ML20217M952

Consolidated Guidance About Materials LICENSES.Program- Specific Guidance About Possession Licenses for Manufacturing and Distribution.Draft Report for Comment

ML20217M952
Person / Time
Issue date:	07/31/1999
From:	Dan Collins, Gill C, Louis Manning, Schwartz M, Zelac R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V12-DR-FC, NUDOCS 9910280094
Download: ML20217M952 (275)

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yGLw/ I)unv NUREG-15d6 Vol.12 Consolidated Guidance About Materials Licenses.

Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution #$

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Draft Report for Comment y ..

U.S. Nuclear Regulatory Commission s W Office of Nuclear Material Safety and safeguards  !

R.E. Zelac, D.J. Collins, C.F. Gill, L. Manning III, M.E. Schwartz ,

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AVAILABILITY NOTICE Availability of Reference Materials Cited in NRC Publications l NRC publications in the NUREG series, NRC regu. NRC Public Document Room lations, and Title 10, Energy, of the Code ofFederal 2120 L Street, N.W., Lower Level Regulations, may be purchased from one of the fol- )

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Publicly released documents include, to name a l The NUREG series comprises (1) brochures few, NUREG-series reports; Federal Register no- l (NUREG/BR-XXXX), (2) proceedings of confer- tices; applicant, licensee, and vendor documents ences (NUREG/CP-XXXX), (3) reports resulting and correspondence; NRC correspondence and from international agreements (NUREG/lA-XXXX), internal memoranda; bulletins and information no-(4) technical and administrative reports and books tices; inspection and investigation reports; licens-

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Comrrission and Atomic and Safety Licensing

) Boards and of Office Directors' decisions under

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NUREG-1556 Vol.12 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Possession Licenses for Manufacturing l and Distribution l

Draft Report for Comment Manuscript Completed: July 1999 Date Published: July 1999 Prepared by R.E. Zelac, DJ. Collins, C.F. Gill, L. Manning III, M.E. Schwartz Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.s. Nuclear Regulatory Commission k Wcshington, DC 20555-0001 i

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

. Comments may be accompanied by additional relevant information or supporting data.- Please specify the report number NUREG-1556, Vol.12, draft in your comments, and send them by the

. date published in the Federal Register Notice to:

Chief, Rules Review and Directives Branch U.S. Nuclear Regulatory Commission -

Mail Stop T6-D59 Washington, DC 20555-0001 You may also provide .omments at the NRC Web site, http://www.nrc. gov. See the link under " Technical Reports in the NUREG Series" on the " Reference Library" page.

Instructions for sending comments electronically are included with the document, .

NUREG-1556, Vol.12, draft, at the web site.

For any questions about the material in this report, please contact:

Sally Merchant Mail Stop: TWFN 9-F31 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Phone: 301-415-7874 -

E-mail: SLM2 -  ;

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I ABSTRACT As part ofits redesign of the materials licensing process, the United States Nuclear Regulatory Commission (NRC) is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUIEG-1539, " Methodology and Findings of NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, " Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996.

NUREG-1556, Vol.12, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated July 1999, is the twalfth program-specific guidance developed for the new process and is intended for use by applicants, licensees, and NRC staff, and will also be available to Agreement States. This document combines and updates the guidance found in Regulatory Guide 10.7, " Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material," dated August 1979; NMSS Policy and Guidance Directive FC 84-1,

" Review Responsibility - Manufacturing and Distribution of Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26," dated April 1984; NMSS Policy and Guidance Directive FC 85-6, " Standard Review Plan for Applications for Licenses and Approvals to Authorize Distribution of Various Items to Group Medical Licensees," dated February 1985; and Draft Regulatory Guide DG-0007, " Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees," dated March 1997. This draft report takes a more risk-informed, performance-based approach to licensing possession for manufacturing and distribution, and reduces the amount of detailed information needed to support an application. Note that this document is strictly for public comment and is not for use in preparing or reviewing possession licenses for manufacturing and distribution licenses until it is published in final form. If a license of broad scope is being sought (under 10 CFR 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. I1,

" Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope."

i i

iii Draft NUREG - 1556, Vol.12

' CONTENTS -

A B STRA CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii FOREWORD..............................................................................ix A C KNOWLEDG M ENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii ABB REV IATI ON S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x v 1 PURPOSE OF DRAFT REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 A G R E EMENT STATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 3 MANAGEMENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 4 . APPLICABLE REGULATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 5 HO W TO FI LE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1 5.1 PAPER APPUCATION . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... 5-1 5.2 ELECTRONIC APPUCATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . ... 5-2 6- 1 6 WH E R E TO FILE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7 LI CEN S E FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1 8 ' CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1 8.1 ITEM 1: LICENSE ACTION TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 8.2 ITEM 2: APPUCANT'S NAME AND MAILING ADDPJiSS . . . . . . . . . . . . .... . . . 8-1 8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED . 8-3 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION . . . . . . . . . . . . ... 8-4 8.5 ITEM 5: RADIOACTIVE MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . ................ .... 8-5

)

8.5.1 UNSEALED AND/OR SEALED BYPRODUCT MATERIAL . . . . . . . . . . . . . . 8-6 4 8-9 j 8.5.2 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIONING 8.6 ITEM 6: PURPOSE (S) FOR WHICH UCENSED MATERIAL WILL BE POSSESSED  !

.... . ......... ........ . . . . . . . 8- 12 l AND U S ED . . . . . . . . . . . . . . . . . . . . . 1 J

8.7 . ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION S AFETY PROGRAM i 8-18 AND THEIR TRAINING AND EXPERIENCE . . . . . . . . . . . . . . . . . . . . ....

8.7.2 AUTHORIZED USERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . 8-22 0.8 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25 8.9 ITEM 9: FACluTIES AND EQUIPMENT ...... .... ....... ....... . . . . . . . . 8-26

....... 8-29 8.10 ITEM 10: RADIATION S AFETY PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8- 31 8.10.1 AUDIT PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

... ........ .. 8-41 8.10.4 OCCUPATIONAL DOSE . . . . . . . . . . . . . . . .. . . . . . . . . . . . .. .

..... .. 8-44 8.10.5 P UBUC DO S E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OPERATING AND EMERGENCY PROCEDURES ..... ...... .. .. . 8-47 8.10.6

....... . ...... 8-51 8.10.7 SURVEYS AND LEAK TESTS . . . . . . . . . . . . . . . . . . . . . .

8.10.8 MAINTEN ANCE ' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-56

.. ... . 8-57 8.10.9 TRANSPORTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I 8.10.10 MINIMIZATION OF CONTAMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . 8-59 l

. . . . . . . . . . 8-61 8.11 ITEM 11: WASTE MANAGEMENT . . . . . . . . ......... ... .... ..

. . 8-66 8.12 ITEM 12: FEES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . 8-66 f 8.13 ITEM 13: CERTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

v Draft NUREG - 1556, Vol.12

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CONTENTS 9 AMENDMENTS AND RENEWALF 'i O A IJCENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 10 APPLICATIONS FOR EXEMPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 1 11 PLANNING FOR TERMINATION OF LICENSED ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 APPENDICES

- A List of Documents Considered in Development of this Draft NUREG . . . . . . . . ...................A-1 B - United States Nuclear Regulatory Commission Form 313 . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . B-I C Suggested For mat for Providing Information Requested in Items 5 through 1I of NRC Form 313 . . . . . . . C-1 D Sample Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 E Information Needed for Transfer of Control Application ... .. ................ . .......... .. E-1 F License Types - Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F- 1 G Quality Control. Labeling, and Prototype Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1 H Radiation Safety Officer Duties and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . H-1 I Radiation Safety Training Topics . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....... . ..... ... I.1 J Facilities and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............................J.1 K Suggested Audit Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K-1 L Radiation Monitoring Instrument Specifications and Model Surve Calibration Program . . . . . . . . . . . . . . . . . . . . . . . . ................................,11

. . . . . . . .y Instrument and Air Sampler M Material Receipt and Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............M.1 N Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits . . . . . .... .. . ............... ...... . ......... .................N-1 0 Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . O- 1 P General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures . . P-1 Q Notification Requirements . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . Q.1 R Radiation Safety Survey Topics . . . . . . . . . . . . . ...........................................R-1 S Model Leak Test Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ ..... S-1 T Transportation . . . . . . . . . . . . . . .

..... ............ .................. .......... ...... T-1 U . Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . U- l V Using the Internet to Obtain Copies of NRC Documents and Other Information . . . . . . . . . . . . . . . . . . . . . . V-1 W Medical Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . W- 1 FIGURES Figure 2.1 U.S. Map............................................................

2-2 Figure 8.1 Imcation of Possession or Possession and Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Figure 8.2 Financial Assurance for Decomtnissioning ...... .................... . .......... 8-11 Figure 8.3 Records Important to Decommissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 Draft NUREG - 1556. Vol 12 vi

i CONTENTS Figure 8.5 Example of a Product Produced Under Possession for Manufacturing and Distribution

~ Authori zation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 ! 7 Figure 8.6 RSO Responsibilities :. . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21 Figure 8.7 L Facility Diagram for a Radiography Source Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28 Figure 8.8 Shielded Protective Enclosure (Hot Cell) With Remote Manipulator . . . . . . . . . . . . . . . . . . . 8-29

= Figure 8.11 Annual Dese Limits for Occupationally Exposed Adults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 3 Figure 8.12 Calculating Public Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-46 Figure 8.15 Types of Surveys ' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-52 Figure P.1 S torage of Food and Drink '. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P-2 Figure R.lu Are a Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. R-7

. TABLES Who Regulates the Activity? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-1 Table 2.1 8-6 Table 8.1 .-Types of Radioactive Materiala . . . . . . . . . . . . . . . . . . . .. ........ .. ... . . -........

Table 8.3 ~ Package Monitoring Requirements . . . . . . .. .... ...... ........ ........... ... 8-37 Table A.1 List of NJREG Reports. Regulatory Guides, and Policy and Guidance Directives . . . . . . . . . . . A- 1 Tabw A.2 List of 1. formation Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

.. . ......... ... ......... . ........ ... . . . A-9 Table A.3 : Miscenaneous NRC Documents

. ...... . . L-1 Table L1 Typical Surycy lnstruments . . . . . . . . . . . . . . . . . . . . . . . . . . ..........

1

' Table R.1 Suggested Frequency of Contamination Surveys from Regulatory Guide 8.23 . . . . . . . . . . . . . . R.3 Survey Frequency Category . . . . . . . . . . . . . . . ......... ........... ..............R-3 Table R.2 Table R.3 Survey Frequency Category Modifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R-4

- Table R.4 Isotope Groups . . . . . . . . . . . . . . . . . . . ............... ... .............. . . . . . . R-4 Table R.S . Acceptable Surface Contamination levels . . . . . . . . . . . . ........ ....... . . . . . R-5 i

vii Draft NUREG - 1556, Vol.12 i

t .

l f

FOREWORD 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," dated April 1996. A critical element of the new process is the consolidation and updating of numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series," Consolidated Guidance About Materials Licenses":

Vol. Volume Title Status No.

1 Program-Specific Guidance About Portable Gauge Licenses Final Repon 2 Program-Specific Guidance About Radiography Licenses Final Report 3 . Applications for Sealed Source and Device Evaluation and Final Report Registration 4 Program-Specific Guidance About Fixed Gauge Licenses Final Report 5 Program-Specific Guidance About Self-Shielded Irradiators Final Report 6 Program-Specific Guidance ANut 10 CFR Part 36 Irradiators Final Report  !

7 Program-Specific Guidance About Academic, Research and Draft for Comment Development, and Other Licenses of Limited Scope 8 Program-Specific Guidance About Exempt Distribution Licenses Final Report 9 Program-Specific Guidance Abcut Medical Use Licenses Draft for Comment 10 Program-Specific Guidance About Master. Material Licenses Draft for Comment 11 Program-Specific Guidance About Licenses of Broad Scope Final Report 12 Program-Specific Guidance About Possession Licenses for Draft for Comment Manufacturing and Distribution 13 Program-Specific Guidance About Commercial Radiopharmacy Draft for Comment Licenses 14 Program-Specific Guidance About Well Logging, Tracer, and Field Draft for Comment Flood Study Licenses 15 Guidance About Changes of Control and About Bankruptcy Draft for Comment Involving Byproduct, Source, or Special Nuclear Materials Licenses i

The current document, draft NUREG-1556, Vol.12," Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and ix Draft NUREG - 1556, Vol.12 Y

\

l FOREWORD Distribution," dated July 1999, is the twelfth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in Regulatory Guide 10.7," Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material," dated August 1979; NMSS Policy and Guidance Directive FC 84-1, " Review Responsibility - Manufacturing and Distribution of Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26," dated April 1984; NMSS Policy and Guidance Directive FC 85-6, " Standard Review Plan for ,

Applications for Licenses and Approvals to Authorize Distribution of Various Items to Group Medical Licensees," dated February 1985; and Draft Regulatory Guide DG-0007, " Guide for the f

Preparation of Applications for Licenses to Authorize Distribution of Various items to Commercial Nuclear Pharmacies and Medical Use Licensees," dated March 1997. This draft report also contains pertinent information found in Information Notices and other documents, as listed in Appendix A.

This draft report takes a risk-informed, performance-based approach to licensing possession for manufacturing and distribution. It reduces the amount ofinfom1ation needed from an applicant seeking to possess and use byproduct, source, and/or special nucler .verials for activities associated with possession for manufacturing, and/or distribution to specific licensees and distribution to medical use licensees. A team composed of NRC staff from Headquarters and Regional offices drafted this document, drawing on their collective experience in radiation safety in general, and as specifically applied to licensing of possession for manufacturing and di.;tribution. A representative of NRC's Office of the General Counsel provided a legal perspective.

Draft NUREG-1556, Vol.12, " Consolidated Guidance about Materials Licenses:

Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution,"

dated July 1999, represents a step in the transition from the current paper-based process to the new electronic process. This draft document is available on the Internet at the following address:

<http://www.nrc. gov /NRC/NUREGS/SR 1556/V 12/index.html>.

This draft report is strictly for public comment and is not for use in preparing or reviewing applications for possession for manufacturing and distribution until it is published in final fom1.

It is being distributed for comment to encourage public participation in its development. NRC is requesting comments on whether a risk-informed, performance-based approach to licensing is

. valid, as well as comments on the information provided about possession for manufacturing and distribution. 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 Servies Office of Administration, U. S. Nuclear Regulatory Commission, Washington, DC 20;55-0001.

Hand-deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and Draft NUREG - 1556, Vol 12 x

FOREWORD 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.12," Consolidated Guidance about Materials Licenses:

Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution,"

dated July 1999, 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. If a license of broad scope is being sought (under 10 CFR 33," Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG - 1556, Vol. l1," Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope."

/ . EY Donald A. Cool, Director ' ' '

fY~

Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards xi Draft NUREG - 1556, Vol.12 Y

1 ACKNOWLEDGMENTS The writing team thanks the individuals listed below for assisting in the development and review of the drafl :eport. All participants provided valuable insights, observations, and L recommendations.

The Participants Cain, Charles L.

Camper, Larry W.'

Caniano, Roy J.

Collins, David J.

Collins, Douglas M.

Combs, Frederick C.

Cool, Donald. A.

Gill,- Charles F.

Howe, Donna-Beth Manning, Louis, til

' McGrath, John R.

Merchant, Sally L.

Phillips, Monte P.

Roe, Mary Louise Schwartz, Maria E.

Treby, Stewart A.

Ullrich, Elizabeth Vacca, Patricia C. i 7elac, Ronald E.

The team also thanks Kay Avery, Judy Boykin, Randy Glantz, Rolonda Jackson, D.W. Benedict j Llewellyn, Steven W. Schawaroch, Agi Seaton, Gina G. Thompson, and Nora Younger of l Computer Sciences Corporation.  ;

i l

xiii Draft NUREG - 1556, Vol.12

ABBREVIATIONS ALARA as low as is reasonably achievable ALI annual limit on intake ANSI American National Standards Institute AU authorized user bkg background BPR Business Process Redesign Bq becquerel = 1 disintegration (transformation) per second CD-ROM compact disc with read-only memory Ci curie = 3.7 x 105 disintegrations per second CFR Code of Federal Regulations CoC certificate of compliance (shipping packages) cpm counts per minute CDE committed dose equivalent CEDE committed effective dose equivalent DAC derived air concentration DDE deep dose equivalent DFP Decommissi .;ing Funding Plan DIS decay in storage DOE United States Department of Energy DOT- United States Department of Transportation dpm disintegrations per minute EA environ lental assessment EDE effective dose equivalent EPA United States Environmental Pro'ection Agency )

F/A financial assurance  !

FDA United States Food and Drug Administration I GBq gigabecquerel GC gas chromatograph G-M Geiger-Mueller GPO Government Printing Office l IAEA International Atomic Energy Agency IN information notice l IMC inspection manual chapter l L/C license condition I LDE lens (eye) dose equivalent LLW low level radioactive waste LSC liquid scintillation counter LSA low specific activity mBq millibecquerel MCA multichannel analyzer MDA minimum detectable activity mGy milligray xv Draft NUREG - 1556, Vol.12

- ABBREVIATIONS

.mR milliroentgen mrem millirem mSv millisievert Nal(TI) sodium iodide crystal doped with thallium NCRP National Council on Radiation Protection and Measurements ND not detectable NIST National Institute of Standards and Technology.

~NMSS Office of Nuclear Materials Safety and Safeguards NORM naturally occurring radioactive materials NR not required NRC Nuclear Regulatory Commission NVLAP National Voluntary Laboratory Accreditation Program OCFO Office of the Chief Financial Officer OCR optical character reader OMB Office of Management and Budget OSP Office of State Programs QC quality control QA quality assurance R roentgen rem roentgen equivalent man RG regulatory guide RQ reportable quantities RSO/RPO Radiation Safety Officer / Radiation Protection Officer SDE shallow dose equivalent SI International System of Units (abbreviated SI from the French, "Systeme i Intemationale d' Unites")

SPO NRC Spent Fuel Project Office SSD sealed source and device Std standard Sv sievert Tl/2 half-life TAR - technical assistance request TEDE total effective dose equivalent TI transportation index TLD thermoluminescent dosimeters USDA. United States Department of Agriculture

- kilo (k) 1,000 micro ( ) 1 x 104 milli (m) 1 x 10-3 mega(M) 1 x 106 giga (G) 1 x 10' tera (T) 1 x 10i2 1 l

Draft NUREG - 1556, Vol 12 xvi 4

1 PURPOSE OF DRAFT REPORT This document is strictly for public comment and is not for use in preparing or reviewing applications for possession for manufacturing and distribution, or for distribution (only) for medical use, until this document is published in final form.

This draft repoit provides guidance to an applicant in preparing a license application for

. possession for manufacturing and distribution, and for distribution (only) for medical use, as well as NRC criteria for evaluating such a license application.

This document contains the standard requirements and guidance for materials licensing for:

1) possession and use for manufacturing, including distribution of products to other specific licensees; 2) possession for distribution only (which requires a separate distribution license);

and 3) one type of distribution only, transfer of radioactive drugs, sealed sources, and devices directly to medical use licensees. Note that this guidance does not apply to those quantities of special nuclear material exceeding those listed in 10 CFR 70.22 (h)(2)(i)(1). For the purpose of this NUREG, materials manufacturers are those licensees that process raw material and/or sources and distribute those processed materials or manufactured products to users as finished products.' Examples are:. major radiopharmaceutical processor / manufacturers (not radiopharmacies); sealed source fabricators; device manufacturers; and other manufacturing licensees that possess and use irradiated bulk quantities of raw materials or sources. As noted above, this NUREG also applies to licensing for distribution to specific licensees and to medical use licensees. Guidance for obtaining licenses for distribution to general licensees and for I distribution ofitems to persons exempt from license requirements is supplied in other NUREGs in this series. Distribution-only licensees are not involved in the processing of raw materials or sources, nor in the manufacturing of devices. Distributors include importers for purposes of distribution.

Quality control for finished products is part of the manufacturer licensee's responsibilities.

These obligations are described in the regulations of 10 CFR Part 32. Quality control applicable to medical use distribution are listed in Appendix G. Quality control of fimished products to be distributed to general licensees or individuals exempt from license are listed in NUREG-1556, Vol.16 and NUREG-1556, Vol. 8, respectively.

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

" Application for Material License," for the possession and use of byproduct, source and/or j special nuclear materials for manufacturing and distribution, and for distribution (only) for medical use; If a license of broad scope is being sought (under 10 CFR 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol,11," Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." The information collection requirements in  ;

10 CFR Part 30, Part 32, Part 40, Part 70, and NRC Form 313 have been approved under the Ofrice of Management and Budget (OMB) Clearance Nos. 3150-0017,3150-0001,3150-0020, 3150-0009, and 3150-0120, respectively.

1-1 Draft NUREG - 1556, Vol.12

PURPOSE OF DRAFT REPORT The format within this document for each item of technical information is:

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; and Response from Applicant -provides suggested response (s), offers the option of an alternative 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 found for each item on NRC Form 313.

NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For convenience and for streamlined handling of possession for manufacturing and distribution applications, applicants may use Appendix C,

" Suggested Format For Providing Information Requested In Items 5 through 11 of NRC Form 313," to proside supporting information to the NRC.

Appendices D through W contain additional information on various radiation safety topics.

Appendix D has sample possession for manufacturing and distribution licenses; it contains the conditions most often found on these licenses, although not all licenses will have all conditions.

Appendix F provides information on the types oflicenses. Appendix X provides guidance in applying for distribution (only) for medical use licenses.

In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent (EDE), committed dose equivalent (CDE), committed effective dose equivalent (CEDE), or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20.

Roentgen equivalent man (rem), and its International System of Units (SI) equivalent, sievert (Sv)(1 rem = 0.01 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 rads or roentgens (R).

Draft NUREG - 1556, Vol.12 1-2

c; 2 AGREEMENT STATES Certain states, called Agreement States (see Figure 2.1), have entered into agreements with 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 must contact the responsible officials in that State for guidance on preparing an application; file these applications with State officials, not with NRC.

In general, NRC's materials licensees who wish to conduct service, installations, or demonstrations at temporary jobsites in an Agreement State should contact that State's radiation control program office for information about State regulations. To ensure compliance with Agreement State reciprocity requirements, a licensee should request authorization well in advance of the scheduled possession and use.

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

" exclusive Federaljurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for fimding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal Agency controlling the site (e.g., contract j 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 the "All Agreement States Letter," SP-96-022, dated February 16,1996, which is available from NRC upon request.

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

Table 2.1 Who Regulates the Activity?

Applicant and Proposed Location of Work Regulatory Agency Federal Agency, regardless oflocation (note 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 nori-Federally controlled site Agreement State 2-1 Draft NUREG - 1556, Vol.12 ;

AGREEMENT STATES Applicant and Proposed Location of Work Regulatory Agency 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 subject to NRC exclusive Federaljurisdiction Locations of NRC Offices and Agreement States Region IV Region lli MN NH WA MT ND : VT, SD MA g nl MI NY

. OR / 10

~

' IA '-

WY . e PA e R1 NE~ IN OH gg NJ CT NV' . MO D'C' UT , CO.. .

WV '

DE CA ,.N

'AZ NM AR pg s t4 ..C a TM .

AL g 8C'>

C y*i pt Region 11

• Region 11 61 Forsyth Street, SW, Suite 23T85 PR A]anta, GA 30303

1. RegionalOffice U Headquarters C 30 Agreement States Headquarters 01 arr nville Road (approx.15,800 licensees) Washington, D.C. 20555-0001 L sie, IL 60532-4351 301 415-7000, 1-800-368-5642 630-829-9500, 1-800-522-3025 O 20 Non-Aqreement States (approx. v,000 licensees)

Region i Region IV Note: Alaska and Hawaii are included in 475 Allendale Road 611 Ryan Plaza Drive Suite 400 Region IV, Puerto Rico and Virgin Islands King of Prussia, PA 19406-1415 Arlington, TX 76011-8064 in Region 11 610-337-5000,1-800-432-1156 817-860-8100, 1-800-952-9677 62W-4029-m Figure 2.1 U.S. Map. Location ofNRC Offices andAgreemem atates. )

I

Reference:

A current list of Agreement States (including names, addresses, and telephone j numbers of responsible officials) is available by choosing " Directories" on NRC Office of State '

Programs' (OSP's) home page <http://www.hsrd.ornl. gov /nrc/home.html>, or by requesting the list from NRC's Regional Offices. i 1

1 All Agreement States Letter, SP-96-022, on determining jurisdictional status at a Federal facility, dated February 16,1996, is available on OSP's home page  ;

<http://www.hsrd.ornl, gov /ntc/home.html>; choose "NRC-State Letters," then scroll down to 1

l l

Draft NUREG - 1556, Vol.12 2-2 I i

AGREEMENT STATES l

"Other Information - 1996" for SP-96-022. You can also request the letter from OSP by calling NRC's toll free number (800) 368-5642, extension 415-3340, l

l l

2-3 Draft NUREG 1556, Vol.12 L

i 3 MANAGEMENT RESPONSIBILITY

\

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 licensee's 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 rubmitted application, acknowledging management's commitments and responsibility for the following:

a F.adiation 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.

. Compliance with current NRC and Department of Transportation (DOT) regulations and the licensee's operating and emergency procedures.

. Commitment to provide adequate resources (including space, equipment, personnel, time, and, ,

I if needed, contractors) to the radiation protection program to ensure that public and workers are protected from radiation hazards and compliance with regulations is maintained.

. Selection and assigmnent of a qualified individual to serve as the Radiation Safety Officer (RSO) for licensed activities.

. Prohibition against discrimination of employees engaged in protected activities (10 CFR 30.7, 40.7 and 70.7).

. Commitment to provide information to employees regarding the employee protection and deliberate misconduct provisions in 10 CFR 30.7,40.7 and 70.7 and 10 CFR 30.10,40.10 and 70.10, respectively.

. Obtaining NRC's prior written consent before transferring control of the license.

. Notifying appropriate NRC Regional Administrator in writing,immediately following filing of petition for voluntary or involuntary bankruptcy.

For information on NRC inspection, investigation, enforcement, and other compliance programs, see the current versions of" General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, and Manual Chapter (MC) 87110, Appendix A, 3-1 Draft NUREG - 1556, Vol.12

MANAGEMENT RESPONSIBILITY

" Industrial / Academic /Research Inspection Record." The current version of NUREG-1600 is available electronically at <http://www.nre. gov /OE>. To obtain hard copies of the current versions of NUREG-1600 and MC 87110, see the Notice of Availability (on the inside front cover of this report).

l l

Draft NUREG - 1556, Vol.12 32

)

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

The following Parts of Title 10, Code of Federal Regulations (CFR), contain regulations applicable to possession for manufacturing and distribution:

. 10 CFR Part 2," Rules of Practice for Domestic Licensing Proceedings and issuance of Orders"

. 10 CFR Part 19, " Notices, Instructions and Reports to Workers: Inspection and Investigations

. 10 CFR Part 20, " Standards for Protection Against Radiation"

. 10 CFR Part 21. " Reporting of Defects and Noncompliance"

. 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material"

• 10 CFR Part 31, " General Domestic Licenses for Byproduct Material"

. 10 CFR Part 32, " Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material"

. 10 CFR Part 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"

. 10 CFR Part 40, " Domestic Licensing of Source Material"

. 10 CFR Part 70, " Domestic Licensing of Special Nuclear Material"

. 10 CFR Part 71, " Packaging and Transportation of Radioactive Material" ]

1 Part 71 requires that licensees or applicants who transport licensed material or who may offer such material to a carrier for transport must comply with the applicable requirements of the DOT that are found in 49 CFR Parts 170 through 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 110, " Export and Import of Nuclear Equipment and Material"

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

.- 10 CFR Pan 171, " Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and I Materials Licenses, Including IIolders of Certificates of Compliance, Registrations, and {

Quality Assurance Program Approvals and Government Agencies Licensed by NRC" 4-1 Draft NUREG - 1556, Vol.12

. APPLICABLE REGULATIONS b

k. To request copies of the above documents, call GPO's order desk in Washington, DC at

.(202) 512-1800. You may order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954,' Pittsburgh, Pennsylvania, 15250-7954. You may also contact the GPO electronically at <http://www.gpo. gov >. Request single copies of the above documents from

. NRC's Regional Ollices (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.12 4-2

I l

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. If a license of broad scope is being sought (under 10 CFR 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG - 1556, Vol. I1,, " Consolidated Guidance About Materials Licenses: Program-Specific Guidance Abouit Licenses of Broad Scope."

. 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 with original attachments (if any) and one copy of the entire document.' ,

i

?

. Retain one copy of the license application and attachments for future reference.

As required by 10 CFR 30.32 (c), applications must be signed by an authorized representative; see section in this report entitled " Certification."

Use of the suggested wording of responses and a commitment to use the model procedures in this report will expedite NRC's review. It is not intended that applicants change their programs l to conform to the model procedures.

i All license applications will be available for review by the general public in NRC's Public Document Rooms. Ifit is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal l- information (i.e., home address, home telephone number, social security number, date of birth, '

L and radiation dose information) should not be submitted unless specifically requested by NRC.

5-1 Draft NUREG - 1556, Vol.12 1'

HOW TO FILE As explained in the foreword to this document, NRC's new licensing process will eventually become faster and more efficient, in part, through accepting and processing electronic applications. In the meantime, NRC will continue to accept paper applications, which will be scanned and converted to electronic format. To ensure a smooth conversion, applicants are requested to follow these suggestions:

. Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed easily into the scanner.

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

. Choose sans serif typeface designs 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 stylized characters such as script, italic, etc.

. Be sure the print is clear and . sharp.

- 5.2 ELECTRONIC APPLICATION in the future, as the electronic licensing process develops, it is anticipated that NRC will provide mechanisms for filing electronic applications on diskette, compact disc with read-only memory (CD-ROM), or via the Internet. NRC will provide additional filing instructions as these new mechanisms become available. The existing paper process will continue to be used until the electronic process is available.

Draft NUREG - 1556, Vol.12 5-2

_ _ _ _ _ _ _ _ _ _ _ _ ____9

i

'6 WHERE TO FILE Applicants wishing to possess or use licensed material in any State or U. S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which tne material will be possessed and/or used. Figure 2.1 shows NRC's four Regio:tal Offices and their respective areas for licensing purposes, and it identifies Agreement States, j In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State, not NRC. However, iflicensed materials will be possessed or used at Federally-controlled sites in Agreement States, applicants must first i determine the jurisdictianal status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See the section on " Agreement States" for additional information.

1 I

6-1 Draft NUREG - 1556, Vol.12

<T

1 l

7 LICENSE FEES r :h application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. If applying for both a possession and use licenso and a " Medical Distribution" lionse, fees should be included for both licensing actions. 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 NRC's disposition of an application or should an application be withdrawn.

Most NRC 'anwes are also subject to ar.nual fees; refer to 10 CFR 171.16. Consult 10 CFR "/1.11 for additional information on exemptions from ennual 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. You may also call NRC's toll free number (800) 368-5642, extension 415-7554 7-1 Draft NUREG - 1556, Vol.12

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

8.1 ITEM 1: LICENSE ACTION TYPE THIS IS AN APPLICATION FOR (Check appropriate item)

Type of Action License No.

[ ] A. New Licen<e Not Applicable

[ ] B. Amendment XX-XXXXX-XX

[ ] C. Renewal XX-XXXXX-XX -

Check box A for a new license request.

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

Check box C for renewal' of an existing license, and provide license number.

8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS List the legal name of the applicant's corporation or other legal entity with direct control over possession and use of the radioactive material. A division or department within a legal entity may not be a licensee; however, a subsidiary of a larger entity may be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the possession and use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address.

Notify NRC of any changes in the mailing address; these changes do not require a fee. 3 Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NUREG - 1556, Vol.15,

" Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses" discusses the potential for the security and control oflicensed material to be compromised during periods of organizational instability.

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

81 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b),10 CFR 40.41(b); 10 CFR 70.32(a)(3).

Criteria:' Licensees must provide full information and obtain NRC'sprior written consent before transferring control of the license, also commonly referred to as " transferring the license."

Discussion: Transferring 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 prior NRC written consent. This ensures that:

. 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 the licensed materials.

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

Response from Applicant: None from an applicant for a new license. For additional information, refer to NUREG-1556, Vol.15 for guidance on changes of control and about bankruptcy.

Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h); 10 CFR 40.41(f)(1); 10 CFR 70.32(a)(9)(i).

Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing.

Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in j bankruptcy proceedings, in order to determine whether there are any public health and safety l concerns (e.g., contaminated facility). NRC shares the results ofits determinations with other j involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy

[ actions are completed.

1 Draft NUREG - 15,16, Vol.12 82

1 CONTENTS OF AN APPLICATION Response from Applicant: None a: time of application for a new license. Licensees must I immediately (within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) notify NRC following the filing of a voluntary or involuntary { '

petition for bararuptcy for or against the licensee.

References:

Information Notices are available in the " Reference Library" on NRC's llome Page at <http://www.nrc. gov >. 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 NRC Inspection Manual, inspection Procedure 87103," Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing." For additional information, refer to NUREG-1556, Vol.15 for guidance on changes of control and about bankruptcy.

8.3 ITEM 3: ADDRESS (ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED Regulations: 10 CFR 30.34(c); 10 CFR 40.41(c); and 10 CFR 70.41(at Specify each proposed location of possession or possession and use by street address, city, state, i and zip code, or other descriptive address (e.g., on Highway 10,5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State). A Post Office box address is not acceptable, as illustrated in Fig. 8.1. _Iflicensed material is to be possessed or possessed and used at more than one location, give the specific address of each location. Applicants for a broad scope license need not identify each facility at a particular address where licensed material will be possessed or possessed and used. For example, broad scope applicants can specify that licensed material will be possessed or possessed and used on the manufacturing campus of ABC Corporation located on Presidential Avenue in Anytown, State.

Each applicant should identify alt facilities designed or established for special uses, e.g., hot cells, interim or long-term waste storage facilities, high activity laboratories, iodination facilities, alpha laboratories, and incinerators (see NUREG-1556, Vol.7).

An NRC-approved license amendment identifying a location of possession or possession and use is required before receiving, using, and storing licensed material at that location.

3 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION 32 Elm St.

P O.Bo JCXX U' City, 12345 V

w. n, 072498 I Figure 8.1 Location of Possession or Possession and Use. An acceptable location of possession orpossession and use specifies street address, city, state, and:ip code and does not {

i include a Post Office box number.

Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or local regulations (e.g., local zoning requirements or a local ordinance requiring registration of a radiation-producing device).

Note: As discussed later under " Financial Assurance and Recordkeeping for Decommissioning,"

licensees must maintain permanent records of where licensed material was possessed or possessed and 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). Acceptable records are sketches, written descriptions of the specific locations, or room numbers where licensed material is possessed and used or stored, and any records of spills or other unusual occurrences involving the spread of contamination in or around the licensee's facilities.

8.4 ITEM 4: PERSON TO BE CONTACTF.D ABOUT THIS '

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

Draft NUREG - 1556, Vol.12 8-4

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

8.5 ITEM 5: RADIOACTIVE MATERIAL As indicated on NRC Form 313 (Appendix B), Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use Appendix C for this purpose and should note that use of the suggested wording of responses and a commitment to use the model procedures in this draft report will expedite NRC's review. It is not intended that applicants change their programs to conform to the model procedures.

Regulations: 10 CFR 30.6; 10 CFR 30.11; 10 CFR 30.32; 10 CFR 30.33; 10 CFR 30.36; 10 CFR 30.37; 10 CFR 30.38; 10 CFR Part 32; 10 CFR Part 40; 10 CFR Part 51; 10 CFR Part 70; 10 CFR 110.9; 10 CFR 110.9a; 10 CFR 110.31; 10 CFR 110.32

' Criteria: A specific license is required, describing and authorizing the manufacture or distribution of materials and devices to persons generally licensed, specifically licensed, or l specifically licensed to distribute materials and devices to medical use licensees. Licenses authorizing distribution only to specifically licensed or generally licensed persons do not generally allow possession and processing oflicensed materials. Licenses authorizing the distribution of materials to persons exempt from licensing are not described in this document.

l See NUREG-1556, Vol. 8, Exempt Distribution Licenses. For additional guidance, see NUREG - 1556, Vol.16, General Distribution Licenses. If a license of broad scope is being i sought (under 10 CFR 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG - 1556, Vol. I1, " Consolidated l- Guidance About Materials Licenses: Program-Specific Guidance About Licen.e s of Broad l

j Scope."

Discussion: Licensees are required to have a specific license authorizing manufacturing or incorporating licensed materials into devices or materials. Licensees or applicants desiring to 1 incorporate a material into a sealed source or incorporate a sealed source into a device shall have l the combination approved by the NRC according to 10 CFR'32.51 or an Agreement State regulation, and listed in the Sealed Source & Device (SSD) Registry.

Licensees who possess and use licensed materials to support the process of manufacturing and/or distribution shall have the appropriate possession and uses described in their licenses. An example may be that a manufacturer of depleted uranium counterweights or shields possesses and uses a cesium 137 level gauge to detect blockage in the raw material hopper feed line. The manufacturer would need authorization not only to possess, use, and distribute the uranium for the counterweights and the shields, but also a line authorization to possess and use the level 85 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION gauging device. If the licensee wishes to calibrate its own survey meters and perform leakage / contamination tests, then separate line authorizations on the same license are needed for the survey instrument calibration source / device, and the calibration sources for the detection system for leakage / contamination testing. The licensee should have procedures for these uses.

Response from Applicant: No response required.

8.5.1 UNSEALED AND/OR SEALED BYPRODUCT MATERIAL Regulations: 10 CFR 30.6; 10 CFR 30.11; 10 CFR 30.32; 10 CFR 30.33; 10 CFR 30.36; 10 CFR 30.37; 10 CFR 30.38; 10 CFR 32.11; 10 CFR 32.14; 10 CFR 32.17; 10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.51; 10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74; 10 CFR 32.210; 10 CFR 40.13; 10 CFR 40.31; 10 CFR 40.32; 10 CFR 40.34; 10 CFR 40.35; 10 CFR 40.36; 10 CFR 40.38; 10 CFR 40.41; 10 CFR 40.44; 10 CFR 51.20; 10 CFR 51.21; 10 CFR 51.22; 10 CFR 70.39; 10 CFR 70.40; 10 CFR 70.41; 10 CFR 110.9; 10 CFR I 10.9a; 10 CFR 110.31; 10 CFR 110.32; 10 CFR 150.7.

Criteria:- An application for a license will be approved if the requirements of 10 CFR 30.33, 10 CFR 40.32,10 CFR 51.20,10 CFR 70.39,10 CFR 110.31 or 10 CFR 110.32 are met. In addition, licensees will be authorized to possess and use only those sealed sources and devices that are specifically approved or registered by NRC or an Agreement State.

Discussion: Each authorized radioisotope is listed on the NRC license by its element name, chemical and/or physical form, and the maximum possession limit, as shown in the sample licenses in Appendix D. Table 8.1, below, shows the type of radioactive material covered by this draft report. If a license of broad scope is being sought (under 10 CFR 33," Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. I1," Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope."

Table 8.1 Types of Radioactive Materials Type of Material Covered by this Examples j Draft Report l

Byproduct (reactor-produced) Yes H-3, C-14,1-131, I-125, S-35, P-32, P-33, Ca-45, Ni-63, Cd-109 Cs-137 '

Source material Yes U,Th Special nuclear material Yes Pu, etc.

I f Draft NUREG - 1556, Vol.12 8-6 V _ A

CONTENTS OF AN APPLICATION I Type of Material Covered by this Examples  !

Draft Report j l

Naturally occurring radioisotopes No Ra-226 Accelerator-produced radioisotopes No Co-57, Na-22, TI-201, Ga-67 The applicant should list each requested radioisotope by its element name and its mass number (e.g., carbon-14 (C-14]) in item 5. It is necessary to specify whether the material will be acquired and possessed and used in unsealed or sealed form. The name of the specific chemical compound that contains the radioisotope is not required. For volatile radioactive material, however, it is necessary to specify whether the requested radioisotope will be ccquired in free (volatile) or bound (non-volatile) form, because additional safety precautions are required when handling and using volatile material. For example, when requesting authorization to possess and use iodine-125 (I-125), the applicant must specify whether the material will be acquired in free form or bound form. If a radioisotope will be acquired in both free and bound fomis, then separate possession limits for each form must be requested.

Applicants requesting an authorization to possess and use volatile radioactive material must provide appropriate facilities, engineering controls, and radiation safety procedures for handling such material.

If a dose evaluation indicates, due to a release of radioactive materials, that the potential dose to a person off-site would exceed 0.01 Sv (1 rem) EDE or 0.05 Sv (5 rem) to the thyroid, an emergency plan for responding to a release shall be included with the application (10 CFR 30.32(i)).

i The anticipated possession limit in megabecquerels (MBq) (or in millicuries) or gigabecquerels j (GBq) (or in curies) for each radioisotope should also be specified. Possession limits must cover j the total anticipated inventory, including licensed material in storage and waste, and should be commensurate with the applicant's needs and facilities for safe handling. Applicants should review the requirements for submitting a certification for financial assurance for decommissioning before specifying possession limits of any radioisotope with a halflife greater than 120 days. These requirements are discussed in the section on Financial Assurance and Decommissioning.

Requests to license naturally-occurring radioactive material (NORM) and acer mduced radioactive material should be made to the appropriate State regulatory ageni does not regulate NORM or accelerator-produad radioactive material.

Before proceeding further, applicants should determine if their proposed possession and uses of byproduct material are in excess of the quantities specified in 10 CFR 30.71, Schedule B, or if their proposed possession and uses of source material are covered by the exemption from 8-7 Draft NUREG "56, Vol.12

CONTENTS OF AN APPLICATION licensing in 10 CFR 40.13. It is not necessary to submit an application to NRC for byproduct material that is covered by the exemption in 10 CFR 30.18 and initially distributed pursuant to 10 CFR 32.18. Similarly, certain prepackaged units (typically called kits) containing byproduct material for conducting in vitro clinical or laboratory tests, are distributed to persons who are generally licensed. Regulations related to possession and use of such prepackaged kits under a general license are stated in 10 CFR 31.11. Persons eligible for this general license are limited to physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, and hospitals; however, these persons are required to register with NRC before acquiring or using these units, unless they have an NRC license under 10 CFR Part 35.

