEnJ/r

. L Describe tb irradiatar including diagrams, sketches, and.

, [ )-

photographs, as appropriate..

. Show locations of safety-related equipment and features as

[]

required in 10 CFR Part 36.*

i

. Provide a sketch and describe the uses of property adjacent to the

[]

proposed facility.

.i Provide a construction schedule for the'irradiator.

[]

l

}

I i

~C3 Draft NUREG - 1556, Vol. 6 i

APPENDIX C

. Item Title and Criteria Yes Description

. No.-

Attached 9.

Access Control

. Submit specific information describing the access control system

[]

and how it works that demonstrates compliance with the requirements of 10 CFR 36.23. Specific drawings or sketches should be submitted, as appropriate.

. For panoramic irradiators, describe the facility alarm systems.

[]

= For panoramic irradiators, describe the lock and key system for

[]

controlling source movement and discuss how it meets the requirements of 10 CFR 36.31(a).

9.

Shielding for Panoramic Irradiators

. : Describe the shielding to be used and its composition.

[]

. Submit a diagram showing the configuration of shielding walls

-[ ]

and indicate the thickness of each and peratio as in the shield wall.

If any accessible areas outside the shield are expected to have a.

[]

dose rate exceeding 0.02 mSv (2 mrem) per hour, identify the areas and tell how access will be controlled.

. For requests to possess more than 2 x 10" becquerels (5,000,000

[]

curies), describe how cooling of the shielding walls will be accomplished [see 10 CFR 36.39(a)].

Note: For underwater irradiators, no response is required from the N/A N/A applicant in a license application.

DraA NUREG - 1556, Vol. 6 C-4

l APPENDIX C l

Item Title and Criteria Yes Description

' No.

Attached 9.

Fire Protection for Panoramic Irradiators l

Describe:

Type and location of the heat and smoke detectors to be used to

[]

I detect a fire in the radiation room

. Alarms to alert personnel who will be trained to summon

[]

assistance

. How the sources will automatically become fully shielded if a

[]

fire is detected

. How the heat and smoke detectors will be tested.

[]

Note: For an underwater irradiator, no response is required, since N/A N/A the sources are always underwater and not subject to damage by fire.

9..

Radiation Monitors

. Describe the location and type of radiation monitors that will be -

[]

used to meet the requirements of 10 CFR 36.23(c),

- 10 CFR 36.29, and 10 CFR 36.59(b)."

. Describe the location and types of alarms and those individuals

[]

{

i who are trained to respond to those alarms. Diagrams and,

' sketches should be used, as appropriate.

. Discuss the alarm set-points or the methods for establishing the

[]

alarm set-points.

. > For irradiators whose construction begins after July 1,1993,

[]

describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and sensitivity and the wpenace testing that will be' performed to meet 10 CFR 36.41(c).

Neer: Underwater irradiators in which the product moves within an~

N/A N/A~'

enclosed stationary tube are exempt from the requirements of 10 CFR 36.29.

m t

C-5 Draft NUREG - 1556, Vol. 6 l

APPENDIX C

. Item

. Title and Criteria -

Yes Description No.

Attaebed 9.

Irradiator Pools l

For irradiators licensed before July 1,1993, write "Not applicable."

[]

i l

For irradiators licensed after July 1,1993, describe:

. The pool liner [If no water-tight stainless steel liner or a liner

[]

metallurgically compatible with other components in the pool is used, explain why the pool has a low likelihood of substantial leakage and how decontamination could be accomplished if necessary]

. The high and low water-level indicators and their locations

[]

. The purification system for the pool and explain why it is

[]

considered capable of maintaining pool water conductivity less than 20 microsiemens per centimeter l

. The means to replenish pool water

[]

The barrier used during normal operation to prevent personnel

[]

from falling into the pool How high radiation doses from radiation streaming will be -

[]

avoided when using long-handled tools or poles (use sketches if appropriate)

. If the pool has outlets more than 0.5 meter below the surface that

[]

could allow water to drain out of the pool, the means of preventing inadvertent excessive loss of pool water (in this context outlets do not include transfer tubes between adjacent pools because the transfer tubes do not provide a means to allow water to drain out of the pools).

9.

Source Raek

. Submit procedures for ensuring source rack pr6tection. If the

[]

product moves on a product conveyer system, describe the source rack protection to be provided to prevent products and product carriers fron2 touching the source rack or mechanism that moves the rack. Provide diagrams or sketches of those systems, if appropriate.

5 Draft NUREG - 1556, Vol. 6 C-6

APP!

Item Title and Criteria Yes Description.

No.

Attached 9.

Power Failures for Panoramic Irradiators

)

Describe how the sources are automatically returned to the

[]

shielded position if offsite power is lost for longer than 10 seconds.

[]

Describe how loss of power will affect the lock on the doors in j

the radiation room for a panoramic irradiator.

N/A N/A Note: For underwater irradiators, no response is required from the applicant in a license application.

10.

RADIATION SAFETY PROGRAM Need Not be Submitted with Audit Program Application The applicant's program for reviewing the content and implementation ofits radiation protection program will be examined during inspections, but should not be submitted in the license applicaion I

l C-7 Draft NUPIG - 1556, Vol. 6

l APPENDIX C j

l j

ltem Title and Criteria Yes Description No.

Attached 10.

Instruments l

Survey Instruments We will use survey instruments that meet the Criteria in the

[]

l section entitled " Radiation Safety Program - Instruments" in draft NUREG-1556, Vol. 6, dated March 1998.

AND ONE OF THE FO.LLOWING:

. Each survcy meter will be calibrated by the manufacturer or other

[]

person authorized by the NRC or an Agreement State to perform survey meter calibrations.

OR

= We will implement the model survey meter calibration program

[]

published in Appendix L in draft NUREG-1556, Vol. 6, dated l

March 1998.

OR

Submit alternative calibration procedures for NRC review.

[]

OR,IN LIEU OF ALL OF TIIE ABOVE, SUBMIT:

A description of an attemative method to perform surveys

[]

pursuant to 10 CFR 20.1501.

10.

Radiation Monitors

. Describe the type of monitors used to meet the requirements of

[]

10 CFR. 36.23(c),10 CFR 36.29, and 10 CFR 36.59(b).

10.

Material Accountability i

. Submit a description of procedure (s) for ensuring material accountability.

[]

Draft NUREG - 1556, Vol. 6 C-8

APPENDIX C ltem Title and Criteria Yes Description No.

Attached 10.

Occupational Dosimetry Need Not De l

Submitted with The applicant's occupational dosimetry program required by 10 Application CFR Parts 20 and 36 will be examined during inspection, but should not be submitted in a license application.

10.

Public Dose Need Not Be Submitted with The applicant's program to control doses received by individual Application members of the public will be examined during inspection, but should not be submitted in a license application.

10.

Operating Procedures Routine Operations

= Provide an outline that specifically states the radiation safety aspects of the written operating procedures listed in 10 CFR

[]

36.53(a)).

10.

Non-Routine Operations Submit either of the following:

The irradiator manufacturer or other person authorized by NRC

[]

or an Agreement State will perform non-routine operations such as source loading, unloading and repositioning, electrical troubleshooting of the control console, clearing stuck source racks, investigating /remediating removable contamination / leaking sources, (re) installing source cables, and other critical operations requiring special skills or having the potential for radiation overexposure.

OR

[]

The information listed in Appendix I in draft NUREG-1556, Vol.

6, dated March 1998.

l C-9 Draft NUREG - 1556, Vol. 6 l

l I

APPENDIX C Item Title and Criteria Yes Description l

No.

Attaebed 10.

Emergency Procedures

. Provide an outline that specifically states the radiation safety aspects of the written emergency procedures listed in the

[]

" Discussion" section (i.e., those procedures listed in 10 CFR 36.53(b)).

10.

Leak Tests For Dry-Source-Storage Irradiators Provide one of the following three alternatives:

. - Leak tests will be perfonned at intervals not to exceed 6 months.

[]

Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the irradiator manufacturer's (or distributor's) and the kit supplier's instructions.

Records ofleak test results will be maintained.

OR

= We will implement the model leak test program published in

[]

Appendix P to draft NUREG-1556, Vol. 6, dated March 1998.

OR

\\

. A description of alternative equipment and/or procedures for

[]

]

determining whether there is any radioactive leakage from sources contained in the irradiator.

i I

Draft NUREG - 1556, Vol. 6 C-10

APPENDIX C Item Title and Criteria Yes Description No.

Attached 10.

For PoolIrradiators Submit either of the following:

A description of equipment, procedures, and sensitivity of

[]

method that will be used to check for contamination by analysis ofa sample ofpool water.

OR

= A description ofequipment, procedures, and sensitivity of

[]

method that will be used to check for contamination by continuous monitoring of pool water.

10.

Inspection and Maintenance Describe laWon and ' maintenance checks, including the -

[]

fmquency of the checks listed in 10 CFR 36.61.

10.

Transportation Need Not Be i

Submitted with No response is needed from applicants during the licensing phase.

Application However, before making shipments oflicensed materials on its own in Type B packages, 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.

' 19.

Miniminneans of Com*amamation -

Need Not Be Submitted with The applicant does not need to provide a msponse to' this item under Appucation the following condition. ~NRC will consider that the criteria have.

been met if the applicant's responses meet the criteria for the following sections: " Radioactive Material - Scaled Sources and -

I Devices," " Facilities and Equipment - Irradiarar Pools" (If.

i applicable), " Radiation Safety Pmgram - Operating Procedures,"

"Radation Safety Program - E.wgay Procedums,"" Radiation ~

Safety Program - leak Tests," and " Waste Management - Scaled Source Transfer and Disposal."

C-11 Draft NUREG - 1556, Vol. 6

APPENDIX C Item Title and Criteria Yes Description i

No.

Attached l

11.

WASTE MANAGEMENT - SEALED SOURCE DISPOSAL Need Not Be AND TRANSFER Submitted with Application The applicant does not need to provide a response to this item during the licensing process. However, the licensee should establish and include waste disposal procedures in its radiation safety program.

l l

Draft NUREG - 1556, Vol. 6 C-12

Appendix D l

l Information Needed for Transfer of Control Application 1

APPENDIX D Information Needed for Transfer of Control Application Licensees must provide full information and obtain NRC'sprior written consent before transferring control of the license; some licensees refer to this as " transferring the license."

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.

3. Any changes in personnel having control over licensed activities (e.g., officers of a corporation) and any changes in personnel named in the license such as radiation safety officer, authorized users, or any other persons identified in previous license applications a.9 responsible for radiation safety or use oflicensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals.

4. An indication of whether the transferor will remain in non-licensed business without the license.

5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control.

6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or 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, surveys, inventories, and accountability requirements) will be current at the time of transfer.

Provide a description of the status of all surveillance requirements and records.

10. Confirmation that all records conceming the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g),40.36(f),70.25(g), and 72.30(d); public dose; and waste disposal by release to sewers, incineration, radioactive material spills, and on-site D-l Draft NUREG - 1556 Vol. 6

APPENDIX D burials, have been transferred to the new licensee, iflicensed activities will continue at the same location, or to the NRC for license terminations.

I1. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site?

12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35,40.36, and 70.25. Include information about how the transferee and transferor propose to divide the transferor's assets, and responsibility for any cleanup needed at the time of transfer.