Certain devices containing sealed sources of byproduct material, for example, gas chromatographs (GCs), are also authorized by NRC for distribution to persons who are generally licensed; therefore, such devices can be acquired by the users without obtaining a specific license from NRC. Regulatory requirements for such devices possessed under a general license are stated in 10 CFR 31.5. Distributors of such devices must provide users with appropriate infonnation related to the acquisition, use, and transfer of these generally licensed devices. For additional guidance, see NUREG - 1556, Vol.16, " General Distribution Licenses."

A safety evaluation of sealed sources and devices is performed by NRC or an Agreement State i before authorizing a manufacturer (or distributor) to distribute them. The safety evaluation is documented in an SSD registration certificate. Information on SSD regist*ation certificates may be obtained by calling NRC's foll-free number, (800) 368-5642, extension 415-7231. Before the formalization of the SSD registration process, some older sources or devices may have been specifically approved on a license. Licensees can continue to possess and use those sources and devices specifically listed on their licenses. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in an SSD registration certificate or specifically approved on a license. See also NUREG-1556, Vol. 3.

Consult with the proposed supplier, manufacturer, or distributor to ensure that requested sources and devices are compatible with and conform to the SSD designations registered with NRC or an Agreement State. Licensees may not make any changes to the sealed source, device, m source / device combination that would alter the description or specifications from ihose indicated in the respective registration certificates, without obtaining NRC's prior permission in a license amendment. To ensure that applicants possess and use sources and devices according to the registration certificates, they may want to get a copy of the certificate and review it or discuss it {

with the manufacturer.

I l

}

Draft NUREG - 1556, Vol.12 8-8

CONTENTS Of AN APPLICATION l Response from Applicant:

. For unsealed materials: 1

- Provide element name with mass number, chemical and/or physical form, and maximum requested possession limit.

. For potentially volatile materials (e.g., I-125,1-131, H-3):

- Specify whether the material will be free (volatile) or bound (non-volatile) and the requested possession limit for each form.

• For sealed radioactive materials:

- Identify each radionuclide (element name and mass number) that will be used in each source.

- Provide the manufacturer's (distributor's) name and model number for each sealed source and device requested.

- Confirm that each sealed source, device, and source / device combination is registered as an approved sealed source or device by NRC or an Agreement State.

- Confirm that the activity per source and maximtun activity in each device will not exceed the maximum activity listed on the approved certificate of registration issued by NRC or by an Agreement State.

. Identify the chemical and physical form (s) that will be possessed.

. Identify the largest quantity of each radionuclide to be possessed at one time under the license,

- including receipts, in-process materials, and waste.

- Licensees who request a possession limit in excess of the quantities specified in 10 CFR 30.72, must submit an emergency plan, as specified in 10 CFR 30.32(i).

l 8.5.2 FINANCIAL ASSURANCE AND RECORD KEEPING FOR DECOMMISSIOMlNG Regulations: 10 CFR 30.34(b); 10 CFR 30.35; 10 CFR 40.36; 10 CFR 40.41(b); 10 CFR 70.25; 10 CFR 70.32(a)(3).-

+

8-9 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35,10 CFR 40.36 and/or 10 CFR 70.25, must submit a decommissioning funding plan (DFP) or provide a certification of financial assurance for decommissioning (F/A).

Even if no financial assurance is required, all licensees are required to maintain, in an identified location, decommissioning records important to the decommissioning of a facility. Pursuant to 10 CFR 30.35(g),10 CFR 40.36(f), and/or 10 CFR 70.25(g), licensees must transfer these records to either of the following:

. The new licensee before licensed activities are transferred or assigned according to 10 CFR 30.34(b),10 CFR 40.41(b), and 10 CFR 70.32(a)(3).

. The appropriate NRC Regional Office before the license is terminated.

Discussion: NRC wants to ensure that decommissioning will be carried out with minimum impact on public and occupational health and safety and the environment. There are two parts to the rule: financial assurance that applies to some licensees and recordkeeping that applies to all licensees.

NRC regulations requiring an F/A or a DFP are designed to provide reasonable assurance that the decommissioning oflicensed facilities will be accomplished in a safe and timely manner and that licensees will provide adequate funds to cover all costs associated with decommissioning. These requirements, if applicable, specify that a licensee either set aside funds for decommissioning activitics or provide a guarantee, through a third party, that funds will be available. Applicants are required to submit an F/A or a DFP when the possession of radioactive material of half-life (Tl/2) greater than 120 days exceeds certain limits. Criteria for determining whether an applicant is required to submit a DFP or has an option of submitting either a DFP or an F/A are stated in 10 CFR 30.35,10 CFR 40.36, and /or 10 CFR 70.25.

. " Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning" can be found in 10 CFR 30, 1 Appendix A.

" Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning" can be found in 10 CFR 30, Appendix C.

i

=

" Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning by Commercial Companies That Have No Outstanding Rated Bonds" can be found in 10 CFR 30, Appendix D.

=

" Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable l j

Assurance of Funds for Decommissioning by Nonprofit Colleges, Universities, and Hospitals" can be found in 10 CFR 30, Appendix E.

Draft NUREG - 1556, Vol.12 8-10 l

)

CONTENTS OF AN APP [.lCATION Refer to 10 CFR 30.35(d) for a table of required amounts of fm' ancial assurance for decommissioning by quantity of material.

Regulatory Guide (RG) 3.66," Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, provides guidance acceptable to the NRC staff on the infonnation to be provided for establishing financial assurance for decommissioning and a standard format for presenting the information.

Secu@

g Bond _M Statement Tru Agreement of Intent Cert cate Cnay Guaranty Deposit _

t Figure 8.2 Financial Assurance for Decommissioning. Most manufacturer licensees do not need to providefinancial assurancefor decommissioning. Large mam;facturers may need one of several approvedfinancial mechanisms.

The requirements for maintaining records important to decommissioning, including the type of l information required, are stated in 10 CFR 30.35(g),10 CFR 40.36(f) and/or 10 CFR 70.25(g).

All licensees are required to maintain these records in an identified location until the site is released for unrestricted use. In the event that the licensed activities are transferred to another person or entity, these records shall be transferred to the new licensee prior to transfer of the licensed activities. The new licensee is responsible for maintaining these records until the i i

license is terminated. When the license is terminated, these records must be transferred to NRC.

Careful recordkeeping of radionuclides possessed and used, including fonn, amount, and area used, will facilitate area release and license termination.

8-11 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION

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""'M I Figure 8.3 Records Important to Decommissioning. Allpossessionfor manufacturing and I distribution licensees must maintain records important to decommissioning, regardless of i whether they needfinancial assurancefor decommissioning.

Response from Applicants: No response is needed from most applicants. If F/A or a DFP is required, submit :he required documents as described in RG 3.66.

References:

See the Notice of Availability (on the inside front cover of this report) to obtain ]

copies of RG 3.66, " Standard Format and Content of Financial Assurance Mechanisms Required i for Decommissioning Under 10 CFR Parts 30,40,70, and 72," dated June 1990, and Policy and Guidance Directive FC 90-2 (Rev. i)," 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 POSSESSED AND I,' SED Regulations: 10 CFR 30.4,10 CFR 30.33(a)(1); 10 CFR 32.2; 10 CFR 32.11; 10 CFR 32.14; 10 CFR 32.17; 10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.51; 10 CFR 32.9: 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74; 10 CFR 32 'ty 10 CFR 40.4; 10 CFR 40.32(a); 10 CFR 51.21; 10 CFR 51.22; 10 CFR 70.4; Draft NUREG - 1556, Vol.12 8-12

CONTENTS OF AN APPLICATION 10 CFR 70.39; 10 CFR 70.42; 10 CFR 110.2; 10 CFR 110.20; 10 CFR 110.42; 10 CFR 110.43 and 10 CFR 110.50.

Criteria: Requested radioisotopes shall be possessed and used for purposes authorized by the Atomic Energy Act of 1954, as amended. All sealed sources and devices containing licensed material shall be possessed and used only for the purpose for which they are designed, and according to manufacturer's (distributor's) instructions and recommendations for possession and use as specified in the SSD Registration Certificate.

In order to have a license for Distribution of sources and devices containing radioactive materials, the applicant must first apply for and receive a dealed Source and Device (SS&D) registration in accordance with the procedures in NUREG - 1556, Volume 3.

Discussion: Applicants should pay particular attention to the applicable regulations listed above when applying for a license to manufacture and distribute licensed material. See Figure 8.4.

This list is not exhaustive, nor does it relieve the applicant from complying with applicable Federal, State, and local requirements. Applicants considering research and development can include the requested licensed materials in this application and should refer to NUREG - 1556, Vol. 7. Applicants intending to possess and use licensed materials for research involving humans must file a separate application for a license under 10 r'FL Part 35 and should refer to NUREG-1556, Vol. 9. Applicants intending to become a br . . cope licensee should refer to NUREG-1556, Vol. I1.

l l

l 8-13 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION G- Distribution Licenses E-Distribution Licenses 10 CFR 10 CFR 31.5 30.21 10 CFR 30.20 10 CFR 31.7 10 CFR 10 CFR 2.51 32.21 10 CFR 10 CFR 10 CFR 32.26 30.19 32.53 10 CFR 10 CFR 31.8 32.22 10 CFR 10 CFR 32.57 30.18 10 CFR 10 CFR 30.33 32.18 Possession arid Use of Byproduct Material for 10 CFR + Manufacturers and + 10 CFR 10 CFR 32.61 FR Distnbutors 32.17 h10 10 CFR g 10 CFR 32.14 1 32.71 10 CFR f

10 CFR 10 CFR 10 CFR 2.11 31.11 32.72 10 CFR 10 CFR 32.74 30.41 10 CFR 30.14 Radioactive Drugs to e Medcol Use Licensees 10 CFR 35.100s Medical Use License Transfer of 10 CFR 35.200s 10 CFR 35 57 Manufactured Products 10 CFR 35 400 to Limited Spec (c and 10 CFR 35 300s 10 CFR 35 500 B Scope nsees MD Distribution Licenses Radiopharmacies Autnonzed to Possess and Use the Products Specific Licenses 02 299 Figure 8.4 Regulation Wheel for Byproduct Material. Possessionfor manufacturing and distribution ofradioactive materials is authorized by several distinct regulations. The appropriate regulations to refer to depends on the nature ofthe material, the purpose (s)for which it will be possessed and used, and to whom it is sent.

Applicants may use the format given in Table 8.2 to provide the requested information. l l

l l

l l 1 l

Drafi NUREG - 1556, Vol.12 8-14

CONTENTS OF AN APPLICATION Table 8.2 Sample Format for Providing Information About Requested Radioisotopes

~

Radiosotope Chemical / Physical Maximum Proposed Use Form Possession Limit Manufacturing - Internal Uses Any byproduct Any Not to exceed Research and material with atomic 10 ctuies per development as numbers 1 through 83 radionuclide and defined in 100 curies total 10 CFR 30.4 Hydrogen-3 unbound / volatile 100 millicuries Labeling of x '

compounds

{

Phosphorus-32 Any 30 millicuries In vitro studies; labeling ofcompounds Iodine-125 Unbound / volatile 30 millicuries Protein iodination Cesium-137 Sealed source, Mfg. 20 millicuries Calibration of name/model number instruments Manufacturing and Distribution Hydrogen-3 unbound / volatile 100 millicuries Labeling of I compounds I Iodine-125 unbound / volatile 30 millicuries Protein iodination Any byproduct Any Not to exceed For possession, use, material with atomic 10 curies per and processing numbers 1 through 83 radionuclide and incident to

' 100 curies total manufacture of radiochemicals, radiopharmaceuticals, and sealed sources I

Any byproduct Any Not to exceed For storage prior to material with atomic 50 millicuries per distribution of numbers 84 through radionuclide and manufactured 94 2 curies total radiochemicals, radiopharmaceuticals, and sealed sources 8-15 Draft NUREG - 1556, Vol.12

~ CONTENTS OF AN APPLICATION Radiosotope. Chemical / Physical Maximum . Proposed Use Form Possession Limit

! Hydrogen 3 Any 100,000 curies For storage prior to Carbon 14 Any 500 curies distribution of Phosphorus 32 Any 100 curies manufactured Phosphorus 33 Any 20 curies radiochemicals,

' Sulfur 35 Any 400 curies radiopharmaceuticals, and sealed sources Hydrogen 3 Any 100,000 curies For packaging and Carbon 14; ,, Any 500 curies distribution of Phosphorus 32 - Any 100 curies manufactured Phospliofus 33 Any 20 curies radiochemicals, Sulfur 35 Any 400 curies radiopharmaceuticals, and sealed sources to persons authorized to receive the licensed material pursuant to the terms and conditions of specific licenses

, hlolybdenum Any 500 curies Foi possession, use, 99/ Technetium 99m and processing incident to the manufacture of radiochemicals nnd radiopharmaceuticals Distribution Xenon 133 Prepackaged Units 50 curies For possession incident to commercial redistribution of unopened containers to authorized recipients Hydrogen 3 Any 100,000 curies Distribution of Carbon 14 Any 500 curies manufactured Phosphorus 32. Any 100 curies radiochemicals, Phosphorus 33 Any 20 curies radiopharmaceuticals, Sulfur 35 Any 400 curies and sealed sources Draft NUREG - 1556, Vol.12 8 16

CONTENTS OF AN APPLICATION h" co%ct MGI >

j i

( 0 w J Technetium Tc 99m w V Y i t - 1 l

Mo-99/Tc-99m I 50 to 200 Millicuries uruo2g Figure 8.5 Example of a Product Produced Under Possession for Manufacturing and Distribution Authorization. Other designs oftechnetium generators can contain up to 4 curies ofMo-99/ic-99m.

Applicants should clearly specify if the licensed material will be used in animal studies and/or tracer studies as part of< manufacturing. Use oflicensed material in animals may be in quality control or research studies. Applicants should ulso state whether the studies will be limited to small animals (e.g., rats, mice) or may also include larger animals (e.g., pigs, dogs, horses). See NUREG-1556, Vol.7.

Applicants requesting a license for distribution-only will need to submit the required infonnation as described in Appendix F, which describes the different types of distribution licenses (i.e.,

General "G" Distribution License, Medical "MD" Distribution License, and Exempt "E" .

. Distribution License). Applic* ats for medical distribution. licenses must refer to 10 CFR 32.72 l and 32.74, in addition to the guidance specified in Appendices F and W. The applicant should i also see the sample "MD" distribution licenses in Appendix D.

Some " manufacturers" are importers of materials and devices from abroad and do not require the same extent ofinformation submission and review as a facility that produces an item. However, they are required to have a manufacturer / distributor license as the initial importer and distributor 8-17 Draft NUREG - 1556. Vol.12 j

f- 1 4

CONTENTS OF AN APPLICATION in the United States. The device distributor may be the sponsor of the " Sealed Source and Device Registry" certificate. This license is separate from the "G" or "E" distribution license.

Please note that exempt distribution guidance is addressed in NUREG-1556, Vol. 8, Exempt Distribution Licenses. Guidance for licenses authorizing the distribution of materials to generally licensed persons, is provided in NUREG-1556, Vol.16, " General Distribution Licenses."

Response from Applicant: Describe in general tenns the purposes for which the licensed material vill be possessed and used. Use of the suggested table format will facilitate review of the application. i 1

Identify each device, manufactured article, or material that becomes the product by manufacturer and model number.

Identify the SSD registration certificate number of each scaled source proposed for possession and use or incorporation into a manufactured article.

. Submit information requesting authorization to possess and use any other licensed materials in support of the manufacturing and distribution license.

Note: Applicants intending to manufacture sealed sources or devices should refer to Appendix G for the appropriate quality control and prototype testing requirements.

8.7 ITEM 7: INDIVIDUAL (S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE Regulations: 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.22(a)(6); 10 CFR 70.23(a)(2).

Criteria: Executive management, the RSO (and his/her staff, as necessary), and users work as a team to implement the radiation protection program. Each individual and position plays a critical role within his/her area of responsibility. The roles and responsibilities of executive management, the RSO, the radiation safety office staff, users and others in restricted areas are discussed in the sections that follow.

Note: NUREG-1516," Management of Radioactive Material Safety Programs at Medical Facilities," describes the role of executive management and the RSO at medical facilities but contains information that may be of help to the possession for manufacturing and distribution L licensee.-

Drah NUREG - 1556, Vol.12 8-18 t

CONTENTS OF AN APPLICATION Discussion: You must be qualified by training and experience to possess and use the material for the purpose requested in a manner that will protect health and minimize danger to life or property before an application for a license is approved.

Each program in which radioactive materials are possessed and used under a Commission license will have someone responsible for radiation safety and compliance with the Commission's regulations. In a small program, the responsibility may be assigned to (or assumed by) each individual using radioactive materials. In a medium-sized program, the responsibility may be assigned to an individual on a part-time basis, with that person's primary responsibility being in another area of work. In a large program, the many facets of occupational and environmental radiation safety require that responsibility for the radiation safety program be assigned to a qualified individual on a full-time basis. His or her training and experience must be commensurate with his or her duties and responsibilities. Supporting staff should be provided, as appropriate for the size and scope of the program. A large program may have some or all of the following characteristics:

. In-house calibration of radiation survey, monitoring, and measurement instruments;

. The possession and use of multiple chemical and physical forms of multiple radionuclides for various purposes; 1

- Program flexibility with regard to the possession and use of radionuclides, their chemical and physical form, and the uses to be made of such radionuclides;

. The need for accurate detection, identification, and measurement of radioactivity in various types of effluents (gas, liquid, solid) containing varying amounts of different radionuclides and for evaluation of these effluents against NRC regulatory requirements and limitations; l The need for radioactive effluent treatment by filtration, absorption, adsorption, holdup, etc.;

. The need for the selection, evaluation, design, fabrication, maintenance, and use of radioactive effluent treatment systems;  !

. The need for the selection, evaluation, and maintenance of radiation measurement and analysis equipment; A potential for the contamination of facilities, equipment, and personnel accompanied by the need to control such contamination (including airborne contamination), decontaminate personnel and equipment, and evaluate possible internal dose (including determination of the need for bioassays and interpretation of bioassay results).

If a license of broad scope is being sought (under 10 CFR 33," Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG - 1556, Vol. I1," Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope."

8-19 Draft NUREG - 1556, Vol.12 L

I

- CONTENTS OF AN APPLitaTION Response from Applicant:

Provide the name(s) of the proposed responsible individual (s), including statements of training and experience. The statements should include sufficient information to show the ability to manage a program of the same size or complexity as the licensed possession limits and uses dictate. Do not include private, personal infonnation. Do not provide information that is not I relevant to demonstrating a person's ability to use or supervise the use of, the types, and/or the f quantities ofmaterials requested.  ;

8J.1 RADIATION SAFETY OFFICER Regulations: 10 CFR 30.33(a)(3),10 CFR 40.32(b) and 10 CFR 70.23(a)(2). ,

Criteria: RSOs must have adequate training and experience. RSOs must also have specific experience with the types and quantities oflicensed material to be authorized on the license.

Discussion: The person responsible for oversight of the radiation protection program is called the RSO, or the Radiation Protection Officer (RPO). The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are possessed and used in a safe manner. Typical RSO duties are illustrated in Figure 8.6 and described in Appendix H. NRC requires the name of the RSO on the license to ensure that licensee management has identified a responsible, qualified person and that the named individual knows of his or her designation as RSO.

l l

l.

Draft NUREG - 1556, Vol.12 8-20

CONTENTS OF AN APPLICATION i

For Licensed Materials Stop unsafe activites Maintain records j a

Supervise Audit program annually decontamination ,,

f Ensure secunty s Perform surveys Control disposal Train personnel w

Interact with NRC, Investigate abnormal other authontes events i

Y " Tim Figure 8.6 RSO Responsibilities. Typical duties and reaponsibilities ofRSOs.

NRC believes that to demonstrate adequate training and experience, the RSO should have: (1) at a minimum, a college degree at the bachelor level or equivalent training and experience in physical, chemical, biological sciences, or engineering; and (2) training and experience commensurate with the scope of proposed activities. Training should include the following subjects:

. Radiation protec: ion principles

. Characteristics ofionizing radiation l

= Units of radiation dose and quantities

. Radiation detection instrumentation

- Biological hazards of exposure to radiation (appropriate to types and forms of licensed material to be possessed and used)

. NRC and DOT regulatory requirements and standards

. Hands-on use of radioactive materials.

The length of training and experience will depend on the type, form, quantity, and proposed use of the licensed material requested. Ultimately, the proposed RSO's training and experience  !

should be sumcient to identify and control the anticipated radiation hazards. In addition, the l RSO designee should have obtained the above training in a formal course designed for radiation l safety presented by an academic institution, commercial radiation safety consulting company, or a professional organization of radiation protection experts.

S-21 Draft NUREG 1556, Vol.12 l

L

CONTENTS OF AN APPLICATION

'Risponse from Applicant: ' Provide the following:

. Name of the proposed RSO

= Information demonstrating that the proposed RSO is qualified by training and experience.

Applicants should provide information about the proposed RSO's training and experience relative to the licensed material and uses requested in the application. Applicants should not submit extraneous information such as unrelated lists of publications, research grants, committee and society memberships, and personal private information. Submittal of unrelated material serves only to slow'the review process.

I 1

Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. The name and qualifications of the replacement R.SO must be submitted to NRC as part of an amendment request.

I 8.7.2 AUTHORIZED USERS

- Regulations 10 CFR 19.12'; 1 CFR 20.1101 (b); 10 CFR 30.33(a)(3); 10 CFR 40.32(b);

-10 CFR 70.23(a)(2); 10 CFR 71.5; 10 CFR 110.26; 10 CFR 110.27; 10 CFR 110.28; 10 CFR 110.29; 10 CFR 110.30; 10 CFR 110.42; 10 CFR 110.43; 10 CFR 110.44; and 49 CFR Parts 170 through 189 (appropriate to the mode of transport).

Criteria: Authorized Users (AUs) must have adequate training and experience with the types and quantities oflicensed material that they propose to possess and use.

Discussion: The AU_'s primary responsibility is to ensure that radioactive materials are possessed and used safely and in accordance with NRC regulations and the terms and conditions of the NRC license. An AU is considered to be supervising the possession and use of radioactive materials when he or she directs personnel in the conduct of operations involving the licensed material.

Although the AU may delegate specific tasks associated with the possession and use of radioactive material to supervised users (such as conducting surveys, keeping records), he or she, as the representative of the licensee, is ultimately responsible for its safe possession and use.

AUs should be responsive to the concerns of the RSO regarding regulatory commitments, safe practices, and other relevant issues. When required or appropriate, the AU should assist the RSO in maintaining an up-to-date inventory oflicensed material by providing periodic information on material received, taken out of facility inventory, stored, or disposed. The AU may be responsible for generating and submitting various types ofinformation to the RSO for approval Draft NUREG - 1556, Vol.12 8-22

I CONTENTS OF AN APPLICATION to possess and use licensed material. Such information may include protocols for the safe possession, use, and storage of material, purpose of work, maximum quantity of radioactivity to j be on site at any one time, waste disposal procedures, housekeeping responsibilities, contamination controls, ALARA practices, personnel dc,simetry needs, etc.

Supervision Appropriate supervision ensures that personnel possess and use licensed materials according to the requirements of the license or regulations, and in a manner that protects public health and safety. To provide adequate supervision, the authorized user must establish a system to ensure that supervised staff know the proper procedures and when to contact the authorized user or RSO for assistance.

The AU should do the following:

. Acquire knowledge about each of the following:

- general radiation safety procedures;

- procedures specine to the type oflicensed material they will possess and use, including the sources / devices manufactured;

- regulatory requirements;

- site-specine license requirements;

- equipment and facilities;

- production processes associated with the manufactured products. {

{

- Adequately plan for the possession or possession and use oflicensed material, including determining types and quantities of material to be possessed and used and establishing an outline of the procedures for each specific use oflicensed material that will enable supervised users to understand how to carry out their assigned tasks;

• Ensure that supervised individuals understand and comply with radiation safety procedures, policies, and regulations by providing the necessary training. Even though a supervised individual has been trained by the RSO or already has experience using licensed material, the authorized user must ensure that the supervised user is trained in the specinc possession and use of material and equipment and facilities;

• Monitor performance to detect deficiencies, develop corrective measures, and provide feedback to supervised users. The complexity and formality of this monitoring system varies from facility to facility and should be commensurate with its size, scope, and potential risks; 8-23 Draft NUREG - 1556. Vol.12

CONTENTS OF AN APPLICATION Notify RSO in advance of changes in procedures, uses oflicensed material, personnel, or facilities; a

Stop production assembly line work for unsafe radiation conditions.

Training and Experience NRC believes that to demonstrate adequate training and experience, the AU should have: (1) a college degree at the bachelor level, or equivalent training and experience in physical chemical or biological sciences or in engineering; and (2) training and experience commensurate with the scope of proposed activities including production practices, as applicable. Training should include the following subjects:

Radiation protection principles;

. Characteristics ofionizing radiation;

. Units of radiation dose and quantities;

• Radiation detection instruments; Biological hazards of exposure to radiation (appropriate to the types and forms oflicensed material to be possessed and used);

. Hands-on use of radioactive materials reflecting their proposed uses.

The length of(2) above, will depend upon the type, form, quantity, and proposed use of the licensed material requested, but it should cover the subjects stated.

Applicants must name at least one individual who is qualified to possess and use the requested licensed materials. In general, AUs must demonstrate training and experience with the type and quantity of material that they propose to use. For example, someone with training and experience only with sealed radioactive sources may not be qualified to possess and use or supervise the possession or possession and use of unsealed licensed material. In addition, someone with experience using only tracer quantities may not understand the risks of working with much larger (e.g.,10 or 100 times larger) quantities of the same substance. Applicants should pay particular attention to the type of radiation involved. For example, someone experienced with gamma emitters may not have appropriate experience for high energy beta emitters.

Draft NUREG - 1556, Vol.12 8-24

t CONTENTS OF AN APPLICATION Response from Applicant:

Provide the following:

• Name of each proposed AU with the types and quantities oflicensed material to be possessed or possessed and used; a Information demonstrating that each proposed AU is qualified by training and experience to possess and use or supervise the use of the requested licensed materials.

Applicants should provide information about the proposed AU's training and experience relative to the licensed material requested in the application. Applicants should not submit extraneous information, such as unrelated lists of publications, research grants, committee and society memberships, etc. Submittal of unrelated material serves only to slow the review l process.

! Note: Applicants for broad scope programs should refer to NUREG-1556, Vol. I1. Broad Scope programs may be permitted to name authorized users without amending the license. To do so, these programs must follow NRC guidelines such as in Volume 11.

l l 8.8 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.

l l Regulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 20.1801; 10 CFR 20.1802; j 10 CFR 30.7; 10 CFR 30.9; 10 CFR 30.10; 10 CFR 30.33(a)(3); 10 CFR 30.34(e); j l

10 CFR 40.32(b); 10 CFR 40.41(e); 10 CFR 70.23(a)(2); 10 CFR 70.32(b) l l Criteria: Individuals whose assigned duties involve exposure to radiation and/or radioactive material (from both licensed and unlicenced sources), and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem),

whether from all external sources, all internal sources, or any combination, must receive instruction commensurate with their' duties and responsibilities, as required by 10 CFR 19.12. If a licensee's prospective analysis determines that the potential exposure is greater than 5 mSv (500 mrem), then more extensive training commensurate with the potential radiological health protection problems is appropriate.

Discussion:' Before beginning work with licensed material, individuals must receive radiation safety training commensurate with their assigned duties and specific to the licensee's radiation safety program. Each individual should also receive periodic refresher training at no more than ,

12-month intervals.

8-25 Drah NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Licensees should not assume that safety instruction has been adequately covered by prior employment or academic training. Site-specific training should be provided for all individuals.

Ancillary personnel (e.g., clerical, housekeeping, security) whose duties may require them to work in the vicinity of radioactive material (whether escorted or not) need to be informed about radiation hazards and the appropriate precautions. The licensee should assess each individual's involvement with licensed material and cover each applicable subject appropriately.

Training may be in the form oflecture, demonstrations, videotape, or self-study, and it should emphasize practical subjects important to the safe possession and use oflicensed material. If training is not conducted by an instructor, a method should be adopted whereby a trainee can ask questions and discuss topics relating to occupational radiation exposure. The guidance in Appendix I may be used to develop a training program. The program should consider all topics pertinent for each group of workers and also the method and frequency of training. The program should evaluate whether or not the audience understands the materials presented.

The person conducting the training should be a qualified individual (e.g., a person who meets the

. qualifications for RSO or authorized user on the license and is familiar with the licensee's program).

Response from Applicant: A description of the radiation safety training program, including topics covered, groups of workers, assessment of training, qualifications ofinstructors, and the method and frequency of training. .

8.9 ITEM 9: FACILITIES AND EQUIPMENT Regulations: 10 CFR 30.33(a)(2),10 CFR 20.1406,10 CFR 20.1101(b),10 CFR 30.35 (g),

10 CFR 40.27(b),10 CFR 40.28(b),10 CFR 40.31(h),10 CFR 40.32(c); 10 CFR 40.34(a);

10 CFR 51.20(b); 10 CFR 70.23(a)(3); 10 CFR 70.39(a)

Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. They must minimize the possibility of contamination and keep exposures to workers and the public ALARA.

Discussion: Applicants must demonstrate that their facilities and equipment provide sufficient engineering controls and barriers to protect the health and safety of their employees and the public, keep exposures to radiation and radioactive materials ALARA, and minimize the danger to life and property from the uses of the types and quantities of radioactive materials to be possessed and used.

Radioactive materials are much like other hazardous materials in that protection is needed to prevent or limit occupational exposure. The license authorizing the manufacture or incorporation

. Drrd NUREG - 1556, Vol.12. 8-26

l l

CONTENTS OF AN APPLICATION  !

oflicensed materials into devices requires the applicant to describe the potentirl hazards and the engineering methods or administrative controls that will keep radiation exposure levels as low as is reasonably achievable (ALARA) from either internal radioactive materials or external radiation. The engineering controls to be applied should describe the processes that will be used (e.g., exhaust hoods, hot cells, shipping casks, in-plant shielding, rubber gloves for beta protection, goggles / masks to prevent skin / extremity / eye exposures).

4 1

Applicants may delay completing facilities and acquiring equipment until after the application review is completed, in case changes are required as a result of the application review. This also ensures the adequacy of the facilities and equipment before the applicant makes a significant financial commitment. In all cases, the applicant cannot possess or use licensed material until after the facilities are approved, equipment is procured, and the license is issued. l f

Applicants are reminded that records important to decommissioning are required to be maintained in an identifiable location. For further information, see the section entitled,

" Financial Assurance and Recordkeeping for Decommissioning."

For additional guidance regarding facilities and equipment, refer to Appendix J.

Response from Applicant: Describe the facilities and equipment to be made available at each location where radioactive material will be possessed or possessed and used (see Appendix J for topics to consider). Include a description of the area (s) assigned for the receipt, shipping, ,

storage, preparation and measurement of radioactive materials and production of radioactive products. A diagram should be submitted showing the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety (see Figures 8.7 and 8.8). When applicable to facilities where radioactive materials may become airborne, the dit crams should contain schematic descriptions of the ventilation systems, with pertinent airfiow rates, pressures, filtration equipment, and monitoring systems. Diagrams shculd be drawn to a specified scale, or dimensions should be indicated. For facilities where it is anticipated that more than one laboratory or room may be used, a generic laboratory or room diagram may be submitted. This information should be from the point of view of performance criteria, For example, state the purpose of your filtration equipment and the associated acceptance criteria to accomplish this purpose (such as the ventilation flow rate you are trying to maintain).

8-27 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Parking Lot Cast Storage Area Outside Receiving Area 1 Leak Testing for Radioactive Final Package Materials and --

Survey Other Deliveries QA/QC Benches l

Machine Shop Depleted Door "'*"'"'"""'

l Ports T i

e l

l l

l l HotCell l 4 u.

30 ft.

i i e I 0 i s Approved l 5 Window and Manipulators Material g Storage , { <

l 8, l l l 5 a

j i ,

i l Manager's Office a Omce l l

l ._

FiSs ,,

30 ft.  :

l MD20c ppt 021299 Figure 8.7 Facility Diagram for a Radiography Source Manufacturer.

i I

i Draft NUREG - 1556, Vol.12 8-28

CONTENTS OF AN APPLICATION

y; '  ?

J  ;

[gh .

n+74 g g Figure 8.8 Shielded Protective Enclosure (Ilot Cell) With Remote Manipulator.

If radioactive materials will be used with animals, include a description of the animal handling housing facilities. Appendix 11 to N'UREG-1556, Vol.7 may also be used as guidance.

8.10 ITEM 10: RADIATION SAFETY PROGRAM Regulations: 10 CFR 20.1101; 10 CFR 20.2102; 10 CFR 30.34(e); 10 CFR 30.50; 10 CFR 30.51; 10 CFR 40.41(e); 10 CFR 40.60; 10 CFR 40.61; 10 CFR 40.64; 10 CFR 40.65; 10 CFR 40.66; 10 CFR 40.67; 10 CFR 70.32(b); 10 CFR 70.50; 10 CFR 70.51; 10 CFR 70.52; 10 CFR 70.53; and 10 CFR 70.54.

Criteria: The requirement to develop, document. and implement a radiation protection program commensurate with the scope of the license request is contained in 10 CFR 20.1101; record keeping requirements related to the program are in 10 CFR 20.2102. In addition, the applicant or licensee (if renewing the license) should reference the applicable parts of the regulations for additional record keeping and reporting requirements. An applicant wishing to manufacture devices using source material should refer to the appropriate parts in 10 CFR Part 40, in addition 8-29 Draft NUREG - 1556, Vol.12 a - -

l I

CONTENTS OF AN APPLICATION to the appropriate requirements in 10 CFR Part 32. An applicant wishing to manufacture devices using special nuclear material should refer to the appropriate parts in 10 CFR Part 70, in addition to the appropriate requirements in 10 CFR Part 32.

10 CFR 20.1101 states that each licensee must develop, document, and implement a radiation protection program commensurate with the scope of the licensed activity. The program must assure compliance with established standards, procedures, and provisions of NRC regulations.

Additionally, any calculations or measurements used to demonstrate compliance with NRC l

regulations must either be representative of typical quantities possessed or in use or maximum i doses. The licensee is responsible for the conduct of all licensed activities and the acts and l

omissions of radiation workers and ancillary personnel. 10 CFR 30.34(e),10 CFR 40.41(e), and 10 CFR 70.32(b) permit NRC to incorporate into licenses additional requirements and conditions that it deems appropriate or necessary to protect health and safety or to minimize danger to life and property.

Discussion: Applicants / licensees must abide by all applicable regulations, develm and implement procedures, and/or provide requested information about the proposeGadiation l

protection program during the licensing process. Appendix C may be helpful in determining the information that must be provided when requesting a license. The applicant / licensee must consider the following functional areas (as applicable to the type of program):

. Audit program;

. Occupational dose;

• Public dose;

• Minimization of contamination;

. Operating and emergency procedures, including site-specific manufacturing processes; Material receipt and accountability:

- ordering and receiving;

- opening packages;

- sealed source inventory;

- ue records;

- leak tests;

- area surveys;

- safe possession or possession and use of unsealed licensed material;

- maintenance of devices containing sealed sources;

- spill procedures; Draft NUREG - 1556, Vol.12 8-30

CONTENTS OF AN APPLICATION

]

- emergency response for sealed sources or devices containing sealed sources;

- safety procedures;

- safety and device calibration procedures;

• Transportation; a Waste management.

a Response From Applicant: Specinc responses are identiGed in the subsections that follow.

8.10.1 AUDIT PROGRAM l'

Regulations: 10 CFR 20.1101,10 CFR 20.2102.

Criteria: Licensees must review the content and implementation of their radiation protection programs annually to ensure the following:

. Compliance with NRC and DOT regulations (as applicable), and the terms and conditions of the license; a Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101);

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

Discussion: It is in the best interest oflicensees to have a strong audit program that identifies potential violations of regulatory requirements and to take necessary steps to correct them. NRC will normally exercise discretion and not cite the licensee for violations if prompt and effective corrective actions are implemented. NRC's goal is to encourage prompt identincation and prompt, comprehensive correction of violations and denciencies.

Appendix K contains an acceptable suggested audit program for manufacturer licensees. All areas indicated in Appendix K may not apply to every licensee, and all items may not need to be  ;

addressed during each audit. Licensees need not address areas that do not apply to their activities. Activities that have not occurred since the last audit need not be reviewed at the next audit. Generally, audits are conducted at least annually.

1 Currently the NRC's emphasis in inspections is to perform actual observations of work in  !

progress. As a part of their audit programs, applicants should consider performing unannounced audits of users to observe work in progress and determine if, for example, operating and emergency procedures are available and are being followed.

8-31 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION If an audit identifies violations of NRC requirements, the licensee should first evaluate the safety significance of each violation to set priorities and identify resources to correct these violations. It is essential that once identified, problems be corrected comprehensively and in a timely manner.

. Information Notice (IN) 96-28,"Suggestec Guidance Relating to Development and Implementation of Corrective Action," provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to NRC. For information on NRC's reporting requirements, refer to the current version of" Guide to NRC Reporting and Recordkeeping Requirements"(NUREG-1460). Licensees are encouraged to contact NRC for guidance if they are uncertain about a reporting requirement. NRC routinely reviews licensee's records to verify if appropriate corrective actions were implemented in a timely manner to prevent recurrence. For additional information on NRC's use of discretion in issuing violations, refer to the current version of NUREG-1600, " General Statement of Policy and Procedures for NRC Enforcement Actions."

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 follow-up.

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

References:

The current version of NUREG-1600 is available electronically at

<http://www.nrc. gov /OE>. ins are available in the " Reference Library" on NRC's Home Page at <http://www.nrc. gov >. For hard copies of NUREG-1600, IN 96-28, and IMC 87111, Appendix A," Materials Processor / Manufacturer Inspection Record," see the Notice of Availability (on the inside front cover of this report).

8.10.2 RADIATION MONITORING INSTRUMENTS Regulations: 10 CFR 20.1501; 10 CFR 20.2103(a); 10 CFR 30.33(a)(2).

Criteria: Licensees must possess radiation monitoring instruments to evaluate possible radiation hazards that may be present. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured.

Discussion: Licensees must possess calibrated radiation detection / measurement instruments to perform, as necessary, the following:

Draft NUREG - 1556, Vol.12 8-32

CONTENTS OF AN APPLICATION l

. Package surveys,

. Personnel and facility contamination measurements, ,

. Sealed source leak tests,

. Air sampling measurements,

• Bioassay measurements,

. Effluent reler. 2asurements,

. Dose rate surveys.

For the purposes of this document, radiation monitoring instruments are defined as any device used to measure the radiological conditions at a licensed facility. Some of the instruments that may be used to perform the above functions include:

. Portable or stationary count rate meters,

. Portable or stationary dose rate or exposure rate meters,

• Single or multichannel analyzers (MCA), 3 1

. Liquid scintillation counters (LSC),

• Gamma counters,

. Proportional counters,

. Solid state detectors,

. Neutron detectors.

l 8-33 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Contamination Detector I

I v BBf dog EG 3F Beta / Gamma Probes x;

n .

Survey Meter and Attached BetaIGamma Probe "NE Figure 8.9 Examples of Portable Instruments Used in Laboratorv Settings.

The choice ofinstrument should be appropriate for the type of radiation to be measured, and for the type of measurement to be taken (count rate, dose rate, etc.). Applications should include descriptions of the instrumentation available for use and the instrumentation that applicants 1 intend to purchase prior to starting licensed activities. The description should include type of instrument and probe, and the instrument's intended purpose.

NRC requires that calibrations be performed by the instrument manufacturer or a person specifically authorized by NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey instrument calibrations ,

must submit procedures for review. Appendix K provides information about instrument specifications and model calibration procedures. Applicants should be aware that calibrations often require possession and use of a calibration source or device. Instrumentation for counting smear wipes to detect contamination and/or leakage need calibration sources that may be listed on the manufacturing license.

Draft NUREG - 1556, Vol.12 8 34 i

I

1 CONTENTS OF AN APPLICATION Response fruin Applicant: Provide one of the following: ,

A description of the instrumentation (as described above) that will be used to perform required surveys, and a statement that: "We will use instruments that meet the radiation monitoring instrument specifications published in Appendix K to NUREG-1556, Vol.12. We reserve the right to upgrade our survey instruments as necessary."

017 A description of the instrumentation (as described above) that will be used to perform required surveys, and a statement that: "We will use instruments that meet the radiation monitoring instrument specifications published in Appendix K to NUREG-1556, Vol.12. Additionally, we will implement the model survey meter calibration program published in Appendix K to NUREG-1556, Vol.12. We reserve the right to upgrade our survey instruments as necessary."

)

OR l l

A description of alternative equipment and/or procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment vill be performed. Calibrations may be performed by licensees specifically authorized to provide the service. It is not necessary to have a copy of the instrument manufacturer's license, but calibration vendors other than the instrument manufacturer must be verified to have authorization to calibrate instruments for others. Further, the statement "We reserve the right to upgrade our survey instruments as necessary and change calibration services to other authorized providers" should be added to the response.

AND A description of the instruments used to quantitatively measure the radioactivity in the products and process, and the procedures followed to ensure accuracy of those measurements.

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

8.10.3 MATERIAL RECEIPT AND ACCOUNTABILITY Regulations: 10 CFR 30.34(e),10 CFR 30.35(g),10 CFR 40.13,10 CFR 30.41,10 CFR 30.51, 10 CFR 20.1501(a),10 CFR 20.1801,10 CFR 20.1802,10 CFR 20.1906,10 CFR 20.2001, 10 CFR 20.2201,10 CFR 31.11,10 CFR Part 32,10 CFR Part 40,10 CFR Part 70.