13. Confirmation that the transferee agrees to abide by all commitments and representations previously made to NRC by the transferor. These include, but are not limited to: maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions.

With regard to contamination of facilities and equipment, the transferee should confirm, in writing, that it accepts full liability for the site, and should provide evidence of adequate resources to fund decommissioning; or the transferor should provide a commitment to decontaminate the facility before transferring control.

With regard to open inspection items, etc., the transferee should confirm, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferec proposes attemative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer.

14. Documentation that the transferor and transferee agree to transfer control of the licensed material and activity, and the conditions of transfer; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions.

15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description ofits program, to ensure compliance with the license and regulations.

Reference:

The information above is contained in IN 89-25, Revision 1, " Unauthorized Transfer of Ownership or Control of Licensed Activities." See the Notir.e of Availability (on the inside front cover of this draft report) to obtain copies.

Drail NUREG - 1556. Vol. 6 D-2

i l

l Appendix E f

Suggested Wording for a Statement of Intent for a Government Licensee l

l l

I

i APPENDIX E i

Suggested Wording for a Statement of Intent for a Government Licensee

[DATE]

TO: U. S. NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555 [or appropriate regional address]

STATEMENT OF INTENT i

As [ Title] of [ Licensee Name] I exercise express authority and responsibility to approve funding for decommissioning activities associated with operations authorized by U. S. Nuclear Regulatory Commission Material License No. [ License No.]. This authority is established by

[Name of Document (s) Governing Control of Funds]. Within this authority, I intend to have funds made available when necessary in an amount up to [ Dollar A. mount] to decommission

[ Description of Facilities). I intend to request and obtr.in these funds sufficiently in advance of decommissioning to prevent delay of required activities.

A copy of[Name of Doctunents] is attached as evidence that I am authorized to represent i

[ Licensee Name] in this transaction.

[ SIGNATURE]

[NAME]

[ TITLE]

l i

i i

l l

E-1 Draft NUREG - 1556, Vol. 6 L---------_------------------------_-----------------------

i Appendix F i

Irradiation of Explosive Materials or Greater Than Small Quantities of Flammable Materials l

APPENDIX F Explosive Materials i

Irradiation of explosive materials is prohibited under 10 CFR Part 36 unless the applicant has received prior written authorization from the NRC. If an applicant requests authorization to irradiate explosive materials, he or she must be able to demonstrate that detonation of the explosive would not rupture the irradiator sealed sources, injure personnel, damage safety systems, or cause radiation overexposure of personnel.

Greater Than Small Quantities of Flammable Materials Prior written authorization from NRC is required by 10 CFR 36.69(b) before irradiation of more than small quantities of flammable materials with a flash point below 60 C (140 F). As defined in the National Fire Code NFPA 30, " Flammable and Combustible Liquids Code," published by the National Fire Protection Association, the flash point is "the minimum temperature at which a liquid gives off vapor in sufficient concentration to form an ignitable mixture with air near the surface of the liquid.... "According to the NFPA 30 classification system, Class I and Class II liquids have flash points below 60*C (140 F). The flash points of many substances are tabulated in National Fire Code NFPA 325M, " Fire Hazard Properties of Flammable Liquids, Gases, and Volatile Solids."' Flash points are also specified on the Material Safety Data Sheets for industrial chemicals, when applicable. Examples of common flammable liquids with a flash point below 60 C (140 F) are acetone, benzene, most alcohols, number two fuel oil, gasoline, kerosene, toluene, turpentine, and any flammable gas.

NRC is concemed about irradiating flammable materials which may cause an explosion, if the flash point of a flammable liquid is exceeded, the concentration of the vapor in air could exceed the flammable limit and the potential for an explosion could exist.

The NRC considers that compliance with the requirements in 10 CFR 36.21,36.27,36.35, 36.39(h),36.41(h), and 36.53(b)(7) will provide adequate protection against radiological impacts arising from a fire. With an energetic explosion, however, applicants should consider the possibility of direct damage to the source encapsulation or to the source rack preventing it from being lowered to the shielded position.

A "small quantity" of flammable material can be defined as a quantity of flammable material that, when dispersed evenly throughout the radiation room with no loss to ventilation, would have a concentration below the lower flammable limit concentration. Although local concentrations could exceed the average room concentration, the movement of air into and out of the radiation room provides a margin of safety. In addition, the time required to vaporize all the

' Copies may be obtained from the National Fire Protection Association,1 Batterymarch Park, P. O. Box 9146, Quincy, MA 02269-9959 (Telephone No. 1-800-344-3555).

l F-1 Draft NUREG - 1556, Vol. 6

APPENDIX F material also adds to the margin of safety. Further, small pockets of flammable vapor will contain quantities of energy too small to provide a force strong enough to significantly damage the irradiator. Given these factors, the definition of small quantity is considered to be conservative enough to ensure safe operation of an irradiator.

(

Special precautions must be taken when irradiating cryogenic material. The hazard from cryogenic irradiation occurs when air condenses o: freezes (possibly insidiously without detection) on cold surfaces during irradiation. While the exact details are uncertain, oxygen in the air is converted by the radiation to ozone. Under certain circumstances (often during a subsequent warm-up), the ozone decomposes or reacts with other agents explosively. If cryogenic material is to be irradiated the applicant must submit procedures for ensuring the safe handling of such material.2 Example of Determining a Small Quantity of Flammable Material This example considers the irradiation ofisopropyl alcohol in a radiation room whose total volume is 100 m). NFPA 325M states that the lower flammable limit for isopropyl alcohol is 2 percent by volume, the specific gravity of the liquid is 0.8, and the vapor density relative to that of air is 2.1. The density of air is 1.293 kg/m'. The volume ofisopropyl alcohol in the room at 3

3 the lower flanunable limit will be 2 percent of 100 m, which is equal to 2 m. The weight will be 2 m' x 1.293 kg/m x 2.1 (density relative to air) = 5.43 kg. With a specific gravity of 0.8, the 3

volume of the liquid isopropyl alcohol would be 6.79 liters. If the liquid mixture were 70 percent isopropyl alcohol and 30 percent water, the volume of a small quantity would be 6.79/0.7 = 9.7 2

liters. Thus, in a radiation room with a volume of 100 m, a volume less than 9.7 liters of 70 percent pure isopropyl alcohol (exposed to the direct radiation beam) can be considered a small quantity because the flammable limit could not be reached in any significant volume even if there were no ventilation.

If the applicar.t irradiates small quantities of flammable material, the licensee's records should demonstrate that the above criterion for small quantities has been met, including how the licensee limited the quantity of flammable material in the radiation room at one time.

If the quantity to be exposed to the direct beam at any one time would exceed a small quantity, it is necessary to consider whether the concentration of flammable vapor in the room air could exceed the lower flammable limit. If product movement through the irradiator stopped and the radiation sources could not be retumed to the shielded position, the temperature of the irradiated 2

This information was taken from Oak Ridge National Laboratory Report ORNL/M-260, DE87 002877, " Safety Analysis Report for the National Low-Temperature Neutron Irradiation Facility (NLTNIF) at the ORNL Bulk Shielding Reactor (BSR)," June 1986.

Draft NUREG.1556, Vol. 6 F-2

APPENDIX F product would rise, the vapor pressure of the flammable material would increase, and that pressure might cause the containers to leak and release flammable vapor into the room air. If ventilation were insufficient, the flammable vapor concentration might exceed the lower flammable limit and a spark could cause the mixture to explode.

I Requests for Approval to Irradiate More than Small Quantities of FlammabM Material The applicant must demonstrate that it is unlikely that the concentration of flammable vapor in air in a significant volume of the room would exceed the lower flammable limit. There are two methods to do this. The first method is to demonstrate that no single failure would be likely to cause the product to become immobilized in the radiation room and prevent the sources from being returne.1 to the shielded position. Such a situation theoretically might arise if the product carriers becamejammed and pushed into the source rack preventing its return to the shielded position. The second method is to demonstrate that even if the product became immobilized and j

the source rack could not be returned to the shielded position, the ventilation system would i

prevent the concentration of flammable vapor in a significant volume of the room air from reaching the lower flammable limit.

If an applicant is applying for authorization to irradiate more than a small quantity of flammab.e material, the application should include all of the following information:

Name of the flammable material that has a flash point below 60 C (140*F) and its flash point Its flammable limit as percent by volume in air f

Its specific gravity as a liquid Its vapor density relative to that of air j

Maximum quantity to be in the direct radiation beam in the radiation room at any one time Description of the packaging for the product.

l In addition, the application should:

EITIIER Describe why a single failure is unlikely to cause immobilization of the product being irradiated with the simultaneous inability to return the sources to the shielded position.

)

F-3 Draft NUREG - 1556, Vol. 6 l

l

' APPENDIX F OR Describe why the ventilation system will prevent the concentration of vapor in air from exceeding the lower flammable limit in a significant volume of the room if the product is immobilized and the sources cannot be returned to the shielded position. If this second approach is taken, the applicant should also provide a procedure to return the source to the shielded position and remove the product from the radiation room if the ventilation system fails. The procedure should also identify the means to detect ventilation system failure.

l Draft NUREG - 1556, Vol. 6 F-4

Appendix G Training for Radiation Safety Officers and Irradiator Operators

l.

l APPENDIX G Training for Radiation Safety Officers and Irradiator Operators Course Content Instruction may be in the form oflecture, videotape, or self-study emphasizing practical subjects important to safe use ofirradiators:

Radiation Safety:

- Extemal radiation vs. radioactive contamination

- Intemal vs. extemal exposure

- Biological effects of radiation (e.g., why large radiation doses must be avoided)

- Units of radiation dose

- Types and relative hazards of radioactive material possessed

- ALARA concept

- Use of time, distance, and shielding to minimize exposure (e.g., how shielding and access controls prevent large doses)

- Proper use of survey meters and personnel dosimeters.

. Regulatory Requirements:

- Applicable regulations

- NRC dose limits

- License conditions, amendments, renewals

- Locations of use and storage of radioactive materials

- Material control and accountability

- Annual audit of radiation safety program

- Transfer and disposal

- Record keeping

- Case histories of accidents or problems involving irradiators

- Handling incidents

- Recognizing and ensuring that radiation waming signs are visible and legible

- Licensing and inspection by regulatory agency G1 Draft NUREG - 1556, Vol. 6

APPENDIX G

- Need for complete and accurate information (10 CFR 30.9)

- Employee protection (10 CFR 30.7)

- Deliberate misconduct (10 CFR 30.10).

Practical Explanation of the Theory and Operation'for Irradiators:

- Basic function of the irradiator

- Radiation safety features of an irradiator

- Operating and emergency procedures which the individual is responsible for performing

- Routine vs. non-routine maintenance

- Lock-out procedures -

- How an irradiator is designed to prevent contamination.

On-the-job or simulator training must be done under the supervision of a qualified irradiator operator:

. Supervised Hands-on Experience Performing:

- Operating procedures which the individual is responsible for performing

- Test runs of emergency procedures which the individual is responsible for performing

- Routine maintenance

- Lock-out procedures.

. Training for an RSO should include at least 3 months (full-time equivalent) of experience at the applicant's irradiator or at another irradiator of a similar type. The 3 months of experience may include preoperational involvement, such as acceptance testing, while the irradiator is being constructed.

Course Examination i

. Written examination designed to verify an individual's competency and understanding of the subject matter (e.g.,25 to 50 question, closed-book written test with 70 percent as passing grade

- Emphasis on radiation safety ofirradiator operations and maintenance, licensee operating j

and emergency procedures that the individual will be responsible for performing, and other operations necessary to safely operate the irradiator without supervision j

- Review of correct answers to missed questions with prospective irradiator operators immediately following the scoring of the test.

j Draft NUREG 1556, Vol. 6 G-2

APPENDIX G l

l Training Assessment Management will ensure that potential RSOs and authorized operators are qualified to work independently with irradiators. This must be demonstrated by written examination and by direct observations.

l Course Instructor Qualifications Instructor should have either:

. Bachelor's degree in a physical or life science or engineering

. Successful completion of an irradiator manufacturer's course for users (or equivalent)

. Successful completion of an 8 hour9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months radiation safety course AND 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months hands-on experience with irradiators OR

Successful completion of an irradiator manufacturer's course for users (or equivalent)

Successful completion of 40 hour4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months radiation safety course; AND 30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months of hands-on experience with irradiators.

Note:

Licensees must maintain records of training (10 CFR 36.81(b)).

. Additional training is required for those applicants intending to perfonn non-routine l

operations such as source loading and unloading. See Appendix I, "Non-Routine Operations."

I 1

G-3 Draft NUREG - 1556, Vol. 6 l

L

l Appendix H Typical Duties and Responsibilities of the Radiation Safety Officer I

i l

l APPENDIX }{

Typical Duties and Responsibilities of the Radiation Safety Officer The RSO's duties and responsibilities include ensuring radiological safety and compliance with both NRC regulations and the conditions of the license. Typically, the RSO's duties and responsibilities include:

Stopping activities that the RSO considers unsafe Keeping exposures ALARA e

Developing, maintaining, distributing, and implementing up-to-date operating and emergency procedures Ensuring that individuals associated with irrediator operations are properly trained and evaluated Ensuring that non-routine operations (See Appendix I) for irradiators are consistent with the limitations in the license, the Sealed Source and Device Registration Cenificate(s), and the manufacturer's (distributor's) written recommendations and instructions Analyzing potential safety consequences of non-routine operations before conducting any such activities that have not been previously analyzed Ensuring non-routine operations are performed by the manufacturer (distributor) or other i

person specifically authorized by the NRC or an Agreement State to perform those operations Ensuring that personnel monitoring devices are used and exchanged at the proper intervals, e

and records of the results nf such monitoring are maintained by the licensee Maintaining documentation that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10 percent of the allowable limits or provide personnel monitoring devices Notifying proper authorities ofincidents such as damage to or malfunction ofirradiators, fire, loss or theft oflicensed materials (See also Appendix 0)

Investigating emergencies and abnormal events involving the irradiators (e.g., malfunctions or damage), identifying cause(s), implement appropriate and timely corrective action (s)

Performing radiation safety program audits at least every 12 months and developing, implementing, and documenting timely corrective actions Ensuring transport oflicensed material according to all applicable DOT requirements Ensuring proper disposal oflicensed material e

Maintaining appropriate records associated with irradiator operations e

Maintaining an up-to-date license and timely submission of amendment and renewal requests l

11-1 Draft NUREG - 1556, Vol. 6

1 APPENDIX H 1

. Ensuring that when the licensee identifies violations of regulations or license conditions or program weaknesses, corrective actions are developed, implemented, and documented i

DraA NUREG - 1556, Vol. 6 H-2

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l Appendix I l

l l

Information Needed to Support Applicant's Request I

to Perform Non-Routine Operations l

APPENDlX i l

information Needed to Support Applicant's Request to Perform Non-l Routine Operations Non-routine operations may include the following:

. Source loading, unloading and repositioning

= Troubleshooting the control console

Clearing stuck source racks

. Investigating /remediating removable contamination / leaking sources

. (Re) installing source cables

Any other activity during which personnel could receive radiation doses exceeding NRC limits.

If these operations are not performed properly with attention to radiation safety principles, the irradiator may not operate as designed and personnel performing these tasks could receive lethal radiation doses.

Applicants wishing to perform non-routine operations must use personnel with special training and follow appropriate procedures consistent with the manufacturer's (distributor's) written instructions and recommendations that address radiation safety concerns (e.g., use of radiation survey meter, personnel dosimetry). Accordingly, provide the following information:

. Describe which non-routine operations will be performed. The pnu,cipal reason for obtaining this information is to assist in the evaluation of the qualifications ofindividuals who will conduct the work and the radiation safety procedures they will follow.

Identify who will perform non-routine operations and their training and experience applicable to these operations. Acceptable training would include manufacturers' courses for non-routine operations or equivalent.

. Submit procedures for non-routine operations. These procedures should ensure the following:

- doses to personnel and members of the public are within regulatory limits and ALARA l

(e.g., use of shielding and adequate planning when working with unshielded sources)

- manufacturer's (distributor's) written instructions and recommendations are followed

- planned special exposure requirements (10 CFR 20.1206), if applicable, are met

- operations involving source loading, unloading, and repositioning include recording the rack position of each source and surveying all empty or loaded source transport containers 1-1 Draft NUREG - 1556, Vol. 6

APPENDIX I for removable contamination to prevent the introduction of radioactive contaminants into the irre.diator.

. Confirm that individuals performing non-routine operations will wear whole body radiation

. dosimetry, if appropriate.

Describe steps to be taken to ensure that radiation levels in areas where non-routine operations will take place do not exceed 10 CFR 20.1301 limits. For example, applicants can do the following:

- commit to performing surveys with a survey instrument;

- specify.where and when surveys will be conducted during non-routine operations; and

- commit to maintaining, for 3 years from the date of the survey, records of the survey (e.g.,

who performed the survey, date of the survey, instrument used, measured radiation levels correlated to location of those measurements), as required by 10 CFR 20.2103.

t 1

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m.o sum. isse.

te l

t l

i Appendix J Construction Monitoring and Acceptance Testing l

l t

1

APPENDIX J Construction Monitoring and Acceptance Testing To ensure that irradiators and their components are built and installed as designed,10 CFR Part 36 requires that licensees conduct monitoring and acceptance testing before loading sealed sources. Figure J.1 illustrates this point and Table J.1 correlates the components to be checked and the types of tests with the type ofirradiator to which the requirement applies.

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. b $%(;.1.gh$kh

'"""*Ef Figure J.1 Construction Monitoring and Acceptance Testing. Before loading sealed sources, irradiator licensees must ensure that the as-built irradiator meets design criteria.

Table J.1 Construction Monitoring and Acceptance Testing Irradiator Irradiator Type Licensee Requirement Elements Shielding Panoramic Monitor the constmetion of the shielding to make sum that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.

Foundations Panoramic Monitor the construction of the foundations to verify that their construction meets design specifications.

PoolIntegrity Pool Verify that the paol meets design specifications including requirements in 10 CFR 36.33(a) and test the integrity of the pool.

Verify that outlets and pipes meet the requirements of 10 CFR 36.33(b).

J-1 Draft NUREG - 1556, Vol. 6

APPENDIX J Irradiator Irradiator Type Licensee Requirement Elenients Water Pool Verify that the water purification system, the conductivity Handling meter, and the water level indicators operate properly System (water level controls should be checked, ifinstalled).

All Verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by 10 CFR 36.29(a).

Pool Verify the proper operation of the radiation monitors and the related alarm if used to meet 10 CFR 36.59(b).

Radiation Underwater Verify the proper operation of the over-the-pool monitor, Monitors alarms, and interlocks required by 10 CFR 36.29(b).

Source Rack Panoramic Test the movement of the source racks for proper operation prior to source loading; testing must include source rack lowering due to simulated loss of power.

Irradiator with Observe and test the operation of the conveyor system to Product Conveyor ensure that the requirements in 10 CFR 36.35 are met for Systems protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

Access Panoramic Test the completed access control system to ensure that it Control functions as designed and that all alarms, controls, and interlocks work properly.

i Fire Panoramic Test the ability of the heat and smoke detectors to detect a Protection fire, to activate alarms, and to cause the source rack to automatically become fully shielded. The licensee must test the operability of the fire extinguishing system.

{

Source Panoramic Demonstrate that the source racks can be returned to their Retum fully shielded positions without offsite power.

l 1

Dran NUREG - 1556, Vol. 6 J-2 i

APPENDIX J Irradiator Irradiator Type Licensee Requirement Elements Computer Panoramic, that use Verify that the access control system will operate properly Systems a computer system if offsite power is lost and verify that the computer has to control the access security features that prevent an irradiator operator from control system commanding the computer to override the access control system when it is required to be operable.

Wiring Panoramic Verify that the electrical wiring and electrical equipment that were installed meet the design specifications (e.g.

radiation-resistant wiring installed in appropriate locations and according to code).

J-3 Draft NUREG - 1556, Vol. 6

l Appendix K Suggested Audit Checklist for 10 CFR Part 36 Irradiators

APPENDIX K Suggested Audit Checklist for 10 CFR Part 36 Irradiators Note: All areas indicated in audit notes may not be applicable to every license and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities and activities which have not occurred since the last audit need not be reviewed at the next audit, l

i Licensee's Name:

License No.:

Date ofThis Audit:

Date,:

(Auditor Signature)

Date:

(Management Signature) 1 Audit History A. Last audit of this location conducted on (date)

B. Were previous audits conducted at intervals not to exceed least every 12 months? [10 CFR 20.1101]

C. Were records of previous audits maintained? [10 CFR 20.2102]

D. Were any deficiencies identified during last two audits or two years, whichever is longer?

E. Were corrective actions taken? (Look for repeated deficiencies).

Organization and Scope of Program A. If the mailing address or places of use changed, was the license amended?

B. If ownership changed or bankruptcy filed, was NRC prior consent obtained or was NRC notified?

l C. Radiation Safety Oflicer I

I I

K1 Draft NUREG - 1556, Vol. 6

APPENDIX K

1. If the RSO.was changed, was license amended?

1 1

2. Does new RSO meet the licensee's training requirements?

l

3. Is RSO fulfilling his/her duties?

4. To whom does RSO report? -

D. If the designated contact person for NRC changed, was NRC notified?

E. Scaled Sources and Devices

1. Does the license authorize all of the NRC regulated radionuclides contained in irradiators?

2. Have copies of(or access to) SSD Certificates?

3. Are the sealed sources, and if applicable, devices in accordance with the description in the Scaled Source and Device (SSD) Registration Certificates? [10 CFR 32.210]

4. Have manufacturers' (distributor's) manuals for operation and maintenance? =

5. Are the actual uses of the irradiator consistent with the authorized uses listed on the license?

6. Are the sealed sources used under conditions specified in the " Conditions of Normal Use" and " Limitations and/or Other Considerations of Use" on the SSD Registration Certificates?

Training and Instructions to Workers A. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed per (10 CFR 19.12]? Refresher training provided, as needed? Records maintained?

B. Did each individual permitted to operate the irradiator without a supervisor present, receive instruction according to the license commitments and 10 CFR 36.51 before operating the irradiator?

C. Are records of training, tests, safety reviews, and annual evaluations maintained for each authorized irradiator operator? [10 CFR 36.81(b), (c)]

D. Did individuals who perform non-routine operations receive training before performing these

- operations?-

E. Did interviews reveal that individuals know the emergency procedures?

F. Did this audit include observations ofirradiator operations?

G. Do workers know requirements for the following:

Draft NUREG - 1556, Vol. 6 K-2

APPENDIX K

. the radiation safety program J

= annualdoselimits

. new Form NRC 4 and 5 10% monitoring threshold

. dose limits to embryo / fetus and declared pregnant worker

. gravedangerposting?