8-35 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICAllON Criteria: Licensees must do the following:

Develop, implement, and maintain written procedures for safely opening packages; Develop, implement, and maintain written procedures to ensure security and accountability of licensed material; Maintain records of receipt, transfer, and disposal of licensed material; a

Conduct physical inventories, at intervals not to exceed 6 months, to account for all sealed sources and devices received and possessed under the license.

{

i l

Discussion: Licensees are required to develop, implement, and maintain v ritten procedures for safely opening packages in accordance with 10 CFR 20.1906. Some packages may require l

special procedures that take into consideration the condition of a returned product, the type {

and/or the quantity of the nuclide being delivered. Packages that contain licensed material may i be received from suppliers as either raw or partially finished materials or components

~

(e.g., krypton 85 gas in bulk tanks for manufacturing weight determination gauges; americium- l 241 plated on foils for manufacturing smoke detectors; cobalt 60 in rods for encapsulation as

{

sealed sources for an irradiator). Other packages may cantain finished products which were l

undeliverable, damaged in transit, defective, or damaged during use. Manufacturers and distributors may desire to accept devices in exchange, or return d from licensees at the end of useful life (e.g.: static elimination devices; decayed iridium-192 radiography sources; expired medical diagnostic and therapeutic materials). Additionally, some manufacturers and distributors may wish to offer maintenance and repair services during the useful life of the devices (e.g.,

moisture-density devices, process control devices, self-luminous exit signs). Packages may also contain licensed materials that are used in the manufacturing process, such as level gauges.

Licensees should make arrangements to receive radioactive packages when they are delivered or to be notified when radioactive packages arrive at the cairier's terminal, so that the licensee can pick up the package expeditiously.

A model procedure for safely opening packages containing licensed materials is included in Appendix M.

Note: If the package is transported over public roads by the licensee, it must be repackaged and transported in accordance with DOT regulations.

If the package oflicensed material is delivered to the licensed facility's receiving department, individuals working in that department should be trained to follow the safe opening procedures.

NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for monitoring packages containing licensed material. These requirements are described in Table 8.3.

l l

Draft NUREG - 1556, Vol 12 8-36 I

CONTENTS OF AN APPLICATION l

Table 8.3 Package Monitoring Requirements Package Contents Survey Type Survey Time

• Labeled (White I, Gas or Special Form Radiation Level As soon ae j Yellow II, Yellow III) Greater Than Type A practicable, but not later than 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt of package Labeled (White I, Not Gas Nor Special Contamination As soon as Yellow II, Yellow III) Form Radiation Level practicable, but not Greater Than Type A later than 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after i

receipt of package Labeled (White I, Gas or Special Form None None Yellow II, Yellow III) Less Than Type A Labeled (White I, Not Gas Nor Special Contamination As soon as Yellow II, Yellow III) Form practicable, but not Less Than Type A later than 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt of package Not Labeled Licensed Material None None Damaged Licensed Mate:ial Contamination As soon as practicable, but not  ;

Radiation Level later than 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt of package

• Assumes packages are received during normal working hours. If packages are received outside of normal working hours, the licensee has three hours after the beginning of the next work day to perform the required surveys.

Note: Additional information on DOT regulations is contained in this NUREG in Section 08.10.09 TRANSPORTATION and Appendix T Transportation.

10 CFR 20.1906(d) requires that the licensee immediately notify (1) the final delivery carrier and,(2) the Administrator of the appropriate NRC Regional Office (listed in Appendix D to 10 CFR Part 20) by telephone, telegram, mailgram, or facsimile, when removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i); or external radiation levels exceed the limits of 10 CFR 71.47.

As illustrated in Figure 8.10, licensed materials must be tracked in order to ensure both accountability and that possession limits listed on the license are not exceeded.

8-37 Draft NUREG - !$56, Vol.12

CONTENTS OF AN APPLICATION et y 3 - -- '

--e Receipt Disposal or Transfer

$$5 Figure 8.10 Material Receipt and Accountability. Licensees must maintain records of l receipt, transfer, and disposal oflicensed material. i I

The NRC must be notified when licensed material is lost or stolen. The RSO must be proactive in evaluating whether NRC notification is required. Refer to Appendix Q and the regulations (10 CFR 20.2201-20.2203,10 CFR 30.50, and 10 CFR 21.21) for a description of when and I where notifications are required.

f Accountability for Materials Not included in the Manufactured I Products j

{

In addition to that which is specifically listed on their license, licensees frequently possess radioactive material that is generally licensed. Generally licensed material possessed by a specific licensee may continue to be possessed at the same location under a general license. A specific license does not automatically remove general licensee status nor automatically " move" generally licensed material to the specific license. >

Similarly, radioactive material received by a specific licensee that is distributed to it pv.:.uant to an exempt distribution license is not subject to the terms and conditions of the specific license.

l For example, any person may possess, use, receive, transfer, own, or acquire byproduct material in individual quantities that do not exceed the applicable quantity (i.e., exempt quantity) in 10 CFR 30.71, Schedule B, that were initially distributed pursuant to 10 CFR 32.18. This would also apply to items such as smoke detectors, gun sights, and self-luminous products. Most licensees do not possess and control these types of devices under the provisions of their specific license, and NRC does not require or encourage this practice.

The possession limits of 7.4 MBq (200 Ci) for generally licensed materials specified in 10 CFR 31.11 only apply to any one location of storage or use. The general licensee cannot possess at any one time, at any one location of storage or use (i.e., a location that is physically Draft NUREG - 1556, Vol.12 8-38

1 CONTENTS OF AN APPLICATION and administratively separate), a total amount ofiodine-125 (I-125), iodine-131 (1-131),

selenium-75 (Se-75), and/or iron-59 (Fe-59) in excess of 7.4 MBq (200 Ci). The licensee may have more than one location of storage or use at its facility, and therefore may possess a total of more than 7.4 MBq (200 Ci) at any one time, as long as there is not greater than 7.4 MBq (200 pCi) at any one location.

It is recognized that loss, theft, or misplacement oflicensed material can occur. However, licensees must have an accountability and control system in place for detecting losses oflicensed material.

Accountability for Materials included in the Manufactured and Distributed Products I l

Licensees who use and/or possess sealed sources are required by license condition to perform inventories of sealed sources every six months (see Condition Nos.15 and 16, respectively, in I the sample manufacturing licenses, in Appendix D). Some sealed sources may not be in use or j are rarely used and are placed in storage. In these cases, licensees should, at least every 6 months, confirm that these sealed sources have not been disturbed. Licensees are also required to ;onduct leak tests of sealed sources, not in storage, at 6-month intervals (or at longer intervals I

as specified in the SSD Registration Certificate). Since the leak tests require an individual to locate and work with the sealed source, records ofleak tests may be used as part of an inventory and accountability program.

For unsealed licensed material, licensees use various methods (e.g., computer programs, manual ledgers, log books) to account for receipt, use, transfer, disposal, and radioactive decay. These methods help to ensure that possession limits are not exceeded.

l To ensure that only trained, experienced, and authorized individuals possess or possess and use or supervise the possession or possession and use oflicensed material, the RSO should know who has requested an order oflicensed material and the types and amounts oflicensed materials requested. Control procedures should also be established for the procurement ofIsensed materials that may be obtained outside normal channels (e.g., through the loan or other transfer of materials without purchase, or through surplus). A model procedure for Ordering and Receiving Radioactive Material is included in Appendix M.

NRC regulations applicable to transfers are stated in 10 CFR 30.41. Sample policy transfer statements are included in Appendix M. Transfer oflicensed materials within the facility may require special procedures to ensure proper control. In many facilities, pieces oflaboratory equipment or components, including refrigerators and freezers, may become contaminated.

Removal of these items for maintenance, repair, or disposal should also be carefully controlled, including surveys.

8-39 Draft NUREG - 1556, Vol.12 L

CONTENTS OF AN APPLICATION Licensees must maintain records of receipt, use, transfer, and disposal (as waste) of all licensed material. Table 8.4, below, lists each type of record and how long the record must be maintained. Other records, such as transfer records, could be linked to radioactive material inventory records. Receipt records should also document cases where excessive radiation levels or radioactive contamination were found on packages or containers of material received and describe the action taken. The current version of NUREG-1460 provides additional information.

Table 8.4 Record Maintenance

~

Type of Record How Long Record Must be Maintained Receipt For as long as the material is possessed until 3 years after transfer or disposal Transfer For 3 years after transfer Disposal Until NRC terminates the license Important to decommissioning Until the site is released for unrestricted use Receipt, transfer, and disposal records typically contain the following information:

• Radionuclide and activity (in units of becquerels or curies), and date of measuremem of byproduct material For each sealed source, manufacturer, model number, location, and, if needed for identification, serial number, and as appropriate, manufacturer and model number of device containing the sealed source

. Date of the transfes and name and license number of the recipient, and description of the affected radioactive material (e.g., radionuclide, activity, manufacturer's name and model number, serial number)

. For licensed materials disposed of as waste, include the radionuclide, activity, date of disposal, and method of disposal (decay, sewer, etc.).

See Section 8.11, " Waste Management" for additional information.

Information about locations where licensed material is used or stored are among the records important to decommissioning, and required by 10 CFR 30.35(g),10 CFR 40.36(f), and f

j 10 CFR 70.25(g). See also the section on " Financial Assurance and Recordkeeping for Decommissioning."

i Response from Applicant: No response is necessary for assuring material accountability.

Draft NUREG - 1556, Vol 12 8-40

- a

CONTENTS OF AN APPLICATION I

Note: No response is needed from applicants for package opening procedures. Package opening procedures will be reviewed during NRC inspections.

Reference:

See the Notice of Availability on the inside front cover of this draft report to obtain I a copy of:

. NUREG-1460, Revision 1," Guide to NRC Reporting and Recordkeeping Requirements,"

dated July 1994, ar current revision;  ;

. NUREG-1516," Management of Radioactive Material Safety Programs at Medical Facilities,"

dated May 1997, or current revision.

Additional

References:

l

. Larson, William A., A Health Physics Manacement Procram for the Receipt and Shipment of j Radioactive Materials. Proceedines of the Ninth Midvear Tonical Symnosium of the Health

- Physics Society on "Onerational Health Physics." Denver, CO, USA (1976)

• NCRP Report No. 32, " Radiation Protection in Educational Institutions."(1966)2

- NCRP Report No. 48, " Radiation Protection For Medical and Allied Health Personnel."

(1976)2

- NCRP Report No. 59, " Operational Radiation Safety Procram."(1978)2

. . NCRP Report No.105, " Radiation Protection For Medical and Allied Health Personnel."

(1989)2

. NCRP Report No. I14, "Maintainine Radiation Protection Records."(1992)2 l

8.10.4 OCCUPATIONAL DOSE Regulations: 10 CFR 20.1003; 10 CFR 20.1201; 10 CFR 20.1202; 10 CFR 20.1203; 10 CFR 20.1204; 10 CFR 20.1207; 10 CFR 20.1208; 10 CFR 20.1501; 10 CFR 20.1502; 10 CFR 20.1703; 10 CFR 20.2104; 10 CFR 20.2106; and 10 CFR 20, Appendix B.

i~ 2 Copics may be obtained from the National Council on Radiation Protection and Measurements,7910 Woodmont Avenue Suite 800, Bethesda. MD 20814-3095 or ordered electronically at <http://www.ncrp.com>

8-41 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Criteria: The use ofindividual monitoring devices for external dose is required for:

. Adults who are likely to receive an annual dose in excess of any of the following (each evaluated separately):

- 5 mSv (0.5 rem) deep-dose equivalent (DDE)

- 15 mSv (1.5 rem) eye dose equivalent (LDE)

- 50 mSv (5 rem) shallow-dose equivalent to the skin (SDE)

- 50 mSv (5 rem) SDE to any extremity

. Minors who are likely to receive an annual dose in excess of any of the following (each evaluated separately):

)

- 1 mSv (0.1 rem) DDE

- 1.5 mSv (0.15 rem) LDE J

- 5 mSv (0.5 rem) SDE l

- 5 mSv (0.5 rem) SDE to any extremity Declared pregnant women who are likely to receive an annual dose from occupational exposures in excess of 1 mSv (0.1 rem) DDE, although the dose limit applies to the entire gestation period

. Individuals entering a high or very high radiation area Internal exposure monitoring (not necessarily individual monitoring devices) is required for:

Adults likely to receive in 1 year an intake in excess of 10% of the applicable Annual Limit on Intake (ALI) for ingestion and inhalation (see 10 CFR 20, Appendix B for applicable ALI)

Minors and declared pregnant women likely to receive in 1 year a CEDE in excess of 1 mSv (0.1 rem)

I Discussion: '

l TEDE = DEEP DOSE FROM EXTERNAL EXPOSURE + DOSE FROM INTERNALLY DEPOSITED rat,!ONUCLIDES i

According to 10 CFR 20.1502, if an adult is likely to receive in 1 year a dose greater than 10% of .f any applicable limit (See Figure 8.11 for annual dose limits), monitoring for occupational

)

Draft NUREG - 1556, Vol.12 8-42

CONTENTS OF AN APPLICATION exposure is required. The licensee should perform an evaluation of the dose the individual is likely to receive prior to allowing the individual to receive the dose. This evaluation need not be made for every individual. Evaluations can be made for employees with similarjob functions or work areas. Further guidance on evaluating the need to provide monitoring is provided in Regulatory Guide 8.34," Monitoring Criteria and Methods to Calculate Occupational Doses,"

dated July 1992. In addition, Appendix N gives guidance for demonstrating that unmonitored individuals are not likely to exceed 10% of the allowable limits.

skin Eyes Annual Dose Limits for 0.5 Sv -l 0.15 Sv Occupationally (50 rems) (15 rems)

Exposed Adults (10 CFR 20.1201)

Total effective dose equivalent TEDE Elbows (whole body) 0 05 Sv (5 rems) 0.5 Sv m7 p5 (50 rems) -

Intemal g g" Organs j 0.5 Sv (50 rems)

$5 Sv (50 rems)

> li

{

k j k > "*'37.

Figure 8.11 Annual Dose Limits for Occupationally Exposed Adults.

If this prospective evaluation shows that the individual's dose is not likely to exceed 10% of any applicable regulatory limit, there are no recordkeeping or reporting requirements. For individuals who have received doses at other facilities in the current year, the previous dose need not be considered in this prospective evaluation. When determining the need for monitoring, only a dose that could be received at the facilities of the applicant or licensee performing the evaluation needs to be considered, including any recordkeeping and reporting requirements. If an evaluation determined that monitoring was not required and a subsequent evaluation indicated  !

- that the 10% regulatory threshold may or will be exceeded, the dose received by an individual when monitoring was not provided should be estimated, recorded, and reported (if required).

These estimates can be based on any combination of work location radiation monitoring, survey j results, monitoring results ofindividuals in similar work situations, or other estimates to produce a "best estimate" of the actual dose received.'

If monitoring is not required to demonstrate compliance with all limits, but is required relative to one or more specific limits, the licensee should enter "NR," for "Not Required" in the blocks on NRC Forms 4 and 5 to indicate the areas for which monitoring was not required (e.g., extremity or skin doses). Where monitoring was provided but not measurable, the licensee should enter "ND," for "Not Detectable".

8-43 Draft NUREG - 1556, Vol.12

I I

CONTENTS OF AN APPLICATION If the prospective dose evaluation shows that the individual is likely to exceed 10% of an applicable limit, monitoring is required (10 CFR 20.1502). Recordkeeping of the results of monitoring performed, regardless of the actual dose received, is required by 10 CFR 20.2106 (a).

For guidance about methodologies for determination ofinternal occupational dose and summation of occupational dose, refer to Regulatory Guide 8.34, " Monitoring Criteria and Methods to Calculate Occupational Doses," dated July 1992.

1 Response from Applicant: Provide either of the following:

. A statement that: "We have done a prospective evaluation and determined that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits in 10 CFR Part 20, or we will monitor individuals in accordance with the criteria in the section entitled ' Radiation Safety Program - Occupational Dose in ,

NUREG - 1556, Vol.12." l l

OR I i

A description of an alternative method for demonstrating compliance with the referenced regulations.

Note:

Alternative responses will be evaluated using the criteria listed above.

Some licensees choose to provide personnel dosimetry to their workers for reasons other than compliance with NRC requirements (e.g., to respond to worker requests).

Reference:

See the Notice of Availability on the inside front cover of this draft report to obtain copies of:

-1. Regulatory Guide 8.7, Revision 1," Instructions for R.ecording and Reporting Occupational Radiation Exposure Data," dated June 1992

2. Regulatory Guide 8.34, " Monitoring Criteria and Methods to Calculate Occupational Radiation Doses," dated July 1992 8.10.5 PUBLIC DOSE l

Regulations: 10 CFR 20.1003; 10 CFR 20.1301; 10 CFR 20.1302; 10 CFR 20.1801;

- 10 CFR 20.1802; 10 CFR 20.2107.

Draft NUREG - 1556, Vol.12 8-44 >

CONTENTS OF AN APPLICATION

' Criteria: Licensees must ensure that licensed material will be possessed or possessed and used, transported, or stored in such a way that members of the public will not receive more than 1 mSv (100 mrem) in one year, and that_ the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour from licensed operations.

Discussion: "Public dose" is defined in 10 CFR Part 20 as "the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee." Public dose excludes doses received from background radiation, from medical procedures, and from licensees' release of radioactive materials into sanitary sewerage. Whether the dose to an individual is an occupational dose or a public dose depends on the individual's assigned duties. It does not depend on the area

. (restricted,' controlled, or unrestricted) the individual is in when the dose is received.

For guidance about accepted methodologies for dee mining dose to members of public, please refer to Appendix 0.

Figure 8.12 shows the steps to calculate the annual dose to an individual member of the public.

l i

8-45 Draft NUREG - 1556, Vol.12 I l

I

CONTENTS OF AN APPLICATION Calculating the Annual Dose to an Individual Member of the Public O

y identrfy all potential sources of extemal and intemal exposure to members of the public y identdy all locations of use, transport, or storage of radioactive material Perform surveys of alllocations of use, transport, or z

storage of radioactive material Identify from survey data, at each location, maximum 4 levels of dose rates q Calculate predicted occupancy factors at points of '

maximum dose rates g . Multiply the dose rates by the number of hours in a year to produce the maximum annual dose Multiply the maximum annual dose by the 7

occupancy factors to get the annual dose g Another facilty/ Perform the above steps for all facilities mo11e ppt 072798 Figure 8.12 Calculating Public Dose. Steps to calculate the annual dose to an individual member ofthepublic (see Appendix Ofor more information about occupancyfactors).

l l

l 4

l I

Draft NUREG - 1556, Vol.12 8-46 J

CONTENTS OF AN APPLICATION There are many possible internal dose pathways that contribute to the TEDE. The TEDE can, however, be broken down into three major dose pathway groups:

1. Airborne radioactive material;

2. Waterborne radioactive material;

3. External radioactive exposure.

The licensee should review these major pathways and decide which are applicable to its operations.

. Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1302(b).

The extent and frequency of monitoring will depend upon each licensee's needs. For addhional guidance regarding monitoring of effluents, refer to the section entitled, " Radiation Safety Program - Surveys and Leak Tests."

10 CFR 20.2107 requires that licensees maintain records sufficient to demonstrate compliance with the dose limits for members of the public until the Commission terminates the license.

Additional information on recordkeeping can be found in the current version of NUREG - 1460,

" Guide to NRC Reporting and Recordkeeping Requirements."

1 Response from Applicant: Initially, the applicant need not provide a detailed response. The J application will be evaluated and the license reviewer will determine if enough information is present to assure compliance with the limiting exposure to a member of the public. A response may be required when there is insufficient information to assure that a member of the public will not receive a total exposure exceeding 0.1 mSv (100 millirem). When no response is required, compliance will be examined during inspection. During NRC inspections, licensees must be able to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the i annual limit for members of the public. See Appendix 0 for examples of methods to demonstrate comphance.

]

8.10.6 OPERATING AND EMERGENCY PROCEDURES Regulations: 10 CFR 30.34(e),10 CFR 20.1101,10 CFR 20.1801,10 CFR 20.1802,

.10 CFR 20.2201-2203,10 CFR 30.50,10 CFR 21.21,10 CFR 19.11(a)(3),10 CFR Part 32, 10 CFR Part 40,10 CFR Part 70.

8-47 Draft NUREG - 1556, Vol.12

CONTENTS OF AN Al" PLICATION Criteria: Licensees are required to do all of the following:

. Keep radiation doses to workers and members of the public ALARA

. Ensure security oflicensed material

. Make the required notifications of events to NRC.

Discussion: Licensees are responsible for the security and safe possession and use of all licensed material from the time it arrives at their facility until it is used, transferred, and/or disposed. Licensees should W velop written procedures to ensure safe possession and use of licensed material, and the procedures should also include operational and administrative guidelines. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public.

General Safety and Manufacturing Process Procedures The written procedures should include the following elements:

. Contamination controls;

. Waste disposal practices;

• Personnel and area monitoring (including limits);

. Use ofprotective clothing and equipment;

. Recording requirements;

. Reporting requirements;

• Responsibilities.

These procedures should include policies for:

. Frequency ofpersonn:1 monitoring;

. Use of appropriate shielding (see Figure 8.13);

• Frequent change of gloves to minimize exposure to the individual and to avoid spread of l contamination in the laboratory. j I

Applicants should also develop product and radioisotope-specific procedures based on the respective hazards associated with the products and radioisotopes. General safety guidelines are

' described in Appendix P. Licensees are encouraged to use these guidelines to develop Drafl NUREG - 1556, Vol.12 8-48

l I

i CONTENTS OF AN APPLICATION

]

procedures for the safe use of radioisotopes. Procedures may be revised without amending the license if they contain the following commitments:

. The changes are reviewed and approved by licensee management and the RSO;

• Licensee staffis trained in the revised procedures before they are implemented;

• The changes are consistent with the procedures submitted with the license application; a The changes do not degrade the e:Tectiveness of the program.

In addition, licensees must identify all areas that require posting in accordance with 10 CFR 20.1902, unless they meet the exemptions listed in 10 CFR 20.1903. Also, containers of licensed material (including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they meet the exemptions in 10 CFR 20.1905.

Working Behind a Shield i

1

- _ f

.3_ , , i m X

+

ex

- \\h', *+

R4 M

"+x x el is 4j 3 g>

/ s .

I l l.

l

'"TE Figurc 8.13 Use of Appropriate Shielding. This worker is using high densityplastic shielding, which is appropriatefor radioisotopes that emit high energy beta radiation. l l

8-49 Draft NUREG - 1556. Vol.12 I

l l

l

, CONTENTS OF AN APPLICATION Emergency Procedures-Accidents and emergencies can happen during any operation with radioisotopes, including their

. transportation, use, production processes, transfer, and disposal. Such incidents can result in contamination or release of material to the environment, and unintended radiation exposure to

' workers and members of the public. In addition, loss or theft oflicensed material, sabotage, fires, floods, etc., can jeopardize the safety of personnel and members of the public. It is therefore necessary to develop written procedures to minimize, as much as possible, the impact of these incidents on personnel, members of the public, and the environment.

Applicants should ~ establish written procedures to handle events ranging from a minor spill (see Figure 8.14) to a major accident that may require intervention by outside emergency response personnel. These procedures should include provisions for immediate response, after-hours notification, handling of each type of emergency, equipment, and the appropriate roles of users and the radiation safety staff. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the user, the licensee staff should have a clear understanding of their limitations in an emergency, along with step-by-step instructions and clear guidelines for

- whom to contact.

. Licensees should have a sufficient number of appropriate and calibrated survey instruments

. readily available. Emergency spill kits should be strategically placed in well-marked locations for use by all users and the radiation safety staff. All equipment should be periodically inspected for proper operation, and replenished as necessary. Appendix P includes model emergency procedures. - Applicants may adopt these procedures or develop their own, incorporating the safety features included in these model procedures.

Certain incidents and emergencies require notification of NRC. The current version of

- NUREG .1460," Guide to NRC Reporting and Recordkeeping Requirements," includes a list of

. incidents or events involving licensed material that are required to be reported either immediately or within a certain time.

' Draft NUREG - 1556, Vol.12 8-50 L_ _ ____ _ _ _ _--- - - - -

CONTENTS OF AN APPLICATION 1 .

~

• .- *. 1 g h- *.

oo v

= . .+( \

"*2l%

Figure 8.14 Proper Handling of Incident. Panels 1 and 2 indicate how contamination can be spread ofthe incident is not handledproperly as in panels 3 and 4.

Response from Applicant: Licensees will commit to establishing appropriate operating and emergency procedures.

Reference:

See the Notice of Availability on the inside front cover of this draft report to obtain copies of NUREG-1460," Guide to NRC Reporting and Recordkeeping Requirements." 4 i

The NRC must be notified when licensed material is lost or stolen or if other conditions occur.

The RSO must be proactive in evaluating whether NRC notification is required. Refer to f Appendix Q and the regulations (10 CFR 20.2201-20.2203,10 CFR 30.50, and 10 CFR 21.21) l for a description of when and where notifications are required. l l

)

8.10.7 SURVEYS AND LEAK TESTS Regulations: 10 CFR 20.1501; 10 CFR 20.2103; 10 CFR 30.53; 10 CFR 32.59; 10 CFR 32.102; 10 CFR 40.63; 10 CFR 70.56; and 10 CFR 70.57.

8-51 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION Criteria: Licensees are required by 10 CFR 20.1501 to make surveys of potential radiological hazards in their workplace. NRC requires testing to determine whether there is any radioa'ctive leakage from sealed sources. Records of surveys and leak tests results must be maintained.

Discussion: Surveys are evaluations of radiological conditions and potential hazards (see Figure 8.15). These evaluations may be measurements (e.g., radiation levels measured with survey instruments or results of wipe tests for contamination), calculation, or a combination of measurements and calculations. The selection and proper use of appropriate instruments is one of the most important factors in ensuring that surveys accurately assess the radiological conditions. In order to meet regulatory requirements for surveying, measurements of radiological quantities should be understood in terms of their properties (i.e., alpha, beta, gamma) and compared to the appropriate limits.

3

/ Types of ,

/ Surveys I

/

. Contamination

- Fixed e - Removable

,b . Air Effluent

.

• Water Effluent

• Leak Test a Bioassays s

• Air Sample

's '

• General Area

- Restricted N

- Unrestricted b q s

MN

"'%M Figure 8.15 Typcs oiSurveys. There are many different types ofsurveysperformed by manufacturer and distribution licensees.

Radiation surveys are used to detect and evaluate contamination of:

• Facilities;

• Equipment; Personnel (during use, possession, transfer, or disposal oflicensed material) (see Figure 8.16); l

. Restricted and unrestricted areas; Draft NUREG - 1556, Vol.12 8-52

i CONTENTS OF.AN APPLICATION

. Packages;

• Products produced.

Surveys are also used to plan work in areas where licensed material or radiation exists and to evaluate doses to workere and individual members of the public.

Surveying arm and hand using survey Surveying feet and legs using survey meter and beta / gamma probe. meter and beta / gamma probe "TE Figure 8.16 Personnel Surveys. Users ofunsealed licensed material should check themselves for contamination (frisk) before leaving the area ofuse.

10 CFR 20.1501 states that surveys are required when it is reasonable under the circumstances to evaluate a radiological hazard, and when necesscry for the licensee to comply with the regulations. Many different types of surveys may need to be performed due to the particular use oflicensed materials. The most important are as follows:

• Surveys for radioactive contamination that could be present on surfaces of floors, walls, laboratory furniture, production line, packages, and equipment.  ;

• Measurements of radioactive material concentrations in air for areas where radioactive materials are handled or processed in unsealed form, and where operations could expose workers to the inhalation of radioactive material, or where licensed material is, or could be, released to unrestricted areas.

• Measurements of radioactive material concentrations in water that is released to the environment or to the sanitary sewer.

• Bioassays to determine the kinds, quantities or concentration, and in some cases, the location of radioactive material in the human body. A bioassay can be made by direct measurement 8-53 Draft NUREG - 1556, Vol.12

\

)

CONTENTS OF AN' APPLICATION l(in vivo counting), or by analysis and evaluation of material excreted or removed from the human body (in vitro counting).-

. Surveys of external radiation exposure levels in both restricted and unrestricted areas.

The frequency ofroutine surveys depends on the nature, quantity, and use ofradioactive

~

materials, as well as the. specific protective facilities, equipment, and procedures that are designed to protect the worker from external and internal exposure. Also, the frequency of the survey; depends on the type _ ofsurvey, such as those listed above (see Appendix R). '

j i

Not all instruments can measure a given type of radiationi The presence of other radiation may L interfere with a detector's ability to measure the radiation ofinterest. ' Correct use of radiation '

detection and measurements is an important aspect of any radiation safety program. Table L.1 in Appendix L contains radiation monitoring and survey instruments and calibration programs that l

are acceptable to NRC. '

10 CFR Part 20 does not specify limits for surface contamination. Each applicant should .

propose andjustify.what removable surface contamination limits will be allowable before  !

decontamination will be performed in each work area. Contamination checks are required before distributing fabricated sources. Table R.5 in Appendix R contains contamination limits that are acceptable to NRC.

Sealed Source and Plated Foil Leak Test When issued, a license will require performance ofleak tests of sealed / plated foil sources at intervals as approved by NRC or an Agreement State and specified by the SSD Registration Certificate. The measurement of the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 Bq (0.005 Ci) of radioactivityi Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State either to perform the entire leak test sequence for other licensees or provide leak test kits to licensees.' In the latter case, the licensee is expected to take the leak test sample according to the sealed source or plated foil manufacturer's (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. Licensees may also be authorized to conduct the entire leak test sequence themselves.

Draft NUREG - 1556, Vol.12 ' 8-54

CONTENTS OF AN APPLICATION Leak tests are not required if:-

- . Sources contain only H-3;

• Sources contain only licensed material with a half-life ofless than 30 days;

. Sources contain only a radioactive gas;

• . Sources contain 3.7 MBq (100 Ci) or less of beta-emitting or gamma-emitting material or 370 kBq (10 ' Ci) or less of alpha-emitting material; or

• . Sources are stored and are not being used (must be leak tested before use or transfer).

- For more information regarding leak tests, see Appendix S.

Service Licenses: If a licensee wants to perform leak tests for its customers, it must obtain a service license. This may also be accomplished by amending an existing license. For more information regarding license applications, see Section 5, "How to File;" Section 8, " Contents of an Application;" and Section 8.1," Item 1: License Action Type."

Response from Applicantf Do one of the following:

4

• State: "We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamin'ation levels published in Appendix R to NUREG-1556, Vol.

12.-' If applicable, state: "We will perform contamination checks on all fabricated sealed sources prior to distribution. Leak tests will be performed at the intervals approved by NRC or an Agreement State and specified in the SSD Registration Certificate. 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 sealed source or plated foil manufacturer's (distributor's) and kit supplier's instructions."

OR-1 State: "We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in Appendix R to NUREG-1556, Vol.

12. If applicable, state: "We will perform contamination checks on all fabricated sealed sources prior to distribution.~ Leak tests will be performed at the intervals approved by NRC or an Agreement State and specified in the SSD Registration Certificate. 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 sealed source or plated foil manufacturer's (distributor's) and kit supplier's 8 55 DraR NUREG - 1556, Voi,12 1

a

l l

CONTENTS OF AN APPLICA3ON instructions. As an attemative, we will implement the model leak test program published in Appendix S to NUREG-1556, Vol.12."

OR

. Submit description of alternative equipment and/or procedures to evaluate a radiological hazard and for determining whether there is radioactive leakage from sealed sources or plated foil.

Note:

• Alternative responses will be reviewed using the criteria listed above.

• If a sealed source or plated foil is added to an existing license, that license might already authorize the licensee to perform the entire leak test sequence. In this case, the licensee may perform the leak testing on 11 - -

' d source or plated foil according to the procedures previously approved on ii e,tse

. When dealing with specia e,.. r . rial, the applicant should refer to 10 CFR 70.57 for additional requirement Responses: See the Notice of Availability on inside front cover of this draft report to obtain a copy of Draft Regulatory Guide FC 412-4, " Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985.

8.10.8 MAINTENANCE Regulations: 10 CFR 20.1101,10 CFR 30.34(e).

Criteria: Maintenance of devices and facilities that use radioactive materials is necessary.

Maintenance should be planned and carrier'. out as frequently as needed, using ALARA principles. Individuals performing maintenance should be trained in the procedures they implement. Procedures should be written to account for the skills of the implementing pei sonnel. Oidinarily, individuals handling unshielded materials should have up to forty hours of dassroom and on-the-job training in radiation safety. Instructors should be more extensively

. qual, fled than the staff they teach.

Discussion: Maintenance of equipment and facilities is necessary in order to produce a quality product safely and efficiently and to ensure a safe environment for staff and the public.

Manufacturing a product incorporating radioactive materials is an additional hazard, requiring attention to detail when incorporating maintenance information into procedures. Licensee staff should ensure that materials in the process stream are properly shielded / located / protected to Draft NUREG - 1556, Vol.12 8-56

CONTENTS OF AN APPLICATION minimize the hazard to maintenance staff. Maintenance staff should be aware of the hazards and

~

tne procedures to minimize their exposure to radioactive materials that are possessed and used to control the manufacturing process. As examples, (1) a radioisotope hot cell should have its contents moved or shielded before any maintenance requiring entry is begun, and the staff should survey the hot cell working area prior to entry; and (2) a maintenance procedure should direct the shutdown and lockout of applicable process control gauges before beginning work in the area, which may be in the direct beam of the gauge, whether inside the process vessel, or outside the vessel. Maintenance procedures should be prepared with the use of engineering controls first, using ALARA principles and administrative controls, as needed.

Response from Applicant: No response is required in the application process. The results of actions taken in the maintenance and repair of facilities and equipment process will be reviewed during inspection.

8.10.9 TRANSPORTATION Regulations: 10 CFR 71.5,10 CFR 71.12,10 CFR 71.13,10 CFR 71.14,71.37,71.38,71.47, 71.87, 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 who will transport or ship licensed material, including radioactive waste, must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and DOT regulations.

Discussion: Packages shipped by licensees frequently meet the " Limited Quantity" criteria

.lescribed in 49 CFR 173.421 and therefore could be exempt from certain DOT requirements.

However, they may be subject to other, less restrictive, DOT requirements (e.g.,49 CFR 173.422 and 173.424; also see Appendix T for more information).

However, if not exempted, licensed material, including radioactive waste, must be packaged and transported in accordance with NRC and DOT requirements if the transportation involves the use of public highways. Licensees should develop and maintain their own radiation safety procedures for transporting licensed material within their own facilities ifit does not involve the use of public highways. (See NUREG-1660/RAMREG-002, "U.S.-Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments,"

November 1998.)

Licensees should consider the safety of all individuals who may handle or come into contact with the packages containing licensed material. The primary considerations in packaging licensed material should be to ensure that package integrity is not compromised during transport and that 8-57 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION radiation levels (including removable contamination levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but are ALARA.

Licensees shipping radioactive waste for disposal must prepare appropriate documentation, as specified in 10 CFR 20, Appendix G.

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 some facilities involves quantities of radioactive material that require a Type B package. The manufacturer (or service licensee), who is subject to the provisions of 10 CFR 71.12 or 10 CFR 71.14, as appropriate, is responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations.

Licensees who use another manufacturers's Type B package must ensure that the other manufacturer (or sersice licensee):

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

location); '

. Actually takes possession of the licensed material under its license; i Uses an approved Type B package; Is registered with NRC as a user of the Type B package;

. Has an NRC-approved QA plan.

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

If a licensee plans to make shipments oflicensed materials in Type B packages on its own, the licensee must be registered as a user of the package and have an NRC-approved quality I 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 ofRadioactive 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 i number, 800-368-5642, extension 415-8500. For information about associated fees, contact  !

NRC's Office of the Controller by calling NRC's toll-free number,800-368-5642, extension 415-7554.

During an inspection, NRC uses the provisions of 10 CFR 71.5 and a " Memorandum of Understanding with DOT on the Transponation of Radioactive Material," signed June 6,1979, to examine and enforce various DOT requirements, listed in Appendix T.

' Draft NUREG - 1556, Vol.12 8-58

CONTENTS OF AN APPLICATION 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 licensee needs to have registered with NRC as a user of the package and obtained NRC's approval ofits QA program. Transportation issues will be reviewed during inspection.

References:

"A Review of Department of Transportation Regulations for Transportation of Radioactive Materials," 1983 revision, can be obtained by calling DOT's Office of Hazardous Material Initiatives and Training, at (202) 366-4425. See the Notice of Availability (on the inside front cover of this draft report) to obtain a copy of the " Memorandum of Understanding with DOT on the Transportation of Radioactive Material," signed June 6,1979, and Revision 1 of Regulatory Guide 7.10," Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986.

8.10.10 MINIMlZATION OF CONTAMINATION Regulations: 10 CFR 20.1406.

Criteria: Applicants for new licenses must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the fullest extent practicable, the generation of radioactive waste.

1 Discussion: All applicants for new licenses need to consider the importance of designing and operating their facilities to minimize the amount of radioactive contamination generated at the site (s). When designing facilities and developing procedures for their safe use, applicants should think ahead, considering how to minimize radioactive contamination during operations, decontamination because of operational incidents, decommissioning efforts, and radioactive waste generation.

Manufacturing activities that produce sealed sources should be aware that a common business option is to accept damaged, unwanted, and replaced sources from their customers or salvagers.

Sealed sources that may be retumed to the facility present an unknown risk to the receiving department staff and to the persons charged with evaluating the condition of recebed materials.

The manufacturing and distribution applicant may also be requested by customers to provide recovery and shipping services for unwanted, damaged and replacement sources. As such, the applicant should consider the designs of shipping and recovery containers to meet transportation requirements. Procedures should be developed to enable these activities to be carried out with small impact on the radiological condition of the facility, decommissioning in the future, and employee extemal and intemal radiation exposure.

8-59 Drail MUREG - 1556, Vol.12

CONTENTS OF AN APPL.lCATION When submitting new applications, applicants should consider the following:

Implementation of, and adherence to, good health physics practices in operations; Minimization of areas, to the extent practicable, where licensed materials are used and stored;

• Maximization of the frequency of surveys, within reason, to minimize spread of contamination in the event of a spill;

. Choice ofisotope to be used, whenever practical, in consideration of half-life and chemical composition;

• Appropriate filtration of effluent streams; Use of non-porous materials for laboratory bench tops, flooring, etc.;

Ventilation stacks and ductwork with minimal lengths and minimal abrupt changes in direction;

• Air flows appropriate to the work being conducted;

. Use of appropriate plumbing materials with minimal pipelengths and traps; f

. Minimization of the number of disposal sites (sinks) where liquid waste is disposed if there is a sanitary sewer system.

Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSD Registration Certificates usually pose little risk of contamination.

Leak tests performed as specified in the SSD Registration Certificate should identify defective sources. Leaking sources must be immediately withdrawn from 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 in the following sections: " Radioactive Material - Sealed Sources and Devices or Unsealed Radioactive Material,"" Facilities and Equipment,"" Radiation Safety Program - Operating and Emergency Procedures," " Radiation Safety Program - Surveys and Leak Tests," and " Waste Management."

Draft NUREG - 1556, Vol.12 8-60

t CONTENTS OF AN APPLICATION 8.11 ITEM 11: WASTE MANAGEMENT Regulations: 10 CFR 20.1906; 10 CFR 20.2001; 10 CFR 20.2002; 10 CFR 20.2003; 10 CFR 20.2004; 10 CFR 20.2005; 10 CFR 20.2006; 10 CFR 20.2007; 10 CFR 30.51; 10 CFR 61; and 10 CFR 70.42.

Criteria: Radioactive waste must be disposed ofin accordance with regulatory requirements and appropriate records of waste disposal must be maintained. Licensed materials received from others as waste (such as decayed sources or devices at end of useful life) must be received and sent for disposal properly.

Discussion: The applicant should discuss the methods for management and disposal of radioactive waste. The program should include procedures for handling of waste, safe and secure storage, waste characterization, waste minimization, and disposal of radioactive waste.

Appropriate training should be provided to waste handlers. EPA guidance for developing a comprehensive program to reduce hazardous waste was transmitted to licensees by the NRC in IN-94-23," Guidance to Hazardous, Radioactive, and Mixed Waste Minimization Program,"

dated March 1994. The application should include, where appropriate for the types of waste involved, provisions for monitoring and segregating waste materials (e.g., radioactive from non-radioactive, short from long half-life, liquid from solid waste).

The following methods of waste disposal may be considered and should be addressed in the application as appropriate.

Transfer to an Authorized Recipient Waste may be transferred to a recipient (usually a waste disposal service company or the original supplier) who is properly licensed to receive such waste in accordance with 10 CFR 20.2001(a).

Each shipment must comply with all applicable NRC and DOT requirements.

Licensees should implement procedures to reduce the volume of radioactive waste for final disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures include volume reduction by segregating, consolidating, compacting, or allowing certain waste to decay in storage. Waste compaction or other treatments can reduce the volume of radioactive waste, but such processes may pose additional radiological hazards (e.g., airborne radioactivity) to workers, members of the public, and the environment. Safety procedures to address these concerns should be implemented. ,

1 Decay-in-Storage I

Storage of radioactive materials with half-lives of greater than 65 days should be characterized l regarding volume and anticipated time in residence at the licensee's facility prior to disposal.

Draft NUREG - 1556, Vol.12  !

8-61

CONTENTS OF AN APPLICATION NRC has concluded that materials with half-lives ofless than or equal to 120 days are appropriate for decay-in-storage (DIS). The minimum holding period for DIS is ten half-lives of the longest-lived radioisotope in the waste. Care should be taken that the waste form should not degrade or adversely interact with the waste container. Also, care should be taken to group waste packages by half-life. Waste packages having mixed half-lives must be held for 10 half-lives of the longest lived radionuclide. Therefore, waste with a 65-day half-life (held in storage for 650 days), should not be held in the same container for the 1,200 days as required for material with a 120-day half-life. Such waste may be disposed of as ordinary trash if radiation surveys (performed in a low background area and without any interposed shielding) of the waste at the end of the holding period indicate that radiation levels are indistinguishable from background.