Radiation Survey instruments and Radiation Monitors I

A. Are all portable survey meters calibrated at least annually to an accuracy of +/- 20% for the gamma energy of the sources in use? [10 CFR 36.57(c)]

B. Are portable survey meters of a type that does not saturate and read zero at high dose rates?

j

[10 CFR 36.57(c)]

i B. Are calibration records maintained?

C. Are all operable survey instruments able to detect 0.5 microsievert (0.05 mrem) per hour?

D. Has the licensee evaluated the location and sensitivity of the radiation monitor to detect j

sources carried by the product conveyor system for automatic conveyor systems? [10 CFR 36.29(a)]

E. Has the lirensee tested the operability and sensitivity of monitor used to detect the presence of high radiation levels in the radiation room before personnel entry at frequency specified in license application?

L F. Has the licensee tested the operability and sensitivity of monitor used to detect contamination of pool water due to leaking sources? (frequency of checks as specified in license i

application?)

l G. For underwater irradiators not in a shielded radiation room, has the licensee tested the l

operability and sensitivity of monitor used to detect abnormal radiation levels? (frequency of checks as specified in license application?)

Conductivity Meters A. Are appropriate operable conductivity meters possessed and used?

' B. Are conductivity meters calibrated at least annually? [10 CFR 36.63(b)]

K-3 Draft NUREG - 1556, Vol. 6

- APPENDIX K Sealed Source Accountabn3ty Program

{

A. Are records maintained showing the receipt, location, transfer, and disposal of each sealed source? [10 CFR 30.51(a)(1)]

B. Is material accountability program as described in application being implemented?

I Personnel Radiation Protection A. Are ALARA considerations incorporated into the radiation protection program? [10 CFR 20.1101(b)]

B. Is documentation kept showing that unmonitored individuals receive 510% oflimit? [10 CFR 20.1502(a)]

C. Did unmonitored individuals' activities change during the year which could put them over 10% oflimit?

D. If yes to C. above, was a new evaluation performed?

E. Is extemal dosimetry provided to individuals as required by 10 CFR 36.55 and to individuals likely to receive >10% oflimit?

1, Irradiator Operators: Is the dosimetry supplier NVLAP approved? [10 CFR 20.1501(c)]

2. Are the dosimeters exchanged monthly for film badges and quarterly for TLDs?

3. Are dosimetry reports reviewed by the RSO upon receipt?

4. Are dosimeters provided to persons who enter the radiation room of a panoramic irradiator? [10 CFR 36.55(b)]

5. Annual checks of accuracy of pocket dosimeters performed? [10 CFR 36.55(b)]

6. Are the records NRC Forms or equivalent? [10 CFR 20.2104(d),10 CFR 20.2106(c)]

a. NRC-Form 4 " Cumulative Occupational Exposure History" completed?

1

b. NRC-Form 5 " Occupational Exposure Record for a Monitoring Period" completed?

l

7. Declared pregnant worker / embryo / fetus

]

If a worker declared her pregnancy, did licensee comply with [10 CFR 20.1208]?

a.

b. Were records kept of embryo / fetus dose per [10 CFR 20.2106(e)]?

F. Are records of exposures, surveys, monitoring, and evaluations maintained [10 CFR 20.2102, 10 CFR 20,2103,10 CFR 20. 2106,10 CFR 36.57(a)]

)

1 I

Draft NUREG - 1556. Vol. 6 K-4

APPENDIX K Public Dose k

A. Is public access controlled in a manner to keep doses below I mSv (100 mrem) in a year?

[10 CFR 20.1301(a)(1)]

B lias a survey or evaluation been performed per 10 CFR 20.1501(a)? Have there been any i

additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation?

C. Do unrestricted area radiation levels exceed 0.02 mSv (2 rnrem) in any one hour? [10 CFR 20.1301(a)(2)]

D. Is access to sealed sources controlled in a manner that would prevent unauthorized use or removal? [10 CFR 20.1801]

l E. Records maintained? [10 CFR 20.2103,10 CFR 20.2107]

l Operating and Emergency Procedures A.' Have operating and emergency procedures been developed? [10 CFR 36.53]

B. Do they contain the required elements?

C. Does each individual working with the sealed sources have a current copy of the operating and emergency procedures (including emergency telephone numbers)?

D. Did any emergencies occur?

1. ' If so, were they handled properly?

2. Were appropriate corrective actions taken?

3. Was NRC notification or reporting required? [10 CFR 20.2201,2202,2203,10 CFR 30.50 and 10 CFR 36.83]

Leak Tests A. Were valed sources leak tested at prescribed intervals? [10 CFR 36.59]

B. Was the leak test performed according to regulatory requirements? [10 CFR 36.59]

C. Are records of results retained with the appropriate information included?

D. Were any sealed sources found leaking and if yes, were appropriate actions taken end was NRC notified? [10 CFR 20.2201,10 CFR 20.2203,10 CFR 21.21,10 CFR 30.50, 10 CFR 36.59,10 CFR 36.83]

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K-5 Draft NUREG - 1556, Vol. 6 j

I L-

. APPENDIX K -

Inspection and Maintenance Checks A. Are all procedures for maintenance of the irradiator being followed where applicable?

B. Are all checks to determine proper functioning and wear of the source movement systems performed at frequencies as specified in the license application?

C. Are labels, signs, and postings clean and legible?

D. Are checks for operability as required by 10 CFR 36.61(a)(not included previously under

" Radiation Survey Instruments and Radiation Monitors.) performed at frequencies and according to procedures described in license application:

= Each aspect of the access control system

. Emergency source retum control

. Heat / smoke detectors, extinguisher system

. Pool water replacement system high and low water indicators

. For underwater irradiators, was the intrusion alarm tested for operability? (frequency of checks as specified in license application?

E. Are checks for functioning and condition of equipment performed at required frequencies and according to procedures described in license application:

. ~ Assessment of the condition and operability of the source rack protector are performed at the required frequencies [10 CFR 36.61(a)].

Assessment of water added to the pool to determine if there is pool leakage are performed

. at required frequencies as required by (10 CFR 36.61(a)(14)].

. Assessment of radiation damage to electrical wiring are performed at required frequencies as required by [10 CFR 36.61(a)(15)].

. Water conductivity and analysis are performed at required frequencies [10 CFR 36.63]

. Confirmation that water circulation system is leak tight. [10 CFR 36.61(a)(7)]

1

. Functioning of the source position indicator [10 CFR 36.61(a)(2)]

. Leak tightness of water circulation system, visual inspection [10 CFR 36.61(a)(7)]

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Draft NUREG - 1556, Vol. 6 K-6 j

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APPENDIX K Repair and Preventive Maintenance A. Are repair and maintenance of components related to the radiological safety of the irradiator performed by the manufacturer or person specifically authorized by the NRC or an Agreement State and according to license requirements (e.g., extent of work, procedures, dosimetry, survey instrument, compliance with 10 CFR 20.1301 limits)?

B. Malfunctions and defects found during inspection and maintenance checks are repaired without undue delay.

Transportation Note: This section will not apply if sealed sources have not been transported during the period covered by this audit.

A. Were sources shipped ~since the last audit?

B. If so, were 10 CFR Part 71 requirements followed?

C. DOT-Type A or Type B packages used? [10 CFR Part 71,49 CFR 173.415,49 CFR 173.416(b)] If Type B, NRC Certificate of Compliance granted before shipment or shipper is registered as a user of the Type B package? NRC-approved QA program?

D. Package performance test records on file? [49 CFR 173.415(a)]

E. Special form sources documentation? [49 CFR 173.476(a)]

F. Package has 2 labels (ex. Yellow-II) with TI, Nuclide, Activity, and Hazard Class? [49 CFR 172.403,49 CFR 173.441]

G. Package properly marked? [49 CFR 172.301,49 CFR 172.304,49 CFR 172.310, 49 CFR 172.324]

H. Package closed and sealed during transport? [49 CFR 173.475(f)]

1. Shipping papers prepared, used, and maintained? [49 CFR 172.200(a))

J. Shipping papers contain proper entries? (Shipping name, Hazard Class, Identification Number (UN Number), Total Quantity, Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form,' Activity, category oflabel, TI, Shipper's Name, Certification and Signature, Emergency Response Phone Number, Cargo Aircraft Only (if applicable)}

[49 CFR 172.200,49 CFR 172.201,49 CFR 172.202,49 CFR 172.203,49 CFR 172.204,49 CFR 172.604 ]

' K. Secured against movement? [49 CFR 177, 834 )

r L. Placarded on vehicle, if needed? [49 CFR 172.504]

h K-7 Draft NUREG - 1556, Vol. 6 E-_____________

]

APPENDIX K i

l M. Proper overpacks, if used? [49 CFR 173.25]

N. Any incidents reported to DOT? [49 CFR 171.15,49 CFR 171.16]

Auditor's independent Survey Measurements A. Describe the type, location, and results of measurements. Does any radiation level exceed

~

regulatory limits [10 CFR 20.1501(a) & 1502(a)]?

Notification and Reports A. Was a telephone report made within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months as described in 10 CFR 36.83(b),10 CFR 30.50(c)(1), and a written report within 30 days as described in 10 CFR 30.50(c)(2) of any of the following:

1. Source stuck in an unshielded position

2. Any fire or explosion in a radiation room

3. Damage to the source rack

4. Failure of the cable or drive mechanism used to move the source racks

5. Inoperability of the access control system

6. Detection of radioactive contamination attributable to licensed radioactive material

7. Detection of radioactive contamination attributable to licensed radioactive material

8. Structural damage to the pool liner or walls

9. Abnormal water loss or leakage from the source storage pool

10. Pool water conductivity exceeding 100 microsiemens per centimeter.

B. Was any radioactive material lost or stolen? Were reports made? [10 CFR 20.2201,10 CFR 30.50]

C. Did any reponable incidents occur? Were reports made? [10 CFR 20.2202,10 CFR 30.50]

D.' Did any overexposure and high radiation levels occur? Reported? [10 CFR 20.2203,10 CFR 30.50]

E. If any events (as described in items a through c above) did occur, what was root cause? Were corrective actions appropriate?

l F. Is the management /RSO/ shift foreman /irradiator operator aware of telephone number for NRC Emergency Operations Center? [(301) 816-5100]

I Draft NUREG - 1556, Vol. 6 K-8 j'

APPENDIX K Posting and Labeling '

A. NRC-Form 3 " Notice to Workers" posted? [10 CFR 19.11]

B. NRC regulations, license documents posted or a notice posted? [10 CFR 19.11,10 CFR 21.6]

C. Other posting and labeling? [10 CFR 20.1902,10 CFR 20.1904]

According to 10 CFR 36.23(g), the radiation room of a panoramic irradiator must be posted as a "high radiation area." However,10 CFR 20.1902(c) requires that the area be posted as a "very high radiation area." There has been an oversight in not adopting in 10 CFR Part 36 the "very high radiation area" concept that is contained in 10 CFR Part 20. The NRC plans to change 10 CFR 36.23(g) to require posting as a "very high radiation area." In the meantime, the preferred posting is "very high radiation area," and irradiators posted in this manner will not be subject to enforcement action under 10 CFR 36.23(g).

Record Keeping for Decommissioning A. Records kept ofinformation important to decommissioning? [10 CFR 30.35(g)]

B. Records include all information outlined in [10 CFR 30.35(g)]?

Bulletins and Information Noticos A. NRC Bulletins, NRC Information Notices, NMSS Newsletters, received?

B. Appropriate training and action taken in response?

Special License Conditions or issues A. Did auditor review special license conditions or other issues (e.g., non-routine operations)?

Deficiencies identified in Audit; Corrective A. Summarize problems / deficiencies identified during audit.

B. If problems / deficiencies identified in this audit, describe corrective actions planned or taken.

Are corrective actions planned or taken at ALL licensed locations (not just location audited)?

l Include date(s) when corrective actions are implemented.

l' C. Provide any other recommendations for improvement.

p' K-9 Draft NUREG - 1556, Vol. 6 I

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APPENDIX K Evaluation of Other Factors A. Senior licensee management is appropriately involved with the radiation protection program and/or Radiation Safety Officer (RSO) oversight?

B. RSO has sufficient time to perform his/her radiation safety duties?

C. Licensee has sufficient staff to support the radiation protection program?

Draft NUREG - 1556, Vol. 6 K-10

Appendix L Model Survey Instrument Calibration Program

APPENDIX 1 Model Survey instrument Calibration Program Training Before calib;ating survey instruments independently, the individual should complete both classroom and on-the-job training as follows:

. Classroom training may be in the form oflecture, videotape, or self-study and will cover the following subject areas:

- Principles and practices of radiation protection

- Radioactivity measurements, monitoring techniaues, and the use of instruments

- Mathematics and calculations basic to using and measuring radioactivity

- Biological effects of radiation.

. On-the-job-training will be considered complete if the individual has:

- Observed authorized personnel perfonning survey instrument calibration, and

- Conducted survey metc r librations under the supervision, and in the physical presence of an individual already authorized to perfonn calibrations.

Facilities 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.

I i

Model Procedure for Calibrating Survey Instruments l

= A radioactive sealed source (s) will be used for calibrating survey instruments, and this source i

will:

- Approximate a point source

- Have its apparent source activity or the exposure rate at a given distance traceable by documented measurements to a standard certified to be within

5% accuracy by National Institutes of Stat.dards and Technology (NIST)

L-1 Draft NUREG - 1556, Vol. 6

APPENDIX L

- Contain a radionuclides which emits photons ofidentical or similar energy as the sealed sources that the instrument will measure

- Be strong enough to give an exposure rate of at least 30 mR/ hour (7.7 microcoulomb / kilogram per hour) at 100 cm (e.g.,3.1 gigabecquerels (85 millicuries) of Cs-137 or 780 megabecquerels (21 millicuries) of Co-60].

. Inverse square and radioactive decay laws must be used to correct changes in exposure rate due to changes in distance or source decay.

A record must be made of each survey meter calibration.

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A single point on a survey meter scale may be considered satisfactorily calibrated if the indicated exposure rate differs from the calculated exposure rate by less than *20%.

There are three kinds of scales frequently used on radiation survey meters. They are calibrated as follows:

- Meters on which the user selects a linear scale must be calibrated at not fewer that two paints on each scale. The points will be at approximately 1/3 and 2/3 of the decade.

- Meters that have a multidecade logarithmic scale must be calibrated at one point (at the least) on each decade and not fewer than two points on one of the decades. Those points will be approximately 1/3 and 2/3 of the decade.

- Meters that have an automatically ranging digital display device for indicating exposure rates must be calibrated at one point (at the least) on each decade and at no fewer than two points on one of the decades. Those points should be at approximately 1/3 and 2/3 of the decade.

Readings above 200 mR/ hour'(50 microcoulomb / kilogram per hour) need not be calibrated.

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However, higher scales should be checked for operation and approximately correct response.

Survey meter calibration reports will indicate the procedure used and the results of the calibration. The reports will include:

- The owner or user of the instrument

- A' description of the instrument that includes the manufacturer's name, model number,

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serial number, and type of detector

- A description of the calibration source, including the exposure rate at a specified distance on a specified date, and the calibration procedure

. For each calibration point, the calculated exposure rate, the indicated exposure rate, the deduced correction factor (the calculated exposure rate divided by the indicated exposure rate), and the scale selected 'on the instrument

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. Draft NUREG - 1556, Vol. 6 L-2 1

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APPENDIX I l

- The exposure reading indicated with the instrument in the " battery check" mode (if available on the instrument) j-

-- For instruments with external detectors, the angle between the radiation flux field and the detector (i.e., parallel or perpendicular)

- For instruments with internal detectors, the angle between radiation flux field and a l

specified surface of the instrument l

- For detectors with removable shielding, an indication whether the shielding was in place or removed during the calibration procedure

- The exposure rate from a check source, if used

- The signature of the individual who performed the calibration and the date on which the calibration was performed.

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j The following information will be attached to the instrument as a calibration sticker or tag:

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- The source that was used to calibrate the instrument i

- The proper deflection in the battery check mode (unless this is clearly indicated on the l

instrument) l

- For each scale or de,de not calibrated, an indication that the scale or decade was checked only for function bt aot calibrated

- The date of calibration and the next calibration due date

- The apparent exposure rate from the check source, if used.

Referenees: Detailed information about survey instrument calibration may be obtained by referring to ANSI N323-1978, " Radiation Protection Instrumentation Test and Calibration."

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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.

See the Notice of Availability (on the inside front cover of this draft report) to obtain copies of Draft Regulatory Guide FC 413-4, " Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments,"

dated June 1985.

L-3 Draft NUREG - 1556, Vol. 6

1 Appendix M Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits

APPENDIX M l

Guidance for Demonstrating that Unmonitored Individuals are Not l

Likely to Exceed 10 Percent of the Allowable Limits Dosimetry is required for individuals likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the applicable regulatory limits in 10 CFR 20.1201. However, irradiator operators are required by 10 CFR 36.55(a) to wear either a film badge or a i

thermoluminescent dosimeter (TLD) while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. Also, other individuals who enter the radiation room of a panoramic irradiator must wear a dosimeter, which may be a pocket dosimeter. When groups of visitors enter the radiation room at least two people must wear dosimeters. In those instances where pocket chambers are used instead of film badges or TLDs, a check of the response of the dosimeters to radiation must be made at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the true radiation dose. To demonstrate that dosimetry is not required for other workers, 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 l

limits.

The most common way that individuals might exceed 10% of the applicable limits is by performing work near the irradiator shield or areas of cable or equipment penetration of the I

shield of the irradiator. However, for most irradiators even these activities result in the individual receiving minimal doses. A licensee will need to evaluate the doses which its workers might receive in performing these tasks to assess whether dosimetry is required. The evaluation may be done by carefully measuring the dose rates when the source is in the irradiate position using techniques similar those as described in Appendix N. An evaluation of the actual time workers spend in the area can provide the information needed to estimate the annual dose of the workers.

The applicable TEDE (whole body) limit is 50 mSv (5 rems) per year and 10% of that value is 5 mSv (500 millirems) per year.

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Example: A careful measurement of the highest dose rate at the face of the shield of a panoramic irradiator is found to be 0.015 mSv/hr (1.5 mrem /hr). An individual is expected to i

spend no more than 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months per week in the area near the shield. Based on the dose rate, assuming the source is continuously in the irradiate position while the work is being performed, the annual dose is expected to be less than 2.34 mSv (234 mrem) (i.e.,3 hr/wk x 1.5 mrem /M 4 l

52 wk/yr). Based on the above specific information, no dosimetry is required if the individual performs work in the area less than 6.4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months per week.

M.1 Draft NUREG - 1556, Vol. 6

Appendix N Guidance for Demonstrating that Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits

APPENDIX N Guidance for Demonstrating that Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits Licensees must ensure that:

. The radiation dose received by individual members of the public does not exceed 1 millisievert (mSv) [100 millirem (mrem)] in one calendar year resulting from the licensee's i

l possession and/or use oflicensed materials.

l Members of the public include persons who live, work, or may be near locations where an l

irradiator is used or where the sealed sources for the irradiator are stored and employees whose assigned duties do not include the use oflicensed materials and who work in the vicinity where irradiators are used or sources stored.

. The radiation dose in unrestricted areas does not exceed 0.02 mSv (2 mrem)in any one hour.

Typical unrestricted areas may include offices, shops, laboratories, areas outside buildings, property, and nonradioactive equipment storage areas. The licensee does not control access to these areas for purposes of controlling exposure to radiation or radioactive' materials. However, the licensee may control access to these areas for other reasons such as security.

Licensees must show compliance with both portions of the regulation. For areas around irradiator facilities, a combination of calculations and measurements (e.g., using an environmental TLD)is often used to prove compliance.

Combined Measurement - Calculational Method' These measurements must be made with calibrated survey meters sufficiently sensitive to measure background levels of radiation. However, licensees must exercise caution when making l

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 hours0.0241 days 0.578 hours 0.00344 weeks 7.9144e-4 months (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.

l 8 For case of use, the examples in this Appendix use conventional units. The conversions to SI units are as follows:

I ft = 0305 m; I mrem = 0.01 mSv.

N1 Draft NUREG - 1556, Vol. 6 I

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l APPENDIX N I

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 I

instrument equipped with a scintillation-type detector (e.g., NaI(TI)) or a micro-R meter used in making very low gamma radiation measurements should be adequate.

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Licensees may also choose to use environmental TLDs in unrestricted areas next to the irradiator area for monitoring. This direct measurement method would provide a definitive measurement of actual radiation levels in unrestricted areas without any restrictive assumptions. Records of these measurements can then be evaluated to ensure that rates in unrestricted areas do not exceed the 1 mSv/yr (100 mrem /yr) limit.

The combined measurement-calculational method may be used to estimate the maximum dose to a member of the public. Since 10 CFR Part 36 irradiators are designed so that the maximum dose rate in any public area is less than 0.02 mSv (2 mrem) in any one hour, the licensee will generally be able to show by calculation that the maximum dose to an individual will be less than the 1 mSv/yr (100 mrem /yr) limit. The combined measurement-calculational method takes a tiered approach, going through a two-part process starting with a worst case situation and moving f

toward more realistic situations. It makes the following simplifications: (1) each irradiator is a point source and (2) no credit is taken for any shielding found between the irradiator shield and the unrestricted areas. The method is only valid for the source activity at the time of measurement and must be repeated if the source strength or shielding is changed.

Even though most large irradiators approximate a planar source, the results obtained from a point source assumption will be conservative and therefore may be used.

Part 1 of the combined measurement-calculational method is simple but conservative. It assumes that an affected member of the public is present 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months a day and uses only the inverse square law to determine if the distance between the irradiator and the affected member of the public is sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but also the time that the affected member of the public is actually in the area under consideration.

Using this approach, licensees make only those calculations that are needed to demonstrate compliance. The results of these calculations typically result in higher radiation levels than 2 TLDs used for personnel monitoring (e.g., LiF) may not have sufficient sensitivity for this purpose. Generally, the minimum reponable dose received is 0.1 mSv (10 mrem). Suppose a TLD monitors dose received and is changed once a month. If the measurements are at the minimum reportable level, the annual dose received could have been about 1.2 mSv (120 mrem), a value in excess of the 1 mSv/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.