All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. If the decayed waste is compacted, all labels that are visible in the compacted mass must also be defaced or removed.

The NRC does not consider storage as a substitute for final disposal of radioactive wastes. Other than storage for radioactive decay, LLW should be stored only when disposal capacity is  ;

unavailable, and for no longer than is necessary. l A model procedure for DIS is contained in Appendix U of this guidance document.

1 Release into Air and Water j l

Release of radioactive material into air and water must conform to the requirements described in '

10 CFR 20.1302(b)(2)(See Figure 8.17). The applicant should discuss the monitoring and control mechanisms in place to ensure compliance with the requirements. Applicants considering release of radioactive material into air and water should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993. which ,

deals with the application of ALARA in controlling gaseous and liquid effluents and references l documents with acceptable methods of effluent monitoring.

Draft NUREG - 1556, Vol.12 8-62

~

~ ~ ~

l CONTENTS OF AN APPLICATION j

• ( $

88889 B;

i. bb.O ' .. .

s2mo2n Figure 8.17 Air and Water Effluents From Manufacturing Facility. Eso note thefence, creating a " controlled area. "

Licensees considering disposal by release to the sanitary sewerage system must comply with the requirements of 10 CFR 20.2003. Licensees are responsible for demonstrating that licensed materials discharged into the sewerage system are readily soluble or biologic readily dispersible in water NRC IN-94-07," Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR 20," dated January 1994, provides the criteria for evaluating solubility ofliquid waste. Liquid scintillation media and ash are examples of material that may or may not be readily dispersible. Licensees should carefully consider the possibility of reconcentration of radioisotopes that are released into the sewerage system. NRC alerted licensees to the potentially significant problem of reconcentration of radionuclides released to sanitary sewerage systems in IN-84-94, " Reconcentration of Radionuclides involving Discharges into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003)," dated December 1984.

Applicants should provide procedures that will ensure that all releases of radioactive waste into the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the monthly and annual limits specified in the regulations. Licensees are required to maintain accurate records of all releases oflicensed material into the sanitary sewerage. A model procedure for disposal of radioactive waste via sanitary sewer is described in Appendix U of this guidance document.

Incineration Applicants who wish to treat or dispose oflicensed material by incineration must comply with the requirements of 10 CFR 20.2004. Applicants proposing incineration should be aware that a 8-63 Draft NUREG - 1556, Vol.12

CONTENTS OF AN APPLICATION notice in the Federal Register may be required before disposal of ash as ordinary waste can be approved. However, approval ofincineration pursuant to 10 CFR 20.2004 does not require notice in the Federal Register if the ash is disposed as radioactive waste, transferred to a specific licensee, or contains non-detectable radioactivity. Policy and Guidance Directive PG 8-10,

" Disposal ofIncinerator Ash as Ordinary Waste," dated January 1997, provides guidance relative to the disposal of ash. A model procedure for incineration of waste is described in Appendix U of this guidance document.

Applicants who are considering disposal of radioactive material by incineration should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993. Regulatory Guide 8.37 deals with the application of ALARA in controlling gaseous and liquid effluents and references documents containing acceptable methods of effluent monitoring.

Waste Volume Reduction Waste volume reduction operations that could create a radiological hazard to licensee employees or the general public must be described in detail in the application. A model procedure for waste compaction is described in Appendix U of this guidance document.

Disposal of Specific Waste As if it Were Not Radioactive The following radioactive wastes may be disposed of as non-radioactive waste:

Liquid scintillation medium containing no more than 1.85 kBq (0.05 Ci) of H-3 or C-14 per gram of the medium;

. Animal carcasses or animal tissue containing no more than 1.85 kBq (0.05 Ci) of H-3 or C-14 per gram averaged over the weight of the entire animal.

Applicants should have procedures that will ensure that the above limits are not exceeded and j that the disposal of animal tissue or carcasses containing licensed material is in a manner that l will not permit their use either as food for humans or animals. Applicants must maintain accurate records of these disposals.

Burial Licensees who were previously authorized to bury radioactive materials pursuant to 10 CFR 20.304 prior to January 28,1981 should describe the locations, condition and current status of these former sites (i.e., controlled or uncontrolled, active monitoring of the site, and current condition of burial site). Licenses will not ordinarily be written to allow this option; however, an applicant can submit a request pursuant to 10 CFR 20.2002.

Draft NUREG - 1556, Vol.12 8-64

CONTENTS OF AN APPLICATION Other Methods Specifically Approved by NRC Pursuant to 10 CFR 20.2002

! Applicants may also request alternate methods for the disposal of radioactive waste generated at their facilities. Such requests must describe the waste containing licensed material, including the physical and chemical properties that may be important to assess risks associated with the waste, and the proposed manner and conditions of waste disposal. Additionally, the applicant must submit its analysis and evaluation of pertinent information on the nature of the environment, nature and location of other affected facilities, and procedures to ensure that radiation doses are maintained ALARA and within regulatory limits.

Additional Considerations The application should describe the ALARA considerations taken before disposal of radioactive materials. Discuss the potential for unmonitored or unanticipated release of radioactive materials to work areas and from release points (i.e., hoods and incinerator stacks). To be in compliance with the ALARA philosophy stated in 10 CFR 20.1101, radioactive material waste stream concentrations should be a fraction (generally 10% to 20%) of the limits specified in Appendix B, Table II,10 CFR Part 20. Furthermore, due to the variability ofinventory control programs for monitoring disposal and releases oflicensed material possessed or possessed and in use, a program for physically measuring releases should be in place whenever releases exceed the specified ALARA action point.

l' Because of the difficulties and costs associated with disposal of sealed sources, applicants should pre-plan the disposal. Applicants may want to consider contractual arrangements with the source supplier as part of a purchase agreement. Sealed source manufacturers and suppliers that accept return of sealed sources should consider this when developing their waste management program.

Response from Applicant: Applicants should commit to establish procedures for waste ,

collection, storage, and disposal by any of the authorized methods described in this section.

Applicants should contact the appropriate NRC Regional Office for guidance and obtain advance  ;

approval of any method (s) of waste disposal other than those discussed in this section.

Note: Applicants do not need to provide information to NRC if they plan to dispose of LLW via transfer to an authorized recipient or to dispcse ofliquid scintillation media or animals containing low levels of H-3 or C-14 as authorized by 10 CFR 20.2005.

8-65 Draft NUREG - 1556, Vol.12

)i CONTENTS OF AN APPLICATION 1

8.12 ITEM 12: FEES <

The next two items on NRC Form 313 are to be completed on the form itself.

On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. Refer to Section 7," License Feas."

8.13 ITEM 13: CERTIF; CATION :j 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 i

Form 313. Representatives signing an application must be authorized to make binding \

commitments and to sign officialdocuments on behalfefthe applicant. As discussed previously in " Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applicationsforproper signature.  !

l Note:  !

• It is a criminal offense to make a willful false statement or r.: presentation 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.

Draft NUREG - 1556, Vol.12 8-66

9 AMENDMENTS AND RENEWALS TO A LICENSE It is the licensee's obligation to keep the license current. If any of the information provided in the original application is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109,10 CFR 30.36(a),10 CFR 40.43(a), and 10 CFR 70.38(a)).

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

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

. Submit, in duplicate, either 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, j the licensee's organization, or radiation protection program. Alternatively, describe clearly the  !

exact nature of the changes, additions, and deletions.

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

I 1

9-1 Draft NUREO - 1556, Vol.12

'10 APPLICATIONS FOR EXEMPTIONS Various sections of NRC's regulations address requests for exemptions (e.g.,10 CFR 19.31, {

I 10 CFR 20.2301,10 CFR 30.11(a),10 CFR 40.14(a), and 10 CFR 70.14(a)). These regulations state this NRC may grant an exemption, either 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.

Exemptions always require an amendment request and associated fees. Until NRC has granted an exemption in writing, NRC expects strict compliance with all applicable regulations and license conditions. An exemption will be a license condition.

i Exemptions are not intended for large classes oflicenses and are generally limited to unique situations. Exemption requests must be accompanied by descriptions of the following: l

' Exemption and why it is needed;

• Proposed compensatory safety measures intended to provide a level of health and safety equivalent to the regulation for which the exemption is being requested;

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

I 10 1- Draft NUREG - 1556, Vol.12

11 PLANNING FOR TERMINATION OF LICENSED ACTIVITIES Regulations: 10 CFR 30.34(b); 10 CFR 30.35(g); 10 CFR 30.36(d); 10 CFR 30.36(g);

10 CFR 30.36(h); 10 CFR 30.36(j); and 10 CFR 30.51(f); 10 CFR 40.42; and 10 CFR 70.38.

Criteria: For other than medical distribution-only licenses, 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);

- 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 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.

l

. Submit decommissioning plan, if required by 10 CFR 30.36(g),10 CFR 40.36, and ,

10 CFR 70.38.

. Conduct decommissioning, as required by 10 CFR 30.36(h) and (j),10 CFR 40.42, and 10 CFR 70.38.

. 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),10 CFR 40.51,10 CFR 40.62(e), and 10 CFR 70.38, transfer records important to decommissioning to the new licensee.

Discussion: As discussed above in " Criteria," before a licensee can decide whether it must notify NRC, the licensee must detennine 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.

11-1 Draft NUREG - 1556, Vol.12

PLANNING FOR TERMINATION OF LICENSED ACTIVITIES Draft Regulatory Guide DG-4006, " Demonstrating Radiological Criteria For License Termination," issued July 8,1998 and NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contains the current regulatory guidance concerning decommissioning of facilities and termination oflicenses.

Appendix B of NUREG/BR-0241 contains a comprehensive list of NRC's decommissioning regulations and guidance. NUREG/BR-0241 will be revised. Many regulatory guides in it have been superseded. Applicants are encouraged to consult with NRC staff regarding updates of guidance listed in its appendix. NUREG-1575," Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December 1997, should be reviewed by licensees f who have large facilities to decommission.

I An acceptable computer code for calculating screening values to demonstrate compliance with the unrestricted dose limits is DandD, Version 1.0; this was issued August 20,1998.

Supplemental information on the implementation of the fmal rule on radiological criteria for license termination was published in the Federal Register (Volume 63, Number 222, Pages 64132-64134), November 18,1998. This includes a table of acceptable license termination screening values of common beta / gamma radionuclides for building surface contamination, and methods for conducting site-specific dose assessments for facilities with contamination leve's above those in the table.

It should be noted that the current Draft Regulatory Guide DG-4006 and DandD, Version 1.0 code are for test and evaluation, for a 2 year period (July,1998-July,2000). In addition, NRC staffis developing a comprehensive standard review plan (SRP) for decommissioning.

Therefore, in the interim period, until revision of DG-4006 and DandD, Version 1.0 code, and until issuance of the SRP, applicants should maintain communication with NRC staff regarding use of DG-4006 and testing of DandD code. Applicants are encouraged to consult with NRC staff regarding updates of currently available code and regulatory guides.

Response from Applicant: The appF. ant is not required to submit a respo ise to NRC during the initial application. The applicanti obligatirens in this matter begin when the license expires or at the time the licensee ceases opercions. whichever is earlier. These obligations are to undertake the necessary decommissioning activities, to submit NRC Form 314 or equivalent information, and to perform any other actions as summarized in the Criteria.

Reference:

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

Draft NUREG - 1556, Vol.12 11-2

i l

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

l APPENDlX A I List of Documents Considered in Development of this Draft NUREG This draft report incorporates and updates the guidance previously found in the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives (P& gds or PGs), and Information

Notices (ins). Other NRC documents such as Manual 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 issued in final 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 Directives Document Title Date Identification RG 10.7 Guide for the Preparation of Applications for Licenses for 08/79 )

Laboratory and Industrial Use of Small Quantities of Byproduct Material P&GD FC 84-l** Review Responsibility-Manufacturing and Distribution of 04/84 Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26 I PG 8-10 Disposal ofIncinerator Ash as Ordinary Waste 01/97 P&GD FC 85-6** Standard Review Plan for Applications for Licenses and 02/85 Approvals to Authorize Distribution of Variour Items to Group Medical Licenses NUREG/BR-0241 NMSS Handbook for Decommissioning Fuel Cycle and 03/97 Materials Licenses NUREG-1575 Multi-Agency Radiation Survey and Site Investigation 12/97 Manual (MARSSIM)

NUREG-1460 Guide to NRC Reporting and Recordkeeping 07/94 Requirements 09/93 NUREG-1400. Air Sampling in the Workplace NUREG-1516 Management of Radioactive Material Safety Programs at 05/97 Medical Facilities NUREG 1600, Rev.1 General Staternent of Policy and Procedures for NRC 05/98 Enforcement Actions Interpretation of Bioassay Measurements 07/87 NUREG/CR-4884 _

A-1 Draft NUREG - 1556, Vol.12

APPENDIX A Document Title Date Identification Draft NUREG-1562 Standard Review Plan for Applications for Licenses to 12/88 Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License Draft RG FC 413-4 Guide for the Preparation of Applications for Licenses for 6/85 the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments RG 3.66 Standard Format and Content of Financial Assurance 06/90 Mechanisms Required for Decommissioning Under 10 CFR Parts 30,40,70, and 72 RG 7.10 Rev.1 Establishing Quality Assurance Programs for Packaging 06/86 Used in the Transport of Radioactive Material PG 3-16 Licensing of Certain Sealed Sources and Devices for 09/95 Medical Use in Accordance with 10 CFR 35.49 Draft RG DG-0005 Applications for Licenses of Broad Scope 10/94 Draft RG DG-0007* Guide for the Preparation of Applications for Licenses to 03/97 Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees P&GD FC 90 02 Rev.1 Standard Review Plan for Evaluating Compliance with 04/30/91 Decommissioning Requirements P&GD PG l-26 Processing of Exemptions for Material Licensees 07/25/97 P&GD PG 8-11 NMSS Procedures for Reviewing Declarations of 08/08/96 Bankruptcy RG 3.4 Rev. 2 Nuclear Criticality Safety in Operations with Fissionable 03/86 Materials at Fuels and Materials Facilities RG 3.65 Standard Format and Content of Deconunissioning Plans 08/89 for Licenses Under 10 CFR Parts 30,40 and 70 RG 4.13 Rev.1 , Performance Testing, and Procedural Specifications for 07/77 Thermoluminescence Dosimetry: Environmental Applications RG 4.15 Rev.1 Quality Assurance for Radiological Monitoring Programs 02/79 (Normal Operations)-Effluent Streams and the Environment Draft NUREG - 1556, Vol.12 A2

APPENDIX A Document Title Date Identification RG 4.20 Constraint on Release of Airborne Radioactive Materials 12/96 to the Environment for Licensees other than Power Reactors RG 5.1i Rev.1 Nondestructive Assay of Special Nuclear Material 04/84 Contained in Scrap and Waste RG 5.13 Conduct of Nuclear Material Physical Inventories 11/73 RG 5.53 Rev.1 Qualification, Calibration, and Error Estimation Methods 02/84 forNondestructive Assay RG 6.1 Rev.1 Lcak Testing Radioactive Brachytherapy Sources 07/74 RG 6.2 Rev.1 Integrity and Text Specifications for Selected 07/74 Brachytherapy Sources RG 6.3 Design, Construction, and Use of Radioisotopic 03/74 Generators for Certain Land and Sea Applications

(

RG 6.4 Rev. 2 Classification of Containment Properties of Sealed 08/80 l Radioactive Sources  !

RG 6.5 General Safety Standard for Installations Using 06/74 Nonmedical Sealed Gamma-Ray Sources l l

RG 6.6 Acceptance Sampling Procedures for Exempted and 06/74 Generally Licensed Items Containing Byproduct Material RG 6.7 Rev.1 Preparation of an Environmental Report to Support a Rule 06/76 Making Petition Seeking an Exemption for a Radioactive-Containing Product '

RG 6.9 Establishing Quality Assurance Programs for the 02/95 Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material Draft RG TP 102-5 Safety Features of Gauges Containing Radioactive 11/80 Material RG 7.1 Administrative Guide for Packaging and Transporting 06/74 Radioactive Material RG 7.2 Packaging and Transportation of Radioactively 06/74 Contaminated Biological Materials A-3 Draft NUREG - 1556, Vol.12

l APPENDIX A Document Title Date Identification RG 7.3 Procedures for Picking Up and Receiving Packages of 05/75 Radioactive Material RG.7.4 Leakage Tests on Packages of Radioactive Material 06/75

RG 7.5 Rev. O-R Administrative Guide for Obtaining Exemptions from 05/77 i Certain NRC Requirements over Radioactive Material Shipments RG 7.6 Rev.1 Design Criteria for the Structural Analysis of Shipping 03/78  ;

Cask Containment Vessels j RG 7.7 Administrative Guide for Verifying Compliance with 08/77 l Packaging Requirements for Shipments of Radioactive Materials

~ Draft RG TP 914-4 Measurement of Radiation Levels on Surfaces of 12/79 i Packages of Radioactive'. Materials

]

RG 8,4 Direct-Reading and Indirect-Reading Pocket Dosimeters 02/73 RG 8.5 Rev.1 Criticality and Other Interior Evacuation Signals 03/81 RG 8.6 Standard Test Procedure for Geiger-Muller Counters 05/73 RG 8.7 Rev._1 - Instructions for Recording and Reporting Occupational 06/92 Radiation Exposure Data RG 8.9 Rev.1 Acceptable Concepts, Models, Equations, and 07/93 Assumptions for a Bioassay Program

- RG 8.10 Rev.1-R ' Operating Philosophy for Maintaining Occupational 05/77 Exposures As Low As is Reasonably Achievable RG 8.11 Applications of Bioassay for Uranium 06/74 RG 8.12 Rev. 2 Criticality Accident Alarm Systems 10/88

RG 8.13 Rev. 2 Instruction Concerning Prenatal Radiation Exposure 12/87

. RG 8.14 Rev. Personnel Neutron Dosimeters 08/77

- RG 8.15. Acceptable Programs for Respiratory Protection 10/76 RG 8.20 Rev.1 Applications of Bioassay for I-125 and I-131 09/79 RG 8.21 Rev.1* Health Physics Surveys for Byproduct Material at NRC- 10/79 Licensed Processing and Manufacturing Plants

- Draft NUREG - 1556, Vol.12 '. A-4

APPENDIX A Document Title Date Identification RG 8.23 Rev.1 Radiation Safety Surveys at Medical Institutions 01/81 RG 8.25 Rev.1 Air Sampling in the Workplace 06/92 RG 8.26 Applications for Bioassay for Fission and Activation 09/80 Products RG 8.28 Audible-Alarm Dosimeters 08/81 RG 8.29 Rev.1 -

Instruction Concerning Risks from Occupational 02/96 Radiation Exposure RG 8.32 Criteria for Establishing a Tritium Bioassay Program 07/88 RG 8.34 Monitoring Criteria and Methods to Calculate 07/92 j Occupational Radiation Doses RG 8.35 Planned Special Exposures 06/92 RG 8.36 Radiation Dose to the Embro/ Fetus 07/92 RG 8.37 ALARA Levels for Effluents from Materials Facilities 07/93 Draft RG DG-8014 Proposed Rev. 3-Instruction Concerning Prenatal 10/94 Radiation Exposure Draft RG OH 940-4 Proposed Rev.2-Personnel Neutron Exposures 02/80 Draft RG OP 032-5 Test and Calibration of Radiation Protection 09/84 Instrumentation Draft RG OP 722-4 Qualifications for the Radiation Safety Officer in a Large- 04/82 Scale Non-Fuel-Cycle Radionuclide Program RG 10.3 Rev.1 Guide for the Preparation of Applications for Special 04/77 Nuclear Materials Licenses of Less Than Critical Mass Quantities RG 10.4 Rev. 2 Guide for the Preparation of Applications for Licenses to 12/87 Process Source Material RG 10.12 Preparation of Petitions for Rulemaking Under 12/96 10 CFR 2.802 and Preparation and Submission of Proposals for Regulatory Guidance Documents Draft RG FC 406 Guide for the Preparation of Applications for Licenses 2/85 and Approvals to Authorize Distribution of Various Items to Group Medical A-5 Draft NUREG - 1556, Vol.12

APPENDIX A Document Title Date Identification Draft RG FC 411-4 Guide for the Preparation of Applications for Licenses for 06/85 the Use of Radioactive Materials in Servicing Preregistered Gauges, Measuring Devices, and Sealed Sources Used in Such Devices Draft RG FC 413-4 Guide for the Preparation of Applications for Licenses for 06/85 the Use of Radioactive Materials in Calibrating Radiation l Survey and Monitoring Instruments Draft RG FC 412-4 Guide for the Preparation of Applications for Licenses for 06/85 the Use of Radioactive Materials in Leak-Testing Services _ ,

I Table A.2 List of Information Notices Document Title Date Identification IN 84-94 Reconcentration of Radionuclides Involving Discharges 12/84 into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003)

IN 88-10 Material Licensees': Lack of Management Controls over 03/28/88 Licensed Programs IN 89-25 Rev. I Unauthorized Transfer of Ownership or Control of 12/07/94 Licensed Activities IN 93-14 Clarification of 10 CFR 40.22, Small Quantities of Source 02/18/93 Material IN 93-7_7 Human Errors that Result in Inadvertent Transfers of 10/04/93 Special Nuclear Material at Fuel Cycle Facilities -

IN 93-100 Reporting Requirements for Bankruptcy 12/22/93 IN 94-07 Solubility Criteria for Liquid Effluent Releases to 01/28/94 Sanitary Sewerage Under the Revised 10 CFR Part 20 IN 94-16 Recent Incidents Resulting in Offsite Contamination 03/03/94 IN 94-15 Radiation Exposures During an Event Involving a Fixed 03/02/94 Nuclear Gauge IN 94-21 Regulatory Requirements When No Operations are being 03/18/94  !

Performed Draft NUREG - 1556, Vol.12 A-6 l l

1

i l

APPENDIX A Document Title ~ Date Identification

- IN 94-23 ~ Guidance to Hazardous, Radioactive and Mixed Waste 03/25/94 Generators on the Elements of a Waste Minimization Program IN 94-47 Accuracy ofInformation Provided to NRC During the 06/21/94 Licensing Process IN 94-64" Reactivity insertion Transient and Accident Limits for 08/31/94 High Burnup Fuel IN 94-64 Reactivity Insertion Transient and Accident Limits for 04/06/95 Supplement 1** - High Burnup Fuel IN 94-70 Issues Associated with Use of Strontium-89 and Other 09/29/94 Beta Emitting Radiopharmaceuticals IN 94-73~ Clarification of Criticality Reporting Criteria 10/12/94 ]

l IN 95-01. DOT Safety Advisory: High Pressure Aluminum 01/04/95 Seamless and Aluminum Composite Hoop-Wrapped Cylinders IN 95-511 Recent Incidents Involving Potential Loss of Control of 10/27/95 Licensed Material IN 96-04' Incident Reporting Requirements for Radiography 01/10/96 Licensees IN 96-18 Compliance With 10 CFR Part 20 for Airborne Thorium 03/25/96 IN 96-20 Demonstration of Associated Equipment Compliance 04/04/96 With 10 CFR 34.20 IN 96-33 Erroneous Data from Defective Thermocouple Results in 05/24/96 a Fire IN 96-28 Suggested Guidance Relating to Development and 05/01/96 Implementation of Corrective Action -

IN 96 Failure of Safety Systems on Self-Shielded Irradiators 06/11/96 because ofInadequate Maintenance and Training IN 96-51 Residual Contamination Remaining in Krypton-85 09/11/96 Handling System after Venting IN 96-54 Vulnerability of Stainless Steel to Corrosion When 10/17/96 Sensitized ~

A-7 Draft NUREG - 1556, Vol.12

APPENDlX A Document Title Date Identification IN 96-63 Potential Safety Issue Regarding the Shipment of Fissile 12/05/96 Material IN 96-70 Year 2000 Effect on Computer System Software 12/24/96 IN 97-03 Defacing of Labels to Comply with 10 CFR 20.1904(b) 02/20/97 IN 97-23 Evaluation and Reporting of Fires and Unplanned 05/07/97 Chemical Reaction Events at Fuel Cycle Facilities

~

IN 97-30 Control of Licensed Material during Reorganizations, 06/03/97 Employee-Management Disagreements, and Financial  !

Crises IN 97-36 Unplanned Intakes by Workers of Transuranic Airborne 06/20/97 l Radioactive Materials and External Exposure Due to j Inadequate Control of Work IN 97-24** Failure of Packing Nuts on One-Inch Uranium 05/08/97 l Hexafluoride Cylinder Values j IN 97-47 Inadequate Puncture Tests for Type B Packages Under 06/27/97 l 10 CFR 71.73(c)(3)

]

IN 97-50 Contaminated Lead Products 07/10/97 IN 97-56 Possession Limits for Special Nuclear Material at the 06/28/97 Envirocare of Utah Low-Level Radioactive Waste l Disposal Facility IN 97-61 U.S. Department of Health and Human Services Letter, to 08/06/97 Medical Device Manufactures, on the Year 2000 Problem l IN 97-72 Potential for Failure of the Omega Series Sprinkler Heads 09/22/97 l

IN 97-75 Enforcement Sanctions Issued as a Result of Deliberate 09/24/97 '

Violations of NRC Requirements IN 97-89 Distribution of Sources and Devices without 12/29/97 Authorization IN 98-01 Thefts of Portable Gauges 01/15/98 IN 98-06 Unauthorized Use of License to Obtain Radioactive 02/19/98 Materials, and its Implication under the Expanded Title 18 of the U.S. Code Draft NUREG - 1556, Vol.12 A8

APPENDIX A Document Title Date Identification i 1

IN 98-12 Licensees' Responsibilities Regarding Reporting and 04/03/98 Follow-up Requirements for Nuclear-Power Pacemakers j IN 98-16 Inadequate Operational Checks of Alarm Ratemeters 04/30/98 IN 98-08 Information Likely to be Requested if an Emergency is 03/02/98 Declared IN 98-17 Federal Bureau ofInvestigations's (FBI) Awareness of 05/07/98 National Security Issues and Responses (ANSIR)

Program IN 98-18 Recent Contamination Incidences Resulting from Failure 05/13/98 to Perform Adequate Surveys IN 98-20 Problems with Emergency Preparedness Respiratory 06/13/98 l Protection Programs l

Table A.3 Miscellaneous NRC Documents Document Title Date Identification IP 87111, Appendix A Materials Processor / Manufacturer Inspection Record 06/11/98 IP 87111, Appendix B Materials Processor / Manufacturer Inspection References 06/11/98 IMC 2800 MaterialInspection Program 04/17/95 IP 87103 Inspection of Material Licensees Involved in an Incident 06/11/97 or Bankruptcy Filing IP 87104 Decommissioning Inspection Procedure for Materials 06/04/97 Licensees IP 87104, Appendix A Materials Decommissioning Inspection Field Notes for 06/04/97 Facilities Needing Significant Decommissioning Effort MOU Memorandum of Understanding with DOT on the 06/06/79 Transportation of Radio' active Material A-9 Draft NUREG - 1556, Vol.12

APPENDIX A Document - Title Date Identification MOU- Memorandum of Understanding Between the Nuclear 10/21/88 Regulatory Commission and the Occupational Health and Safety Administration; Worker Protection at NRC-Licensed Facilities

• When this drafi report is issued in final form, these documents will be considered superseded and should not be used.

"These documents were reviewed but are not relevant to this NUREG.

. Drafi NUREG - 1556, Vol.12 A-10

i i

Appendix B United States Nuclear Regulatory Commission Form 313  !

l

Arrmato sY OMe: NO,31eo41ao cm=S: Ti31/1see NRC FORM 313 U. S. NUCLEAR REGULATORY COMMISSION (S'i997) Eshmated burden per response to comply with ens Wormaton ma-emn 10 CFR 30,32,33 recpect 7 hoors. Submdtal of the appicahon IB r=w/ ot determrie that 34, ?5,36,39 and 40 the appicant is cluehhed and that adequale procedures exet to protect the ptelt heellh and safety Forward commente regarthn0 burden eeumais to the informaton and Recorde Management Branch (T4 F33), U S. Nuclear

"**'r c a"""*'=a **"9'* DC 205=nd io ine Paperwo,=

APPLICATION FOR MATERIAL LICENSE Reduction Protect (3150 0120), Ofhcm of Manecement aid Budgel Weenington, DC 20503. NRC may not conduct or sponsor, and a person a not requred to roepend to, en Wormahon collecten unless R depieys a curently vahd OMB control rumber.

INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND 1WO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.

APPUCATION FOR MTRisVTION OF EXEMPT PRODUCTS FILE APPUCA110NS WITH: IF YOU ARE LOCATED IN:

Df'!! SON OF INDUSTRIAL AND MEDICAL NUCLEAR SAe ETY ILUNOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHlo, OR WISCONSIN, OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS SEND APPUCATIONS TO:

U S NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 2055lW)OO1 MATERIALS UCENSING SECTION 1 ON W t.LL OTHER PERSONS FILE APPUCATIONS AS FOLLOWS: S01 WARRENVILLE RD.

USLE, IL 605324 351 IF YOU ARE LOCATEDIN:

CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, MAINE, MARYLAND, ALASKA, ARIZONA ARKANSAS, CAUFORMIA. COLORADO, HAWAll, IDAHO, KANSAS, LOUISIANA, MONTANA, NESRASKA, NdVADA, NEW MEXICO, NORTH DAKOTA, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, NEW YORK, PENNSYLVANIA, OKLAHOMA, OREGON, PACIFIC TRUST TERRf70 RIES, SOUTH DAKOTA. TEXAS, UTAH, RHODE ISLAND, OR VERMONT, SEND APPUCATIONS TO:

WASHINGTON, OR WYOMING, SEND APPUCATIONS TO:

UCENSING ASSISTANT SECTON NUCLEAR MATERIALS UCENSING SECTON NUCLEAR MATERIALS SAFEfY BRANCH U S NUCLEAR REGULATORY COMNilSSON, REGION IV U S NUCLEAR REQULATORY COMMISSON, REGION I 611 RYAN PLAZA DRIVE, SulTE 400 475 ALLENDALE ROAD ARLINGTON, TX 76011 4064 KING OF PRUSSIA, PA 10106-1415 ALABAMA, FLORIDA, GEORGIA, KENTUCKY, MISSISSIPP1, NORTH CAROUNA, PUERTO RfC'3, SOUTH CAROUNA, TENNESSEE, VIRGINIA, VIRGIN ISLANOS, OR WEST VlflGINIA.

SEND APPUCATIONS TO:

ATLANTA FEDERAL CENTER U S. NUCLEAR REGULATORY COMMISSION, REGON ll 61 FORSYTH STREET S W., SUITE 23T65 ATLANTA, GEORGIA 30303-3415 PERSONS LOCATED IN AGREEMENT STATES SEND APPUCATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WlSH TO POSSESS AN MATERIAL IN STATES SUBJECT TO U.S. NUCLEAR REGULATORY COMMISSION JURISDICTIONS.

THIS18 AN APPUCATION FOR (Check appropnadeitem) 2 NAME AND MAILING ADDRESS OF APPLICANT (incfude 7;pcode) 1.

A NEW UCENSE B. AMENDMENT TO UCENSE NUMBER C. RENEWAL OF LICENSE NUMBER

~

I 3 ADDRESS (ES) WHERE UCENSED MATERIAL WILL BE USED OR POSSESSED

4. NAME OF PERSON TO DE CONTACTED ABOUT THIS f APPLICATON TELEPHONE NUMBER SUBMIT ITEMS 5 THROUGH 11 ON 01/2 X 11" PAPER THE TYPE AND SCOPE OF INFORMATON TO BE PROVIDED IS DESCRIBEQ IN THE LICENSE APPUCAT g, RADIOACTIVE MATERIAL.

a Element and mese number, b. chemmal and/or physcal form, and c. monumum amount 6. PURPOSE (S) FOR WHICH UCENSED MATERIAL WILL BE USED.

whch wdl be moed at any one tune.

7. INDfVIDUAL(S) RESPONSIBLE FOR RADIATON SAFETY PROGRAM AND THElR 8. TRAINING FOR INDMDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.

TRAINING EXPERIENCE.

9 FACluTIES AND EOUIPMENT. 10. RADIATION SAFETY PROGRAM

12. UCENSEE FEES (See 10 CFR 170 and Sechon 170 31)

I AMOUNT

11. WASTE MANAGEMENT. FEE CATEGORY l ENCLOSED S

13. CERTIFICATION. (Must De compdefed by aspecent) THE APPUCANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATONS MADE IN THIS APPLICATON ARE BINDING UPONTHE APPUCANT.

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATON ON BEHALF OF THE APPUCANT, NAMED IN ITEM 2. CERTIFY THAT THIS APPUCATION IS PREPARED IN CONFORMITY WITH TITLE 10. CODE OF FEDERAL REGULATIONS, PARTS 30,32,33,34. 35,36,39 AND 40, AND THAT ALL INFORMATON CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF WARNING 18 U S C. SECTON 1001 ACT OFJUNE 25,1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE AWILLFULLY F ALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION SIGNATURE DATE CEXTIFYING OFFICER -TYPED / PRINTED NAME AND TITLE FOR NRC USE ONLY TYPE OF FEE FLE LOG FEE CATEGORY AMOUNT RECEIVED CHECK NUMBER COMMENTS I

APPROVED BY DATE PRWTTf1 ON RFCYCLED PAPER l

NRC FORM 313 (519117)

B.1 Draft NUREG - 1556, VOl.12  !

i

Appendix C Suggested Format for Providing Information Requested in items 5 through 11 of NRC Form 313

i APPENDIX C l Suggested Format for Providing information Requested in items 5 through 11 of NRC Form 313 i

For broad scope usage applications, refer to NUREG - 1556, Vol.11.

Item Suggested Respone Yes Description No. Attached

5. RADIOACTIVE MATERIAL Unsealed and/or Scaled Sources

• For unsealed materials: N/A []

- Provide radionuclide (element name and mass number),

chemical and/or physical form, and maximum requested possession limit.

- For potentially volatile materials (e.g.,1-125,1-131, H-3),

specify whether the material will be free (volatile) or bound (non-volatile) and the requested possession limit for each form.

• For sealed . materials: N/A []

- Identify each radionuclide (element name and mass number) that will be used in each source. I

- Provide the manufacturer's (distributor's) name and model .

number for each sealed source and device requested.  !

- Confirm that each sealed source, device, and source / device combination is registered as an approved sealed source or device by NRC or an Agreement State.

- Confirm that the activity per source and maximum activity  ;

in each device will not exceed the maximum activity listed on the approved certificate of registration issued by NRC or by an Agreement State.

• Provide an Emergency Plan (if required). N/A []

C-1 Draft NUREG - 1556, Vol.12

APPENDIX C Item Suggested Response Yes Description No. Attached

5. RADIOACTIVE MATERIAL (Cont'd)

Financial Assurance and Recordkeeping for Decommissioning N/A []

No response is neeued from most applicants. If F/A or a DFP is required, submit the required documents as described in Regulatory Guide 3.66.

6. PURPOSE FOR WHICH LICENSED MATERIAL WILL, BE USED List the specific use or purpose of each radioisotope. N/A []

7. INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE RSO Provide the name of the proposed RSO and information N/A []

demonstrating that the proposed RSO is qualified by training and experience.

AUs Provide the name of each proposed AU, with the types and N/A []

quantities oflicensed material to be used. Also provide information demonstrating that each proposed AU is qualified by training and experience to use the requested licensed materials.

8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS (Occupationally Exposed Individuals and Ancillary Personnel)

Submit a description of the radiation safety training program, N/A []

including topics covered, groups of workers, assessment of training, qualifications ofinstructors, and the method and frequency of training.

Draft NUREG - 1556, Vol.12 C-2

APPENDIX C ltem Suggested Response Yes Description No. Attached

9. FACILITIES AND EQUIPMENT Describe the facilities and equipment to be made available at each N/A []

location where radioactive material will be used. Include a 1 description of the area (s) assigned for the receipt, storage, preparation and measurement of radioactive materials. Submit a diagram showing the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety. When applicable to facilities where radioactive materials may become airborne, the diagrams should contain schematic descriptions of the ventilation systems, with pertinent airflow rates, pressures, filtration equipment, and monitoring systems. Diagrams should be drawn to a specified scale, or dimensions should be indicated. For facilities where it is anticipated that more than one area of use or room may be used, a generic area or room diagram may be submitted.

10. RADIATION SAFETY PROGRAM Audit Program The applicant is not required to, and should not, submit its audit N/A N/A l

program to the NRC for review during the licensing phase.

C-3 Draft NUREG - 1556, Vol.12

APPENDIX C Item Suggested Response Yes Description No. Attached

10. RADIATION SAFETY PROGRAM (Cont'd)

Radiation Monitoring Instruments Describe the instrumentation that will be used to perform required [] [] 1 surveys, and state that: "We will use instruments that meet the radiation monitoring instrument spec!fications published in Appendix L to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About j Manufacturing and Distribution.' We reserve the right to upgrade

{

our survey instruments as necessary." l I

OR Describe the instrumentation that will be used to perform required [] []

surveys, and state that: "We will use instruments that meet the radiation monitoring instrument specifications published in Appendix L to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.' Additionally, we will implement the model survey meter calibration program published in Appendix L to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.' We reserve the right to upgrade our survey instruments as necessary."

Material Receipt and Accountability Provide procedures for ensuring material accountability N/A []

AND l

" Physical inventa hs will be conducted at intervals not to exceed [] []

6 months, to account for all scaled sources and devices received and possessed under the license."

i Draft NUREG - 1556, Vol.12 C-4

APPENDIX C ltem Suggested Response Yes Description No. Attached

10. RADIATION SAFETY PROGRAM (Con'd)

Occupational Dose "We have done a prospective evaluation and determined that [ .] N/A unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits in 10 CFR Part 20."

OR "We will monitor individuals in accordance with the criteria in the [] []

section entitled ' Radiation Safety Program - Occupational Dose' in NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.'"

Public Dose No response is required from the applicant in a license application. N/A N/A Safe Use of Radionuclides and Emergency Procedures Submit procedures for safe use and einergencies. N/A []

t Procedures may be revised without submission to NRC if: [] N/A

• The changes are reviewed and approved by licensee management and the RSO.

. Licensee staffis trained in the revised procedures before they are implemented.

• The changes are consistent with the procedures submitted with the license application.

• The changes do not degrade the effectiveness of the program. ,

l C-5 Draft NUREG - 1556, Vol.12 l l

APPENDIX C ltem Suggested Response Yes Description No. Attached

10. RADIATION SAFETY PROGRAM (Cont'd)

Surveys "We will survey our facility and maintain contamination levels in [] []

accordance with the survey frequencies and contamination levels published in Appendix R to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.' Leak tests will be performed at the intervals approved by NRC or an Agreement State and specified in the SSD Registration Certificate. Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees l or using a leak test kit supplied by an organization authorized by j NRC or an Agreement State to provide leak test kits to other licensees and according to the sealed source or plated foil i manufacturer's (distributor's) and kit supplier's instructions."

OR "We will survey our facility and maintain contamination levels in []

accordance with the survey frequencies and contamination levels i published in Appendix R to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.' Leak tests will be performed at the intervals approved by NRC or an Agreement State and specified in the SSD Registration Certificate. Leak tests will be performed by an organization authorized by NRC or an 1 Agreement State to provide leak testing services to other licensees j 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 sealed source or plated foil )'

manufacturer's (distributor's) and kit supplier's instructions. As an alternative, we will implement the model leak test program published in Appendix S to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Lic:nses: Program-Specific Guidance About Manufacturing and Distribution.'" i i

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Drafi NUREG - 1556, Vol.12 C-6

)

f APPENDIX C Item Suggested Response Yes Description No. Attached

- 10. RADIATION SAFETY PROGRAM (Cont'd)

Transportation ,

No response is needed from applicants during the licensing phase. N/A N/A i

Minimization of Contamination The applicant does not need to provide a response to this item N/A N/A under the following condition. NRC will consider that the above I

criteria have been met if the applicant's responses meet the criteria in the following sections: " Radioactive Material - Sealed Sources and Devices /or/ Unsealed Radioactive Material,"" Facilities and Equipment," " Radiation Safety Program - Operating and Emergency Procedures,"" Radiation Safety Program - Surveys and Leak Tests," and " Waste Management."

l 11. WASTE MANAGEMENT "V'e will use the model waste procedures published in Appendix U [] []

to NUREG-1556, Vol.12, ' Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Manufacturing and Distribution.'"

OR "We will use the (specify either (1) Decay-In-Storage, (2) Disposal []

of Liquids Into Sanitary Sewerage) model waste paedures that are published in Appendix U to NUREG-1556, Vol.12,

' Program-Specific Guidance About Manufacturing and Distribution.'"

I C-7 Draft NUREG - 1556, Vol.12

Appendix D Sample Licenses I

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APPENDIX D l

Sample Licenses  ;

Sample Licenses appear on the following pages.

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D-1 Draft NUREG - 1556, Vol.12

NRc FORM 374 u.s. NUCLEAR REGULATORY COMMisslON PAGE 1 OF_4 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the 'Inergy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33, W. 35,36,39,40, and 70, and in reliance on statements and representations hirstofore 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 d livrr or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee

1. Sample Manufacture License, Inc. 3. License Number 01-23456-78

2. 1234 Anywhere Street 4. Expiration Date February 28,2008 Anytown, State 01234 5. Docket Nog 030-01234 Reference No.1 j Byproduct, source, and/or special 7. Chemical and/or physical form ~ 8.7 Maximum amount that licensee may nuclear material y < possess at any one time under this

,.,% Ng j y license A. Any byproduct material A. Any g 7 y tl ' A. Not to exceed with atomic numbers 370 gigabecquerels (GBq) 1 through 83 [s\ t 's!y (10 curies (Ci)) per

,y QA'p radionuclide and 3.7 terabecquerels (TBq) hQ W@M $,$ (100 Ci) total n  %~

B. Any byproduct material ny y B. Not to exceed 1.85 GBq with atomic numbers 84 through 94 c QB@Q gjp

\j (50 millicuries (mci)) per radionuclide and 74 GBq r

$V^7.

up -o r y 6. (2 Ci) total C. Hydrogen-3 W GC. Any C. 3.7 petabecquerels (PBq)

.ibjN (100,000 Ci)

D. Carbon-14 D. Any D. 18.5 TBq (500 Ci)

E. Phosphorus-32 E. Any E. 3.7 TBo (100 Ci)

F. Phosphorus-33 F. Any F. 740 GB > . J Ci)

G. Sulfur-35 G. Any G. 14.8 TBq ?00 Ci)

9. Authorized Use A. through G. l (1) Research and development as defined in 10 CFR 30.4.

(2) For possession, use, and processing incident to manufacture of radiochemicals,  ;

radiopharmaceuticals and sealed sources. (Sealed sources are not identified by specific j manufacturer model numbers %cause they will be distributed under a G , E , or MD- distribution license, and will be identified on that license.)