2 Drafi NUREG - 1556, Vol. 6 N-2

I APPENDIX N 1

would exist at typical facilities, but provide a method for estimating conservative doses which could be received.

Example To better understand the combined measurement-calculational method, we will examine Food.

Safe, Inc., an irradiator licensee. Yesterday, the company's president noted that the shield of the new irradiator area is close to an area used by workers whose assigned duties do not include the use oflicensed materials and he asked Leslie, the Radiation Safety Officer (RSO), to determine if the company is complying with NRC's regulations.

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'Ihe area in question is near the wall which constitutes the primary shield of the irradiator. Leslie measures the distance from the shield to the center of the area in question and, using a calibrated survey instrument, measures the highest dose rate at one foot from the shield, to be 2 mrem per hour.

Table N.1 summarizes the information Leslie has on the irradiator.

Table N.1 Information Known about Dose at the Shield of the irradiator i

Description of Known Information Co-60 Panoramic Irradiator l

Dose rate encountered at I foot from the face 2 mrem /hr.

of the shield, in mrem /hr.

Distance from the face of the shield to the 4h nearest occupied work area, in ft.

Example: Part 1 Leslie's first thought is that the distance between the irradiator shield and the area in question i

may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach,he assumes: 1) the irradiator is constantly in use (i.e.,24 hr/d), and 2) the workers are constantly in the unrestricted work area (i.e.,24 hr/d). Leslie proceeds to calculate the dose the workers might receive hourly and yearly from the irradiator as shown in Table N.2 below.

N-3 Draft NUREG - 1556, Vol. 6 l

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APPENDIX N Table N.2 Combination Measurement - Calculational Method, Part 1: Hourly and l

Annual Dose Received from Irradiator Step Description Input Data Results

. No.

1 Multiply the measured dose rate measured at 1.0 ft from the 2 x (1)2 2

face of the shield wall in mrem /hr by the square of the distance (ft) at which the measurement was made (e.g.,1 foot from the face of the shield) 2 Square of the distance (ft) from the face of the shield to the (4)2 16 nearest unrestricted area,in ft2 3

Divide the result of Step 1 by the result of Step 2 to 2/16 0.125 calculate the dose received by an individual in the area near the shield. HOURLY DOSE RECEIVED FROM IRRADIATOR,in mrem in an hour 4

Multiply the result of Step 5 by 40 hr/ work week x 52 0.125 x 40 x 52 260 i

weeks / year = MAXIMUM ANNUAL DOSE RECEIVED j

FROM IRRADIATOR,in mrem in a year 1

Note: The result in Step 3 demonstrates compliance with the 2 mrem in any one hour limit.

l Reevaluate if assumptions change. If the result in Step 4 exceeds 100 mrem /yr, proceed to Part 2 of the calculational method.

At this point, Leslie is pleased to see that the total dose that an individual could receive in any one hour is only 0.125 mrem in an hour, less than the 2 mrem in any one hour limit but notes that an individual could receive a dose of 260 mrem in a year, higher than the 100 mrem limit.

I Example: Part 2 l

Leslie reviews the assumptions and recognizes that the workers are not in the area near the shield

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all of the time. A realistic estimate of the number of hours the workers spend in the area is made, 1

keeping the other assumptions constant (i.e., the irradiator is in constant use (i.e.,24 hr/d)). The i

annual dose received is then recalculated.

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J Draft NUREG - 1556, Vol. 6 N-4 J

l APPENDIX N Table N.3 Combination Measurement - Calculational Method, Part 2: Annual Dose Received from a 10 CFR Part 36 Irradiator Step Description Results No.

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A. Average number of hours per day an individual spends in area 1.5 l

of concern (e.g., a non-radiation worker spends 1.5 hr/ day in the area near the shield; the remainder of the day the workers are away from the area assigned to jobs unrelated to radiation.

(painting, grounds keeping, desk jobs, etc.)

B. Average number of days per week in area 5

C. Average number of weeks per year in area (e.g., full time 52 workers) 8-Multiply the results of Step 7.A. by the results of Step 7.B. by the 1.5 x 5 x 52 = 390 results of Step 7.C. = AVERAGE NUMBER OF HOURS IN.

I AREA OF CONCERN PER YEAR-9 Multiply the results in Step 3 by the results of Step 8 = ANNUAL 0.125 x 390 = 49 DOSE RECEIVED FROM IRRADIATOR CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN AREA OF CONCERN,in mrem in a year 1

Leslie is pleased to note that the calculated annual dose received is significantly lower, and does I

not exceed the !nD mrem in a year limit.

Since most irradiators are in use a majority of the time, and down time is usually unpredictable, generally no additional allowance for irradiator duty cycle is made.

Had the result in Step 9 been higher than 100 mrem in a year, then Leslie could have done one or more of the following:

Consider whether the assumptions used to determine occupancy are accurate, revise the assumptions as needed, and recalculate using the new assumptions

. Calculate the effect of any shielding located between the irradiator shield and the public area 2

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- such calculation is beyond the scope of this Appendix 3 National Council on Radiation Protection and Measurements (NCRP) Report No. 49, " Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV," contains helpful information. It is available from NCRP,7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814.

NCRP's telephone numbers are: (301) 657-2652 or 1 800-229-2652.

N-5 Draft NUREG - 1556, Vol. 6

APPENDIX N

Take corrective action (e.g., change work patterns to reduce the time spent in the area near the shield) and perform new calculations to demonstrate compliance

Designate the area inside the use area as a restricted area and the workers as occupationally exposed individuals. This would require controlling access to the area for purposes of radiation protection and training the workers as required by 10 CFR 19.12 Note that in the example, Leslie evaluated the unrestricted area outside only one wall of the irradiator area. Licensees also need to make similar evaluations for other unrestricted arcas and to keep in mind the ALARA principle, taking reasonable steps to keep radiation dose received below regulatory requirements. In addition, licensees need to be alert to changes in situations (e.g., adding sources to the irradiator, changing the work habits of the workers, or ( 'herwise changing the estimate of the portion of time spent in the area in question) 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.

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Draft NUREG - 1556, Vol. 6 N-6 i

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1 Appendix O i

Typical NRC incident Notifications Required for Irradiator Licensees l

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APPENDIX O Table O.1 Typical NRC incHent Notifications Required for Irradiator Licensees Event

. Telephone Written Regulatory Requirement Notification Report l

Theft or loss of material immediate 30 days 10 CFR 20.2201(a)(1)(i)

Whole body dose greater than 0.25 Sv (25 immediate 30 days 10 CFR 20.2202(aXIXi) rems) l l

Extremity dose greater than 2.5 Sv (250 immediate 30 days 10 CFR 20.2202(a)(1)(iii) j rems)

Whole body dose greater than 0.05 Sv (5 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 20.2202(bXIXi) l rems)in 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months Extremity dose greater than 0.5 Sv (50 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 20.2202(b)(1)(iii) l rems)in 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months Whole body dose greater than 0.05 Sv (5 none 30 days 10 CFR 20.2203(aX2)(i) rems) l Dose to individual member of public none 30 days 10 CFR 20.2203(a)(2)(iv) greater than 1 mSv (100 mrems)

- Defect in equipment that could create a 2 days 30 days 10 CFR 21.21(dX3Xi) l

' substantial safety hazard Event that prevents immediate protective immediate 30 days 10 CFR 30.50(a) actions necessary to avoid exposure to radioactive materials that could exceed regulatory limits Equipment is' disabled or fails to function -

24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 30.50(bX2) as designed when required to prevent

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radiation exposum in excess of regulatory l

ilimits Unplanned fire or explcsion that affects 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 30.50(b)(4) the integrity of any licer2 sed material or device, container, or equipment with licensed material Source stuck in an unshielded position 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(aX1)

Any fire or explosion in a radiation room 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(2)

Damage to the source racks 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(aX3)

O-1 Draft NUREG - 1556, Vol. 6

APPENDlX O E

Event Telephone - Written Regulatory Requirement Notification Report

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l Failure of the cable or drive mechanism 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(4) used to move the source racks Inoperability of the access control system 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(5)

Detection of radiation source by the 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(6) prodect exit monitor Detection of radioactive contamination 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(7) attributable to licensed radioactive material Structural damage to the pool liner or 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(8) walls Abnormal water loss or leakage from the 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(9) source storage pool Pool water conductivity exceeding 100 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 30 days 10 CFR 36.83(a)(10) microsiemens per centimeter Note: Telephone notifications shall be made to the NRC Operations Center at (301) 816-5100 except as noted.

Draft NUREG - 1556, Vol. 6 0-2

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1 Appendix P Model Leak Test Program For Dry-Source-Storage Irradiator I

Sealed Sources l

APPENDIX P Model Leak Test Program for Dry-Source-Storage Irradiator Sealed Sources Training Before allowing an individual to perform leak testing, the RSO will ensure that he or she has sufficient classroom and on-the-job training to show competency in performing leak tests independently.

Classroom training may be in the form oflecture, videotape, or self-study and will cover the following subject areas:

Principles and practices of radiation protection

. Radioactivity measurements, monitoring techniques, and the use ofinstruments Mathematics and calculations basic to the use and measurement of radioactivity

. Biological effects of radiation.

Appropriate on-the-job-training consists of:

. Observing authorized personnel collecting and analyzing leak test samples

. Collecting and analyzing leak test samples under the supervision and in the physical presence of an individual authorized to perform leak tests.

Facilities and Equipment

. To ensure achieving the required sensitivity of measurements, leak tests will be analyzed in a low-background area.

Individuals conducting leak tests will use a calibrated and operable survey instrument to check leak test samples for gross contamination before they are analyzed.

A Nal(Tl) well cmmter system with a single or multichannel analyzer will be used to count samples from sealed sources containing gamma-emitters (e.g., Cs-137, Co-60).

Frequency for Conducting Leak Tests of Sealed Sources

Leak tests will be conducted at least every 6 months.

P-1 Draft NUREG - 1556, Vol. 6

APPENDIX P Model Procedure for Performing Leak Testing and Analysis

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For each source to be tested, list identifying information such as serial number, radionuclides, activity.

If available, use a survey meter to monitor exposure.

Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source.

. Number each wipe to correlate with identifying information for each source.

. Wipe the most accessible area where contamination would accumulate if the sealed source were leaking.

. Select an instrument that is sensitive enough to detect 200 becquerels (0.005 microcurie)' of the radionuclides.

. Using the selected instrument, count and record background count rate.

. Check the instrument's counting efficiency using standard source of the same radionuclides as the source being tested or one with similar energy characteristics. Accuracy of standards should be within +/ 5% of the stated value and traceable to a primary radiation standard such as those maintained by the National Institutes of Standards and Technology (NIST).

. Calculate efliciency.

efliciency in epm /Bq For example:

[(com from std)-(cpm from bkgT]

=

activity of std 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:[(cpm from wipe sample)-(cpm from bkg)) = Bq on wipe sample efficiency in cpm /Bq i

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10 CFR Part 36 uses one significant figure in converting becquerels to microcurie.

Draft NUREG - 1556, Vol. 6 P-2

APPENDIX P Sign and date the list of sources, data and calculations. Retain records for 3 years.

If the wipe test activity is 200 becquerels (0.005 microcurie) or greater, notify the RSO, so that the source can be withdrawn from use and disposed of properly. Also notify NRC.