(3) For storage prior to distribution of manufactured radiochemicals, radiopharmaceuticals and sealed sottrees.

l Draft NUREG - 1556, Vol.12 D-2

)

NRC FORM 374A u.s. NUCLEAR REGULATORY Commission PAGE 1 OF 1 PAGEs License Number 01-23456-78 Docket or Reference Number MATERIALS LICENSE SUPPLEMENTARY SHEET 030-01234  !

l (4) For packaging and distribution of manufactured radiochemicals, radiopharmaceuticals, and sealed sources to persons authorized to receive the licensed material pursuant to the terms and conditions of specific licenses issued by the Nuclear Regulatory Commission or Agreement States. 8 (5) For use in calibration of Sample Manufacture License, I ts.

(6) For storage as radioactive wastes. g %sp/m (7) For transfer of waste to the Sample Manufacture Ochnse, d facility in Anytown, State, for i storage prior to disposal and/or processing.fM Mp' )

l CONDITIONS'

@A %

10. Licensed material may be used only at the licensee's facilities at 1234 Anywhere Street,5678 East

- Anyplace Street, and 0123 and 4567 W gnytown, State.

11.A. Licensed material shall be used by, of underithe supervision of, individuals designated in writing by j I

the Radiation Safety Comm.itdeiNohn OhPublic, Ph.D., CHP, Chairperson.

W%% v B. The Radiation Safety Offider forpis)cerse is John ' Doe, M.S., CHP

'12. This license does not .d W -

auth'orize comm& m :ercial distribution of licensed material pursuant to

~ ~

persons generally licens$d puNuadt tf10 CFR Part 31'or equivalent regulations of any Agreement State or to persons exempt fronillcinsinig' pursuant to .10 CFR 30.14 through 30.20 inclusive, or equivalent i'

regulations of any Agreement'Siste.

13.A. Sealed sources and detectdr cells containing licensed material shall be tested for leakage and/or contamination at intervals 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.

B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to be exceed three montos.

C. In the absence of a certificate from a transferor indicating that a leak test has been made within six l months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

D. Each sealed source fabricated by the licensee shall be inspected and tested for ecostruction defects, leakage, and contamination prior to any use or transfer as a sealed source.

E. Sealed sources and detector cells need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or D-3 Draft NUREG - 1556, Vol.12 i

NRC FoR] 374A U.s. NUCLEAR REGULATORY Commission PAGE 3 oF 4 PAGEs License Number 01-23456-78 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-01234 (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 Ci of beta and/or gamma ernitting material or not more than 10 uCi of alpha emitting material; or 8 fr/ A

)

j (v) they are not designed to emit alpha particles, are in storage,,and argnot being used. However, when they are removed from storage for use or transfer to another person, and have not been tested within the required leak test intervals, they shall be tested bbfore use or transfer. No sealed source or detector cell shall be stored for a period of mMe than 10 years without being tested for leakage and/or contamination. n gg-,

u Nb[ $

F. ,

The test shall be capable of detecting the presence of 0.005hCi of radioactive material on the test i sample. If the test reveals the presence of'O.005)Ci or more of removable contamination, a report " I shall be filed with the U.S. Nuclear RegulatoyCommission in accordance with 10 CFR 30.52(b)(2),  !

and the source or detector cell shall tie removhd imniediately from service and decontaminated, I repaired, or disposed of in accordanceivithComidssion reguir.tions. The report shall be filed within five days of the date the leak test result is kiiown with the U.S. Nuclear Regulatory Commission, Region , ATTN: Chief, Ni/ clear Materials Safety Brane;i, (insert aooropriate recional address).

The report shall specify the solice N detector cellinvoNed, the test results, and corrective action G.

taken.

gEp Q The licensee is auth{$zedkdoll$ cit leak test samples for analysis by the licensee. Alternatively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreefhehtitate to perform such services.

14. Licensed material shall not be used in or on human beings.

15. The licensee shall not use licensed material in field applications where activity is released except as provided otherwise by specific condition of this license.

16. The licensee shall conduct a physical inventory every six months to account for all sealed sources and devices containing licensed material received and possessed under the license.

17. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."

18. The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal in ordinary trash, provided:

A. Waste to be disposed of in this manner shall be held for decay a minimum of ten half-lives.

B. Before disposal as ordinary trash, the waste shall be surveyed at the container surface with the I appropriate survey instrument set on its most sensitive scale and with no interposed shielding to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated.

I Draft NUREG - 1556, Vol.12 D-4

i NRC FoR] 374A u.s. NUCLEAR REGULATORY Commission PAGE 4 OF 4 PAGES License Number j 01-23456-78 Docket or Reference Number MATERIALS LICENSE SUPPLEMENTARY SHEET 030-01234 C. A record of each such disposal permitted under this License Condition shall be retained for three years. The record must include the date of disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste containerf aiid the name of the individual who performed the disposal. (

19. The licensee shall not receive title to, own, acquire, deliver, receive, possess, use, or transfer hydrogen-3 under this license for research in, or development, manufafcture, storadel testing, or transportation of atomic weapons or components thereof.  %

4?$h,%ChA$* $

the licensee shall conduct its program in 20.accordance Except aswith specifically provided the statements, otherwise in pthis license,Medures contained in the docume representations,'ar0d any enclosure, listed below. The Nuclear ReMry' Commission's regulations shall govern unless the statements, representations, and procedures ii1Meilicei1Ne's application and correspondence are more restrictive than the regulations.  % $

A.

B. Application dated October Radiological Contingency Plan dated

^ Q' 23fi99(' February 6,1998 3.- y a- .,s fgh

• s

^

I 1

]

i For the U.S. Nuclear Regulatory Commission l Date: By:

Division of Nuclear Materials Safety Region City, State Zip Code ,

D-5 Draft NUREG - 1556, Vol.12

NRC FORM 374 u.s. NUCLEAR REGULATORY CoMMisSloN PAGE 1 OF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations 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 bslow.

Licensee

1. Sample Smoke Detector Company 3. License number 12-34567-89 2.12345 South Any Street 4. Expiration date August 31,2008 Any Town, State 12345-6789 5. Docket No. 030.12345 Reference No ,

[

6. Byproduct, source, and/or special 7. Chemical and/or physical form 3 8? Maximum amount that licensee may ,

nuclear material  % <? possess at any one time under this 4: ,h" 7 j/ license y,. d A.

4 Americium-241 A. Foil sources (Arnersham A. No single foil to exceed 33.3 Int., loc)Modeljk. kilobecquerels (kBq)

No. AMM 1001H)} (0.9 Ci), l d 1.665 gigabecquerels (GBq)

Ne[y[Q> (45 millicuries) total

9. Authorized Use:

g% g ggy A. To be used for storage in Sample Smoke Detector Company XY Series ionization smoke detectors incident to distribution IEaccordance with the conditions of NRC Byproduct Material License No.12-34567-89E. WTPM #

ga 7 CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 12345 South Any Street, Any Town, State.

11. Licensed material shall be used by, or under the supervision of, Named Person One or Named Person Two.

12. This license does not authorize commercial distribution of licensed material. l f

13. Licensed material shall not be used in or on human beings.

{

14, Sealed sources containing licensed material shall not be opened.

15. The licensee shall conduct a physicalinventory every 6 months to account for all sources and/or devices i received and possessed under the license.

16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71,

" Packaging and Transportation of Radioactive Material."

Draft NUREG - 1556, Vol.12 D-6

I NRC FORM 374A u.S. NUCLEAR REGULATORY CoMMisSloN PAGE 1 OF 1 PAGES I License Number 34-23772-01 j Docket or Reference Number MATERIALS LICENSE SUPPLEMENTARY SHEET 030-31617 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 govern unless the statements, representations and procedures in the licensee's applica$dn and correspondence are more restrictive than the regulations.- 7 A. Application dated July 25,1998. 'QA/V Yt% k ^

g;p RQf{! ' hN.' . .,

-N

/

1 FOR THE U.S. NUCLEAR REGULATORY COMMISSION Date: By:

Reviewer's Name Materials Licensing Branch Region D-7 Draft NUREG - 1556, Vol.12

NRC FORM 374 u.s. NUCLEAR REGULATORY Commission PAGE 1 oF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10. Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations herstofore 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 dzlivsr or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee

1. Sample Source Distribution Company 3. License number 01-23456-78MD i

2. 01234 North Any Street 4. Expiration date September 30,2008 Any Town, State 01234-5678 5. Docket No. 030-01.234 Reference No.' 8

6. Byproduct, source, and/or special 7. Chemical and/or physical form Y5. Maxiinum amount that licensee may nuclear material Ni po'ssess at any one time under this license eg*g .

A. As specified in Condition 10

.a .8 A. As specified in CbSditioniOff A. Not applicable py W i Authorized Use:  ?,  %%V x s .

A. Pursuant to 10 CFR Part 32.74, the licensee is authorized to distribute the sources specified in Condition 10 of this license to persons licensedhuisudnt to 10 CFR Part 35.57, or under equivalent licensees of Agreement States.

• g[&[W.s %' d p/ CONDITIONS ge,fw jv p3, u

a

10. Each sealed source distributed under this license shall not contain, as of the assay date, more than the quantity of byproduct materiailisted in the following table:

Ciy >

Byproduct Material Model No. Chemical and/or Physical Form Maximum Quality A. Cobalt-60 NES-354 Dose calibrator reference source 1 millicurie Solid epoxy matrix in vial E B. Cesium-137 NES-356 Dose calibrator reference source 1 millicurie Solid epoxy matrix in vial E C. Barium-133 NES-358 Dose calibrator reference source 1 millicurie Solid epoxy matrix in vial E D. Barium-133 NES-8060 Spot Marker reference source 200 uCi E. Cesium-137 NES-8021 Dose calibrator reference source 50uCi F. Cesium-137 NES-8023 Dose calibrator reference source 50 uCi G. Gadolinium-153 NES-8412 Reference sources to be used in gamma cameras for 1 curie through medicalimaging NES-8425 Drafl NUREG - 1556, Vol.12 D-8

NRC FORM 374A u.S. NUCLEAR REGULATORY CoMMISSloN PAGE_3 oF 3_PAGEs License Number 01-23456-78MD MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-01234

11. The licensee is authorized to distribute the licensed materials listed in Condition 10 of this license from 01234 North Any Street, Any Town, State.

4

12. This license does not authorize possession or use of licensed material:

13. Any proposed changes in packaging, labeling, shielding, or instru usie and storage shall be submitted for review to the Nuclear Materials Safety Brancp, U.S. Ndelaar R6gulatory Commission, Region , (insert appropriate Region and address]'and approvafMthe changes shall be received by the licensee prior to implementing the change. V P,

g% .

yy w licensee shall conduct its program in

14. accordance Except as withspecifically the statements,provided otherwise in this license,6cedures' contained in the representatioris;;a5sM any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations and proced k1g%sie's application and correspondence are more restrictive than the regulations'.

s;g p i A. Application dated August 28,#1 in

'Yf ;{dfiljV .-

~^

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v. t .

FOR THE U.S. NUCLEAR REGULATORY COMMISSION Dcte: By:

Division of Nuclear Materials Safety Region City, State Zip Code D-9 Draft NUREG - 1556, Vol.12

NRC FORM 374 u.s. NUCLEAR REGULATORY Commission PAGE 1 OF 2 PAGEs MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of 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 E.t the place (s) designated below; to deliver ortransfer 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.

Ucensee in accordance with the letter dated April 13,1995, l

1. Sample Radiopharmaceutical Distribution 3. Ucense number 01-23456-04MD is amended in its License, Inc. entirety to read as follows:

2. P.O. Box 191 4. Expiration date March 31,2008 I City, State Zip Code 5. Docket No. 030-56789 Reference No., W O q

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. [ Maximum amount that licensee may nuclear material *@ e ' possess at any one time under this gy % ' s '/ license q?mf ~ , ,

A. Chromium-51 li V A. Not applicable 1 A. (NDA Sodium 13-993N yc Chromatek m

l i

B. lodine-131 B. Sodium l'oNbNippu' fate B. Not applicable l (NDAj6-666) y>

C. lodine-131 Nbl% 5 C;sSodium lodide C. Not applicable M(NDA.10-929/S-01, S-002)

9. Authorized Use: jeg Q/ '

o

{msm-% V A. through C. @{gp @g w ff Pursuant to Section 32.72 of 10 CFR Part 32, the licensee is authorized to distribute the byproduct material described in items 6 and 7 of this license to persons licensed pursuant to Sections 35.14,35.100,35.200 and 35.300 of 10 CFR Part 35, or under equivalent licenses of Agreement States.

CONDITIONS

10. Each product distributed under this licensee shall not contain as of the assay date, more than the quantity of byproduct material listed in the following table.  ;

Byproduct Material Product Name Maximum Quantity )

A. Chromium-51 Chromitope Sodium Injection 37 megabecquerels (MBq) (1.0 millicurie (mci))

B. lodine-131 Hippuran i 131 Injection 74 MBq (2.0 mci)

C. lodine-131 lodotope Therapeutic Capsules 5.55 gigabecquerels (Gbq) (150 mci)

D. lodine-131 lodotope Therapeutic Oral 3.959 GBq (107 mci)

I l

l Draft NUREG - 1556, Vol.12 D-10

NRC FoRJ 3NA u.s. NUCLEAR REGULATORY CoM:ItssioN PAGE _J_ OF _3_ PAGEs Ucense Number 01-23456-04MD MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-56789 i

11. The licensee may distrib:ite material from licensee's facilities located at 1 Medical Drive, Any Town, Any State.

12. This license does not authorize possession or use of licensed mater i

13. Except as specifically provided otherwise in this license, the licen a cohduct its program in accordance with the statements, representations, and procedures ccIntainsidln the documents, including any enclosures, listed below. The Nuclear Regulatory Coi$njssion's J$guiations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more

~

restrictive than the regulations. TS Nig7 ^

A. ' Application dated January 27,1998 B. Letter dated February 10,1998 ~

{p '

C. Letter dated March 2,1998

~

FOR THE U.S. NUCLEAR REGULATORY COMMISSION Date: By: '

Division of Nuclear Materials Safety Region City, State Zip Code D-11 Draft NUREG - 1556, Vol.12

i 1

Appendix E Information Needed for Transfer of l Control Application

e. .

APPENDIX E Information Needed for Transfer of Control Application i

For information needed for transfer of control application, refer to NUREG-1556, Vol.15,

" Consolidated Guidance about Materials Licenses: Guidance about Change of Control and Guidance About Bankruptcy Involving Byproduct, Source, or Special Nuclear Material Licenses."

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1 E.1 Draft NUREG - 1556, Vol.12

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Appendix F l License Types - Guidance 1

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APPENDIX F 1

License Types - Guidance XX (state code) -XXXXX (institution code - a unique identifier for each licensee) -XX (sequential number oflicense for that licensee)

Letters that follow the license number indicate the following: E, G, MD. No letters indicates possession heense.  !

i Manufacturer's Possession License XX-XXXXX-XX This specific license is issued to a manufacturer to possess, use, manufacture, etc. licensed material for distribution and for use by the licensee in process controls. It can include distribution to other specific licensees.

Importer's Possession License XX-XXXXX-XX This specific license is issued to an importer to possess (only) licensed material for distribution. '

It can included distribution to other specific licensees.

General Distribution License XX-XXXXX-XXG

' This specific license is issued to manufacturers and also to distributors to distribute approved materials to persons who are generally licensed to possess and use the materials. This licensee does not have to be a manufacturer.

Most common products distributed to general licensees are:

32.51/51a/52 Certain measuring, gauging, or controlling devices, including: fixed gauges including density, thickness, etc. and may include multi-curie sources; gas chromatograph ECDs, X-ray fluorescence or other analytical devices; curie-quantity tritium light sources for exit signs; and similar devices. For possession and use by persons authorized by a General License pursuant to 10 CFR 31.5.

-32.71 .

i

' Kits for in-vitro clinical or laboratory testing. Ci quantities of H-3, C-14, Fe-55, I-125, etc. For possession and use by persons authorized by a General License pursuant to 10 CFR 31.11.

F-1 Draft NUREG - 1556, Vol.12. i

APPENDIX F Exempt Distribution License XX-XXXXX-XXE Specific license to distribute approved materials to persons who are not required to have any license in order to possess or use the material. Exempt Distribution is authorized by a Specific License ISSUED BY HEADQUARTERS.

Medical Distribution License (XX-XXXXX-XXMD) 32.72 and 32.74 Sources / devices for medical use pursuant to 10 CFR 35.57/400/500 for radiopharmaceuticals for medical use pursuant to 10 CFR 35.100/200/300 (since the "new pharmacy rule," which eliminated regulation of cold kits, regulation of distribution ofgenerators is also included).

Manufacturers of medical devices may wish to plan for return shipments oflicensed materials.

Manufacturers of sealed source devices such as eye applicators or bone densitometers may wish l to provide a return at end of useful life service. Nuclear pharmacies may wish to retrieve spent 1 syringe assemblies from their customers and dispose of them by decay-in-storage, thence to a

- biohazard service. The manufacturer should prepare return shipping procedures for customers to use. Ti alpper is responsible for the proper preparation for shipment. Many licensees request assistar. e from manufacturers about shipments.

l Draft NUREG - 1556, Vol.12 ' F-2

l Appendix G -.

i Quality Control, Labeling, and Prototype Tests

i APPENDIX G l

Quality Control, Labeling, and Prototype Tests 10 CFR 32 describes several types of prototype tests, quality control (QC) tests, and labeling requirements that need to be performed for various manufactured devices (e.g., sealed sources, generators, automobile lock illuminators, etc.). These regulations are found in the following sections: 10 CFR Parts 32J 5,32.25,32.27,32.29,32.40,32.51,32.54,32.55,32.57,32.58, 32.59, 32.61, 32.62, 32.71, 32.72, 32.74, 32.101, 32.102, 32.103, 32.1 10, and 32.210. The applicant should be sure to review these sections when manufacturing a particular device (e.g., manufacturers of gas and aerosol detectors containing byproduct material need to ensure that the requirements in 10 CFR Parts 32.27 and 32.29 are satisfied).

A medical distribution applicant should have in mind that a significant effort must be devoted to ensure that the customer receives: the radionuclide ordered; in the form that was ordered; in the quantity that was ordered; and, according to the license authorizing the material. The Quality Control applied to molybdenum-99/ technetium-99m generators and their products are in )'

10 CFR Part 35.204.

You must possess, calibrate and use instrumentation to measure the radioactivity of dosages of alpha , beta , or photon-emitting radioactive drugs prior to transfer for commercial distribution.

Applicants should describe (1) the methods used to measure this radioactivity in dosages of radioactive drugs, (2) the instrumentation that will be used to measure this radioactivity, and (3) the instrumentation calibration procedures (e.g.: accuracy, linearity, geometric dependence, constancy). Measurements may be made by direct measurement or a combination of direct l

measurement and calculation. I Radioactive Drugs - Licensing Criteria for Labeling Your product labeling must fulfill the requirements of 10 CFR 20.1901 and 20.1904 and 10 CFR 32.72(a)(4) except for the exemptions in 10 CFR 20.1905.

Radioactive drug containers must be labeled in compliance with 10 CFR 20.1904 and 20.1905 and 10 CFR 32.72(a)(4),

in order to meet the requirements in 10 CFR 32.72(a)(4)(i), you must agree to label each transport radiation shield to show the radiation symbol and the words," CAUTION, RADIOACTIVE MATERIAL" OR " DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. The " transport radiation shield" could be constructed oflead glass, plastic, or other material, as appropriate for the isotope to be transferred for commercial distribution. The phrase

" transport radiation shield" does not refer to the outer suitcase, package, packing, or other carrying device, even though that barrier may provide some radiation shielding. Also, the radiation symbol must be the same as described in 10 CFR 20.1901.

G-1 Draft NUREG - 1556, Vol.12

APPENDIX G In order to meet the requirements in 10 CFR 32.72(a)(4)(ii), you must agree to label each syringe, vial, or other container (e.g., generators or ampules) used to hold radioactive drugs to be transferred for commercial distribution to show the radiation symbol and the words " CAUTION, RADIOACTIVE MATERIAL" OR " DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. The radiation symbol must be the same as described in 10 CFR 20.1901.. Acceptable identifiers may include, but are not limited to, the lot number or the name of the radioactive drug or its abbreviation.

Subpart C (QC Sampling Procedures) of 10 CFR 32 describes acceptable sampling criteria for testing random sections from each production lot.

g G G

Appendix H Radiation Safety Officer Duties and Responsibilities

)  !

i W

APPENDIX 11 Radiation Safety Officer Duties and Responsibilities The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license (see Figure 8.5). Typically, these

' duties and responsibilities include the following

. Ensure that licensed material possessed b; L w m. s limited to the types and quantities of licensed material listed on the license;

• Oversee all activities involving radioactive material, including monitoring and surveys of all areas in which radioactive material is possessed or possessed and used;

• Act as liaison with NRC and other regulatory authorities;

. Provide necessary information on all aspects of radiation protection to personnel at all levels of responsibility, pursuant to 10 CFR Parts 19 and 20, and any other applicable regulations;

. Oversee proper delivery, receipt, and conduct of radiation surveys for all shipments of radioactive material arriving at or leaving from the institution, as well as packaging and labeling all radioactive material leaving the institution;

• Distribute and process personnel radiation monitoring equipment; determine the need for and evaluate bioassays; monitor personnel radiation exposure and bioassay records for trends and high exposures; notify individuals and their supervisors of radiation exposures approaching established limits; and recommend appropriate remedial action; i

• Conduct training programs and otherwise instruct personnel in the proper procedures for handling radioactive material prior to possession or possession and use, both at periodic intervals (refresher training), and as required by changes in procedures, equipment, regulations, etc.;

. ' Supervise and coordinate the radioactive waste disposal program, including effluent monitoring and recordkNping on waste storage and disposal records;

. ' Oversee the storage of radioactive material not in current use, including waste; i

. Perform or arrange for leak tests on all sealed sources and calibration of radiation survey instruments;

. ' Maintain an inventory of all radioisotopes possessed under the license and limit the quantity to the amounts authorized by the license;

• Immediately terminate any unsafe condition or activity that is found to be a threat to public l

health and safety or property;

• Supervise decontamination and recovery operations;

• Maintain other records not specifically designated above, (e.g., records of receipts, transfers, and surveys as required by 10 CFR 30.51 and 10 CFR 20, Subpart L," Records"); j 11-1 Draf t NUREG - 1556, Vol.12 l

APPENDIX 11

. Hold periodic meetings with, and provide reports to, licensee management;

. Ensure that all users are properly trained; Perform periodic audits of the radiation safety program to ensure that the licensee is complying with: all applicable NRC regulations; the terms and conditions of the license (e.g., leak tests, inventories, possession or possession and use limited to trained, approved users, etc.); the content and implementation of the radiation safety program to achieve occupational doses and doses to members of the public that are ALARA, in accordance with l 10 CFR 20.1101; and the requirement that all records be properly maintained;

. Ensure that the results of audits, identification of deficiencies, and recommendations for change are documented (and maintained for at least 3 years) and provided to management fo.

review; ensu'r e that prompt action is taken to correct deficiencies;  ;

. Ensure that the audit results and corrective actions are communicated to all personnel who possess or possess and use licensed material;

• Ensure that all incidents, accidents, and personnel exposure to radiation in excess of ALARA or Part 20 limits are investigated and reported to NRC and other appropriate authorities, if required, within the required time limits;

. Maintain an understanding of, and up-to-date copies of, NRC regulations, the license, and revised licensee procedures; and ensure that the license is amended whenever there are

- changes in licensed activities, responsible individuals, or information or commitments provided to NRC during the licensing process.

Draft NUREG - 1556, Vol.12 H-2

Appendix 1 Radiation Safety Training Topics

APPENDIX 1 Radiation Safety Training Topics This Appendix is intended ont as a guide for developing a training program. Individuals working with radioisotopes may not require training on every topic provided. For example, housekeeping staff may need to know only what symbols to look for, which waste cans to empty, or which areas to enter or avoid. Conversely, laboratory technicians may require detailed information on particular topics. As a result, instruction for some individuals may be provided by providing a simple hand-out; whereas others may require extensive training, including a written exam to assess retention of the topics presented.

Frequency of Training A.~ Before assuming duties with, or in tne vicinity of, radioactive materials B. Whenever there is a significant change in duties, regulations, or the terms of the license C. Annually (refreshertraining)

General Information A. Radiation safety

1. radiation vs. contamination

2. internal vs. external exposure

3. biological effects of radiation

4. ALARA concept

5. use of time, distance, and shielding to minimize exposure B. Regulatory requirements

1. RSO

2. material control and accountability

3. personnel dosimetry

4. radiation safety program audits

5. transfer and disposal

6. record keeping

7. surveys

8. postings 1-1 Draft NUREG - 1556, Vol.12

APPENDIX 1

- 9. labeling of containers

10. handling and reporting ofincidents or events

11. licensing and inspection by NRC

. 12. need for complete and accurate information

13. employee protection 1

14. deliberate misconduct Licensee-Specific Program Elements A. Authorized ' users and supervised users B. Worker-specific manufacturing process tasks ,

C. Shipping '

D. Ordering and receiving radioisotopes E. Applicable regulations and license conditions F. - Areas where radioactive material is used or stored G. Potential hazards associated with radioactive material in each area where the individuals will work H. Appropriate radiation safety procedures i I. Licensee's in-house work rules (for instructions on laboratory safety and uses of radioisotopes, see Section IV) q J. Each individual's obligation te report unsafe conditions to the RSO K. Appropriate response to spills, emergencies or other unsafe conditions -

L. Worker's right to be infonned of occupational radiation exposure and bioassay results, if {

applicable 4 M. Locations where the licensee has posted or made available: notices, copies of pertinent regulations, and copies of pertinent licenses and license conditions (including applications and applicable correspondence), as required by 10 CFR Part 19 N. Emergency procedures:

1. RSO name and telephone number i

2. immediate steps to prevent or control spread of contamination

3. clean-up instructions, decontamination l

Draft NUREG - 1556, Vol.12 1-2

APPENDIX 1 O.L Survey program

.1. survey instrument' accessibility

' i: - 2. who is responsible

3. i types, contamination, and areas

- 4,ffrequency

5. : levels of contamination

6. - personnel, hands, shoes

7. records .

P. Waste

1. liquid

2. solids 3.f sanitary sewer

'4. burial (transfer to low level waste repository)

5. storage

6.' . decay-in-storage

7. waste storage surveys' j

8. incineration-i

. Q. Dosimetry i

1. ? whole body .

2. extremities - l

3. lost or replacement badges and dose assessment

4. bioassay procedures -

R; Instrumentation -

U- - 1. survey meters - use, calibration frequency, use of check sources

2. analytical instruments - gas flow counters, liquid scintillation counters i

- I-3 Draft NUREG - 1556, Vol.12 f,

h i

APPENDIX 1 S. Procedures for receiving packages containing radioactive materials

1. normal-

2. off-duty

3. notification of user and RSO -

'.4. . security

5. exposure levels

6. possessionlimit

. 7. : receipt of damaged packages i T. ' Procedures for opening and examining packages.

1. leakage and contaminatim

2. monitoring packages

3. monitoring packing materials

4. gloves

5. transferring material to users U. Animal experiments.

~ 1. description of facilities

2. safety instructions, including handling of animals, waste, carcasses, and cleaning and decontamination of cages

3. . security V. Scaled sources 1; leak-test requirements

2a . inventory requirements L 3. exempt quantities ,

'W. Other topics, as applicable X. Question and answer period

'I Draft NUREG - 1556, Vol.12 1-4 e -- .

l APPENDIX 1 For Laboratory Safety and Use of Radioisotopes A. Control procedures for obtaining permission to possess or possess and use radioactive materials at the facility; give limitations on quantity to be handled per user, or allowed per experiment, etc.

B. Protective clothing and what laboratory apparel to wear and what equipment to use.

C. Limitations and conditions relative to handling unsealed licensed material and what laboratory equipment to use when working with such material. For example, discuss which licensed materials and what procedures should be confined to radiochemical fume hoods or gloveboxes. Explain what shielding or remote handling equipment is to be used when beta and/or gamma-emitting licensed materials are handled.

D. Routine survey and monitoring procedures to be followed for contamination control. Include where and how contaminated articles and glassware are to be handled and stored.

E. Emergency procedures concerning spills, fires, release of material, and/or accidental ,

contamination of personnel. l F. Decontamination procedures to use and whom to contact in case of an emergency.

G. Instructions conceming transfer oflicensed materials between rooms, halls, or corridors, if applicable.

H. Requirements for storage, labeling of containers, and identification of areas where licensed materials are possessed or possessed and used.

I. Personnel monitoring devices to use, where to obtain them, and exchange procedures and exposure results.

J. Waste disposal procedures to follow, limitations for disposal ofliquid or solid wastes, and procedures to use for waste storage. If program involves experiments with animals, procedures for cleaning animal quarters and handling animal excreta and carcasses for disposal.

K. Records to be maintained on possession, use, and disposal oflicensed materials.

L. Prohibition of pipetting by mouth; eating, smoking, and drinking in areas where licensed materials are possessed or possessed and used.

l 15 Draft NUREG - 1556, Vol.12 u

Appendix J Facilities and Equipment i

l

c

]

APPENDIX J Facilities and Equipment Below is a list of topics that should be considered when developing a description of the facilities and equipment that a licensee will use or otherwise have available. Not every applicant will need 1

to address each of these topics in its application.

. Restricted areas are defined as areas to which access is limited by the licensee to protect individuals against undue risks from exposure to radiation and radioactive materials. The application should contain detailed descriptions and diagrams of the facilities, including .

information about the shielding properties of the construction materials used. Scaled drawings j and sketches should be submitted showing the relationship between restricted areas and )

unrestricted areas and the location of all pertinent safety-related equipment. Drawings should show the uses of adjacent areas, including those beside, above, and below, and a recitation of the various shielding materials in the separating surfaces.

. A site diagram should indicate buildings and areas and their uses such as research, production, waste storage. l

. Benchtop or open work areas may be used for sealed sources, for small quantities of solid materials in a form not likely to become airborne or dispersed, and for small quantities of l liquids of such low volatility as not to cause airborne contamination or toxicity problems.  !

Trays and/or absorbent surface covers to catch and retain spilled liquids should be used on these open work surfaces and inside closed systems discussed below. Surfaces should be smooth and non-porous, to facilitate decontamination.

. Radioactive materials that are handled or used in unsealed forms should be confined to control the release of material and to prevent the spread of contamination. Gaseous, volatile, and fine j particulate solid materials should be handled in closed or isolated systems such as fume hoods j or glove boxes with controlled, and possibly filtered, exhaust systems. j 1

Chemical-type fume hoods provide a working area with controlled inward airflow from the  !

room to the hood exhaust system. Hoods are used for gases. for unsealed volatile licensed  !

mater a, and for processes such as evaporation that may telease gases and vapors. Fume l i

hoods provide emergency ventilation and exhaust for unplanned releases, such as accidental spills and ruptures, as well as routine exhaust of effluents. Filters may be required in the exhaust stream unless monitoring and/or calculations demonstrate that any planned or likely effluent will be in accordance with the limits found in 10 CFR 20, Appendix B. I Glove boxes are sealed boxes with transparent viewing windows, sealable ports and/or doors for transferring materials and equipment, and gloves sealed to the box through which licensed materials are handled. Glove boxes are used for the containment during storage and use of liquids and solids that can become airborne particulates or aerosols. Glove boxes can be closed or exhausted, with filtration systems if appropriate, to prevent contamination.

J-1 Draft NUREG - 1556. Vol.12

APPENDIX J Sink faucets should be designed, where possible, for operation by foot, knee, or elbow rather than by hand.

. Plumbing and ductwork should be designed to avoid radioactive contamination build-up. This build-up of contamination can create external radiation exposure hazards and problems for decommissioning.

. Shielding consisting oflead or other high-density material in the form of bricks, panels, i L-shields, storage containers, or other shapes may be used on bench tops, in fume hoods or in l glove boxes to reduce radiation exposure from gamma-emitting radioactive materials. 2 Similarly, shielding oflow atomic number material, such as high-density plastic, may be used to reduce the exposure from high-energy beta-emitting materials. Shielded shipping containers are frequently used for continued storage after receipt of materials.

. Particular sinks should be designated for disposal ofliquid radioactive waste to the sanitary sewerage system. In some cases, depending on number of users and distance between areas of l

use, more than one sink may need to be designated. j Labeled waste containers should be used. These containers may be shielded as necessary, i placed near the waste-generating areas, placed away from areas frequently occupied by l personnel, and secured from unauthorized removal. Additionally, these containers should be effectively enclosed to prevent airborne contamination from radioactive materials deposited.

. Remote handling tools, such as forceps or extension handles, should be used to provide distance in the handling of radioactive materials (ALARA). In addition, shielded handling devices, such as shielded syringes, can be used to protect workers from materials that cannot be handled remotely. Pipetting should be done using appropriate devices. Pipetting by mouth should be strictly forbidden.

. Where appropriate, ventilation systems should be designed, such that, in the event af an accident, they can be shut down and isolated to contain radioactivity.

. Designated areas should be provided for coats and personal belongings, to avoid contamination.

• Areas with low background radiation levels should be designated for personnel dosimetry storage when not in use.

. Areas of use should be well-lighted to avoid spills and other accidents that could result in contamination build-up.

Observation of activities' conducted behind shielding with remote tools (or with extended arms and hands, within limits consistent with permissible occupational exposures) can be accomplished by mirrors, through shielded (e.g., leaded glass) windows, through transparent plastic beta shields, or by remote video monitoring.

Draft NUREG - 1556, Vol.12 J2

r APPENDIX J

. The combination of containment, shielding, and handling devices proposed for any use of radioactive materials should be appropriate to the type and quantity of materials to be used and to the type and duration of operations to be conducted.

. If respiratory protective equipment will be used to limit inhalation of airborne licensed material, follow the provisions of 10 CFR Part 20, Subpart H.

l f

J3 Draft NUREG - 1556, Vol.12

Appendix K Suggested Audit Program 1

I

p l

APPENDIX K Suggested Audit Program This appendix outlines areas to be examined during the licensee's annual review ofits radiation protection program.

1 An audit is conducted, in part, to fulfill the requirements of 10 CFR 20.1101 for an annual i

review of the content and implementation of the licensee's radiation protection program. It should also identify program weaknesses and allow licensees to take early corrective actions (before an NRC inspection). During an audit the auditor needs to keep in mind not only the requirements of NRC's regulations, but also the licensee's commitments in its applications and other correspondence with NRC. The auditor should also evaluate whether the licensee is maintaining exposures to workers and the general public ALARA and, if not, make suggestions for improvement.

In general, the licensee should consider the following (refer to the sample checklist):

. Audit History Enter the date of the last audit, whether any deficiencies were identified, and whether actions were taken to correct the deficiencies. J

. Organization and Scope ofProgram Give a brief description of the organizational structure, l noting any changes in personnel. Describe the scope oflicensed activities at the audited location. Check whether the Radiation Safety Officer (RSO) is the person identified in the license and fulfills the duties specified in the license.

= Training, Retraining, andInstructions to Workers Ensure that workers have received the training required by 10 CFR 19.12. Be sure that, before being permitted to possess or possess  !

and use licensed mate-ial, the user has received training and has a copy of the licensee's safe use and emergency procedures. Note whether refresher training is conducted in accordance with licensee commitmcyts. By interview and/or observation of selected workers, ensure that eaci.1as a copy of the licensee's procedures and can implement them properly.

Audits Verify that audits fulfill the requirements of 10 CFR 20.1101, are conducted in accordance with licensee commitments, and are properly documented.

Facilities Verify that the facilities are as described in the license documents. Note whether the licensee has permanent field offices and/or temporaryjob sites. Indicate any findings noted for those sites audited. ' If some sites were not visited, explain why they were not audited.

= Materials Verify that the license authorizes the quantities and types oflicensed material that the licensee possesses.

. Leak Tests Verify that all sealed / plated foil sources are tested for leakage at the prescribed l frequency and in accordance with licensee commitments. Records of results should be maintained.

I K-1 Draft NUREG - 1556, Vol.12

APPEND 1X K

. Inventories Verify that inventories are conducted at least once every 6 months to account for all sources, and that inventory records are maintained.

. Radiation Surveys and Measurements Verify that the licensee has appropriate, operable, and calibrated survey and radiation measurement instruments available, that the instruments are calibrated (at the required frequency) in accordance with license conditions and in accordance with 10 CFR 20.2103. Calibration records must be retained for 3 years. Check that radiation levels in areas adjacent to possession or possession and use areas are within regulatory limits and in accordance with 10 CFR 20.2103. Verify compliance with 10 CFR 20.1301. Records of surveys and measurements must be retained for 3 years.

l

• Receipt and Transfer ofRadioactive Material (includes commercial distribution and waste j disposai) Verify that packages containing licensed material received from others are received, opened, and surveyed in accordance with 10 CFR 20.1906. Ensure that transfers are performed in accordance with 10 CFR 30.41,40.51, and 70.42. Records of surveys, receipt, and transfer must be maintained in accordance with 10 CFR 20:2103,30.51,32.12,40.61, 70.51, and 70.54.

. Transportation Determine compliance with Department of Transportation (DOT) requirements. Verify that radioactive packages are prepared, marked, and labeled in l accordance with 49 CFR Parts 172 and 173 requirements. Verify that shipping papers are prepared, contain all needed information, and are readily accessible during transport (49 CFR 172.200-204 and 177.718).

• Personnel Radiation Protection Evaluate the licensee's determination that unmonitored personnel are not likely to receive more than 10% of the allowable limits. Alternatively, if personnel dosimetry is provided and required, verify that it complies with 10 CFR 20.1501(c) and licensee commitments. Review personnel monitoring records; compare exposures of individuals doing similar work; determine reasons for significant differences in exposures. If any worker declared her pregnancy in writing, evaluate umpliance with 10 CFR 20.1208.

Check whether records are maintained as required by 10 CFR 20.2101-2104 and 20.2106.

Auditor's Independent Measurements (ifmade) The auditor should make independent survey measurements and compare the results with those made or used by the licensee.

. Noti /lcation and Reports Check for compliance with the notification and reporting requirements in 10 CFR, Parts 19,20,21,30,40, and 70. Ensure that the licensee is aware of the telephone number for NRC's Emergency Operations Center, (301) 816-5100. {

l

. Posting andLabeling Check for compliance with the posting and labeling requirements of l 10 CFR 19.11,10 CFR 20.1902,20.1904, and 10 CFR 21.6.

. Recordkeepingfor Decommissioning Check to determine compliance with 10 CFR 30.35(g), j 10 CFR 40.36(f), and 10 CFR 70.25(g). {

l l

Draft NUREG - 1556, Vol.12 K-2

APPENDIX K

. Bulletins and Information Notices Check to determine if bulletins, information notices, NMSS Newsletters, etc., are received from NRC. Check whether appropriate actions were taken in response to NRC mailings.

. SpecialLicense Conditions orIssues Verify compliance with any special conditions in the license. If there are any unusual aspects of work, review and evaluate compliance with regulatory requirements.

Problems or Deficiencies Noted

. Recommendations List any recornmendations to improve the overall program.

. Evaluation of Other Factors Evaluate management's involvement with the radiation safety program, whether the RSO has sufDcient time to perform his/her duties, and whether there is sufDeient staff to handle the workload and maintain compliance with regulatory requirements.

. For Medical Distribution licensees, include the items discussed in Appendix X, as appropriate.

Sample Audit Form The form in this Appendix can be used to document the annual audit of the radiation protection program. In the " remarks" portions of the form, note any denciencies that were identined and the corrective actions taken (or to be taken).

All areas indicated in the audit form may not be applicable to every licensee and may not need to l be addressed during each audit. For example, hunsees do not need to address areas that do not apply to the licensee's activities, nor do they need to address activities that have not occurred since the last audit.

K-3 Draft NUREG - 1556, Vol.12 l

APPENDIX K Sample Checklist Audit Repon No. License No.

Licensee's name and mailing address:

i l

Audit of activities at (Address):

1 l

Contact at Audit Location Telephone No.

Date of this Audit Summary of Findings and Action:

[ ] No deficiencies

[ ] Deficiencies

[ ] Action on previous deficiencies Recommendations: ,

l Auditor: Date (Signature)

Reviewer: Date l (Signature) i Draft NUREG - 1556, Vol.12 K-4

APPENDIX K Audit History [ ] N/A (NIA means "Not applicable"-Initial Audit)

A.~ Last audit of this location conducted B. Problems / deficiencies identified during last two audits or two years, whichever is longer- I]Y []N C. Open problems / deficiencies from previous audits:

Status Requirement Prob./Def. Corrective Action Taken (Y/N) Open/ Closed D. Any previous problem / deficiency not corrected or repeated []Y []N [ ] N/A Explain:

Organization and Scope of Program A. Briefly describe organizational structure

1. Stnicture is as described in license documents [] Y []N

2. Multiple authorized locations of use []Y []N

3. Briefly describe scope of activities involving byproduct material, frequency of use, staff size, etc. []Y []N B. Radiation Safety Officer [] Y []N

1. Authorized on license []Y []N 2..- Fulfills duties as RSO []Y []N C. - Use only by authorized individuals []Y []N Remarks-1 K-5 Draft NUREG - 1556, Vol.12

APPENDIX K

. Training, Retraining, and Instructions to Workers A. Instructions to workers [10 CFR 19.12] [.] Y []N

. B. Training program required [] Y []N

' C. ' Training records maintained

[] Y []N D. Evaluation ofindividuals' understanding ofprocedures and

regulations based on interviews, observation of selected workers

1. Each has an up-to-date copy of the licensee's safe use and emergency procedures [] Y []N

2. Adequate understanding of:

Current safe use procedures [] Y []N Emergency procedures [] Y []N E. . Part 20 Workers cognizant of requirements for:

1. Radiation Safety Program [10 CFR 20.1101] [] Y []N

2. Annual dose limits [20.1301,1302] [] Y []N

3. Forms 4 and 5 -[ ] Y []N

4. 10% monitoring threshold [20.1502] [] Y []N

5. Dose limits to embryo / fetus and declared pregnant women [20.1208] [] Y []N

6. Procedures for opening packages [20.1906] [] Y []N Remarks:

Internal Audits, Reviews or Inspections A. Audits are conducted [] Y []N

1. Audits conducted by

2. Frequency Draft NUREG - 1556, Vo! 12 K-6

r APPENDlX K B. Content and implementation of the radiation protection program reviewed annually [20.1101(c)] []Y []N C. Records maintained [20.2102] . []Y []N Facilities A. Facilities as described in license application Remarks:

Materials A. Isotopes, quantities, and use as authorized on license []Y []N Remarks:

Contamination Checks and Leak Tests A. Leak test performed as described in correspondence with NRC (consultant; leak test kit; licensee performed) []Y []N B. Frequency: every 6 months or other interval, as approved by NRC or Agreement State [] Y []N C. Contamination checks performed prior to distribution [] Y []N D. Records with appropriate information maintained [] Y []N Remarks:

Inventories 4

' A. Conducted at 6-month intervals []Y []N B. Records with appropriate information maintained []Y []N ,

i Remarks:

Radiation Surveys and Measurements A. Instruments and equipment:

1. Appropriate operable survey instrumentation possessed or readily available- [] Y []N K-7 Draft NUREG - 1556, Vol.12 '

APPENDIX K

2. Calibrated as required [20.1501] [] Y []N

3. Calibration records maintained [20.2103(a)] []Y []N B. Briefly describe survey measurement requirements [20.1501(a)]:

C. Performed as required [20.1501(a)]

[] Y [] N j

1. Radiation levels within regulatory limits [] Y []N l

2. Corrective action taken and documented [] Y []N D. Records maintained [20.2103] [] Y []N

- E. Protection of members of the public

1. Adequate surveys made to demonstrate either (a) that the TEDE to the individual likely to receive the highest dose does not exceed 100 mrem in a year, or (b) that if an  ;

individual were continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour and {

50 mrem in a year [20.1301(a)(1),1302(b)] []Y []N 1 l

2. Unrestricted area radiation levels do not exceed 2 mrem in any one hour [20.1301(a)(2)] [] Y []N

3. Records maintained [20.2103,2107] [] Y []N Remarks:

i Receipt and Transfer of Radioactive Material (includes Waste D'aposal) l A. Describe how packas es are received and by whom: [}Y []N B. Written package oper.ing procedures established and followed [20.1906(e)j []Y []N ,

C. Ifpackage shows evidence of degradation, monitor for contamination and radiation levels []Y []N [ ] N/A

. D. Monitoring of degraded packages performed within time specified [20.1906(c)] [] Y []N [ ] N/A E. Transfer (s) between licensees (including commercial distribution and " disposal") performed per [10 CFR 30.41] []Y []N [ ] N/A F. Records ofreceipt/ transfer maintained [20.2103(a),3051] []Y []N G. Transfers within licensee's authorized uscrs or locations performed as required [L/C] [] Y []N [ ] N/A Draft NUREG - 1556, Voi.12 K-8

l APPENDIX K H. Package receipt / distribution activities evaluated for compliance .

with 20.1301 (20.1302] [] Y []N [ ] N/A Remarks:

Transportation (10 CFR 71.5(A) and 49 CFR 170-189) = [ ] N/A q l

A. Licensee shipments are:

1. delivered to common carriers [] Y []N [ ] N/A

2. transported in licensee's own private vehicle [] Y []N . [ ] N/A B. Packages' [ ] N/A

1. Authorized packages used [49 CFR l'/3.415,416(b)] []Y []N [] N/A

2. Closed and sealed during transport [173.475(f)] [] Y [-] N C. Shipping Papers [ ] N/A

1. Prepared and used [172.200(a)] []Y [-] N

2. Proper (Shipping name, Hazard Class, UN Number, Quantity, Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, Activity, Category oflabel, T1, l Shipper's Name, Certification and Signature, Emergency l Response Phone Number," Cargo Aircraft Only" (if applicable)} [172.200-204] []Y []N

3. Readily accessible during transport 177.718(e)] []Y []N D. . Vehicles []Y []N

1. Cargo blocked and braced [177.842(d)] []Y []N

2. Placarded,ifneeded (172.504] []Y []N

3. Proper overpacks, if used (shipping name, UN Number, labeled, statement indicating that inner package ' complies with specification package) [173.25] []Y []N I

E. Any incidents reported to DOT [171.15,16] []Y []N Remarks:

l i

K-9 Draft NUREG - 1556. Vol.12 l

J

APPENDIX K Personnel Radiation Protection i

A.. ALARA considerations are incorporated into the Radiation  !

Protection Program [20.1101(b)] []Y []N B. ' Adequate documentation of determination that unmonitored occupationally individuals are not likely to receive >10% of allowable limit [20.1502(a)] [.] Y []N [ ] N/A OR C. - External dosimetry provided and required []Y []N [ ] N/A

1. Supplier Frequency

2. SupplierisNVLAP-approved [20.1501(c)] [] Y []N

3. Dosimeters exchanged at required frequency [L/C] [] Y []N D. Occupationalintake monitored and assessed [20.1502(b)] []Y []N [ ] N/A E. Reports [ ] N/A

1. Reviewed by Frequency

2. Auditor reviewed personnel monitoring records for period to

3. Prior dose determined for individuals likely to receive doses' [20.2104] [] Y []N

4. Maximum exposures TEDE Other

5. NRC Forms or equivalent [20.2104(d),2106(c)]

a. NRC-4 " Cumulative Occupational Exposure History" [] Y []N Complete: [.] Y []N

b. NRC-5 " Occupational Exposure Record for a Monitoring Period" [] Y []N Complete: [] Y []N

6. Worker declared her pregnancy in writing during inspection period (review records) [ ] Y. []N [ ] N/A If yes, determine compliance with [20.1208] [] Y []N check for records per [20.2106(e)] []Y [] N Draf) NUREG - 1556, Vol.12 K-10

APPENDIX K F. Records of exposures, surveys, monitoring and evaluations maintained [20.2102,2103,2106, L/C] []Y []N Remarks:

Auditor's Independent Measurements (if Made)

A. Survey instrument Serial No. Last calibration B. Auditor's measurements compared to licensee's []Y []N C. Describe the type, location, and results of measurements:

Notification and Reports [ ] N/A A. Licensee in compliance with [19.13,30.50](reports to individuals, public and occupational, monitored to show compliance with Part 20) []Y []N [ ] N/A B. Licensee in compliance with (20.2201,30.50] (theft or loss) [] Y []N [ ] None C. Licensee in compliance with [20.2202,30.50](incidents) [] Y []N [ ] None D. Licensee in compliance with [20.2203,30.50](overexposures and high radiation levels) [] Y []N [ ] None E. Licensee aware of telephone number for NRC Emergency i Operations Center [(301) 816-5100] []Y []N l I

F. Licensee in compliance with [21.21] (failure to comply or existence of a defect and its evaluation) []Y []N Posting and Labeling A. NRC-3 " Notice to Workers"is posted [19.11] [] Y []N B. Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures adopted pursuant to Part 21, and license documents are posted, or a notice indicating where documents can be j examined is posted [19.11,21.6] []Y []N C. Other posting and labeling per (20.1902,1904] and the license is i not exempted by [20.1903,1905] []Y []N ,

Remarks:

K-11 Draft NUREG - 1556, Vol.12

' APPENDIX K Recordkeeping for Decommissioning (if needed) [ ] N/A A. Records ofinformation important to the safe and effective l

decommissioning of the facility maintained in an independent and identifiable location until license termination []Y []N B. Records include all information outlined in [30.35(g)] [] Y []N Remarks:

Bulletins and information Notices A. Receipt of NRC Bulletins, NRC Information Notices, NMSS Newsletters, etc. [] Y []N B. Appropriate action taken in response to Bulletins,Information Notices, etc.. [] Y []N Remarks:

Special License Conditions or issues [ ] N/A A. Review special issue conditions or other issues, and describe findings: [] Y' [] N. [ ] N/A B. Problems / deficiencies identified at licensee facilities other than i at audit location: [] Y []N [ ] N/A !

C. Evaluation of compliance: [] Y []N Remarks:

)

Continuation of Report items [ ] N/A (If more space is needed, use separate sheets and attach to report.)

Problems'or Deficiencies Noted; Recommendations

' Note: Briefly state (1) the requirement and (2) how and when violated. ' Provide recommendations forimprovement.

Draft NUREG - 1556, Vol.12 K-12

APPENDIX K Evaluation of Other Factors A. Senior licensee management is appropriately involved with the radiation safety program and/or Radiation Safety Officer (RSO) '

oversight [] Y []N B. RSO has sufficient time to perform his/her radiation safety duties and is not too busy with other assignments [] Y []N Ci Licencee has sufficient staff , [] Y []N Remarks / recommendations:

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l Appendix L Radiation Monitoring Instrument Specifications and Model Survey  !

Instrument and Air Sampler Calibration !

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APPENDIX L Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program The specifications in Table L.1 will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility (ies).

Table L.1 Typical Survey Instruments' (Instruments used to measure radiological conditions at licensed facilities.)

Portable Instruments Used for Contamination and Ambient Radiation Surveys Detectors Radiation Energy Range / Range Efficiency REM Meter Neutron mrem - rem Low Exposure Rate Gamma, pR-R N/A Meters X-ray Count Rate Meters Zine Sulfide

• Alpha All energies Moderate GM Beta All energies (dependent on window thickness) Moderate Gamma All energies <1%

Nal Scintillator Gamma All energies (dependent on crystal thickness) Moderate Gas Flow Alpha All energies Moderate Proportional Plastic Scintillator Beta C-14 or higher (dependent on window Moderate thickness)

Stationary Instruments Used to Measure Wipe, Bioassay, and Emuent Samples I)etectors Radiation Energy Range Efficiency LSC* Alpha All energies High Beta All energies High Gamma Low energy Moderate Gamma Counter Gamma All energies High (Nal)*

L-1 Draf+ NUREG - 1556, Vol.12 s

APPENDIX L Portable Instruments Used for Contamination and Ambient Radiation Surveys Detectors Radiation Energy Range / Range Efficiency Gas Proportional Alpha All energies High Beta All energies Moderate Gamma All energies <1%

' Table from The 18ealth Physics & Radiologicalliealth 11andbook, Revised Edition, Edited by Bernard Shleien, 1 1992 (except for

• items).

Model Instrument Calibration Program Training B.efore allowing an individual to perform survey instrument calibrations, the RSO will ensure that he or she has sufficient training and experience to perform independent survey instrument calibrations.

Classroom training may be in the form oflecture, videotape, or self-study and should cover the following subject areas:

. Principles and practices of radiation protection;

._ Radioactivity measurements, monitoring techniques, and using instruments;

. Mathematics and calculations basic to using and measuring radioactivity;

. Biological effects of radiation.

' Appropriate on-the-job-training consists of the.following:

Observing authorized personnel performing survey instrument calibration;

. Conducting survey meter calibrations under the supervision and in the physical presence of an individual authorized to perform calibrations.

Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments

. To reduce doses received by individuals not calibrating instruments, calibraticas should be conducted in an isolated area of the facility or at times when no one else is present.

Individuals conducting calibrations should wear assigned dosimetry.

Draft NUREG - 1556, Vol.12 . L-2

APPENDIX L l.

! . Individuals conducting calibrations should use a calibrated and operable survey instrument to ensure that unexpected changes in exposure rates are identified and corrected.

Model Procedure for Calibrating Survey Instruments A radioactive sealed source (s) used for calibrating survey instruments will:

. Approximate a' point source;

. Have its apparent source acti /ity or the exposure rate at a given distance traceable by documented measurements to a national standard (standard certified by National Institutes of Standards and Technology (NIST));

• Approximate the same energy and type of radiation as the environment in which the calibrated device will be employed;

• For dose rate and exposure rate instruments, the source should be strong enough to give an exposure rate of at least about 7.7 x 104 coulombs / kilogram / hour (30 mR/hr) at 100 cm (e.g.,3.1 gigabecquerels (85 mci) of cesium-137 or 7.8 x 102 megabecquerels (21 mci) of

. cobalt-60).

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I L-3 Draft NUREG - 1556, Vol.12

" APPENDIX L The three kinds of scales frequently used on dose or dose rate survey meters are calibrated as

' follows5:

. Linear readout instrunients with a single calibration control for all scales shall be adjusted at the point recommended by the manufacturer or at a point within the normal range of use.

Instruments with calibration controls for each scale shall be adjusted on each scale. After

' adjustment, the response of the instrument shall be checked at approximately 20% and 80% of full scale. The instrument's readings shall be within 15% of the conventionally true values for the lower point and 10% for the upper point.

Logarithmic readout instruments, which commonly have a single readout scale spanning several decades, normally have two or more adjustments. The instrument shall be adjusted for each scale according to site specifications or the manufacturer's specifications. After adjustment, calibration shall be checked at a minimum of one point on each decade.

Instrument readings shall have a maximum deviation from the conventionally true value of no more than 10% of the full decade value.

• Meters with a digital display device shall be calibrated the same as meters with a linear scale.

. Readings above 2.58 X 10d coulomb / kilogram / hour (1 R/hr) need not be calibrated, but such scales should be checked for operation and response to radiation.

. The inverse square and radioactive decay law should be used to correct changes in exposure rate due to changes in distance or source decay.

Surface Contamination Measurement instruments 8

. Survey meters' efficiency must be determined by using radiation sources with similar energies

- and types of radiation that the survey instrument will be used to measure.

. If each scale has a calibration potentiometer, the reading shall be adjusted to read the conventionally true value at approximately 80% of full scale, and the reading at approximately 20% of full scale shall be observed. If only one calibration potentiometer is available, the reading shall be adjusted at mid-scale on one of the scales, and readings on the other .ccales shall be observed. Readings shall be within 20% of the conventionally true value.

8 ANSI N323A-1997 " Radiation Protection Instrumentation Test and Calibration."-

. Draft NUREG 11556, Vol.12 _L-4

APPENDIX L l i

Model Procedures for Calibrating,' Liquid Scintillation Counters, Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers A radioactive scaled source used for calibrating instruments will do the following:

• Approximate the geometry of the samples to be analyzed;

= Have its apparent source activity or the exposure rate at a given distance traceable by documented measurements to a national standard (standard certified by National Institutes of Standa-ds and Technology (NIST));

Approximate the same energy and type of radiation as the samples that the calibrated device will be used to measure.

Calibration Calibration must produce readings within 20% of the actual values over the range of the instrument.

. Calibration ofliquid scintillation counters will include quench correction.

Calibration Records Calibration records, for all survey instruments, should indicate the procedure used and the data obtained. The description of the calibration should include:

• The owner or user of the instrument;

• A description of the instrument, including the manufacturer's name, model number, serial number, and type of detector;

• A description of the calibration source, including the exposure rate at a specified distance or activity on a specified date;

. For each calibration point, the calculated exposure rate or count rate, the indicated exposure rate or count rate, the deduced correction factor (the calculated exposure rate or count rate divided by the indicated exposure rate or count rate), and the scale selected on the instrument; j

. For instruments with external detectors, the angle between the radiation flux field and the f detector (i.e., parallel or perpendicular);

• For instruments with internal detectors, the angle between radiation flux field and a specified surface of the instrument; ,

i L-5 Draft NUREG - 1556, Vol.12

APPENDIX L

. For detectors with removable shielding, an indication whether the shielding was in place or removed during the calibration procedure;

. The exposure rate or count rate from a check source, if used;

. The name of the person who performed the calibration and the date it was performed.

The following information should be attached to the instrument as a calibration sticker or tag:

. For exposure rate meters, the source isotope used to calibrate the instrument (with correction

{

factors) for each scale:

The efficiency of the instrument, for each isotope the instrument will be used to measure (if efficiency is not calculated before each use); i For each scale or decade not calibrated, an indication that the scale or decade was checked t only for function but not calibrated; I The date of calibration and the next calibration due date;

• The apparent exposure rate or count rate from the check source, if used.

Air Sampler Calibration In order to assess accurately the air concentration of radioactive materials in a given location, the volume of air sampled and the quantity of contaminant in the sample must be determined.

Accurate determination of the volume of air sampled requires standard, reproducible, and periodic calibration of the air metering devices that are used with air sampling instruments.

The publication entitled Air Samnline Instruments. 7th Edition, American Conference of Governmental Industrial ifygienists,1989, provides guidance on total air sample volume calibration methods acceptable to NRC staff, as supplemented below.

Frequency of Calibration

. A licensee committed to a routine or emergency air sampling program should perform an acceptable calibration of all airflow or volume metering devices at least annually (see Regulatory Guide 8.25).

Special calibrations should be performed at any time there is reason to believe that the operating characteristics of a metering device have been changed, by repair or alteration, or whenever system performance is observed to have changed significantly.

Routine instrument maintenance should be performed as recommended by the manufacturer.

Draft NUREG - 1556, Vol.12 L-6

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! APPENDIX L

. Primary or secondary standard instruments used to calibrate air sampling instrumems should be inspected frequently, for consistency of performance.

Error Limit For Measurement of Air Sample Volume l

Most methods of calibrating airflow or air volume metering devices require direct comparison to j i

a primary or secondary standard instrument, to determine a calibration curve or a correction factor. An example of a primary standard is a spirometer that measures total air volume directly -

with high precision by liquid displacement. An example of a secondary standard is a wet-test meter that has been calibrated against a primary standard Primary standards are usually accurate to within

• 1% and secondary standards to within

• 2%.

The following are signincant errors associated with determining the total air volume sampled:

- Ec: The error in determining the calibration factor. (An acceptable estimate is the percentage error associated with the standard instrument used in the calibration.)4 E:3 Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage equivalent of one-half of the smallest scale division, compared to the scale reading.)

E,: The percentage error in measurement of sampling time that should be kept within 1%.

Ev: The most probable value of the cumulative percentage error in the detennination of the l l

total air volume sampled.

l Ev: can be calculated from the following equation, provided there are no additional significant sources of errors:

I Ev = [Es2+'Ec2 + E,272 The most probable value of the cumulative error Ev, in the determination of total volume, should be less than 20%.'

A sample calculation of the most probable value of the cumulative error in total volume measured is as follows: If accuracies of the scale reading, the calibration factor, and sample time

• The calibration factor should be based on two kinds of determinations. First, correction factors should be determined at several flow rates distributed over the full-scale range. Each flow rate co:Tection factor should be determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of data should % compared. Second, subsequent calibrations should compare the new correction factors to those determined during the previous calibration. if observed differences ere significant compared to the overall volume error limit of 20%, an additional error term should be included in the calculation above.

L-7 Draft NUREG - 1556, Vol.12

APPENDIX L are

• 4,2, and 1%, respectively, and there are no other significant sources of error, the cumulative error would be:

Ev = [42 + 22 + 123v2 = 4.58% or approx. 5%

If there are significant differences in pressure and temperature between the calibration site and the sampling site, appropriate corrections should be made using the ideal gas laws provided below:

Vs = VI * (Pl/760) * (273/Tl) where Vs = volume at standard conditions (760 mm & 0 C)

VI = volume measured at conditions P1 and Tl T1 = temperature of VI in *K t P1 = pressure of VI in mm Hg Documentation of Calibration of Air Metering Devices The licensee should maintain records of all routine and special calibrations of airflow or volume metering devices, including the primary or secondary standard used, method employed, and estimates of accuracy of the calibrated metering devices. All instruments should be clearly labeled as to the date and results of the most recent calibration and should include the appropriate correction factors to be used.

References:

See the Notice of Availability on the inside front cover of this draft report to obtain a copy 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.

. Regulatory Guide 8.25, Revision 1, " Air Sampling in the Workplace," dated June 1992.

. FUREG-1400, " Air Sampling in the Workplace," dated September 1993.

Additional

References:

. The Health Physics & Radiological Health Handbook, Revised Edition, Edited by Bernard Shleien, dated 1992.

ANSI N323A-1997," Radiation Protection Instrumentation Test and Calibration." Copies may be obtained from the American National Standards Institute,1430 Broadway, New York.

NY 10018 or ordered electronically at the following address: <http://www. ansi.org>.  !

Draft NUREG - 1556, Vol.12 L-8 1

APPENDIX L

= . Air Samoline Instruments for Evaluation of Atmosohere Contaminant. 7th Edition, Cincinnati: American Conference of Governmental Industrial Hygienists,1989.

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L-9 Draft NUREG - 1556, Vol.12

i Appendix M Material Receipt and Accountability h-

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APPENDIX M l

l Material Receipt and Accountability '

Sample Model Procedure for Ordering and Receiving Radioactive Material

. The RSO should approve or place all orders for radioactive material and should ensure that the requested material, quantities, manufacturer, and model are authorized by the license and that the possession limits are not exceeded.

• During normal working hours, carriers should be instructed to deliver radioactive packages directly to the Radiation Safety Office (or designated receiving area).

• During off-duty hours, security or other designated trained personnel should accept delivery of radioactive packages in accordance with the procedure outlined in the sample memorandum below:

Sample Memorandum

- Memorandum for Security Personnel From RSO, President, Vice President, etc.

Subject:

Procedures for Receipt of Packages Containing Radioactive Material If the package appears to be damaged, immediately contact the RSv. Ask the carrier to remain at j the facility until it can be determined that neither the carrier nor the vehicle is contaminated..

Any packages containing radioactive material that arrive between (state times, e.g.,4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) shall be signed for by the security guard (or other l designated trained individual) on duty and taken immediately to the designated receiving area. i Security personnel (or other designated trained individual) should unlock the door, place the package in the designated secured storage area and re-lock the door.

Radiation Safety Officer (RSO):

Office Phone:

Home Phone:

M1 Draft NUREG - 1556, Vol.12

- APPENDIX M Sample Instructinns to Personnel involved in Material Receipt

- Shipping and Receiving Personnel During normal working hours, immediately upon receipt of any package oflicensed material, each package must be visually inspected for any signs of shipping damage such as crushed or punctured containers or signs of dampness. Any obvious damage must be reported to the RSO immediately. Do not touch any package suspected ofleaking. Request the person delivering the package to remain until monitored by the RSO.

Outside of normal workirg hours (e.g., nights, weekends, and holidays), deliveries will usually be handled by security personnel (or other trained individuals) as described in the above procedures. Since certain packages oflicensed material will have detectable external radiation, they should be sent immediately to a designated storage area, where they will be checked for contamination and external radiation level as soon as practical. They should not be allowed to remain in the receiving area any longer than necessary, as they may be a source of exposure for receiving personnel.

If the instructions are not clear, or if there are questions regarding receiving packages containing !

radioactive material, please contact:

Name Phone For additional information on worker training, see the section entitled Training for Individuals Working In or Frequenting Restricted Areas.

Sample' Model Procedure for Safely Opening Packages Containing Licensed Materials For packages received under the specific license, authorized individuals shall implement procedures for opening each package, as follows:

. Wear gloves to prevent hand contamination.

. Visually inspect the package for any sign of damage (e.g. crushed, punctured). If damage is noted, stop and notify the RSO.

Check DOT White I, Yellow II, or Yellow III label or packing slip for activity of contents, to ensure that the shipment does not exceed license possession limits.

DraR NUREG - 1556, Vol.12 M-2 i

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l APPENDIX M

= Monitor the external surfaces of a labeled package according to specifications in Table 8.4, Section 13.14, Item 10.

. Open the outer package (following supplier's directions, if provided) and remove packing slip.

Open inner package to verify contents (compare requisition, packing slip and label on the l bottle or other container). Check integrity of the final source container (e.g., inspecting for l breakage of seals or vials, loss ofliquid, discoloration of packaging material, high count rate on smear). Again check that the shipment does not exceed license possession limits. If you find anything other than expected, stop and notify the RSO.

. Survey the packing material and packages for contamination before discarding. If contamination is found, treat as radioactive waste. If no contamination is found, obliterate the radiation labels prior to discarding in the regular trash.

• Maintain records of receipt, package survey, and wipe test results.

. Notify the final carrier and by telephone, telegram, mailgram, or facsimile, the Administrator of the appropriate NRC Regional Office listed in 10 CFR 20, Appendix D when removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i); or external radiation levels exceed the limits of 10 CFR 71.47.

Sample Transfer Policy Statements Internal Transfers Licensed materials that may be transferred from one department or laboratory or AU's control to anothei should have prior approval from the RSO. A written transfer procedure should be developed by the RSO to ensure that transfers are done in accordance with the conditions of the license. All transfers shall be done in a way that minimizes the probability of spillage or breakage. Double containers should be used, including suitable shielding, for such transfers.

External Transfers Licensed material shall not be transferred or shipped from one institution to another without the approval of the RSO. Such transfers / shipments must be packaged and labeled in accordance with DOT, NRC, or U.S. Postal Service Regulations, whichever is applicable.

Gifts On occasion, licensees may be offered or have donated licensed materials by other individuals as gifts (e.g., a retiring medical practitioner donating his cesium needles to the university medical center). All such gifts of radioactive materials must be transferred to the licensee and handled in accordance ,ith NRC requirements and the conditions of the license, in any case, the RSO

'should approve the gift prior to the transfer.

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Appendix N Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits

APPENDIX N Guidance for Demonstrating that Unmonitored Individuals are Not Likely to Exceed 10 Percent of the Allowable Limits Dosimetry is required for individuals likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the applicable regulatory limits in 10 CFR 20.1201. To demonstrate that dosimetry is not required, a licensee needs to perform a prospective evaluation to demonstrate that its workers are not likely to exceed 10% of the applicable annual limits.

The most common way that individuals might exceed 10% of the applicable limits is through involvement in the processing of sealed sources and/or unsealed material (e.g., assembly lines, manufacturing processes and quality control activities). This could include internal radioactive uptake, as well as external radiation exposure. However, for many processes even these activities result in the individual receiving minimal doses. Before allowing workers to perform these tasks, a licensee will need to evaluate the doses that its workers might receive to assess whether dosimetry is required; this is a prospective evaluation.

Example One gauge manufacturer has estimated the doses to the extremities and whole body of a person replacing the assay plate on one ofits series of gauges. Each gauge in the series is authorized to contain up to 7.4 gigabecquerels (200 millicuries) of Cs-137. The manufacturer based its estimate on observations ofindividuals performing the recommended procedure according to accepted radiation safety practices. The manufacturer had the following types ofinformation:

. Time needed to perform the entire procedure (e.g.,15 minutes)

. Lxpected dose rate received by the whole body of the individual, associated with the shielded source and determined using measured or manufacturer-determined data (e.g.,0.02 mSv/hr

[2 mrem /hr] at 46 cm [18.1 in] from the shield)

. Time the hands were exposed to the shielded source (e.g.,6 min)

. Expected dose rate received by the extremities of the individual, associated with the shielded source and determined using measured or manufacturer-determined data on contact with the shield (e.g.,0.15 mSv/hr [15 mrem /hr])

From this information, the manufacturer estimated that the individual performing each routine cleaning and lubrication could receive the following:

. Less than 0.005 mSv [0.5 mrem] TEDE (whole body); and

. u.ol5 mSv [1.5 mrem] to the hands.

I N-1 Draft NUREG - 1556, Vol.12 I

I APPENDIX N The applicable TEDE (whole body) limit is 50 mSv (5 rem) per year and 10% of that value is 5 mSv (500 millirem) per year. If one of these procedures delivers 0.005 mSv (0.5 mrem), then an individual could perform 1,000 of these procedures each year and remain within 10% of the applicable limit.

The applicable shallow-dose equivalent (SDE) (extremities) is 50u mSv (50 rem) per year, and 10% of that value is 50 mSv (5 rem or 5000 millirem) per year. If one of these procedures delivers 0.015 mSv (1.5 mrem), then an individual could perform 3,333 of these procedures each year and remain within 10% of the applicable limit.

Based on the above specific situation, no dosimetry is required if a worker performs fewer than 1,000 routine procedures per year.

Guidance to Licensees Licensees who wish to demonstrate that they are not required to provide dosimetry to their workers need to perform prospective evaluations similar to that shown in the example above.

The expected dose rates, times, and distances used in the above example may not be appropriate to all licensees. In their evaluations, licensees need to use information appropriate to the type (s) of processes they intend to use.

- Table N-1 may be helpful in performing a prospective evaluation. This example demonstrates the dosimetry evaluation method for the processing of a sealed source gauge.

Licensees should review evaluations periodically and revise them as needed. Licensees should check assumptions used in their evaluations to ensure that they continue to be up-to-date and accurate. For example, if workers become lax in following good radiation safety practices, perform the task more slowly than estimated, work wkn new gauges containing sources of different activities or radionuclides, or use modified procedures, the licensee would need to conduct a new evaluation.

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APPENDIX N l . .

. Table N.1 Dosimetry Evaluation Dosimetry Evaluation for Model Gauge A. Time needed to perform the entire routine processing minutes /60 hour

! procedure.

B. Expected whole body dose rate, determined using mrem /hr -

measured or manufacturer-provided data, which the individual will encounter while performing the routine 4 processing procedure.

!. C. Time the hands were exposed to the shielded source. minutes /60 hour D. Expected extremity dose rate received by the individual, mrem /hr determined using measured or manufacturer-provided l data for the shielded source at the typical distance from the hands to the shielded source.

! Formula: ( # hours in Row A) x ( mrem /hr in Row B) = ( mrem per routine procedure) x

l. ( # of routine processing procedures each year) = mrem

• Whole Body Dose Formula: ( # hours in Row C) x ( mrem /hr in Row D) = ( mrem per routine procedure) x

( # of routine processing procedures each year) = mrem ** Extremity Dose

- * . Espected Whole Body Doses less than 500 mrem requires no dosimetry j- ** Expected Extremity Doses Itss then 5000 mrem requires no dosimetry I

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Appendix O Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits l

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c APPENDlX O Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits This appendix describes methods for determining radiation doses to members of the public.

Licensees must ensure that:

. The radiation dose received by individual members of the public does not exceed 1 millisievert (mSv) (0.1 rem) in one calendar year resulting from the licensee's possession and/or use oflicensed materials.

. The radiation dose in unrestricted areas does not exceed 0.02 mSv (2 mrem) in any one hour.

Members of the public include persons who live, work, study, or may be near locations where licensed material is used or stored and employees whose assigned duties do not include the use oflicensed rnaterial but may work in the vicinity where such materials are used or stored.

Doses to Members of the Public INCLUDES doses from: DOES NOT INCLUDE doses from:

• Radiation and/or radioactive material . Sanitary sewerage discharges from licensees; released by a licensee;

• Natural background radiation; i

. Sources of radiation under the control of a . Medical administration of radioactive licensee; material; a Air effluents from sources oflicensed . Voluntary participation in medical research.

radioactive materials.

l Typical unrestricted areas may include offices, shops, laboratories (where licensed material is not used or stored), areas outside buildings, property, and storage areas. The licensee does not control access to these areas for purposes of controlling exposure to radiation or radioactive  ;

materials, but the licensee may control access to these areas for other reasons, such as security.

Simple Method The licensee may use any acceptable method from either 10 CFR 20.1302(b)(1) or 10 CFR 20.1302(b)(2) for determining compliance with the annual dose limits in 10 CFR 20.1301. The method described in 10 CFR 20.1302(b)(2) limits the worst-case dose to 1 mSv (0.1 rem). Under this method, the maximum concentration of radionuclides permitted at the unrestricted area boundary would result in a dose to an individual of 0.5 mSv (0.05 rem), and the dose from external radiation to an individual who is always present to receive the dose would 0-1 Draft NUREG - 1556, Vol.12

APPENDIX 0 l l

be 0.5 mSv (0.05 rem). This method provides licensees with an easy way to demonstrate compliance without considering occupancy factors or summing ofinternal and extemal doses.

Calculation Methods The licensee may also show compliance with 10 CFR 20.1301 by using the method described in 10 CFR 20.1302(b)(1). This method allows the licensee to take into account the length of time an individual is receiving the dose from external sources and the concentration of radionuclides l J

in gaseous and liquid releases at the location of the individual. In practice, the licensee may wish to make conservative assumptions to simplify the dose calculation. For example, if the actual {

dose to an individual from external sources plus the maximum possible dose from gaseous and liquid releases is below the public dose limit, the licensee may chose to use this " theoretical" value rather than try to evaluate the exact concentration of radionuclides at the individual's location. If the former calculation is over the limit, the licensee can show compliance by performing the more dimcult calculation. If appropriate, the licensee also has the option, with prior NRC approval, of adjusting the dose to take into account the physical and chemical characteristics ofits emuent.

Because the dose limit applies to an individual who is likely to receive the highest dose from the licensed operation,' dose calculations need to take into account the worst-case scenario in which an individual would be located at the areas of greatest internal and external exposures. The calculation could use an occupancy factor of 1, which means the individual was continuously present 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day,365 days a year. If this result shows that the limit is not exceeded, then there is no need for further calculations. If the limit iz exceeded with an occupancy factor of 1, then realistic assumptions of how many hours in a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> day an individual would be present at the points of highest internal and external exposures would have to be made. To obtain the occupancy factor, the licensee would take the number of hours of predicted occupancy in a day and divide it by 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, e.g.,8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> ofpredicted occupancy divided by 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> would give an occupancy factor of 8/24 or 1/3. Some licensees will require in-depth reviews of their use of radioactive material to obtain appropriate assumptions for the external (and internal) dose rates and occupancy factors.

-Survey and Monitoring Emuent monitoring programs are designed to assess dose rates or concentrations of radionuclides released. Dose rates vary, depending upon the nature of the source and its condition.. It may be necessary to provide continuously operating dose-rate meters, or if the source is predictable,it may be adequate to integrate dose rates over periods of time. The mode of discharge'of airborne and waterborne emuents will vary from facility to facility. Airborne emuents are most frequently discharged continuously during operations, but the operation itself may be discontinuous, whereas liquid emuents may be discharged continuously or may be stored and subsequently discharged on a batch basis. For each type of source and for each route of -

Draft NUREG - 1556, Vol 12 0-2

l l

l APPENDlX O potential exposure, consider the location of measurement points, whether continuous monitoring is required, the frequency of sampling and measurement, and any additional information. For discharges of radionuclides, for example, it may be necessary to obtain information on chemical form, concentration, and flow-rate of the discharge as well as meteorological and hydrological data and other information relating to the receiving environment.

Records 10 CFR 20.2107 requires that the licensee maintain records sufficient to demonstrate compliance with the dose limit for individual menbers of the public, until the Commission terminates the license. Each licensed operation is ditrerent, so the records must be appropriate to each operation. In general, survey and monitoring records of radiation and airborne or waterborne radioactivity should be adequate.

Records of radiation survey results should include a unique identification ofinstruments used in the survey, name of the surveyors, location and date of survey, reason for the survey, and survey ,

results. Unique identification of the survey instrument allows it to . * ._ :ts calibration and maintenance records. Radiation survey records should also include a description or drawing of the area surveyed, administrative action levels for controlling exposures and evaluations of the impact of measured radiation levels, and documentation of any corrective action taken.

Radioactive material release records should contain adequate information to allow reasonable off-site dose assessments to be made in the future. In addition, records should include  !

information on quantities of specific radionuclides and the estimated uncertainty in activity release values, if known.

Radioactivity releases may be determined by effluent monitors or by efnuent sampling and subsequent laboratory analysis. For those facilities that use sampling as the primary quanti 6 cation method, appropriate records for laboratory counting systems should be kept (e.g., calibration, minimum detectable activity determinations, chi square, resolution, etc.).

Information contained in dose assessment records should include the following (if applicable):

. Type and energy of radiation involved;

• Physical, chemical and isotopic description of the radioactive material, i.e., gaseous, liquid or particulate, the chemical compound and particle size distribution, if known;

. Total activity released and the method of determination;

• Time and date of the start and end of the release;

• Dilution volume of the effluent stream;

. Identification of the release point, i.e., roof vent, facility stack, drain to the sewer system, etc.;

O-3 Draft NUREG - 1556, Vol.12 l

APPENDIX O

=

Location, identification, and function of the facility surveyed; Time and date of surveys;

. Location at which measurements were made, or where liquid and air samples were obtained, either by. written description or by sketches;

. Methods and instruments used in measurements, i.e., the method of obtaining the air or water samples;

. Results of the measurements, with the quantities and in the units in which they were obtained (e.g., Sv/h, mSv, R/h, mrem /h, or count / min);

• Dose or activity calculations, including occupancy factors and the assumptions made;

• Statement of conclusions from the survey and whether the findings are in compliance with the regulations;

• Recommendations regarding remedial actions and re-survey;

• Name of the persons performing surveys.

Constraint on Releases of Airborne Radioactive Materials to the Environment In 10 CFR Part 20 " Standards for Protection Against Radiation," 10 CFR 20.1302(b) requires that:

A licensee shall show compliance with the annual dose limit in 10 CFR 20.1301 by:

(1) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose froin the licensed operation does not exceed the annual dose limit; or (2) Demonstrating that (i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table 2 of Appendix B to Part 20; and (ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.

In addition,10 CFR 20.1101(d) requires that.

3 To implement the ALARA [as low as is reasonably achievable] requirements of 10 CFR 20.1101(b), and notwithstanding the requirements in 10 CFR 20.1301, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, l shall be established by licensees other than those subject to 10 CFR 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive j a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. 1 If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the Draft NUREG - 1556, Vol.12 O-4

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! APPENDlX O exceedance as provided in 10 CFR 20.2203 and promptly take appropriate corrective action to ensure against recurrence.

For further information regarding guidance on compliance with the Constraint Rule, refer to Regulatory Guide 4.20, Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors, issued December 1996.

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O.5 Draft NUREG - 1556, Vol.12

Appendix P General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures

APPENDIX P General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures This Appendix describes general topics for safe possession and use of radioactive materials, and procedures for handling and reporting emergencies.

General Topics for Safe Possession and Use of Radioactive Materials ,

Each area where radioactive material is used or stored should have general rules, so that workers know what is required. Typical instructions should include:

. Wear a laboratory coat or other protective clothing at all times in areas where licensed materials are used.

. Wear disposable gloves at all times when handling licensed materials.

. After each procedure or before leaving the area, monitor hands, shoes, and clothing for ccas. : tation in a low-background area.

• Do not eat, drink, smoke, or apply cosmetics in any area where licensed material is stored or used.

. Do not store food, drink, or personal effects in areas where licensed material is stored or used (see Figure P.1).

. Wear personnel monitoring devices, if required, at all times while in areas where licensed materials are used or stored.

. Dispose of radioactive waste only in designated, labeled, and properly shielded receptacles.

. Never pipette by mouth.

. Store radioactive solutions in clearly labeled containers.

. Secure all licensed material when it is not under the constant surveillance and immediate control of the user (s).

I P-1 Draft NUREG - 1556, Vol.12

APPENDIX P Food / Drink Storage 4,4 is Prohibited 4

4

~$$

Figure P.1 Storage oi Food and Drink. Food or drink shall not be stored in r frigerators with radioisotopes.

Radionuclide-specific Procedures '

Licensees should develop written procedures for use of different radionuclides so that users know the types of shielding, protective clothing, survey instruments, surveys, and decontamination activities that are required. Examples of such procedures are included below.

Example 1:

If requesting more than 37 MBq (1 mci) ofiodine-125 or iodine-131, special safety instructions should be provided to users, including the following:

A mandatory radiation survey and wipe test for radioactive contamination after each use; Bioassay procedures for individuals working with millicurie quantities of radioiodine; The use of vented hoods for iodination and for the storage of millicurie quantities of radioiodine; A dry run prior to the performance of unfamiliar procedures, in order to preclude unexpected complications. In addition, it is recommended that the RSO be present during new procedures;

• Procedures for measuring the concentration of radioiodine effluents from the hoods.

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Draft NUREG - 1556, Vol.12 P-2 1

1 i

APPENDIX P Example 2:

If requesting more than 37 MBq (1 mci) of phosphorus-32, special safety instructions should be provided to users, including the following:

. The use oflow-density plastic shielding in order to keep bremsstrahlung radiation to a minimum;

• A mandatory radiation survey and wipe test for radioactive contamination after each use;

. The use of extremity monitors for procedures that involve one millicurie or more;

• A dry run prior to the performance of unfamiliar procedures in order to preclude unexpected complications. In addition, it is recommended that the RSO be present during new ,

i procedures;

. The use of eye protection for procedures that involve 10 millicuries or more.

I Model Procedure.s for Handling Emergencies 1 General Safety Procedures to Handle Spills

. Name and telephone number of RSO or an alternate person (s) should be posted conspicuously in areas of use, so that it is readily available to workers in case of emergencies. Licensee should have emergency equipment readily available for handling spills. Spill kits should include the following:

- Disposable gloves;

- Housekeeping gloves;

- Disposable lab coats;

-_ Disposable head coverings;

- Disposable shoe covers;

- Roll of absorbent paper with plastic backing; .

- Masking tape;

- Plastic trash bags with twist ties;

- " Radioactive Material" labeling tape;

- Marking pen;

- Pre-strung " Radioactive Material" labeling tags;

- Box of Wipes;

- Instructions for " Emergency Procedures;"

P-3 Draft NUREG - 1556, Vol.12

APPENDIX P

- Clipboard with a copy of the Radioactive Spill Report Form for the facility;

- Pencil;

- Appropriate survey instruments including batteries (for survey meters).