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P-3 Draft NUREG - 1556, Vol. 6

Appendix Q Transportation

l APPENDIX Q l

Major DOT Regulations I

The major areas in the DOT regulations that are most relevant for transportation oflicensed l

materials used in irradiators are as follows:

l T61e of Hazardous Materials and Special Provisions 49 CFR 172.101, and App. A, Table 2:

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Hazardous materials table, list of hazardous substances and reportable quantities

Shipping Papers 49 CFR 172.200-204: general entries, description, additional description requirements, shipper's certification Package Markings 49 CFR 172.300,49 CFR 172.301,49 CFR 172.303,49 CFR 172.304, e

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, e

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 e - Emergency Response Information, Subpart G,49 CFR 172.600,49 CFR 172.602, 49 CFR 172.604: Applicability and general requirements, emergency response information, emergency response telephone number j

Training, Subpart H,49 CFR 172.702,49 CFR 172.704: Applicability and responsibility for training and testing, training requirements

Radiation Protection Program for Shippers and Carriers, Subpart I,49 CFR 172.800, etc.

Shippers - General Requirements for Shipments and Packaging, Subpart I,49 CFR 173.403, 49 CFR 173.410,49 CFR 173.411,49 CFR 173.412,49 CFR 173.413,49 CFR 173.415, 49 CFR 173.416,49 CFR 173.415,49 CFR 173.433,49 CFR 173.435,49 CFR 173.441, 49 CFR 173.471,49 CFR 173.475,49 CFR 173.476: Definitions, general design requirements, industrial packages, additional design requirements for Type A packages, requirements for Type B packages, authorized Type A packages, authorized Type B packages l

(including package certification requirements), requirement for determining A and A i

2 table of A and A values for radionuclides, radiation level limit, requirements for USNRC-i 2

approved packages (Type B), quality control requirements prior to each shipment..., approval of special form radioactive materials l

Q-1 Draft NUREG - 1556, Vol. 6

APPENDIXQ

. 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 DraR NUREG - 1556, Vol. 6 Q-2

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i Appendix R Exemptions for Teletherapy Units Converted to Non-Human Use l

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APPENDIX R l

Exemptions for Teletherapy Units Converted to Non-Human Use l

The following are technicaljustifications and commitments which are acceptable to exempt licensees from specific sections of 10 CFR Part 36. The Regions may grant the exemptions shown below without prior coordination with NMSS. Acceptable license conditions are also shown below.

1. 10 CFR 36.23(a) "The personnel entrance door or barrier must have a lock that is 3

operated by the same key used to move the sources."

j For converted teletherapy units, the use of a single key or even several keys on a key-ring may be impractical. The key-switch on many control panels is a 3-position switch which controls electrical power to the teletherapy unit. The key can only be inserted / removed in the "off" position, and in this position the main power and control circuits are without electrical power. Power is required to move collimators, activate field lights, align system, etc.

Requiring a single key would not allow the licensee to operate these powered systems.

Therefore, a licensee may be exempted from this requirement, provided that the licensee i

commits to have the operator present for the entire period of time that the key is in the control panel.

The following license condition should be used:

\\

"Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may use separate keys to j

operate the lock on the personnel entrance door or barrier and to move the sources in

)

accordance with procedures described in the letter / application dated

2. 10 CFR 36.23(b)

"...each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while sources are exposed."

The licensee may be granted an exemption from this requirement provided that the licensee l

has an electrical interlock system meeting all of the conditions specified in 10 CFR 35.615(b) on each entrance to the radiation room. Alterations of the electrical interlocks of the teletherapy unit to meet the requirements of 10 CFR 36.23(b) may cause the interlock system to function incorrectly. A working electrical interlock system on each entrance suffices to prevent personnel entry while the source is exposed. The licensee should commit in its application to each of the conditions of 10 CFR 35.615(b). In addition, the licensee should commit to having an operator present during the entire irradiation who can visually observe the entrance, and to having a radiation monitor that can be read before entering the radiation area.

R-1 Draft NUREG - 1556, Vol. 6 I

w

- APPENDIX R The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.23(b), the licensee is exempt from having an independent backup access control to detect personnel entry while sources are exposed f

based on the commitments described in the letter / application dated 1

3. 10 CFR 36.23(c)

"...The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high."

l Alteration of the interlock system to meet this requirement would prevent entry to the treatment room to remove a patient in the event of a stuck source. The region may grant the licensee an exemption from this requirement provided that the licensee has an electrical :

. interlock system which will retract the source, upon opening access doors to the radiation room and commits to its use. In addition, the licensee must commit to having an operator present and having a radiation monitor in the room as described above.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.23(c), the licensee is exempt from having the monitor integrated with personnel access door locks to prevent room access when radiation levels are high based on the commitments described in the letter / application dated

4. 10 CFR 36.23(d) "... visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position."

An acceptablejustification is that an audible alarm within the treatment room may cause undue distress to the patients (human or animal). If the licensee commits to having a visual f

alarm provided on the outside of the treatment room, and to having the operator visually f

check the room before starting treatments, the regions may grant the licensee an exemption.

The following license condition should be used:

l l

"Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exempt from having

. an audible alarm within the treatment area, based on the commitments described in the letter / application dated

5. 10 CFR 36.23(f) "Esch radiation room at a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door... has been closed within a preset time...."

I s

J

i l

APPENDIX R Exemptions may be granted to licensees having teletherapy units that are being used for irradiation of materials only (no patients), provided that the licensee commits to the operator visually verifying that the room is not occupied before closing the door, and that the converted teletherapy unit (irradiator) activates a visual and audible alarm in the teletherapy room for at least 15 seconds before moving the source from the shielded position. ' This visual / audible alarm must be interlocked with the teletherapy unit such that the source will t

not move to the exposed position until the visual / audible alarm has been activated and is finished alarming. The use of a visual / audible alarm in a patient treatment room may cause anxiety for patients. Therefore, licensees having teletherapy units that are being used for both patient treatment (human or animal) and object or material irradiation may be authorized an exemption from 10 CFR 36.23(f) without the need to have a visual / audible alarm, if the licensee commits to having an operator visually verify that the room is not occupied before closing the door and if the licensee has a means of visually observing the area as required in 10 CCR 35.615(e).1 If the unit is not used for patients, then the audible / visible alarm described above is required.

The following license condition should be used:

l l

"Notwithstanding the requirements of 10 CFR 36.23(f), the licensee is exempt from having a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time based on the commitments described in the letter / application dated l

6. 16 CFR 36.27(a)

"...The sources must automatically become shielded if a fire is j

detected."

I l

10 CFR 36.27(b)

"...be equipped with a fire extinguishing systems capable of extinguishing a fire without entry of personnel. The system must have a shutoff valve to control flooding into unrestricted areas."

The Statements of Consideration state that the purpose of the fire extinguishing system is to prevent a fire from damaging the access control system or preventing the sources from being shielded. Most converted teletherapy units are designed to retract the source when the electrical pwer fails, as may occur during a fire. The licensee may be granted an exemption l

from these requirements provided that the licensee commits to the following:

1

Having smoke detectors, fire extinguishers and a fire alarm at the site to detect and fight small fires Alerting authorities of the fire l.

I I

I R-3 Draft NUREG - 1556, Vol. 6

APPENDIX R 11aving a means of measuring the radiation levels in the radiation room during an electrical failure Instructing the operators to retract the source before exiting for a fire involving major a

portions of the facility, provided this action does not jeopardize the operator's safety.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.27(a) and (b), the licensee is exempt from (as reauested by the licensee) based on the commitments described in letter / application dated

7. 10 CFR 36.31(a) "The key must be attached to a portable radiation survey meter by a chain or cable.... The door to the radiation room must require the same key."

Converted teletherapy units require that the source activation key be inserted in the console to provide power to the unit to activate field lights and align the head. Therefore, the region may grant the licensee an exemption from this requirement provided that the licensee commits to having administrative controls in place to ensure that personnel entering the radiation room use a portable survey meter to verify that the source has retracted. The licensee must also commit to attach the survey meter to the exposure room door key.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.31(a), the licensee is exempt from the requirement to have console key attached to a portable survey meter by a chain or cable and that the door to the radiation room require the same key, based on the commitments described in the letter / application dated

. The radiation room door key shall be attached to the portable survey meter."

8. 10 CFR 36.31(b)

"...The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in... transit."

In converted teletherapy units the source is moved nearly instantaneously from the shielded to the exposed position. Most teletherapy units are designed with two indicator lights -

green indicates the source is in the fully shielded position, red indicates the source is exposed. During transit both lights are "on" indicating that the source is in transit. To require that the licensee install an electronic system to indicate "in transit" for the period of time the source is in transit, less than a second, does not provide any additional protection.

Therefore, the region may grant this exemption provided the licensee submits a description of its device indicators.

Draft NUREG - 1556, Vol. 6 R-4 1

l I

1 l

APPENDIX R The following license condition should be used:

I "Notwithstanding the requirements of 10 CFR 36.31(b), the licensee is exempt from the requirement to have a separate position indicator to indicate when the source is in transit, in accordance with letter / application dated

9. 10 CFR 36.67(b)(2)

"...the irradiator operator... must activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control."

Because of the risk of malfunction associated with alterations to the existing electrical interlocks of the teletherapy unit, and considering the licensee's commitment to administratively control access to the room to meet the intent of this regulation, the region may grant this exemption, if the licensee demonstrates that a retrofit to install such a control would not be possible with the teletherapy unit and a licensee commits to the following:

The operator will close the doors immediately upon completion of the visual inspection required by 10 CFR 36.67(b)(1).

The operator will verify that each door has locked automatically before stepping to the control panel.

The following license condition should be used:

"Notwithstanding the requirements of 10 CFR 36.67(b)(2), the licensee is exempt from the requirement to have a control in the radiation room which must be activated prior to irradiation which would not allow the source to be moved from the shielded position unless the door to the radiation room is locked within a preset time, based on the commitments described in the letter / application dated R5 Draft NUREG - 1556, Vol. 6

i l

l i

Appendix S Sample Licenses for 10 CFR Part 36 Irradiators I

l f

l

}-

i

APPENDIX S Sample Licenses for 10 CFR Part 35 Irradiators This appendix contains examples ofirradiator licenses that the NRC would issue to an applicant who meets the requirements in 10 CFR Part 36. The three types are:

Dry-source-storage panoramic

Wet source-storage panoramic l

Underwater type irradiator.

I l

The authorizations in the sample licenses do not necessarily reflect those normally provided to an -

i applicant. For example, any authorizations for exemptions to 10 CFR Part 36 would require the applicant to have specific procedures approved by the NRC, following a specific request for an l

exemption.

1 I

l l

i l

l S.1 Draft NUREG - 1556, Vol. 6

N'C FORM 374 PAGE 1

OF 2

PAGES U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a liznse is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shril be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Ucensee

3. Ucense No. 19-12345-01

1. Best Research Institute

4. Expiration date September 30,2007 hR F ERaerenceNo L" 5 5 Docket No. 030 2.1234 Main Street Anywhere, USA 20000 e

6.

Byproduct, source, and/or special CIIemical and/or physical form (

um amount that licensee may nuclear material ss at any one time under this j

nse h 2,000 curies A.

Sealed sources (

Ca A.

Cobalt - 60 g

g Type X-145)

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9.