Minor Spills of Liquids and Solids Instructions to Workers

- Notify persons in the area that a spill has occurred.

- Prevent the spread of contamination by covering the spill with absorbent paper. (Paper  ;

should be dampened if solids are spilled.)

- Clean up the' spill, wearing disposable gloves and using absorbent paper.

- Carefully fold the absorbent paper with the clean side out and place in a plastic bag for transfer to a radioactive waste container. Put contaminated gloves and any other contaminated disposable material in the bag.

- Survey the area with an appropriate low-range radiation detector survey meter or other appropriate technique. Check the area around the spill for contamination. Also check hands, clothing, and shoes for contamination.

- Report the incident to the Radiation Safety Officer (RSO) promptly.

- Allow no one to return to work in the area unless approved by the RSO.

- Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of requested bioassay samples).

- Follow the instructions of the RSO/RSO staff (e.g., decontamination techniqu ;, surveys, provision of bioassay samples, requested documentation).

1 Reminders to RSO

- Follow up on the decontamination ' activities and document the results.

- As appropriate, determine cause and corrective actions needed; consider bioassays if licensed material may have been ingested. l

- If necessary, notify NRC.

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Draft NUREG - 1556, Vol.12 P l

l APPENDIX P 1 Major Spills of Liquids and Solids

• Instructions to Workers

- Clear the area. If appropriate, survey all persons not involved in the spill and vacate the room.

- Prevent the spread of contamination by covering the spill with absorbent paper (paper should be dampened if solids are spilled), but do not attempt to clean it up. To prevent the spread of contamination, limit the movement of all personnel who may be contaminated.

- Shield the source only ifit can be done without further contamination or significant increase in radiation exposure.

- Close the room and lock or otherwise secure the area to prevent entry. Post the room with a sign to warn anyone tryir.g to enter that a spill of radioactive material has occurred.

- Notify the RSO immediately.

- Survey all personnel who could possibly have been contaminated. Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with l lukewarm water and then washing with a mild soap. l

- Allow no one to return to work in the area unless approved by the RSO. f

- Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of requested i bioassay samples). l

- Follo.v the instructions of the RSO/RSO staff (e.g., decontamination techniques, surveys,  !

provision of bioassay samples, requested documentation).

• Reminders to RSO

- Confirm decontamination of personnel. If de:ontamination of personnel was not fully succestful, consider inducing perspiration by covering the area with plastic. Then wash the affected area again to remove any contamination that was released by the perspiration.

- Supervise decontamination activities and document the results. Documentation should include location of surveys and decontamination results.

- Determine cause and needed corrective actions; consider need for bioassays iflicensed material may have been ingested.

- If necessary, notify NRC.

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1 I

APPENDlX P Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases Instructions to Workers

- Notify all personnel to vacate the room immediately.

- Shut down ventilation system, if possible.

- Vacate the room. Seal the area, if possible.

- Notify the RS: immediately.

- Ensure that all access doors to the area are closed and posted with radiation warning signs, or post guards (trained) at all access doors to prevent accidental opening of the doors or entry to the area.

- Survey all persons who could have possibly been contaminated. Decontaminate as directed by the RSO.

- Promptly report suspected inhalation and ingestion oflicensed material to the RSO.

- Decontaminate the area only when advised and/or supervised by the RSO.

- Allow no one to return to work in the area unless approved by the RSO.

- Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of requested bioassay samples).

- Follow the instructions of the RSO/RSO staff (e.g., decontamination techniques, surveys, provision and collection of bioassay samples, requested documentation).

Reminders to RSO

- Supervise decontamination activities.

- Perform air sample surveys in the area before permitting resumption of work with licensed materials.

- Provide written directions to potentially contaminated individuals about providing and collecting urine, breath, blood, or fecal samples, etc.

- Consider need for medical exam and/or whole body count before permitting involved individuals to return to work with licensed material.

- Determine cause and corrective actions needed; consider need for bioassays iflicensed material may have been ingested. Document incident.

- If necessary, notify NRC.

Draft NUREG - 1556, Vol.12 P-6

I l

APPENDIX P I

Minor Fires j

- Instructions to Workers

- Immediately attempt to put out the fire by approved methods (i.e., fire extinguisher) if other fire hazards or radiation hazards are not present.

- Notify all persons present to vacate the area and have one individual immediately call the )

RSO and fire department (as instructed by RSO).

- Once the fire is out, isolate the area to prevent the spread of possible contamination.

- Survey all persons involved in combating the fire for possible contamination.

- Decontaminate personnel by removing contaminated clothing and flushing contaminated skin with lukewarm water, then washing with a mild soap.  !

- In consultation with the RSO, determine a plan of decontamination and the types of protective devices and survey equipment that will be necessary to decontaminate the area.

- Allow no one to return to work in the area unless approved by the RSO.

- Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of requested bioassay samples).

- Follow the instructions of the RSO/RSO staff (e.g., decontamination techniques, surveys, provision of bioassay samples, requested documentation).

. Reminders to RSO

- Supervise decontamination activities.

- If decontamination of personnel was not fully successful, consider inducing perspiration by covering the area with plastic. Then wash the affbeted area again to remove any contamination that was released by the perspiration.

- Consult with fire safety officials to assure that there are no other possibilities of another fire starting.

- Determine cause and needed corrective actions; consider need for bioassays iflicensed material may h.c e been ingested. Document incident.

- If necessary, notify NRC.

Fires, Explosions, or Major Emergencies I

• Instructions to Workers

- Notify all persons in the area to leave immediately.

I P-7 Draft NUREG - 1556, Vol.12 i

i

APPENDIX P

- Notify the fire department.

- Notify the RSO and other facility safety personnel.

- Upon arrival of firefighters, inform them where radioactive materials are stored or where radioisotopes were being used; inform them of the present location of the licensed material and the best possible entrance route to the radiation area, as well as any precautions to avoid exposure or risk of creating radioactive contamination by use of high pressure water, etc.

- Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of requested bioassay samples).

- Allow no one to return to work in the area unless approved by the RSO.

- Follow the instructions of the RSO/RSO staff (e.g., decontamination techniques, surveys, provision of bioassay samples, requested documentation).

. Reminders to RSO

- Coordinate activities with facility's industrial hygienist or environmental health and safety office, and with local fire department.

- Consult with the firefighting personnel and set up a controlled area where the firefighters can be surveyed for contamination of their protective clothing and equipment after the fire is extinguished.

- Once the fire is extinguished, do not allow the firefighters to enter the radiation area until a thorough evaluation and survey are performed to determine the extent of the damage to the licensed material use and storage areas.

{

- Perform thorough contamination surveys of the firefighters and th:ir equipment before they leave the controlled area and decontaminate, if necessary.

- Supervise decontamination activities. l

- Consider bioassays iflicensed material may have been ingested. Document incident.

- Notify NRC. l Copies of emergency procedures should be provided to all users. Post a current copy in each laboratory or other area where radioactive material is used.

Draft NUREG - 1556, Vol.12 P-8

l Appendix Q Notification Requirements l

APPENDIX Q Notification Requirements This Appendix lists the specific notification requirements found in Title 10 of the Code of Federal Regulations.

10 CFR 19.11 Instructions to workers (posting of specified notices of violation), NRC Form 3 10 CFR 19.13 Notifications to individuals concerning radiation exposure results, during and at termination of employment, resulting from 10 CFR Part 20 notifications 10 CFR 20.2201 Reports of theft or loss oflicensed material, immediate and 30-day telephone, follow-up written 10 CFR 20.2202 Notification ofincidents, immediate and 24-hour to NRC Operations Center and Regional Office 1

10 CFR 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits 10 CFR 20.2204 Reports.of planned special exposures 10 CFR 20.2205 Reports to individuals exceeding dose limits 10 CFR 20.2206 Reports ofindividual monitoring 10 CFR 21.6 Reporting of defects and noncompliance, posting notifications to workers 10 CFR 21.21 Notification of failure to comply or existence of a defect and its evaluation 10 CFR 30.34(f) Notification of changes to an emergency plan 10 CFR 30.34(h) Notification of bankruptcy 10 CFR 30.36(d) Expiration and termination oflicenses and decommissioniag of sites and separate buildings or outdoor areas 10 CFR 30.50 Immediate and 24-hour reports 10 CFR 32.12 Reports to NRC for exempt concentration distribution Q-1 Draft NUREG - 1556, Vol.12

' APPENDIX Q 10 CFR'32.16 - ' Reports to NRC for distribution ofitems in 10 CFR 30.15 10 CFR 32.20 Reports to NRC for exempt quantity distribution 10 CFR 32.25 Reports to NRC for self-luminous product distribution 10 CFR 32.29 - Reports to NRC for gas and aerosol detectors distribution 10 CFR 32.52. ' Notices to the generallicensee 10 CFR 32.52 - Reports to NRC of generally licensed item distribution 10 CFR 32.56 Reports to NRC ofluminous safety devices for use in aircraft 10 CFR 40.41(f) . Reports to NRC of bankruptcy filing 10 CFR 40.42(d) - Notification of cessation of use of areas 10 CFR 40.60 - Immediate'and 24-hour notifications

' 10 CFR 40.64 Nuclear material transaction report 10 CFR 40.65 Effluent monitoring reports 10 CFR 40.66 Advance notice of export shipments of natural uranium 10 CFR 40.67 ' Advan'ce notice ofimportation of natural uranium i 10 CFR 70.38 ' Expiration and termination oflicenses 3

l'0 CFR 70.39 Specific licenses for manufacture or initial transfer of calibration or reference sources

- 10 CFR 70.50 . Reporting requirements, immediate and 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />' 10 CFR 70.52 Reports of accidental criticality or loss Draft NUREG - 1556, Vol.12 Q-2

3 l

Appendix R Radiation Safety Survey Topics 1

1

APPENDIX R i Radiation Safety Survey Topics j This Appendix provides applicants and licensees with additional information on surveys, including training requirements, survey frequency, contamination limits, and bioassays. j Training

]

' Before allowing an individual to perform surveys, the RSO will ensure that he or she has sufficient training and experience to perform surveys independently.

Academic training may be in the form oflecture, videotape, or self-study and will cover the following subject areas:

Principles and practices of radiation protection; Radioactivity measurements, monitoring techniques, and using instruments;

. Mathematics and calculations; i

. Using and measuring radioactivity;

. Biological effects of radiation.

Appropriate on-the-job-training consists of the following:

. Observing authorized personnel using survey equipment, collecting samples, and analyzing samples;

. Using survey equipment, co llecting samples, and analyzing samples under the supervision and in the physical presence of an individual authorized to perform surveys.

Facilities and Equipment

. To ensure achieving the required sensitivity of mersurements, survey samples will be analyzed in a low-background area.

. A gamma counter system with a single or multichannel analyzer can be used to count samples containing gamma-emitters (e.g., cesium-137, cobalt-60).

. A liquid scintillation or gas-flow proportional counting system can be used to count samples containing alpha-emitters,. beta-emitters, and gamma-emitters (if efficiency is great enough to achieve the required sensitivity for measurements).

R-1 Draft NUREG - 1556, Vol.12

APPENDIX R Ambient Radiation Level Surveys

. Dose-rate surveys, at a minimum, should be performed in locations where workers are exposed to radiation levels that might result in radiation doses in excess of 10% of the occupational dose limits or where an individual is orking in a dose rate of 0.025 mSv (2.5 mrem /hr) or more (50 mSv/ year div'ded by 2,000 hr/ year).

10 CFR 20.1301 requires that the total effective dose equivalent to an individual member of the public from the licensed operation does not exceed 1 mSv (0.1 rem) in a year and the dose in any unrestricted area from extemal sources does not exceed 0.02 mSv (2 mrem) in any one hour.

Contamination Surveys Licensees

• contamination surveys should be sufficient to identify areas of contamination that might result in doses to workers or to the public. Combined removable and fixed contamination should be surveyed using appropriate radiation detection equipment. Removable contamination ,

can be detected and measured through a wipe test of the surface, which is counted in an appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or germanium gamma counter, or a proportional alpha / beta vaunter.

Contamination surveys should be performed:

. To evalure radioactive contamination that could be present on surfaces of floors, walls, laboratory furniture, and equipment;

. After any spill or contamination event;

. When procedures or processes have changed; To evaluate contamination of users and the immediate work area, at the end of the day, when licensed materialis used; In unrestricted areas at frequencies consistent with the types and quantities of materials in use, but not less frequently than quarterly;

. In areas adjacent to restricted areas and in all areas through which licensed materials are transferre 1 and temporarily stored before shipment.

I Contamination Survey Frequency Personnel should survey for contamination in locations where individuals are working with an l unsealed form of radioactive material in an amount greater than or equal to 10% of the smallest annual limit on intake (ALI) (either the inhalation or ingestion ALI) listed for that radionuclide in Draft NUREG i556, Vol.12 R-2 I

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o APPENDIX R 10 CFR Part 20 Appendix B. These surveys should be done at a frequency appropriate to the types and quantities of radioactive materials in use, but at a minimum quarterly. If amounts are used that are greater than or equal to the smallest ALI listed for that radionuclide in 10 CFR Part 20, detailed, documented surveys should be performed at least monthly.

Table R.1 contains suggested contamination survey frequency from Regulatory Guide 8.23.

Table R.1 Suggested Frequency of Contamination Surveys from Regulatory Guide 8.23

, Areas Wher[ RAM lias Been Used Frequency Areas where > 7.4 MBq (200 uCi) is used at any one time Weekly Areas where < 7.4 MBq (200 Ci)is used at any one time Monthly Alternate Survey Frequency Please note that Tables R.2, R.3, and R.4 are appropriate for a manufacturer that has engineering controls in the manufacturing process. These tables are not intended for any other type of license.

Classification of Laboratories or Areas of Use Table R.2 Survey Frequency Category Group Low Medium High 1 < 370 kBq (10 Ci) 370 kBq (10 Ci) to 37 MBq > 37 MBq (1 mci) i (1 mci) 2 < 37 MBq (1 mci) 37 MBq (1 mci) to 3.7 GBq > 3.7 GBq (100 mci)

(100 mci) 3 < 3.7 GBq (100 mci) 3.7 GBq (100 mci) to 370 GBq 370 GBq (10 Ci) 4 (10 Ci) 4 < 370 GBq (10 Ci) 370 GBq (10 Ci) to 37 TBq > 37 TBq (1000 Ci)

(1000 Ci) _

Proportional fractions are to be used for more than one isotope.

R-3 Draft NUREG - 1556, Vol.12

- APPENDIX R l Table R.3 Survvy Frequency Category Modifiers Modifying Factors Factors Simple storage x 100 l

l Very simple wet operations (e.g., preparation of aliquots of stock solutions) x 10 Normal chemical operations (e.g., analysis, simple chemical preparations) x1

- Complex wet operations (e.g., multiple operations, or operations with complex glass x0.1 apparatus)

Simple dry operations (e.g., manipulation of powders) and work with volatile x0.1 radioactive compounds

! Exposure of non-occupational persons x 0.1 Dry and dusty operations (e.g., grinding) x 0.01 The object is to determine how often to survey the laboratory or area of use. To do this, multiply the activity range under LOW, MEDIUM, and HIGH survey frequency in Table R.2, by the appropriate Modifying Factor to construct a new set of mci ranges for LOW, MEDIUM, and HIGH survey frequency.

Survey Frequency:

Low- Not less than once a month Medium - Not less than once per week High - Not less than once per normal working day.

Table R.4 isotope Groups Group 1 Pb-210 Po-210 Ra-223 Ra-226 Ra-228 Ac-227 Th-227 Th-228 Th-230 Pa-231 U-230 U-232 U-233 U-234 Np-237 Pu-238 Pu-239 Pu '240 Pu-241 Pu-242 Am-241 Am-243 Cm-242 Cm-243 Cm-244 Cm-245 Cm-246 Cf-249 Cf-250 Cf-252 Group 2 Na-22 Cl-36 Ca-45 Sc-46 Mn-54 Co-56 Co-60 Sr-89 Sr-90 Y-91 Zr-95 Ru-106 Ag-110m ul-ll5m In-ll4m Sb-124 Sb-125 Te-127m Te-129m I-124 I-126 I-131 1-133 Cs-134 Cs-137 Ba-140 Ce-144 Eu-152 (13 y)

Eu-154 Tb-160 Tm-170 Hf-181 Ta 182 Ir-192 TI-204 Bi-207 Bi-210 At-211 Pb-212 Ra-224 Ac-228 Pa-230 Th-234 U-236 Bk-249 Draft NUREG - 1556, Vol.12 R-4

APPENDIX R Group 3 Be-7 C-14 F-18 Na-24 Cl-38 Si-31 P-32 S-35 Ar-41 K-42 K-43 Ca-47 Sc-47 Sc-48 V-48 Cr-51 Mn-52 Mn-56 Fe-52 Fe-55 Fe-59 Co-57 Co-58 Ni-63 Ni-65 Cu-64 Zn-65 Zn-69m Ga-72 As-73 As-74 As-76 As-77 Se-75 Br-82 Kr-85m Kr-87 Rb-86 Sr-85 Sr-91 Y-90 Y-92 Y-93 Zr-97 Nb-93m Nb-95 Mo-99 Tc-96 Tc-97m Tc-97 Tc-99 Ru-97 Ru-103 Ru-105 Rh-105 Pd-103 Pd-109 Ag-105 Ag-111 Cd-109 Cd-l15 In-ll5m Sn-ll3 Sn-125 Sb-122 Te-125m Te-127 Te-129 Te-131m Te 132. I-130 I-132.1-134 I-135 Xe-135 Cs-131 Cs-136 Ba-131 La-140 Ce-141 Ce-143 Pr-142 Pr-143 Nd-147 Nd-149 Pm-147 Pm-149 Sm-151 Sm-153 Eu-152 Eu-155 Gd-153 Gd-159 Dy-165 Dy-166 Ho-166 Er-169 Er-171 (9.2 hr) Tm-171, Yb-175 Lu-177 W-181 W-185 W-187 Re-183 Re-186 Re-188 Os-185 Os-191 Os-193 Ir-190 Ir-194 Pt-191 Pt-193 Pt-197 Au-196 Au-198 Au-199 Hg-197 Hg-197m Hg-203 TI-200 T1-201 Tl-202 Pb-203 Bi-206 Bi-212 Rn-220 Rn-222 Th-231 Pa-233 Np-239 Group 4 H-3 0-15 Ar-37 Co-58m Ni-59 Zn-69 Ge-71 Kr-85 Sr-85m Rb-87 Y-91m Zr-93 Nb-97 Tc-96m Tc-99m Rh-103m In-ll3m I-129 Xe-131m Xc-133 Cs-134m ' Cs-135 Sm-147 Re-187 Or-191m Pt-193m Pt-197m Th-232 Th-Nat U-235 U-238 U-Nat Contamination in Unrestricted Areas Contamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table R.5.

J Table R.5 Acceptable Surface Contamination Levels Nuclide* Average6

• Maximum6d Removable6 '

I-125,1-129 1.7 Bq/100 cm 2 5.0 Bq/100 cm 2 0.3 Bq/100 cm 2 (100 dpm/100 cm2 ) (300 dpm/100 cm2) (20 dpm/100 cm2) 1-126,I-131,I-133, 16.7 Bq/100cm 2 50.0 Bq/100cm2 3.3 Bq/100cm2 Sr-90 (1,000 dpm/100 cm2) (3,000 dpm/100 cm2) (200 dpm/100 cm2 )

Alpha emitters 8.33 Bq/100 cm2 25 Bq/100 cm2 1.67 Bq/100 cm 2 (500 dpm/100 cm2) (1500 dpm /100 cm2 ) (100 dpm/100 cm2 )

l R-5 Draft NUREG - 1556, Vol.12

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APPENDIX R Nuclide' Average *" Maximumbd Removable *d Beta-gamma emitters 833 Bq/100 cm 2 250 Bq/100 cm 2 16.7 Bq[100 cm2 (nuclides with decay (5,000 dpm/100 cm2 ) (15,000 dpm (1,000 dpm/100 cm2 )

modes other than /100 cm )

2 alpha emission or spontaneous fission) except Sr-90 and others noted above.

I a) Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established I for alpha- ar.d beta-gamma-emitting nuclides should apply independently, b) As used in this table, dpm (disintegration per minute) means the rate of emission by radioactive material as determined by correcting the count; per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation.

c) Measurements of average contaminant should not be averaged over more than 100 square centimeters. For objects of less surface area, the average should be derived for each such object. ,

d) The maximum contamination level applies to an area of not more than 100 cm2 .  !

2 c) The amount of rcmovable radioactive material per 100 cm of surface area should be determined by wiping k that area with filter or soft absorbent paper, applying moderate pressure, and assessing the amount of l radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects ofless surface area is determined, the peninent levels should be reduced proportionally and the entire surface should be wiped.

When equipment or facilities that are potentially contaminated are to be released for unrestricted use, the above table provides the maximum acceptable residual levels. To the extent practicable, it is appropriate to decontaminate to below these levels. Surface contamination surveys should be conducted for both removable and fixed contamination before these facilities or equipment are released from restricted to unrestricted use, to ensure that they meet these limits.

A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removabh contamination.

Survey Record Each survey report should include the following:

• A diagram of the area surveyed (See Figure R.1);

A list ofitems and equipment surveyed; Specific locations on the survey diagram where wipe test was taken; Ambient radiation levels with appropriate units; Contamination levels with appropriate units; Draft NUREG 1556, Vol.12 R-6

APPENDIX R

• Make, model number and date last calibrated for instruments used;

. Background levels; i Name of the person making the evaluation and recording the results and date.

Licensees should record contamination levels observed and procedures followed for incidents involving contamination ofindividuals. The record should include names ofindividuals involved, description of work activities, calculated dose, probable causes (including root causes),

steps taken to reduce future incidents of contamination, times and dates, and the surveyor's signature.

Area Diagram gadioay, E-- E '

• O Sink Fume Hood l

l Table I

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Refrigerator Non-radioactive Waste O

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Figure R.1 Area Diagram. This is an example ofa laboratory survey map.

L R-7 Draft NUREG - 1556, Vol.12

APPENOlX R Air Sampling Air sampling can be used to do the following:

. Determine whether the confinement of radioactive materials is effective;

. Measure airbome radioactive material concentrations in the workplace;

• Estimate worker intakes of radioactive material;

• Determine posting requirements;

• Determine what protective equipment and measures are appropriate;

. Warn of significantly elevated levels of airbome radioactive materials.

If bioassay measurements are used to determine worker doses of record, air sampling may be used to determine time ofintake and to determine which workers should have bioassay j measurements.

I Refer to Regulatory Guide 8.25, Revision 1, " Air Sampling in the Workplace," dated June 1992, and NUREG-1400, " Air Sampling in the Workplace," dated September 1993, or current revision for further guidance on the air sampling.

Air Stack Release Monitoring When practicable, airbome radioactive effluents should be released from monitored release points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to estimate public exposure. Licensees should verify the performance of effluent monitoring systems by

. regular calibration (at least annually) to ensure their reliability. The use of engineering controls and a good air sampling program can eliminate need for bioassays.

Regulatory Guide 4.20, " Constraints on Release of Airbome Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996, provides guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the constraint on air emissions to the environment.

l Regulatory Guide 8.37, ALARA Levels for Effluents from Materials Facilities," dated Jul," 1993, provides guidance on designing an acceptable program for establishing and maintaining ALARA levels for gaseous and liquid effluents at materials facilities.

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For release points for which monitoring is not practicable, the licensee should estimate the magnitude of the unmonitored effluents. These unmonitored releases will occur anytime unsealed material is handled outside a fume hood or other device that will control the releases.

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Draft NUREG - 1556, Vol.'12 R-8

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APPENDIX R The licensee should include these estimates when demonstrating compliance with dose limits and ALARA goals. Unmonitored releases may be estimated based on the quantity of material used in these areas or the number of procedures performed or other appropriate methods. The unmonitored effluents should not exceed 30% of the total estimated effluent releases or 10% of the permissible air effluent concentrations found on column 1 of Table 2 in 10 CFR Part 20, Appendix B, whichever is greater.

Effluent monitoring systems should be designed in accordance with ANSI N13.1 (1969),

" Document to Sampling Airborne Radioactive Materials in Nuclear Facilities," and ANSI N42.18 " Specification and Ferformance of On-site Instrumentation for Continuously Monitoring Radioactive Effluents." l Sanitary Sewerage Release Monitoring The licensee should evaluate the concentrations of radioactive material in water that is released ,

to the environment and to the sanitary sewer. The licensee must show that these releases meet the limits in 10 CFR 20.1301 and 20.2003, respectively.

The topic of sanitary sewerage releases is more fully discussed in Appendix U.

Bioassay Monitoring Frequency of Required Bioassay Measurements Determining the appropriate frequency of routine bioassay measurements depends upon the exposure potential and the physical and chemical characteristics of the radioactive material, and the route of entry to the body. Consider the following elements:

• Potential exposure of the individual;

. Retention and excretion characteristics of the radionuclide;

. Sensitivity of the measurement technique; a Acceptable uncertainty in the estimate ofintake and committed dose equivalent.

Bioassay measurements used for demonstrating compliance with the occupational dose limits should be conducted often enough to identify and quantify potential exposures and resultant intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10% ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes and assess occupational doses for exposed individuals who are likely to exceed 10% of the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults).

R-9 Draft NUREG - 1556, Vol.12 E

i APPENDIX R Separate categories of bioassay measurements, routine measurements, and special measurements further determine the frequency and scope of measurements.

Routine Measurements

' Routine measurements include baseline measurements, periodic measurements, and termination measurements. These measurements should be conducted to confirm that appropriate controls exist and to assess dose.

An individual's baseline measurement of radioactive material within the body should be conducted before beginning work that involves exposure to radiation or radioactive materials for which monitoring is required.

In addition to the baseline measurements, perio_dic bioassay measurements should be performed.

The frequency of periodic measurements should be based on the likelihood of significant exposure of the individual. In determining the worker's likely exposure, consider such information as the worker's access, work practices, measured levels of airborne radioactive material, and exposure time. Periodic measurements should be made when the cumulative exposure to airbome radioactivity, since the most recent bioassay measurement, is > 0.02 ALI (40 DAC hours). Noble gases and airborne particulates with a radioactive half-life ofless than 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> should be excluded from the evaluation, since external exposure generally controls these radionuclides.

At a' minimum, periodic measurements should be conducted annually. Periodic measurements provide additional information on any long-term accumulation and retention of radioactive material in the body, especially for exposures to concentrations of airborne radioactive material below monitoring thresholds.

When an individual is no longer subject to the bioassay program because of change in employment status, a termination bioassay measurement should be made, when practicable. to ensure that any unknown intakes are quantified.

Special Monitoring Because of uncertainty in the time ofintakes and the absence of other data related to the exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent intakes from situations such as a failed r:spiratory protective device, inadequate engineering controls, Draft NUREG - 1556, Vol.12 R-10~

APPENDIX R inadvertent ingestion, contamination of a wound, or skin absorption, should be evaluated on a case-by-case basis. When determining whether potential intakes should be evaluated, consider the following circumstances:

. The presence of unusually high levels of facial and/or nasal contamination;

• Entry into airbome radioactivity areas without appropriate exposure controls;

. Operational events with a reasonable likelihood that a worker was exposed to unknown quantities of airbome radioactive material (e.g., loss of system or container integrity);

. Known or suspected incidents of a worker ingesting radioactive material;

• Incidents that result in contamination of wounds or other skin absorption;

• Evidence of damage to or failure of a respiratory protective device.

References

1. Regulatory Guide 4.20, " Constraints on Release of Airbome Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996.

2. Regulatory Guide 8.9, Revision 1, " Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program," dated July 1993, i

3. Regulatory Guide 8.23, Revision 1, " Radiation Safety Surveys at Medical Institutions,"

dated January 1981.

4. Regulatory Guide 8.25, Revision 1, " Air Sampling in the Workplace," dated June 1992.

5. Regulatory Guide 8.32, " Criteria for Establishing a Tritium Bioassay Program," dated July 1988. l l

6. Regulatory Guide 8.37, " ALARA Levels for Effluents from Materials Facilities," dated July 1993.

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7. NUREG-1400, " Air Sampling in the Workplace," dated September 1993 or current

- revision.

8. NUREG/CR- 4884, " Interpretation of Bioassay Measurements," dated July 1987 or current revision.

9. ANSI N13.1 (1969), " Document to Sampling Airbome Radioactive Materials in Nuclear Facilities," dated 1991.

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APPENDIX R

10. ANSI N42.18, ',' Specification and Performance of On-site Instrumen... tion for Continuously Monitoring Radioactive Efiluents," 1991.

I 1. NCRP Commentary No. 3, " Screening Techniques for Determining Compliance with Environmental Standards," published in January 1989 and the addendum published in October 1989.

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Draft NUREG - 1556. Vol.12 R-12

Appendix S l

Model Leak Test Program

APPENDIX S Model Leak Test Program 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 should cover the following subject areas:

. Principles and practices of radiation protection;

. Radioactivity measurements, monitoring techniques, and instrumentation;

. Mathematics and calculations;

. Using 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 sodium iodide crystal doped with thallium (Nal(TI)) well counter system with a single or multichannel analyzer will be used to count samples containing gamma-emitters (e.g., Cs-137, Co-60, etc.).

• A liquid scintillation or gas-flow proportional counting system will be used to count samples containing beta-emitters (e.g., Sr-90).

. A gas-flow proportional, liquid scintillation, or solid state counting system will be used for alpha emitters (e.g., Am-241).

S-1 Draft NUREG - 1556, Vol.12

- APPENDIX S Frequency for Conducting Leak Tests of Sealed Sources

. Leak tests will be conducted at the frequency specined in the respective SSD Registration CertiScate.

Procedure for Performing Leak Testing and Analysis

= For each source to be tested, list identifying information such as serial number, radionuclide, and 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 185 Bq (0.005 Ci) of the radionuclide.

. Using the selected instrument, count and record background count rate.

• Check the instrument's counting emciency using a standard source of the same radionuclide as the source being tested or one with similar energy characteristics. Accuracy of standards should be within

• 5% of the stated value and traceable to primary radiation standard such as those maintained by NIST.

. Calculate emeiency.

For example: f(cpm from std)-(com from bkcIl = emciency in epm /Bq (activity of std in Bq) where: cpm = counts per minute std = standard bkg = background Ilq = Becquerel Count each wipe sample; determine net count rate.

• For each sample, calculate and record estimated activity in Bq (or Ci).

For example: f(com from wine samnle)-(com from bke)] = Bq on wipe sample (emciency in cpm /Bq)

Draft NUREG - 1556, Vol.12 S-2

1 APPENDIX S

. Sign and date the list of sources, data, and calculations. Retain records for 3 years (10 CFR 20.2103(a)).-

'. If the wipe test activity is 185 Bq (0.005 Ci) or greater, notify the RSO so that the source can be withdrawn from use and disposed of properly. Also notify NRC.

I S-3 Draft NUREG - 1556, Vol.12

l Appendix T Transportation Part 1 Regulations

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i APPENDIX T Pan 1 I

Transportation Tiie . major areas in the DOT regulations that are most relevant for transportation oflicensed

. material shipped as Type A quantities are contained in NUREG - 1660/RAMREG-002, "U.S.

. Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material l . Consignments,"' November 1998.

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T1 Draft NUREG - 1556, Vol.12 l

Appendix T Transportation l

Part 2 Sample Shipping Documents, Placards and Labels

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APPENDIX T, Part 2 }

Hazard Communications for Class 7 (Radioactive) M t:ri 13 1

DOT Shipping Papers (49 CFR 172.200-205) l NOTE: lAEA. ICAO. and IMO may require additional hazard commu..ication information for intemational shipments l This table must not be used as a substitute for the DOT and NRC regulations on the transportation of radioactive materials j i

Entries Always Required Additional Entries Sometimes Required Optional Entries Unless Excepted I

o The basic description, in Materials-Based Reouirements:

• The type of packaging (e.g., j sequence: Type A, Type B, IP-1, . ..) l Pr:per Shipping Name,

• If hazardous substance, "RQ" as part of the H:zard Class (7), basic description

• The Technical / chemical U.N. Identification Number name may be in included

• The LSA or SCO group (e.g., LSA-II) (if listed in 172.203(k), in a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> emergency response parentheses between the proper t:lephone number *

• Highway Route Controlled Quantity" as part of shipping name and hazard ,

the basic description ,if HRCO class; otherwise inserted in 2 Name of shipper parenthesis after the basic

• Fissile materialinformation (e.g.," Fissile description) o Proper page numbering Exempt," controlled shipment statement [see

• Other information is permitted (Page 1 p.f_4) a172.203(d)(7)])

(e.g., functional description of o Except for empty and bulk

• If the materialis considered hazardous waste the product), provided it does packages, the total quantity and the word waste does not appear in the not confuse or detract from (mass, or volume for liquid), in shipping name, than " waste" must precede the the proper shipping name or appropriate units (Ibs, mL....) shipping name (e, , Waste Radioactive other required information Material, nos, UN2982) e For fissile radionuclides, o if not specialform, chemical cnd physical form * ' Radioactive Material"if not in proper shipping except Pu-238, Pu-239, and name Pu-241, the weight in grams o The name of each or kilograms may be used in Packaae-Based Reauirements: pbce of activity units. For i radionuclide (95% rule) and Pu-238, Pu-239, and Pu-241, totPI package activity. The auivity must be in SI units (e g.,

• Package identification for DOT Type B or NRC the weight in grams or Bq, TBq), or both SI units and certified packages kilograms may optionally be entered in addition to activity customary units (e.g., Ci, mci).

However, for domestic

• 1AEA CoC ID number for export shipments or units [see 172.203(d)(4)]

shioments, the activity may be shipments using foreign-made packaging (see expressed in terms of customary 173.473)

• Emergency response units only, until 4/1/97, hazards and guidance Administrative-Based Reauirements: information ( 9 172.600-604) o For each labeled package: may be entered on the

- The category of label used; e

• Exclusive Use-Shipment" shipping papers, or may be carried with the shipping

- The transport index of each package with a Yellow-ll or e instructions for maintenance of exclusive use- papers ( 172.602(b)]

Yellow-Ill label shipment controls for LSA/SCO strong-tight or NRC certified LSA ( 173.427) o Shipper's certification (not required of private carriers) e if a DOT exemption is being used," DOT-E" f followed by the exemption number Some Special Considerations / Exceptions for Shipping Paper Requirements o Shipments of Radioactive Material, excepted packages, under UN2910 (e.g., Limited Quantity, Empty packages, and Radioactive instrument and Article), are excepted from shipping papers. For limited 4. mtities ($173.421), this is only true if the limited quantity is not a hazardous substance (RO) or hazardous waste (40 C. a ?62) o Shipping papers must be in the pocket on the left door, or readily visible to person entenny Giver's compartment and within arm's reach of the driver o For shipments of multiple cargo types, any HAZMAT entries must appear as the first entries on the shipping papers, be designated by an *X" (or "RQ") in the hazardous material column, o_r be highlighted in a contrasting color T-5 Draft NUREG - 1556, Vol.12

APPENDIX T, Pan 2 Hczard Communicctions for Cicca 7 (Radioactivo) Matarials Marking Packag2s (49 CFR 172.300-338)

NOTE: lAEA. ICAO, and IMO may require additional hazard communication information for international .hipments This table must not be used as a substitute for the DOT and NRC regulations on the transportation of radioactnre materials I Markings Always Required Additional Markings Sometimes Required Optional Unless Excepted Markings Non-Bulk Packaaes Materials-Based ReauiremenA e "lP-1," "lP-2," or "lP-3" on industrial o Proper shipping name e If in excess of 110 lbs (50 kg), Gross Weight packaging is recommended o U.N. identification number e If non-bulk liauid package, underlined double arrows indicating upright orientation (two e Both the name and o Name and address of consignor opposite sides)[ ISO Std 780-1985 marking) - address of consignor or consignee, unless: and consignee are

- highway only and no motor e if a Hazardous substance in non-bulk package, the letters recommended carrier transfers, gr "RQ" in association with the proper shipping name

- part of carload or truckload lot e Other markings (e g.,

or freight container load, and Packaae-Based Reauirements: advertising) are entire contents of railcar, truck, permitted, but must or freight container are shipped e The package type if Type A or Type B (%" or greater letters) be sufficiently away from one consignor to one from required consignee [see @172.301(d))

• The specification-required markings (e.g., for Spec. 7A markings and packages: " DOT 7A Type A" and " Radioactive Matarial" (see labeling Bulk Packaaes (i.e., net capacity gr:at:r than 119 gallons as a e For approved packages, the certificate ID number r:c:ptacle for liquid, or 119 gallons (e g., USA /9166/B(U), USA /9150/B(U)-85, ..)

and 88.2 pounds as a receptacle for solid, or water capacity greater thar e if Type B, the trefoil (radiation) symbol per Part 1000 lbs, with no consideration of 172 App. B [ size: outer radius > 20 mm (0.8 in))

interm:diate forms of containment) e For NRC certified packages, the model number, o U N. identification number. on gross weight, and package ID number (10 CFR 71.85) orange, rectangular panel (see 172.332)- some exceptions Administrative-Based Reavirements:

exist e if a DOT exemption is being used, " DOT-E" followed by the exemption number if an expon shipment, " USA" in conjunction with the specification markings or certificate markings Some Special Considerations / Exceptions for Marking Requirements

) o Marking is required to be: (1) durable, (2) printed on a package, label, tag, or sign, (3) unobscured by labels or attachments, l (4) isolated from other marks, and (5) be representative of the hazmat contents of the pauxage

} o Limit:d Quantity ($173.421) packages and Articles Containing Natural Uranium and Thorium (6173.426) must bear the l marking " radioactive" on the outside of the inner package or the outer package itself, and are excepted from other marking.

j The ex,cepted packages shipped under UN 2910 must also have the accompanying statement that is required by 173.422.

o Empty ( 173.428) and Radioactive Instrument and Arl;cle ( 173.424) packages are excepted from marking o Shipment of LSA or SCO required by @t73.427 to be consigned as exclusive use are excepted from marking except that the exterior of each nonbulk package must be markeo " Radioactive-LSA" or " Radioactive-SCO," as appropriate. Examples of this category are domestic, strong-tight containers with less than an A2 quantity, and domestic NRC certified LSA/SCO l packages using 10 CFR 71.52.

o For bulk packages, marking may be required on more than one side of the package (see 49 CFR 172.302(a))

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l Draft NUREG - 1556, Vol.12 T-6

APPENDIX T, Part 2 l

Hazard Communications for Class 7 (Radioactive) Materials i Labeling Packages (4C CFR 172.400-450) j l

NOTE: lAEA. ICAO, and IMO may require additional hazard communication information for international shipments This table must not be used as a substitute for the DOT and NRC regulations on the transportation of radioactive materials Placement of Radioactive Labels o Labeling is required to be: (1) placed near the required marking of the proper shipping name, (2) printed or affixed to the packac$e surface (5) wit in color, design,(not andthesize bottom), (3) and tolerance, in contrast with its background, (6) representative of the HAZMAT (4) contents unobscured of theby markings or attachment package o For labeling of radioactive materials packages, two labels are required on opposite sides excluding the bottom Determination of Required Label size: 4 f p u,,, g j _____________.g.

\ ,, ,

> E0 rnm dea g g, NoMN. g / Aok'sg '

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~(3.9 in.)

Border: VRADiDACTIVE 17 s RADIDACTIVE It' sRADl0ACTIVElll7 5-6.3 mm . . . ..

7 T,. j( ' l l 05 \'~~ "; D *~ "'

) N 7/ .________..____2_

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49 CFR 172.438 49 CFR 172.440 49 CFR 172.450 49 CFR 172.436 Label white-l YELLOW-il YELLOW-Ill EMPTY LABEL Surface radiation level 0.005 mSv/hr (0.5 0.5 mSv/hr (50 mrem /hr) The EMPTY labelis Rroulred < 0.005 mSv/hr mrem /hr) < surface < surface radiation level required for shipments when: (0.5 mrem /hr) radiation level < 0.5 < 2 mSv/hr (200 mrem /h) of empty Class 7 mSv/hr (50 mrem /hr) [ Note: 10 mSv/hr (1000 (radioactive) packagei mrem /hr) for exclusive-use made pursuant to i closed vehicle ( 173.441(b)] $173.428. It m.ust cover any previous Or: Tl = 0 [1 meter dose rate < 1 meter dose rate < Tl < 10 [1 meter dose rate < labels, or they must be

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0.0005 mSv/hr (0.05 Tl O f1<m1 [Sv/hr OfmSv/hr (10 mrem /hr)] removed or mrem /hr)] (1 mrem /hr)] [ Note: There is no package Tl obliterated.

limit for exc'usive-use]

Notes: e Any package containing a Highway Route Controlled Quantity (HRCQ) must bear YELLOW-illlabel

• Although radiation level transport indices (Tis) are shown above, for fissile material, the Tl is typically determined on the basis of enticality control Content on Radioactive Labels o RADIOACTIVE Label must contain (entered using a durable, weather-resistant means):

(1) The radionuclides in the package with consideration of available space). Symbols (e.g., Co-60) are acceptable (2) The activity in SI units (e 9., Bq, T(Bq), or both SI units with customary units (e g., Ci, mci) in pa However, for domestic shipments, the activity may be expressed in terms of customary units only, until 4/1/97.