Authorized use 9

For use in XYZ Pinto-22 teletherapy unit'to -

tudio's on cell cultures and small animals, excluding

^

A.

explosives, flammables;pt corrosives. }W

' $7 /

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10. Licensed material may be used d

Ne,elfftles tocafed at 432 Main Streeti Anywhere, USA.

h h[thh M

der the supens[ision ef, individ6als designated in writing by th 11 A.

Ucensed material shall be Committee, Dr. Lawrence Uve airman. The lic'ensee shall maintairirecords of individuals designated as users for

~

three years after the last use of d material by the individual. Mi

)q Q $

B.

The Radiation Safety Officer for this license is Enrico Foomie.

12. Sealed sources containing licensed material shall not be opened c,r sources removed from source holders or detector cells by the licensee.

13. The licensee is authorized to collect leak test samples for analysis by the licensee. Attematively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

14. The licensee shall not perform repairs or al erations of the irradiator involving removal of shielding or access to the licensed material. Removal, replacement, and disposal of sealed sources in the irradiator shall be performed by pert.ons specifically licensed by the Commission or an Agreement State to perform such services.

15. Ucensed material shall not be used in or on human beings.

j

16. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR 71, " Packaging and l

Transportation of Radioactive Matenal."

17. The procedures contained in the manufacturer's instruction manual for the irradiator authorized by this license shall be followed and a copy of this manual shall be made available to each person using or having responsibility for the use of the device.

Draft NUREG - 1556, Vol. 6 S-2

t NRC FORM 3744 U.S. NUCLEAR REGULATORY COMMISSION PAGE1of1 PAGES License Number 08-12345-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-12345 Amendment No.

18J Except ac specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restridive than the regulations.

A. Application dated September 1,19g7 Q

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Th FOR THE U.S. NUCLEAR 1.ATO Y MISSION U

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5-3 Draft NUREG - 1556, Vol.6

U.S. NUCLEAR REGURATORY COMMISSION MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified

{

below.

Licensee

3. License No. 08-01234-01

1. Really Big irradiator Inc.

4. Expiration date September 30,2007

5. Docket No. 030 2.1234 Main Street G b\\ b F-CRSrence N A

Anywhere USA 2MM Chemical and/or physical form (

M um amount that licensee may h(7[.j

6. Byproduct, source, and/or special ess at any one time under this nuclear material g

h

(,

nse A. Cobalt - 60 (j3 A. Sealed sources

h. 3,000,000 curies (XYZ Co. D

.4

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9.

Authorized use f

f.

k i.-

t For use in an XYZ Co. M3 del D-230 irrNiiator -

+. -

=iateriais except explosives, flammables, or corrosives.

A.

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10. Licensed material may be used only at lities located at.12,. Main Street nywhere, USA.

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11. A.

Licensed material shall be supervision and in the' physical presence of individuals who have

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satisfactorily completed the xamination' described in item'8 of application dated June 28,1997 and have been designated in writing by the Rad fety Officer.

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B.

The Radiation Safety Officer for this license is Jayson M. Rutherford.

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12. Sealed sources containing licensed material shall not be opened by the licensee.

13. The licensee shall implement the material accountability program discribed in application dated June 28,1977, to account for all sealed sources containing licensed material received and possessed under the license.

14. The licensee is authorized to transport licensed materialin accordance with the provisions of 10 CFR Part 71," Packaging and Transportation of Radioactive Material."

i

10. Irradiation and distribution of foods for human consumption shall be in accordance with the rules and regulations of the Food and Drug Administration and the U.S. Department of Agriculture.

1

16. The licensee is authorized to make modifications to the source rack as requested in letter dated August 27,1997. The licensee sha!! test the movement of the source rack for proper operation in accordance with 10 CFR 36.41(f) and (i) prior to source loading.

{

(

Draft NUREG - 1556, V01. 6 S-4

I

)

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 of 2 PAGES License Number 08-01234-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-12346 Amendment No.

l l

l 17, Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A.

Applicatxm dated June 28,,1997 B.

Letter dated August 27,1997 g>BREGy c},

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g C,OMMISSION FOR THE U.S. NUCL R

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.b Date:

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l S-5 Draft NUREG - 1556, Vol. 6

U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE Pursuant to the Atorruc Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93438), and Title 10 Code of Federal Regulations, Chapter 1 Parts 30,31,32,33,34,35,36,39,40 and 70, and in reliance on statements and representations heretofore made by the heensa, a heense is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclea material designated below; to use such matenal for the purpose (s) and at the place (s) designated below; to delwer or transfer sus malensi to persons authorized to receeve it in accordance with the regulations of the apphcable Part(s). This license shall be deemed to contain the conditions specified in Sechon 183 of the Atomic Energy Act of 1954, as amended, and is subject to all j

apphcable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specsfied j

below. ~

Licensee

3. License No. 08-12346-01 l

1

1. UnderWaterIrradiator,Inc.

4. Expiration date April 30,2007 j

2.1234 Main Street

5. Docket No. 0 7

Anywhere, USA 20000 t'"'.

DINorence A

6. Byproduct, source, and/or special (C6ermcaland/orphysicalform (

amount that licensee may

+h at a9y one time under this nuclear material

=

h.,80,000 curies A. Cobalt - 60

(/)

A. Sealed sources g

Inc. DWG

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Dwg.[

B(2#00,000 curies T h,I B. Cobalt-60 b

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C. Cobalt 40 21 Ikn[lodM CISO millicuries Q

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Authorized use 9

6 b ll, A. and B.

For irradiation of than ex jommables,'or coriosive materials.

C.

For use in t,alibrating

's radiation ion equipment N

mr xs 1

n d CONDITIONS

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10. Licensed material may be used only at the licensee's facilities located at 1234 Main Street, Anywhere USA.

11. A.

Licensed material shall be used by, or under the supervision and in the physical presence of A. Loyd Webber or individuals designated by the licensee's Health and Safety Committee.

i i

B.

The Radiation Safety Officer for this license is A. Loyd Webber i

12. A.

Sealed sources containing licensed material specsfied in item 6.C shall be tested for leakage and/or contamination at intervals f

not to exceed six months or at such other intervals as are specified by the certificate of registration referred to in 10 CFR 32.210, not to exceed three years. [ Note: The calibration source le not covered by the leak test requirement in 10 CFR 34.99]

B.

In the absence of a certificate from a transferor indicating that a leak test has been made within six months prior to the transfer, a sealed sourm or received from another person shall not be put into use until tested.

C. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material or the test sample. If the test reveals the presence of 0.005 rmcrocurie or more of removable contamination, the licensee shall immediately remove the i

source from service, report to the Nuclear Regulatory Commission according to 10 CFR 30.50(b)(2) and (c)(1), and have the j

i Draf t NUREG - 1556, Vol. te 3-6

- - _ - - _ - _ _ _ _ _ _ _ _ _ - - - _ _ _ - _ _ - _ - _ - - - _ _ _ _ = _ - _ - - _ - - - _ _

l l

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 of 2 PAGES l

Ucense Number 08-01234-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-12346 Amendment No.

source decontaminated, repaired, or disposed of according to Commission regulations. The licensee shall file a written toport according to 10 CFR 30.50(c)(2).

l D. The licensee is authorized to collect leak test samples for analysis by the licensee. Altematively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

13. Sealed sources containing licensed material shall not beopened. $ Q f i

Q hU O

14. The licensee shall implement the material accountability program described fr( %

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ar 8,1997, to account for all sealed l

sources containing licensed material received and processed under the license.

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15. The limnsee is authorized to transport licensed material in accordance provi of 10 CFR Part 71, " Packaging and Transportabon of Radioactive rail."

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16. Irradiation and distribution of hs form consumption sh with the rul' s and regulations of the Food and i

e Drug Administration and the b.S. Departrhent of A0ncultu

//c ' ;

O

17. Except as specifically provided otherwise irhhis licanas,

' conduct its programin accordance with the statements, n

I representations, and procedjus contained iin the in y eni:losures, listeh 4Elow. The Nuclear Regulatory Commission's regulations sheJI govem unlest the

.and procedures in the licensee's application and correspondence are more rdslbk:tive the 7,

b ! A p' c [, y <

/

N I

-4 e

A. Application dated January 29,1997 l

B.

Latter received March 8, p

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FOR THE U.S. NUCLEAR REGULATORY COMMISSION pm Date:

BY I

John Q. Reviewer, Hecith Physicist Nuclear Materials Licensing Branch NRC Region City, State 54321 i

l i

S-7 Draft NUREG - 1556, Vol.6

NRC FORM 33s u.6. NUCLEAR REGULATORY Commission

1. LEPORT NuMBEM L2 M (Assigned by NRC, Add Vol, Supp., Rev, NRCM 1102.

and Addendum Numbers,if any.)

22o1.32a2 BIBLIOGRAPHIC DATA SHEET (s= mstruceoas oa rae mw=1 NUREG-1556

2. TITLE AND SUBTITLE Vol. 6 Consolidated Guidance About Materials Licenses 3.

DATE REPORT PUBLISHED l

Progr:m-Specific Guidance About 10 CFR Part 36 Irradiator Licenses l

YU R MONTH Draft Report for Comment March 1998 4 FIN OR GRANT NUMBER i

5. AUTHOR (S)

6. TYPE OF REPORT J.D. Jones, W.T. Loo, E.H. Rober, M.E. Schwartz, P.C. Vacca, Dran j

7. PERIOo COVERED (#nctumve Dates) l

s. PERFORMING ORGANIZATION NAME AND ADDRESS (#NRC, prowde Dwoon, oAlce or Regen, U S Nutdoor Repufatwy Commsmort. and meeng ad@ess. # contractor poede nome and meeng edposa J Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety anc' cafoguards l

U.S. Nuclear Regulatory Commission 1

Washington, DC 20555-0001

s. SPONSORING ORGANIZATION NAME AND ADDRESS (# NRC type 'same es ecove' # corvrector, proude MRc Owman, omco or Regen, & S Nuclear ReputstJfy Commtsson, and menne edeoes }

Same as above

10. SUPPLEMENTARY NOTES

11. A1STRACT (200 woros orless)

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents int) O single comprehensive reposito as described in NUREG-1539," Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated ril 1996, and draft NUREG-1541, " Process and Design for Consolidating and Updating Miterials Licensing Guidance," dated pril 1996. Draft NUREG-1556, Vol. 6, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses," dated March 1998, is the sixth 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 Draft Regulatory Guide DG-0003, " Guide for the Preparation of Applications for Licenses for Non-Self-Contained Irradiators," dated January 1994, and NMSS Policy and Guidance Directive, FC 84-23," Standard Review Plan for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Containeci Wet Source-Storage, and Panoramic Wet Source-S?orage irradiators," dated December 27,1984. This draft report, where applicable, provides a more risk-informed, performance-based approach to licensing 10 CFR Part 36 irradiators consistent with the current regulations. Note that this docunent is strictly for public comment and is not for use in preparation or review of 10 CFR Part 36 irradiator licenses until it is published in final form.

$3 AVAILAB6uTV STATEM'.NT

12. KEY WORDSIDESCRIPTORS (bst nords or phrases that ner asmat sesseictura m socanng tae report J unlimited materials 14 SECURITY CLAS$1FICATION licensees irradiator 4 p.,,,

risk-informed unclassified performance-based

_(ms neport; program-specific unclassified

16. NukBER OF PAGES to price I

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ML20236S655

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