(3) The Transport Index (TI) in the supplied box. The Tl is entered only on YELLOW-Il and YELLOW-ill labels Some Special Considerations / Exceptions for Labeling Requirements o For materials meeting the definition of another hazard class, labels for each secondary hazard class need to be affixed to the package. The subsidiary label may not be required on opposite sides, and must not display the hazard class number o Radioactive Material, excepted packages, under UN2910 (e g., Limited Quantity, Empty packages, and Radioactive instrument and Article), are excepted from labeling. However, if the excepted quantity meets the definition for another hazard class, it is re-classed for that hazard. Hazard communication requirements for the other class are required o Labeling exceptions exist for shipment of LSA or SCO required by 173.427 to be cor signed as exclusive use o The " Cargo Aircraft Only" label is typically required for radioactive makrials packages shipped by air [@ 172.402(c)] . - -

T7 Draft NUREG - 1556, Vol.12

APPENDIX T. Part 2 Hazard Communications for Class 7 (Radioactive) Materials Placarding Vehicles (49 CFR 172.500-560)

NOTE: lAEA, ICAO, and IMO may require additional hazard communication information for intemational shipments This table must not be used as a substitute for the DOT and NRC regulations on the transportation of radioactive materials Visibility and Display of Radioactive Pbcard o Placards are required to be displayed:

o on four sides of the vehicle o visible from the direction they face, (for the front side of trucks, tractor-front, trailer, or both are authorized) o clear of appurtenances and devices (e g., ladders, pipes, tarpaulins) o at least 3 inches from any markings (such as advertisements) which may reduce placard's effectiveness o upright and on-point such that the words read horizontally o in contrast with the background, or have a lined-border which contrasts with the background o such that dirt or water from the transport vehicle's wheels will not strike them o securely attached or affixed to the vehicle, or in a holder.

o Placard must be maintained by carrier to keep color, legibility, and visibility.

Conditions Requiring Placarding o Placards are required for any vehicle containing package with a RADIOACTIVE Yellow-lll label o Placards are required for shipment of LSA or SCO required by $173.427 to be consigned as exclusive use. Examples of this category are domestic, strong-tight containers with less than an A2 quantity, and domestic NRC certified LSA/SCO packages using 10 CFR 71.52. Also, for bulk packages of these materials, the orange panel marking with the UN Identification number is not required.

O Placards are required any vehicle containing package with a Hi hway Route Controlled Quantity (HRCQ). In this case, the placard must be placed in a square background as shown belo (see 173.507(a))

Radioactive Placard Siza Specs: /

Sides: > 273 mm (1([8 in.) g e g4g ,

g e

Solidiine inner -

ADl0ACTIV > ,

• ADl0ACTIV border: RADIDACTWE About 12.7 mm s /

7 (0.5 in.) from edges 7 7

Lettering: >41mm n

(1.6I~.)

Square fo.'HRCQ: 49 CFR 172.556 lAEA SS 6 (1985) paras 443-444 See 49 CFR 1/2 527 AND 556 387mm (15.25 in.)

outside length by RADIOACTIVE PLACARD RADIOACTIVE PLACARD RADIOACTIVE PLACARD 25.4 mm (1 in.) thick (Dornestic) (International) FOR HIGHWAY ROUTE Base of vellow solid area:

CONTROLLED QUANTITY (either domestic or international 2915 mm (1.11 0.2 in.) above placard could be in middle) honzontal centerline i

Some Special Considerations / Exceptions for Placarding Requirements I o Domestically, substitution of the UN ID number for the word " RADIOACTIVE" on the placard is prohibited for Class 7 materials. However, some import shipments may have this substitution in accordance with international regulations.

I o Bulk packages require the orange, rectangular panel marking containing the UN ID number, which must be placed adjacent l to the placard (see 172.332)[ NOTE: except for LSA/ SCO exclusive use under 9173.427, as above]

i 0 if placarding for more than one hazard class, subsidiary placards must not display the hazard class number. Uranium H:xaflouride (UF o For shipments of.) shipments radiography > 454inkg cameras (1001 lbs)overpacks, convenience require bothif theRADIOACTIVE overpack does not and CORROSIVE require a RADIOACTIVE(Class- 8) placard YELLOW lll label, vehicle placarding is not required (regardless of the label which must be placed on the camera) l Draft NUREG - 1556, Vol.12 T-8

APPENDIX T. Part 2 Minimum Required P ck_ging Fcr Cla.a 7 (Ridisctiv4) Mat;rtil2 This ts%e must not be used as a substitute for the dot and NRC regulations on the transportation of radioactive materials Quantity: < 70 sq/g Limned ouanidy A 1 rem /hr at 3 m unshielded e o002pcvg> ($173 421)q/A2 value ($173 435) ($173 427)

Non-LSA/SCO Excepted Type A Type B

• l Dim;stic or international LSA/SCO:

LSA-1 solid. (liquid)' IP-l Type B s SCO-l LSA-l Liquid LSA-ll Solid, (liquid or gas)' Excepted lp-ll Type B8 (LSA-Ill)'

SCO-Il LSA-Il Liquid or Gas lp-ill TypeB8 LSA-Ill Domictic (only) LSA/SCO: Type B

• LSA-1,11, Ill; SCO-1,11 Excepted Strong-tight : DOT Spe M ype NRC Type A LSA 8d

1. For entries in parentheses, exclusive use is required for shipment in an IP (e.g., shipment of LSA-l liquid in an IP-l packaging would require exclusive use consignment)

2. Exclusive use required for strong-tight container shipments made pursuant to Q173.427(b)(2)

3. Subject to conditions in Certificate, if NRC package

4. Exclusive use required, see 9173.427(b)(4). Use of these packages expires on 4/1/99 (10 CFR 71.52)

Package end Vehicle Radiation Level Limits (49 CFR 173.441)^

This table must not be used as a substitute for the dot and NRC regulations on the transportatin of radioactive materials Transport Vehicle Use: Non-Exclusive Exclusive Transport Veh/cle Type: Open or Closed Open (flat-bed) l Open w/ Enclosure ' l Closed Prcktge (or freight container) Limits:

External Surface 2 mSv/hr 2 mSv/hr 10 mSv/hr 10 mSv/hr (200 mrem /hr) (200 mrem /hr) (1000 mrem /hr) (1000 mrem /hr)

Transport Index (TI) C 10 nu hmit Roadway or Railway Vehicle (or freight container) Limits:

Any point on the outer surface N/A N/A 2 mSv/hr (200 mrem /hr) l VIrtical planes projected from N/A 2 mSv/hr 2 mSv/hr N/A outsr edges (200 mrem /hr) (200 mrem /hr)

Top of . load: enclosure: 2 mSv/hr vehicle: 2 mSv/hr (200 mrem /hr) (200 mrem /hr) (200 mrem /hr) 2 meters from. vertical planes: vertical planes: outer lateral surfacer 0.1 mSv/hr 01 mSv/hr 01 mSv/hr (10 mrem /hr) (10 mrem /hr) (10 mrem /hr)

Unde. e 2 mSv/hr (200 mrem /hr)

Occupied positen N/A D 0 02 mSv/hr (2 mrem /hr)'

Sum of package Tra 50 no limit '

A. The limits in this table do not apply to excepted packages - see 49 CFR 173.421-426 B. Securely attached (to vehicle), access-limiting enclot.ure; package personnel barriers are considered as enclosures C. For nonfissile radioactive materials packages, the dimensionless number equivalent to maximum radiation level at 1 m (3.3 feet) from the exterior package surface, in millirem / hour D. No dose limit is specified, but separation distances apply to Radioactive Yellow-Il or Radioactive Yellow-lli labeled packages E. Does not apply to private carrier wearing dosimetry if under radiation protection program satisfying 10 CFR 20 or 49 CFR 172 Subpart i F. Some fissile sh,pments i may have combined conveyance Tl limit of 100 - see 10 CFR 71.59 and 49 CFR 173.457 T-9 Draft NUREG - 1556, Vol.12

APPENDIX T, Part 2 Pack:ga cnd Vshicla Contemination Limits (49 CFR 173.443)

This table must not be used as a substitute for the DOT and NRC regulations on the transportation of radioactive materials NOTE: All values for contamination in DOT rules are to be averaged over each 300 cm2 Sufficient measurements must be taken in the appropriate locations to yield representative assessments 6y means the sum of beta emitters, gamma emitters, and low-toxicity alpha emitters

" means the sum of all other alpha emitters (i.e., other than low-toxicity a!pha emitters)

General Requirement: Non-fixed (removable) contamination must be kept as low as reasonably achievable (ALARA)

Th3 Casic Contamination Limits 49 CF 17 .4N(a), ble 11 6'y: 0.4 Bq/cm = 2 40 Bq/100 cm 2= 1x104 Ci/cm =2 2200 dpm/100 cm2 0.04 Bq/cm2 = 4 Bq/100 cm 2= 1x104 pCl/cm2= 220 dpmi100 cm 2 The following exceptions and deviations from the above basic limits exist:

Deviation from Regulation Applicable Location and Conditions Which must Be Met:

Basic Limits 49 CFR $$

10 times the basic 173.443(b) On any external surface of a package in an exclusive use shipment, during transport limits and including end of transport. Conditions include:

173.443(c) (1) Contamination levels at beg, inning of transport must be below the basic limits.

(2) Vehicle must not be returned to service until radiation level is shown to be < 0.005 Also see mSv/hr (0.5 mrem /hr) at an j 177.843 (non-fixed) contamination. y accessible surface, and there is no significant rerEo4 (highway) 10 times the basic 173.443(d) On any external surface of a package, at the beginning or end of transport, if a closed limits transport vehicle is used, solely for transport;ng radioactive materials packages. Conditions Also see include:

177.843 '1) A survey of the interior surfaces of the empty vehicle must show that the radiation (highway) level at any point does not exceed 0.1 mSv/hr (10 mrem /hr) at the surface, or 0.02 mSv/hr (2 mrem /hr) at i meter (3.3 ft .

(2) Exterior of vehicle must be consp)cuously i stenciled, "For Radioactive Mate Use Only" in letters at least 76 mm (3 inches) high, on both sides.

(3) Vehicle must be kept closed except when ioading and unloading.

100 tim;s the 173.428 Internal contamination limit for excepted package-empty packaging, Class 7 b; sic limits (Radioactive) Material, shipped in accordance with 49 CFR 173.428. Conditions include:

1 The basic contamination limits (above) apply to external surfaces of package.

2 Radiation level must be <: 0.005 mSv/hr (0.5 mrem /hr) at any external surface.

3 Notice 4 in $173.422(a)(4)

Package is in unimpaired , must accom &pany shipment.

condition securely closed to prevent leakage.

5 Labels are removed, obliterated, or covered, and the " empty" label ( 172.450) is a ixed to the package.

In addition, after any incident involving spillage, breakage, or suspected contamination, the modal-specific DOT regulations 177.861(a), highway; 174.750(a), railway; and

{no significant removable surface contamination," before being 9175.700(b), air) specify retumed to service that vehicles, or routinely buildings, occupied. The carrier mustareas, or e clso notify offeror at the earliest practicable moment after incident.

Draft NUREG - 1556, Vol.12 T-10

APPENDIX T, Part 2 SAMPLE CERTIFICATE ENCLOSED IN, OR ON PACKAGE, INCLUDED WITH THE PACKINC LIST, OR OTHERWISE FORWARDED WITH THE PACKAGE This package conforms to the conditions, and limitations specified in 49 CFR 173.424 for radioactive material, excepted package-instruments or articles, UN2910.

(Signed) Radiation Safety Officer T-ll Draft NUREG 1556, Vol.12

Appendix U Waste Disposal

i APPENDIX U Waste Disposal General Discussion

1. All radioactivity labels must be defaced or removed from containers and pack 9ges prior to disposal into non-radioactive waste streams. If waste is compacted, all labels that are visible in the compacted mass must be defaced or removed.

2. Remind workers that nonradioactive waste such as leftover reagents, boxes, and packaging material should not be mixed with radioactive waste.

3. Occasionally monitor all procedures to ensure that radioactive waste is not created unnecessarily. Review all new procedures to ensure that waste is handled in a manner consistent with established procedures.

4. In all cases, consider the entire impact of various available disposal routes. Consider occupational and public exposure to radiation, other hazards associated with the material and routes of disposal (e.g., toxicity, carcinogenicity, pathogenicity, flammability), and costs.

5. The waste management program should include waste handling procedures for the vsers within their laboratories or assigned areas, and for waste handlers who may collect waste from areas of use to bring to the storage area for eventual disposal.

6. Housekeeping staff should be provided adequate training to avoid the possibility of unauthorized disposal or exposure of these individuals to radioactive materials or radiation.

Model Procedure for Decay in Storage (DIS)

Applicants should assure that adequate space and facilities are available for the storage of waste for DIS. Licensees can minimize the need for storage space if the w.-de is segregated according to physical half-life.

1. Only waste with a physical half-life ofless than or equal to 120 days) may be disposed of by DIS.

2. Waste with a half-life of greater than 65 days but less than or equal to 120 days should be segregated at the source of generation from waste which has a half-life ofless than or equal to 65 days.

3. Waste shall be stored in suitable well marked containers, the containers should provide

, adequate shielding, and the waste's physical form should be compatible with the waste contamer.

4. Liquid and solid wastes must be stored separately.

5. Filled containers must be sealed. Sealed containers shall be identified with labels affixed or attached to them.

6. The identification label should include the date when the container was sealed, the longest-lived radioisotope in the container, the date when ten half-lives of the longest-lived U-1 Draft NUREG - 1556, Vol.12 i

i l

APPENDIX U radioisotope will have transpired, and the initials of the individua' Ao sealed the container. The container may then be transferred to the DIS area.

7. The contents of the container should be allowed to decay for at least ten half-lives of the longest-lived radioisotope in the container.

8. Prior to disposal as ordinary trash, each container should be monitored as follows:

a. Check the radiation detection survey meter for proper operation with a radiation source.

b. Survey tb contents of each container in a low background area.

c. Remove any shielding from around the container.

d. Monitor all surfaces of the container.

e. Discard the contents as ordinary trash only if the surveys of the contents indicate no residual radioactivity (i.e., surface readings are indistinguishable from background readings).

f. If the surveys indicate residual radioactivity, return the container to DIS area and contact the RSO for further instructions.

9. If the surveys indicate no residual radioactivity, record the date when the container was sealed, the disposal date, type of waste (used or unused material, gloves, etc.), survey instrument used, and the imtials of the individual performing surveys and disposing of the waste.

All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. Syringes / needles placed into sealed waste containers for decay do not need the labels removed provided that the following is done: waste barrels are sealed prior to delivery to the waste disposal firm and delivered directly from the licensee's facility; labels are removed from the waste barrels / containers; and that the waste is incinerated, not placed in a landfill, and the waste disposal firm is cautioned not to open the container prior to incineration.

Model Procedure for Disposal of Liquids into Sanitary Sewerage

1. Confirm that the liquid waste being discharged is readily soluble (or is easily dispersible biological material)in water.

2. Calculate the amount of each radioisotope that can be discharged by using the information .

from prior, similar discharges and the information in 10 CFR 20, Appendix B. j

3. Make sure that the amount of each radioisotope does not exceed the monthly and annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR 20, Appendix B, Table 3.

4. If more than one radioisotope is released, the sum of the ratios of the average monthly i discharge of a radioisotope to the corresponding limit in 10 CFR Part 20, Appendix B, Table 3 must not exceed unity.

Draft NUREG - 1556, Vol.12 U-2 l

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l 1

APPENDIX U

5. Total quantity oflicensed material released into the sanitary sewerage system in a year does not exceed 185 GBq (5 Ci) of H-3 (tritium),37 GBq (1 Ci) of C-14, and 37 Gbg (1 Ci) of all other radioisotopes combined.

l

6. Record the date, radioisotope (s), estimated activity of each radioisotope, location where the 1 material is discharged, and the initials of the individual discharging the waste.

l

5. Liquid waste must be discharged only via designated sinks or toilets.

l 6. Discharge liquid waste slowly with water running from the faucet to dilute it.

7. Survey the sink and surrounding work surfaces to confirm that no residual material or I

contamination remained in the sink or on work surfaces.

8. Prior to leaving the area, decontaminate all areas or surfaces if found to be contaminated.

9. Maintain records of each radioisotope and its quantity and concentration that is released into the sewer system.

Model Procedure for incineration These guidelines apply to noncommercial waste disposal, (i.e., incineration of a licensee's own waste). You do not need specific NRC approval in order to incinerate certain categories of radioactive waste. For example,10 CFR 20.2005 provides that tritium and carbon-14 in low level concentrations in liquid scintillation media and ammal tissue may be disposed of without regard to radioactivity. After you review your program and confirm that you have waste which requires specific NRC approval for incineration, please provide the following information.

I

1. Describe the training and experience of the person who will be responsible for the on-site I and day-to-day superv sion ofincinerator operations.

2. Describe the waste that is proposed to be incinerated to include, the chemical and/or physical form of the waste containing licensed material and a description of how the waste is segregated, packaged, and labeled for transfer from the generatioa site to the incinerator; i the name of the radioisotope, concentration of radioactivity averaged over the weight of the i material to be incinerated ( Ci per gram of waste medium) for each isotope to be I incinerated; and the total radioactivity of each isotope per burn and the total number of burns per year. Describe procedures for ensteing that these frequencies and activities will not be exceeded.

3. Describe the procedures for packaging, handling, securing and monitoring of waste to prevent contamination and/or unnecessary exposure to personnel or property during the waste life cycle.

4. Describe your method for measuring or estimating the concentration of radioactive material i remaining in the ash residue. Desenbe your p:ocedures for collection, handling and disposal of the ash residue,

5. Describe the recordkeepino procedures for the wate incineration program. Records must be adequate to document all receipts, incineration, envienmental releases of effluents, and any disposals of ash generated in the incineration process. These records must be maintamed in the same units as applicable regulations.

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U-3 Draft NUREG - 1556, Vol.12 l

APPENDIX U 6.- Describe the characteristics of the incinerator and site location, including: height of the stack; rated air flow (cubic feet per hour or similar units); proximity of the stack or other

discharge to occupied areas (eg., residences, school, hespital); and distance to the nearest air intake ducts ot adjacent bui dings. Describe any scrubbers, filters, or air cleaning equipment that is present.

7. State how the concentration of radionuclides released, both as airborne effluent and as any lic.uid effluent from scrubbers, condensers, or associated systems, will be measured or otherwise determined. Describe any stack monitoring that is planned.

8. Provide a copy of the written safety analysis that demonstrates that the applicant will be

, able to incinerate the types and quantities of radioactivity specified in the application without exceeding the environmental release limits specified in 10 CFR Part 20.

I

9. Provide a copy of the radiation safety procedures for monitoring personnel involved in incineration operations, and for momtoring all effluent generated by the incineration process. The procedures must ensure that regulatory limits for environmental releases of radioactivity will not be exceeded. The apphcant must describe how any ash generated l exceeding regulatory limits will be disposed of. i Model Procedure for Compaction l The following information should be provided from licensee's who propose to compact waste.

1. Describe the compactor to demonstrate that it is adequately designed and manufactured to safely compact the type and quantity of waste generated during licensed operations (e.g., manufacturer's specifications, annotated sketches, photographs, etc.).

2. . Describe the type, quantities, and concentrations of waste to be compacted.

3. Pside an analysis of the potential for airborne release of radioactive material during qsetion savities.

~ 4. as well as a

'~State the location description of theand of the ventilation compactor (s) within filtering systems used mthe waste processing conjunction wi area (s)th the compactors. Include a description of the procedures for monitoring filter blockage and change out.

5. Discuss the methods used to monitor worker breathing zones and/or exhaust systems.

6. Discuss the types and frequencies of surveys that will be performed for contamination controlin the compactor area.

7. > Discuss the instruction provided to compactor operators including instructions for protective clothing, checks for proper functioning of equipment, method of handling uncompacted waste and examimng containers for defects.

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DrsA NUREG - 1556, Vol.- 12 U-4

i Appendix V Using the in 'rnet to Obtain Copies of NRC Docume its and Other Information i

l

l j APPENDIX V Using the Internet to Obtain Copies of NRC Documents and Other Information In an effort to make its documents and information readily available to licensees and the general public, NRC is placing documents and information on its Web site.

of the reference sections of this draft NUREG refer to the NRC home page Many//www.nrc.

<http: gov >. Applicants and licensees who have Internet access may use th to find more information on a topic, the referenced document, or information on obtaining the referenced document.

To access the site, type the address into the location box of the Internet browser software and 3ress the enter key. Sometimes the given address does not go directly to the necessary page; lowever, the addressed page will have links to the information referenced in this draft NUREG.

Generally, links appear either as blue text or as a picture in the document To use a link, place the pointer on the blue text or picture. The pointer will change from an arrow to a hand with the index finger extended. By single-clicking t:1e mouse on the blue text or picture, the Internet browser will go to the selected page. For example, if you wanted to review the definitions in 10 CFR Part 20, type http://www.nre. gov in the location box of your browser and press the enter j key. After the NRC homepage comes up, place the pointer on the reference librar ~ icon. The arrow will chan.;e to a hand with the index finger extended. Single-click the pointing device button. Next, p' ace the pointer on the blue text," Title 10 of the Code of Federal Regulations" and single-click the mouse. Place the pointer on the blue text "20" and single-click. Finally, place the pointer on the blue text "Defimitions" and single-click.

I V-1 Draft NUREG 1556, Vol.12

)

Appendix W Medical Distribution l

7 APPENDIX W j 1

Medical Distribution. )

1. INTRODUCTION 1.1 PURPOSE OF APPENDIX 1 j

The purpose of this appendix is to provide assistance to you, the applicant or licensee, in preparms applications for new licenses, license amendments, and renewals of medical distribution licenses under 10 CFR Part 32," Specific Domestic Licenses To Manufacture or '

Transfer Certain Items Containing Byproduct Material" (i.e., licenses that authorize the distribution of radioactive drugs and sealed sources containing byproduct material to the Nuclear Regulatory Commission's (NRC's) and Agreement States' medical use licensees). Medical distribution by applicants registered or licensed with the U.S. Food and Drug Administration or State agency as a drug or sealed source manufacturer is provided for in 10 CFR 32.72 and 32.74 or equivalent provisions of an Agreement State. The medical distribution license only authorizes distnbution; it does not authorize the possession of byproduct material.

Holders oflicenses to manufacture and conduct broad scope research and development, who were authorized on January 1,1995, to distribute radio labeled drugs to medical use licensees by specific license conditions or under the authorized use item of the ficense but who did not have a 10 CFR Part 32 medical distribution license, may continue to distribute the radio labeled drugs

. pursuant to the authorization without obtaining a medical distribution license. However, when the licensee wishes to amend or renew this authorization, a new 10 CFR Part 32 medical distribution license or authorization will be needed.

Several words and phrases used in this guide should be explained. The phrase " byproduct I material" mean= any radioisotope produced by a nuclear reactor. The term " distribution" has the same meaning as in 10 CFR Part 32, i.e., the routine transfer oflicensed materials to others. For organizations licensed in accordance with 10 CFR 32.72 and 32.74, these transfers oflicensed material are to specific licensees in accordance with the requirements of 10 CFR 30.41; these organizations' principal customers are medical use licensees. The phrase " medical use licensee" means a physician, podiatrist, dentist, or medical institution licensed under 10 CFR Part 35 for

" medical use," as defined in 10 CFR 35.2. l 1.2 FILING AN APPLICATION FOR MANUFACTURING If you are a manufacturer or initial distributor of sealed sources (or devices containing sealed sources), you may need to submit a separate application for authorization to distribute the sealed sources or devices. This separate application will facilitate NRC's review and evaluation of the radiation safety information for the saled source or device and its certificate of registration.

2. CONTENTS OF AN APPLICATION The following paragraphs are numbered as on NRC Form 313 " Application for Material License," Appendix B.

Item 1: LICENSE ACTION TYPE See Section 8.01.

Item 2: APPLICANT'S NAME AND MAILING ADDRESS See Section 8.02.

W1 Draft NUREG - 1556, Vol.12

APPENDIX W Item 3: LOCATIONS OF USE See Section 8.03. l 1

Item 4: PERSON TO BE CONTACTED ABOUT APPLICATION See Section 8.03.

Items 5 and 6: RADIOACTIVE MATERIALS AND USES Identify the materials you wish to be authorized to distribute to NRC's and the Agreement States' medical use licensees. The regulatory require ments and the subse is needed are different for radioactive drug and for sealed source licenses. quent information t For radioactive drugs, specify the radionuclide and chemical form (for generators, specify the parent and daughter radionuclides and the name and model number, if appropriate, of the 1 generator).

For sealed sources, specify the radionuclide, manufacturer's name and model number of each source, the maximum activity in each source, and the anticipated use of the sources. The NRC needs to know the anticipated use of the source to perform its safety evaluation. If the sealed sources are usuall used in a device (e.g., bone mineral analyzer), specify the manufacturer's name and the mo el number of the device.

The following examples show appropriate responses to Items 5 and 6.

Radioactive Druns:

Chromium-51 as Sodium Chromate Molybdenurn-99 as Molybdenum-99/ Technetium-99m Generator (Model MTG-1)

Sealed Sources:

Cesium-137, XYZ Corp., Model 1234 Maximum activity per source: 100 Ci To be used by medical use licensees as dose calibrator reference sources as authorized in 10 CFR 35.57.-

Strontium-90, ABC Corp., Model 567 Maximum activity per source: 150 millicuries To be used as a strontium-90 beta eye applicator for treatment of superficial eye conditions.

Iodine-125, FGH Corp., Model 890 Maximum activity per source: 300 millicuries To be used in an FGH Corp. Model BMA-1 device for bone mineral analysis.

Item 7 INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE Enter " Not Applicable;" see Section 8.07.

Item 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING I RESTRICTED AREAS  !

Enter "Not Applicable;" see Section 8.08. i Item 9 FACILITIES AND EQUIPMENT {

Enter "Not Applicable;" see Section 8.09 Draft NUREG - 1556, Vol.12 W-2

F APPENDIX W Item 10 RADIATION SAFETY PROGRAM Accordin to 10 CFR 32.72 and 32.74, certain radiation safety information must be submitted regardin icensed material to be distributed to medical use hcensees. The information to be submitt for each type oflicensed material to be distributed to medical use licensees is identified in the following sections.

Item 10.1 Radioactive Drugs If you wish to distribute radioactive drugs to medical use licensees pursuant to 10 CFR 35.100, 35.200, or 35.300 and to commercial nuclear pharmacy licensees, you need to provide the information identified below.

Item 10.1.1 Radioactive Drugs - Commercial Distribution According to 10 CFR 32.72(a)(2), you must provide evidence that you are registered or licensed with either the U.S. Food and Drug Administration (FDA) or a State agency as a drug manufacturer.

Item 10.1.2 Radioactive Drugs -Instrumentation According to 10 CFR 32.72(c), you must possess and use instrumentation to measure the radioactivity in dosages of alpha , beta , or ahoton-emitting radioactive drugs prior to transfer for commercial distribution. Applicants shoulc describe (1) the methods used to measure the radioactivity in dosages of radioactive drugs, (2) the instrumentation that will be used to measure this radioactivity, and (3) the instrumentation calibration procedures (e.g., accuracy, linearity, geometry dependency, constancy testing). Measurements may be made by direct measurement or a combination of direct measurement and calculation.

Item 10.1.3 Radioactive Drugs - Packaging and Shielding Licensing Criteria According to 10 CFR 20.1101(b), you must use, to the extent practicable, procedures and engineering controls based upon sound radiation protection pnneiples to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

According to 10 CFR 32.72(a)(3), you must agree to provide shielding for the product that is adequate for safe handling and storage by medical use licensees.

For each radioactive drug you intend to distribute, you should:

1. Specify the radionuclide and its chemical and physical form;

2. State the maximum activity per type of container (vial, syringe, generator, or other container of the radioactive drug);

3. Describe the type and thickness of shielding that you will provide for each type of container; and

4. Indicate the maximum radiation dose rate to be expected at the surface of each transport i radiation shield when the radioactive drug container is filled with the maximum activity.

W-3 Draft NUREG - 1556, Vol.12

APPENDIX W The reg jations in 10 CFR 32.72(a)(3) relate to information necessary for safe handling and

. storage of the final source container by medical use licensees, so it is not acceatable for you to .

say only that you will comply with Department of Transportation (DOT) re gulations. DOT regulations apply to shipping. The dose rate limits of DOT regulations app.y to the surface of the package, not the surface of the shielded syringe or vial containing the radioactive drug.

Item 10.1.4 Radioactive Drugs - Licensing Criteria for Labeling Your product labeling must fulfill the requirements of 10 CFR 20.1901 and 20.1904 and

- 10 CFR 32.72(a)(4) except for the exemptions in 10 CFR 20.1905.

Radioactive drug containers must be labeled in compliance with 10 CFR 20.1904 and 20.1905 and 10 CFR 32.72(a)(4).

In order to meet the req uirements in 10 CFR 32.72(a)(4)(i), you must agree to label each transport radiation shield to show the radiation symbol and the words " CAUTION, RADIOACTIVE MATERIAL" OR " DANGER, RADIOACTIVE. MATERIAL;" the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. The." transport radiation shield" could be constructed oflead glass, plastic, or other material, as appropriate for the isotope to be transferred for commercial distribution. The phrase

" transport rac iation shield" does not refer to the outer suitcase, package, packing, or other carrymg device, even though that barrier may provide some radiation shielding. Also, the radiation symbol must be the'same as described in 10 CFR 20.1901.

In order to meet the requirements in 10 CFR 32.72(a)(4)(ii), you must agree to label each syrin3e, vial,'or other container (e.g , generators or am ules) used to hold radioactive drugs to be transterred for commercial distribution to show the ra[ation symbol and the words " CAUTION, RADIOACTIVE MATERIAL" OR " DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures the syringe. vial, or other container can be correlated with the information on the transport radiation shield label. The radiation symbol must be the same as described in 10 CFR 20.1901. Acceptable identifiers may include, but are not limited to, the lot number or the name of the radioactive drug or its abbreviation.

Item 10.1.5 Generators - Ret' urn Program Some licensees offer a generator return program. In this program, customers may return used or spent genera' ors to the icensee. Experience has shown that customers who do not ship radioactive materials frequently may not be familiar with the DOT regulations govermng such

.. shipments; the manufacturer's or distributor's instructions to customers have not been sufficiently detailed for these inexperienced shippers. As a result, when some spent generators were shimped back to the manufacturer or distributor, the shipment was not in accordance with applicab' e regulations. ,

j a

. Draft NUREG - 1556, Vol.12. W-4

1 l

APPENDIX W Item 10.1.5.1 Licensing Criteria If you wish to offer a generator retum program, the instructions (including instructions on l labeling and shipping documents) you have developed and will supply to your customers should )

be sufficiently detailed to ensure that the shipper can comply.with 10 CFR 71.5 and with DOT  !

1 regulations. As a minimum, these instructions are to:

1. Establish the user's responsibility and liability as the shipper;

2. Provide step-by-step instructions for completing each item on each form and label that is involved in the shipping process; and

3. Discuss all the customer's responsibilities as a shipper under 49 CFR Parts 170 to 189.

Item 10.1.5.2 Return Program Procedures If you do not plan to offer a generator return program, so state; no additional information is necessary. However, if you plan to ofter a generator return program, copies or facsimiles of all forms, labels, and instructions you will provide to customers for shipping the spent generators back to your facility should be provided. To avoid the problems expenenced in the past by inexperienced shippers, you should ensure your instructions achieve the objectives outlined in items 1 through 3 above. The discussion of the customer's responsibilities mentioned in item 3 should include (but is not limited to):

. The requirements for surveying and wipe-testing the packages; l

• The distance at which to survey packages;

• The action levels for the package wipe-test results;

• The dose rate limitations on the particular shipping label that you provide; and

• The need for sealing tape or another mechanism to fulfill the security seal (tamper-indicating) requirement.

Item 10.2 Sealed Sources -

If ou intend to distribute sealed sources to medical use licensees, provide the information id ntified below.

Item 10.2.1 Sealed Sources in Devices - Licensing Criteria for Evaluation of Design and Construction According to 10 CFR 32.74(a)(2)(i) to (vii), you must provide information that each sealed source (and device, if appropriate) to be distributed to medical use licensees is designed and constructed to ensure contamment of the radioactive material during normal use anct likely accident situations. Both 10 CFR 32.74(a) and 32.210 require applicants to submit details of c uality control procedures to ensure that production sources and devices meet the standards of tie design and prototype test.

Applicants who request leak-test intervals of more than 6 months (as permitted by 10 CFR 32.74(b)) must justify the longer time interval based on (1) the performance of the sealed sources, devices, or similar sources or devices, and (2) the design features that reduce the probability or consequences ofleakage.

W-5 Draft NUREG - 1556, Vol.12

1 APPENDIX W For xeht licensees,ype of sealed source (and device, if appropriate) to be distributed to medical use you should submit evidence that the source or device is either currently registered with NRC under 10 CFR 32 210 or an Agreement State, or it is currently under review by NRC or an Agreement State. (The information needed in support of a request for review of a sealed source or device may be submitted with the request for a medical distribution license. Include your request with your response to this item.)

NUREG-1556, Volume 3 " Applications for Sealed Source and Device Evaluation and Registration," July 1998 may be used by applicants who wish to submit a source or device design for a safety evaluation and registration. This safet evaluation is required by 10 CFR 32.74 prior l to the source or device being approved for distrib ion and use. The NUREG contains information on several areas:

1

• Applicable regulations;

• Information on filing an application, including where to file, how to determine the fees associated with the evaluation, how to handle proprietary information, other a be involved in the review process, and applicable transportation regulations; gencies tha Information that should be included in the application and suggestions on the format in which the information should be arranged;

• Amendments to current registration certificates; {

. The responsibility of the registrant once the safety evaluation has been performed and a registration certificate has been issued.

The NUREG contains a checklist that may be used by applicants to ensure their submission is complete.

Applicants for registration of sources or devices may submit a quality assurance program instead of, or in conjunction with, guality control procedures. The quality assurance program should provide control over all activities applicable to the design, fabrication, inspection, testing, maintenance, air, modification, and distribution of the source or device. Regula Guide 6.9,

" Establishing lity Assurance Programs for the Manufacture and Distribution of S aled Sources and Devices Containing Byproduct Material," provides information necessary to establish and implement a quah,ty assurance program that encompa.9ses all the ' quality assurance and quality control provisions needed for the manufacture and distribution of a source or device.

Item 10.2.2 Scaled Sources -Labeling Item 10.2.2.1 Licensing Criteria Your product labeling must fulfill the requirements of 10 CFR 20.1901,20.1904,20.1905 and of 10 CFR 32.74(a)(2)(viii) and 32.74(a)(3).

A label, leaflet, or brochure accompanying the sealed source or device must contain a?pr,opriate instructions from a radiation safety standpoint for handling and storing the source or c evice. For example, the instructions ma pecify the use of extremity monitors, the use of tongs or other devices to pick up sources, storage within auxiliary shielding, and any special (rather than bare han seeds). procedures needed in the handling and sterilizing of" fragile" sources (e.g., iodineI A label, leaflet, or brochure must also contain the licensing statement required by 10 CFR 32.74(a)(3). For sources, the statement should read, "The (name of source or device) is Draft NUREG - 1556, Vol.12 W-6

APPENDIX W licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to [10 CFR 35.57,35.400, or 35.500] or under equivalent licenses of Agreement States."

For each type of sealed source or device you intend to distribute, you should:

1. Submit copies or facsimiles of the labels that will accompany the product and specify where each label will be placed (e.g., on the device, on the source shield); and

2. Submit copies of all leaflets and brochures that will accompany the product.

For each type of source or device to be distributed, you should provide a copy of correspondenc(

to and from the FDA that clearly shows that the FDA finds the source or device to be safe and effective or "substantially equivalent" to sources or devices offered for sale in the United States before May 1976. (Note: An NRC registration will not be issued unless the applicant has submitted to the NRC a substantially equivalent letter pursuant to Section 510(K) of the Food, Drug, and Cosmetic Act, as amended, or a similar indication of premarketing approval by FDA.)

' Devices and sources used in conjunction with medical applications involving computers and patient planning systems are within FDA jurisdiction and must also have a substantially equivalent letter pursuant to Section 510(k) of the Food, Drug, and Cosmetic Act, as amended, or a similar indication of premarketing approval by FDA.

Item 10.2.2.2 FDA and NRC Coordination.

FDA and NRC signed a Memorandum of Understanding on August 26,1993, to coordinate existing FDA and NRC regulatory programs for medical devices, drugs, and biological products that make use of byproduct, source, or s 3ecial nuclear materials. The principal statute under which the FDA -egulates devices is the ?ood, Drug and Cosmetic Act, as amended by the Safe Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical Devices Act of 1992.

Under the Memorandum of Understanding, the agencies agree to promptly inform each other whenever they receive a report or otherwise become aware of potential public health problems involving products of mutual regulatory concern. Further, the agencies will share information to the extent aracticable. For the NRC's Office of Nuclear Materials Safety and Safeguards (NMSS), t ais includes information on the design, manufacture, testing, quality assurance and control, etc., used by FDA and NRC for its product approval.

Item 10.2.3 Sealed Sources-Return Program and Device Service Item 10.2.3.1 Experience with Returns Some licensees offer a source return program or a device service or both. In this program, customers may return unused sources for credit or may return used sources or devices, for disposal, service, or replacement. Similar programs have been offered by manufacturers of other products. Experience with these other products indicates that customers who do not ship radioactive materials frequently are often not familiar with Department of Transportation (DOT)

. regulations governing such shipments. Unless the manufacturer's or distributor s instructions to customers were sufficiently detailed for these inexperienced shippers, some shipments were not in accordance with applicable regulations. Similar problems may arise with sealed sources or devices that are being returned.

W-7 Draft NUREG - l$56, Vol.12

APPENDIX W Item 10.2.3.2 Licensing Criteria If you do not plan to offer a source return program or device service, so state; no additional information is necessary. However, if you offer a source return program or device service, you must have developed and must supply to your customers sufficiently detailed instructions (including instructions on labeling and shipping documents) to ensure that the shipper can comply with 10 CFR 71.5 and with DOT regulations. You must also submit to NRC copies or facsimiles of all forms, labels, and instructions that you will provide to customers for shipping sources back to your facility. As a minimum, the instructions must:

1. ' Establish the user's responsibility and liability as the shipper;

2. Provide step-by-step instructions for completing each item on each form and label that is involved in the shipping process; and

3. Discuss all the customer's responsibilities as a shipper under 49 CFR Parts 170 to 189.

This discussion of the customer's responsibilities should include (but is not limited to):

The requirements to survey and wipe-test packages; The distance at which to survey packages; The action levels for the package wipe-test results;

. The dose rate limitations on the particular shipping label that you will f.rovide; and

. The need for sealing tape or another mechanism to fulfill the security seal requirement.

Item 10.2.4 ' Calibration of Reference Sources --- Compatibility with 10 CFR 35.57 Licensing Criteria You must request authorization to distribute calibration or reference sources that are described in 10 CFR 35.57. These calibration or reference sources must not exceed the activity limits of 10 CFR 35.57, and according to 10 CFR 32.74, you must confirm this in your license application.

If a source to be distributed contains byproduct material exceeding the activity limits of.

10 CFR 35.57, source material, or special nuclear materials, it may not be distributed to medical licensees under the provisions of 10 CFR 35.57. In such cases, medical use licensees may purchase such sources only if their licenses specifically authorize possession and use of them. In these cases, you may not use a license issued under 10 CFR 32.74 to distri'uute the sources; rather, you need a license issued pursuant to 10 CFR Part 30,40, or 70, as appropriate, that authorizes you to distribute such sources to your proposed customers.

Item 11 WASTE MANAGEMENT Enter "Not Applicable;" see Section 8.11.

Item 12 LICENSE FEES See Section 8.12.

Item 13. CERTIFICATION i See Section 8.13. l l

Draft NUREG - 1556, Vol.12 W-8

1 APPENDIX W TERMINATION OF ACTIVITIES I See Section 11.

The distribution license does not authorize the possession and use of byproduct material.

Therefore, termination of your distribution license only requires a letter notifying NRC of the termination. If you are also terminating your possession license,10 CFR 30.36(b) requires that a licensee notify the NRC promptly and request termination of the license. This notification normally requires (1) a completed form NRC-314," Certificate of Disposition of Materials,"

certifying that all sources have been disposed of properly and (2) the results of a final radiation survey of the premises where the licensed activities were carried out.

1 l

W-9 Draft NUREG - 1556, Vol.12

NRC FORM 335 u.s. NUCLEAR REluLATORY COMM2slON 1. REPORT NUMBER Q 89)

(Assigned by NRC. Add Vol Supp.,Rev.,

E7 El!LIOGRAPHIC DATA SHEET '"'*"*"""""***"*"N (see matructens on me ren<n)

NUREG 1556

2. TITLE AND SUBTITLE Volume 12 Consolidated Guidance About Materials Licenses Program-Specific Guidance Abou t Possession Licenses for Manufacturing and Distribution 3. DATE REPORT PUBLISHED MONTH YEAR l

Draft for comment July 1999

4. FIN OR GRANT NUMBER

3. AltrHOR(S) 6. TYPE OF REPORT R. E. Zelac, D. J. Collins, C. F. Gill, L. Manning, Ill, M. E. Schwar'.2 Draft

7. PERIOD COVERED (inclus;w ostes)

B. O N O ANLZATION - NAME AND ADDRESS (19NRC. pmmon DMsm Othce or Regan, V5. Nuc6ar Reguntary Commossm and mailng adeess; dcontractor, Office of Nuclear Material Safety and Safeguards Division of industrial and Medical Nuclear Safety US Nuclear Regulatory Commission Washington, DC 20555-0001

9. SPONSONNG ORGANIZATION NAME AND ADDRESS (It NRc. type Same as abon) M contractor, pmvbs NRC Dwson, omce or Regan, US. duckerRogustory Commossen. t and maeng address)

Same

10. SUPPLEMENTARY NOTES

11. ABSTRACT (200 words a ess) i As part of its redesign of the materials licensing process, NRC is consolidatin g 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 a nd Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG 1556, Vol.12, 'C onsolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturin g and Distdbution," dated July 1999, is the twelth program-specific guidance document developed for the new process and is intended for use by applicants, licensees, tnd NRC staff, and will also be available to Agreement States. This draft rep ort takes a more risk-informed, performance +ased approach to licensing for manufacturing and distribution, and reduces the information (amount and level of detail) needed to support an application. Note that this document is strictly for public comment and is not for use in preparing or reviewing applications until it is published in final form.

12. KEY WORDS/DESCRIPTORS (ust wwds orphases eat wirassest reseseers a bestog me report.) 13. AVAILABluTY STATEMENT a au

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9 n Sealed Source rThis Page) unclassified (This Report) unclassified

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